Tobacco Documents Online

5 3 1 PURPOSE 2 SEC. 3. It is the purpose of this Act to provide a new 3 strategy to educate and provide information to the American 4 public that will allow individuals to make informed decisions 5 concerning smoking. 6 SMOKING RESEARCH, EDUCATION, AND INFORMATION 7 SEC. 4. (a) Title XVII of the Public Health Service Act 8 is amended by adding at the end thereof the following new 9 section: 10 "SMOKINO AND HEALTH 11 "SEC. 1711. (a) The Secretary shall establish and carry 12 out a program to inform the public of the dangers to health 13 from cigarette smoking. In carrying out such program, the 14 Secretary shall- 15 "(1) coordinate all activities of the Department 16 which relate to smoking and its effects on health, in- 17 cluding research and demonstration projects and educa- 18 tional activities; 19, "(2) through the Interagency Committee on 20 Smoking and Health established under subsection (b), 21 coordinate the activities referred to in clause (1) of this 22 subsection with all other activities of the Federal Gov- 23 ernment which relate to smoking and its effects on 24 health; S. 1sx9-ie

COMPREHENSIVE SMOKING PREVENTION EDUCATION ACT OF 1981 HEARING BEFORE THE COMMITTEE ON LABOR AND HUMAN RESOURCES UNITED STATES SENATE NINETY-SEVENTH CONGRESS SECOND SESSION ON S. 1929 TO AMEND THE PUBLIC HEALTH SERVICE ACT AND THE FED- ERAL CIGARETTE LABELING AND ADVERTISING ACT TO IN- CREASE THE AVAILABILITY TO THE AMERCAN PUBLIC OF INFORMATION ON THE HEALTH CONSEQUENCES OF SMOKING AND THEREBY IMPROVE INFORMED CHOICE, AND FOR OTHER PURPOSES MARCH 16, 1982 Printed for the use of the Committee on Labor and Human Resources U.S. GOVERNMENT PRINTING OFFICE Db-077 O WASHINGTON : 1982

4 2 1 FINDINGS 2 SEC. 2. The Congress finds that- 3 (1) cigarette smoking is the largest preventable 4 cause of illness and premature death in the United 5 States, and is associated with the unnecessary deaths 6 of over three hundred thousand Americans annually; 7 (2) smoking is the primary cause of lung cancer 8 and emphysema in the United States, and is associated 9 with other cancers; 10 (3) heart disease accounts for nearly one-half of 11 the deaths in the United States, and one-third of the 12 deaths attributable to heart disease are associated with 13 smoking; 14 (4) the risks of miscarriage, stillbirths, premature 15 births, and child weight deficiencies for pregnant 16 women who smoke are higher than for pregnant 17 women who do not smoke; 18 (5) certain occupational hazards, in conjunction 19 with smoking, increase substantially the risk of disease 20 and death; and 21 (6) present Federal, State, and private initiatives 22 have been insufficient in conveying to the American 23 public the information contained in clauses (1) through 24 (5) of this section and other information regarding 25 smoking. S. 1929-is 5 3 1 PURPOSE 2 SEC. 3. It is the purpose of ti 3 strategy to educate and provide infc 4 public that will allow individuals to 5 concerning smoking. 6 SMOKING RESEARCH, EDUCATIO 7 SEC. 4. (a) Title XVII of the I 8 is amended by adding at the end t' 9 section: 10 "SMOKING AND H 11 "SEC. 1711. (a) The Secretar3 12 out a program to inform the public 13 from cigarette smoking. In carryin 14 Secretary shall- 15 "(1) coordinate all actiN 16 which relate to smoking and 17 cluding research and demonsti 18 tional activities; 19. "(2) through the Intc 20 Smoking and Health establis: 21 coordinate the activities referr 22 subsection with all other actiN 23 ernment which relate to sm 24 health; O W ~ O ~ C11 S. 1929-ie W N

9 7 1 "(C) 'WARNING: The Surgeon General has De- 2 termined that Cigarette Smoking Causes Heart Dis- 3 ease.'. 4 "(D) 'WARNING: The Surgeon General has De- 5 termined that Cigarette Smoking by Pregnant Women 6 May Result in Miscarriage, Premature Births, or Child 7 Weight Deficiencies.'. 8 "(E) 'SMOKERS: No Matter How Long You 9 Have Smoked, Quitting Now Greatly Reduces The 10 Risks To Your Health.'. 11 "(2) The labeling statements specified in paragraph (1) 12 of this subsection shall be rotated on the packages of each 13 brand of cigarettes and the advertisements for each brand of 14 cigarettes in a manner that assures that each of such labeling 15 statements appears an equal number of times on each brand 16 of cigarettes and all such advertisements within the fifteen- 17 month period beginning on the effective date of this subsec- 18 tion and each succeeding fifteen-month period. 19 "(3) Any labeling statement required under this subsec- 20 tion shall be located in a conspicuous place on every cigarette 21 package and in each advertisement for cigarettes, and shall 22 appear in conspicuous and legible type in contrast by typog- 23 raphy, layout, or color with all other printed material on the 24 package or advertisement.

6 4 1 "(3) through the Interagency Committee on 2 Smoking and Health established under subsection (b), 3 coordinate the activities of the Federal Government re- 4 ferred to in clauses (1) and (2) of this subsection with 5 similar activities in the private sector; 6 "(4) conduct research and develop new methods 7, for informing the public of the effects of smoking on 8 health, either independently or in conjunction with the 9 private sector, for use in a national effort; 10 "(5) collect, analyze, and disseminate information, 11 studies, and other data related to smoking and its ef- 12 fects on health; 13 "(6) make available, through specific publications 14 and bibliographic and reference materials, information 15 on research efforts relating to smoking and its effects 16 on health; and 17 "(7) undertake any other additional informational 18 and research activities which the Secretary determines 19 necessary and appropriate. 20 In carrying out the requirements of this subsection, the Sec- 21 retary shall seek to develop methods of communication with 22 Federal, State, and local entities, as well as with the private 23 sector. 24 "(b)(1) To carry out the activities described in clauses 25 (2) and (3) of subsection (a), there is established an Inter- 7 5 1 agency Committee on Smoking and Heq 2 shall be composed of- 3 "(A) representatives from ai 4 and agencies of the Department, 5 the National Heart, Lung, and Bloc 6 tional Cancer Institute, the Nationt 7 Health and Development, the Heal 8 istration, the Health Resources Adn 9 Center for Disease Control; and 10 "(B) at least one representatiN 11 Trade Commission, the Departmen 12 Department of Labor, and any otl 13 designated by the Secretary. 14 "(2) The Committee shall meet at lf 15 year. 16 "(c) The Secretary shall transmit a 17 not later than January 1 of each year wl 18 "(1) current information on thc 19 on health; - 20 "(2) an overview and assessme 21 ities undertaken to inform the publ 22 smoking on health; 23 "(3) information regarding th 24 private sector with respect to the ef 25 health; and S. 1929-1a r7 S S. 1929-ie

CONTENT Text of: S. 1929 ........................................................................ CHRONOLOGICAL LIST OF COMMITTEE ON LABOR AND HUMAN RESOURCES ORRIN G. HATCH, Utah, Chairman ROBERT T. STAFFORD, Vermont DAN QUAYLE, Indiana PAULA HAWKINS, Florida DON NICKLES, Oklahoma LOWELL P. WEICKER, JR., Connecticut GORDON J. HUMPHREY, New Hampshire JEREMIAH DENTON, Alabama JOHN P. EAST, North Carolina EDWARD M. KENNEDY, Massachusetts JENNINGS RANDOLPH, West Virginia HARRISON A. WILLIAMS, JR., New Jersey CLAIBORNE PELL, Rhode Island THOMAS F. EAGLETON, Missouri DONALD W. RIEGLE, JR., Michigan HOWARD M. METZENBAUM, Ohio GeoaGe W. Parrrs, JR., Chief Counsel Rnvrr M. PATet[, Staff Director and General Counsel LAwasxcE C. Hoxowrrz, M.D., Minority Staff Director cnl TUESDAY, MARCH 16, Packwood, Hon. Bob, a U.S. Senator from the State Brandt, Edward N., Jr., M.D., Assistant Secretary Service, Department of Health and Human Serv Everett Koop, Surgeon General, U.S. Public HeE Luoto, Acting Director, Office of Smoking and Hf Pollin, William, M.D., Director, National Institute, Holbrook, John H., M.D., associate professor, Un Medicine ........................................................................ LeMaistre, Charles A., M.D., president, Universit_ Hospital and Tumor Institute, on behalf of._the Health .....................................................................:...... Horrigan, Edward A., Jr., chairman and chief exec Tobacco Co., on behalf of the Tobacco Institute, iard, assistant professor of marketing, Ohio S senck, professor of psychology, Institute of London; Sheldon C. Sommers, scientific directo search ...................................................................:........ STATEMENTS American Cancer Society, the, prepared statement American Heart Association, John A. Oates, M.I on smoking, prepared statement ............................. American Lung Association, prepared statement ... Brandt, Edward N., Jr., M.D., Assistant Secretary Service, Department of Health and Human Sen Everett Koop, Surgeon General, U.S. Public He: Luoto, Acting Director, Office of Smoking and H Prepared statement ............................................... Eysenck, H. J., Ph. D., S.Sc., professor of psycholc University of London, prepared statement........... Hawkins, Hon. Paula, a U.S. Senator from the statement ............................................................::....... Holbrook, John H., M.D., associate professor, Un Medicine ....................................................................... Prepared statement ............................................... Horrigan, Edward A., Jr., chairman and chief exec Tobacco Co., on behalf of the Tobacco Institute, iard, assistant professor of marketing, Ohio S senck, professor of psychology, Institute of London; Sheldon C. Sommers, scientific direct< search ........................................................................... Prepared statement ............................................... Huddleston, Hon. Walter D., a U.S. Senator frc prepared statement .................................................... am

2 cigarettes. It causes chronic disease, premature death, and billions of dollars of lost productivity every year. In fact, this legislation enjoys endorsement from virtually every major health and medical professional organization concerned with public health. I am not interested in legislating health, in telling people how to live their personal lives. I am particularly not interested in having the Federal Government step in if a problem can be solved in the private sector, as it usually can. But I am convinced that the health consequences of smoking are of such magnitude, and that the public is sufficiently unaware of these problems, that we need another major national effort to help our citizens make informed choices about their health. It is not Government regulation, but more public education, I have in mind. I agree with former Assistant Secretary of Health, Dr. Ted Cooper, when he said, "We will achieve the greatest good not through absolute bans, but by giving our people the knowledge nec- essary to make rational and informed personal decisions." That is why Senator Packwood and I have introduced the Com- prehensive Smoking Prevention Education Act. Senator Packwood, of course, is with us today, and I am grateful to have him here. He is chairman of the Senate Commerce Committee. We introduced this bill on December 9, 1981. This bill is designed to stimulate a cooperative effort with the private sector to provide health education on smoking. We would -like the Federal Government to continue the activities of the Office of Smoking and Health, which does a commendable job in coordi- nating and disseminating smoking related information. The stimu- lus and support that this legislation can provide will further aug- ment these admirable efforts. In addition, our bill asks the tobacco industry to rotate the mes- sages on the warning labels already mandated by the Federal Ciga- rette Labeling and Advertising Act. These new labels would inform our smoking population not only of cigarettes' causal link with cancer of the lung, but also with emphysema, a chronic lung dis- ease which causes a slow and agonizing death and disables over 1 million Americans. Other labels will indicate that cigarettes cause heart disease, and may cause miscarriages or premature births. To- bacco manufacturers will also be asked to provide information re- garding the chemical additives used as flavor enhancers so that our scientists can determine if these chemicals aren't possibly as cancer-causing as tobacco itself. [The text of S. 1929 follows:] 3 97TH CONGRESS 1ST SESSION S*1929 To amend the Public Health Service Act and the Feder Advertising Act to increase the availability to the mation on the health consequences of smoking and choice, and for other purposes. IN THE SENATE OF THE UNIT] DECEMBER 9 (legislative day, NoVEMBEE Mr. HATCH (for himself and Mr. PACItx'oOD) introduced was read tw-ice and referred jointly by unanimous co on Commerce, Science, and Transportation and Labo A BILL To amend the Public Health Service Act Cigarette Labeling and Advertising Ac availability to the American public of ii health consequences of smoking and th( formed choice, and for other purposes. 1 Be it enacted by the Senate and Hot 2 tiaes of the United States of America in Cc 3 That this Act may be cited as the "Compr 4 Prevention Education Act of 1981".

CONTENTS I Text of S. 1929 .................................................................................................... ..................... Page 3 CHRONOLOGICAL LIST OF WITNESSES ' TUESDAY, MARCH 16, 1982 Packwood, Hon. Bob, a U.S. Senator from the State of Oregon ............................. 13 Brandt, Edward N., Jr., M.D., Assistant Secretary for Health, Public Health Service, Department of Health and Human Services, accompanied by Dr. C. Everett Koop, Surgeon General, U.S. Public Health Service and Dr. JoAnn Luoto, Acting Director, Office of Smoking and Health ........................................ 6 Pollin, William, M.D., Director, National Institute on Drug Abuse ...................... 48 Holbrook, John H., M.D., associate professor, University of Utah College of Medicine .................................................................................................... ..................... 71 LeMaistre, Charles A., M.D., president, University of Texas M. D. Anderson Hospital and Tumor Institute, on behalf of the Coalition on Smoking OR Health .................. :................................................................................................... ....... .......................................... 81 Horrigan, Edward A., Jr., chairman and chief executive officer, R. J. Reynolds Tobacco Co., on behalf of the Tobacco Institute, accompanied by Paul Min- iard, assistant professor of marketing, Ohio State University; Hans Ey- senck, professor of psychology, Institute of Psychiatry, University of London; Sheldon C. Sommers, scientific director, Council for Tobacco Re- search .................................................................................................... ......................... 36 STATEMENTS American Cancer Society, the, prepared statement .................................................. 121 American Heart Association, John A. Oates, M.D., chairman, subcommittee on smoking, prepared statement ............................................................................... 109 American Lung Association, prepared statement ..................................................... 99 Brandt, Edward N., Jr., M.D., Assistant Secretary for Health, Public Health Service, Department of Health and Human Services, accompanied by Dr. C. Everett Koop, Surgeon General, U.S. Public Health Service and Dr. JoAnn Luoto, Acting Director, Office of Smoking and Health ........................................ 6 Prepared statement ................................................................................................. 30 Eysenck, H. J., Ph. D., S.Sc., professor of psychology, Institute of Psychiatry, University of London, prepared statement ............................................................. 155 Hawkins, Hon. Paula, a U.S. Senator from the State of Florida, prepared statemen t .................................................................................................... ................... 18 Holbrook, John H., M.D., associate professor, University of Utah College of Med icine .................................................................................................... ..................... 71 Prepared statement ................................................................................................. 74 Horrigan, Edward A., Jr., chairman and chief executive officer, R. J. Reynolds Tobacco Co., on behalf of the Tobacco Institute, accompanied by Paul Min- iard, assistant professor of marketing, Ohio State University; Hans Ey- senck, professor of psychology, Institute of Psychiatry, University of London; Sheldon C. Sommers, scientific director, Council for Tobacco Re- search .................................................................................................... ......................... 36 Prepared statement ................................................................................................. 14 0 Huddleston, Hon. Walter D., a U.S. Senator from the State of Kentucky, prepared statement .................................................................................................... .. 20 (III)

10 11 8 9 1 "(4) In accordance with the provisions of section 553 of 2 title 5, United States Code, the Federal Trade Commission 3 shall establish by rule a system to ensure that labeling state- 4 ments required under this subsection are rotated in accord- 5 ance with the provisions of paragraph (2) of this subsection, 6 and that at any time each of the five labeling statements 7 appears on at least 15 per centum of all cigarette packages 8 and advertising. 1 Health and Human Services a complete 2 additive used in the manufacture of suc 3 quantity of such additive. 4 "(2) The Federal Trade Commissi 5 ment of Health and Human Services an 6 ployee thereof shall not disclose to any 7 Commission or the Department any infori 8 suant to paragraph (1). 9 "(b)(1) It shall be unlawful for any person to manufac- 9 "(3) For purposes of section 552(b)i 10 ture, import, or package for sale or distribution within the 11 United States any cigarettes, the package of which fails to 12 disclose the level of- 13 "(A) tar; 14 "(B) nicotine; and 10 States Code, and section 1905 of title 11 Code, any information received by the I 12 mission and the Department of Health a 13 pursuant to paragraph (1) shall be consi 14 secret.". 15 "(C) carbon monoxide, 16 contained in such cigarettes. 15 16 PREEMPTION SEC. 6. Section 5(a) of the Federal 17 "(2) Such tar, nicotine, and carbon monoxide levels 17 and Advertising Act (15 U.S.C. 1334(a)) 18 shall be based on the results of the most recent tests of ciga- 18 (1) by striking out "statement' 19 rettes by the Federal Trade Commission. The Federal Trade 19 pears and inserting in lieu thereof 20 Commission shall perform such tests at least on an annual 20 (2) by inserting before the pe ~ ' 21 basis. 21 . "or in any cigarette advertising 22 ."(e)(1) It shall be unlawful for any person to manufac- 22 EFFECTIVE DATE 23 ture, import, or packagee for sale or distribution within the 23 SEO. 7. (a) Except as provided in 24 United States any cigarettes unless such person has provided 25 to the Federal Trade Commission and the Department of 24 provisions of this Act shall take effect or 25 ment. ~ W ~.r:~ S. 1929-is wr 95-077 0-62--2

COMPREHENSIVE SMOKING PREVENTION EDUCATION ACT OF 1981 TUESDAY, MARCH 16, 1982 U.S. SENATE, COMMITTEE ON LABOR AND HUMAN RESOURCES, Washington, D.C. The committee met, pursuant to notice, at 9:30 a.m., in room 4232, Dirksen Senate Office Building, Senator Orrin Hatch (chair- man of the committee) presiding. Present: Senators Hatch and East. Also present: Senator Packwood. OPENING STATEMENT OF SENATOR HATCH The CHAIRMAN. The committee will be in order. It is a pleasure for me to welcome you here today to these full committee hearings devoted to the Comprehensive Smoking Pre- vention Education Act, S. 1929. As chairman of the Labor and Human Resources Committee, I have had the opportunity to learn a great deal about the health needs of our citizens. Over the past decade, there have been numerous Federal initiatives intended to meet these needs, all of which have worthy motives, but with a price tag which has proven to be more costly than the taxpayers can afford. Consequently, Congress is slowly but surely rediscovering a lost virtue. It is called prudence. And so now, in cooperation with Presi- dent Reagan, we are trying to target our resources and activities where they are likely to reap the most benefit, where they will give us the "biggest bang for the buck." In this regard, I have consulted with scientists and health profes- sionals within the public and private sector_for their recommenda- tions. I am impressed with their strong consensus favoring more emphasis on preventive medicine and health promotion. We simply cannot afford to spend the lion's share of our Federal health dollar on the treatment of disease, particularly when so many of the ill- nesses which cause death and disability are preventable. I speak here not only of the dollar costs but also of the human costs. Our Government's commitment to health prevention must therefore become more than sentimental lip service. Our comment should translate into action. The health of the American people de- pends on it. Our Nation's preeminent health experts agree that the mos worthwhile single effort we could make to improve the health o our citizens is to convince them of the harmfulness of smokin ' (1) .1 ~., ~ ~

8 6 1 "(4) such recommendations for legislation as the 9 1 7 "(C) 'WARNING: The Sur 2 Secretary may consider appropriate.". 3 (b) Section 8 of the Federal Cigarette Labeling and Ad- 4 vertising Act (15 U.S.C. 1337) is amended by striking out 5 subsection (a) and by striking out "(b)" before "The Federal 6 Trade Commission". 7 CIGARETTE LABELING 8 SEC. 5. Section 4 of the Federal Cigarette Labeling and 9 Advertising Act (15 U.S.C. 1333) is amended to read as fol- 10 lows: 11 "LABELING 12 "SEC. 4. (a)(1) It shall be unlawful for any person to 13 manufacture, import, or package for sale or distribution 14 within the United States, or advertise any cigarettes, the 15 package or advertisement for which fails to 16 following statements: bear one of the 17 "(A) 'Cigarette Smoking is Dangerous to Your 18 Health. For Information on the Specific Health Conse- 19 quences of Smoking, Write: Surgeon General, U.S. 20 Public Health Service, Washington, D.C., 20201.'. 21 "(B) 'WARNING: The Surgeon General has De- 22 termined that Cigarette Smoking Causes Emphysema, 23 Lung Cancer, and Other Cancers.'. 2 termined that Cigarette Smokir 3 ease.'. 4 "(D) 'WARNING: The Sur 5 termined that Cigarette Smoking 6 May Result in Miscarriage, Prem 7 8 9 10 11 Weight Deficiencies.'. °`(E) 'SMOgERS: No Ma Have Smoked, Quitting Now ( Risks To Your Health.'. "(2) The labeling statements spec 12 of this subsection shall be rotated on 13 brand of cigarettes and the advertisemt 14 cigarettes in a manner that assures that 15 statements appears an equal number oi 16 of cigarettes and all such advertisemei 17 month period beginning on the effectiv 1S tion and each succeeding fifteen-month ~ 19 "(3) Any labeling statement requir 20 tion shall be located in a conspicuous ph 21 package and in each advertisement for 22 appear in conspicuous and legible type 23 raphy, layout, or color with all other pr 24 package or advertisement. O w ~ 0 ~ ~ w ~

7 :zods ; on the ion, ef- ons ion cts ial ies 'c- th te 5 1 agency Committee on Smoking and Health. The Committee 2 shall be composed of- 3 "(A) representatives from appropriate institutes 4 and agencies of the Department, which may include 5 the National Heart, Lung, and Blood Institute, the Na- 6 tional Cancer Institute, the National Institute on Child 7 Health and Development, the Health Services Admin- 8 istration, the Health Resources Administration, and the 9 Center for Disease Control; and 10 "(B) at least one representative from the Federal 11 Trade Commission, the Department of Education, the 12 Department of Labor, and any other Federal agency 13 designated by the Secretary. 14 "(2) The Committee shall meet at least four times each 15 year. 16 "(c) The Secretary shall transmit a report to Congress 17 not later than January 1 of each year which shall contain- 18 "(1) current information on the effects of smoking 19 on health; 20 "(2) an overview and assessment of Federal activ- 21 ities undertaken to inform the public of the effects of 22 smoking on health; 23 "(3) information regarding the activities of the 24 private sector with respect to the effects of smoking on 25 health; and O W ~ ~ S. 1929-ia ~ ~

3 )illions ilation Iedical iow to iaving in the it the I that ~ need )rmed i, but . Ted d not e nec- Corn- wood, e. He luced i the vould )ffice )ordi- :imu- aug- mes- '.iga- form with dis- -er 1 ause .To- I re- our . as II 97TH CONGRESS 1ST SESSION So1929 To amend the Public Health Service Act and the Federal Cigarette Labeling and Advertising Act to increase the availability to the American public of infor- mation on the health consequences of smoking and thereby improve informed choice, and for other purposes. IN THE SENATE OF THE UNITED STATES DECEMBER 9(Ieglslative day, DIOVEMBEB 30), 1981 Mr. HATCH (for himself and Mr. PACKwooD) introduced the following bill; which was read twice and referred jointly by unanimous consent to the Committees on Commerce, Science, and Transportation and Labor and Human Resources A BILL To amend the Public Health Service Act and the Federal Cigarette Labeling and Advertising Act to increase the availability to the American public of information on the health consequences of smoking and thereby improve in- formed choice, and for other purposes. 1 Be it enacted by the Senate and House o f Representa- 2 tives of the United States of America in Congress assembled, 3 That this Act may be cited as the "Comprehensive Smoking 4 Prevention Education Act of 1981".

13 10 1 (b) The amendments made by sections 5 and 6 of this 2 Act shall take effect upon the expiration of the one-year 3 period beginning on the date of the enactment of this Act. 4 During such.one-year period, the Federal Trade Commission 5 shall promulgate such regulations as may be necessary to 6 implement the amendments made by sections 5 and 6 on 7 their effective date. 0 The CHAIRMAN. Today we are going to hear tes resentatives of the administration, from a panel c entists, and from a distinguished spokesman repr three" volunteer agencies, the American Can American Heart Association, and the American I I would like to take this opportunity to recogn Heart Association for their assistance in draftinj sive Smoking Prevention Education Act. We will also hear testimony from a representati Institute as well. The testimony presented today i: the health-related aspects of this bill. Senator Pac uled Commerce Committee hearings for May 10, tising and trade issues, and I might add, we arE have Senator Packwood join our committee today. Senator Packwood and myself, as I have mentic sponsored this legislation, and I certainly apprec terest in these hearings and welcome his participa Senator Packwood. STATEMENT OF HON. BOB PACKWOOD, A U.S. S THE STATE OF OREGON Senator PACxwooD. Mr. Chairman, thank you invitation to me and to all of the members of thc mittee to participate in this hearing on the bill are aware, the major purpose of this legislation sumers with more information about the advers, ing. As a member of the Commerce Committee, and man of that committee, I have long been concernE of unfair or deceptive product labeling in adve: particularly concerned about what I believe is i ness about the specific health hazards of smoking tising campaigns that target segments of the p( young adults. We all know that women who are pregnant ar birth control pills may be uniquely affected by : young adults may be unduly affected by advertisu The legislation, Mr. Chairman, that you and I has been condemned as an example of burdensc regulation and an abridgment of the first amenc Constitution. This could not be further from the on these subjects is clear. I have been a propone. in the communication industry, the transportat where there was a demonstrated need for a fre have supported that deregulation. I have also bc porter of civil liberties. But, in the marketplace of information, the An desperately in need of more information about th smoking in order to make a truly free and inform I look forward to hearing from the witnesses . morning and learning more about thJe health issues. Thank you. W ~ O ~ G1 44 0

17 "health informational problem." It involves deeper and broader matters than that. Thank you, Mr. Chairman. The CHAIRMAN. Well, thank you, Senator East. I know that you feel deeply about this, and we are happy to have you here. At this time, without objection, we will include the statements of Senators Hawkins and Huddleston in the record. [Material referred to follows:J 0

0 13 The CHAIRMAN. Today we are going to hear testimony from rep- resentatives of the administration, from a panel of outstanding sci- entists, and from a distinguished spokesman representing the "big three" volunteer agencies, the American Cancer Society, the American Heart Association, and the American Lung Association. I would like to take this opportunity to recognize the American Heart Association for their assistance in drafting the Comprehen- sive Smoking Prevention Education Act. We will also hear testimony from a representative of the Tobacco Institute as well. The testimony presented today is going to address the health-related aspects of this bill. Senator Packwood has sched- uled Commerce Committee hearings for May 10, regarding adver- tising and trade issues, and I might add, we are very grateful to have Senator Packwood join our committee today. Senator Packwood and myself, as I have mentioned, have jointly sponsored this legislation, and I certainly appreciate his active in- terest in these hearings and welcome his participation. Senator Packwood. STATEMENT OF HON. BOB PACKWOOD, A U.S. SENATOR FROM THE STATE OF OREGON Senator PACKWOOD. Mr. Chairman, thank you for extending an invitation to me and to all of the members of the Commerce Com- mittee to participate in this hearing on the bill before us. As you are aware, the major purpose of this legislation is to provide con- sumers with more information about the adverse effects of smok- ing. As a member of the Commerce Committee, and now as the chair- man of that committee, I have long been concerned with the effects of unfair or deceptive product labeling in advertising, and I am particularly concerned about what I believe is inadequate aware- ness about the specific health hazards of smoking and about adver- tising campaigns that target segments of the population such as young adults. We all know that women who are pregnant and those who take birth control pills may be uniquely affected by smoking and that young adults may be unduly affected by advertising. The legislation, Mr. Chairman, that you and I have cosponsored has been condemned as an example of burdensome governmental regulation and an abridgment of the first amendment of the U.S. Constitution. This could not be further from the truth. My record on these subjects is clear. I have been a proponent of deregulation in the communication industry, the transportation industry, and where there was a demonstrated need for a freer marketplace, I have supported that deregulation. I have also been a fervent sup- porter of civil liberties. But, in the marketplace of information, the American people are desperately in need of more information about the health effects of smoking in order to make a truly free and informed choice. I look forward to hearing from the witnesses scheduled for this morning and learning more about the health aspects of these 0 issues. C+~ Thank you. ~% ~ ~ G1 .D~ Y~+

PW son OR ...... 81 84 )re- ...... 169 "ty, 116 ...... 13 48 ..... 52 .. 181 wt, 59 194 204 208 212 218 .... 227 241 .... 248 .... 268 271 ~ 293 .... 328 334 3's ... 838 .... 353 864 Lia 372 376 ol 389 h- ... 416 .425 459 n- ... 463 s- 477 li- •.. 495 501 i- 531 542 562 568 598 606 Dr. Jay Roberts, professor and chairman of the department of pharmacology, Medical College of Pennsylvania, Philadelphia ..................................................... Henry Rothchild, M.D., Ph. D., professor of medicine and anatomy, Louisiana State University .................................................................................................... ....... Dr. Henry 1. Russek, practicing specialist in the field of cardiovascular dis- ease .. .................................................................................................... ........................... Bernice C. Sachs, M.D., Seattle, Wash ......................................................................... G. N. Schrauzer, Ph. D., La Jolla, Calif ....................................................................... Dr. Carl C. Seltzer .................................................................................................... ........ Sheldon C. Sommers, M.D .............................................................................................. Theodore Sterling, University Research Professor at Simon Fraser University, Burnaby, British Columbia ........................................................................................ Yoram J. Wind, professor of marketing, Wharton School, University of Penn- sylvania .................................................................................................... ...................... Tobacco Institute, the, Robert Casad Hockett, research director, Council for Tobacco Research U.S.A., Inc .................................................................................... Charles D. Spielberger, Ph. D., University of South Florida, Tampa, Fla............ Page 643 646 650 653 667 672 683 714 726 753 765

15 not only for the tobacco industry generally, but for related indus- tries. Now, there are several points here, Mr. Chairman, and then I shall cease and desist so we can get on with the hearings and get into the particulars of them. I think this bill does great violence to the concept of separation of power. As chairman of the Separation of Powers Subcommittee of the Judiciary Committee, I think this bill is simply a massive grant of power to the Department of Health and Human Services, frankly, to do about whatever they choose to do. For example, on page 4 of the act, after listing all of the things that the Secretary of Health and Human Services might do, No. 7 is that all-expansive, open-ended clause that simply is a total invi- tation to the Federal bureaucracy to move in, lock, stock, and barrel. It says, "Undertake any other additional informational and research activities which the Secretary determines necessary and appropriate." This is one of the fundamental things taken up in the election of 1980. I think it is contrary to the philosophy of this administration. It certainly is contrary to my philosophy and, I think, to that of the distinguished gentlemen on my right, that we once again, with honorable intentions, mind you-always there are good intentions in this legislation-simply to give this broad, sweeping grant of power to the Federal bureaucracy, which in this case is the Secre- tary of Health and Human Services. Eventually, we are going to be back with this problem of having to rein them in. There will be excesses. Again, if we are going to maintain the doctrine of separation of powers, when we give power to the bureaucracy, there ought to be parameters to it; it ought to be carefully spelled out; it ought to be limited and defined. That is a fundamental tenet of separation of power because it is the legis- lative branch that ought to define the basic policy direction in any area, including this. Also on this matter of separation of power, I am troubled with the fact that we are told we are going to create another committee. Naturally, of course, I like the title here, "Interagency Committee on Smoking and Health." That is fine, but we are told who will be on this committee, which is a wide range of people, and then, final- ly, on this matter of separation of power, we are told, at least one representative from the Federal Trade Commission, the Depart- ment of Education, the Department of Labor, and any other Feder- al agencies designated by the Secretary. So the Secretary can do anything he wants to in terms of so-called informational and re- search activities; he can do anything he wants to in terms of invit- ing people on board. I do not want to put it too strongly, Mr. Chairman, but it sounds to me like we are getting up a lynching bee here for the tobacco industry. It is an honorable industry, a legal industry, and a long- term industry in this country. The first tobacco went out of this country from Virginia by John Rolfe back in 1712, so we are not talking about a Johnny-come-lately industry. I will admit I come from a part of the country where this is a part of the heritage, the culture, and tradition. We are a little weary-I will be candid-of

11 3 of sion ate- )rd- ion, -nts ges ac- ,he to Is 1- il i 9 1 Health and Human Services a complete list of each chemical 2 additive used in the manufacture of such cigarettes and the 3 quantity of such additive. 4 "(2) The Federal Trade Commission and the Depart- 5 ment of Health and Human Services and any officer or em- 6 ployee thereof shall not disclose to any person outside the 7 Commission or the Department any information received pur- 8 suant to paragraph (1). 9 "(3) For purposes of section 552(b)(4) of title 5, United 10 States Code, and section 1905 of title 18, United States 11 Code, any information received by the Federal Trade Com- 12 mission and the Department of Health and Human Services 13 pursuant to paragraph (1) shall be considered to be a trade 14 secret.". 15 PREEMPTION 16 SEC. 6. Section 5(a) of the Federal Cigarette Labeling 17 and Advertising Act (15 U.S.C. 1334(a)) is amended- 18 (1) by striking out "statement" each place it ap- 19 pears and inserting in lieu thereof "statements"; and 20 (2) by inserting before the period the following: 21 `br in any cigarette advertising". 22 EFFECTIVE DATE 23 SEC. 7. (a) Except as provided in subsection (b), the 24 provisions of this Act shall take effect on the.date of enact- 25 ment. S. 1929-ie 95-077 0-82-2

0 21 CbmprPhensive Smoking Prevention Education Act of 1981 Mr. Chairman, Members of the Cbmmittee, I appreciate this tatly opportunity to present my views on S. 1929, the •Cbsprehensive Smoking Prevention Education Act of 1981." I oppose the bill. As introduced this measure is counter- productive and will defeat the principal goals shared by its sponsors. Let me explain why the proponents' good intentions are so misguided in this instance. Mr. Chairman, cigarette advertising is directed to the sswker -- it's an effort to sell a particular brand to an tstablished consumer. The advertising designed to attract new consumers of proprietary drugs, or dog food, or breakfast cereals, is vastly different in content and style and ieunediatelv apparent to the casual observer. As noted in Advertising Aqe of October 19, 1981, the advertising expenditures of these industries are higher, as a percentage of sales, than those of the tobacco products industry. The "hard sell" is conspicuous by its absence from tobacco products advertising -- and for good reason. The industry is conscious of the controversy about smoking and health, and advertising is styled accordingly. Over the past ten years, a revolution has occurred in cigarette production and marketing. Low "tar" brands accounted for nearly fifty per cent of all cigarette sales in 1980,

25 -5- The Congress simply could not have legislated the progress made in the past decade. And Congress should not, at this time, attempt to legislate in a manner that could undermine the basis for the recent, voluntary successes of the industry. After concrete data are obtained about the true effects of the labeling provisions proposed in this bill, either through in-depth studies cr experience abroad, then Congress will be in a position to evaluate rationally the proposition advanced in S. 1929. Until then, the more cautious approach is certainly the most prudent approach. I respectfully recommend, Mr. Chairman, that S. 1929 be set ,aside by your committee as an unwarranted and untested intrusion into an industry program of adaptation which has been accepted by the public and has achieved successes not expected by the anti-smoking advocates of a decade ago. Thank you, Mr. Chairman. 0 0

19 i :n The current warning labels on cigarettes have served a useful purpose in informing the public about the possible adverse health effects of snokin;. However, a great deal of additional information and evidence concerning the toxic nature of cigarette smoking has been compiled since the first Surgeon General's report on smoking was issued in 1964. We must continue in our efforts to keep the public informed as to the latest information concerning ssoking's effect on lung, larnyx, esophagus, urinary, mouth and pancreatic cancers, emphysema and chronic bronchitis, coronary heart disease, arteriosclerotic peripheral vascular disease, retarded fetal growth and increased risk of prenatal death. We in Congress have a duty to inform the public so they can make informed choices involving their health. t do not view this bill as imposing regulatory constraints upon the tobacco industry. I veiw it as an educational measure consistent with the Government's duty to warn consumers about adverse health effects of the substances they use.

0 23 -3- t 2 There are several reasons, in my judgment, for the declining per capita consumption of cigarettes in the United States. First, almost all people, including young people, are informed about the smoking and health controversy. The 1978 Gallup Opinion Index indicated that 90 per cent of the respondents actually believe that "smoking is hazardous to health." The same results were found in the 1978 and 1980 Roper Reports, and in the Chilton Study, as cited by the Federal Trade Commission staff in its May, 1981, report on the cigarette advertising investigation. Second, the advertising of cigarettes, as I have said, is directed to the brand preferences of current adult smokers. Third, the young people who begin smoking are responding to peer pressure, not advertising claims, and peer pressure to beqin smoking has declined as the smoking and health controversy has been debated over the years. The rotating labels of S. 1929 may actually spark the rebellious tendencies of American teenagers, as the initial warning label may have done in the 1960's. In testimony before a House committee on March 12th, Dr. Bernice C. Sachs, a noted psychiatrist and President of the Academy of Psychosomatic Medicine, recalled her prediction in 1965 that proposed warnings for cigarette packages and advertising "could well fan the fire of youthful rebelliousness, rather than deter smoking by teenagers." Dr. Sachs continued, "As I predicted, surveys

IV Page LeMaistre, Charles A., M.D., president, University of Texas M. D. Anderson Hospital and Tumor Institute, on behalf of the Coalition on Smoking OR Health .................................................................................................... ......................... 81 Prepared statement ................................................................................................. 84 Miniard, Paul, assistant professor of marketing, Ohio State University, pre- pared statement ................................................... . . . . ................................... 169 National Interagency Council on Smoking and Health, Robert M. Daugherty, Jr., M.D., Ph. D., prepared statement ...................................................................... 116 Packwood, Hon. Bob, a U.S. Senator from the State of Oregon ............................. 13 Pollin, William, M.D., director, National Institute on Drug Abuse ....................... 48 Prepared statement ................................................................................................. 52 ADDITIONAL INFORMATION - Articles, publications, etc.: Blackwell, Roger, M.D., biographical sketch of .................................................. 181 Technical Review on Cigarette Smoking as an Addiction, final report, from the National Institute on Drug Abuse .................................................... 59 APPENDIX ADDITIONAL STATEMENTS SUBMITTED FOR THE RECORD American College of Cardiology .........................................:.......................................... American Medical Association ...................................................................................... American Association for Respiratory Therapy ........................................................ American College of Physicians .................... :............................................................... American College of Chest Physicians ......................................................................... Action on Smoking and Health ..................................................................................... Bakery, Confectionery and Tobacco Workers International Union ....................... Domingo M. Aviado, president; Atmospheric Health Sciences, Inc ....................... Cigarette Smoking of Pregnant Women by Bea J. van den Berg ........... :............... Peter L. Berger, professor, Boston University ............................................................ Rodger L. Bick, M.D., medical director, San Joaquin Hematology & Oncology Medical Group .................................................................................................... .......... Theodore H. Blau, Ph. D ................................................................................................. Walter M. Booker, Ph. D., president, Walter M. Booker & Associates, Inc.......... Oliver Gilbert Brooke, M.D., FRCP, Department of Child Health, St. George's Hospital, London .................................................................................................... ...... Barbara B. Brown, Ph. D ................................................................................................ Victor Buhler, M.D., pathologist, Kansas City, Mo ................................................... Jack Matthews, M.D., emeritus professor of surgery, University of California at San Diego .................................................................................................... .............. Sherwin J. Feinhandler, Ph. D., president, Social Systems Analysts, Inc............ i Edwin R. Fisher, M.D, professor of pathology, University of Pittsburgh School of Medicine .................................................................................................... ................ H. Russell Fisher, M.D., emeritus professor of pathology, University of South- ern California .................................................................................................... ............ Jean Dickinson Gibbons, professor of statistics, University of Alabama .............. Katherine McDermott Herrold, certified pathologist ............................................... Arthur Furst, Ph. D., Institute of Chemical Biology, University of San Fran- cisco .................................................................................................... ............................. Richard J. Hickey, Ph. D., senior research investigator, department of statis- tics, Warton School, University of Pennsylvania ................................................... Duncan Hutcheon, M.D., D. Phil., departments of pharmacology and medi- cience, New Jerse~yMedical School .......................................................................... Leon O. Jacobson, University of Chicago .................................................................... Lawrence L. Kupper, professor of biostatistics, School of Public Health, Uni- versity of North Carolina at Chapel Hill ................................................................ Hiram Thomas Langston, M.D., clinical professor of surgery (emeritus), Northwestern University Medical School ............................................................... S. C. Littlechild, B. Com. Ph. D., professor of commerce, University of Bir- mingham .................................................................................................... .................... Eleanor J. Macdonald, professor emeritus, department of cancer prevention, University of Texas System Cancer Center, Houston, Tex .................................. John E. O'Toole, chairman, Foots, Cone & Belding Communications, Inc........... L. G. S. S. Rao, Ph. D., Bellshill Maternity Hospital, Bellshill, Scotland, U.K.... V Dr. Jay Roberts, professor and chairman of the dep; Medical College of Pennsylvania, Philadelphia ....... Henry Rothchild, M.D., Ph. D., professor of inedicinc State University ............................................................ Dr. Henry I. Russek, practicing specialist in the fi ease .. ................................................................................. Bernice C. Sachs, M.D., Seattle, Wash ........................... G. N. Schrauzer, Ph. D., La Jolla, Calif ......................... Dr. Carl C. Seltzer .............................................................. Sheldon C. Sommers, M.D ................................................. Theodore Sterling, University Research Professor at Burnaby, British Columbia ........................................... Yoram J. Wind, professor of marketing, Wharton Sc sylvania ............................ ..................... . . .. ........ Tobacco Institute, the, Robert Casad Hockett, resea Tobacco Research U.S.A., Inc ....................................... Charles D. Spielberger, Ph. D., University of South F:

29 The reason that the lower red line shows that rather steep slope -downward is due to the fact that we have made progress against other cancers such as prostate, rectum, colon, and breast. " And, finally, I would call your attention to the fact that if you look at the last 3 years of that slide, the slope of all cancer paral- 4kle exactly the slope of lung cancer at the same time that other cancers remain absolutely flat. So I think the conclusion is self-evi- dent there: smoking and cancer are related in that very specific way. I would like to provide for you, Mr. Chairman, a copy of the Sur- geon General's report for the record if you so desire. The CHAIRMAN. Thank you. I appreciate that. [The prepared statement of Dr. Brandt follows:]

*!r. ~.'hairman, Members of the Cbmmittee, I a; early opportunity to present my views on S. 192 'CbTprehensive Smoking Prevention Education Act I oppose the bill. As introduced this meas productive and will defeat the principal goals : sponsors. Let me explain why the proponents' g, are so misguided in this instance. Mr. Chairman, cigarette advertising is direc eeoker -- it's an effort to sell a particular b established consumer. The advertising designed consumers of proprietary drugs, or dog food, or cereals, is vastly different in content and sty Imsediatelv apparent to the casual observer. A. Advrrtisina Aqe of October 19, 1981, the advert expcnditures of tt-.ese industries are higher, as Rales, than those of the tobacco products indus sell" is conspicuous by its absence from tobacc, edvertisinq -- and for good reason. The indust of the controversy about smoking and health, an: styled accordingly. Over the past ten years, a revolution has o, ciqarette production and marketing. Low "tar" i for nearly fifty per cent of all cigarette sale.

27 chronic bronchitis in both men and women were the two diseases wbich the committee identified as being caused by cigarette smok- e evidence which links cigarette smoking with lung and other ancers was reviewed in the most careful detail in the 1982 report jusi issued. Today, 18 years after the 1964 report, additional human eWrience and enormous amounts of new research make it possi- ble for science to conclude that cigarette smoking is a major cause of cancers of the lung, larynx, oral cavity, and esophagus, and that it is a contributing factor in the development of cancers of the bladder, pancreas, and kidney. - Lung cancer accounts for one out of every four cancer deaths, &nd 85 percent of these are due to smoking. Overall, approximately 30 percent of all cancer deaths are attributable to cigarette smok- ing. A subject which was hardly touched upon in the 1964 report is the effect of smoking on women and, in the case of maternal smok- ing, its effect on the fetus and infant. In 1980, this was the topic of the Department's report to Congress. Its conclusions were that women are not immune to the damaging effects of smoking and that the lesser occurrence of smoking-related diseases among women smokers is a result of their having lagged about 25 years behind men in their widespread use of cigarettes. The 1980 report further established that cigarette smoking is a major threat to the outcome of pregnancy and the well-being of the bab y. Another public health question, now enormously important, re- lates to the use of the new, low-yield cigarettes. This was the sub- ject of the Department's 1981 report. The conclusions were that al- though there is no safe cigarette, smoking cigarettes with lower yields of tar and nicotine poses a lower risk of lung cancer than smoking higher yield cigarettes, provided there is no compensatory change in smoking patterns. The 1982 report noted that the more than 100 diseases we call cancer are the second leading cause of death in the United States. It further concluded that smoking is causally related to at least 30 percent of all cancer deaths and that these relationships are quite strong. Let me mention one program of the Office of Cancer Communica- tions, because we are very proud of its success. Based on the well- documented evidence that counseling by a physician can motivate smokers to quit, the office developed a kit for physicians to use with patients. More than 135,000 of these kits have been distribut- ed. The kit was so well received that a similar one has now been created for dentists. Chronic obstructive pulmonary disease today represents the fast- est growing of the major causes of death, now ranking fifth. In 1980, 55,000 Americans died of pulmonary disease. Almost 3 mil- lion Americans now suffer from emphysema, a terribly debilitating disease. The evidence is substantial and unequivocal that cigarette smoking is the chief culprit in the onset or exacerbation of emphy- sema and chronic bronchitis. During the past 10 years, we have obtained a far better under- standing of the mechanisms of lung damage, including the destruc- 95-077 0-82-3

22 -2- compared to two percent just six years earlier. The development of new brands -- low "tar" brands -- and the aggressive advertising of these new brands, has been one industry response to the continuing controversy addressed in these hearings. ' Another has been the contribution of more than $100 million in unrestricted grants for scientific research on smoking and health. Who can complain about these voluntary industry initiatives? Who can say the "blunt instrument" approach of government controls and regulation, reflected in S. 1929, will be more productive? I say that-S. 1929 will place the progress being made today, under current law and regulation, in the most dire jeopardy. The premise of S. 1929 is that certain draconian, rotating warning labels against the continued consumption of this lawful product will deter such continued consumption. We simply cannot know whether that assumption is correct or incorrect, but we can cite evidence that it probably is not correct. In Sweden rotating labels have been in effect since 1977 -- and cigarette consumption has increased. In the United States the single warning label has been required since 1966, and its message has become part of the lexicon. And per capita consumption of cigarettes has declined since the single-label requirement was established. ThPre are several reasons, in my judgment per capita consumption of cigarettes in the U First, almost all people, including young informed about the smoking and health controv Ga11up opinion Index indicated that 90 per ce respondents actually believe that "smoking is h~alth." The same results were found in the pePorts, and in the CYiilton Study, as cited t commission staff in its May, 1981, report on AdvPrtisinq investigation. Srcond, the advertising of cigarettes, a. directed to the brand preferences of current Third, the young people who begin smokin pPor pressure, not advertising claims, and p touin smo'Kinq has declined as the smoking ar has been debated over the years. The rotating labels of S. 1929 may actue rebellious tendencies of American teenagers, warninq label may have done in the 1960's. a House committee on March 12th, Dr. Bernic psychiatrist and President of the Academy o Medicine, recalled her prediction in 1965 t for cigarette packages and advertising "cou of youthful rebelliousness, rather.than det t,enaqers." Dr. Sachs continued, "As I pre

0 31 'Ir. Cw-1:r-.an ar.d ''e^^5ers e_ 'he Comm!ttee: I Akm pleased to submit to you today this statement f the Department of Health &nd Human Services on the health effects of cigare-te smoking. These health tffeets and their significance to the American peopfe must necessarily provide the r3tionale and justification for whatever action our Committee cal take hf regard to the bill before you. lith me today are Dr. C. Everett Koop, Surgeon General, and Dr. Joanne Luoto, Aeung Director, Office on Smoking and Health. I will begin by presenting a capsule description of the health effects of cigarette smoking and then a more detailed description of smoking and cancer and cardiopulmonary diseases. I will also address research efforts by the National Institute on Drug Abuse on the addictive characteristics of cigarette smoking. N summary, cigarette smoking is clearly the single most important preventable puse of premature illness and death in the United States. Estiaiates of the number of deaths related to smoking exceed 300,000 annually. One may compare this flgure with the 105,000 deaths that occur each year as a result of all injuries, 20,000 deaths from homicides, or the 40,000 infant deaths. Cigarette smoking is one of the three major independent risk factors for coronary heart disease and arteriosclerotic peripheral vascular disease; a major cause of cancer of the lung, larynx, oral cavity and esophagus; and a major cause of dtronic bronchitis and emphysema. Cigarette smoking is a contributory factor in cancer of the urinary bladder, kidney, and pancreas. It is also associated with peptic ulcer disease. Maternal cigarette Wmoking is associated with retarded fetal growth, an increased risk for spontaneous abortion and prenatal death, and slight impairment of growth and development during early childhood. "

16 being the punching bag for those who simply look upon this as the only health issue in the United States. Now, on this matter of health findings in this bill, I think what we are going to do, Mr. Chairman, is get into this matter of the subtlety of scientific proof and determination, if you take the very vague way in which it is phrased under section 2. Here we have Congress going on record, proclaiming by edict, very profound sci- entific conclusions and implications which are going to serve, I fear, as a basis for lawsuits not only against the tobacco industry but to other industries in this country, because it will be charged that Congress has found that if you smoke in addition to working in this kind of industry, it produces this health problem. So I would remind all industries in this country, not only the to- bacco industry, that you open yourself up for serious lawsuits- workmen's compensation, private civil suits, ad infinitum. In other words, it is "welcome everybody aboard," and "anything is fair game." On this rotational requirement that is provided for here, inter- estingly, on the House side in the testimony, Mr. Chairman, behav- ioral scientists pointed out that rotating the advertisements would be counterproductive, because behavioral science has shown, by taking one specific well-worded warning and repeating it is more effective than by confusing and garbling the message. So, curiously, interestingly, the very thing you seek to achieve would be counter- productive. Again I would get back to this premise: 92 percent of the people, according to the Gallup polis in this country, already know there is a health problem. How much more could you do to inform the American people? That again brings me back to my point of depar- ture. I fear the intention here is not informational, though it is so stated; it is prohibitional, and we are back to, if you will, the Carry Nation mentality as far as smoking goes. Again, the intentions are honorable. I am not questioning that. The intentions are always good in this sort of thing. But I fear we are going to saddle not only our industry but other industries and the American people with a bill that simply will not work and will do great violence to some fundamental concepts of our Constitution, as well as to what our party, quite candidly, has traditionally stood for. So again, I appreciate the opportunity, Mr. Chairman, to speak at the length that I have, and I greatly appreciate your indulgence. I might say that Senator Hatch and I, and frequently Senator Packwood and I, agree on many other things, and I greatly respect their judgments and leadership in so many areas. So I would like to make it understood that this is a family feud, and it is not evi- dence that I am filing divorce proceedings. [Laughter.] We have not yet gone that far. The CHAIRMAN. You keep smoking, and we will have a divorce. [Laughter.] Senator EAST. But they have clearly stepped upon the toes of one of their colleagues, and we expect to respond as responsibly and as effectively as we can at these hearings and any others that are posted, and to make our colleagues know that this is not strictly a 17 "health informational problem." It involvE matters than that. Thank you, Mr. Chairman. The CHAIRMAN. Well, thank you, Senator feel deeply about this, and we are happy to I At this time, without objection, we will in, Senators Hawkins and Huddleston in the re( [Material referred to follows:]

18 STATEMENT OF SENATOR PAULA HAWKINS . ON COMPREHENSIVE SMOKING PREVENTION EDUCATION ACT OF 1981 Mr. Chairman, I am pleased that the Labor and Human Resources Committee is holding hearings on S.1929. This legislation, which I have cosponsored, strengthens warning labels on cigarettes, requires disclosure of tar, nicotine and carbon dioxide levels on packages,requires cigarette manufacturers to supply FTC and HHS with a list of the types and quantities of all additives and substances contained in cigarettes and establishes an Interagency committee within the Office of Smoking and Health to coordinate federal activities relating to smoking. I am delighted with the Administration's decision to support this legislation. Their endorsement is consistent with a desire to reduce illness and death and a desire to reduce the expenditures caused by the adverse health effects of smoking. The Department of Health and Human Services has estimated tht the annual health and economic costs of cigarette smoking will exceed $41 billion in 1981. But the truely sad statistics involve the over 300,000 lives lost each year due to smoking. We must accelerate our campaign to educate the public about smoking, the most preventable cause of death and illness today. 19 ront «nrning labels on cigarettes r; - i.: informino the public about the ,•:f,„ •f <noking. However, a great deal ~.; r.:•irnce concerning the toxic nature !.i. rc: :c^piled since the first Surgeon :. c ~~ issued in 1964. We must cont i.eep tne public informed as to the latest •-.>kin,,'s effect on lung, larnyx, esophag pancreatic cancers, emphysema and chronic !:e.irt ..i<ease, arteriosclerotic periphera rctar.ie.i fetal growth and increased risk :n -~-n.:rrss have a duty to inform the pub 3nfor-,e,i choices involving their health. ! 1o not view this bill as imposing regul the tobacco industry. I veiw it as an edu +.ith tht2 Government's duty to warn consum vffects of the substances they use.

24 -4- following the adoption of warning statements showed a rise in smoking by children, particularly girls...." Major educational efforts have not deterred youthful alcohol abuse, teenage promiscuity, or other conduct that is regarded as damaging to young people. These proposed warnings will not stop experimenting with cigarettes either, and an existing program that is relatively balanced should not be cast aside for a new and untried program of potentially counterproductive effect. Mr. Chairman, I applaud the emphasis on low "tar" cigarettes in brand development and advertising. I applaud the continuing contributions of the industry to unrestricted research on the smoking and health controversy. This committee, with the best of intentions, should not initiate a legislative program which can only impede the voluntary progress that is being made. There are those who will always smoke cigarettes, no matter what scientific assertions or medical claims are made against the product. And there are those who will be zealots in the war against tobacco, no matter what breakthroughs may be achieved by the manufacturers of cigarettes. If Congress concludes -- based upon incomplete and in- conclusive scientific data -- that the zealots deserve the law's support, the industry's determined efforts to achieve real progress will be demeaned and repudiated in every advertisement they place, on every package of cigarettes they manufacture. 25 -5- The Congress simply could not have legi: wade in the past decade. And Congress shou- attempt to legislate in a manner that could for the recent, voluntary successes of the : After concrete data are obtained about t the labeling provisions proposed in this bi: in-depth studies cr experience abroad, then a position to evaluate rationally the propoe S. 1929. Until then, the more cautious appr tne most prudent approach. I respectfully recommend, Mr. Chairman, aside by your committee as an unwarranted ar Into an industry program of adaptation whicFE by the public and has achieved successes not anti-amokina advocates of a decade ago. Thank you, Mr. Chairman.

I1FP 1R t)1L\T 1)I IIE.-1l Tli & H( tt 4\ ]ER1 ICEy ?uJe Hea~t- 5er<ce 0ffice or the Ass,stanc Sea 'or Hemth ..;.. ; ..C{____ .r-,,.•- :~ s~tnit to you today this statement ~f the Depar .'_es on the health effects of cigarecte smoking. e:r s:Kn,ficance to the American peooie Ttust nece .-, t. •.. _,stlf lcation for whatever action our Commit .. .. e -):!l before you. •'or•av are Dr. C. Everett Koop, Surgeon General, and D! Office on Smoking and Health. EDWARD N. BR.ANDT, JR., ,14.D. ASSISTANT SECRETARY FOR HEALTH PUBLIC HEALTH SERVICE DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE SENATE LABOR AND HUMAN RESOURCES COMMITTEE MARCH 16, 1982 .,•r.n 7~, oresenting a capsule description of the health effe ar-a :'.en a more detailed description of smoking and car viv.. :.::i a;so address research efforts by the National Inst t^r ace,ctrve characteristics of cigarette smoking. r w'^muv, c:carette smoking is clearly the single most importa slx ot oremature illness and death in the United States. Esti•"n -t oeittns re:a:ea to smoking exceed 300,000 annually. One may :ir.re v,tn tne 105•700 deaths that occur each year as a result o; ;eatrs trom homicides, or the 40,000 infant deaths. sMorung is one of the three major independent risk fac 'e+te :aease ana arteriosclerotic peripheral vascular disease; a n t; s^<er ',: ;ne lung, larynx, oral cavity and esophagus; and a me 'ron:c '-roncn)ta and emphysema. ;arette smoa:ng is a contributory factor in cancer of the urinar ~:+rcreas. i: .s also associated with peptic ulcer disease. Mat •s assoc:ateo with retarded fetal growth, an increased ris ~91. ar.a orenatal death, and slight impairment of growth and

0 37 r The CHAIRMAN. Dr. Brandt, we appreciate your very informative `.~teatimony. ; How likely is it that the average person in this country would i.*etnderstand all of the health risks involved with smoking cigarettes : `fiom present warnings? Dr. BRANDT. I think that the major association or major thing that most people associate with cigarette smoking is lung cancer. *Certainly the American Heart Association has expressed concern, -,~ that more people are not aware of this being one of the three major ; risk factors in heart disease, and I think only those families, prob- ., &bly, that have connection with someone who has emphysema are ~,Sware of that risk. So I think people are aware that there are adverse health effects <, aesociated with cigarette smoking, but I do not think they are as aware of the specific situations. The CHAIRMAN. The data you presented regarding the health consequences of smoking, I think, would be frightening to anybody. : You have said that the causal relationship is strong. Could you ex- plain again how it is determined that cigarette smoking causes the j. diseases that you identified? Dr. BRANDT. The vast bulk of the evidence is epidemiologic in aature. Epidemiology is that science which is oriented to attempt- ing to find the causal factors and contributing factors to the devel- opment of disease. Clearly, the evidence from such studies must be evaluated and must be examined on the basis, really, of five crite- ria, one being the consistency of these findings; that is, in repeated ; studies of various populations and various groups, you continue to Gnd a higher incidence of the disease among smokers than non- smokers. Second, the strength of that association. One needs to be sure that the association is in fact strong and that it can be consistently identified. Specificity of the association; the temporal relationship. Clearly, if cigarette smoking results in disease, then the disease must follow the cigarette smoking. And, finally, the coherence of the association; namely that there should be some biological explanation for these things, including what is most commonly used, the dose-response relationship, and the dose-response relationship of cigarette smoking with those ill- nesses is quite well demonstrated. That is, the more you smoke, the greater the likelihood of the disease. The CHAIRMAN. Obviously, a great deal of research has been done relating to smoking and health, and the great majority of sci- entific evidence does conclude that smoking is indeed harmful to health. Nonetheless, it seems to me some scientists do not accept the conclusion that cigarette smoking is the cause of disease and death, so how do you account for their skepticism? Dr. BRANnT. I think some scientists clearly look for complete identification of the mechanism before they will accept factors as being causal. As I pointed out in my testimony, at the present time, the exact physiologic or pathophysiologic mechanisms for cigarette smoking in these illnesses has not been clearly demonstrated, but certainly medicine, throughout history, has identified problem

t 58 -6- is the relative degree of control over the behavior of users which that drug is able to achieve. We have heard about the severe health consequences that result fran smoking. Smoking behavior itself is the disease process which lead to these health consequences. When we can provide more effective help to smokers who wish to regain freedan of choice and reduce or discontinue smoking behavior, then the hundreds of thousands of yearly smoking-related cancer and heart deaths can be sharply reduced. Thank you, Mr. Chairman. I would be happy to respond to any questions you ma hve at this time. \ 59 NATIONAL INSTITUTE ON DRUG ABUSI TECHNICAL REVIEW ON CIGARETTE SHOKING AS AN ADDICTION Thursday and Friday, August 23 and 24, FINAL REpORT Hoderators: Norman A. Krasnegor, Ph.D. Pierre F. Renault, M.D. '+' ro :,rstems, Inc.

14 The Chairman. Thank you, Senator Packwood. I notice that Senator East is with us. Senator, we are happy to invite you to participate in the hearings today. Senator EAST. Thank you, Mr. Chairman. I appreciate the oppor- tunity to be with my two distinguished colleagues from the Senate, who are and also distinguished leaders in the Republican Party. Mr. Chairman, I appreciate, as a member of this committee, the opportunity to make some observations on this legislation. I cer- tainly understand the good intentions of you two distinguished gen- tlemen, but I will be blunt and categorical about it. I think this is a bad bill. I would like to briefly state, at the outset, why I think it is a bad bill, and then we can take these matters up with greater precision and focus as we lace our way through the hearings today. I would hope, Mr. Chairman, that in terms of the panels we have here, we can have a balanced presentation this morning, and we shall cer- tainly strive for that end, as I know you will, too, but I would like to say that if it would appear, after the conclusion of our hearings this morning, that additional hearings may be in order so that we can get the broad perspective of opinion on this, I would certainly, as one member of the committee, like to have us move in that di- rection if it would seem it would be useful as we pursue this sub- ject. As both of the gentlemen have indicated, the purpose of this bill is to increase the information level of the American people con- cerning the health hazards of smoking. Now, it is interesting to note that a recent Gallup poll has shown that 92 percent of the American people already know that cigarette smoking does, carried to excess, involve certain health risks, as many things do, such as drinking, excessive use of sugar, salt, fast driving, obesity, and ad infinitum. My concern here Mr. Chairman, is that you have a bill that is purported to be informational in basic structure and design but, ul- timately, if you strip it down to its theoretical base, it has a prohi- bitional mood about it, because what it would do-and I find this contrary to the philosophy of this administration and to the man- date of 1980-is that this would saddle a legitimate, and honorable, and long-standing industry in this country with an enormous bu- reaucratic regulation. We deeply fear that this bill would be used as a frontal assault on an honorable industry by the Government and, also, that it would serve as the basis for very serious assault by the courts upon a very honorable industry. I would like to put this thing in perspective. There is nothing wrong-in fact, I support, and those who would share my position, I believe, would support the idea-for the Government to inform people about relative health problems, be it tobacco, drinking, salt, sugar, automobiles, obesity, and so forth. This is an appropriate and a useful role of Government. But again, this bill goes beyond that line. It goes beyond the pale of that legitimate Government responsibility and moves us into an area of excessive, extraordinary involvement by the regulatory side of Government, the executive branch, and also opening up the courts to people who would harass and cause incredible problems, 15 not only for the tobacco industry general tries. Now, there are several points here, M shall cease and desist so we can get on v into the particulars of them. I think this the concept of separation of power. As chairman of the Separation of Pow Judiciary Committee, I think this bill is s power to the Department of Health and J to do about whatever they choose to do. For example, on page 4 of the act, afte that the Secretary of Health and Human is that all-expansive, open-ended clause tl- tation to the Federal bureaucracy to m barrel. It says, "Undertake any other add: research activities which the Secretary d appropriate." This is one of the fundamental things ta 1980. I think it is contrary to the philosopl It certainly is contrary to my philosophy a distinguished gentlemen on my right, t1- honorable intentions, mind you-always t in this legislation-simply to give this b power to the Federal bureaucracy, which tary of Health and Human Services. Eventually, we are going to be back wit: to rein them in. There will be excesses. 1 maintain the doctrine of separation of pow to the bureaucracy, there ought to be par. be carefully spelled out; it ought to be lim a fundamental tenet of separation of powE lative branch that ought to define the basi area, including this. Also on this matter of separation of po the fact that we are told we are going to ci Naturally, of course, I like the title here, on Smoking and Health." That is fine, but on this committee, which is a wide range o ly, on this matter of separation of power, representative from the Federal Trade C ment of Education, the Department of Lab. al agencies designated by the Secretary. : anything he wants to in terms of so-calle search activities; he can do anything he w., ing people on board. I do not want to put it too strongly, Mr. to me like we are getting up a lynching t industry. It is an honorable industry, a leg term industry in this country. The first t country from Virginia by John Rolfe back 0 talking about a Johnny-come-lately indust tj from a part of the country where this is a tT culture, and tradition. We are a little wea ~ ~ G^ ~ N

0 39 .71 is t q .o ,ny hat ot t n ny he 3 at the eo ~ate ~ n18- 11's li es, y I 0 ionI t s ~ rogrpm of public education, which the Public Health Service is at- t-umtpting to carry out. ~, Senator PACxwooD. Let's go down our bill, then. Can you tell us '~`-~rhich parts of our bill the administration endorses and which ?;' p4rts they want to change? Dr. BRANDT. I cannot tell you which parts in specific, Senator Packwood, because in fact the bill report for this bill has not been Completed, to my knowledge. Therefore, I can only support the con- Cept of stronger health warnings. Senator PACKWOOD. Say that again. The bill report is what? Dr. BRANDT. To my knowledge, the bill report has not been com- pleted; at least I have not been provided with such a report. Senator PACKWOOD. The bill report. Do you mean by your depart- Rlen t? Dr. BRANDT. The analysis of it, yes, sir. Senator PACKWOOD. Well, all right. You did support, 5 days ago, the House bill's requirements for the strong health warnings. Dr. BRANDT. Well, we supported that bill with the reservations that are included in the testimony and in the questions. Senator PACKWOOD. All right. Let's go through those reserva- tions. Do you support the mandatory requirement of the placing of the warnings on the cigarette package? Dr. BRANDT. If that is the most effective way to accomplish it, yes. Senator PACKWOOD. Do you support that? Dr. BRANDT. I personally support the idea that we must have stronger health warnings. Senator PACKWOOD. Does the administration support that? Dr. BRANDT. As I say, the specifics of this bill-I mean the bill that you are talking about-certainly support the concept of stronger health warnings. Yes, sir. Senator PACKWOOD. Doctor, then tell me what your statement means before Congressman Waxman's committee. "We support the bill's requirements-the bill's requirements-for strong health warnings, because we believe," and so on. What does that mean? Dr. BRANDT. It means-- Senator PACxwooD. Do you know what is in his bill? Dr. BRANDT. I am sorry? Senator PACKWOOD. Do you know what is in the House bill? Dr. BRANDT. Yes, I do. Senator PACKWOOD. And do you know how strong the health warnings are in that bill? Dr. BRANDT. Yes, sir. Senator PACKWOOD. And you know that the ones in our bill are slightly weakened from that, not the specific warnings but the bill is slightly weaker than the House bill. Dr. BRANDT. You will note also, sir, that in that testimony, we requested or we disagreed with the specific wording of those warn- ings and in fact suggested that if warnings are to be placed on ciga- rette packages, that the Secretary of HHS be permitted to design the specific wording. Senator PACKWOOD. Now, where does it say that? Dr. BRANDT. I don't have a copy of the testimony.

32 Cigarette smoking acts svner„istically vith oral contraceptives to enhance ciiP lsttstla3iiitj' of"coronar,v and some cerebrovascular disease: with alcohol to increase the risk of cancer of the larynx, oral cavity, and esophagus: with asbestos and some other occupationally encountered substances to increase th,~ likelihood of cancer of the lung; and with other risk factors to enhLnce cardiovascular ris'<. Involuntary or passive inhalation of cigarette smoke can precipitate or exacerbate symptoms of existing disease states, such as asthma and cardiovascular and respiratory diseases and may be carcinogenic for nonsmokers. Smoking is also the major identifiable cause of deaths and injuries from residential fires. Mr. Chairman, cancer was the first disease to be associated with cigarette smoking. As Dr. Koop pointed out in introducing our 1982 report on smoking and health a few weeks ago, reports linking smoking and lung cancer began appearing in the scientific literature as long as 50 years ago. In 1964, when the Surgeon General's Advisory Committee's report was issued, lung cancer in men, and chronic bronchitis in both men and women, were the two diseases which the Committee identified as being caused by cigarette smoking. The evidence which links cigarette smoking with lung and other cancers was reviewed in the most careful detail in the 1982 report just issued. Today, 18 years after the 1964 report, additional human experience and enormous amounts of new research make it possible for science to conclude that cigarette smoking is a major cause of cancers of the lung, larynx, oral cavity, and esophagus, and that it is a contribut- ory factor in the development of cancers of the bladder, pancreas, and kidney. Lung cancer accounts for one out of every four cancer deaths, and 85 percent of these are due to smoking. Overall, approximately 30 percent of all cancer deaths are attributable to tobacco use. 33 as tyuc~ed upon in the IY6u reDc ' c~'-e case of maternal smoking, its effec )e tc7);c of the Deoartment's report to . . 1. , are not immune to the damaging effect e e;, .--,.. e^r_e nf smoking-related diseases among ---er havinQ lagged one-quarter century behin .Y ... ~.:]' ...t'S. - --~ ;43; -:)ort estaSlished that cigarette smoking is a m ;~.rCs^n and the well-being of the baby. The risk of fetal oertti. and neonatal death increases directly with ir ^;r.re oreQnancv. Smoking causes a markedly ic ~rat. anc s~,~arachnoid hemorrhage. arot^e+ avol c nealt!t ouestion, now enormously importan ,i! t'=e new. iow-vield cigarettes. This was the subject of •.oert. Tl,e Renort's conclusions were that although ther amok:nR c:¢arettes with lower yields of tar and nicotine F rrR '.anter r.•an smoking higher-yield cigarettes, provide cnarRe n sr^cking patterns. Increasingly, smokers have t .eetC procucts: there is evidence to suggest that in doing _-rr.asM t^etr smoking or changed the way they smoke. .-r ouunt,al oene!it in their having switched to these pr 'I.rc..-e 3^a 'snce. ^e :11;2 ?e-or, of the Surgeon General on the Health Cc 'rvu«; oon cancer. The report noted that the more the -i r.• ar- I-e second leading cause of death in the Unite a:.o ^. Sx t^ese :mpor.ant points: 3

. 41 rith in ul age ing )be ® v )n'S der irn- nse )rts ' igs;~ ne-in ed.' ito an ut, „ s, ve th ur th # Dr. BRANDT. My personal opinion is that the health warnings to ~ prevent cigarette smoking and to encourage people to stop are ef- `` fective in accomplishing that goal, yes. Senator PACKWOOD. And you think they are effective on the ciga- V rette packages and on the advertising? Dr. BRANDT. I think that the evidence that we have now, in my ~ personal opinion, is that it has been effective. ': Senator PACKWOOD. Thank you, sir. No other questions. Senator East. ; Senator EAST. Ladies and gentlemen, I wish to, as a member of the Labor Committee, welcome you here this morning, and we ap- preciate your taking the time to come and discuss with us what I "think is a very important subject, not only in terms of the area of the country that I come from but, of course, in terms of an item of considerable national interest and concern. I think that the two of you together somewhat symbolize the dif- ficulty of the problem we face; that is, Dr. Koop coming at this Froblem from the standpoint of scientific causation, which I would ke to pursue briefly with him, and then I think Dr. Brandt sym- bolizes, of course, in his position, the question of proper responsibil- ity for government in terms of scientific evidence that it has; what it ought to do with it? Should it inform, should it go further into other things, and so forth? Let me start, if I might, with this question, Dr. Koop, of scientific causation. My background has been in law and the behavioral sci- ences, social sciences, as opposed to your field of medical science, but there are certain common threads that I think are of our inter- est and that run through this. Let me just state my position briefly, and I would appreciate your reaction to it. We all know that problems of causation and the scientific establishment of causation are, again depending upon the subject matter, but quite frequently can be, intricate, difficult, com- plex. Solutions do not yield themselves up easily. "Intractable" is a word we might use to identify this problem of identifying scientific causation in so many areas. A word that I know is used a lot in your field of physical sci- ences, natural sciences, medical science, and of course we use it in the social sciences and behavioral sciences, is this idea of variables, that in any given context in which you are trying to establish sci- entific causation, what greatly ups the probability or improbability of determining and establishing causation is this problem of varia- bles, and particularly the independent variables, the ones that you cannot isolate. We have a terribly difficult time with that in the social sciences. In politics, for example, behavioral studies in politics, you have an enormous problem of isolating all the variables because you cannot hold them constant, and so we try, at least in political science, in the behavioral science there, to appreciate the enormous limita- tions that we have frequently to establish the scientific causation. A problem I have with this, and with the bill in particular, but just generally, on this question of scientific causation, is that, for example, in the findings that we are asked to conclude here, we are told that Congress finds that-somewhat like a laboratory report- cigarette smoking is the largest preventable cause of illness and

r7 33 { t,up-ect %chir_h ~ as ~ar~lv touc`,ed upon in the l96'+ renort is the effect of sr^oki.n; -Pan women. and in the case of maternal smoking, its effect on the fetus and infant. " fn 1930, this uas t'ne topic of the Deoartment's report to Congress. Its conclusions s`wtre that women are not immune to the da^ aging effects of smoking, and that q* lesser occurrence of smoking-related diseases among women smokers is a ' ftsult of women having lagged one-quarter century behind men in their widespread ' ufe of cigarettes. The 1930 report established that cigarette smoking is a major threat to the outcome of pregnancy and the well-being of the baby. The risk of spontaneous abortion, fetal death, and neonatal death increases directly with increasing levels of maternal smoking during pregnancy. Smoking causes a markedly increased risk of heart attack and subarachnoid hemorrhage. Another public health question, now enormously important, relates to the use of the new, low-yield cigarettes. This was the subject of the Department's 1981 report. The Report's conclusions were that although there is no safe cigarette, smoking cigarettes with lower yields of tar and nicotine poses a lower risk of Fung cancer than smoking higher-yield cigarettes, provided there is no compensatory change in smoking patterns. Increasingly, smokers have turned to these lower- yield products; there is evidence to suggest that in doing so, at least some have increased their smoking or changed the way they smoke. This may have negated any potential benefit in their having switched to these oroducts. Smoking and Cancer The 1982 Report of the Surgeon General on the Health Consequences of Smoking focussed upon cancer. The report noted that the more than 100 diseases we call cancer are the second leading cause of death in the United Sates. The report afso made these important points: 3

51 as f toba holo -1ber . co I of t ni ister jectiv iden verf ! Ag ectiv, •ed ori ie e t g h ru u ita ve ces va i a nica" Brit; Aat~ the ired tiv ugs bac rag ,ub= rug ese cco 'ar. 3ry ult ia- is- to be o- as r-,- ~, ; ~ret show substantial evidence of being physically addictive, may ~t~ot do so because we have not yet learned enough about the rela- tionship tianship between brain, drugs, and behavior to be able to identify tlyo:ce physical systems which are at the basis of compulsive and ad- ~ dictive drug use patterns. ~~ The important point which must be stressed in the discussion of , peychoactive and addictive drugs is the relative degree of control ~, over the behavior of users which that drug is able to achieve. ; We have heard about the severe health consequences that result = from smoking. Smoking behavior itself is the disease process which leads to those health consequences. When we can provide more ef- fective help to smokers who wish to regain freedom of choice and reduce or discontinue smoking behavior, then the hundreds of thousands of yearly smoking-related cancer and heart deaths can be sharply reduced. Thank you, Mr. Chairman. I would be happy to respond to any questions you or members of the committee may have. (The prepared statement of Dr. Pollin and report of the Task Force on Smoking follow:]

55 -3- dgme is consistent with how we use the term "dependence" with other drugs, as alcohol and cocaine. y researchers--some supported by NIDA--are currently exploring the same sttoRS that we ask of any drug-using behavior: what factors determine (1) t!a1 experimentation or use; (2) the progression from casual recreational use eputar, compulsive use; (3) the maintenance of abstinence; and (4) the high PHtf of relapse. ki txik of research findings to date implicate nicotine as the main factor in W AfRa41/shtng and maintaining dependence on tobacco. This results from M0~ine's powerful biological and psychological effects, which include ~F- nrtMulation of the release of a number of substances (norepinephrine, rq,aepnrine, growtn hormone, cortisoi, vasopressin, ana proDaDly Deta MOOrDh1n); the production of behavioral arousal and EEG alerting patterns; and w fact that it is one of the most rapidly metabolized of all self-administered 'W`trAstances. ~`r1GOtine is a psychoactive drug. That is, it influences subjective state and ;~R71Awior. Not all psychoactive drugs lead to dependence or craving: the major ~~fiiftquilizers, for example, are powerful drugs which do not do so. NIDA's *Afdtttion Research Center has developed a test --the ARC Inventory-- for ~ZOfltlsely quantifying psychological and/or subjective drug effects. Over the ~-%~iMrs, this test has been administered to over 3,000 individuals, both with and ' rlthout drug abuse histories. A major finding of current NIDA studies, derived " 110 this euphoria sub-scale of the ARC Inventory, is the marked similarity that

28 tion of elastin, a major structural protein of the lung which is 8 versely affected by cigarette smoke. ; Despite a dramadc decline in mortality during the past decad coronary heart disease remains the No. 1 killer in this count claiming three-quarters of a million lives in the United States eac year. Cigarette smoking is one of the three major risk factors fi coronary heart disease, the other two being high blood pressu and high serum cholesterol. Further evidence indicates that the more one smokes, the greVa er the risk. The exact mechanisms of how cigarette smoking affe coronary heart disease are still unknown and are the subject considerable research now underway. Nevertheless, the evidenc based on epidemiologic and autopsy studies clearly linking tli amount of smoking with higher incidence of heart disease is inde impressive. Mr. Chairman, Dr. William Pollin, Director of Drug Abuse, wi appear on the next panel to address the serious issues of the addic tive nature of smoking. Let me now ask Dr. Koop to give a brief presentation on the 198 Surgeon General's report, following which we will be happy to r spond to questions. The CHAIRMAN. Dr. Koop, we are happy to have you with us. Dr. Koop. Mr. Chairman, Senator Packwood, Senator East, fo the sake of brevity, I will try to condense this rather lengthy report , into a discussion of the two charts on your right, and we will just, be talking about death and about cancer. The first chart over there confirms what Dr. Brandt has just said, that cancer of the lung, larynx, oral cavity, and esophagus are those that have been known to be linked with smoking now for many years, and these are two old fashioned comparative pie dia- grams which compare 1950 with 1977. In each instance, the blue pie is all cancer deaths, and in each instance the red slice is the percentage of those cancer deaths which are due to lung, larynx, oral cavity, and esophagus, and you can see very graphically there the increase in proportion of the deaths from cancer due to those four. Please remember that we have additional evidence that smoking is linked to other types of cancer, but they are not included in any way on this diagram. If you would then turn your attention to the chart that is closer to you, this shows time trends in cancer mortality. Simply look at those three lines. The top red line shows the mortality for cancer of all types of cancer, and you can see that as far as this graph is con- cerned, from 1950 to 1978, there has been a steady swing upward of mortality from all cancers. Below that, you will see a blue line that deals with lung cancer only, and that line is ever so much more steep than is the other one. Then the bottom red line shows all cancers, other than lung, have been decreasing from 1950 to 1978 and, indeed, were it not for that blue intervening line of lung cancer, then the upper line of all cancer would also have been coming down with a slope approach- ing that of the other cancers. 29 l.,c r,•:,,On that the lower red line shows tha dem nµ•ar(> is due to the fact that we have ma ctnrr ran<ers such as prostate, rectum, colon, a: .1nd. cin:~ll~. I would call your attention to ;,;,,,ik at t he last 3 years of that slide, the slope k;% ,•xartlv the slope of lung cancer at the so c.ncY•n, mmain absolutely flat. So I think the c drnt there: smoking and cancer are related i wa• {.+ ou ld l i ke to provide for you, Mr. Chairma C")n Genc•ral's report for the record if you so df Ti,t• t'fi.aiKataN. Thank you. I appreciate that I•The prepared statement of Dr. Brandt follow

observed with alcohol and heroin use. It is of interest to note that indi- 'w/ruls who use both heroin and cigarettes report that they would find it easier MjSve up heroin than cigarettes. pQF1NITION OF ADDICTION AND AN ADDICTING SUBSTANCE Before proceeding to consider whether current evidence allows the cate- Me{sstlon of cigarette smoking as an addiction, we must define this term. In be pro.dest sense, addiction is a state characterized by the repeated ingestion :aj a substance that is toxic and leads to undesirable social consequences. This -tidynitlon e^compasses other terms often used to describe nonmedical drug use, #a! as abuse, habituation, and dependence. An addicting substance is one t1W has: (L) pharmacological properties leading to compulsive use; (2) a capa- b6ty of producing organ and/or behavioral toxicity; and (3) a use pattern asseeiated with adverse social consequences. In addition, this term is generally ilplf.d when the ingestion of such substances is viewed by a large segment of So society as undesirable. There have been two general approaches to obtaining data to determine lb.ther tobacco can be viewed as an addicting substance: (1) the study of WCfrstte smoking eer se, and (2) studies of nicotine alone, since its phanna- Mo6feal actions suggest that it is the most likely component in tobacco leading r 1ts repetitive use. A variety of behavioral studies of the action of nicotine 6M been carried out in animals. One of the methods used in the animal labora- 11" to determine the addiction potential of drugs is the drug self-administration Protedure. There is a good correspondence between drugs that are sel.f- 6611lnistered by laboratory animals and those that are common Irugs of addic- I~q in humans. This genernlity hu61:; ttve Gu• ih'iiyts wilhin thr ol,inid, sr,ta- Oat. and psychomotor stimulant class. Furthermore, drugs which are not M"etive substances are not self-administered by animals.

I 35 ts. rM ra: c-;rr.er I st'.t.te li interested irn oursuina so:ne new leads. Tiere i, a=ros in,t bocc of e,: idence that ?eople who smoke low tar and nicotine cigarettes &p}ust titnr s:no;:n; beiiavior--inhaling more deeply or covering the ventilation 1iqI" in te e ciearette `ilters. This is thought to be an attempt to compensate to't!K "e" -sed nicotine vield. We olan to take a look at tiis question. If these prt;:.n:!,ar; cudies are confirmed, it would imply that smokers of todays' cigarettes &re -so: decreas:ng their exposure to nicotine and in fact may actually be increasing tAtIt e<posure to har-nful combustion products such as hydocarbons and carbon "%pno.I de. $rtsok:r.q and Cardio-pulmonary Disease Chroeuc obstructive pulmonary diseases (COPD) today represents the fastest Rrowing of the major causes of death, now ranking fifth. In 1980, 55,700 Americans Q'ied of pulmonary diseases. Almost three million Americans now suffer from trnph,yserna, a terribly debilitating disease. More than seven million have chronic Otonchitis. Chronic respiratory diseases account for approximately ten percent ot disability benefits for lost work hours. And, the evidence is substantial and ur*quivocal that cigarette smoking is the chief culorit in the onset or exacerbation of these diseases. Research has for some time provided us with data demonstrating that smokers hive higher mortality rates from chronic bronchitis and emphysema and that fr^okers have far less pulmonary function than nonsmokers. During the past ten years, we have also obtained a far better understanding of the mechanisms of wng damage, including the destruction of elastin, a major structural protein of the lung which is adversely affected by cigarette smoking. And, within recent years, evidence has been reported which suggests that the small airways function ot the lung may be adversely affected in healthy nonsmokers if they are exposed W Cigarette smoke from others. 5

36 Research continues in this area to give us a better basis of knowledge in order to prevent or arrest the progress of pulmonary diseases. Studies have demonstrated the benefits of smoking cessation, including improvements in lung performance on standard spiro netric (breathing) tests soon after one quits. However, pulmonary' diseases represent a progressive condition and once a certain point is reached we can only hope to retard its progression. Investigators are working towards developing a simplified means of detecting the disease condition at an early enough stage to intervene and reverse the process. At the same time, research continues to try to develop and evaluate programs designed to help individuals give up smoking, since smoking prevention or cessation represents the only effective intervention measure we now have. Despite a dramatic decline in mortality during the past decade, coronary heart disease remains the number one killer in this country, claiming three-quarters of a million lives in the United States each year. For every minute of the day, there are about three Americans who suffer a heart attack. While the progress in reducing coronary heart disease and other cardiovascular deaths during recent years is heartening, the scope of the problem remains enormous. Cigarette smoking is one of the three major risk factors for coronary heart disease; the other two being high blood pressure and high serum cholesterol. Epidemiological evidence clearly places the smoker at a higher risk of heart disease than the nonsmoker. The more one smokes, the greater the risk. There is also evidence that smoking cessation can decrease the risk. After only one year free of cigarettes, a former smoker may be able to reduce the risk of heart disease to close wlthin that of the nonsmoker. The exact mechanisms of how cigarette smoking affects coronary heart disease are still unknown and are the subject of considerable research now underway. Nevertheless, the evidence based on epidemiologic and autopsy studies clearly linking the amount of smoking with higher incidence of heart disease, is indeed impressive. 6 37 1'},C CtIAIRatnx. Dr. Brandt, we appreciate trstimom'. 11o..• likely is it that the average person understand all of the health risks involved N from present warnings? I)r. BRnND'r• I think that the major asso that most people associate with cigarette s? i'rrt,unlv the American Heart Association that more people are not aware of this being risk lactors in heart disease, and I think on wbly, that have connection with someone w avrare ot that risk. So I think people are aware that there arf aa*ocinted with cigarette smoking, but I do avrnre uf the specific situations. The CHAIRMAN. The data you presented cnnncquences of smoking, I think, would be- l ou have said that the causal relationship i piutn again how it is determined that cigare dim-ases that you identified? Dr. 131tA:. DT. The vast bulk of the evidel rinture. Epidemiology is that science which rnu to tind the causal factors and contributi optnent of disease. Clearly, the evidence froi evaluated and must be examined on the ba, na. one being the consistency of these findif uudles of various populations and various € find it higher incidence of the disease amc amoker5. aecond. the strength of that association. that the association is in fact strong and thi idPntltied. Jpeciiicity of the association; the temporl &f cigarette smoking results in disease, then the cigarette smoking. Arid. iinally, the coherence of the associa, .hould be some biological explanation for M hat is must commonly used, the dose-res} the dose-response relationship of cigarette nrmes is quite well demonstrated. That is, tI grnjuer the likelihood of the disease. hhe CEIAtxHArr. Obviously, a great deal rione relating to smoking and health, and t) rntlfic evidence does conclude that smokin hr:,lth. lonetheless, it seems to me some scien- conclusion that cigarette smoking is the cau ao how do }•ou account for their skepticism? Dr. I3xAtiDe. I think some scientists cle tdentification of the mechanism before the. 1x•tny; causal. As I pointed out in my testimo the exnct phvsiologic or pathophysiologic m •moking in these illnesses has not been c1E cert:unlr• medicine, throughout history, I

57 -5- exists between morphine, cocaine, and nicotine. During the first several minutes after administration of the drugs, there is an immediate and mark change In feeling-state (euphoria). This reflects the fact that during period morphine, cocaine, and nicotine all "feel" very much alike. The experiences a'rush," which after a few minutes shows a variable course depending on the particular drug. Both from self-reported information and from intravenous administration nicotine, we have found that subjects who have histories of narcotic addi say they `like" tobacco and/or nicotine as well as or even more than other drugs. A British epidemiological study of 210 subjects seeking treatme opiate addiction showed that (on a scale of one to five, with five being "most liked"), tobacco received a"liking" score of 4.3, compared with 4.1• heroin, 4.2 for cocaine, and 2.4 for amphetamine. This same study measured these subjects'comparative perceived "need" for different drugs. On a scal to 4, with 4 representing the "most needed", tobacco received the highest 3.3--compared to 2.8 for heroin, and 1.5 for cocaine. Although there may questions as to the generalizability of the felt needs of individuals in treatment for drug abuse to the general population, we think that these dat indicative of the powerful, compulsive effect of tobacco smoking in general the ingestion of nicotine in particular. These data support both the NIDA~ studies and the common anecdotal report that heroin addicts find it more difficult to give up tobacco than heroin. As with other classic drugs of abuse such as the opioids and sedatives, tolerance and physical dependence are important characteristics of a drug ti,. .,acerbate the user's tendency to contin •. 'xes the pharmacological effects of drug as•.•.,r,t•cn of higher doses of the drug, whic %.. .+ .•+: :.l c• a 1 consequences for the user. Tol e s.a+.r •;• , xe or the effects of smoking cigarette ,w .•-v of tne components of cigarettes. As most #ss •% cwwon among novice smokers, but disappears r c .•,-r can be demonstrated in smokers to var r.E* u.:.. •or example, nicotine), as well as to a . L•-" .•,•.et and chlorpromazine. As with other d w. + t~ c,-;ear when heavy smokers abruptly qu ••r - .-crawal symptoms, but it is not unusual q u,•.,. a:ecrease in excreted epinephrine and no .,,^ernore, there is a decrease in mean EE • 'n apDetite and weight, and an impairme 'y •a:,t ,nd in concentration. Disturbance in s i,. 'eel anxious, irritable and even aggressi f:,re trying to stop feel an increased crav t'4 " a4' . 's Itkely that drugs such as nicotine an "f a*ft••'.!,-+,"t torming, and yet do not show irrefu -e;,.een brain, drugs, and behavior to be ,e, nay not do so because we have not y "''• 'rl'~s -0):ch are at the basis of compulsive dru •^ust be stressed in the discussion

U.S. Department of Health and Human Services: The Health Consequences of Smoking - The Changing Cigarette. DHHS. Publication No. (PHS) 81-50156, 1981. 2. Leffingwell JC et al: Tobacco Flavoring for Smoking Products. R.J. Reynolds Tobacco Company, Winston-Salem, North Carolina, 1972. 3. Hunter Report: Developments in Tobacco Products and the Possibility of "Lower-Risk" Cigarettes. Her Majesty's Stationary Office, London, 1979.

40 Senator PACKWOOD. All I have in your testimony from last wee is that you were opposed to the creation of a separate Office Smoking and Health; you thought that was redundant and unn essary. You indicate that the Secretary be given the authority fi possibly modifying the actual wording. Dr. BRANDT. Yes. Senator PACKWOOD. Again, I do not think we would quarrel wi that so long as there is a mandatory requirement for the warnin I am not sure that what Senator Hatch and I would draft woul necessarily be the health warnings you might want on the pack 2 or 3 or 4 years from now, as you have had more research comi in. There may be other things we find, and this does not have to written in stone. I am not trying to unduly badger you, Doctor, but I want make sure that there has been no change in the administration position between last week and this week, because we were und the impression that the administration supported the health wa ings, varying the wording slightly, but supported them, and I sen some difference now from last week. Dr. BRANDT. The administration's position is that it suppo stronger health warnings. The specific wording of those warnin and so forth, and the way in which they are to be used is som thing that is still being studied. Senator PACKWOOD. Now, the way in which they are to be use Do you mean whether or not they will be compulsorily required be put on cigarette packages is still an issue being weighed? Dr. BRANDT. Yes, it is. Senator PACKWOOD. Have you talked with anybody between 1 week and this week about your testimony, anybody in the adminise tration? Dr. BRANDT. Have I? Senator PACKWOOD. Yes. Dr. BRANDT. Well, I have talked to various members of my sta as well as the Secretary. Senator PACKWOOD. Have you talked with anybody who sugges ed that the statement that you made last week was too strong, an perhaps it should be toned down? Dr. BRANDT. Nobody has spoken directly to me about that, no. Senator PACKWOOD. Has anybody spoken indirectly to you abouti that? [Laughter.] Dr. BRANDT. The testimony that I gave today has been complete,~ ly approved by the administration. Senator PACxwooD. It is substantially weaker testimony than last week. You have left off the whole part of the testimony about; "We support the bill's requirements for stronger health warnings, out of your testimony this week. Dr. BRANDT. On the other hand, Senator Packwood, we havee come here principally to discuss not the legislation but the health. consequences of smoking. Senator PACKWOOD. Let me ask your personal opinion, not your administration position. Do you personally think these health warnings are necessary? 41 ; t r f i E{A.; nT. My personal opinion is that r rv%ent cigarette smoking and to encourag rcttve in accomplishing that goal, yes. ~•nator PACKWOOD. And you think they z rrtte packages and on the advertising? 1)r. f;kANtrr. I think that the evidence tl- t,rrAU,nal opinion, is that it has been effectiv ti•natur 1'ncxwoon. Thank you, sir. No ot -~•nator East. &•nator EAST. Ladies and gentlemen, I v the 1.:k1x,r Committee, welcome you here tl rririute your taking the time to come and think is a very important subject, not only the country that I come from but, of coursE conriderable national interest and concern. I t h in k t hat the two of you together somt tr;ulty ot the problem we face; that is, D ~robl~~m trom the standpoint of scientific c is!<e to pursue briefly with him, and then : botizx~:• ot course, in his position, the questi itv tor ,;overnment in terms of scientific ev it ougnt to do with it? Should it inform, s other thint;s, and so forth? t.•t me start, if I might, with this questio cawtiatton. My background has been in lavt rnci-x, r;oc:ial sciences, as opposed to your but there are certain common threads that ftt and that run through this. L•t me just state my position briefly, .our reaction to it. We all know that problc wrent,fic establishment of causation are, at .ubyrct matter, but quite frequently can be. plVs -Solutions do not yield themselves up '00rd we• might use to identify this problen cawsation in so many areas. A word that I know is used a lot in yc •ncm natural sciences, medical science, ai the social sciences and behavioral sciences, that in any given context in which you ar entlfic cau5ation, what greatly ups the pro o( determining and establishing causation b". and particularly the independent var cxtnnot isolate. N'r have a terribly difficult time with th (n polrttcs, for example, behavioral studies "lormous problem of isolating all the varit hold thern constant, and so we try, at lea: tt+- txhavioral science there, to apprecia t:`nA thnt we have frequently to establish A hroblem I have with this, and with t' :u•= Kencrallv , on this question of scientif ctampl~., in the findings that we are asked '"id that ('ongress finds that-somewhat 1 :rnr~ tt~ smoking is the largest preventa 03607568

States and ICD-9, the World Health Organization's International Classificati of Disease, both include "Tobacco Dependence" as a drug dependence disorder. Thus, five major national and international reviews of this question, which N involved the most knowledgeable and experienced authorities in the area, have all reached the same conclusion: cigarette smoking is an addiction. "Dependence"in the classic sense is indicated by (1) persistent regular use drug, (2) attempts to stop such use which lead to discomfort and which often result in termination of the effort to stop, (3) continued drug use despite damaging physical and/or psychological problems, and (4) persistent drug seek behavior. People are drug dependent when a drug takes over and controls their ability to choose to take the drug or not. The relative degree of dependence between the two most widely used licit drugs in this country--alcohol and tobacco--is demonstrated by the fact that whereas the large majority of Americans who use alcohol are subjectively and objectively able to satisfactorily control their level of use, and only some 10 percent lose control. The opposite is true with tobacco smokers: the great majority of smokers report they would like to smoke less, or quit smoking, but find it very difficult or Impossible to do so. Data from the National Center for Health Statistics tell us that 99 percent of those who say they smoke tobacco, smoke regularly. Seventy percent of those wh d report current smoking, say they smoke more than 15 cigarettes a day. Nine out of 10 smokers say they would like to quit smoking. Unfortunately, between 80 and 85 percent of current smokers who have ever tried to quit say they have been, unable to do so for more than three months. Smokers spend time, money, and a lot of energy on a behavior they would rather not engage in. This view of 490,,,,M,r, •s consistent with how we use the term 'dependence' • uWq M ,i-~roi and cocaine. supported by NIDA--are currently explori ++e ask of any drug-using behavior: what factors .,,,•!, e.:er+mentation or use; (2) the progression from casual %* ,"„ !r, comoulsive use; (3) the maintenance of abstinence; ,a.! ;. ,.l . :P. ta. a.+r •-f tesearch findings to date implicate nicotine as the ncaet+in- ~, and maintaining dependence on tobacco. This resul ti,werful biological and psychological effects, which i.*.%0,.rlt+cn ot the release of a number of substances (norepinep qrowth hormone, cortisol, vasopressin, and probabl .ww...n+nl; the Droduction of behavioral arousal and EEG alerti ts. •!ct t)at it Is one of the most rapidly metabolized of all i-rltt!*CeS. ••:.c'-* is a csychoactive drug. That is, it influences subjec %-swa.'.r. 'sa all psychoactive drugs lead to dependence or crE ta r.a.+l're~s, for example, are powerful drugs which do not do a+n e!'a+ +esearch Center has developed a test --the ARC Invem a«r+e.ty n.antifying psychological and/or subjective drug efff »s•+, tl!"s test has been administered to over 3,000 individua c+.q aouse histories. A major finding of current NIDA '• ~'•~'ti ,r.horia sub-scale of the ARC Inventory, is the mark

William Pollin, M.D. Director National Institute on Drug Abuse Alcohol, Drug Abuse, and Mental Health Administration Public Health Service Department of Health and Human Services before the Committee on Labor and Human Resources United States Senate on Tuesday, March 16, 1982 •;-,e^bers of the Committee, thank you for ,eeictive properties of tobacco smoking. :.estion and of research conducted in our .. •, r tolat cigarette smoking represents a protc or... •. •.. •, ••ne most widespread example of drug deper r r.v~ :e the evidence for these conclusions. -.c .•n frequent suggestions in the past from bo, ~. e. reat the auestion of the possible addictive nat ..~r ~.. ... :n July 1978, NIDA and the National Aca( 6~mtsraa.wi a cinrerence which explored the background ~ +am r.ac..a-as of that meeting "Cigarette Smoking as a .,aw +•it ~• :articipants has been submitted for the re, .a'r a.::A ••:onsored Technical Review was held to spe• •.es.!s ':. :•qarette smoking an addiction?"; it concl 'tr p•.:c. ~~,.rng behavior should be considered a form •e forrn of cigarettes, an addicting substan «+: 'na ;articipants, has also been submitted. M Lo.•.ory Council on Drug Abuse passed the foll ""e National Advisory Council on Drug Abu •.cornends to the Surgeon General that wo '" the warning on cigarette packages. Th read 'The Surgeon General has determined ~--oktng is addictive and dangerous to yor. .•th these conclusions and recommendations i titandard diagnostic manual of psychiatric c

75 I ingredients, or additives. The chief concern is additives. The Public Health Service has been unable to assess the relative risks of cigarette additives because information was not available from manufacturers as to what these additives are".1 In the highly competitive world of cigarette marketing, ilavor additives appear to have been used increasingly to sticulate consumer acceptance of a product containing reduced seounts of tobacco. These additives are not regulated by any agency of the federal government, and public disclosure of substances currently in use is not required. To my knowledge this is a unique legal loophole, i.e. other industries whose products are taken into the body are regulated and manufacturers are held responsible for the effects of their products. It should be emphasized that the cigarette is a delivery vehicle which results in the prompt distribution of thousands of tobacco smoke consti- tuents throughout the body. The evidence concerning the harmful effects of cigarette smoke is compelling, e.g. toxicity, carcinogenicity, mutagenicity, and possibly teratogenicity. What additional effects tobacco additives and their combustion products may exert on the chemical Composition and biological activity of smoke are not known. Their presence in tobacco products represents an unmeasured risk for the active smoker, the involuntary smoker and the unborn child. 95-077 0-82--6

.. There are cogent reasons to anticipate adverse interactions between tobacco additives and other smoke constituents. For example, smokers who are exposed to certain medications, e.g. oral contraceptives and to certain workplace substances, e.g. asbestos, face greatly increased health risks compared to both nonsmokers and smokers who are free from such exposures. In 1972 the R.J. Reynolds Tobacco Company published a booklet listing several hundred chemical substances or natural products "used in the compounding of tobacco flavors".2 The classes included organic acids, amino acids, alcohols, aldehydes acetals, amides, amines, anhydrides, esters, ethers, pyrones, imides, ketones, lactones, phenols, pyridines, quinolones, indoles, pyrazines, pyrroles, sulfur compounds, herbs, essential oils and extracts. The Hunter Committee's Second Report listed a few hundred substances approved for use as tobacco additives in the United Kingdom.3 Unfortunately, these lists do not provide specific information on the types and amounts of substances actually being added to tobacco products. Many smokers believe that smoking lower "tar" and nicotine cigarettes is not harmful. Senate Bill 1929 will focus attention on the risks of smoking in general and on the potential risks posed by tobacco additives. This bill will also mandate disclosu of tobacco additives, which is a first step in the assessment of health risks. I applaud and support this bill. .-partment of Health and Human Ser Consequences of Smoking - The .:,,:ctte. DHHS. Publication No. ( .,r,iwell JC et al: Tobacco Flavorir .coducts. R.J. Reynolds Tobacco Cor. ~;orth Carolina, 1972. r Renort: Developments in Tobaccc ,.,sibility of "Lower-Risk" Cigaret- ,_3tionary Office, London, 1979.

35 o It is now clear frorn a large number of epide-niolozic studies--both retro- spective and prospective--that smoking is causally related to at least 30 percent of all cancer deaths. This means that aporoximately 129,000 people a year die of cancers related to smoking. o The causal relationships are strong. If we just look at lung cancer, the major cause of cancer death among U.S. males, a cigarette smoker is 10 times more likely to die of this disease than a nonsmoker. And this risk increases with the number of cigarettes smoked--a direct dose- response relationship. :;ve Dulmonary diseases (COPD) today represer or causes of death, now ranking fifth. In 19f -.:r~io-nulmonarv Disease o For the first time, two preliminary epidemiologic studies are suggesting an increased risk of lung cancer in nonsmoking wives of smoking husbands, implicating sidestream smoke as a cancer risk factor. o We are encouraged by the figures on people who have been able to quit smoking, most of them through their own efforts. In 1965, 42 percent of adults in the United States smoked. In 1980, the proportion dropped to 33 percent. I would like to mention one program of the Office of Cancer Communications because we are proud of its success. Based on the well-documented evidence that counseling by a physician can motivate smokers to quit, the office developed a "Helping Smokers Quit Kit" for physicians to use with patients. More than 135,000 of these kits-which include posters for the waiting room, take-home materials for smokers, and information on counseling the smoking patient--were distributed. In fact, the kit was so well received that a similar one was created for dentists. This project was endorsed by the American Dental Association, which is cooperating with us to distribute the kit. Staff are now working with the American Pharmaceutical Association to develop a similar program for oharmaci 4 ..-jte !s interested ir. pursuina some ne ,.icence that people who smoke low tar a: z oenavior--inhaling more deeply or coverin e'ilters. This is thought to be an attempt cer.ne yield. We plan to take a look at tiis s~re confirmed, it would imply that smokers : e:r exposure to nicotine and in fact may a ;',ar•nful combustion products such as hydocar ,r, :iseases. Almost three million Americans nc :.errioiv debilitating disease. More than seven n-. ,ronic respiratory diseases account for approxima for lost work hours. And, the evidence is ~ >> "... ':;are*.te smoking is the chief culorit in the o - '•~t• ::St~)rS. r~.r ^-ss ::r some time provided us with data demonstratir ~-cr'ai :v rates from chronic bronchitis and emphy "- :`a.e :ar .ess pulmonary function than nonsmokers. Du .i.e a: o aotained a far better understanding of the :cinq t:ne destruction of elastin, a major struc • J+• s acverseiy affected by cigarette smoking. An, -',as .een reported which suggests that the sma. `= 1 Le saverseiy affected in healthy nonsmokers if -s4Ir. c -. .e :rpm others.

47 Now, again, getting back to information, I think information of all kinds should be passed out, good science and good information. I ; simply say, Dr. Brandt, when over 90 percent of the American people know the health hazards of smoking and we can continue to , inform them in reasonable and prudent and responsible ways, what •, else can Government genuinely do, except in the case of Sweden r;where they have announced that they want to prohibit it? I do not think, in a free society, we are quite prepared to go that far. I am -_4ure you gentlemen are not; I would not be; and there are other areas where I think we should not attempt to prohibit-you know, : we are not going to force people to jog; we are not going to force them to cut down on salt, sugar, obesity. There is something about free choice. Informed people, yes, but < I they make free choices. I don't know how Government can do more than that and be responsible and be consistent with the history of what we consider to be responsible Government in the Anglo- American tradition. The centralized Socialist approach in 0 Sweden-we are not trying to emulate that in this country. I think to use that as a model is chilling, in and of itself. I had not greatly , i admired Swedish Government, quite frankly,_ and I am sure Sena- tor Hatch does not, either. I just wonder, can we inform them any more than we have, Dr. Brandt? Dr. BRANDT. I think we must continue to inform them, particu- larly as new evidence accumulates and new information is availa- ble. I think it is our responsibility to do so. I do not think that our preventive programs should be aimed only at cigarette smokers. I think, clearly, that alcohol abuse, drug abuse, the abuse of certain _ other elements in our society like salt, and so forth, need to be ex- plained and the best scientific evidence brought to the American people so that they can decide on healthy lifestyles. However, at the same time, I think it is important that we con- tinue these efforts and that we target them at those areas that `.. have the greatest possibility of being prevented, such as infectious diseases and things of that sort where we do target our efforts, and ~` at leading problems. I think that the evidence is absolutely over- whelming now, and this is not something new; this has been going on since the 1930's when the first reports linking cigarette smoking '~-with cancer came out. It just seems that it is clearly the single "4most preventable cause of human suffering and illness in this coun- try, and I think, therefore, it behooves us to make that a high pri- :ority. I am not arguing that we should make it only cigarette smoking. `;Obviously, the very thing you are talking about, people who smoke and drink and drive too fast; clearly, all of those things have to be Pointed out to them. I do not have any argument that people have to have the right of choice, and I in no way would endorse prohibi- tion of cigarettes because, pragmatically, I do not think it would work, anyway, but I still think it is important. I think we have been responsible in our efforts to do that. I think this is a responsible scientific document. I think the information O ~ that we make available to the public is not intended to terrorize or otherwise; it is intended to inform. I think that we have to contin- O ~ ue to inform them. We have to give them the latest kind of infor- C11 I ~ Cl1

38 areas and other areas to intervene to in fact prevent the deve ment of disease, and I think the evidence is just irrefutable th you get people to stop smoking, the risk of their developing t , diseases goes down dramatically, so that it seems clear that; action that is warranted is in fact to encourage people to smoking or not to begin because their risk is certainly reduced. The CHAIRMAN. Thank you. Senator Packwood. Senator PACKWOOD. Dr. Brandt, I was struck by the similari your testimony 5 days ago before Congressman Waxman's co tee and your testimony here today. Indeed, as I go through the timony there and your testimony here, it is clear that it was t on the same automatic typewriter. Page 1 is identical; page identical. You expand your testimony a bit in the House, but also have in the House testimony: We support the bill's requirements for strong health warnings because we be they would increase the public knowledge of the hazards of smoking and m _ possible for smokers and potential smokers to make better informed judgment whether to continue or begin smoking. But the typewriter seems to have run out of ribbon before finished your testimony here. Is that still your position? i Dr. BRANDT. The position is that we certainly support stron health warnings about cigarette smoking, yes, sir. Senator PACKWOOD. Well, now, in the testimony in the Ho you said, "We support the bill's requirements for strong he " warnings. Is that still your position? Dr. BRANDT. Well, I think that what we are concerned with, tried to expand in some of the questions and answers, is the cept of having stronger health warnings. I think, in that testimo you will find that we disagreed with some of the specifics of t bill, and in fact the reason that the testimony today is different because we addressed it strictly to the health consequences and to any specific piece of legislation. Senator PACKWOOD. Well, now, let me ask you this. Is there change in the degree of your support for this bill as opposed to House bill, which is indeed a slightly stronger bill than this? Dr. BRANDT. I am sorry? Senator PACKWOOD. The House bill has two provisions in it t this bill does not have. One is allowing private suits to enforce remedy on labeling disclosure, and the other is public disclosure , the cigarette contents, whereas ourr bill does not have the priv8 suits and it has private disclosure to the Federal Trade Com sion. But, most specifically, I am curious if you still support the bi requirements for the strong health warnings. Dr. BRANDT. We support having stronger health warnings, y sir. Senator PACKWOOD. Is there any difference between your positid last week and this week on the health warnings? Dr. BRANDT. I am sorry, on the health warnings? Senator PACKWOOD. On the health warnings on the packages cigarettes. Dr. BRANDT. I don't think there is any difference in that we ce tainly support stronger health warnings and, furthermore, a to 39 P"Vrnm ot public education, which the Public tcrr:ptrnr; to carry out. ;wn,Itor 1'AcKwooD. Let's go down our bill, t vhrch parts of our bill the administration par+a tnev want to change? IIr l;it.%Nu'r. I cannot tell you which parts }`ackKocxi. because in fact the bill report for t cunprt.teci. to my knowledge. Therefore, I can c c,rfrt ot titruni;er health warnings. .`wnator PACKWOOD. Say that again. The bill Dr iinANu-r. To my knowledge, the bill repo p4rt-<j: c,t least I have not been provided with : ..•n:rtor I'ACxwooD. The bill report. Do you i mwnt ' Dr Isrc.a`nT. The analysis of it, yes, sir. :x•nat„r PACKWOOD. Well, all right. You did trs. }fuuk uill's requirements for the strong hE Ur. 'ttrcaxrrr. Well, we supported that bill v t!tat are inciuded in the testimony and in the ( :~+•nator PACKWOOD. All right. Let's go th: t,oru. Ih) ' you support the mandatory requiren tr.e wnrnrni;s on the cigarette package? Ih IikA`nT. If that is the most effective v .Vw Srnatur YACKwooD. Do you support that? 1)r ItrtANnT. I personally support the idea ,trancter nealth warnings. Senator !'AcxwooD. Does the administration [lr fikA`rrr. As I say, the specifics of this !hat vou are talking about-certainly sup .truni;er health warnings. Yes, sir. ti.•nator I'ACxwooD. Doctor, then tell me rswnnM tx•lore Congressman Waxman's commi' h0l'-s recauirements-the bill's requirement: warnrnu;s, because we believe," and so on. 'A I1r NKAti Irr. It means-- %enntor I'ACxwooD. Do you know what is in f)r likANrrr. I am sorry? wnntor 1'ACrcwooD. Do you know what is in I)r IIRAtitrr. Yes, I do. '-nator I'ActcwooD. And do you know hc •arntngs are in that bill? hr HuANrrr. Yes, sir. ',~-nntor I'ACKWOOD. And you know that th eitrhtly -4•;rkened from that, not the specific :. .lu;htly weaker than the House bill. I>r EircnNnr. You will note also, sir, that '"Iur,tod or we disagreed with the specific %k •^•s;* and in fact suggested that if warnings ar 'rttv packages, that the Secretary of HHS b •!:o %p.rrfic wording. N•natur I'ACKwooD. Now, where does it say f)r 13rtANuT. I don't have a copy of the testi

, pu!re,an and members of the Committee, thank you for the opportunity to ttfy on the addictive properties of tobacco smoking. On the basis of our tti of this question and of research conducted in our own laboratories, it is cwlusion that cigarette smoking represents a prototypic dependence process VN /i in fact the most widespread example of drug dependence in this country. T<* .e sumarize the evidence for these conclusions. `:hr* had been frequent suggestions in the past from both research and policy #Mw cn that the question of the possible addictive nature of cigarette smoking . ~elraCed review. In July 1978, NIDA and the National Academy of Sciences tNponsored a conference which explored the background of this issue: a copy of W proceedings of that meeting "Cigarette Smoking as a Dependence Process," oft list of participants has been submitted for the record. Fir)ally, in August 1f79, a N1DA sponsored Technical Review was held to specifically review the 4mtton "Is cigarette smoking an addiction?"; it concluded, and I quote, 'Ciyarette smoking behavior should be considered a form of addiction, and ta0itco in the form of cigarettes, an addicting substance." A summary of that Ifwtew and the participants, has also been submitted. More recently, the Rational Advisory Council on Drug Abuse passed the following resolution: "The National Advisory Council on Drug Abuse strongly recommends to the Surgeon General that words be added to the warning on cigarette packages. The label should read 'The Surgeon General has determined that cigarette smoking is addictive and dangerous to your health'." Coeststent with these conclusions and recomnendations is the fact that DSM-III, tlre current standard diagnostic manual of psychiatric disorders in the United

57 -5- pKy may exacerbate the user's tendency to continue its use. Tolerance, e, reduces the pharmacological effects of drugs and may lead to more lralth and social consequences for the user. Tolerance has been rratad for some of the effects of smoking cigarettes and also to the of many of the components of cigarettes. As most of us know, nausea and adsinistration of higher doses of the drug, which in turn may produce .ass is common among novice smokers, but disappears with tic talerance can be demonstrated in smokers to various Otte seake (for example, nicotine), as well as to a wide w barbiturates and chlorpromazine. As with other drugs wral signs do appear when heavy smokers abruptly quit. litty in withdrawal symptoms, but it is not unusual for 9 experience. components of variety of drugs of abuse, There is some a smoker who stops ty to show a decrease in excreted epinephrine and norephinephrine and its l/tes. Furthermore, there is a decrease in mean EEG frequency, in heart . Mn increase in appetite and weight, and an impairment in performance on <-IMPAoNIotor tasks and i n concentration. ?*tttidwls may feel anxious, irritable ~ 11l0r/Qwls who are trying to stop feel -1N1ti p. Disturbance in sleep may occur and the and even aggressive. Finally, most an increased craving for tobacco O. OM1tran, it is likely that drugs such as nicotine and cocaine, which are .~a. V" prerfully habit forming, and yet do not show Irrefutable evidence of being 00#19it411y addictive, may not do so because we have not yet learned enough about w Witionship between brain, drugs, and behavior to be able to identify those O"1C41 systems which are at the basis of compulsive drug use patterns. The "Metant Point which must be stressed in the discussion of psychoactive drugs

, 45 itl -leg ~ n w th ha la did rus vho its,' vas the ver is, the ; rst ink ; a, I hat I do l ow ant to he 1 it his ilk ~;_ I would not by any means limit the educational effort in refer- ~ toce to smoking to just cancer. It has got to be far broader than ~Wt. With your interest in behavioral sciences, sir, I think you => would be very pleased to work along something like this, because =.what we need is a method of understanding how we can overcome peer pressure in young people who are about to smoke, giving them - the facts of health and then working on them psychologically so they don't start, because if you don't start, then you never have to quit. ~ I could talk on and on about this, sir. I would just conclude by F one thing and say that your comments about other substances have a great deal of truth to them, and I would say that I do eat bacon and I do drink drinks with saccharin in them, but I do not smoke. The CHAIRMAN. Thank you, doctor. Thank you, Senator East. Dr. Brandt and Dr. Koop, you have both indicated, at least in Dr. Brandt's statement, that the deaths as a result of smoking are 300,000 a year compared to deaths from all injuries of 105,000. You indicated that smoking is one of three major independent risk fac- tors contributing to coronary heart disease, arteriosclerotic periph- eral vascular disease, that smoking is a major cause of cancer of lung, larynx, oral cavity, esophagus; it is a major cause of chronic bronchitis and emphysema; it is a contributing factor in cancer of the urinary bladder, kidney, and pancreas; it is associated with peptic ulcer disease; that maternal cigarette smoking is associated aith retarded fetal growth and increased risk of spontaneous abor- tion and prenatal death and slight impairment of growth and de- velopment during early childhood. You also state that cigarette smoking acts synergistically with oral contraceptives to enhance the probability of coronary and some cerebrovascular disease, that it acts synergistically with alco- hol to increase the risk of cancer of the lung and with other risk factors to enhance cardiovascular risk. Now, that sounds pretty serious to me. Do the health conse- quences of smoking warrant stronger warning labels on cigarette packages? What do you think, Dr. Koop? Dr. Koop. Well, I think it is broader than just cigarette packages, sir. I think it requires broader education across the whole board. As I indicated to Senator East, I think, if we could stop people from starting rather than stop them from continuing, we would be way ahead. So I think we have got to broaden our whole educational outlook, not just to one aspect. The CHAIRMAN. So labels are one aspect of it? Dr. Koop. Certainly. Senator HATCH. And certainly one that ought to be taken. Senator Packwood. Senator PACKWOOD. I want to ask Dr. Brandt another question. In your testimony before the House, you had this statement: "We believe that the system recommended as proposed section 4(b) might be more effective if all of the proposed warnings appear on ~ each brand simultaneously, so that the smoker does not know W which warning may appear on the packages he buys. This is the m system in use in Sweden where 16 different warnings appear on 0 packages at a given time. Is that still your position? -1 Dr. BRANDT. It is certainly my position. ~ W

26 The CHAIRMAN. Our first panel of witnesses represents the ad- ministration. And we are very pleased to have them with us. They are Dr. Edward Brandt, the Assistant Secretary for the Depart- ment of Health and Human Services; with Dr. Brandt is Dr. C. Ev- erett Koop, the Surgeon General of the United States of America, of the Public Health Service, and Dr. JoAnn Luoto, the Acting Di- rector of the Office of Smoking and Health. So, Dr. Brandt, why don't we begin with you? STATEMENT OF EDWARD N. BRANDT, JR., M.D., ASSISTANT SEC- RETARY FOR HEALTH, PUBLIC HEALTH SERVICE, DEPART- MENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY DR. C. EVERETT KOOP, SURGEON GENERAL, U.S. PUBLIC HEALTH SERVICE AND DR. JoANN LUOTO, ACTING DIRECTOR, OFFICE OF SMOKING AND HEALTH Dr. BRANDT. Thank you very much, Mr. Chairman, Senator Packwood, Senator East. I am pleased to submit to you today this statement of the Department of Health and Human Services on the health effects of cigarette smoking. As you pointed out; I am accompanied by Dr. C. Everett Koop, the Surgeon General of the Public Health Service, and Dr. JoAnn Luoto. Let me begin by presenting a capsule description of the health effects of cigarette smoking and then a somewhat more detailed de- scription of smoking and its relationship to cancer and cardiopul- monary diseases. In summary, cigarette smoking is clearly the single most impor- tant preventable cause of premature illness and death in the United States. Estimates of the number of deaths related to smok- ing exceed 300,000 annually. One may compare this figure with the 105,000 deaths that occur each year as a result of injuries, 20,000 deaths from homicides, or the 40,000 infant deaths. Cigarette smoking is one of the three major independent risk fac- tors for coronary heart disease and for arteriosclerotic peripheral vascular disease. It is a major cause of cancer of the lung, larynx, oral cavity, and esophagus and a major cause of chronic bronchitis and emphysema. Maternal cigarette smoking is associated with retarded fetal growth, an increased risk for spontaneous abortion and for prena- tal death, and slight impairment of growth and development during early childhood. Cigarette smoking acts synergistically with oral contraceptives to enhance the probability of coronary and some cerebrovascular dis- ease; with alcohol to increase the risk of cancer of the larynx, oral cavity, and esophagus; with asbestos and some other occupationally encountered substances to increase the likelihood of cancer of the lung; and with other risk factors to enhance cardiovascular risk. Mr. Chairman, cancer was the first disease to be associated with cigarette smoking. As Dr. Koop pointed out in introducing our 1982 report on smoking and health a few weeks ago, reports linking smoking and lung cancer began appearing in the scientific litera- ture as long as 50 years ago. In 1964, when the Surgeon General's Advisory Committee's report was issued, lung cancer in men and 27 chronic bronchitis in both men and women wE which the committee identified as being eausec Ing. The evidence which links cigarette smoking cancers was reviewed in the most careful detai ;ust issued. Today, 18 years after the 1964 repol ezperience and enormous amounts of new resE ble for science to conclude that cigarette smok of cancers of the lung, larynx, oral cavity, and it is a contributing factor in the developmer bladder, pancreas, and kidney. Luni; cancer accounts for one out of every and ti5 percent of these are due to smoking. Ov aU percent of all cancer deaths are attributabl ing. A subject which was hardly touched upon i the effect of smoking on women and, in the ca: in~,~. its effect on the fetus and infant. In 1980, the Department's report to Congress. Its co, women are not immune to the damaging effi that the lesser occurrence of smoking-relat women smokers is a result of their having la bchind men in their widespread use of cigarett( The 19r0 report further established that cii major threat to the outcome of pregnancy and baby. Another public health question, now enorrr. lates to the use of the new, low-yield cigarett( )ect of the Department's 1981 report. The conc though there is no safe cigarette, smoking c yields of tar and nicotine poses a lower risk smoking higher yield cigarettes, provided ther, change in smoking patterns. The 1982 report noted that the more than cancer are the second leading cause of death : It further concluded that smoking is causally percent of all cancer deaths and that these rE strong. [.et me mention one program of the Office oi tions, because we are very proud of its succes documented evidence that counseling by a ph smokers to quit, the office developed a kit I with patients. More than 135,000 of these kit~ ed. The kit was so well received that a simil. created for dentists. C hronic obstructive pulmonary disease toda. t~+t growing of the major causes of death, n 19SO. :i.i,000 Americans died of pulmonary d lion Americans now suffer from emphysema, : dl-lwa.se. The evidence is substantial and uneq "moking is the chief culprit in the onset or ea "ema and chronic bronchitis. During the past 10 years, we have obtaine standing of the mechanisms of lung damage, 03607554

aet lis :ts used led sev t these; .tl ed sub-'. I King- de spe- 73 information on the types and amounts of substances actually added to tobacco products. Cll conclude by pointing out that many smokers of lower tar and ine cigarettes believe that as long as they use the lower tar nicotine cigarettes this habit is not harmful. S. 1929 will focus ntion on the risk of smoking in general and on the potential posed by tobacco additives. This bill will also mandate disclo- re of tobacco additives which, in my judgment, is a first step in ns.qeGsment of health risks. I applaud and support this bill. e prepared statement of Dr. Holbrook follows:] r

tim at ~ h 0 Q © I an= ou id iow ion, so mt. ere ats on hat we lth n't )ne ab- 3on zgs ' ec- by he nd nd an- big he )re 43 r t Government information on that. I certainly hope we would not -==hnve our salt shakers taken away from us. The same goes for our ~Alu~Car bowls. We will want more information on that. F I think the scientific findings of the Surgeon General, as turned # over to Dr. Brandt and his department, and the great work that ~'Secretary Schweiker is doing to inform us of those things, combine to perform a valuable public service. It is a proper bringing togeth- er of science and Government. But again, when we get into this prohibitional mentality, and everybody is sucked into the mael- strom, including science, and asked to conclude things that, if you } seally got them down and sat them down and got them in the corner and said, gentlemen, as you understood science in medical ,tchool, as you understand the very difficult and intractable world of establishing scientific correlation, we are uncomfortable with it. We may in fact have prostituted ourselves a bit in order to be a xpa rt of this so-called great movement that has great and good and ' honorable intentions. In the case of Dr. Brandt-and then I will let the two of you re- spond to it-in terms of the responsibility of your department-and <I appreciate there is one, and I might note that I appreciate that the Department of Health and Human Services will, of course, have to carry out the law that we pass, and that is your responsi- bility. Secretary Schweiker came from the Senate and is a very dis- tinguished person. He is doing it and would be expected to do it. I :.have no quarrel with that. I am not asking that anyone pull punches in terms of the laws passed by the legislative body. You ought to do it, and I know you intend to do it and are doing it. But on this matter with the bill and what we are trying to do now, we are trying to take these so-called alleged scientific findings and do something with them now in the policy public arena. That is your responsibility; that is the Department of Health and Human Service's responsibility, and I think you do have a responsi- bility on a whole range of health matters. The CHAIRMAN. Senator, your 10 minutes are about up. Senator EAST. Just let me ask one more question, Mr. Chairman, `~and I will stop. I wonder, Dr. Brandt, in terms of information ` which you are stressing, and I think rightly so, when the figures ;, show, as they did in the House hearings, that 92 percent of the ~.American people know there are health hazards involved in smok- F ing, what, honestly, else could Government do except to begin to prohibit? I don't even think these gentlemen are prepared to go to : those lengths. I am just asking that the Surgeon General's department stick with general scientific causation, that the Department of Health and Human Services, in the policy public arena, stick with infor- mation dimensions of this, and I think we can have a responsible health policy in the United States on smoking or anything else we choose to take up. So let me rest on that, Mr. Chairman. If they might respond briefly to that, I would appreciate it. Dr. Koop. Well, Senator East, I would not take issue with most of the things that you have said and, of all people that you know, I am more anxious than any to be certain that anything that the Surgeon General says in the future carries the absolute utmost 95-077 0-82--4

"verat studies implicating nicotine's role in the subjective aspects of smok- N weU as the frequency. For instance, subjects have been given cigarettes t nicotine (or with greatly diminished nicotine) and they fail to report customary enjoyment of smoking. Some subjects seem to enjoy the low- ci`arettes, but it is possible that they are able to extract more nicotine gWging their manner of smoking (e.g., increased inhalation). Another of experiment involves delivering nicotine to subjects via another route of tration besides inhalation. Subjects of these experiments do not experi- 40pe Hft usual degree of satisfaction that they get from their customary ciga- , although in some instances they do report some satisfaction from the lurther evidence implicating the role of nicotine in cigarette smoking is by human studies that have directly measured cigarette smoking vlor These studies have shown: (1) increases or descreases in nicotine w cigarettes are associated with compensatory changes in smoking which JMsd to mamtain nicotine blood levels within certain limits; (2) manipulation of WU.ry excretion of nicotine either upwards or downwards is also associated tisL tampensatory changes in smoking which tend to maintain nicotine blood bVels rnthut certain limits; (3) pretreatment with nicotine (intravenously or Mflly) produces compensatory decreases in smoking; and (4) pretreatment with SdtoGUe antagonist produces elevation in smoking. As with other classic drugs of abuse such as the opioids and sedatives, MKtaace and physical dependence are important characteristics of a drug because Ot)L may exacerbate the user's tendency to continue its use. Tolerance, for Ualaoet, reduces the pharmacolnrticil offecrs of drugs and may lead to more 6quenl a,hninisu•nl.iun of hi/;her (I-sc.+ ,f Ihf. drIiIf, wbirh in [tn•n may pru li.ice St7ater risks of toxicity or untoward effects on the user. Tolerance has been demonsl.r:itcd f r ihc cIY•cts -,f ,nwkinl; cignrrites rd also to the effects of many of the components of cigarettes. Nausea and

® 85 -2- The consequences of past poorly informed decisions are quite familiar: 340,000 premature American deaths each year due to smoking, health injury due to smoking to 10 million Americans, and, - a cost to the American public of $41 billion in medical care expenditures and lost economic productivity. Can there by any question about the stark fact that cigarette smoking is the single most preventable cause of illness and the single most preventable cause of death in the United States? Thirty thousand studies link cigarette smoking to illness; six surgeon generals have repeatedly documented the overwhelming scientific evidence that cigarette smoking causes cancer of the lung, larynx, esophagus, urinary bladder, mouth and pancreas, that cigarette smoking causes emphysema and chronic bronchitis, that cigarette smoking is associated with retarded fetal growth and increased risk for miscarriage and prenatal death. Even so, the message is still not reaching many Americans. 54 million living Americans have already made the decision to smoke cigarettes and continue to smoke today. They are destined to become tomorrow's medical statistics and economic loss. Tragically, a substantial number of Americans are still not fully aware of the dangers of smoking, and take up the habit ignorant of the facts. If the 54

i 67 ~.3.< T}Ie CHAIRMAN. Well, thank you, Dr. Pollin. As I understand it, you need to leave to go to a funeral. Dr. POLLIN. That is right. > The CHAIRMAN. When is the latest you need to leave? _~ Dr. PoLLIN. I have at least 20 to 25 minutes, Mr. Chairman, that J could stay. °= The CHAIRMAN. Do you have any questions? ~" Senator PACKWOOD. I have only one question. That is, on page 2 of your testimony, where you talk about adding the words "addic- t{ve" and "dangerous," are you suggesting that to the present label ~ or to any other additional labels that we may choose to legislate we ~afhould add the word "addictive"? - Dr. PoLLiN. The National Advisory Council, which passed that ~:;itaeolution, was suggesting the addition of the word "addictive" to ~"the present label. I would conclude from the nature of their discus- 0~:,:pon that they would think it would be important to have the addic- c~-Y dve warning part of any campaign emphasizing the health risks of t-;pnoking cigarettes. Senator PACKWOOD. Is that your personal conclusion, also? ` Fr-' Dr. POLLIN. Yes, it is. ~. ~ Senator PACKWOOD. Is it the administration's position? Dr. POLLIN. As Dr. Brandt indicated today, the administration is < stronRly in favor of stronger health warnings. The specific mecha- 1 tiems which may most optimally achieve that are still under con- "` -dderation. °~ Senator PACKWOOD. Thank you. The CHAIRMAN. Dr. Pollin, let me ask you this question. We ap- preciate your expert testimony, and you have concluded in front of this committee that tobacco is an addicting substance and should be treated as a drug. • In your opinion, why has tobacco escaped being regulated like other drug substances? Dr. POLLIN. I am sure that there is a complex political history, and I don't really feel equipped at this point to analyze the balance of forces which has led to, indeed, a very different and unique ~tteatment for tobacco as compared with other substances in this '4ountry. `' W''TII6 CHAIRMAN. You have a distinguished background in behav- :' 1oral science as well. Do you believe that requiring multiple health tlMarnings is going to be an effective method of public education, ltrld do you believe that these types of warnings will result in less MeoDpleP~ o~kNng bel eve that knowledge of health consequences, in this as in any other field, is clearly not a simple either/or proposi- tion where people either know it or don't know it. Whenever we at'e concerned with the reasons that lead to behavior change, we are dealing with gradations and multiple levels of knowledge. I atrongly believe that, as is demonstrated by the American ad- rertising industry, which is perhaps one of the most effective be-O havior change instruments that man has developed, increasingCJ knowledge, increasing presentation of messages, varied presenta-M tion of messages, presentation of health consequence knowledgeO phich alerts an individual because it represents a new message~, rather than one which has become so well known that it is taken~ CJl

47 Senator PACKWOOD. Is it the administration's position? Dr. BRANDT. I think the issue of precisely how to go about effr ing the warnings, stronger warnings, is something that is currentl, being discussed. Senator PACKWOOD. Public health warnings are not new. N thaniel Hawthorne labeled Hester Prynne for the public to watc out for. I think what you are telling me, Dr. Brandt, is this. Yo. are a very good and very true man. You strongly support the labe " ing; you strongly support, perhaps, at least the Swedish syste and that was in your testimony last week. Between that time ah this time, somebody has indirectly talked to somebody in your d partment and said to tone the testimony down, and you are a go soldier and you have done so, and I am not going to ask you comment any further on it unless you want to rebut what I saying. I But it appears to me that the things that you personally belieV ' which were reflected in your testimony last wee and support , touched a sensitive near someplace in the administration, and th testimony today does not reflect quite that staunch support that w saw 5 days ago. No other questions. The CHAIRMAN. Thanks. Senator East, do you have any oth questions? Senator EAST. Thanks, Senator Hatch. I would like to at least give Dr. Brandt the opportunity to spond to the point that I was making earlier, and I had overrun m, time. Not to make you try to answer the unanswerable, and I suppos ' it will sound a little bit like a rhetorical question, but the pol again indicate, and I think commonsense and conventional observa ' s informatio tion would indicate that probably the Government program on the hazards of smoking has been the most widesprea and high profile, high visibility campaign of any health issue in the `t I would say transcending again the general pro United States , lems of salt, sugar, nutrition, obesity, high blood pressure, geneti ` auto safety, and a whole range automobile accidents problems , , other things that I know you have to deal with-and, of course, thl Surgeon General is rightly interested in them-but on this que tion of informing us, it strikes me that in recent years we hav seen that these things tend to feed on themselves. I think thi hearing and this bill are an example. We single out certain things, " and a certain obsession builds up about them. I think it tends distort the broad pattern of what makes for good health. In other words, if someone smoked 5 cigarettes a day, or 10, bti was a heavy user of salt, a heavy user of sugar yet was obese , drank too much, and drove too fast, one might really say, frankly; ' in a balance concept, their problem was not smoking so much as i was the combination of the other variables. I am just concerned about this obsession that we take smokin and raise it to the first principle of good health, and everythin else is sort of downplayed, and we go at it tooth and nail. I am no too sure that at some point we do not do a disservice to the Ameri can people in terms of distorting the whole range of things they'A should be weighing. \' .~. ::~ain. getting back to information, a;,,na: ~hould be passed out, good science : „n,p;v •;iY. I)r. Brandt, when over 90 pej i;rt<,w the health hazards of smoking intcrrn t ni•m in reasonable and prudent and t,,r c:in Government genuinely do, except ,, nf•ri• t h(•v have announced that they want thr:fk. In r free society, we are quite prepat .ur.• %()n ::entlemen are not; I would not b Art•A.M «r,(•re I think we should not attempt w.• are nut L;oing to force people to jog; we tr:rm !t) cut down on salt, sugar, obesity. "I ?wre is something about free choice. In: ttes rnake free choices. I don't know how G( tn.in tnat and be responsible and be consist %%(- consider to be responsible Gove Amrrrc:rn tradition. The centralized ',- ~.~.~i~ n-µeare not trying to emulate that to u.w.• th:rt as a model is chilling, in and of adtnrreYf Swedish Government, quite frankl tor If:rtch does not, either. I;.:,t ar,nder, can we inform them any r iSra^dt ' Ur lirtA`uT. I think we must continue tc tarf.• :rs nv«• evidence accumulates and nev blr I ttunk it is our responsibility to do so. prnrrnttve programs should be aimed only th:nk. c•ie.:rly, that alcohol abuse, drug abu c4hrr vrements in our society like salt, and Plutnrd and the best scientific evidence br vwiwe so that they can decide on healthy 1if F{im-e••er. at the same time, I think it is tisture tho•.e efforts and that we target thE ha+r the greatest possibility of being preve drr'aw•% and things of that sort where we d( at :r,drnv problems. I think that the evid• •helmtnc; now, and this is not something n un +,nce the 19a0's when the first reports lii wtth cancur came out. It just seems that "rs.t preventable cause of human suffering trr, nnd I think, therefore, it behooves us t +ntt. I am not arguing that we should make it r7hvtou%lv, the very thing you are talking a 4r4 qrrnk and drive too fast; clearly, all of tu"nt-f out to them. I do not have any arg tn h.,tir thr• right of choice, and I in no wa3 tgm of crgarettes because, pragmatically, l -in~«a_v, but I still think it is importa 1 t'.,t:K «e have been responsible in our e th=• "% •r r(•.ponsible scientific document. ; "'at w'' tn;rke available to the public is not it is intended to inform. I think them. We have to give them o3s(Y7s74

The sustaining of these functions is considered an essential first in the preparation of Americans to make informed decisions t bmoking. Mr. Chairman, this legislation seeks only to provide the consum- with information that the consumer has every right to know. commend the passage of this bill to assure that the consumer ves the needed information on the tragic consequences of ciga- smoking. ?he C'oalition on Smoking or Health and the millions of volun- these private sector groups represent stand ready to work y with the Congress and government at all levels to see that information on the hazards of smoking reaches all segments of American public. _ Thank cou very much, Mr. Chairman. e prepared statement of Dr. LeMaistre with attachments fol-

~. APPENDIX To ~ TESTIMONY OF CHARLES A, LEMAISTRE, M.D. ~ EEHALF OF THE COALITION ON SMOKING OR HEALTH FORE THE COMMITTEE ON LABOR AND HUMAN RESOURCES UNITED STATES SENATE

i 87 -4- million Americans had never'taken up the habit approximately 30% of all cancer would not occur, and cardiovascular and pulmonary disease would have their toll substantially lessened. The provisions of S.1929 for rotational warning labels is a key element for making available to the American public brief, direct and fresh factual information necessary for informed decisio making. The present warning label has lost its effectiveness due to its generalized message and sameness over the years. Perhaps the most important provision is that which would make it unlawful to manufacture, import or package for sale any cigarette .a without disclosure of all chemicalsand substances used in production For reasons that the non-smoking majority of Americans find hard to understand, cigarettes remain one of the few substances consumed internally which are exempt from full disclosure of ingredients. Yet the facts are clear: cigarettes are burned and the products inhaled and taken internally with the result being the designation of cigarettes as the single most preventable cause of illness. Mr. Chairman, it seems certain that the disclosure provisions requiring full disclosure of ingredients including flavoring additiv will be attacked as excessive regulation or paternalistic. Quite the opposite has been true as history clearly reveals: ._i :)rug Administration has neatly : ruling that tobacco and tobacco ,r 'druqs' and therefore not subj 1it5C cr i'roduct Safety Act specifically . .> >nd tobacco products from the regi 1i:.ardous Substances Act exempts :rom the hazardous product provi u';;tances Act does not provide f ore properly raise the question: • •-,,e danzerous substances, tobacco ,;,portunity for responsible, vc :3r nany years. The only feasit ".;",re these disclosure provisi( -:-nce that tobacco and tobacco p, t':reatening.

61 TECHNICAL REVIEW ON CIGARETTE SMOKING AS AN ADDICTION: REPORT ON THE TASK FORCE ON SMOKING Cigarette smoking is the single most important environmental factor con- tributing to early death and disability in the United States. In 1978, 33 per- cent of the population, age 17 and over, were current cigarette smokers. - Induction into smoking begins in the great majority of individuals before 21 years of age and in over half, before 18 years of age. Despite teenagers' dis- claimers that their cigarette smoking can be voluntarily curtailed, the onset of smoking at this age results in a high probability of sustained lifelong use. Of teenagers who smoke more than one or two casual cigarettes, 85 percent escalate to a lifestyle of regular smoking. It is estimated that only 2 percent of smokers consume cigarettes on an occasional basis. In general, the number of cigarettet: consumed by smokers averages 30 per day. Each inhaled puff of cigarette smoke delivers a dose of drug to the brain resulting in 50-70,000 such doses per person every year. There is no other form of drug-taking that occurs with such regularity and frequency. Despite widespread public acknowledgement of the health consequences of smoking and the documented statements made by the great majority of smokers that they would like to quit, a very large number have been unsuccessful in their attempts. More specifically, of the 33 percent of Americans, age 17 and over, who are smokers, three out of four express a desire to quit. Indeed• over 60 percent of these current smokers claim to have made at least one serious attempt. During 1978 alone, over :10 prrcent (17 inilliom) :tttrmptcd to quit smoking. Unfortunately, the long-term prol ability of success on any given rluit attempt is only 20-25 percent. Even those who seek professional help and are successful in completing an organized smoking cessation program show a 60-80 percent return to smoking within nn,i to t.wo years. Fut•thermore• the proba- bility of relapse over time to cigarette smoking shuws remarkable similarity to " y ,.r--in tf:an cigarettes. ,Icehol and heroin use. It is of interest to : Mth heroin and cigarettes report that they woc oF ADDICTION AND AN ADDICTING SUBSTAI s.r." r-•••dtng to consider whether current evidence all ~tr.r•a <<!rir•tte smoking as an addiction, we must define •.re•.e vr,.. addtiction is a state characterized by the rep ,W s a„ .!. .•r.at ts toxic and leads to undesirable social cons a.N..raw+ •^.cb•.nasses other terms often used to describe nonme .ref s v,..... habituation, and dependence. An addicting sub a.a ss. • pharmacotogical properties leading to compulsive frrs •t ~nq ?rRan and/or behavioral toxicity; and (3) a ...rwsa .rn .,.:•.rse social consequences. In addition, this to+sar. -f..n ,.•• :nzestton of such substances is viewed by a ls ia ~v•r .. ~nj•eu•able. ,M1 M 'u... ~l••:. t,.en two general approaches to obtaining data a%.rar -..o ,n be viewed as an addicting substance: (1) +r.r+aaa sw aanc Y~:r se, and (2) studies of nicotine alone, sin 40r.Par.: wt>n. .uzRest that it is the most likely component in • a. ..r.:.c,.e „e A variety of behavioral studies of the ac 40'•+ +a*a •: r.•a ut ui animals. One of the methods used in cne addiction potential of drugs is the drug is a good correspondence between drugs tha +l.oratory animals and those that atre common . 1'iii t-nor:ttily holds iru<• f~~r 'lritl;s within II s.i-n•,av,tor stunulant class. Furthermore, drugs wh •+'.•ances are not self-administered by animals.

The Food and Drug Administration has neatly avoided itsF:nsibility by ruling that tobacco and tobacco products are neither foods' nor 'drugs' and therefore not subject to the Food, Druq uid Cosmetic Acts. The Consumer Product Safety Act specifically exempts by statute tobacco and tobacco products from the regulations of the Act. The Federal Hazardous Substances Act exempts tobacco and toFacco products from the hazardous product provisions of the Act. The Toxic Substances Act does not provide for tobacco and tobacco products regulation. One might more properly raise the question: why the special trcatment of these dangerous substances, tobacco and tobacco products? Mr. Chairman, the opportunity for responsible, voluntary disclosure has been present for many years. The only feasible course left is for Congress to require these disclosure provisions in view of the orerwhelming evidence that tobacco and tobacco products are not only barnful, but life threatening.

ference which explored the background of this issue. A copy of proceedings of that meeting, "Cigarette Smoking as a Depend- ~fdt Process," has been submitted for the record. 1n August 1979, a NIDA-sponsored technical review was held to fically review the question, "Is cigarette smoking an addic- ?" It concluded, and I quote, "Cigarette smoking behavior _ should be considered a form of addiction, and tobacco in the form d Cigarettes, an addicting substance." A summary of that review wd the participants has also been submitted. More recently, the National Advisory Council on Drug Abuse poee.~d the following resolution: Tbe National Advisory Council on Drug Abuse strongly recommends to the Sur- General General that words be added to the warnings on cigarette packages. The label Id read, "The Surgeon General has determined that cigarette smoking is addic- tiw and dangerous to your health." Consistent with these conclusions and recommendations is the isct that DSM-III, which is the current standard diagnostic mutnual of psychiatric disorders in the United States, and ICD-9, the World Health Organization's International Classification of Diaease, both include "tobacco dependence" as a drug-dependence disorder. Thus, five major national and international reviews of this ques- tian, which have involved the most knowledgeable and experienced authorities in the area, have all reached the same conclusion: Ciga- rette smoking is an addiction. "Dependence" in the classic sense is indicated by: One, persistent regular use of a psychoactive drug; two, attempts to stop such use whica lead to discomfort and which often result in termination of the effort to stop; three, continued drug use despite damaging phys- kal and/or psychological consequences; and, four, persistent drug- seeking behavior. People are drug dependent when a drug takes over and controls their ability to choose freely to take the drug or not. The relative degree of dependence between the two most widely used licit drugs in this country-alcohol and tobacco-is demonstrated by these facta: Whereas the large majority of Americans who use alcohol are both subjectively and objectively able to satisfactorily control their level of use, and only some 10 percent lose control, the oppo- tite is true with tobacco smoking. The great majority of smokers report that they would like to smoke less or quit smoking but find It very difficult or impossible to do so. Ninety-nine percent of those who say they smoke tobacco smoke regularly. Seventy percent of those who report current smoking say they smoke more than 15 cigarettes a day. Nine out of ten smokers say they would like to quit smoking. Unfortunately, between 80 and 85 percent of current smokers who have ever tried to quit say they have been unable to do so for more than 3 months. Many researchers are currently exploring the same questions that we ask of any drug-using behavior: What factors determine initial experimentation or use; the progression from casual recre- ational use to regular, compulsive use; the achievement and main- tenance of abstinence; and the factors leading to the high rate of relapse.

i 88 -5- The provision of statutory authority for the Office of Smoking and Health is commendable and will provide the public wit both facts and documented evidence. Equally important,this provi will ensure the continued monitoring of the voluminous data on smoking and health trends. The sustaining of these functions through stability of the Office of Smoking and Health is considere an essential first step in the preparation of Americans to make informed decisions about smoking. Mr. Chairman, this legislation seeks only to provide the con sumer with information that the consumer has every right to know We commend the passage of S.1929 to assure that the consumer recei the needed information on the tragic consequences of cigarette smoking. The Coalition on Smoking OR Health and the millions of volunteers these citizen groups represent, stand ready to work closely with the Congress and government at all levels to see that information on the hazards of smoking reaches all segments of the American public. 89 APPENDIX To ''iY OF CHARLES A, LEMAIS' r1c THE COALITION ON SMO ~,CIMMITTEE ON LABOR AND f ' I"d I TED STATES SENATE MARCH 16, 1982

50 The bulk of research findings to date implicate nicotine as main factor in establishing and maintaining dependence on to , Co. This results from nicotine's powerful biological and psycholi cal effects, which include stimulation of the release of a numbij substances-norepinephrine, epinephrine, growth hormone , ._ sol, vasopressin, and probably beta endorphin; the production o havioral arousal and EEG alerting patterns; and the fact that tine is one of the most rapidly metabolized of all self-adminis substances. Nicotine is a psychoactive drug; that is, it influences subje _ I state and behavior. Not all psychoactive drugs lead to depende or craving: The major tranquilizers, for example, are powe drugs which do not do so. NIDA's Addiction Research Center has developed a test, the Inventory, for precisely quantifying psychological and/or subje drug effects. Over the years, this test has been administer over 3,000 individuals, both with and without drug abuse histo _ One major finding of current NIDA studies, derived from the phoria subscale of this ARC Inventory, is the marked similarit demonstrates between morphine, cocaine, and nicotine. During _ first several minutes after administration of these three dru , there is an immediate, marked, and similar change in feeling sta . During this period, morphine, cocaine, and nicotine all feel ve much alike to the experimental subject. The subject experiences euphoric rush which, after a few minutes, however, shows a v able course depending on the particular drug. Both from self-reported information and from intravenous ministration of nicotine, we have found that subjects who have tories of narcotic addiction say that they like tobacco and/or ni tine as well as or even more than other drugs. An important B ish epidemiologic study of 210 subjects seeking treatment for opia addiction showed that on a liking scale of 1 to 5, with 5 being t4 most-liked drug, tobacco received a liking score of 4.3, as compar with 4.7 for heroin, 4.2 for cocaine, and 2.4 for amphetamines. This same study also measured these same subjects' comparati perceived need, as they described it themselves, for different drugiq On a scale of zero to 4, with 4 representing the most needed, tob co received the highest score of any of the 10 drugs tested, aver ing 3.3, compared to 2.8 for heroin and 1.5 for cocaine. ' There may well be questions as to the generalizability of the jectively felt needs of individuals who are on treatment for d abuse to the general population. Nonetheless, we think that th data are indicative of a powerful, compulsive effect of tobac smoking in general and the ingestion of nicotine in particul These data support both the NIDA ARC studies and also the ve common anecdotal reports that heroin addicts find it more difficu to give up tobacco than heroin. As with other classic drugs of abuse such as the opioids and sed tives, tolerance and physical dependence are important character tics of a drug because they may exacerbate the user's tendency continue its use. Both of these are shown to varying extents to associated with cigarette smoking. Mr. Chairman, it is likely that drugs such as nicotine and co caine, which are very powerfully habit forming and yet do not, as, 51 ", ,., .. uu,,;tantial evidence of being physic .., ;,•(:;,use we have not yet learned enc :»•twe=en brain, drugs, and behavior tc systems which are at the basis of tiru.: use patterns. :*.:h)rtant point which must be stressed and addictive drugs is the relatix one•r tr,s• :k•riavior of users which that drug is at ~~r -,.11 iward about the severe health consE ft,,r-, Smoking behavior itself is the di JPrA&:, to health consequences. When we c $W,..• I ,.,t, to smokers who wish to regain frE ..t; .; ror discontinue smoking behavior, the ot yearly smoking-related cancer ar b.reduced. i ~%ou. Mr. Chairman. I would be happ ~ou or members of the committee ma, t ; r-•ucired statement of Dr. Pollin and fi=r.v 4:n :,inuking follow:]

, 69 ir1 al ef' nd`~ "th i monality of being addictive, or I understood that one of my was drinking two beers a day, and the addictive quality of , you see-the common thread of addiction, I think, could rrally, if' i did not watch my emotions, the genuine concern t have in terms of the relative health of these individuals. jtust wondering here, when we begin to talk about the addic- ~_ k4ualitv of tobacco, that we must understand that, assuming it sxtst for purposes of argument, it certainly is not to imply that would have the same kind of health implications for the ual and society as a whole as a person who, for example, is a addict. I think, again, it would bring science into disrepute e the commonsense of the man or woman in the street would ;-"Hev, that won't wash." Why? Because commonsense tells us 1 a heroin addict is destroyed as an individual. They simply 0 som dysfunctional and ultimately destroy themselves physically mentailly. They are no longer employable, and they have this usly expensive habit and they go to all kinds of things, pros- and stealing, and it destroys them. the addiction in that case has horrendous implications to it, certainly we would not want to transfer that into an area, for pie. of usage of tobacco, which goes back to the beginning of igarettes, pipe tobacco, and so forth. We have had a long ral experience with it, and I am just resistant to the notion "addiction in this area ought to be looked upon as comparable rea 3 -M ~ L Ld to. Ips,, pr iig Aw itiq m :io 3b ,n id .1 ~s iok ei~ 0 6 the addiction of the alcoholic or the addiction of the heroin :addiCt." ~I do not think commonsense would support that. Am I coming ~ h to you that I am a little bit concerned that we state these ~.iltiM with proportion and balance so as not to distort a legitimate k1Mrlth concern we might have about any or all forms of addiction? Mr. I'oi.LiN. I think your point is well taken and it Senator East , , 11 rery necessary indeed to attempt to be precise when we do make =uW enmparisons. I think, however, that I would end up at the bottom line at some ~iltance from your position in terms of the relative health conse- ;qOences, certainly to the Nation if not to the individual, with VINt'd to the comparative addictive properties of the several sub- that you were mentioning and heroin. alochol tobacco , , , At I pointed out, though alcohol does cause a grievous burden to individuals and to the Nation, our best data suggest that of 1l1e large numbers of people who use it with some regularity, ap- 'imately 90 percent are able to control its use satisfactorily. drinking behavior does not run away with them. Just the opposite ratio is true with regard to smokers. Well over 06 Percent of smokers who have ever begun as a youngster to casu- tlly experiment with a few cigarettes go on to a regular pattern of Iboking and then, as adults, reach a level of smoking which they, tl~emselves, would strongly wish to be able to decrease or to elimi- Qate, and they find themselves unable to do so. And so, in terms of the comparative addictive strength, if you *i11, of these three substances, I would say that tobacco is much dlooer to heroin. Some of the empirical, quantitative data which we ue now beginning to assemble is rather startling in terms of self- hPorts from heroin addicts themselves, who do say that, in the one

48 mation that is available as best we can and in the most eff~ manner that we can devise. Senator EAST. So the role of Government would be to inform not to prohibit, as you are stating it. Would that somewhat rately present your point of view? Dr. BRANDT. I am certainly not an advocate of prohibition', cause, as I say, irrespective of the philosophic viewpoint, I t pragmatically, it is not going to happen. So I think we have to tinue to point out to people the problems that they are having try to give them ways. At the same time, I think we have another obligation, and tha' that I think we need to continue our research efforts on un standing why people smoke and understanding how we can h people quit smoking, and we will do that, and we will inform t about the results of that research as well. Senator EAST. Thank you, Dr. Brandt. The CHAIRMAN. Thank you. We appreciate all three of coming today, and thank you for taking the time to be with us. Senator PACKWOOD. If I might say one thing, Mr. Chairman, Commerce Committee will be having hearings on this on April 2 assume you may be coming, Dr. Brandt. Dr. BRANDT. Yes, sir. Senator PACKWOOD. Maybe the administration would reached some conclusions by that time. Dr. BRANDT. Yes, sir. The CHAIRMAN. Thank you. Our second panel of witnesses today are physicians who focus on two scientific aspects of this bill. The first witness is Dr. William Pollin, the Director of the tional Institute on Drug Abuse, and the second witness is Dr. Jo Holbrook, an associate professor of medicine at the University Utah College of Medicine. So we are very happy to have both you scientists with us here today, and we will look forward taking your testimony at this time. We will start with you, Pollin. STATEMENT OF WILLIAM POLLIN, M.D., DIRECTOR, NATIONA INSTITUTE ON DRUG ABUSE Dr. POLLIN. Mr. Chairman and members of the committee, th, you for the opportunity to testify on the addictive properties cigarette smoking. On the basis of our review of this question and of research co ducted in NIDA's own laboratories, it is our conclusion that cigg rette smoking represents a prototypic-dependence process and is fact the most widespread example of drug dependence in this co tr ~ith your permission, Mr. Chairman, I will summarize the e dence for these conclusions and also summarize my prepared sta ment. There had been frequent suggestions in the past from both r search and policy sources that the question of the possible addictiv nature of cigarette smoking needed review. In July 1978, NIDA an a committee of the National Academy of Sciences cosponsored ,r.afv..,ncr .% hich explored the background of y,,,, ~.~r.-~tinvs of that meeting, "Cigarette ~ has been submitted for the rec( ir, AU,-u%t 1:+7!t• a NIDA-sponsored technic. mpiwilitailv rt•view the question, "Is cigaret- *„-i~ I I! _-imcluded, and I quote, "Cigaret .ta.,ui;i n.. ronsidered a form of addiction, an ,t r,92r,•tci•4. an addicting substance." A sur z,ew• srno c;,trt,crpants has also been submitted. )&-.r the National Advisory Co r,...e.i tar inllo«•ing resolution: ts,,. ~..:. ..,m :kd.,sorv Council on Drug Abuse strong *.,,r. u,at words be added to the warnings on ci .m,,, ~j •.-rt The Surgeon General has determined that ia.w w aa+.e.rous to your health." t'un.i+tent with these conclusions and re( -..,: l)SNi-III, which is the current :L.m ,t ;rti%•chiatric disorders in the Unit tta. %1-,ri,i Hvalth Organization's Internati t%ca•w. rx,th include "tobacco dependence" t~ ~e,rur r ;!:u., ti % v major national and internationc t.,v,n. xh,ch have involved the most knowledg s;.ux,rrt,cs in the area, have all reached the r.air urnrkrn&; is an addiction. Orprnor•nce" in the classic sense is indica saguLar u..• ot a psychoactive drug; two, attE .tx,cn i.•art to discomfort and which often rE 0+ stort to ;top; three, continued drug use c _.i «no ur psychological consequences; and. ...eatru; tx navtor. 1'..,pir are drug dependent when a drug t. ;tw,r aou,tv to choose freely to take the dri dorr" ut dependence between the two most tn tn- countrv-alcohol and tobacco-is d !wna N nereas the large majority of Amer ." toth ,uhjectively and objectively able t 'hl'lt tr%r•i u1 use, and only some 10 percent .~to u true with tobacco smoking. The gret "pwt that they would like to smoke less or 't -*'- d,lficult or impossible to do so. 1tn-tv•nrne percent of those who say the~ +~uturt~•. Sc•venty percent of those who repo arnoke more than 15 cigarettes a day. I\ wr thoy would like to quit smoking. Unfc •-~ p.•rcent of current smokers who havi hnve lxxm unable to do so for more thai titanv n,~,earchers are currently explorir '`ot ~I- 4i-sk of any drug-using behavior: V -1tal ~•xtx•rimentation or use; the progres: a'°inli rj•,• to regular, compulsive use; the ; '°r-4ncl• ()f :rbstinence; and the factors lead ". a;.,.- o3s0'75'7s

The CHAIRMAN. We have asked tobacco companies, in this legis- tion, to include carbon monoxide levels on the cigarette packages. '~y is that important? Dr. HoLSxoox. Carbon monoxide is one of the three substances which, for years, the Surgeon General has identified, along with Ur and nicotine, as one of the most toxic substances in cigarette pnoke. It is an odorless, colorless gas which excerts its toxic effect through combining with hemoglobin. Hemoglobin is the substance that transports oxygen to cells. Carbon monoxide combines very widly with hemoglobin and prevents hemoglobin from transport- ing oxygen to the cell. Consequently, most cigarette smokers are in a chronic state of '1ow,•grade carbon monoxide intoxication. For example, most non- stnokers have 1 percent or less carbon monoxide in their blood; tnost cigarette smokers have 5 percent carbon monoxide and up to ts high as 15 to 20 percent carbon monoxide in their blood. That translates to a decreased oxygen-carrying capacity for the body. This is important in two ways. For people who already have cardio- pulmonary problems or for pregnant women, it exacerbates their disease, and in the case of the pregnant woman, it may be the sub- stance that results in smaller babies being born to women who smoke during pregnancy. In terms of the pathogenesis of tobacco- related diseases, carbon monoxide may play a critical role in the development of arterial narrowing. The CHAIRMAN. Thank you. Senator Packwood. Senator PACKWOOD. No questions. The CHAIRMAN. Senator East. Senator EAST. I would just like to, first of all, thank the doctor for coming. Senator Hatch is always bringing in very fine witnesses from his great State of Utah. I remember, we had the attorney gen- eral of Utah here not long ago on another subject. Doctor, on this matter of additives, you rightly suggest, and I would agree with you, that it is an important problem of science and a difficult one which does not yield up its mysteries easily in terms of the need for extensive testing, and so forth, and I would agree with you on that. I wanted to ask, on the problem of carbon monoxide, not as an expert in physical or medical science, in terms of being able to ` measure carbon monoxide levels, how perfected, as a matter of sci- ? ence, are we in that area? I am just inquiring as to how far one might go in measuring that if one decided to do that. Dr. HOLBROOK. Senator East, that is a complicated question, and I am not qualified to discuss the precise technology of how carbon monoxide is measured, but I can tell you about some of the varia- bles that are involved. There are excellent machines and devices available to measure carbon monoxide, but these measurements are confounded by other variables-such as traveling on congested freeways and workplace exposures. Nonetheless, in spite of these variables, one can obtain d reproducible dependable measurements of carboxyhemoglobin, ~ which is the ~substance with which we are most concerned. Those individuals who have elevated levels of carboxyhemoglobin p face increased health problems, and cigarette smoking is the most ~ ~ O ~

i 95 NATIONAL IITERAGENCY COUNCIL ON SMOKING AND HEALTH Private Sector Member Organizations American Academy of Pediatrics American Alliance for Health, Physical Education, ~ American Association of Respiratory Therapy Recreation and Dance ~ American Cancer Society i..rican College of Chest Physicians r._ American College Health Association ® I Vaociation of State aad Territorial Health Officers 3qs Club of America 1.aricEn College of Radiology American College of Surgeons American Dental Association M.rican Heart Association American Hospital Association American Lung Association American Medical Association American Medical Student Association American Pharmaceutical Association American Public Health Association American School Health Association l4rch of Dimes Birth Defect Foundation National Board of Young Men's Christian Association National Board of Young Women's Christian Association National Congress of Parents and Teachers National Jogging Association National League for Nursing National Medical Association National Student Nurses Association II ®

81 ,jTE1iF:NT OF CHARLES A. LeMAISTRE, M.D., PRESIDENT, UNI- --s'EIt.SITl' OF TEXAS M. D. ANDERSON HOSPITAL AND TUMOR MT1Tl'TE, ON BEHALF OF COALITION ON SMOKING OR 11EALTH jk. Leir~IAisTRE. Thank you very much, Mr. Chairman. JIr. Chairman, members of the committee, Senator Packwood, I Charles LeMaistre, president of the University of Texas M. D. rson Hospital and Tumor Institute. Today I testify in support Senate bill 1929 on behalf of the American Cancer Society, the lmerican Lung Association, and the American Heart Association, _ 27 other health, education, and youth leadership groups. This rthe newly organized Coalition on Smoking or Health. Our tiation s most prestigious agencies have banded together in Washington and throughout the Nation out of concern for de tragic consequences of smoking to Americans. A statement de- ibing the coalition's blueprint for action is submitted for your word. The blueprint explains that the coalition's primary empha- sit is smoking prevention through education. Because of the uniting of the concerned private sector under the banner of this coalition and the tremendous public impact of the aoet recent Surgeon General's report on "The Health Conse- quences of Smoking," the legislation before this committee could 1at be more timely. In particular, we commend the thrust of this bill to provide information not now available and thereby improve the ability of the American public to make an informed choice on the decision to smoke or not to smoke. These decisions, especially those made by younger Americans, are of critical importance to the bealth of our Nation. You have already heard this morning and previously, I am sure, about the consequences of past poorly informed decisions; they are ite familiar. A 1981 estimate of the Department of Health and uman Services states the results very succinctly: 340,000 prema- ture American deaths annually-roughly the population of the cap- ital city of the State of Texas, Austin-health injury to 10 million Americans annually; an annual cost of $41 billion in medical care nditures and lost economic productivity. there be any reasonable doubt about the stark fact that ciga- tette smoking is the single most preventable cause of illness and the single most preventable cause of death in the United States? lhirty thousand studies now link cigarette smoking to illness. Six ns General have repeatedly documented the overwhelming wience that cigarette smoking causes cancer of the lung, the larynx, the esophagus, urinary bladder, mouth, and pancreas; that cigarette smoking causes emphysema and chronic bronchitis; that dgarette smoking is a major risk factor for heart disease; that ciga- rMte smoking is associated with retarded fetal growth and in- Qeased risk for miscarriage and prenatal death. Even so, the message is still not reaching some Americans. The point was made earlier that many smokers are aware in general of the hazards of cigarette smoking, but the Federal Trade Commis- sion's staff report in May of 1981 pointed out, and I quote in part: "Many smokers are unaware of the existence of the relationship

84 Testimony of Charles A. LeMaistre, M.D. On Behalf of the Coalition on Smoking OR Health Before the Committee on Labor and Human Resources United States Senate March 16, 1982 Mr. Chairman and members of the Committee, I am Dr. Charles A. LeMaistre, President of The University of Texas M. D. Anderson Hospital and Tumor Institute. I testify in support of S.1929 on behalf of the American Cancer Society, the American Heart Association, and the American Lung Association and 27 other health education and youth leadership groups -the newly organized, Coalition on Smoking OR Health. Our nation's most prestigious agencies have banded together here in Washington and throughout the nation out of concern for the tragic consequences to Americans of smoking. A statement describing the coalition's blueprint for action in the cause of smoking prevention education is submitted for your record. Because of the uniting of the concerned private sector under the banner of the coalition and the tremendous public impact of the most recent surgeon general's report on The Health Consequences of Smoking, the legislation before this committee could not be more timely. In particular, we commend the thrust of S.1929 to provide information not now available to the American public on the health consequences of smoking and thereby improve the ability to make an informed choice on the decision to smoke or not to smoke. These decisions, especially those to be made by younger Americans,are of critical importance to the health of our nation. 85 -2- equences of past poorly informe ,r: Dremature American deaths eac injury due to smoking to 10 mi ,t to the American public of $41 ; expenditures and lost economic p e by any question about the sta single most preventable cause e,:entable cause of death in the <ir.d studies link cigarette smokin -rals have repeatedly documented t ~,.idence that cigarette smoking ca , e=ophagus, urinary bladder, mou O:;ing causes emphysema and chroni u:,.ing is associated with retarded isk for miscarriage and prenatal d till not reaching many Americans. :e already made the decision to s --~oke today. They are destined t ..=tics and economic loss. Tragic ericans are still not fullv aware t,:',:e up the hahit ignorant of th

79 The CHAIRMAN. Thank you, doctor, for your testimony. You have indicated that although there is no current require- ment for tobacco companies to inform the public about chemical additives, you already have knowledge about many of the sub- stances that are being used, and you list them in your statement here today. Now, why do you think it is important to legislate tobacco com- panies so that they divulge the nature and amount of additives being used? Dr. HoLSROOx. If I conveyed the impression that we have specific knowledge about the substances, I did not mean to do that. I simply meant to indicate that lists have been published by tobacco companies of substances that may be used or have been used, and another list is available from the British industry indicating sub- stances that the Government and the tobacco industry in Great Britain have agreed upon. However, we have no precise informa- tion concerning substances or amounts of substances, and that is the issue that I would like to leave before this committee today. I think it is a scientific question. I think scientists should be pur- suing the possible interactions between tobacco smoke and addi- tives and the effects these interactions may have on the smoker. The CHAIRMAN. Apparently, the United Kingdom has the current knowledge about chemicals being used in the manufacture of ciga- rettes. Have they done any scientific research in that area, and do we have any benefit of that, or can you cite any information along those lines? Dr. HOLBROOK. This particular Hunter committee met intermit- eriod of several years, and there was some agree- over a tl t p y en ment about substances which would be acceptable. However, my .; understanding is that some of the substances were grandfathered ; id- ' i t was cons onto the list; that is, because they were being used, ered acceptable to continue their use. However, to my knowledge, precise assessment of the scientific risks, of these additives was not carried out in Great Britain and certainly had not been carried out in our country. The CHAIRMAN. I see. Are chemical additives only being used in f low tar cigarettes, or are there chemical additives in any type o cigarette? Dr. HOLBROOK. Well, I think you have to specify what kind of ad- There are different categories of ad- ut b ki o ng a ditives you are spea .ditives-additives used in the processing of tobacco, the growing of facturing of cigarettes. h e manu tobacco, t For example, glycerin is a substance used in the manufacturing arettes i f . g c o In the intense, burning heat of the cigarette-and I compare a cigarette to a small chemical factory- a substance such as glycerin ical changes. h d f em c oun or, for that matter, cocoa, can undergo pro i c process. It is pyrolyt onverted to a substance called acrolein, i l s c e, Glycerin, for examp t irritant in the lungs. Cocoa, for example, ? t en which is a very po when it is burned in the intense heat of a burning cigarette, pro' ° ent ' duces many of the substances in its vapor phase which are pres in cigarette smoke. The CHAIRMAN. We have asked tobaccc i:rtion, to include carbon monoxide levels c «'hv is that important? Dr. HOLBROOK. Carbon monoxide is onc which, for years, the Surgeon General h tar and nicotine, as one of the most toxi <moke. It is an odorless, colorless gas whi through combining with hemoglobin. Hen t hat transports oxygen to cells. Carbon - :cVidly with hemoglobin and prevents her iny oxygen to the cell. Consequently, most cigarette smokers E I )w-grade carbon monoxide intoxication. -mokers have 1 percent or less carbon r most cigarette smokers have 5 percent car ;, high as 15 to 20 percent carbon mono), • ranslates to a decreased oxygen-carrying !'s is is important in two ways. For people ~ ;):;imonary problems or for pregnant worr i,~ease, and in the case of the pregnant wc !.,nce that results in smaller babies beii -P~.;,kP during pregnancy. In terms of the -i,rted diseases, carbon monoxide may ph cl(-velopment of arterial narrowing. 1 he CHAIRMAN. Thank you. ~enator Packwood. Senator PACKWOOD. No questions. 'I'he CHAIRMAN. Senator East. ,~enator EAST. I would just like to, first t„t• coming. Senator Hatch is always bringir from his great State of Utah. I remember, v eral of Utah here not long ago on another si 1)octor, on this matter of additives, you %vould agree with you, that it is an import and a difficult one which does not yield uF terms of' the need for extensive testing, an; ,i.;ree with you on that. I wanted to ask, on the problem of carbc "xpert in physical or medical science, in - measure carbon monoxide levels, how perfec ence. are we in that area? I am just inqui might go in measuring that if one decided to Dr. HoLBROOx. Senator East, that is a cor. I~cm not qualified to discuss the precise tec monoxide is measured, but I can tell you at hlE's that are involved. There are excellent machines and device~ carbon monoxide, but these measurements a %'irriables-such as traveling on congested fr "-~:Posures. Nonetheless, in spite of these vai rc'pr•oducible, dependable measurements c "hich is the substance with which we are mc 1'hose individuals who have elevated levels `•:Wc' Increased health problems, and cigarett 0360'7606

The reduction in tar and nicotine has been achieved by _ in cultivating and processing of tobacco and in the manufa of cigarettes. In this process different classes of substances used, including: Flavoring agents, binders, humectants, tob tenders, burn-rate accelerators and retardants, artificial substitutes, fertilizers, and agricultural chemicals. In the 1981 report, Dr. Julius Richmond, the then-Surgeo eral, summarized his concern about the lower tar and nicotiui rettes as follows: :; A final question is unresolved, whether the new cigarettes being produ introduce new risks through their design, filtering mechanisms, tobacco in or additives. The chief concern is additives. The Public Health Service unable to assess the relative risks of cigarette additives because information_ available from manufacturers as to what these additives are. Mr. Chairman, in the highly competitive world of cigare keting, flavor additives appear to have been used increasin. stimulate consumer acceptance of a product containing amounts of tobacco. These additives are not regulated by agency of the Federal Government, and public disclosure o stances currently in use is not required. To my knowledge, this is a unique legal loophole. In other other industries whose products are taken into the body are lated, and manufacturers are held responsible for the eff their products. It should be emphasized that the cigarette is livery vehicle which results in the prompt distribution of tho of tobacco smoke constituents throughout the body. The evidence concerning the harmful effects of cigarette smo is compelling: its toxicity, its carcinogenicity, its mutagenicity, possibly its teratogenicity; in other words, its possible birth d producing effects. What additional effects tobacco additives and also the co tion products of these tobacco additives may exert on the che composition and biological activity of cigarette smoke are s not known. Their presence in tobacco products represents measured risk-an unmeasured risk for the active smoker, fo passive smoker, meaning those of us in a confined space w forced to inhale the smoke coming from a cigarette, and fi unborn child. I would emphasize, we simply do not know the tial effects, and it is an unmeasured risk. There are cogent reasons to anticipate adverse interactio tween tobacco additives and other smoke constituents. For ple, smokers who are exposed to certain medications-oral ceptives, for example-and to certain workplace substances- tos-face greatly increased health risks compared to both no ers and smokers who are free from such exposures. In 1972, the R. J. Reynolds Tobacco Co., published a bookle ing several hundred chemical substances or natural products in the "compounding of tobacco flavors." The classes included eral major groups of chemicals, and I will not bother to list they are included in my written testimony. The Hunter committee's second report listed a few hundred stances approved for use as tobacco additives in the United dom. Unfortunately, Mr. Chairman, these lists do not provide ~n on the types and amounts of : ohcicco products. i . ..., :)%• nointing out that many smokE 1W,.V -I . ,-!t4-; believe that as long as they .-,:r;irettes this habit is not harmfu" •1 -:1ri>k of smoking in general ar 1.:-. ~••, r(,. hacco additives. This bill will a I O :+dditives which, in my judgmer. ,.* . - ....,c )r health risks. I applaud and sul = i-r i ~t:3tement of Dr. Holbrook follos

Coalition - Page Two 97 "The Coalition on Smoking OR Health serves as the public policy action arm of the National Interagency Council on Smoking and Health (NICSH)," ;essler said. NICSH is a voluntary association of leading groups formed in k:;ti7 to inform the public about the dangers of cigarette smoking. Thv coalition will work closely with three major voluntary health organ- izitions -- the American Cancer Society, the American Heart Association and the American Lung Association. Testifying today in support of S. 1929 before the Senate Committee on Labor and Human Resources was Charles A. LeMaistre, M.D., President of the University of Texas M.D. Anderson Hospital and Tumor Institute. "The Coalition on Smoking OR Health represents a banding together of our nation's most prestigious health agencies out of concern for the tragic consequences to Americans of smoking," Dr. LeMaistre said. The coalition stands ready to work closely with Congress and government at all levels to see that information on the hazards of smoking reaches all segments of the American public,he added. Robert M. Daugherty, Jr., M.D., Ph.D., chairman of the NICSH said, "4hrough the Coalition on Smoking OR Health we hope to encourage federal Initiatives and activities on smoking and health." Dr. Daugherty is dean of the school of medicine at the University of Nevada at Reno. -More- 0 e

TESTIMONY BEFORE THE UNITED STATES SENATE LABOR AND HUMAN RESOURCES COMMITTEE ON: Tobacco Additives by - John H. Holbrook, M•D• March 16, 1982 eon General's 1981 Report, The Changing cigaret Sur g The ttention on the dramatic increase in consumPtion of d a focuse lower "tar" and nicotine cigarettes, which currently account 7i for approximately 50% of the United States market• reduction in "tar" and nicotine has been achieved h e T in cultivating and processing of tobacco and in th changes of cigarettes. In this process different clas in g manufactur of substances may be used including: flavoring agents, binde :.A and tobacco extenders, burn-rate accelerators humectants, retardants, artificial tobacco substitutes, fertilizers, and s Richn i u l chemicals• In the 1981 Report Dr. Jul agricultura expressed concern about the lower "tar" and nicotine cigaret =4 new "A final question is unresolved, whether the cigarettes being produced today introduce.new risks through their design, filtering mechanisms, tobacco ?5 ..•::ts, or additives. The chief conce ..,. The Public Health Service has b ~, issess the relative risks of ciga ,•5 because information was not avail +,•.::icturers as to what these additiv .'n1y competitive world of cigarette :•i:es appear to have been used increas *- +-:.••• -,rnsuryer acceptance of a product contai: .Icco. These additives are not regu. .-deral government, and public disc: +•.r-ntly in use is not required. To r :: 1eqa1 loophole, i.e. other indusi +cen into the body are regulated anc t,1aible for the effects of their proc MW "*cr•••:-i c::at the cigarette is a delivery vel :istribution of thousands of tobaccc "r.n.s "nr .• :r,, ut the body. ••!-::ce concerning the harmful effects c "n9, e•g, toxicit y, carcinogenicit •'ratoqcnlcit Y• What additional effe cnoir combustion products may exert ~+"~1a~"' ':v Lioloqical activity of smoke are n '• 1cco products represents an unmeasu involuntary s moker and the unbo

TESTIMONY OF JOHN A. OATES, M.D. CHAIRMAN SUBCOMMITTEE ON SMOKING AMERICAN HEART ASSOCIATION Submitted to the COMMITTEE ON LABOR AND HUMAN RESOURCES U.S. SENATE MARCH 16, 1982

I 65 a 0 I poty t,~ our defintt:on of addiction, it is necessary to demonstrate that an aq aub.rance produces organ and/or behavioral toxicity. Although the IU+Oartaral •ffects of smoking are mild in comparison to those produced by @16dactIng substances, the multiple deleterious health effects of cigarette M4, tt.ciu;hng mortality and disability and their attendant social conse- p.a, ve now well established. Few question that the regular use of = M.da to a wide range of organ toxicity. ""CLi'SIOVS ~ nf etgarettes, an addicting substance. nro uwe, the toxicity, and the adverse social consequences, that cigarette MAavtor should be considered a form of addiction, and tobacco in the 11 ..s the epinion of the group after reviewing the evidence regarding the Oft_SCATIOtiS REGARDING CIGARETTE SMOKING AS AN ADDICTION (1) Tt•e_group concluded that cigarette smoking is an addiction. The iec.A.zt tmplication of this conclusion is that cigarette smoking should now be rs-exammed in light of the range of policy considerations which are 0rsentiv considered germane to the classic forms of drug addiction such r add:cuon to the narocitics, sedatives, stimulants, or alcohol. r.iSY Gr:en that cigarette smoking is considered an addiction it could be tended that it should be viewed as a disease. Such a categorization .Mo.1d allow the application of the methods and conceptual formulations of Pub:1e health to be applied to the smoking problem. ~~ apecial attention to other components of smoke that may modulate its ph t!M utitiation and maintenance of cigarette smoking should be explored WRAut and elanination of cigarette smoking behavior. The role of nicotine bMn7oral and pharmacological variables which influence both the mainte- rct ni_t:chavior_in hwnans. Rr.sc:irch progr:~ms shoubt clucidate the t3t 9asic research efforts should be focused on the analysis of cigarette i

M I 113 }f the clearly deceptive intention of cigarette advertising is attenuated by fectuding an effective warning. The warning is yet another way, at no cost, ie which the federal government can effectively assist the private sector in educating the public about the hazard of cigarette smoking. lterefore, the American Heart Association strongly supports the adoption of tAe five specific warnings proposed in S. 1929. We further propose the tecorporation of the "circle and arrow" format, recommended by the FTC", to dtsplay the warning on advertisements. This format would significantly enhance noticeability of the warning. Finally, requiring that the warning letters measure at least 25% of the maximum brand name letters and be of the sJme proportionate detail would much improve its visibi]ity.l' These simple .easures, at no cost, would contribute greatly to the education efforts of the private sector. N 0

70 study, they feel they need cigarettes more than they need - any other drug and who give a liking score to intravenous that is in the same range as the liking score that they heroin and cocaine. Finally, in terms of the impact on the Nation, it is t heroin has the capacity to be extremely destructive bot. heroin addict and, where there is a high prevalence of hero in a given community, to whole communities. On the other hand, there were a total of approximatel lion deaths due to all causes in this country last year; these is the number of premature deaths accepted by the o jority of scientists who have looked at the question of th consequences and the mortality and morbidity associa_ smoking. That is close to approximately one-sixth, a little than one-sixth of the total deaths from all causes in thi last year. The total number of heroin addicts, our best estimate point is approximately 475,000. So, in terms of the hun_ thousands and millions of people involved, the addictive pro nicotine at this point, it seems to me, should be a grea least as great a cause for public concern as the addictive of heroin. Senator EAST. Knowing that you must leave quickly, let in on this one more time. It was my understanding-and I could be in error, bu what I have been led to believe; you hear it so much from the public health field-that the most abused drug in alcohol. That is the most abused drug, and it is an addicti as you have suggested. Maryland, for example, recently p infinitely tighter law dealing with deaths deriving out of driving. What I am resisting to the notion of now is, you are sing from the pack drinking and saying that it is all right, and cent of the people can give it up anyway, and it is no big p really, and lumping tobacco in with heroin. Now, I would submit, in the real world of my commonse servation of public health problems in America today, that, in terms of the abuse of it and deaths coming not only fr holism and broken families and broken lives and broke and automobile accidents, and the widespread use of alco. drugs of a worse ilk in high schools, and so on and so fo maybe this depends on perspective, but I am profoundly to the notion that that is not really a problem or is less a than cigarette smoking. All I am asking for is a little balance in this whole thin_ will be darned if I can come to the conclusion that you are ing, it seems to me: Don't worry about the drinking. The r lem we have got in America is smoking." I just cannot buyl a matter of scientific observation in terms of the impact t versus the other has had and is having in the public a least people who smoke cigarettes are not killing other their automobiles like drunken drivers are. At least it h - merit in a free society: To the extent there is harm, it is self- ed. 71 ~., n t t he record to show that I s tworry about the drinkers; th N•n`itors, is the smokers." I a aa+r* i ~Py;; •, Senator East, if I conveyed ~.. r;..,; ::ohol was not a major proble. ,t and needed only to focus or ,~.;,nd I would like to correct tha N 111 c t o convey was specificall~ ability of the one substance ~p,,,-., ,., r ro,r• ability of the other substanc f~. ,,.r to comparative health consequ .,.t mport on alcohol and health indi r•.,,;,,.,t,-; oC the number of deaths whic ~t .,Icohol. The maximum figure w ~ 1,4Mr dr•aths per year, and that inc :~ :,.. ItrVnt5• deaths due to careless sei ~,rr -:r:rt•tV correct in that alcohol has ; r n terms of destroying fam and the like, which is cert f3ut if• we precisely try to c yrerti r, .~r• tornmarable-numbers of deathr s.re .L..•Akrntt•d-then, indeed, the numk arA 3a:..t w rth cigarette smoking are s ot deaths which, at the mr s.En a%a.k,ratc•d with the abuse of alcohol. arrmas._4 r.". • I N1 v time is up, Mr. Chairma ae rr:u.: •:,, I hank vou, Senator East. j't<~:::. :n:rnK %uu for being here today. Zo i'+xs: •. i hank vou. r-aa7. i1 hank Vou. 31%0 1 sc,r.W a`. Our next witness will be Dr. dwR.ryU:st,n3 member of the faculty of the w, ~tate. John is widely respected 40.ah .et.rt.•d problems of smoking. He ha VIi.+*i i« ,.-rr:n,unt fur years regarding smok 01. .; :"t uf young people out there t %Oftc hr :_ :rr thc medical school, and he wi ~:..; .n tnat regard. ~.+rt• happy to have you here toc ta•r::,t yuur testimony at this time. ~1 +Tt ti0Ai tl}• Jt)II\ Il. HOLBROOK, bi• Vftrt11-4 -tt_ t N1VE:Rti1TY OF UTAH COLLE t* W-• -•k Mr ( hairman, it is a pleas '*""4'•1* " " -~ 1~•-.,t tobacco additives. 74" '' , r,-nr•ral's 1981 report, the Ch "**Ago? •''-". •, "n thc• dramatic increase in c -4" :"r:;:rrr•ttc•s• which currently „t the U.S. market. 0360'7598

1 94 2 The Coalition on Smoking OR Health will immediately focus its energies on a numb.= public policy issues, including: • promoting a substantial increase in the federal excise tax on cigare tt _ deter children and youth from starting to smoke . • supporting enactment of the Comprehensive Smoking Prevention Act (H.R S. 1929) which would: establish a congressional mandate for the Office of Smoking and 1[ establish a means to coordinate federal smoking and health prcgr strengthen cigarette warning labels • countering fallacies, myths and misinformation on the health hazards e smoking • providing a mechanism for coordinating private sector smoking and healt programs and establishing an interface with public sector programs • raising the question of adequate federal protections for Americans aga exposure to the toxins in tobacco, which is now exempt from protecti controls which govern foods, drugs, substances and products • questioning the consistency and propriety of national public policiesv allocate tax dollars to inform Americans about the health dangers of cigarette smoking and allocate additional tax dollars to subsidize the production of tobacco. The Coalition on Smoking OR Health and the member agencies of NICSH stand ready t, the Congress and the Department of Health and Human Services in providing Americani` the health information they need in order to make an informed choice on whether or smoke. For Information Contact: John D. Kessler Chairman, Steering Committee Coalition on Smoking OR Health 1110 Vermont Avenue, N.W. Suite 820 Washington, D.C. 20005 (202) 822-9380 "Cigarette smoking is the single most preventable cause of death in the United Sta 95 1L I~IERAGENCY COLNCIL ON SMOKING A private Sector Member Organizatio ,.,v of Pediatrics ,.` ince for Health, Physical Education, Re( -I ;ition of Respiratory Therapy -r Society ft.,, a. :011ege of Chest Physicians Am.a;.j~ .;oliege Health Association ,.:~ge of Radiology weccan -ospital Association ai.eri:a:. ..-nq Association s..rlcan. 'edical Association aw.uan ':ed_cal Student Association a..r::a.: ::iar©aceutical Association a..rtta., :,:blic Health Association Mu:cu. `_'_:ool Health Association •ea« :a::on of State and Territorial Health Officers INN7+ _:_o of America 10aa of L:mes Birth Defect Foundation e+t+1-a: Ioard of Young Men's Christian Association *01 .-t:ai 3oard of Young Women's Christian Association Mt.=nai ::ongress of Parents and Teachers ~~~°ral :ogging Association :.eague for Nursing `:edical Association Student Nurses Association

fd 121 TESTIMONY On Behalf of THE AMERICAN CANCER SOCIETY Before The Committee on Labor and Human Resources U.S. Senate March 5, 1982 For further information, contact: Alan Davis The American Cancer Society 777 Third Avenue New York, New York 10017 (212) 371-2900 9

i 96 Coalifion on Smoking OR Health A PUFLIC POLICY PROJECT WITH THE NATIONAL INTERAGENCY COUNCIL ON SMOKING AND HEALTH 419 7TH STREET, N.W., WASHINGTON. D.C. 20004 snES.c conewrrte '~ ,e... o ...~.. c~.o, .oco~ March 16, 1982 .~.~.<m c~.. so~w = mbn6 W.ymrtir • .n..om.vqnuo~4w. if0~n M pdpiWly. l. M D.. M.D. ~ Obrnf~. Na~u.a niwcpw. cu.c+c~ s.b..w ~ wa~ FORMER FTC COUNSEL TO STAFF ron ~saaM~nw caa.cr. Matthew L. Myers (202) 393-4446 COALITION ON SMOKING OR HEALTH WASHINGTON, March 16 -- The "Coalition on Smoking OR Health," recently formed to advance the cause of smoking prevention in the United States, has retained Matthew L. Myers, former staff attorney for the Federal Trade Commission as its staff director, it was announced today. The Washington- based coalition, which is backed by thirty of the nation's leading health, education and youth leadership organizations, will bring i smoking prevention issues to the attention to legislators and federal .~ officials and will promote support for federal smoking prevention educa- tion programs, according to John D. Kessler, chairman of the coalition's ~ steering committee. - , "We are immensely pleased that Mr. Myers has agreed to serve as our staff director" Kessler said. Myers directed the FTC's Staff Report on Cigarette Advertising,released in 1981. -More- . 0\ "CIGARETTE SMOKMG IS THE SWGLE MOST PREVENTABLE CAUSE OF DEATH IN THE UNITED STATES" 97 Coalition - Page Two "The Coalition on Smoking OR Health serves as the arm of the National Interagency Council on Smoking Kessler said. NICSE[ is a voluntary association of in 1967 to inform the public about the dangers of The coalition will work closely with three major v izations -- the American Cancer Society, the Ameri and the American Lung Association. Testifying today in support of S. 1929 before the Labor and Human Resources was Charles A. LeMaistrc the University of Texas M.D. Anderson Hospital anc "The Coalition on Smoking OR Health represents a our nation's most prestigious health agencies out tragic consequences to Americans of smoking," Dr. The coalition stands ready to work closely with C at all levels to see that information on the haz.: all segments of the American public,he added. Robert M. Daugherty, Jr., M.D., Ph.D., chairman c "through the Coalition on Smoking OR Health we ho; initiatives and activities on smoking and health dean of the school of medicine at the University -More-

115 Office on Smoking and Health, "Highlights From the 1980 Supplement to the National Health Interview Survey," May 1981 The Roper Organization, A Study of Public Attitudes Toward Cigarette Smoking and the Tobacco Industry in 1978, Volume 1, May 1978 Public Health Service, The Health Consequences of Smoking - The Changing Cigarette: A Report of the Surgeon General, U.S. Department of Health and Human Services, 1980 Maxwell, J.C. "Cigarette Sales Up in 1981", Advertising Age, p. 77, December 7, 1981 16. Castelli, W.P.; Dawber, T.R.; Feinlief, M.; Garrison, R.J.; McNamara, P.M. and Kannel, W.B. "The Filter Cigarette and Coronary Heart Disease: The Framingham Study," Lancet 2(823B): 109-113, July 18, 1981 17. Myers, M.D.: Iscoe, C.; Jennings, Carol; Lenox, W; Minsky, E. and Sacks, A. Staff Report on the Cigarette Advertising Investigation Federal Trade Commission May, 1981 18. Kaufman, "Memory Without Recall, Exposure Without Perception," Journal Advertising Research, August, 1978 19. Craig, et al "Advertising Wearout: An Experimental Analysis" Journal of Marketing Research, November, 1976 20. Brodsky, L.P. and Myrowitz, Elliott "Visibility of Smoking Warning on Cigarette Billboards, American Journal of Optometry and Physiological Optics 58 (2): 117-124, February, 1981 21. The Tobacco Institute. Comments of the Tobacco Institute on the FTC Staff Report on Cigarette Advertising Investigation Washington, D.C., 1981 22. Smith, R.C. "The Magazines' Smoking Habit" Columbia Journalism 23. Review 16 (5): 29-31 January-February, 1978 Whelan, E; Sheridan, M; Meister, K. and Mosher, B. "Analysis of Coverage of Tobacco Hazards in Women's Magazines." Journal of Public Health Policy The Roper Organization Ommilus Study #726 for the Federal Trade Commission, 1980

i 92 Coalition - Page Three "To counter the immense determination of the tobacco industry to keep Americans smoking, our limited resources must be effectively coordinated and the interface with the federal sector maintained," he said. "We hope the coalition will serve to focus our efforts in this critical public health area." Kessler said the coalition hoped to counter fallacies, myths and misinformation on the health hazards of smoking. In 1981 the Department of Health and Human Services estimated that cigarette smoking caused 340,000 premature deaths, injured the health of an estimated 10 million Americans and cost $41 billion in medical care and economic productivity. "As the Surgeon General's Report on the Health Consequences of Smoking pointed out, Kessler said, "cigarette smoking is the chief, single avoidable cause of death in our society and the most important health issue of our time." . .+ "Ve agree with the Surgeon General and we believe that the majority of Americans feel the same way," he added. "We intend to do our best to keep these issues before the Congress." The NICHS and the coalition said scientific evidence is overwhelming that cigarette smoking: causes cancer of the lung, larynx, esophagus, urinary bladder, mouth and pancreas; causes emphysema and chronic bronchitis; is.a major risk factor for coronary heart disease; is associated with retarded fetal growth; and is an in- creased risk for spontaneous abortion and prenatal death. 8 93 COALITION ON SMOKING OR HE. A Public Policy Project W The National Interagency Council on SmokinE .•.~c;casl Interagency Council on Smoking and Health (NICS •.~dch, edccation, and youth leadership organizations hav .. :. ;`e problem of cigarette smoking on human health. It s .-.a :r._e?endent force to inform the public of the harmful ef (70) national organizations currently comprise the me: .--ed cith the emergence of a number of national initiat- ... .._-H Board of Directors in July, 1981 approved a propos. n:.d focus its resources on public policy issues. ..•.CSH, along with many of its member organizations, part: ._-nce on Smoking OR Health in New York in November, 198: a.•e:c.ince recommended a broad agenda of future actions to a2 pt-ention in the United States. . e,.•.;erence called on the three major voluntary health org Ca._ r Society, the American Heart Association the the Americ ..,e .cedership in establishing a national coalition in Washi ,..;ri;y recommendations in the area of public policy. .... .hree agencies -- working in close cooperation with the p::ress of establishing the Coalition on Smoking OR Health to r•~-;icn of legislators and federal officials and to promote ;revr~:ion education programs. .. .:CSH and the Coalition on Smoking OR Health are deeply c :eis toll in death, debilitation and dollars taken each year . ... :~3: the Department of Health and Human Services estimates •.-...~_c costs of cigarette smoking will total: • more than 340,000 premature deaths in the United St: . the debilitation of an additional 10 million Americ: . the expenditure of an estimated $41 billion, as fol: -- $13 billion in medical care costs -- $25 billion in lost economic productivity -- $ 3.8 billion in Medicare and Medicaid costs !%• %:CSH and the Coalition on Smoking OR Health believe that +.-.. l:azards is overwhelming and clearly indicates that ciga • causes cancer of the lung, larnyx, esophagus, urinar pazcreas • causes emphysema and chronic bronchitis • is a major risk factor for coronary heart disease arn peripheral vascular disease • is associated with retarded fetal growth, an increas abortion and prenatal death

120 REFERENCES 1. The Gallup Poll, The Gallup Report: Gallup Smoking Audit Report N. 190, P^inceton, N.J., July, 1981. 2. Office on Smoking and Health, Highlights From the 1980 Supplement to the National Health Interview Survey, May, 1981. 3. The Roper Organization, A Study of Public Attitudes Toward Cigarette Smoking and the Tobacco Industry in 1978, Volume 1, May 1978. 4. Advertising Age, "Tobacco Group Drive Set", Advertising Age, page 80, January 18, 1982. 5. Business Week, "How Cigarette Makers Aim To Fire Up Sales", Bustn_es pp 65-70; December 7, 1981. 6. Myers, M.L.; Iscoe C.; Jennings C.; Lenox, W.; Minsky, E.; and Sacks, A.: Staff Report on the Cigarette Advertising Investigation, Federal Trade Commission, May, 1981. 7. Whelan, E.; Sheridan, M.; Meister, K.; and Mosher, B. "Analysis of Coverage of Tobacco Hazards in Women's Magazines." Journal of Public Health Policy. 2(1):28-35. March, 1981. 8. Smith, R.C.; "The Magazines' Smoking Habit" Columbia Journalism Review, 16(5):29-31, January-February, 1978. 9. The Tobacco Institute. Comments of the Tobacco Institute on the FTC Staff Report on Cigarette Advertising Investigation. Washington, D.C. 1981. 10. Tyler, William D.; "Tyler's Ten For the Year" Advertising Age p. 52-54, January 18, 1982. cap-420 3/1/82 121 S( The Committee on Labor and Hu U.S. Senate TESTIMONY On Behalf of THE AMERICAN CANCER Before March 5, 1982 For further information, contact: A1.in Davis ''" American Cancer Society Third Avenue a York, New York 10017 1,12) 371-2900

i 98 Coalition - Page Three "Although the prevalence of smoking is declining," Dr. Daugherty said, "we do not underestimate the difficulty of the task that lies ahead." He added, "The tobacco industry, with its vast resources, is very good at waging campaigns designed to create diversion and doubt in the minds- of the public." "To counter the immense determination of the tobacco industry to keep Americans smoking, our limited resources must be effectively coordinated and the interface with the federal sector maintained," he said. "We hope the coalition will serve to focus our efforts in this critical public health area." - Dr. LeMaistre noted that the lack of information on the health hazards of smoking had contributed to the health and economic costs of cigarette smoking which are estimated at 340,000 premature deaths, health injuries to an estimated 10 million Americans and costs of $41 billion in medical care and economic productivity. "Can there be any question,"he asked," that cigarette smoking is the . .;~~ single most preventable cause of illness and death in the United 3tates?" x: Dr. LeMaistre noted that scientific evidence is overwhelming that cigar- ette smoking causes cancer of the lung, larynx, esophagus, urinary bladder, mouth and pancreas; causes emphysema and chronic bronchitis; is a major risk factor for coronary heart disease; is associated with retarded fetal growth; and is an increased risk for spontaneous abortion and prenatal - death. 99 .LMERICAN~ LUNGASSOCIATION The'CMstmas Seaf People • ,Broadway • New York, N.Y. 10019 • (212)245-8000 Statement of the American Lung Associ; to the House Subcommittee on Health - the Environment on H.R. 5653, the Comprehensive Smoking Prevention Educat Presented by Stephen Ayres, M.D. March 5, 1982 I am here to testify in support of H.R. 5653 in m board member of the American Lung Association anc ization's Comoittee on Smoking and Health. In my am Professor and Chairman of the Department of Me University School of Medicine, St. Louis, Missour Although the majority of Americans are aware that to health, there is still confusion--even skeptic Much of this confusion is created and perpetrated- the tobacco industry, whose spokespeople constant seeking access to media of all kinds. What they : that there is a smoking "controversy" about the h( smoking, that the link between cigarette smoking e istical and therefore suspect, even non-existent. The facts, of course, are quite otherwise. The 1' and disease is one.of the most thoroughly document I am introducing into evidence--but will not read recent findings from laboratories around the worlc relationship between cigarette smoking and human c different types of studies--30,000 in all and stil have been performed: epidemiologic studies of dea on effects of stopping smoking; studies of lung fL tion of tissues at autopsy in smokers and nonsmoke In this country alone, 340,000 pecple die prematur the effects of cigarette smoking. (1) At the American Lung Association we are constantly going and new research about the hazards of smokin and smokers. We are alarmed, for example, about r of cigarette smoke and its effects on smokers them their vicinity. Alpha emitters polonium-2T0 and 1 concentrated on tobacco trichomes and insoluble pa smoke. The major source ot the polonium is phosph: in growing the tobacco. (2) ' ~..a u.n. W ~mmrae L,m[ AuocLYw irlWa.m11.W a„xuuw, O.uyGem W V 1.. W,- ,e

91 %eIs:er said the coalition will immediately focus on promoting a substantial in- ar.e%e :a the :ederal excise tax on cigarettes to deter children and youth from atart.ag to smoke and would support enactment of a Comprehensive Smoking Prevention [dlc4::cr. Act (H.R. 4957 and S. 1929) that would, among other provisions, provide for at:ecgthened cigarette warning labels. Me cited other immediate public policy priorities: "We are raising the question of adequate federal protections for Americans against exposure to toxins in tobacco, .lich is now exempt from protective controls which govern foods, drugs, substances aad products. "4sd we are questioning the consistency and propriety of national public policies rhich allocate tax dollars to inform Americans about the health dangers of cigarette s.oking while at the same time allocating additional tax dollars to subsidize the prod::ct£on of tobacco." - fobett K. Daugherty, Jr., H.D., Ph.D., chairman of the NICSH said, "We welcome the establishment of the Coalition on Smoking OR Health as a means by which we can better encourage federal initiatives and activities on smoking and health." Dr. Pausherty is dean of the school of medicine at the University of Nevada at Reno. 'llthough the prevalence of smoking is declining," Dr. Daugherty said, "we do not underestimate the difficulty of the task that lies ahead." He added, "The tobacco iadustry, with its vast resources, is very good at waging campaigns designed to ereace diversion and doubt in the minds of the public." -more-

71 9 0 3t h it 1a ~ m ig 91 0 ~ble se coh 1o 11 st :)ble an mpl pro iat to a. )le i on iflic I just do not want the record to show that I sat here silent while was said, "Don't worry about the drinkers; the problem you need i worry about, Senators, is the smokers." I am not sure that is ;:hought that alcohol was not a major problem or that one need jr~jh. POLLIN. Well, Senator East, if I conveyed the impression that worrv about it and needed only to focus on cigarette smoking, I misspoke, and I would like to correct that impression. ~. What I was trying to convey was specifically comparing the ad- tive power, the ability of the one substance to control behavior compared to the ability of the other substance. ,Sti ith regard to comparative health consequences, the Surgeon neral's last report on alcohol and health indicated that there are ~lwaryin~ estimates of the number of deaths which may be related to glbt abuse of alcohol. The maximum figure which has ever been kdW is 'G011,000 deaths per year, and that includes deaths due to 4cttomobile accidents, deaths due to careless setting of fires, and so 4xth. ~ ~` You are entirely correct in that alcohol has a variety of destruc- 'aire consequences in terms of destroying family life, individuals' Oilibility to function, and the like, which is certainly not shared by ~aprette smoking. But if we precisely try to compare those varia- ~ ble. which are comparable-numbers of deaths which most people 4 believe are associated-then, indeed, the numbers of deaths which @ Sre associated with cigarette smoking are substantially greater '- than the number of deaths which, at the most liberal estimate, liave been associated with the abuse of alcohol. "-< Senator EAST. My time is up, Mr. Chairman, and I appreciate that he must go. The CHAIRMAN. Thank you, Senator East. Dr. Pollin, thank you for being here today. We appreciate your testimony. m Dr. POLLIN. Thank you. -f Senator EAST. Thank you. ~. The CHAIRMAN. Our next witness will be Dr. John Holbrook, who distinguished member of the faculty of the College of Medicine ~koni my home State. John is widely respected for his knowledge of t6e health-related problems of smoking. He has consulted with the Federal Government for years regarding smoking and health. I am -- Wormed by a lot of young people out there that he is one of the besi teachers in the medical school, and he wins numerous awards ' COntinuously in that regard. ~ So, John, we are happy to have you here today, and we will look forward to taking your testimony at this time. STATEMENT OF JOHN H. HOLBROOK, M.D., ASSOCIATE ;. PROFESSOR, UNIVERSITY OF UTAH COLLEGE OF MEDICINE Dr. HOLBROOK. Mr. Chairman, it is a pleasure for me to speak this morning about tobacco additives. The Surgeon General's 1981 report, the Changing Cigarette, fo- t'u8ed attention on the dramatic increase in consumption of lower tar and nicotine cigarettes, which currently account for approxi- mately 50 percent of the U.S. market.

i Statement of the American Lung Association to the House Subconmittee on Health and the Environment on H.R. 5653, the Comprehensive Smoking Prevention Education Act Presented by Stephen Ayres, M.D. March 5, 1982 tb es a © r+ .dder r -tal 99 • Edmund C. Caxy, M.D.. P.endeer Conrad M. Fowleq Pnsidw-E/ecr Rkbud SinsCeimer, Parr-Prrridev Wa1,er 1. Hucher. Vira-Pre,idenr Edward M.Sewe[L M.D.. Vies-Prendenr Roalyn ailtord. Srcrnnry aernud G. Koplow, Trrmurer A.1JERICAN LUNG ASSOCIATION lunesA.Swomley.ManogingDirec+or n,e cnnem,as Seaf Peoole • {TMlBroadway - New York. N.Y.10014 • (212)245-8000 I am here to testify in support of H.R. 5653 in my capacity as a volunteer board member of the American Lung Association and Chairman of that organ- ization's Lommittee on Smoking and Health. In my professional life I am Professor and Chairman of the Department of Medicine, St. Louis University School of Medicine, St. Louis, Missouri. Although the majority of Americans are aware that smoking is hazardous to health, there is still confusion--even skepticism--about the facts. Much of this confusion is created and perpetrated--deliberately--by the tobacco industry, whose spokespeople constantly tour the country, seeking access to media of all kinds. What they perpetuate is the myth that there is a smoking "controversy" about the health effects of smoking, that the link between cigarette smoking and disease is stat- istical and therefore suspect, even non-existent. The facts, of course, are quite otherwise. The link between smoking and disease is one-of the most thoroughly documented in medical history. I am introducing into evidence--but will not read now--some of the recent findings from laboratories around the world confirming the relationship between cigarette smoking and human disease. Many different types of studies--30,000 in all and still accumulating-- have been performed: epidemiologic studies of death rates; research on effects of stopping smoking; studies of lung function; and examina- tion of tissues at autopsy in smokers and nonsmokers. In this country alone, 340,000 people die prematurely every year ffom the effects of cigarette smoking. (l) Ai the American Lung Association we are constantly examining the on- going and new researcn about the hazards of smoking--on both nonsmokers and smokers. We are alarmed, for example, about radioactive components of cigarette smoke and its effects on smokers themselves and others in their vicinity. Alpha emitters polonium-210 and lead-210 are highly concentrated on tobacco trichomes and insoluble particles in cigarette smoke. The major source ot the polonium is phosphate fertilizer, used in growing the tobacco. (2) +w.a.e r,w., me wmaman t..a w,nei.u,n _wre emww ue us.- m e u.aw, ..:me, w wmw,n. ttwat suraar 0 w I II

between smoking and some of its most serious and widespri health consequences such as heart disease." Fifty-four million living Americans have already made the d sion to smoke cigarettes and continue to smoke today. They destined to become tomorrow's medical statistics and economic 1 Tragically, a substantial number of Americans are still not f aware of the dangers of cigarette smoking and take up the ha ignorant of the facts. If the 54 million Americans had never tak r up the habit, as you have already heard, approximately 30 per of all cancer would not occur, and cardiovascular and pulmon disease would have their toll substantially lessened. The provisions of this bill for rotational warning labels is a element in making available to the American public brief, di and fresh factual information necessary for informed decisionm ing. The present warning label has lost its effectiveness due to generalized message and sameness over the years. Perhaps the most important provision of this bill is that w would make it unlawful to manufacture, import, or package sale any cigarettes without disclosure of all chemicals and s stances used in production. For reasons that the nonsmoking jority of Americans find hard to understand, cigarettes remain o of the few substances consumed internally which are exempt fr full disclosure of ingredients. Yet the facts are clear: Cigarettes burned and the products inhaled and taken internally with result being the designation of cigarettes as the single most p ventable cause of illness. . Mr. Chairman, it seems certain that the provisions requiring disclosure of ingredients including flavoring additives will be tacked as excessive regulation or paternalistic. Quite the oppos has been true, as history clearly reveals. The Food and Drug Administration has neatly avoided responi bility by ruling that tobacco and tobacco products are neither foo* nor drugs and are therefore not subject to the Food, Drug, and Cti metic Acts. The Consumer Product Safety Act specifically exempts, by s tobacco and tobacco products from the regulations of the ute , The Federal Hazardous Substances Act exempts tobacco and ~ bacco products from the hazardous products provisions of the The Toxic Substances Act does not provide for tobacco and to co products regulation. One might more properly raise the question: Why the s treatment of these dangerous substances, tobacco and tobacco p ucts? Mr. Chairman, the opportunity for responsible, voluntaryy closure has been present for many years. The only feasible co left for Congress is to require these disclosure provisions in vie ' the overwhelming evidence that tobacco and tobacco produc not only harmful but life threatening. The final provision, the statutory authority for the Interag Council in this bill and in the House for the Office of Smoking Health, is commendable. This will insure the public is pro both facts and documented evidence in the future. Equally im tant, this provision will insure the continued monitoring of vol nous data on smoking and health trends, which is most impo in keeping our factual information up to date. 83 ~u-~taining of these functions is considere :: 11 ! he preparation of Americans to make arAr;: ,m0king. Mr('hai rman, this legislation seeks only to p ~~ A.'': information that the consumer has ev N. .-,,n,mend the passage of this bill to assure i he needed information on the tragic co rr:t~ rn;~kin~ ion on Smoking or Health and the private sector groups represent t s a ,+h h the Congress and government at al :- rmntion on the hazards of smoking read tt- '%-f•rican public. ~ . :::,6~You very much, Mr. Chairman. i•:.• rm-pared statement of Dr. LeMaistre wit ~...

118 S. 1929 would assure that OSH continue to provide this vital function. A secure existence for OSH with delineated functions and objectives, would also be a significant stimulant to the private sector. r The establishment of an Interagency Committee within OSH to coordinate all federal activities that relate to smoking is a very important provision of S. 1929. By requiring federal agencies to coordinate, as the private agencies now do, will further enhance the quality and efficiency of federal perform- ance. Considering the dim prospect for increasing federal outlays in this area, efficiency is critical. The provision of S. 1929 requiring the rotation of five new warning statements' on cigarette packages and advertisements is immensely important. The FTC' has shown convincingly that the current warning is "worn out". Immediate action is needed to make this an effective medium to reach the public with information on the hazard of smoking. This requirement is something which the federal government can do, at no cost, to supplement private efforts. Its importance cannot be overemphasized since the broadcast' and print'-' are largely inaccessible for communicating information on the effects of smoking. The Tobacco Institute' has referred to the rotational warning as a "cumbersome system", implying a burden to the industry. However, an observance of the copy of cigarette advertisements point out how ridiculous this claim is. Brown and Williamson's Barclay ad campaign used at least seven completely different or variations in the copy. This was rated one of the "top ten" campaigns for 1981.10 In accordance with this provision in S. 1929, the same" warning statement would have been used on all these variations. The point is that cigarette ad copy is changed and changed frequently to avoid "wear out". Requiring a label change once a year is indeed a simple matter. The Tobacco Institute has also argued that this represents increased regulation on an over-regulated industry. This argument also lacks merit. It overlooks the fact that tobacco and tobacco products are either exempt by agency determination or specifically by statute from those laws which were enacted by the Congress and in particular this Subcommittee to protect the health and well being of the American consumer. The Food and Drug Administration has by agency determination ruled that tobacco and tobacco products are neither 'foods' nor 'drugs' to be regulated under the Food, Drug and Cosmetic Act. The Consumer Product Safety Act specifically exempts by statute tobacco and tobacco products from being defined as a "product" to be regulated under that Act. The Federal Hazardous Substances Act specifically exempts tobacco and tobacco products from being considered a "hazardous product" under that Act. Tobacco and tobacco products are also not regulated under the Toxic Substances Act. ai So, although the Congress of the United States has declared cigarettes to be' dangerous to ones health, tobacco and tobacco products have escaped being regulated under those Acts which were enacted by the Congress to specifically protect consumers from health and safety risks. While tobacco and tobacco products cannot be considered to be a food under the Food, Drug and Cosmetic Act, I find it somewhat ironic that it continues to be exported as a food under the Food for Peace program. 119 The argument that the provision of more disease "excessively regulatory" and "paternalistic" is 1 :his legislation represents a minimum of governmen considered against the exception to the federal law: S. 1929 would give the consumer the necessary i nealth hazards of cigarette smoking so that the co an informed choice as to whether or not he or sh _=nied the right to smoke under this legislatior :ales or distribution being imposed on the cigare nis legislation seeks only to provide consumers - ^ealth hazards of cigarette smoking. I -.e National Interagency Council on Smoking and Hee :;arts in working closely with the Congress and ~,_ronger partnership to ensure that information or eaching Americans everywhere. ank you.

116 TESTIMONY OF ROBERT M. DAUGHERTY, JR., M.D., PH.D. CHAIRMAN NATIONAL INTERAGENCY COUNCIL ON SMOKING AND HEALTH SUBMITTED TO THE COMMITTEE ON LABOR AND HUMAN RESOURCES U.S. SENATE MARCH 16, 1982 117 +1r. Chairman, Members of the Committee on Labor an Robert Daugherty, Jr., M.D., Ph.D., Dean of the Schoo of Nevada and the present Chairman of National Intera and Health (NICSH). The National Interagency Council on Smoking and association of health, education and youth leadersF responsibility or concern with the problem of cig, nealth. It seeks to provide a cooperative and indeper public of the harmful effects of cigarette smc organizations currently comprise the membership of - those organizations is attached to my statement. "he NICSH, through its member organizations and 80 loc has and will continue its efforts to educate people cigarette smoking and assist these smokers who want information and other service we receive from the fe -ne more efficient utilization of our limited resourc ,,e Office on Smoking and Health, with its limited bu ar. the prviate sector to carry the message to the ,)rivate interface is largely responsible for the conti s.~oking among Americans. .,!ile the prevalence of smoking is decliningl~= we d c;ifficulty of the task that lies ahead. The tobacco resources is very good at waging campaigns designed - c-ubt in the minds of the public. Since the 1978 :~nducted for the Tobacco Institute by the Roper Or tnese and other tactics, such campaigns have prolifera- -onth, the Tobacco Institute launched what Peter `. Psblic Information,• called "the biggest campaign w :ampaign will include nine insertions in national oeo~le, Sports Illustrated, Time, TV Guide, and U.S. c~ring 1982. The cost of a campaign of this magnitude eKcess of $1,000,000. Considering the conclusive evid s-oking to disease, a campaign with the theme "Weigh Take Sides" can only be designed to create confusion. 'o counter the immense determination of the tobacco ind s,oRing, our limited resources must be effectively Interface with the federal sector maintained. The NICSF its role as coordinator in the private sector. However, ^cera1 government to perform its role has become a so As you know, the Office of Management and Budget has tw' t^e Office on Smoking and Health (OSH). Fortunately, DF ^as been able to get the funding restored. The $2-3 mi '.iniscule when compared to over $1 billion' used to c;5arettes. Yet, it provides an essential funct organization that must get the job done.

108 smokers had aignificar.cly more evidence oi inflammation in the smallest areas of the airways and chat this inilammation was orobabiv reversible when smoking was discontinued. Hale et al in an article published in the same journal demonstraced for the first time that smokers dying without obvious heart disease had thickening of the pulmonary blood vessels. These daca suggest a response to reduced oxygen concentrations in the smaller airways related to cigarette smoking. - - The toxicity of cigarette smoke to innocent bystanders as well as to smokers was shown by a recent study of Dahms et al. (Chest 80 530- 534, 1981).Ten patients with bronchial asthma and ten normal indivi- duals were exposed to cigarette smoke in an environmental chamber. Pulmonary function tests (the FEV1.0 ) decreased 21% in the asthmatics but not in the normals. The asthmatic patients were not particularly sick and were ambulatory. A substantial percentage of the general population has the sort of reactive airways demonstrated by the asthmatic so that the study emphasizes a major public health concern. "I 109 TESTIMONY OF JOHN A. OATES, M.D. CHAIRMAN SUBCOMMITTEE ON SMOKING AMERICAN HEART ASSOCIATION Submitted to the COMMITTEE ON LABOR AND HUMAN RESOURCE U.S. SENATE MARCH 16, 1982

44 , credibility, and therefore, if I did not think that this report th t I a , would not have allowed it to be issued over my signa L et me say that I think your difference and mine sir is , , p. ~ ily in one of semantics and in what you consider to be the v t bles. Being a scientist and not a politician, I would have to ass that the variables in political thought far exceed those in scien thought, sir. But the ones that-- ,°I.n Senator EAST. But certainly not, for example, in cancer ca tion. Dr. Koop. Yes, I think that is true because Senator EAST. Well, we may be comparing apples and oran but variables again, we are both agreeing, is the key concept in tablishing scientific causation, and it is intricate, complex, and tractable in so many areas, as in behavioral or physical or nat sciences. I am only resistant to the notion that our area is more co p th an yours. I think, in certain contexts, it is. In other contexts might not be. I would want to see a scientific study of the relat complexity of variables in the two fields. Dr. Koop. Let me finish my semantic difference and that is , difference between cause and mechanism. If we in medical scie only treated those diseases for which we knew the mechanism, would have a much higher mortality for almost everything else do. Let me take one of the first diseases in this country that Public Health Service cared for back in the late 1700's, and t was scurvy. That was before any knowledge of vitamin C. We no idea of the mechanism of the production of scurvy but we , know that one of the causes of scurvy was not having an citt y fruits on board ship for long periods of time and the people w: , did not have it got scurvy, and when you gave them citrus frui , they got over their scurvy. So that was cause. The mechanism w totaly unknown. A more simple explanation: I flick on the light switch all tli time, and I know that that causes the light to go on. But I neve have understood the flow of electrons along copper wire. That mechanism. I think that what Dr. Brandt outlined for you so nicely about 't ' epidemiologists five points, and which is covered in about the fi 40 pages of this report, how we got to that word "cause," I thi we have proved the cause of cancer in this particular volume . ~, Let me also say that when you talk about things like education,' couldn't agree with you more. The actual fact of the matter is tha in the polls, between 89 and 92 percent of American people d know that cancer is associated with smoking, but they do not kno all of the other things that are associated with smoking . When you talk to a young person-and remember that I spen my 111e, the past 40 years of it, with young people-and you talk __ a 14-year-old who is about to smoke about cancer when he is 60, he is not the least bit interested. But if you talk to him about what it will do to his wind when he is a runner or what it might do to his lungs when he is 25 or 30, then you have something you can talk with him about. 45 i x1 u.,1 not by any means limit the educati CVKV to ~rnoking to just cancer. It has got to I t,%,,,t W,th vour interest in behavioral scienc ~A,td ix• vt ' ry pleased to work along somethir wAwt Ne nee•d is a method of understanding hc pw, pr,••sure in young people who are about to ts* t...-t.ti ot health and then working on ther ek,e,r don tstart• because if you don't start, the 4a:' t;%,uid talk on and on about this, sir. I woi one tnin,; and say that your comments about ot .arrat avai ul truth to them, and I would say ar„i i(iu drink drinks with saccharin in them, O;,• k HAIRMAN. Thank you, doctor. Thank yo Irr. tirandt and Dr. Koop, you have both indi lt+an<lt s statement, that the deaths as a re: :±ask),i+4M ave•ar compared to deaths from all inj, tnaicatv(t that smoking is one of three major i u)" clintnbuting to coronary heart disease, ar rrai .:iK•uiar disease, that smoking is a majo tur:.;. t.i rN nx, oral cavity, esophagus; it is a m: beonctutus and emphysema; it is a contributin t-hr urinary bladder, kidney, and pancreas; i r-tx,c utcer disease; that maternal cigarette s .,tn rrtardcd fetal growth and increased risk t*un nnd prt natal death and slight impairmei sek:pment during early childhood. You i,i,o state that cigarette smoking acts aral cuntraceptives to enhance the probabil .nertir cti•rebrovascular disease, that it acts syn( W tn increase the risk of cancer of the lung faetor" to enhance cardiovascular risk. tiuw. that sounds pretty serious to me. r qu.'nc~~x ut smoking warrant stronger warnin wckugcs :' What do you think, Dr. Koop? I)r h0,0i'. Well, I think it is broader than ju .ir I think it requires broader education acr ~1, I indicated to Senator East, I think, if we c .tortinK rather than stop them from continui .h"d. So I think we have got to broaden o outiuuk. nut just to one aspect. The CHAIRMAN. So labels are one aspect of i 1)r . h(x)i,. Certainly. ';.•nator HATCx. And certainly one that ougl `+.•notor Packwood. Senntor PACKWOOD. I want to ask Dr. Bra: tn .our testimony before the House, you had that the system recommended as .. rniwht 1x• more effective if all of the proposec "ACh brand simultaneously, so that the srr * h1ch warning may appear on the packages in use in Sweden where 16 different ttukn~ ~w at a given time. Is that still your po: I)r }3uA,;uT. It is certainly my position. 0360'75'72

i 102 AMERICAN LUNG ASSOCIATION ~The'Chnstmas Seaf People a ® 1740 Broadway • New York, N.Y. 10019 • (212)245-8000 THE IMPORTANCE OF THE FEDERAL GOVERNMENT IN THE PREVENTION OF SMOKING-RELATED DISEASES Testimony in Support of H.R. 5653 a revised version of H.R. 4957 the Comprehensive Smoking Prevention Education Act by The American Lung Association 103 y;arti~ular behavior is iar.nful even thou- .,cz ='-is knowledge into appropriate action. The:. _-:ieve. Health education is pitifully primit: ..,c_s. hea'a 4 educational spots have markedly decli _ c-gramming, and the miniature "warning" on ciga .a:ertisiag is ineffective. At,one time, when a ,_ -,o: Seen appointed to office, the tobacco indus ._~ :arning by pointing to the non-existence of the xp?eared on the cigarette package. .ation of warning labels that would constantly r ..,- ~noicers of specific diseases produced by cigarett _-e :hev reached for a smoke and would have an impor: _r•c:ng fact into belief. While cleariy less effect: -__.n dollar advertising blitz launched annually by t ..,cca rotating labels would be an important first ..-ce_tio^ of advertising material convinces most ob --_ssion is to encourage non-smokers co smoke and t .-..R:ag. Rotation of labels should be followed by ...:_ac.onal techniques such as the publication of ar. _ rrssage if identical size next to each smoking adve ._.:e :n a free society is only possible when each ir r-aa. Crying "fire" in a crowded theatre is not dis ..r3g:ng one's neighbor to regularly inhale smoke: Edmund C. Ca.cey, M.D, penl~'"Conrad N. FowIer, Prrlidnrr.(*pj- ` Richard Sinsheimer. Paa-prryy~ ..~ Walier 1. Hatcher. Virr-Prry/~r~. 0.1 Edward M. 5ewe11. N.D.. V~rr-Pre~~~= Roslrn Bilford, Bernard G. Kuplow. Tm, Jarnes A. Swo.mley- ManaViny D SMOKING DOES CAUSE HUMAN DISEASE Prepared by Stephen M. Avres M.D. Chairman, Smoking or Health Committee February 1982 FeuWN u 19W Ur Americ.n Wne Auocu,inn ixNEe. alllia,M aareciawu NrouaMU, n,e U.S...nd a meCiral recuw, We wmaic.n TLm.ck Sociep .-_aough the tobacco industry characterizes the 14 ._ scoKing and human illness as the "Smoking and Hes --s.+,' the only controversy is the unwillingness of •-_.. :oiuntarily phase out cigarette production and -.•aividuals to stop smoking. The evidence estab: .--re of cigarette smoke has been accumulating since •-l-c~o Df the first report of the Surgeon General in : •- .:sancs o: articles documenting the harmful effects -t -,ave been published and the United States Public He

-3- to treat, the cancers with the least hope for survival. For example, the overall 5-year survival rate for lung cancer is only 10%; for cancer of esophagus, 4% and for cancer of the pancreas, 28.2 When the Surgeon General released his report on February 22 • of this year, the President of the American Cancer Society, Dr. Robert Hutter, said: "When we hear of a bad accident involving 20 .._g l+.+rr<f;oA anA 4f_fi- 125 -4- The American Cancer Society urges the legislation to maintain a formal Office of Such an office dedicated solely to educati ;iangers of smoking and, in addition, worki ^.nerican smoking habit is vital to the vol in real terms as well as symbolically. We knowledgable professionals at the federal office committed to this cause. We are also pleased that the Chairman rr

114 1. American Heart Association, 1981 National Annual Report National Center: Dallas, Texas 1981 2. American Heart Association, Heart Facts: 1982 National Center: Dallas, Texas 1982 3. Kannel, W.B.; Doyle, J.T.; Fredrickson, D.T. and Harlan, W.R. Report of the AD Hoc Committee on Cigarette Smokina and Cardiovascular Diseases: For Health Professionals; No: 71-001-8 American Heart Association; Dallas, Texas 1977 4. Shurtleff, Dewey; Some Characteristics Related to the Incidence of Cardiovascular Disease and Death: Framinaham Study 18 year Follow-up. Framingham Study; Section 30; DHEW Publication No. (NIH) 74-599, February, 1974 5. Weiss, N.S. "Cigarette Smoking and Arteriosclerosis Obliterans: An Epidemiologic Approach". American Journal of Epidemiology 95(1): 17-25, 1972 6. Weinroth, L.A. and Herzstein, J. "Relationship of Tobacco and Smoking to Arteriosclerosis Obliterans in Diabetes Mellitus." Journal of the American Medical Association 131(3): 205-209, May, 1946 7. Kannel, W.B. "Epidemiologic Studies on Smoking in Cerebral and Peripheral Vascular Disease" in Wynder, E.L.; Hoffman, 0; Gori, G.G. (Editors). Proceedings of the Third World Conference on Smoking and Health. DHEW Publication No. (NIH) 76-1221. 1:257 274, 1976 8. Doll, R. and Peto, R. "Mortality in Relations to Smoking: 20 Years' Observations on Male British Doctors." British Medical Journal 2 (6051): 1525-1536, December 25, 1976 9. Gordon, T.; Kannel, W.B.; McGee; Dawher, T.R.; "Death and Coronary Attacks in Men After Giving Up Cigarettes: A Report From the Framingham Study," Lancet 2:1345-1348, December 7, 1974 10. Koch, A. "Smoking and Peripheral Arterial Disease," In: Wynder, E.L.; Hoffman, D; Gori, G.B. (Editors) Proceeding of the Third World Conference on Smoking and Health. DHEW Publication No. (NIH) 76-1221 1: 281-283 1976 11. Kannel, W.B.; Doyle, J.T.; Frederickson, D.T. and Harlan, W.R.; Report of the Ad Hoc Committee on Smoking and Cardiovascular Diseases No. 51-028-A, American Heart Association: Dallas, Texas 1974 115 12. Office on Smoking and Health, "Highlights to the National Health Interview Survey,' 13. The Roper Organization, A Study of Public Smoking and the Tobacco Industry in 1978, 14. Public Health Service, The Health Consec Changing Cioarette: A Report of - Department of Health and Human Services, 15. Maxwell, J.C. "Cigarette Sales Up In 1981' December 7, 1981 16. Castelli, W.P.; Dawber, T.R.; Feinlie McNamara, P.M. and Kannel, W.B. "The Fi Heart Disease: The Framingham Study," July 18, 1981 :7. Myers, M.D.: Iscoe, C.; Jennings, Carol; Sacks, A. Staff Report on the Ciaarettc Federal Trade Commission May, 1981 '.13. Kaufman, "Memory Without Recall, Exposure Witho Journal Advertising Research, August, 197E :9. Craig, et al "Advertising Wearout: An Experimer Journal of Marketing Research, November, 1 20. Brodsky, L.P. and Myrowitz, Elliott "Visib on Cigarette Billboards, American Jc Physiological Optics 58 (2): 117-124, Febr, 2:. The Tobacco Institute. Comments of the Tobacco Staff Report on Cioarette Advertising D.C., 1981 ;2. 23. 24. Smith, R.C. "The Magazines' Smoking Hat Review 16 (5): 29-31 January-February, 197E Whelan, E; Sheridan, M; Meister, K. and Coverage of Tobacco Hazards in Women's Mag Health Policy The Roper Organization _Ommilus Study #726 Commission, 1980 YJ/thd7 3/9/82

122 The American Cancer Society, a voluntary health organization with over 2 million active volunteers dedicated to fighting cancer, is privileged to submit Testimony today. Because of the mandate of the American Cancer Society it is most fitting that we offer our testimony in strong support of S. 1929, the Comprehensive Smoking Prevention Education Act of 1981. We would like to commend you, Mr. Chairman, for your leadership and your foresight in sponsoring this important preventive health care measure. We are pleased to present testimony as part of the new Smoking or Health Coalition. The work that the American Cancer Society will be doing on this bill together with the American Heart Association, the American Lung Association and the National Interagency Council on Smoking and Health is just the beginning of the work of a coalition dedicated to educating Americans to the dangers of smoking. We are all extremely excited about the potential impact on the smoking problem in this country resulting from the joining of forces of our organizations. The reason we are presenting testimony together is to underscore the amount of energy that our organizations are willing to exert to encourage this vital health e;fort. 123 -2- The reasons for our dedication are clear T,:llion Americans will light up a cigarette ,jr,oking will contribute to the death of over this year alone. 430,000 Americans will die ~.:cer in 1982. According to the February 2 :-port on the Health Consequences of Smoking i-3ths will be caused by the use of tobacco 85% of the 111,000 lung cancer deaths th ,King related. We know from the Surgeon G -.-,t the overall cancer death rates of male :,.proximately double those of nonsmokers and e death rate is approximately 30 percent h The Surgeon General found that cigarette ',,or cause of lung, laryngeal, oral cavity, cer. It was also found to be a contribut iier, kidney and pancreatic cancer. In a .,t ^pidemiological studies suggest an asso 3,arette smoking and stomach cancer to a po w en s:noking and uterine and cervical can ,~ndt is even woise, those cancers most c n :iyarette smoking (lung, esophageal, la -"Y -ji'd pancreatic cancer), can be the mo ~ w ~ _QT ~ ~ ()- .L--9 Q

A ~ ou I 111 have tried to do so. " Following an unsuccessful attempt to quit, many of these smokers tend to switch to low tar and nicotine cigarettes. "` This is evidenced by the continuing rise in the market share of these cigarettes to 60.9°,of all sales in 1981.'s This development is alarming because the evidence " suggests that many people swit:h to low tar and nicotine in an effort to lower their risk of adverse health effect. While switching to these cigarettes may lower the risk for some diseases, there is no evidence of a reduction in risk for cardiovascular diseases." In fact, recent evidence from the Framingham Heart Study " suggests that low tar and nicotine cigarettes may even increase the risk of cardiovascular disease. This could be a very dangerous development since most cigarette-related deaths are from heart attacks.' The Arerican Heart Association is committed to helping smokers who want to quit and preventing children from starting to smoke. Accordingly, we rholehzartedly support the passage of S. 1929, the "Comprehensive Smdking Prevention Education Act of 1981". The provision of a congressionally .andated smoking and health program is very important. The proposed role of the federal smoking and health program will be instrumental in combining and coordinating the efforts of the public and private sectors to address the problem of cigarette smoking. This is a clear case where a relatively small federal effort can be used to mobilize enormous private sector resources to address a major health problem. Thr provision requiring the rotation of five new warning statements on cigarette packages and advertisements is needed to better inform the public of the specific dangers of cigarette smoking. The rationale for the requirement of a warning statement in the first place, was to inform consumers of the health hazard. However, the FTC " has recently concluded that the current wrning statement, which has been used on packages and advertisement since 1972, is overexposed and worn out. This conclusion was supported in part by a ftudy by Starch Message Report Service which found that only 2.4% of adults tcposed to cigarette ads reads the Surgeon General's warnings. This should cone as no surprise since any message presented exactly the same rlay will soon Ooccme so familiar that it will lose its effectiveness." "" Furthermore, since cigarette companies vary the copy of their advertisements to avoid the tirear out" effect, it seems reasonable to conclude that the warning statement nauires no less. 4odsky and Myrowitz,S° in a study of cigarette billboards, found the warning ltatrment to be written uniformly on all billboards and in a manner similar to Wt used in newspaper and magazines. Individual letters in the warning CMSistently appeared the same, i.e., reduced detail. When compared with the Mu,l and size of the letters in the brand name, the two lar est observed Mrning statements were 38 and 17 times smaller. These two optometrists tkcluded from their test that while the brand name was visible, the warning Ms eot. t- 0 0

117 Mr. Chairman, Members of the Committee on Labor and Human Resources, I am Robert Daugherty, Jr., M.D., Ph.D., Dean of the School of Medicine, University of 'ievada and the present Chairman of National Interagency Council on Smoking and health (NICSH). The National Interagency Council on Smoking and Health is a voluntary Issociation of health, education and youth leadership organizations having res;or.sibility or concern with the problem of cigarette smoking on human heait.h. It seeks to provide a cooperative and independent force to inform the pub "c of the harmful effects of cigarette smoking. Thirty national organizations currently comprise the membership of the Council. A list of those organizations is attached to my statement. The NICSH, through its member organizations and 80 local interagency councils, has and will continue its efforts to educate people about the dangers of clyorette smoking and assist these smokers who want to quit. The technical inf_rr,ation and other service we receive from the federal sector facilitate the -iore efficient utilization of our limited resources. On the other hand, the ;;ffice on Smoking and Health, with its limited budget, must rely heavily on the prviate sector to carry the message to the public. This federal- private interface is largely responsible for the continuing downward trend in smoking among Americans. While the prevalence of smoking is declining'-3 we do not underestimate the difficulty of the task that lies ahead. The tobacco industry, with its vast resources is very good at waging campaigns designed to create diversion and doubt in the minds of the public. Since the 1978 public opinion survey conuucted for the Tobacco Institute by the Roper Organization' recommended these and other tactics, such campaigns have proliferated in the media. Last eonth, the Tobacco Institute launched what Peter Sparker, Vice-President Public Information,` called "the biggest campaign we've ever done". The campaign will include nine insertions in national editions of Newsweek, Peoole, Sports Illustrated, Time, TV Guide, and U.S. News and World Report durtng 1982. The cost of a campaign of this magnitude is estimated at well in excess of $1,000,000. Considering the conclusive evidence linking cigarette smoking to disease, a campaign with the theme "Weigh Both Sides Before You Take Sides" can only be designed to create confusion. To counter the immense determination of the tobacco industry to keep Americans smoking, our limited resources must be effectively coordinated and the interface with the federal sector maintained. The NICSH is determined to play its role as coordinator in the private sector. However, the commitment of the federal government to perform its role has become a source of great concern. As you know, the Office of Management and Budget has twice tried to "line out" the Office on Smoking and Health (OSH). Fortunately, DHHS Secretary Schweiker has been able to get the funding restored. The $2-3 million budget of OSH is •iniscule when compared to over $1 billion` used to promote the sale of eigarettes. Yet, it provides an essential function to the private organizatioi that must get the job done. I ®

11 125 it M -4- The American Cancer Society urges the sponsors of this legislation to maintain a formal Office of Smoking and Health. Such an office dedicated solely to educating Amer-icans to the dangers of smoking and, in addition, working to eliminate the lunerican smoking habit is vital to the voluntary health sector in real terms as well as symbolically. We need a group of knowledgable professionals at the federal level in such an office committed to this cause. We are also pleased that the Cnairman has shown an interest in adding to his legislation an amendment which would require that all cigarette companies list with the Secretary of HHS all tobacco additives. We are not asking that the trade secrets in the tobacco industry be revealed. However, the ACS questions why the cigarette industry has, for so long been exempt from any requirement to list their additives when most other consumable consumer goods have not had such an exemption. In addition, we are well aware that cigarette smoking is dangerous. It is vital, that at the very least, government scientists be given an opportunity to test the health impacts of burning and inhaling such flavoring additives as cocoa husks. The scientiPic and medical communities must also be allowed to test these additives so as to protect the 54 million smokers and for those other millions whom we are not reaching i through education efforts who may yet start to smoke. 0 0 0 0

119 The argument that the provision of more disease specific warning labels is 'ercessively regulatory" and "paternalistic" is ludicrous. To the contrary, this legislation represents a minimum of government regulation especially when considered against the exception to the federal laws I have just noted. S. 1929 would give the consumer the necessary information on the specific hea'th hazards of cigarette smoking so that the consumer would be able to make an informed choice as to whether or not he or she smoked. No one Is being denied the right to smoke under this legislation nor are any restraints on sales or distribution being imposed on the cigarette manufacturing industry. This legislation seeks only to provide consumers the right to know all of the health hazards of cigarette smoking. The National Interagency Council on Smoking and Health stand ready to do their parts in working closely with the Congress and the Federal government in a stronger partnership to ensure that information on the hazards of smoking is reaching Americans everywhere. Thank you.

J 93 COALITION ON SMOKING OR HEALTH . A Public Policy Project With The National Interagency Council on Smoking and Health fi The Vational Interagency Council on Smoking and Health (NICSH) is a voluntary association •f health, education, and youth leadership organizations having responsibility or concern • yith the problem of cigarette smoking on human health. It seeks to provide a cooperative aed inie?endent force to inform the public of the harmful effects of cigarette smoking. - SLlrcy (30) national organizations currently comprise the membership of the Council. Cencerned with the emergence of a number of national initiatives in smoking and health, tpe VICSH Board of Directors in July, 1981 approved a proposal to relocate in Washington, D.C. ar.d focus its resources on public policy issues. . Yye NICSH, along with many of its member organizations, participated in a National Coeference on Smoking OR Health in New York in November, 1981. The 250 conferees in attead3nce recommended a broad agenda of future actions to advance the cause of smoking pzevention in the United States. The C-ference called on the three major voluntary health organizations -- the American Cancer Society, the American Heart Association the the American Lung Association -- to take leadership in establishing a national coalition in Washington, D.C. to implement its priority recommendations in the area of public policy. TLese three agencies -- working in close cooperation with the NICSH -- are now in the ptocess of establishing the Coalition on Smokinz OR Health to bring these issues to the attention of legislators and federal officials and to promote support for federal smoking Orevcntion education programs. The VICSH and the Coalition on Smoking OR Health are deeply concerned about the relent- 1•ss toll in death, debilitation and dollars taken each year by smoking related diseases. In 1981 the Department of Health and Human Services estimates that the annual health and eccnomic costs of cigarette smoking will total: • more than 340,000 premature deaths in the United States • the debilitation of an additional 10 million Americans • the expenditure of an estimated $41 billion, as follows: -- $13 billion in medical care costs -- $25 billion in lost economic productivity -- $ 3.8 billion in Hedicare and Hedicaid costs The NICSH and the Coalition on Smoking OR Health believe that scientific evidence of the health hazards is overwhelming and clearly indicates that cigarette smoking: • causes cancer of the lung, larnyx, esophagus, urinary bladder, mouth and pancreas • causes emphysema and chronic bronchitis • is a major risk factor for coronary heart disease and arteriosclerotic peripheral vascular disease • is associated with retarded fetal growth, an increased risk for spontaneous abortion and prenatal death

112 This amply supports the need for varied warning statements in a format that is Tobacco Institute:' in response to the FTC Staff th ,.,_,'i e visible. However, Report, argued that the effectiveness of the cigarette advertisement and -: i h l t s t a e warning statement must be judged by different criteria. The rationa i l ~ cu ar "the former (advertisement) must achieve consumer recall for a part brand among numerous other brands, all of which present competing and conflicting messages while the latter (warning) appears consistently to the consumer in every advertisement and on every pack of cigarettes." This dual criteria is not only unsupported but unsupportable. If the warning statement has been "remarkably effective" by being presented consistently the same way ` then it would seem that brand recall would be enhanced if the portrayed image was maintained unchanged over the years. For example, the Marlboro advertisement should be most effective if the original ad copy was continued., Yet, the copy is changed and changed frequently. Different cowboys are used l in different settings. Additionally, Brown and Williamson made severa changes in its very successful Barclay campaign last year. '"q`~ also noted that cigarette advertising uses a multitude~~,.,,. t it I e u nst The Tobacco of images to appeal to different markets. This is indeed consistent with the ~-- concept of market segmentation. The logical extension of this is that the `~ warning must also be tailored to appeal to differing consumers. For example, ,.* smokers with a history of heart disease in their families may find a warning -* on smoking and heart attack much more personally relevant than a general ; u message. A' the argument that cigarette advertising is limited to the print Moreover , media while consumers are exposed in all media to information on the hazards * of smoking is misleading. The number of anti-smoking PSA aired on television ,0 since the ban on cigarette commercials has been drastically reduced with,~ hardly any being shown during prime time. Additionally, information on ti~ n * h as eve smoking and health in the print media has been equally scarce. It been suggested by some='-27 that the tobacco industry may be using its advertising as a leverage to discourage coverage on the hazards of smoking in the print media. For whatever reason, the broadcast and print media is largely inaccessible for informing the public of the dangers of smoking. r Meanwhile, the so called brand advertising goes on at the tune of one billion dollars per year. " Regardless of the intent, non-smokers and children are heavily exposed to this advertising. It would be very difficult to argue especially children and teenagers, are not that some non-smokers incin l n , g y co v attractive,' al of smokers as being young a t t , y por r affected by this constan healthy and enjoying an adventurous and pleasurable lifestyle. With this kind 53X h y of bombardment with no effective counter, it is not hard to understand w of smokers do not know or believe that smoking causes many cases of hea~ attack.2• 113 if the clearly deceptive intention of cigarette adv 'rcluding an effective warning. The warning is yet n which the federal government can effectively ass aducating the public about the hazard of cigarette smo : erefore, the American Heart Association strongly five specific warnings proposed in S. 1929. ccorporation of the "circle and arrow" format, rec ;i;play the warning on advertisements. This for -nlrance noticeability of the warning. Finally, re 'etters measure at least 25% of the maximum brand n; ~:e proportionate detail would much improve its vi ,asures, at no cost, would contribute greatly to the ,-vate sector. label becomes a very important medium to' in h g e warn For the above reasons, t get more information to the public. The American Heart Association has made` rds of h aza and will continue to make efforts to better inform the public about i smoking. However, we do not believe that we have adequate access to the medi to fully inform the public. Our efforts will have a greater chance of success

127 -6- health consequences of smoking, such as lung cancer and emphysema, are more well known. However, even for lung cancer, the most-well known health effect, some substantial gaps in consumer knowledge are evident.„4 We have an obligation to fill those gaps, especially for cigarette today comprehend that they could get oral cavity tAncer and would have to undergo the difficult and painful tehabilitation that is necessary to overcome the disabilities associated with that disease. Not enough: Mr. Chairman, the Congress's own research agency, the Office of Technology Assessment, in its ASSESSMENT OF TECHNOLOGIES FOR DETERMINING CANCER RISKS FROM THE ENVIRONMENT, dated June 1981, states that tobacco smoking "is the single Rost important preventable environmental factor contributing to illness, disability, and death in the United States." The OTA report sites a WHO reference stating "smoking-related diseases are such important causes of disability and premature death in developing countries that the control of cigarette smoking Could do more to improve health and prolong life in these countries than any single action in the whole field of preventive medicine."

62 Several studies have demonstrated that intravenous nicotine can maintain self-administration behavior in rats and monekys, but the environmental condi- tions under which this occurs appear more limited than with drugs such as opioids or psychomotor stimulants. Nicotine appears to be a substance which has the pharmacological properties necessary to lead to its repeated ingestion. Doses of nicotine which are otherwise self-administered may even function as punishers to suppress behavior under certain environmental conditions. The existence of these aversive effects of nicotine may account in part for changes in human cigarette smoking after variations in nicotine content or treatment with nicotine or nicotine antagonists. Effects of pharmocological treatment with nicotine antagonists can alter smoking behavior in humans and suppress nicotinf self-administration in animals. Clearly, further studies are needed to determine, the range of conditions over which nicotine will maintain or suppress behavior,'' the critical factors controlling these properties of nicotine, and the ways in which pharmacological treatments can alter smoking behavior or self-administra of nicotine. There has also been limited research on actual cigarette smoking in animals: ~ The majority of monkeys given free access to cigarettes will smoke, but in a rather sporadic fashion. Certain animals, however, will regularly smoke and obtain nicotine blood levels comparable to those obtained by human cigarette smokers. These studies of smoking behavior and nicotine self-administration in ani- mals support the view that nicotine is the primary constituent in cigarettes that maintains their compulsive use. 4. HUMAN STUDIES AllhouKh it is still nut uncyniv,1r:iI1V rlwn• Ihal nir„lino is Ihr „nly nKenl . responsible for the development of physical dependence on tobacco or the main- tenance of smoking behavior, it is certainly the leading contender. Proof of nicotine's pt•imary role still ,twaits ndemonstration that the cigarette withdrawal syndrome is similar to the nicotine withdrawal syndrome. However, there have 63 unpUcating nicotine's role in the subjective frequency. For instance, subjects have been -r with greatly diminished nicotine) and they f r-r;,vment of smoking. Some subjects seem to er t.;.v... but tt is possible that they are able to extra ty ,war~ : t ~.•.r m.+nner of smoking (e, g. , increased inhalation ~. t..,..- -.•nt :nvolves delivering nicotine to subjects via ar M.,... r. . -•.:es tnhal3tion. Subjects of these experiments *L.. •-re- of satisfaction that they get from their cu .. •-•rn :n sme instances they do report some satisfacti /.. r,.r evtdence implicating the role of nicotine in cigarettt r.+•<n..r .-,n studies that have directly measured cigarette s.trs .. •+- have shown: (1) increases or descrear aw.. ,. ,r• associated with compensatory changes in s 1~ _. .ar•,:n -u%.:rtne blood levels within certain limits; (2) m akvw. .. ..:.,n ,t nicotine either upwards or downwards is als sw .rs..eu•,r•r ,:h:.nqes in smoking which tend to maintain nic t•*m. ..+z n.rt.un tunits; (3) pretreatment with nicotine (intra• trnrti+ =: -.- .• ;:mpensatory decreases in smoking; and (4) pr( • 411111N"*A" w"+t nist produces elevation in smoking. -?•r'P_NDENCE AND TOLERANCE ,-:asstc drugs of abuse such as the opioids an :ut dependence are important characteristics c MIGN. w' •aa'°rt•ate rne user's tendency to continue its use. T~ .••• ph.irmacol,>r'i :ai effects of drugs and may 1 ...:(-u „l h1i;hrt J,.•.,., „f Ih,• ,hr,it;. whirh in ttt 4''0'"• t- a, or untowar l effects on the user. ' ' -n tcm n~tr: tc,l f1,r Ihc cff,•ct: uf ,tm,kinK o( many of the components of cigarettes.

65 dizziness is common among novice smokers, but disappears with experience. Metabolic tolerance can be demonstrated in smokers to various components of cigarette smoke (e.g., nicotine, "tar", benzypyrene, carbon monoxide, other compounds) as well as to a wide variety of drugs such as barbiturates and chiorpromazine. Receptor tolerance can be demonstrated to some extent to cet= tain components of tobacco smoke. For instance, nicotine given intravenously has been shown to have a greater physiological effect upon nonsmokers than oti smokers. Similarly, tolerance to behavior, such as activity level, has been demonstrated in a wide variety of animal studies. Behavioral tolerance to nico- tine also has been demonstrated in animals, i.e., animals learn to compensate for decrements in performance while under the influence of the drug. There is also evidence of physical dependence to tobacco. Clear signs of withdrawal appear when heavy smokers abruptly quit, although there appears to be considerable variability in its manifestation. When a smoker stops smoking suddenly, he/she frequently shows a decrease in heart rate, sometimes in blood pressure, and a decrease in excreted epinephrine and norepinephrine and its metabolities. Other endocrinological changes may also occur. Furthermore, there is a decrease in mean EEG frequency, an increase in appetite and weight, and an impairment in performance on psychomotor tasks and in concentration. _ Disturbances in arousal and sleep may occur; and anxiety, irritability, and aggression increase. Finally, there is an increase in craving for smoking which decreases with time. Despite this reported increase in craving, the extent to which physical dependence on tobacco or nicotine influences the frequency of smoking remains to be determined. Human experiments indicate that, following a period of deprivation, irritability and the probability of smoking increase. In summary, although experimental findings are limited, it is clear that tolerance and physical dependence do occur with cigarette smoking, but the role they play in the maintan:tnce of smoking rrm:tins Io I- rsl,inr,vl. It would seem clear from the evidence presented that tobacco smoking pro- duces pharmacological effects which often lead to compulsive use. As stated 1,,..,, , r viin1tton of addictitm, it is necessary 0,00,,, .:,.-. nroduces organ and/or behavioral to. ..••cts of smoking are mild in compariso ., .., t- .c,,unces, the multiple deleterious healtl ,. ~ r,:wj sortaltty and disability and their atte b6 d ll h F ti th t tI esta . ew ques s e on a : f„r •« .• ~ ~• «..... ~.:, . wtde range of organ toxicity. r•utton of the group after reviewing the :ne toxicity, and the adverse social cons , s.n..r,r anould be considered a form of addictic s. •.. .. •^... an addicting substance. _ r concluded that cigarette smoking is ~;,ucatx,n of this conclusion is that cigare in hght of the range of policy consi •.+ .= r.erdered germane to the classic forms ot •- •.- n t, the narocitics, sedatives, stimulants. r.,t ctgarette smoking is considered an a: :t shouid be viewed as a disease. S •ta' -1rlstlrtttnr rt' 0ter metttods and' conc, +• ~'+.:n to oe applied to the smoking problem. " •••lrch efforts should be focused on th hum.ins. Rcsc:irch programs st +'~,t Pn+rmacologtcal variables which influ .-•rnjt;on of cigarette smoking behavior " ` -' - n and mauttenance of cigarette smokin ~" ' +• .;tentwn to other components of smoke

126 -5- I know the labeling provisions'of the legislation raise ;~ some questions. I cannot say for sure that six rotating labelt;' - listing exactly the ill effects of cigarette smoking will make k_. the difference. I can say that in 1979 13.5% of boys aged 15. and 16 and 11.8% of qirls that age are regular smokers. I can say that at ages 17 and 18, the incidence increases to 19.38 :*4 for boys and 26.2% for girls. Also, the percentage of girls V age 17 and 18 who smoke has risen sharply since 1974. One ::, further point, by 1983, according to statistics from the National Cancer Institute, lung cancer will outdistance breast `"; cancer as the number one cancer killer of women.3 Our children are risking their lives, possibly because of,,4*~ clever advertising, combined with the various reasons that influenced so many people to begin smoking years ago: peer pressure, peer imitation, saying it looks so sophisticated, grown-up, etc. At the very least, we must give them the best, information about the hazards of cigarettes to permit them to make an informed decision. An FTC staff study came to the following conclusion: "...many [smokers] are unaware of the existence of the relationship between smoking and some of its most serious and widespread health conse- quences, such as heart disease...Some of the r 127 -6- health consequences of smoking, s, cancer and emphysema, are more we: However, even for lung cancer, the known health effect, some substant in consumer knowledge are evident. have an obligation to fill those gape -,ng. How many 17 year old girls who e e today comprehend that they could c . r.,nd would have to undergo the difficL ,litation that is necessary to overcome .-..,~-d with that disease. Not enough: Chairman, the Congress's own researc !! e of Technology Assessment, in its ASSF P~,LOGIES FOR DETERMINING CANCER RISKS FF !a' :.!.:ne 1981, states that tobacco smokinc ::-portant preventable environmental fac aisability, and death in the United sites a WHO reference stating "smokir +r" ::n important causes of disability and >ping countries that the control of cic 1 io more to improve health and prolong "3+^'ri-s than any single action in the whol • • 7-' ive medicine."

101 ;s ~Dr rotating and increasing the visibility of warning labels on cicarette oacks and in advertising, we think the time has long been ri:e for that. We reconmend putting the warning message on the face-- nc• t.ne side--of the package. The rotations would alert people cc^stantly about the specific effects of smoking. Obviously, people ne2l m.ore specific information. We also support listing carbon monoxide ccntent as well as tar and nicotine. In addition, we would like to see the additives in cigarettes listed. in a survey of readers of the American Lung Association's Bulletin a-cnthly magazine, we found our readers in favor of rotating labels. An especially popular one was: "WARNING: Cigarette smoking is dangerous to health and may cause death from cancer, coronary heart disease, pul-cnary emphysema and other diseases." Many favored it because l; was the most comprehensive. Some felt it was not strong enough. ~eems clear that Congressional leadership is required to help reeress the massive imbalance of cigarette advertising that affects all areas of our society. H.R.5653 represents the kind of national action desperately needed to begin to counteract the epidemic of r7oKing-related diseases in this country and to encourage the 53 million sra<ers to find the way to quit their life-threatening habit. With r2w seif-help and group programs we developed in 1981, at the American _cn, dssociation we are ready to help show those smokers how to quit sdccessfully. . cooperation with the Office on Smoking and Health, the National :nteragency Council on Smoking and Health and the major voluntary ~r;~nizations such as the American Cancer Society and the American -enrt Association, we look forward to increasing our joint efforts ta corbat this country's number-one preventable public health problem. = newly organized Coalition on Smoking OR Health provides a unique -e.nanism for coordinating private sector smoking and health programs a,d establishing an interface with public sector programs. Thank you for your attention. SDURCES C. Everett Koop, M.D., Surgeon General, Release: 2/22/82 New England Journal of Medicine, 2/11/82 Staff Reoort on the Cigarette Advertising Investigation, FTC, 5/81 Staff Report on the Ci, Advertisina Investigation, FTC, 5/81 I

105 IN .,_,_ ,___.. scews deacn races for cwo hypothetical population sampies; _,,C,J00 smoKers and another group of 100,000 non-smokers. -.-,.-.oer o: deatis expected in the subsequent ten years for the two ,.:.°s oi :en '~et~een the ages of 55 and 59 are shown. Only the four :_a:,cn .auses of death as;ociated with smoking are shown in this c,1_.-_at~0n. Non-Smokers Smokers Artery Disease 6.168 11,454 ancer 257 3,223 Scn<e 1,066 1,600 _ h:sama 69 860 '::a: Deaths Expected 7,560 . 17,137 This analysis shows that for each 100,000 population sample i-1:^e age group 55-59 years, the smoking population will have 9,577 aore deaths than the non-smoking population. If one assumes that the cota' iospital and professional cost of-each individual prior to death ave:aged 510,000, the total excess health cost of the smoking group is c:ose to 100 million dollars. Since there are about five million xn in the United States between the ages of 55 and 59, the total excess health cost in that age bracket is five billion dollars. 3E'd AND CONFIRtiINC EVID^ICE IS CONTINUALLY PUBLISHED Each year a large number of publications from laboratories • arjur.d che world confirm the relationship between cigarette smoking and Suman disease. `fany different types of studies have been performed-- .ptdemioiogic study of death rates, results of stopping smoking, studies of :ung Eunction, and examination of tissues at autopsy in smokers and non-smokers. A brief selection of several recent papers follows. Lach of these has been published in a highly respected, peer-reviewed Mdtcal journal. Two recent studies have shown increased life expectancy in iadividuals who discontinued smoking compared to those who continued

i Coalition on Smoking OR Healt A PUBLIC POLICV PROJECT WITH THE - - NATIONAL INTERAGENCY COUNCIL ON SMOKING AND HEALTH March 5, 1982 (202) 822-9380 John D. ICessle rou esOaM.no" co"r.er COALTION ON SMOKING OR HEALTH SEERS TO INFLUENCE LEGISLATORS WASHINGTON, March 5-- A new "Coalition on Smoking OR Health" backed by thirty the nation's leading health, education and youth leadership organizations, has formed to advance the cause of smoking prevention in the United States, it was announced today. The coalition, which will be based in Washington, D.C., will bring smoking pre- vention issues to the attention to legislators and federal officials and will promote support for federal smoking prevention education programs, according to D. Kessler, chairman of the coalition's steering committee. "The Coalition on Smoking OR Health serves as the public policy action arm of National Interagency Council on Smoking and Health (NICSH)," Kessler said. NI is a voluntary association of leading groups formed in 1967 to inform the publi about the dangers of cigarette smoking. The coalition will work closely with three major voluntary health organizations -- the American Cancer Society, th American Heart Association and the American Lung Association. -more- ~"CIGARETTE SMOKWG IS THE SINGLE MOST PREVENTABLE CAUSE OF DEATH IN THE UNITED STATES" .t:cn will immediately focus on promot •,~,,, ., .•cs: excise tax on cigarettes to deter chi ,..e er.d would support enactment of a Compreher I 3. .957 and S. 1929) that would, among oth< :4irette warning labels. ,.., -•r imediate public policy priorities: "We are r r,,.s.e.. te:eral protections for Americans against exposure ew..~ .• .w eaempt from protective controls which govern for rr.... .. sw .. . e..<st:oning the consistency and propriety of nat? er•-a s.c-a•e t.uc dollars to inform Americans about the heal enoe.y ...• it the same time allocating additional tax doll t+..+,'... . t-oacco." lreet •::r:cnerty, Jr., N.D., Ph.D., chairman of the NICSH = ee•et...•,..-r ~f the Coalition on Smoking OR Health as a mean: -e^••, :r.rte federal initiatives and activities on smokiaF =~ertt ~s _ean of the school of medicine at the University •.«-,at c-.e prevalence of smoking is declining," Dr. Daugher ee'.•'••t.=+ce c^e difficulty of the task that lies ahead." He '~•'"'~•'-i =:s vast resources, is very good at waging camp "•'• :-rs:on and doubt in the minds of the public." -more-

123 -2- Tne reasons for our dedication are clear. Today, 54 sillion Americans will light up a cigarette and we know that smoking will contribute to the death of over 300,000 of them this year alone. 430,000 Americans will die from all forms of cancer in 1982. According to the February 22 Surgeon General's report on the Health Consequences of Smoking 129,000 of those deaths will be caused by the use of tobacco products.l 35% of the 111,000 lung cancer deaths this year will be s:eoKing related. We know from the Surgeon General's report that the overall cancer death rates of male smokers are approximately double those of nonsmokers and for female smokers the death rate is approximately 30 percent higher. The Surgeon General found that cigarette smoking was a major cause of lung, laryngeal, oral cavity, and esophageal Cancer. It was also found to be a contributory factor to blaoder, kidney and pancreatic cancer. In addition, he noted that ~?pidemiological studies suggest an association between cigarette smoking and stomach cancer to a possible association between smoking and uterine and cervical cancer. What is even woti.;e, those cancers most closely associated with cigarette smoking (lung, esophageal, laryngeal, oral cavity and pancreatic cancer), can he the most difficult ones O_KZ--9 I

a 103 a:articulac beh.avior is 'aar^iful even t'nough they do ais Knowleege into appropriate action. They know buc ~-,-~ -e:ieve• Health education is pitifully primitive in che 'ieaith educational spocs have markedly declined from ^rogra:eming, and the miniature "warning" on cigarettes and;;ji:e-•2 ,,.:ercising is ineffective. P.t_one time, when a surgeon ~...;.~_ .ac aot Seen anpointed to office, the tobacco industry ridiculed ,•.. .....ced varning by pointing to the non-existence of the individual ,R.:u a.~a appeared on the cigarette package. 3:;tation of warning labels that would constantly remind aaosers of specific diseases produced by cigarette smoking s.cc ::ce _hey reached for a smoke and would have an important effect iact into belief. While clearly less effective than dollar advertising blitz launched annually by the tobacco suca rotating labels would be an important first step. A cu._•. _nepectio^, of advertising material convinces most observers t14t '._i iission is to encourage non-smokers to smoke and to keep .~a.r. ,muking. Rotation of labels should be followed by other ecucational techniques such as the publication of an anti- sw<:~; ~essage of identical size next to each smoking advertisement. R.a <noice in a free society is only possible when each individual 1s :ncormed. Crying "fire" in a crowded theatre is not dissimilar to encouraging one's neighbor to regularly inhale smokel SMOKING DOES CAUSE HUMAN DISEASE athough the tobacco industry characterizes the linkage of ::g4rette smoking and human illness as the "Smoking and Health :antroversy," the only controversy is the unwillingness of that L^.o-astrr, to voluntarily phase out cigarette production and to •acourage individuals co stop smoking. The evidence establishing the cox:: nature of cigarette smoke has been accumulating since the Pub:ication of the first report of the Surgeon General in 1964. Since than,thousands o: articles documenting the harmful effects of cigarette taoking have been published and the United States Public Health Service r 0

'.tie environmental sanitation movement of the early Twentieth ,;r^curlwith an emphasis on pure drinking water and sanitary waste ..=-csa1 provided clear_ evidence that maintenance of the public health vas a naJor responsibility of government. More recently, the widespread ac ^ci~n of cigarette smoking has led to a new epidemic of preventable iwr•.s that can only be eliminated by direct action of public health r,;~.-r-cies. Like the Black Death or plague of 1348-1350 which killed :ae --ird of the population, cigarette smoking leads to the premature :aach.s of large numbers of a nation's population. Adoption of H.H. ;,;3, the "Comprehensive Smoking Prevention Acc"would place the United Sca:es government squarely in the role of defender of the public health. The Federal Government must attempt to eliminate as many of the aundreds of thousands of deaths due to cigarette smoking as possible ana :a reduce the billions of dollars spent for the care of people• v'.tr. cobacco-related diseases. Every effort must be made to discourage vccng people from starting smoking and to help confirmed smokers stop sxoKing. The increase in cigarette smoking among ~dolescent girls rtas -.een parcicularly alarming and there is reason to believe that a gr-uo of societal pressures are responsible for this situation. Lung cancer was at one time extremely rare in women; its dramatic increase in che past decade is a stark reminder of the risks of adolescent cigarette smoking: IQ70WLEDGE AND BELIEF '.Riy do people smoke? The'Roper Report commissioned by the tzbacco industry warned that most people knew that cigarette smoking , we harmful and that many smokers desired to stop. This public opinion arganization detailed a series of problems that threatened the continued aabilicy of the tobacco industry and emphasized particularly the spread ot hea:th Knowiedge among the public and the growing activism of non- ~ters. Unfortunately, the knowledge that cigarette smoking is dangerous L not necessarilv translated into abstinence. Behavioral scientists Irse developed the "health belief" model to explain why individuals WyV,i 0_hz__d

V 135 other substances, like salt, clearly know plays a role in health de- termination in our society. I would favor very much the kind of educational program that you propose for young people so that they might have all of the facts in all areas and make their own choices about their lifestyles. But the one key, I think, in this, Senator, is that industry has not, despite the fact that there have been pleas for a safe cigarette since 1964, ever successfully marketed a safe cigarette. There have been cigarettes brought out made out of cabbage and other nontobacco substances that were not acceptable to the American public, appar- ently, in that they did not seem to survive and sell; there have been all sorts of other so-called safety mechanisms introduced. The filter itself, in my opinion, was an attempt to try to make a ciga- rette safer. But, despite all the scientific evidence which I am aware of, there is no safe cigarette today. So sitting and hoping for that is not wise. I would condone fur- ther research on the safe cigarette and hope that it would by suc- cessful. But, in the meanwhile, I think we have to go on the as- sumption that that is not likely to happen tomorrow, and we do need to put forward information to the American public that they have every right to know. Senator EAST. I am just concerned that we not call assumptions, suppositions, and wishes facts, and I fear in this area we are doing that, and I fear in these findings we are doing that, and I fear this, "largest preventable cause," that is, I think, a statement of wish or conclusions, surmise, supposition. There may be some validity in it, but I am just curious about the scientific community too quickly giving the mantle of scientific base to what I think, in the real world of scientific integrity as I understand it, could just simply not be demonstrated, and we might as well admit it and thereby have greater credibility in the long run than when we make these grandiose claims. I mentioned earlier about nitrites and saccharin and so on. We are throwing out one scientific finding today and, 3 months later, we are pulling it back, or 1 year later or 2 years later, and finally, what the public says is, those fellows don't know what they're talk- ing about, because they really don't have, quote, scientific findings; what they have are general opinions. You used the word "judg- ments" about things, and they are communicating them out. But all of that is packaged in the terms of these findings. So many dif- ferent mice, what, some 800 mice had so much saccharin. Oh, it sounds like, oh gosh, these mice drank all these soft drinks and they got cancer, a terrible thing. Well, it turned out it had abso- lutely no correlation to genuine human health problems, and so it goes-nitrates, and so on and so forth. Coming out of the behavioral and social sciences, I just want to make sure that-I certainly do not like to see our profession too quickly run into the political fray, and I hope that the scientific community of this country, as zealous as it may feel in terms of its own political judgments or preferences, and they are free to work with those, does not bring the mantle of science in and grace it over this whole problem when, in fact, scientific findings will not bear it out. Thank you, Mr. Chairman. O ~ ~ M I

43 remature death; smoking is the primary cause of lung cancer p emphysema, heart attacks, miscarriage, stillbirths, prema f births . Then we are told, for example, in number 5, certain occupatid hazards in conjunction with smoking increase substantially isk of disease and death. Then we are told present Federal, S r rivate initiatives have been insufficient in conveying to nd p a American people the information contained in clauses 1 throug and so forth. - ' I realize we cannot unravel all of this, but as I look at this 1 so-called scientific findings, it brings me back to my training in:' ' social sciences and behavioral sciences, where we would jus reluctant to make such broad, grandiose conclusion ver ver y y , short, it strikes me that maybe what we are doing here is sta ' • ions in terms of suppositions, but we could not say, l conc us genuine scientific sense of isolating the variables, weighing tli ~ thin s f th ll d g ese o a . t t we have truly scientifically establishe h a oint is that where science allows itself to be politicized, M y p uite candidly-I don't mean you are but I m k it is here I thi q n , the potential of this bill-where you politicize science, in the li ~ d , more pa run, I think you do a great disservice to science an if ic larly, the public begins to be suspicious of so-called scient i ngs . several years ago, we were told that nitrit For example , bacons, meats, and so forth, were cancerous. Cut out bacon, cu and so on and so forth. The other day I read a report, t mea s, heard it discussed in great depth by a scientist on a radio in which he said this is no longer the case, that it has w h so , b through more careful examina en determined subsequently , e that the small amount of nitrites found in terms of foods an ' onexis forth are so infinitesimal, the health risk is negligible, n ' people several years ago, the American oint t on that B , p u on this question of eating bacon and canned m kin i t g c pan jus and bologna and that sort of thing. This occurred more recently { l as, saccharin. Now the warning label is on all of your diet co be hazardous to your health, or something like that. this ma y Again, I read a report the other day and understand that no are less sure that saccharin really does present a serious h ' ther we problem in the United States. So again, I query whe overreact there . Now, here again, I want to make clear to you and to eve i king genu ersonally favor the approach of tane, t I th l p a se e lished scientific fact, which I think your area can do, as Sur, ' t these fin General and informing the American people abou , in an objective, civil, low-keyed way. I think this will be more e thal t ry lity in this coun e in terms of improving health qua ti v ulled into groups and movements that I think go beyon i b ng p e I pale. I think they begin to read their own wishes and values ions into alleged scientific finding. l us conc It is trendy today to be antitobacco, antismoking. I underst r i s o that just as some years ago it was trendy to be antith , tithat. I don't know what it will be next. Time magazine has ii ` salt bu article on salt now, not the Strategic Arms Limitations ' to have white stuff. It is bad for you, and maybe we will have G•,rr•,cr••nt information on that. I certain !,:..• w,r ~:,It shakers taken away from us. surar iwi•xk. We will want more information t-n, r. ~; t he scientific findings of the SurgE ,~+--r rfc 11r. 13randt and his department, an ±,.•rrrt:+rv Schweiker is doing to inform us of t,s ;. rt. rcn ;i valuable public service. It is a f sr rtt ~ wncr• and Government. But again, mentality, and everybody is : ,r.ciudint; science, and asked to concl rra,iv .: t thc•m down and sat them down n'rr.vr .utct said, gentlemen, as you underst w tuxit. :rs You understand the very difficult rA r.t.rtflrshina scientific correlation, we are %ir r;;.,V in fact have prostituted ourselves port ot this so-called great movement that h t:£moran,v intentions. in r c;c .•,;,• ot Dr. Brandt-and then I will t,:--,rt terms of the responsibility of there is one, and I might note t?w j ti•n., rt rnent of' Health and Human Se Katir t„ carrv out the law that we pass, and lra,tr. N•cre•r.rry Schweiker came from the Sc tx•rson. He is doing it and would !t~svr r:o quarrel with that. I am not ask Pv:un.-- in terms of the laws passed by thf Ought to ,;u it. and I know you intend to do it tsut -t : h,s matter with the bill and wh< ft-. KE ,rv trying to take these so-called all aaI riu M,rna•titing with them now in the po] 'n *lxsr rk•,}xonsibility; that is the Depar, 1t;utnan -N•n,ce's responsibility, and I think ~ &!s'% •, '•% hole range of health matters. ~ Tt:_ ('1WICNIASenator, your 10 minutes ~ '4 vnat.,r !':Asr. Just let me ask one more qt ,tr~p. I wonder, Dr. Brandt, in Nou •+re stressing, and I think rightl, - ttiv>' did in the House hearings, t -%MWrk".,t: ;n•o{)le know there are health haz iu0nestly, else could Government 1..+"n't even think these gentlemer tAsking that the Surgeon Gene ,Wh ~cic•ntific causation, that the '~`3 }~af' •~rt ~4•r-vices, in the policy public a of this, and I think we c ~:n the United States on smokii 4'thR;f.t~l t1A '.1ia1• uj), r--st on that, Mr. Chairman. : -ciuld a p t t'''' w'.ll. 4•natorEast,I would not ' "'-ct YOu have said and, of all pc tlt,tn any to be certain t ~avs in the future carrie 036075-M

. 129 The CHAIRMAN. Thank you, Dr. LeMaistre. We appreciate having you with us today, and we appreciate the great work that you people at the M. D. Anderson Clinic have really done through the years in so many areas of cancer. Dr. LEMAISTRE. Thank you, sir. The CHAIRMAN. I have been through your facility, and I am very, .ery impressed with it. Dr. LEMAISTRE. We were very proud to have you there, sir. The CHAIRMAN. Thank you. You have said that the newly founded Coalition on Smoking or Health represents 30 different health education and youth leader- ship groups. Why have they now banded together in this smoking prevention education effort? Dr. LEMAISTRE. Mr. Chairman, I think those of us who have been involved in the question of smoking and its effect upon the health of the American public have wondered that for many years. A conference was held this past fall in New York, sponsored originally by the American Cancer Society and joined by the American Lung and American Heart Associations, along with at that time 21 other agencies. They considered the problem of smok- ing and they found much in common that they could do collectively that previously they had been attempting separately. All of these agencies have been independently concerned about this problem for a very long time. However, the new coalition, working through the National Inter- agency Council on Smoking and Health, is thought to be a far more effective and efficient way of bringing the feelings of all of the vol- unteers that these agencies represent to the attention of those who might be interested in hearing their views. The CHAIRMAN. You have provided testimony representing per- haps the last coalition of interested health groups on this subject, and I am pleased to see the high degree of interest and cooperation directed at what I personally consider to be an important problem. However, with such tremendous effort being generated outside of the Federal Government, within the private sector, why do you think this legislation is necessary? Dr. LEMAISTRE. Mr. Chairman, the legislation requiring disclo- sure of information and new labeling is important for several rea- sons. I consider this bill an essential first step toward other bills that will lead to the education of the American public; in particu- lar, the younger American public that has not yet made the deci- sion to smoke, so that they may have the freedom of an informed choice. In particular, the information that is becoming increasingly alarming about additives that you just heard Dr. John H4lbrook testify to is a major concern of all of these organizations. This is relatively new information, as the health consequences of ciga- rettes have changed over the years as the cigarette also has changed. You have also heard this morning in testimony that, whereas the W majority of the American public does generally appreciate the haz- ~j ards of cigarette smoking, they are not well informed on the specif- p ic hazards, and the relationship to lung cancer is better known %J V~ C11 ~2 ® 0 I N e I I

141 r In his 1979 report, the U.S. Surgeon General said that "notable changes had taken place in public awareness of claimed smoking hazards and expressed doubt that a higher level of,. awareness could have any effect on smoking behavior." We share this skepticism. Indeed, the level of awareness about smoking and health far exceeds public awareness of most, if not all, of the major contemporary issues facing this nation. Let me provide some examples: A 1980 Gallup poll revealed that less than 25 percent of the public knows what the First Amendment is or what it deals with. Other recent national surveys reveal that nearly 25 percent do not know what happened at Three Mile Island; 36 percent are not aware that the United States must import oil to meet its energy needs; 45 percent do not know that automobiles are the major source of air pollution; and one-third do not know whether the Federal budget is balanced. By contrast, at least 90 percent of the public is aware of the allegations that smoking is dangerous to health. This level of awareness demonstrates the success of the current Congressionally mandated warning statement, as well as the efforts of public and private organizations. The Federal Cigarette Labeling and Advertising Act is working. The facts clearly show that the public has been made aware of the so-called health hazards of smoking, and that people are in a position to make a free and informed choice on whether or not to smoke. Given this fact, why substitute a novel and unproven system for the present law. -2- 8

147 Looking at the broader picture regarding cigarette advertising, the record clearly shows that our industry has been responsible in its practices. o In 1954, to meet public demand, we began to advertise low "tar" and nicotine cigarettes. o In 1960, after the FTC stated that it had determined that such advertising could be construed as a health claim, we voluntarily agreed to eliminate from cigarette advertising all references to "tar" and nicotine. o In 1966, when the FTC reversed its position, we agreed that cigarette advertising would disclose "tar" and nicotine content. o In 1967, we began a continuing program of scientific and technical cooperation with the FTC with respect to "tar" and nicotine testing. o In 1970, we began to include in our brand advertising the FTC "tar" and nicotine measurements. o In 1971, we volunteered to depict the cigarette package in all advertising in such a way as to display legibly the warning label. o In 1972, we entered into an agreement with the FTC on uniform terms of conspicuously displaying the warning label in advertising. o In 1981, we reached an agreement with the FTC on an increase in the size of warnings. In short, our industry has acted responsibly in the past and we see no reason anyone should feel that we will not continue to do so in the future. Nor do we see why this bill is needed to regulate further our advertising practices in any way.

155 LUNG CANCER, CORONARY HEART DISEASE AND SMOKING By H. J. Eysenck, Ph.D., D.Sc. Professor of Psychology Institute of Psychiatry University of London March 10, 1982 0 ~.? ~ 0 ~ ~ ~ 9i-n77 O-k1--11 ~

for granted and not attended to, that such principles clearly make efforts to reduce smoking more effective. The CHAIRMAN. I was surprised to hear that the National tute on Drug Abuse's study-or NIDA, as you have been refe to it-found marked similarities among nicotine, cocaine, and phine addiction. What is NIDA doing to inform our citizens i this important finding? E Dr. Pola.iN. NIDA contributes to the overall health infor' programs of the department. The findings with regard to th pendence-producing properties of nicotine represent rather findings. They have been publicized to the scientific commu They have been relayed to the department and, we think, wI creasingly become part of the department's overall effo counter the health consequences of smoking. The CHAIRMAN. Thank you. Senator East, do you have any questions? Senator EAST. I will be brief because I certainly understan doctor must leave very shortly. On this matter that you are testifying about here, this mat addiction, and I am certainly not for a moment questioning expertise and scientific understanding of this problem, I get what intrigued, though, with this coming together of science, policy here. But just sticking with science for a moment, matter of addiction somewhat intrigues me-the addictive q of things, so to speak; for example, what is addiction and the sity of addiction to this, that, or the other thing, and health consequences coming out of it. For example, certainly addiction to heroin is an infinitely gr health problem than a person who might have a couple of dri day. Alcohol, we know, can be addictive. There can be a ce compulsive pattern of use. Some people might have two dri day. Some might even say, at that level, it is helpful to hi There is some scientific evidence that it helps in terms of blood culation and prevents heart attack. Out beyond two drinks a some evidence begins to compound the problem: high blood sure, and so forth. But addiction-I guess there is physical and psychological tion, and this problem of variables again makes it compleg what that would mean in a given context. What I am resistan politicizing too quickly-not that you are, but I think this d into a political context here with tobacco-that we avoid this lem of implying that the drive to do something, whether it be to smoke or to drink or to eat too much or to gamble-I program the other morning on compulsive gambling-this qu of obsession to do something is an interesting problem of h behavior. It has interesting and fascinating scientific implica to it. What I am concerned about is that we not single out this sion to do something on a particular commodity or activity, ari noting it can be identified with other forms-you menti heroin-that, all of a sudden, we are not suggesting that child that I learned, at the age of 25, was smoking 10 cigaret day or whatever, and then I had another child I learned was ing heroin, and I set a plague on both your houses because th 69 .1,r c"r:,mun:rlitv of being addictive, or I understood t] ,dJ*W,,.t, W:rµ drinking two beers a day, and the addict d&I'ta,! .1,1, see-the common thread of addiction, I it i did not watch my emotions, the gei t~r.e r•..r11,• in terms of the relative health of thes -/.m u.t «nndering here, when we begin to talk ab q" ot tobacco, that we must understand tha', idmm ra:•t t,>r Murposes of argument, it certainly is ~ cr.~t ~~ ~,Id have the same kind of health implic. .1na Society as a whole as a person who, for g0v,n I think, again, it would bring science i lavan;,ow r r,e commonsense of the man or woman in thF .", tirti. that won't wash." Why? Because common a r:~notn addict is destroyed as an individual. amwv-.-~ a%aunctional and ultimately destroy themseli ~t Fr~r,~.~:i~• '1'hev are no longer employable, and tl ...rr,w~:.i% s•xrk•nsive habit and they go to all kinds oi ±~ser.xs „ntt tr•.rliniz, and it destroys them. lko ti,~r .:oo;ctton in that case has horrendous impl iMsa mnAin iv «•e wou ld not want to transfer that intc arr.mti~p. ~,t u,at;e ot' tobacco, which goes back to the i~ pi pe tobacco, and so forth. We hav .Ntasrat r:Ix•rif•nce with it, and I am just resistant skAiL .tM:4:., .;,,n in this area ought to be looked upon a tr sa* .wai,tion of' the alcoholic or the addiction c 44&-,.1 t du not think commonsense would support that. . *@GWn ti, %r,u that I am a little bit concerned that v WAUW..tttt oroportion and balance so as not to distort arrczrA ct,rtc ern we might have about any or all forms Ur r`.+ :: v I t h i n k yo u r point is well taken, Senato •10" r~.•-.vrrv indeed to attempt to be precise wher ~Atie t~s-~;,,rri+urt5. t tr x:,~. n„ue%•er, that I would end up at the bottom 1Sss.-.rv :r,irn vour position in terms of the relative : *"W*», r,•rt:rrnly to the Nation if not to the ind *44"d tv tn- comparative addictive properties of the ONSWAM tM t%uu were mentioning, alochol, tobacco, ani 40 1 tY`,nt,Yl aut, though alcohol does cause a grievc 4k%" tnd1vldu:rf5 and to the Nation, our best data su 00 6P" r.urnix•rs of people who use it with some rE ~~,,.°'°t+ =1rr percent are able to control its use : •~~ $t~riR7n4 tx•havior does not run away with them. '~ '"~' ~ uEK>,ite ratio is true with regard to smoke ~ ww'tarit fit ~rrtokers who have ever begun as a youni with a few cigarettes go on to a regul arW titt-rt. as adults, reach a level of smoking 10"'"""""'^ w4juld strongly wish to be able to decreas( t.-Y tind themselves unable to do so. A-ad 1,1 •n ts rrns of the comparative addictive strc '• }t ree substances, I would say that tobt ~ome of the empirical, quantitative dt 4ft r-*. rtrtlrt,; to assemble is rather startling in t :ii'rotrt addicts themselves, who do say th. 03607596

143 As you know, this bill is very similar to H.R. 5653, a House of Representatives bill which, although broader in its approach, seeks to achieve basically the same goals. Just last Friday I, along with expert witnesses from several disciplines, presented the industry's views in opposition to the House bill to a subcommittee headed by Representative Waxman. Also, at that time, there were some 30 highly qualified and respected scientists ready to appear to challenge the scientific "findings" of the House bill which are very similar to those in S. 1929. Only a handful of these scientists were heard; the others were just permitted to file statements. I request at this time that the submissions to the House Subcommittee of all of these scientists be entered into the record of these proceedings. I would also add that the time you are devoting to hearing our industry's position is far too little in view of the com- plexities of the issues. Far more time, rather than the brief hour we have been allowed today, would be required to cover only the medical and scientific questions in regard to this bill. In the House subcommittee hearings, we were allowed only a day to cover the issues, far short of the time needed. Today, we will do our best in the time allotted. In 1969, when the Federal Cigarette Labeling and Advertising Act was amended, the Commerce Committee of the House of Representatives held extensive hearings over a period in excess of two weeks. It heard testimony from Members of Congress, state officials, government health and regulatory agency officials, -4- M 0) IPA

U 137 ant professor of marketing at Ohio State University; Dr. Sheldon Sommers, scientific director of the Council for Tobacco Research; and Hans Eysenck, professor of psychology at the Institute of Psy- chiatry, University of London, and psychologist to the Maudsley and Bethlehem Royal hospitals in London. Again, given the time constraints, if necessary with respect to your questions, I may also call upon Dr. George Schafer, medical director of the Tobacco Institute; Mr. Horace Kornegay, chairman here of the Tobacco Institute and Sam Witt, who is vice president and general counsel of R. J. Reynolds Tobacco Co. and is seated di- rectly behind me. We are here today to express the tobacco industry's position on S. 1929, the Comprehensive Smoking Prevention Education Act. We are firmly opposed to this legislation because we feel that it is bad legislation for the American public and for our industry. We feel that it is unnecessary and ineffective and that the scientific findings cited in the bill in support of its proposals are unsubstanti- ated and incorrect. From this committee's perspective, this bill may well be counter- productive because there is significant evidence, from the stand- point of behavioral science, that its actual result may well be to lessen awareness of cigarette health warnings. A number of very broad, sweeping statements relating to smok- ing and disease are included in the particulars of this bill. Certain- ly there are questions raised by statistical associations which must be answered, and our industry is providing significant funding- more annually than all of the private health agencies combined- to support unrestricted research to find those answers. But the truth is that after three decades of investigation, no causal link between smoking and disease has been established. All of the statements presented as established fact in this bill have been challenged by research findings of many eminent scientists, and I submit that their findings should be considered in your delib- erations. As you know, this bill is very similar to H.R. 5653, the House of Representatives bill which, although broader in its approach, seeks to achieve basically the same goals. Just last Friday, I along with expert witnesses from several disciplines presented the industry's views in opposition to the House bill to a subcommittee headed by Representative Waxman. At that time, there were over 30 highly qualified and respected scientists ready to appear to challenge the scientific findings of that House bill, which are very similar to those in your bill, S. 1929. I request at this time that their written submissions to the House subcommittee be entered into the record of these proceed- ings. I would also add that the time you are devoting to these hear- ings, to hearing our industry's position, is really far too little in view of the complexities of the issues. Far more time, rather than the very brief period we have here this morning, would be required to cover only the medical and scientific questions in regard to this bill. In the House subcommittee hearings Friday, we were allowed only a day to cover the issues, which was still far short of the time

139 ® authors of the bill, those provisions will not prevent unauthorized leaking of these critical trade secrets. On numerous occasions, our industry has been the victim of such unauthorized disclosures of confidential information that we have furnished various Govern- ment agencies. We have been, and we continue to be, engaged in constructive and fruitful discussions with Assistant Secretary Brandt and other HHS officials on this matter, with a view to making available nec- essary information to that agency under appropriate procedures and safeguards. Secretary Brandt himself has recently stated that he is pleased with our industry's cooperative spirit and that he is confident that substantial future progress can be made in resolving this question. This present bill, though, would short circuit this effort to re- solve any legitimate concerns. In other words, the effect of this bill would be to "shoot first and ask questions later." In summary, we are opposed to this bill for many reasons, but key among them are the following: In effect, we believe it will freeze science in its tracks because it may well divert scientific talent and resources from the basic research necessary to resolve the questions of smoking and health, and because it attempts to settle by Congressional edict continuing medical and scientific con- troversies. It also seriously erodes the principle of free choice in our demo- cratic society. In denying a person's right to reject official informa- tion, this bill betrays its fundamental prohibitionist motives. It says, in effect, that Americans are expressing their basic freedom of choice in rejecting the arguments of antismoking activists and that the Government finds this unacceptable; therefore, steps must be taken to make Americans conform and to encourage the prohibi- tion of smoking. I do not believe that the American people will accept such a rationale. Mr. Chairman, I will conclude by saying once again that we regret that we have only been given such a short period of time to address these very key issues which do deserve much more lengthy and indepth consideration. I will end my testimony at this time with the request that my formal written statement, with all attach- ments, be entered into the printed record of these proceedings. I hope that each member of the committee will read my written sub- mission and those of the expert witnesses very carefully in order to gain an accurate picture of the facts in support of our position on this bill. Thank you, sir. The CHAIRMAN. Thank you, Mr. Horrigan. Thank you for your testimony. I appreciate your concern that these hearings do not provide ade- quate time to cover all of the issues related to smoking and health, and therefore all of your statements and the statements of any of your associates here today will be incorporated in the record in full, and we will be pleased to accept whatever additional written testimony you would like to have included in the record, so we will keep the record open for a limited period of time so that you can submit any other additional testimony. 95-077 0-32--1a

151 The bill provides that such information should not be disclosed. Unfortunately these provisions will not serve to prevent the unauthorized leaking of these most important trade secrets. On numerous occasions our industry has been the victim of unauthorized disclosures of confidential information furnished government agencies. The basic defect in this provision is that it is an attempt to provide a quick and easy "solution" to a problem that has not yet been adequately defined. We have been, and continue to be, engaged in constructive and frutiful discussions with Assistant Secretary Brandt and other HHS officials on this matter with a view to making available necessary information to HHS under appropriate procedures and safeguards. Secretary Brandt has recently stated that he is "pleased with" our "cooperative spirit" and that he is "confident that substantial future progress can be made" in resolving this question. The present bill would short-circuit this effort to resolve any legitimate concerns. In other words, the effect of the bill is to "shoot first and ask questions later." In conclusion, we are firmly opposed to this because we believe it to be unnecessary and, most because the medical and scientific assumptions or underlying it are incorrect and unsubstantiated. legislation importantly, "findings" We are not opposing the bill because we wish to exploit the youth market as some have falsely charged; nor are we opposing the bill because of the potential costs of complying with its requirements. -12- 0 ~ ~ ~ c~

142 W I submit that this bill will have little, if any, impact following almost three decades of government and private warnings, the Surgeon General's statements on cigarette packages and advertising, and broad dissemination of anti-tobacco propaganda through the public media. The fact that millions of people choose to continue to smoke, despite the almost universal awareness of the allegations regarding smoking and health, is frustrating to anti-smoking activists and advocates. And it is our belief that this frustration has led them to conclude that those who reject anti-smoking arguments and continue to exercise their freedom of choice are uninformed. Therefore, they seek measures, such as this bill, designed to force smokers to conform, and to encourage prohibition of smoking. Let me take a few minutes to review some of the premises used to support this bill and the charges leveled at the tobacco industry. A number of very broad, sweeping statements relating to smoking and disease are included in the particulars of the bill. Of course, there are questions raised by statistical associations relating to smoking and disease which must be answered. But the truth is that all of the statements that are presented as established fact in this bill have been challenged by the research findings of many eminent scientists, and I submit that their findings should be considered in your deliberations. 143 As you know, this bill is very s of Representatives bill which, althou seeks to achieve basically the same g( along with expert witnesses from seve the industry's views in opposition to subcommittee headed by Representative there were some 30 highly qualifiedan, ready to appear to challenge the sciei House bill which are very similar to ' a handful of these scientists were he: permitted to file statements. I requ, submissions to the House Subcommittee be entered into the record of these p I would also add that the time y( our industry's position is far too li- plexities of the issues. Far more ti7 hour we have been allowed today, woul, the medical and scientific questions In the House subcommittee hearings, w~ to cover the issues, far short of the we will do our best in the time allot In 1969, when the Federal Cigare Act was amended, the Commerce Committ• Representatives held extensive hearin of two weeks. It heard testimony fro: officials, government health and regu -3- -4-

111 Mr. Chairman and members of the Committee on Labor and Human Resources, my name is John A. Oates, M.D. I am Professor of Medicine and Pharmacology at Vanderbilt University and Chairman of the Subcommittee on Smoking of the American Heart Association. The American Heart Association enthusiastically supports S. 1929 the "Comprehensive Smoking Act of 1981." As you may know, the American Heart Association is a nonprofit voluntary health organization with over 119,000 members and almost 2 million other volunteers who are dedicated to the reduction of premature death and disability from cardiovascular diseases.' Cardiovascular diseases kill nearly one million Americans each year. This is more than all other causes combined. Heart attacks, the nation's number one killer, claims most of these lives. This year, as many as 1.5 million Americans can be expected to have a heart attack and about 550,000 of them will die. The survivors will join over 4 million Americans who have a history of coronary disease.= These figures have special significance because cigarette smoking has been firmly implicated as a major contributor to the occurrence of heart attacks, sudden death, peripheral vascular disease and it greatly aggravates other forms of cardiovascular diseases. Cigarette smokers are more likely, than non-smokers, to suffer a heart attack, more likely to die from these attacks and more likely to die suddenly. This effect is directly related to the amount smoked with heavy smokers being at three times the risk of non-smokers. Fortunately, ceasing to smoke reduces the risk toward that of nonsmokers.' Based on data from the Framingham Heart Study', we estimate that over 174,000 Americans will develop peripheral vascular disease this year. While, twenty percent of these people will be diabetics, 70% of the remainder will be cigarette smokers.' Moreover, diabetics who also smoke are at even greater risk.' The link of cigarette smoking to peripheral vascular disease is consistent and independent of diabetes and other risk factors and related directly to the number of cigarettes smoked.' Perhaps most significant is the fact that when people stop smoking, their risk of these cardiovascular diseases gradually returns to normal. The risk of fatal and non fatal heart attacks among ex-smokers is similar to non-smokers in about 10 years.'-' The risk of peripheral vascular disease is similarly reduced to that of a non-smoker in about 5 years.l' The evidence incriminating cigarette smoking as a major risk factor for heart attack and peripheral vascular disease was judged by an expert panel of the American Heart Association to be conclusive. " They further concluded that "Theoretically, cigarette smoking is the most preventable cause of these cardiovascular diseases and mortality therefrom".' In spite of the overwhelming evidence linking cigarette smoking to cardiovascular and other diseases, over 52 million Americans are still smoking.'= However, two thirds of these smokers would like to quit and most have tried to do so. " Following an unsuccessful these smokers tend to switch to low tar and nicotir evidenced by the continuing rise in the market shi 60.9% of all sales in 1981.15 This development is alarming because the evidence' switch to low tar and nicotine in an effort to lc nealth effect. While switching to these cigarett some diseases, there is no evidence of a reduction diseases. " In fact, recent evidence from the suggests that low tar and nicotine cigarettes may cardiovascular disease. This could be a very dange, cigarette-related deaths are from heart attacks.' ,he American Heart Association is committed to he quit and preventing children from starting to wholeheartedly support the passage of S. 1929, t Prevention Education Act of 1981". The provis -,andated smoking and health program is very importe _.e federal smoking and health program will be ins- =oordinating the efforts of the public and privat :,roblem of cigarette smoking. This is a clear case ;=deral effort can be used to mobilize enormous pr adcress a major health problem. 'he provision requiring the rotation of five nc ciqarette packages and advertisements is needed to b tne specific dangers of cigarette smoking. The rat ` a warning statement in the first place, was to ,ealth hazard. However, the FTC " has recently cc warning statement, which has been used on packages ::72, is overexposed and worn out. This conclusion s:udy by Starch Message Report Service which found e*oosed to cigarette ads reads the Surgeon General -c7e as no surprise since any message presented exact c,~come so familiar that it will lose its effecti~ s'rce cigarette companies vary the copy of their ad "H=ar out" effect, it seems reasonable to conclude t requires no less. 9-cdsky and Myrowitz,=' in a study of cigarette billt s:atement to be written uniformly on all billboards a tnat used in newspaper and magazines. Individual =cnsistently appeared the same, i.e., reduced detail etail and size of the letters in the brand name, °a-ning statements were 38 and 17 times smaller. =crcluded from their test that while the brand name .as not.

i 106 with the habit. Doll and Peto (British Medical Journal, 2: 1525-1536, :976) followed 34.000 phvsicians in Great Britain for 20 years; half of the phvsicians followed stopped smoking during that period. Deaths from chronic obstructive lung disease decreased bv 24% in the physician group while the decline was but +X in the general public. The death rate from lung cancer in physicians who continued to smoke was 16 times that observed in lifetime non-smokers; the deach rate for physicians who had refrained from smoking for from five to nine years was six times that of non-smokers and fell to twice the rate of non-smokers after fifteen years of abstinence. The study also demonstrated an important relationship between the duration and the amount of smoking and the occurrence of lung cancer, dose-response relationships that strongly support the concept of direct causality. Friedman and associates (New England Journal of Medicine 300, 213-217, 1979) followed 4004 men and women over an eleven year period after an initial evaluation. The mortality rate in smokers was 2.6 greater than that in non-smokers and the differences could not be explained by any of 48 baseline characteristics. In a later study, the same group (New England Journal of Medicine 304 1407-1410, 1981) studied the effects of stopping cigarette smoking on death rates. The overall death rate was 2.22 greater in those who did noc stop smoking compared to those who did. Of great importance was the observation that among chose individuals who had coronary artery disease at the tine of the initial observation, the death rate in those who continued to smoke was 3.92 times that in the group that stopped smoking. Evidence that cigarette smoking may produce an acute myocardial infarction (heart attack) was presented by Hartz et al (Journal of che American Medical Association 246 851-853, 1981). Heart attacks were 2.27 times more common in the heavy smokers aged 35-49 compared to non-smokers; they were 1.95 times more common in the heavy smokers aged 35-65. ' Both lung function studies and pathologic studies on human Lungs have shown the deleterious effects of cigarette smoking. White and Froeb (New England Journal of Medicine 302 720-723, 1980) observed that lung function was 31% lower in individuals smoking more than two packs of cigarettes each day compared to non-smokers. Of great interest,lung 'unction was 132 lower in non-smokers working in a smoke-filled environment compared to those in a fresh atmosphere. Cosio et al 107 'he environmental sanitation movement of the "aiti an emphasis on pure drinking water and s: ".-;a': orovided clear_ evidence that maintenance of - - ,-.a_or responsibility of government. More recen~ of cigarette smoking has led to a new epidem: .._.s _hat can only be eliminated b,v direct action o: . r__ies. Like the Black Death or Plague of 1348-= of the population, cigarette smoking leads c ._.. _' large numbers of a nation's population. Adc _, :he "Comprehensive Smoking Prevention Act"would _s government squarely in the role of defender of The Federal Government must attempt to elimir •-..,ndreds of thousands of deaths due to cigarette s .. rzd~ce the billions of dollars spent for the ca --oacco-related diseases. Every effort must be ¢ , xopie from starting smoking and to help confira -- 'he increase in cigarette smoking among idol " .... ~articularly alarming and there is reason to .... __ societal pressures are responsible for this -s at one time extremely rare in women; its dr :ast decade is a stark reminder of the risks of ..+recte smoking: KNOWLEDGE AND BELIEF ":nv do people smoke? The'Roper Report commis -"+ .- .adustry warned that most people knew that cig and that many smokers desired to scop. Th detailed a series of problems that threat the tobacco industry and emphasized parti s-owiedge among the public and the growing a ""•=.r:unately, the knowledge that cigarette s - rcessariiy translated into abstinence. Behavi -fed the "health belief" model to explain wh~

[The prepared statements of Mr. Horrigan, Dr. Eysenck, and Ijr. Miniard, and the biographical sketch of Dr. Blackwell follow:] ±; .. Statement of Edward A. Horrigan, Jr. on S. 1929 before the Senate Committee on Labor and Human Resources (March 16, 1982) .::r<3 . t, My name is Edward A. Horrigan, Jr. I am Chairman and Chief Executive Officer, R. J. Reynolds Tobacco Company. I am also the Chairman of the Executive Committee of The 141 In his 1979 report, the U.S. S "notable changes had taken place in smoking hazards and expressed doubt awareness could have any effect on this skepticism. Indeed, the level of awareness exceeds public awareness of most, i- contemporary issues facing this nat- Let me provide some examples: that less than 25 percent of the put Amendment is or what it deals with. surveys reveal that nearly 25 percer at Three Mile Island; 36 percent are States must import oil to meet its e not know that automobiles are the ma and one-third do not know whether tt By contrast, at least 90 percer. the allegations that smoking is dang of awareness demonstrates the succes Congressionally mandated warning sta efforts of public and private organi The Federal Cigarette Labeling working. The facts clearly show tha aware of the so-called health hazard are in a position to make a free and or not to smoke. Given this fact, why substitute for the present law. -2- Tobacco Institute, an association of tobacco manufacturers with -headquarters in Washington, D. C. We are here to express our industry's position on S. 1929, the Comprehensive Smoking Prevention Eduction Act. We are firmly opposed to this legislation because we feel it is bad legislation for the American public and our industry. We feel it is unnecessary and ineffective, and that the scientific findings cited in the bill in support of its proposals are unsubstantiated and incorrect. From this committee's perspective, this bill may well be counterproductive because there is significant evidence from the standpoint of behavioral science that its actual result may well be to lessen awareness of cigarette health warnings. A 1981 Gallup survey, reported by Secretary Schweiker to a large assembly of voluntary health organizations in November of that year, found that "Ninety percent of the population agrees that cigarette smoking is harmful."

146 appealing but unsupported assertion that cigarette advertising encourages a youngster to smoke. Smoking is an adult practice to be considered only by those mature enough to make an informed decision. In 1963, for example, cigarette companies stopped all advertising and promotional activities in school and college publications and on campus. We also stopped using celebrities and sports figures in advertising. In 1964, we adopted a cigarette advertising code prohibiting advertising, marketing and sampling directed at young people. Even though the administrative provisions are no longer in effect, each company still adheres to the principles of this code. A summary of these principles and a copy of our Cigarette . Sampling Code is being submitted with this document for the record. In 1969, we offered to cancel all radio and television advertising because of broadcast's unique reach to young people, and in 1971, pursuant to federal legislation, left the broadcast media. Our advertising is targeted at smokers and is intended to encourage switching from competitive brands. The available evidence clearly shows that our advertising is not designed to attract new smokers of any age and is not having that effect. The same Gallup poll I mentioned earlier also reported that the percentage of smokers found was the lowest ever recorded by that organization. -7- 147 147 Looking at the broader picture r, advertising, the record clearly shows responsible in its practices. o In 1954, to meet public demand. "tar" and nicotine cigarettes. o In 1960, after the FTC stated t such advertising could be construed aE voluntarily agreed to eliminate from c references to "tar" and nicotine. o In 1966, when the FTC reversed cigarette advertising would disclose " o In 1967, we began a continuing technical cooperation with the FTC wit- nicotine testing. o In 1970, we began to include in FTC "tar" and nicotine measurements. o In 1971, we volunteered to depic all advertising in such a way as to dii label. o In 1972, we entered into an agrc uniform terms of conspicuously displayi advertising. o In 1981, we reached an agreement increase in the size of warnings. In short, our industry has acted r we see no reason anyone should feel tha do so in the future. Nor do we see why regulate further our advertising practi -8- 0 ~ ~ ~ rk' ~

y 159 with routine diagnosis, we find that prior to World War 1, out of 100 people found on autopsy to have died of lung cancer, only 3 were so diagnosed. This is typical of the very obvious under-diagnosis of lung cancer then prevalent. In recent years, exactly the opposite has been found, namely an over-diagnosis of lung cancer of up to 200X and more! Whether these changes in diagnostic preference are completely responsible for the alleged tremendous increase in lung cancer over the years or not, and whether it may in part account for the observed correlation between lung cancer and smoking, it is impossible to say; all we can say is that arith the basic data so completely unreliable, the statistics based on them are suspect. Another important point concerns the isolation of smoking from other, correlated habits, such as drinking, living it up, staying out late, wenching, etc., i.e. a certain style of life the totality of which may increase the "rate of living", , so that smokers are biologically older than non-smokers at a given age, for reasons only partly involved with smoking. Non-smokers are different types of persons from smokers, are generally more self-protective, and the personality traits and habits thus linked with non-smoking may be more relevant to the longevity of non-smokers than their refusal to smoke. -4-

145 I should add that the tobacco industry is recognized as a leader in seeking the answers to the questions regarding smoking and health. In the past three decades, the industry has committed, without fanfare, over $100 million for unrestricted, independent research into smoking and health issues. Our spending has been greater than the tobacco-related research expenditures of all of the voluntary health agencies combined. I submit that one of the effects of the bill would be to do significant harm to the scientific effort to resolve these questions. As worded, the bill purports to settle by Congressional edict medical and scientific controversies that are still evolving. Therefore, it may divert scientific talent and resources from the basic research necessary to solve the enigmas of chronic disease. We are aware that there have been some efforts to build support for this bill with claims that its provisions would serve as a deterrent to smoking among young people and that industry advertising and promotional practices are intended to encourage youthful smoking. Such charges are without foundation. On March 5, two witnesses speaking in support of the House bill -- Mr. Keeshan and Mr. Forsyth -- both acknowledged that peer pressure, and not our advertising, provides the impetus for smoking among young people. The written submissions of exvert witnesses we are providing to this committee clearly point out that the provisions of this legislation can in no way be justified by the emotionally -6-

148 Getting back to the specific provisions of the bill, the labeling requirements proposed are unworkable. The bill directs the FTC to establish a rotational warning procedure which can at best be described as a "Rube Goldberg" contraption. Every br and of cigarettes would have to carry each. of the five required warnings an equal number of times during a 15-month period. Then there is the added provision that at any time each of the five warnings must appear on "at least 15 per centum of all cigarette packages and advertising." In December 1981, the FTC reported "tar" and nicotine data on 200 cigarette brand styles. New brands are frequently introduced and old ones withdrawn. It is highly unlikely that the FTC or any other agency will be able to develop anything but a purely arbitrary formula for rotating the warning statements among the various brands. Even if a rational formula could be devised, how could we make sure that each warning statement is presented to the public an equal number of times? Sales volume and advertising for each brand vary greatly. Equalizing warning statements among all brands will have no relationship at all to the number of times that each statement is exposed to the public. Technical complexities aside, there is no reason whatsoever to believe that the proposed rotational warnings would be any more effective in increasing public awareness than the present statement. The proposal is based on a recommendation of the FTC staff, which in turn was based on some undisclosed preliminary research regarding a rotational warning system used in Sweden. -9- 'b 149 The FTC staff admits that the "ef system cannot be measured, and Mr. Watc on March 5, presented persuasive testir to the effect that this system is not i consumption in Sweden. While the FTC : "effectiveness" of the Swedish system c fact is, that according to the Swedish consumption has risen each year since i implemented in 1977. I also call your that the rotational warning system in : program designed to abolish smoking, wt goal -- despite denials -- of many of t organizations which support this bill. There is also strong evidence fror. behavioral science, based upon the evic studies cited by the FTC in support of that such a system might, in fact, eroc In light of these facts, the obvic the proposed rotational system necessai are convinced that the answer is that : Also unwarranted, in our opinion, for disclosure of "tar," nicotine, and packages and in all advertising. As indicated earlier, since 1970 c voluntarily disclosed the "tar" and nic advertising. This information is wide: Smokers who choose their brand on the t levels can readily obtain this informai advertising. -10-

158 the correct order of magnitude) suggests that the scientific proof for any particular theory will be difficult to arrive at, and that any such theory will almost certainly be complex and multi-faceted. Much of the evidence cited in favour of the causal theory is statistical, but many statisticians have severely criticized the evidence on statistical grounds. Such suggested proofs as the correlation between smoking and lung cancer within a given country, or between lung cancer and number of cigarettes smoked between countries, are evidence of correlation, not of causation; one of the first lessons the budding statistician learns is that correlation does not imply causation. (There is a very high correlation between countries linking meat eating and cancer of the large intestine, yet we do not conclude that eating meat causes cancer of the large intestine!). Hence this method of demonstration, while suggestive, is far from compelling. This would be so even if the figures usually quoted could be taken seriously; however, there are good reasons for doubting their accuracy. The figures quoted are based on clinical diagnosis of lung cancer, but these are very unreliable and imprecise. If we take as our criterion autopsy data, and compare these 159 159 with routine diagnosis, we find that pr= out of 100 people found on autopsy to h: cancer, only 3 were so diagnosed. This very obvious under-diagnosis of lung car In recent years, exactly the opposite ha an over-diagnosis of lung cancer of up t Whether these changes in diagnostic pref responsible for the alleged tremendous i over the years or not, and whether it ma the observed correlation between lung ca is impossible to say; all we can say is data so completely unreliable, the stati. are suspect. Another important point concerns ti from other, correlated habits, such as d: up, staying out late, wenching, etc., i.c life the totality of which may increase t so that smokers are biologically older tt given age, for reasons only partly invol~ Non-smokers are different types of persor generally more self-protective, and the F and habits thus linked with non-smoking ¢ to the longevity of non-smokers than thei smoke. , -4- -3-

150 As a matter of fact, the average "tar" yield of cigarettes sold in this country has dropped from 38 milligrams in 1956 to 12.6 milligrams in 1981. Almost 70 percent of all cigarettes sold are in the low "tar" category. With respect to carbon monoxide, there is no purpose to be gained by the determination or publication of yields. As the scientific record will show, the conclusion that exposure to carbon monoxide from cigarette smoking is significant in terms of health is unwarranted. Furthermore, no single method of carbon monoxide measurement in cigarette smoke has gained general acceptance in the scientific community. Therefore, any data presented, by any method, will be subject to question. These issues should be resolved in the scientific community. We firmly believe that a required disclosure of carbon monoxide yields is ill-conceived. The provision requiring'disclosure of ingredients is also unjustified. Cigarette manufacturers use a variety of substances in their products to enhance flavor and appearance and to preserve shelf life. The identity of ingredients used by each manufacturer is among the most closely guarded of their trade secrets, for such ingredients play a substantial role in maintaining consumer acceptance. 151 The bill provides that such info disclosed. Unfortunately these provi to prevent the unauthorized leaking o trade secrets. On numerous occasions the victim of unauthorized disclosure information furnished government agen The basic defect in this provisi to provide a quick and easy "solution yet been adequately defined. We have been, and continue to be frutiful discussions with Assistant S HHS officials on this matter with a v necessary information to HHS under ap safeguards. Secretary Brandt has rec "pleased with" our "cooperative spiri that substantial future progress can question. The present bill would sho resolve any legitimate concerns. In the bill is to "shoot first and ask q In conclusion, we are firmly opF because we believe it to be unnecessa because the medical and scientific as underlying it are incorrect and unsul We are not opposing the bill bec youth market as some have falsely cho the bill because of the potential co= requirements. -12- 0 W ~ ~ ~ ~ ~ ,-{~ Q~

136 Dr. LEMAISTRE. Mr. Chairman, if I may, I think Senator East has an extremely important point in terms of carcinogenic agents and the consequences of Congress action based on the Delaney clause which overstresses certain potentially misleading criteria for screening those possible agents. That causes the American public, to worry about cranberry juice and a lot of other things that are not high priority risks in cancer causation. That false worry does diminish appropriate concern over cigarettes. The very credibility of the arguments about cigarettes is damaged by those rather cursory studies often used in claiming for some substances a high risk in cancer. You mentioned nitrates and several other things this morning. I have the same concern you do in that regard, but I have no concern whatsoever for the overwhelming fact that the evidence is in on cigarettes and that it does lead to proper scientific conclu- sions and, in my opinion, the judgment calls that we were discuss- ing are based on those proper scientific conclusions. But I think there is a wide disparity between the consequences of the Delaney clause and the consequences of information gathered on the hazards of tobacco over the past 20-some-odd years. Thank you, sir. The CHAIRMAN. Well, thank you, Dr. LeMaistre. We are very ap- preciative that you would come and give us the benefit of your tes- timony. Dr. LEMAISTRE. Thank you, sir. The CHAIRMAN. Thank you. Our fourth and final panel consists of representatives from the Tobacco Institute. We will hear from Mr. Edward A. Horrigan, the chairman and chief executive officer of the R. J. Reynolds Tobacco Co., and chairman of the executive committee of the Tobacco Insti- tute. As I understand it, Mr. Horrigan is accompanied by two scien- tists, Dr. Paul Miniard from Ohio State University and Dr. Hans Eysenck from the University of London. Thank you for joining us today, Mr. Horrigan. We are glad to have you here. STATEMENT OF EDWARD A. HORRIGAN, JR., CHAIRMAN AND CHIEF EXECUTIVE OFFICER, R. J. REYNOLDS TOBACCO CO., ON BEHALF OF THE TOBACCO INSTITUTE, ACCOMPANIED BY PAUL MINIARD, ASSISTANT PROFESSOR OF MARKETING, OHIO STATE UNIVERSITY; HANS EYSENCK, PROFESSOR OF PSYCHOLOGY, INSTITUTE OF PSYCHIATRY, UNIVERSITY OF LONDON; SHEL- DON C. SOMMERS, SCIENTIFIC DIRECTOR, COUNCIL FOR TO- BACCO RESEARCH Mr. HORRIGAN. Good morning, Mr. Chairman. As the chairman has mentioned, my name is Edward A. Horri- gan, and I am chairman and chief executive officer of R. J. Reyn- olds Tobacco Co., but I am appearing here this morning in my ca- pacity as chairman of the Executive Committee of the Tobacco In- stitute. Joining me this morning for any questions that might be asked following this very brief summary will be Mr. Paul Miniard, assist- 137 137 ant professor of marketing at Ohio Sommers, scientific director of the ( and Hans Eysenck, professor of psyc chiatry, University of London, and and Bethlehem Royal hospitals in Loi Again, given the time constraints. your questions, I may also call upon director of the Tobacco Institute; Mr here of the Tobacco Institute and Sa and general counsel of R. J. Reynolds rectly behind me. We are here today to express the I S. 1929, the Comprehensive Smoking I We are firmly opposed to this legis is bad legislation for the American pu feel that it is unnecessary and ineffc findings cited in the bill in support of ated and incorrect. From this committee's perspective, I productive because there is significai point of behavioral science, that its r lessen awareness of cigarette health w. A number of very broad, sweeping ing and disease are included in the pa ly there are questions raised by statist be answered, and our industry is prc more annually than all of the private to support unrestricted research to finc But the truth is that after three causal link between smoking and dise. of the statements presented as establ been challenged by research findings and I submit that their findings should erations. As you know, this bill is very simila Representatives bill which, although bi to achieve basically the same goals. JL expert witnesses from several disciplir views in opposition to the House bill t( Representative Waxman. At that time, there were over 30 hig scientists ready to appear to challeng that House bill, which are very simil, 1929. I request at this time that their House subcommittee be entered into t' ings. I would also add that the time you ; ings, to hearing our industry's positior view of the complexities of the issues. I the very brief period we have here this to cover only the medical and scientific bill. In the House subcommittee hearing: only a day to cover the issues, which wo

in i 0 ~ on t of ;rit d 10 ay i ,,ot t sci eir' ~ it U, hic Vhe n he~ he al I ias"t •edib, is not toln Ifi n 1$~ goin 'S co ~ct th iden SUSpIT e rela- le evi7 idde 8 mi1= They 133 were carefully followed as cohorts of those who continued to smoke, &nd that today still provides the best evidence that stopping smok- ing decreases the risk of heart attack. So there are factual exam- ples by which one can bolster each of the scientific judgments based on epidemiologic data. These data include both retrospective data, which I consider exceedingly sound, from Great Britain and this country and prospective data in which groups have been stud- ied. Both enhance the integrity of the scientific conclusions. Coming to your specific point, until we have comprehensive health education in our schools of high quality, from grades K through 12, in my opinion, that allows young people to be fully ac- quainted with the known facts, there will not be an answer to your question about how preventable this really is in terms of a practi- cal application. But, theoretically, it should be preventable. The tragic consequences extend far beyond disease. In my home- town. we had a very tragic fire involving young people with whom I am closely associated only a few weeks ago in a hotel, caused by a cigarette. Over one-half of the hospital fires, a place where I work every day, and over one-half of the fatal home fires are caused by cigarettes. That evidence is irrefutable in terms of why the causes of fires are usually determined. So these factors come together for something that is not a way of life that should be acceptable to the American youngster. I do be- lieve, as a teacher, that young people can be taught about the prob- lems associated with cigarettes in terms of a fair representation of the truth. I have sufficient respect for the young people of this country to let them make their own decisions about which risks of being ill and of dying they are willing to accept. I defend their right to choose those risks, just as I do. I jaywalked coming over here today, and that was an unnecessary risk. But, by the same token, I think that it is not a question of just pure empiricism on prevention. We are now preventing some young people from taking up the habit through better information every year. Senator EAST. But, you see, in the legislation here, it says, "The Congress finds that," meaning a scientific finding, "it is the largest preventable," and you are suggesting that, theoretically, that sort of a supposition really is not scientific fact. For example, let's say we determine in a real scientific study that it is not easy to prevent smoking; therefore, it might direct a public policy-I am just hypothetically speaking-whereby the Government would acknowledge, well, we cannot get people to stop smoking; I'll tell you what let's do. Let's try to develop a safer ciga- rette, you see, because it isn't preventable in the sense it is difficult to get people to stop. OTHER THINGS It may be easier to get people to change their behavioral pat- tern-again, the ones I have worked over this morning, salt, sugar, nutrition, exercise, the whole phalanx of things that go together to make a composite for good health practice. And so when we are told, well, this is easy to do, it is preventable, I don't know that it is any more preventable than these other things, and if scientific findings show that it is not, why not direct our talents and our ef- M

Ae are concerned that 75` of the a'.pha activity of the cigarette smoke may enter the ambient air and is thus available for deposit In the lungs of nearby nonsmokers. As a volunteer Chairman of the Smoking and Health Committee of the American Lung Association, I am distressed that 60< of Americans polled are unaware that smoking causes most cases of bronchitis and emphysema, for example, that 20" do not know that smoking causes lung cancer, that over 50` do not realize that smoking causes many as opposed to only a few cases of heart attack. (3) Clearly current federal, state, and private initiatives have been insufficient in conveying the appropriate health messages to imoortant segments of the American public. Hard as they may try, the voluntary agencies alone are fighting an uphill battle with limited resources to fill this informational gap. Some overriding official, national action that would attract constant attention is required. We believe the provisions of H.R.5653 are important steps to address this crisis. We favor the provisions on providing statutory standing to the Office on Smoking and Health with the Department of Health and Human Services. There must be a clearly visible focus within the federal government which demonstrates the government's commitment to prevention of disease due to smoking. We endorse the requirement that the Office become more actively involved in the preparation and dissemination of educational and scientific information and we look forward to their actively involving a wide range of federal and orivate organizations in these activities. At the ALA we rely strongly on the Office on Smoking and Health for fact-finding and documentation. There is no question that the harm inflicted by cigarettes is more than sufficient to warrant banning production of them. However, in a free society, government--instead of prohibiting production--has at least the responsibility of letting its citizens know the consequences of exposure so they themselves can make informed choices. Because representatives of a multi-billion dollar industry are so hard at work promoting their self-serv;ng myths and spending an astounding S1 billion each year to promote their lethal product in every media available to them, the American Lung Association believes very strongly that H.R. 5653 is critically important to help inform the public about the real dangers--not the tobacco industry's myths--of smoking. What concerns us at the American Lung Association is the incredible imbalance between the citizen's exposure to the facts about smoking and the avalanche of cigarette advertising. We find it shocking that cigarettes are the most heavily advertised product in America, that cigarette ads comprise half of all billboard advertising.(4) We are especially concerned that children are not free to make an informed, balanced choice about smoking when they grow uo in a society saturated with ads that encourage smoking and present that behavior as something healthy, attractive, sexy. The effects of advertising on children are an overriding issue, in our opinion. 101 na and increasing the visibility of warning labels cacks and in advertising, we think the time has long t --,^at. We recortmend putting the warning message on the n e--of the package. The rotations would alert people about the specific effects of smokinq. Obviously, pe -e soecific information. We also support listing carbon as well as tar and nicotine. In addition, we would like accitives in cigarettes listed. of readers of the American Lung Association's Bullet -aqazine, we found our readers in favor of rotating la •311y popular one was: "WARNING: Cigarette smoking is d'c 2ne may cause death from cancer, coronary heart disee e-ohyser:a and other diseases." Many favored it becaus --e ^cst comprehensive. Some felt it was not strong enoL -^s clear that Congressional leadership is required to helF s t^.e massive imbalance of cigarette advertising that affe cas of our society. H.R.5653 represents the kind of nat' n eesoerately needed to begin to counteract the epidemic of .-related diseases in this country and to encourage the 5: 'ind the way to quit their life-threatening habit. k o and group programs we developed in 1981, at the An tion we are ready to help show those smokers how to ,. l r. n.ith the Office on Smoking and Health; the Natior Council on Smoking and Health and the major voluntar s such as the American Cancer Society and the Americ •,c,=:ion, we look forward to increasing our joint effor cnis country's number-one preventable public health pr raanized Coalition on Smoking OR Health provides a ur •cr coordinating private sector smoking and health prc .c,isning an interface with public sector programs. ;,r vour attention. SOURCES Everett Koop, M.D., Surgeon General, Release: : 'lew England Journal of Medicine, 2/11/82 Reoort on the Cigarette Advertising Investi, 5/81 ~caff Reoort on the Ci• Advertisina Investi=-C, 5/81

139 that was needed. Nevertheless, we will do our best here in the time that has been allotted. In the South where I now live, there is a saying, "If it ain't broke, don't fix it." I submit that this bill is an unnecessary at- tempt to change a system that the facts demonstrate is indeed working. The evidence shows that over 90 percent of the American public is aware of the claim that smoking is harmful, the message that is contained in the present health warning required on every ciga- rette pack and ad. This awareness level is virtually, if not totally, unprecedented in comparison to the awareness of the major issues facing this Nation. The facts demonstrate that the Federal Cigarette Labeling Act is working, that the public has been made aware of the claimed health hazards of smoking, and that people are in a position to make a free and informed choice of whether or not to smoke. Why, then, should it be necessary to substitute a questionable, unproven system for the present law? There is also strong evidence from the standpoint of behavioral science, based upon the evidence in the studies by the FTC staff in support of rotating warnings, that such a system might in fact erode awareness. Additionally, I will call your attention to the fact that the Swed- ish Government, upon whose system this proposal is modeled, indi- cates and reports that since their system was instituted back in 1977, cigarette consumption has risen annually. The system of rotating health warnings on cigarette packages proposed by this bill is also technically unworkable and ill-con- ceived. There are now approximately 200 cigarette brands and brand styles on the market, with new brands being added regularly and old ones being withdrawn. There exist vast differences in sales volume and advertising patterns. Therefore, it would be virtually impossible for cigarette manufacturers or the Federal Trade Com- mission to insure compliance with this proposed system. Five rotating warnings required to appear an equal number of times during a 15-month period, with the added provision that at any time each of the five warnings must appear on 15 percent of all cigarette packs and ads, would create chaos. The bill's requirement of disclosure of tar, nicotine, and carbon monoxide levels on packages and in our advertising is unwarrant- ed. Tar and nicotine levels have been readily available to smokers in every cigarette advertisement since 1970. With respect to carbon monoxide, the written submissions of sci- entific experts provided to you will show that carbon monoxide ex- posure through cigarette smoke has not been shown to be a health issue. Furthermore, there is no generally accepted method of carbon monoxide measurement which would make any data that we would present on our packages and in our ads meaningful. Next, the provision requiring disclosure of ingredients is unnec- essary and ill-conceived. Cigarette manufacturers do use a variety of ingredients to enhance flavor, appearance, and to preserve shelf life. These ingredients are among each manufacturer's most closely held trade secrets. The bill provides that such information should not be disclosed. Unfortunately, despite the good intention of the authors of the bill, those provisions leaking of these critical trade secret industry has been the victim of suc confidential information that we h~ ment agencies. We have been, and we continue ? and fruitful discussions with Assista HHS officials on this matter, with a essary information to that agency and safeguards. Secretary Brandt himself has recE with our industry's cooperative spiri substantial future progress can be m This present bill, though, would : solve any legitimate concerns. In oth would be to "shoot nrst and ask ques In summary, we are opposed to t] key among them are the following: freeze science in its tracks because talent and resources from the basic the questions of smoking and healt: settle by Congressional edict continu troversies. It also seriously erodes the princiF cratic society. In denying a person's : tion, this bill betrays its fundamer says, in effect, that Americans are E of choice in rejecting the argument: that the Government finds this unaa be taken to make Americans conform tion of smoking. I do not believe tl accept such a rationale. Mr. Chairman, I will conclude b; regret that we have only been given address these very key issues which c and indepth consideration. I will er with the request that my formal writ ments, be entered into the printed : hope that each member of the commi mission and those of the expert witnE gain an accurate picture of the facts this bill. Thank you, sir. The CHAIRMAN. Thank you, Mr. h testimony. I appreciate your concern that thes quate time to cover all of the issues r and therefore all of your statements your associates here today will be i full, and we will be pleased to accep , testimony you would like to have inc" keep the record open for a limited p submit any other additional testimon: 95-077 0-82--10

156 Statement of Professor Hans J. Eysenck I am Hans J. Eysenck, professor of psychology at the Institute of Psychiatry, University of London and psychologist to the Maudsley and Bethlem Royal hospitals in London. I received my Ph.D. in 1940 and my D.Sc. in 1964, both from the University of London. I was Senior Research Psycho- logist at Mill Hill Emergency Hospital from 1942 through 1946. In 1949 and 1950 I was a visiting professor at the University of Pennsylvania in Philadelphia. Between 1950 and 1954, I was a Reader in Psychology at the University of London's Institute of Psychiatry. In 1954 I was a visiting professor at the University of California at Berkeley. I am a Fellow of both the British Psychological Society and of the American Psychological Association. I have founded and edited three psychological journals, and I am on the editorial boards of some 15 other inter- national psychological journals. I have written or edited for publication approximately 35 technical books and over 600 articles dealing with various aspects of the psychological field, particularly with respect to personality, intelligence, 157 behaviour therapy and behavioural gene research in the area of smoking for ov authored two books, the most recent of The Causes and Effects of Smoking, as articles on this subject. A widely accepted theory asserts causes lung cancer, coronary heart dis diseases with which it is statisticall always realized that (a) such a theory and is beset by many anomalies and dou there is an alternative theory which 1 facts which are not explained by the c present position seems to be that eith the tragic incidence of lung cancer an disease (to which this brief account w that both may be needed to complement There is agreement that smoking nor a sufficient cause of lung cancer. less than 10 will develop lung cancer; a sufficient cause. And of 100 peoplE cancer, approximately 10 will be non-: is not a necessary cause. This simple numbers differ of course from country -2-

163 a certain personality are more likely than others to die of lung cancer irrespective of smoking. It is also assumed that people of a certain personality are more likely to smoke than others. There is evidence for both these propositions. My original work with Dr. Kissen, an eminent British oncologist, showed very marked personality differences between lung cancer patients and patients suffering from non-malignant tumours, with the personality assessment made before diagnosis. Since then, a large-scale study in East Germany has replicated our findings (themselves replicated in another study by Kissen), and has found similar personality traits to those characteristic of lung cancer patients in women with cancer of the breast. Other studies, also indicating a relation between lung cancer and personality, are cited in my book. In a similar way, my early work with Tarrant and Woolf established a correlation between personality and smoking, and many studies in different countries have since confirmed our findings, and added new ones. We may thus say that the fundamental assumption of Fisher's genetic theory have found empirical support, and we may add that there is also some modest support for my own attempt to integrate these two major fields. Unfortunately there has been too little work along these unusual and somewhat unorthodox lines to say that -8-

160 It is often suggested that sex differences, with males showing more lung cancer, are the product of the tendency of males in the past 50 years or so to smoke more. However, as several authorities whom I quote in my book have pointed out, similar sex ratios to those observed now were found before cigarette smoking became popular. Again, it is found that changes in the rate of increase of lung cancer diagnosis occurred simultaneously for men and women, although the women, who took up smoking much later than men, should have shown these changes at a much later date than men. If the causal theory is true, then we would expect a definite dose-response relationship; in other words, the heavy smoker should be light smoker. Yet the stricken with cancer earlier than the amount smoked makes no appreciable difference to the mean age at which the person is reported first to the clinic. Again, inhalation should make lung cancer much more likely than smoking without inhaling, yet the figures show if anything an opposite trend. These two observations are difficult to reconcile with the theory of smoking. causal The most impressive evidence for the causal theory has been the report that physicians who gave up smoking showed less lung cancer than members of the general public who 161 continued to smoke. Thus, it might ap; smoking has saved the lives of those w: proof is only acceptable if those who and those who later on give up smoking identical with respect to their health gave up smoking. Clearly, if those wb smoking are already much healthier tha continue to smoke, then the final diff be due to the already existing differe up smoking, rather than to the cessati there is good evidence to show that s¢ already differed with respect to theii the ex-smokers gave up smoking. Simi~ that from the point of view of person; different from continuing smokers. T' is based on an erroneous assumption. These objections tQ the causal in my book, do not prove the theory t argue that it is still only a theory, More convincing proof is required bef accorded a more advanced status. But there are numerous facts suggesting : and these facts cannot easily be int- theory. Yet a proper theory demands to all relevant facts, and thus agai found wanting. -5- -6-

r 104 has issued 13 subsequent reports on smoking and health. In 1976, the 1lational 8eart, Lune and B1cod Institute. a component of the prestiaious National :nscituces of 5eaah. concluded its 7ask Force Report on ?reventCon. Control and Education in Respiratory Diseases with the followine recommendation: "Cigarette smoking is the single most important risk factor for diseases of the lung. It is known to cause or exacerbate not only the respiratory diseases discussed in this report, but lung cancer, cardio- vascular disease and stroke, as well. Reduction, or ideally, elimination of cigarette smoking would have a major impact on national health and on the social and economic costs that are a consequence of smoking- related diseases. The problem of smoking warrancs the highest priority in all programs concerned with diseases of the lung. The most important target groups for antismoking programs are preadolescents and adolescents who have not yet started to smoke or invhom the smoking habit is not entrenched." In a free society, government cannot directly order abolition of destructive behavior but must constantly warn of the consequences of euch behavior so that individual citizens can make informed choices. Such destructive behavior accounts for a large component of the annual mortality experience. In 1980, for example, approximately 700,000 died from c,ronary artery disease, 180,000 from stroke, 105,000 from lung cancer, 30,000 from bladder cancer, 7,500 from esophageal cancer and 60,000 from emphysema and other chronic obstructive pulmonary diseases. The common factor linking these one million deaths, more than half of the total deaths each year, is a demonstrated relationship to cigarette smoking. Many of these deaths are related to multiple factors includingheredity, exposure to environmental agents and excessive dietary cholesterol as well as to cigarette smoking. Cigarette smoking, hovever, is the single most important factor--nanv times more important than any other risk_factor. Detailed epidemiologic data allow separation of the mortality directly related to smnking. The Geller-Gesner Tables, published by Robbins and Hall in 1970, have been used by many physicians who practice "prospective medicine" to analyze the life expectancv of individual natients. Thn 105 -.e:=a snoes jeath rates for two hypothetical populati _;.:.:m ~' '-:70,J00 smokers and another group of 100,000 no: ::-~.a nur,.ber of deaths expected in the subsequent ten years f;cDups of men between the ages of 55 and 59 are shovn. Onl: -..._: cem-.on causes of death associated with smoking are sho~ :1__1lation. Non-Smokers Smc ;_ronary Artery Disease 6,168 -11, ._ 3 Cancer 257 _ 3, _coke . =.-p'nvsema 1,066 . . 69 -1, . -zca_ Deaths Expected 7,560 . 17,: ''his analysis shows that for each 100,000 populatior _.. ";.e age group 55-59 years, the smoking population will ha, -cre deaths than the non-smoking population. If one assumes hospital and professional cost of each individual prior -eraged $10,000, the total excess health cost of the smoking s_lose to 100 million dollars. Since there are about five men in the United States between the ages of 55 and 59,.the t 1xcess health cost in that age bracket is five billion dollar NEW ,V`7D CO*IFZRHINC EVIDENCE IS CONTINUALLY PUBLISHED Each year a large number of publications from laborac •~-'ucd the world confirm the relationship between cigarette sr -d 'auman disease. Hany different types of studies have been •-o:deniologic study of death rates, results of stopping smokir. ='»g `unction, and examination of tissues at autopsy in smc 'on-smokers. A brief selection of several recent papers f -ch of these has been published in a highly respected, peer-r -e-aca! ;ournal. Two recent studies have shown increased life expectan :ncividuals who discontinued smoking compared to those who con

129 -7- Further, the OTA report adds;' "tobacco is know to contribute more heavily to the number of cancer deaths than any other single substance." Members of this Committee, we urge you and your colleagues in both Houses of the Congress to pass this measure into public law as quickly as your considerations and processes will allow. The American Cancer Society believes this bill can make a difference to the health of our country. We look to you to help us in this crusade: 1/The Health Consequences of Smoking -- Cancer --, A Report o the Surgeon General, U.S. Department of Health and Human Services, OFfice on Smoking and Health, February 22, 1982, p. 4-7. 3/ Dangers of Smoking, American Cancer Society, Inc., 1980, 57 & 66-68. 4/ Staff Report on the Cigarette Advertising Investigation, Federal Trade Commission, May, 1981, p. 3-45. The CHAIRMAN. Thank you, Dr. LeMaistre. %•ou with us today, and we appreciate the people at the M. D. Anderson Clinic have re, vears in so many areas of cancer. Dr. LEMAISrRE. Thank you, sir. The CHAIRMAN. I have been through your f, %•erv impressed with it. Dr. LEMAISTRE. We were very proud to havE The CHAIRMAN. Thank you. 1'ou have said that the newly founded Coz Hc alth represents 30 different health educat: ship groups. Why have they now banded togf pre•,,ention education effort? Dr. LEMAISTRE. Mr. Chairman, I think thosc involved in the question of smoking and its e of the American public have wondered that fo :: conference was held this past fall in I ori-inally by the American Cancer Societ3 American Lung and American Heart Associ that time 21 other agencies. They considered int; and they found much in common that the; that previously they had been attempting se agencies have been independently concerned r a very long time. Ilowever, the new coalition, working throug akency Council on Smoking and Health, is thc effective and efficient way of bringing the fee unteers that these agencies represent to the a mivht be interested in hearing their views. 'I'he CHAIRMAN. You have provided testimc haps the last coalition of interested health g and I am pleased to see the high degree of int directed at what I personally consider to be a However, with such tremendous effort bein€ the Federal Government, within the privatE think this legislation is necessary? Dr. LEMAISTRE. Mr. Chairman, the legisla sure of information and new labeling is impo sons. I consider this bill an essential first st that will lead to the education of the Americ lar, the younger American public that has n, sion to smoke, so that they may have the fre choice. In particular, the information that is bi alarming about additives that you just hear, testify to is a major concern of all of these ( relatively new information, as the health c rettes have changed over the years as th changed. You have also heard this morning in testim- majority of the American public does general ;'rds of cigarette smoking, they are not well ir _c hazards, and the relationship to lung cai

157 behaviour therapy and behavioural genetics. I have conducted research in the area of smoking for over 20 years and have authored two books, the most recent of which is entitled The Causes and Effects of Smoking, as well as numerous articles on this subject. A widely accepted theory asserts that cigarette smoking causes lung cancer, coronary heart disease, and many other diseases with which it is statistically linked. It is not always realized that (a) such a theory is far from proven, and is beset by many anomalies and doubts, and that (b) there is an alternative theory which is based on undeniable facts which are not explained by the causal theory. The present position seems to be-that either theory may explain the tragic incidence of lung cancer and coronary heart disease (to which this brief account will be restricted), or that both may be needed to complement each other. There is agreement that smoking is neither a necessary nor a sufficient cause of lung cancer. Of 100 heavy smokers, less than 10 will develop lung cancer; hence smoking i8 not a sufficient cause. And of 100 people who develop lung cancer, approximately 10 will be non-smokers: hence smoking is not a necessary cause. This simple fact (the precise numbers differ of course from country to country, but indicate -2-

165 controlled for in studies of the effects of smoking; inhalers do not on the whole differ from non-inhalers in disease proneness; the statistical relation between cigarette smoking and CHD disappears in many countries, e.g. Finland, Holland, Yugoslavia, Italy, Greece and Japan; there is an absence of dose-response relationship, i.e. there is little or no relation between duration of heavy cigarette smoking and risk of myocardial infarction; and the correlation between number of cigarettes smoked and CHD is not linear; ex-smokers in some studies appear to be safer than non-smokers; some types of CHD, such as angina pectoris (which comprises some 20;% of CHD in men) fail to show even a statistical correlation with cigarette smoking; some types of smoking (cigar, pipe) fail to show even a statistical correlation with CHD; etc. These are anomalies or failures of the causal theory which demand an explanation before the causal theory can be accepted. Some of these facts are much more readily explained in terms of a genetic-personality theory; thus the differential effects of cigarette vs. pipe/cigar smoking may find an explanation in terms of the known differences in personality type associated with these different smoking patterns. The general conclusion would seem to be that in the• case of CHD, as in the case of lung cancer, proof for the causal influence of smoking is still lacking and is by no -10-

164 the results are anything more than suggestive, and the theory linking them is still in a very elementary stage; nevertheless, as far as the findings go they support the genetic rather than the causal theory, although they do not necessarily contradict the latter. It seems unfortunate that the premature crystal- lization of spurious orthodoxies has prevented the genetic theory from attracting sufficient research grants to work it out in sufficient detail, and to carry out the research necessary to put it on a more acceptable footing. Recently some progress has been made on the theoretical development of the genetic hypothesis by linking it with research on stress, in particular the differential effects of chronic and acute stress, and the "inoculation" theory of stress. However, in the absence of large-scale research into the refinements of this theory, and more widespread familiarity with and criticisms of its details, not too much should be claimed for it other than it presents a viable alternative to the causal theory. In relation to the causal theories of coronary heart disease (CHD), similar criticisms apply as do in the case of lung cancer. There are considerable unreliabilities in diagnosis; there are large numbers of factors other than smoking which have been associated and which are not usually -9- 165 controlled for in studies of the effec- do not on the whole differ from non-in. proneness; the statistical relation be and CFD disappears in many countries, Yugoslavia, Italy, Greece and Japan; t dose-response relationship, i.e. there between duration of heavy cigarette sm myocardial infarction; and the correla cigarettes smoked and CHD is not linea studies appear to be safer than non-sm CHD, such as angina pectoris (which co CfID in men) fail to show even a statis cigarette smoking; some types of smoki to show even a statistical correlatior are anomalies or failures of the causz an explanation before the causal theoi Some of these facts are much more reac of a genetic-personality theory; thus of cigarette vs. pipe/cigar smoking m: in terms of the known differences in I associated with these different smoki: The general conclusion would se case of CHD, as in the case of lung c causal influence of smoking is still -10-

161 continued to smoke. Thus, it might appear that giving up smoking has saved the lives of those who did so. But this proof is only acceptable if those who continue to smoke, and those who later on give up smoking, are essentially identical with respect to their health before some of them gave up smoking. Clearly, if those who later on give up smoking are already much healthier than those who later on continue to smoke, then the final differences in health may be due to the already existing differences before anyone gave up smoking, rather than to the cessation of this habit! But there is good evidence to show that smokers and ex-smokers already differed with respect to their health record before the ex-smokers gave up smoking. Similarly, there is evidence that from the point of view of personality ex-smokers are different from continuing smokers. Thus this alleged proof is based on an erroneous assumption. These objections tQ the causal theory, and others made in my book, do not prove the theory to be wrong; they simply argue that it is still only a theory, not a scientific law. More convincing proof is required before the theory can be accorded a more advanced status. But further than that, there are numerous facts suggesting an alternative theory, and these facts cannot easily be integrated with the causal theory. Yet a proper theory demands that attention be paid to all relevant facts, and thus again the causal theory is found wanting. -6- ®

144 voluntary health organizations, and numerous expert witnesses in the fields of medicine, biomedical research, statistics, and other scientific disciplines. On the basis of these extensive hearings, the House Commerce Committee concluded that "nothing new has been determined with respect to the relationship between cigarette smoking and human health since its hearings in 1964 and 1965." The committee went on to say that "the arguments pro and con with respect to cigarettes are the same now as then, though supported by a larger statistical base." That conclusion is as true today as it was in 1969. After three decades of investigation and millions of dollars invested by the government, the tobacco industry and other private organizations, the smoking and health controversy remains unresolved. The net result of all of this effort has been that no causal link between smoking and disease has been established. That is not merely the opinion of tobacco industry executives. That is scientific fact readily available to anyone willing to make an objective, unemotional'study of the existing evidence. Yet, consider some of the broad, categorical statments on smoking and disease in this bill. What credibility can such statements have in view of the millions of people who have smoked throughout their lifetimes and not incurred any of the ailments mentioned, and the millions who have never smoked and who have incurred these ailments? -5- 145 I should add that the tobacco indu leader in seeking the answers to the qu and health. In the past three decades, committed, without fanfare, over $100 m independent research into smoking and h spending has been greater than the toba expenditures of all of the voluntary he I submit that one of the effects o significant harm to the scientific effo questions. As worded, the bill purport Congressional edict medical and scienti still evolving. Therefore, it may dive resources from the basic research neces of chronic disease. We are aware that there have been support for this bill with claims that as a deterrent to smoking among young p advertising and promotional practices a youthful smoking. Such charges are without foundatio On March 5, two witnesses speaking bill -- Mr. Keeshan and Mr. Forsyth -- peer pressure, and not our advertising, smoking among young people. The written submissions of exDert to this committee clearly point out tha legislation can in no way be justified -6-

130 than the relationship to heart disease and perhaps even to emphy- ` aPm a ..-y~.~. So, for all of these reasons, it is felt that the only mechanism~' ~ which full information can be obtained is by action of Congress 8t' _ `: this point in time. As I pointed out early on, there have been`r;t; peated reports by the Surgeon General, 30,000 scientific reports, all~, ~ of which have given the opportunity for a response on the basis~~z~` scientific evidence, whether epidemiologic or otherwise. That hes~~ not been forthcoming. The American public is not reassured that ' they know all that they need to know about the hazards of ci rette smoking. `"'F ~ _ Those of us who work in the field see that the problem is aggt~e=y vated by the fact that young people are still taking up the cigareEte,~ smoking habit, an alarming habit. For that specific reason, if for nqo other-but there are many other reasons-I feel these agencles now must band together to support any action, particularly such; intelligent and far-reaching action as contained in this bill. "_ t- The CHAIRMAN. You stated in your testimony, "Can there be any` question about the stark fact that cigarette smoking is the single most preventable cause of illness and death in the United States?"'.;- Yet apparently some scientists do not accept the thousands of stud-; ies-you indicated 30,000 studies-linking cigarette smoking to ness. Now, how do you account for their skepticism? ~ , Dr. LEMAISTRE. I have never been able to account for their skef)- ticism in this. I was one of those skeptics before I served on the_ Surgeon General's advisory committee that reported in 1964 on t2l., consequences of cigarette smoking. I was a pipe smoker and a ci smoker. Since I have become intimately acquainted with the dence, I must say my position has changed. " On the other hand, I think that the mounting evidence is na;~ rowing the number-though they still remain vocal-of scientistb.a who have distinguished records in terms of judgment on su& issues as this and the social consequences of smoking. I could A, attempt to explain their position, Senator, except to say that oUT; ` "`' belief is that they do wish to have more information. I believe y the disclosure of these additives and the research that will fo on defining their hazards might provide them with that kind of formation that would be more conclusive on one side or the ot I am not here to plead for anything more than a disclosur~ information, factual information, that clearly is not co through in either advertising or on cigarette packages today. ' The CHAIRMAN. Do you think that if we had these warning labe*' re~ that we have provided in this bill it will have a significant ` tion in those who smoke? ' Dr. LEMAISTRE. Senator Hatch, I particularly feel that rota the warnings and focusing upon specific issues of heart disease of lung disease or of prenatal consequences for the pregna~:_ r individuals who mlght~ f di t ill h h o consequences rec er, w ave mot electing to smoke, especially if the individual is pregnant or has '~ ready had some warning of heart or lung disease or some f,a~ history of cancer. The impact of that is far greater than the general cigarette p age message, which has worn thin over the years. So yes, I do 131 lieve it will have a specific impact and aid sion by those who choose to read it. The CHAIRMAN. In your opinion, how wou] aided by having tobacco companies provide the chemicals used in the manufacture of have indicated that that would be very hel Dr. Holbrook's testimony. Dr. LEMAISTRE. In the bill before the SenG confidential basis in order to protect trade : least the certain knowledge of what is be stances then could be the subject of resear IIoibrook so well stated, the consequences c tw-een 800 and 1,000 degrees-the pyrolys: products to determine whether they are inde K-hother the harm comes from the fact th effect the lungs, or heart, or contribute to cai Indeed, that might encourage the tobacco c additives. The CHAIRMAN. In your testimony, you ir scribed as special treatment of tobacco con Now do you account for that? What do you m Dr. LEMAISTRE. I have no knowledge, as Se earlier, of the political complexities that ov and I agree with him. Sometimes they are fa greater variables than we see in the scientil observations on the basis of history. I did not or effect to that. I do think the record is clear The CHAIRMAN. Thank you. Senator East? Senator EAST. Thank you, Mr. Chairman. Doctor, I wish to again thank you for comi this testimony and hearing. As you have been here this morning, I hav to some extent with the other people from th and from the perspective of medical science, word science here. You used a phrase which we hear a great dE build a base of support for this legislation. Th bi11. under section 2, says that Congress finds Ing is the largest preventable cause of illness ; In the United States," and you used that phr rentable cause of illness." ~k am just curious. On this matter of sciel ~ould wantlto look tait, nottto have it pollit ci meaningful, how could one say with total assu Grc finding that it is the largest preventable c: f'or example, I could see how, conceivably, y t am not saying they are there, but one might " a matter of scientific causation, that a pa "'rgeSt cause of illness and premature death, b 111t;ht conceivably bear it out in some way-c 'l't+ar, obesity, nutrition, and so on and so forti 4ble to establish that. 03'O7s5S

a 149 The FTC staff admits that the "effectiveness" of Sweden's system cannot be measured, and Mr. Waterson, an advertising expert, on March 5, presented persuasive testimony to the House subcommittee to the effect that this system is not working to reduce consumption in Sweden. While the FTC staff concedes that the "effectiveness" of the Swedish system cannot be evaluated, the fact is, that according to the Swedish government, cigarette consumption has risen each year since the new system was implemented in 1977. I also call your attention to the fact that the rotational warning system in Sweden was part of a total program designed to abolish smoking, which is the ultimate goal -- despite denials -- of many of the anti-smoking organizations which support this bill. There is also strong evidence from the standpoint of behavioral science, based upon the evidence available in the studies cited by the FTC in support of rotating warnings, that such a system might, in fact, erode awareness. In light of these facts, the obvious question arises: Is the proposed rotational system necessary or appropriate? We are convinced that the answer is that it is neither. Also unwarranted, in our opinion, is the bill's requirement for disclosure of "tar," nicotine, and carbon monoxide levels on packages and in all advertising. As indicated earlier, since 1970 cigarette manufacturers have voluntarily disclosed the "tar" and nicotine levels in cigarette advertising. This information is widely available to the public. Smokers who choose their brand on the basis of "tar" and nicotine levels can readily obtain this information from cigarette advertising. -10- 0

well informed as nonsmokers, implying that such informational differences are responsible for the decision whether or not to smoke. That conclusion is flatly refuted by the 1980 Chilton Study, the very study cited by the FTC Staff to demonstrate the supposed difference in the levels of awareness between smokers and nonsmokers. The conclusion reached by the Chilton Study was as follows: "Factual knowledge about the health consequences of smoking was not found to be significantly related to current smoking behavior. No more differences between knowledge levels of smokers compared with non-smokers were found to be significant at the 0.05 level than were to be expected by chance." (page 22) This important finding that consumer knowledge has no relationship to smoking behavior refutes the notion that people who smoke do so because they are "uninformed" about the claimed dangers of smoking. The lack of a relationship between aware- ness and smoking also demonstrates that increasing consumers' awareness about the health hazards attributed to smoking is unlikely to influence their smoking behavior. Consequently, to the extent that the present bill is based on a desire to reduce smoking -- and putting aside the question whether behavior modification is an appropriate goal for government in this country -- the warning statements proposed by Section 4 are simply irrelevant. Given these facts, a change of the sort contemplated by Section 5 should not be undertaken unless there is significant evidence that the proposed system of rotated warnings would better

134 forts, rather than in a direct prohibition, which I submit this bill does, why not direct it-we could still inform people of the relative health problems of this or any other thing-why not devote re- search to perhaps finding a safe cigarette? Then we would be home free. Then we would really have solved the health problem coming out of smoking. But what I find here is somewhat of a closed mind in the scientif- ic community. We simply decree it is the largest preventable."' hence, what do we do? We gather together, form a wedge, and move forward to, if you will, stamp out smoking. We move down the line of prohibition. Again, I am just, as a scientist, inquiring how well conceived that is. Is it the largest preventable? The U.S. Congress is proclaiming it is. If I were in the medical sciences, as I translate my knowledge from what I learned in the behavioral sciences, I would be very re- luctant to publicly say, "No question about it. It is 'the largest pre- ventable." I query whether the scientific conclusion of that is true, and it seems to me you are bearing me out. You are saying, "Well, it's true, Senator," in somewhat of a speculation of theory, and so on and so forth, "but we couldn't really say categorically that it is so." But yet these findings are categorical findings. "The Congress finds that." We cannot have it both ways, it strikes me. Dr. LEMAISTRE. With all due respect to your argument, Senator, I don't think I said the word speculation. I think this is the judg- ment by the-- Senator EAST. You used the word "theoretical," which would imply something less than-- Dr. LEMAISTRE. Theoretical is far from speculation. I think the point is that, in theory, a lot of things can be postulated; they are not speculated. Senator, let me see if I can put in perspective the only area in which I think you and I are in agreement. I do think that is a judg- ment call. Senator EAST. Not a scientific finding; a judgment call. Dr. LEMAISTRE. I think it is based on scientific findings, Senator. The point I am driving at is, the mass of scientific evidence is weighted in making that call. Similarly, I cannot give you today a complete definition of the way aspirin works, but that is not going to keep me from taking aspirin when I have a headache. Senator EAST. But what evidence do we have that it is prevent- able, I mean in terms of ease of eliminating it more than any of these other areas? That is all I want to know. Dr. LEMAISTRE. I think the most overwhelming part of this is that 18 million Americans quit in 1965, as I testified just a few mo- ments ago, with the publication of a single report. There has been a decrease in the taking up of the habit through educational activi- ties. If you asked, would the behavioral scientists come together and say that they can do this or they can do that, either in encour- aging peop-;--- to give up cigarette smoking or prevent them from starting, I am quite sure that there would be a wide range of opin- ions. But, I think the consensus would be that education-and you said it yourself-comprehensive health education-of which smok- ing information is only a part, dealing with the consequences of 135 other substances, like salt, clearly I termination in our society. I would favor very much the kin you propose for young people so t1- facts in all areas and make their ow But the one key, I think, in this, Se despite the fact that there have beer 1964, ever successfully marketed a: cigarettes brought out made out of substances that were not acceptable ently, in that they did not seem t been all sorts of other so-called safe filter itself, in my opinion, was an rette safer. But, despite all the s( aware of, there is no safe cigarette t( So sitting and hoping for that is ther research on the safe cigarette cessful. But, in the meanwhile, I tl sumption that that is not likely to need to put forward information to have every right to know. Senator EAST. I am just concernec suppositions, and wishes facts, and I that, and I fear in these findings we "largest preventable cause," that is, conclusions, surmise, supposition. Ti but I am just curious about the sc giving the mantle of scientific bas( world of scientific integrity as I ui not be demonstrated, and we migh- have greater credibility in the long grandiose claims. I mentioned earlier about nitriter are throwing out one scientific find we are pulling it back, or 1 year lat what the public says is, those fellow ing about, because they really don't what they have are general opinic ments" about things, and they are all of that is packaged in the terms ferent mice, what, some 800 mice sounds like, oh gosh, these mice d they got cancer, a terrible thing. V lutely no correlation to genuine hui goes-nitrates, and so on and so fort Coming out of the behavioral anc make sure that-I certainly do not quickly run into the political fray, community of this country, as zealo own political judgments or preferer with those, does not bring the ma over this whole problem when, in '. bear it out. Thank you, Mr. Chairman.

179 "It seems that the birth control message could have relevance to a highly select group of people who could be best reached through very specific media. The message might be lost to the population as a whole." (Burke Focus Group Study Analysis at p. 6.) That same conclusion appears to apply with equal validity to each of the specific disease warnings contemplated by S. 1929. Thus, even the preliminary research that has been done tends to support the conclusion that the proposed rotational warnings would be considered irrelevant by some consumers, as compared to the present warning statement that announces to every consumer the Surgeon General's conclusion that "smoking is dangerous to your health." . These findings are particularly significant in view of one of the major premises of the FTC Staff Report, and pre- sumably of the present bill: that consumers should perceive information concerning smoking and health to be personally relevant. Since it is basic to human nature to conclude that risks apply to "the other person," specific warnings that might be more personally relevant to some consumers would by definition be personally irrelevant to most other consumers. For the individual who sees these diseases as unlikely to occur per- sonally, then the proposed new warnings would be less relevant. Such individuals are particularly likely to be young consumers who may be making the decision of whether to smoke or not. While the decision to smoke is not related to advertising, at least in the preseqt situation parents or peers can say to

162 The alternative theory, first suggested by the eminent geneticist and statistician Sir Ronald Fisher, suggests that genetic factors are important in causing lung cancer; that genetic factors are active in causing people to maintain the smoking habit; and that possibly the same genetic factors may be involved in both these trends, thus producing the observed correlation between smoking and cancer (insofar as'such a correlation is real). There is evidence that genetic factors do play a part in the causation of lung cancer; this is not in doubt. I have brought forward evidence (in addition to already very convincing evidence produced by many other people) to show that genetic factors are relevant to the maintenance of the smoking habit. Thus there is evidence for both the assumptions on which Fisher's argument was based. The origin of the smoking habit, on the other hand, is hardly at all influenced by genetic factors. It appears from our genetic analysis and from the direct study of the problem by Professor Spielberger that the origin of the smoking habit is due to peer pressure; parental influences play a much smaller part, and advertising almost none. My own contribution has been to suggest that the mediat- ing factor between cancer and smoking may be the personality of the people involved. Thus it is assumed that people of 163 a certain personality are more likely lung cancer irrespective of smoking. people of a certain personality are mc others. There is evidence for both t: original work with Dr. Kissen, an emir showed very marked personality differF patients and patients suffering from r with the personality assessment made t then, a large-scale study in East Gerrr findings (themselves replicated in anc and has found similar personality tra' of lung cancer patients in women with Other studies, also indicating a rela* and personality, are cited in my book. In a similar way, my early work established a correlation between per~ and many studies in different countri~ our findings, and added new ones. We fundamental assumption of Fisher's ge empirical support, and we may add tha modest support for my own attempt to major fields. Unfortunately there ha along these unusual and somewhat unor -8- -7-

In my opinion, the change in the warning statement proposed by Section 5 is fundamentally flawed. First, the labeling provisions of Section 5 would replace a highly success- ful program of informing consumers about the claimed health risks of smoking with a program of unknown and potentially counterproductive consequences. All of the studies conducted about consumer awareness of smoking and health issues lead to - the conclusion that people are universally aware of the claims that smoking is hazardous to health. Why abandon this program in favor of a course that is not only uncharted bui, as I hope to demonstrate, likely to lead to results quite the opposite of those apparently intended by the bill's sponsors. The other basic flaw in Section 5 is that the system of rotated warnings attributing specific health problems to smoking will probably lead to one of two unhappy effects: either consumers will erroneously believe that they will per- sonally suffer the specific health problems identified in the warning statements, even though such problems affect only a minority of the smoking and nonsmoking population, in which case the warnings would be deceptive; or consumers will correctly perceive that only a small proportion of the population is at risk from the stated health problems, and will thus conclude that the Surgeon General and other health authorities have now decided that smoking is not hazardous to all people. Since it appears that the specific diseases identified in the proposed varning systems apply primarily to older people and pregnant 95-077 0-82--12

172 women, the probable effect of the law would be to reduce dras- tically the impact of the warning statement on young people. The rotational warning system proposed in the present bill and the FTC Staff Report apparently is based on the assump- tion that present public awareness of the claimed health'conse- quences of smoking is "insufficient." Finding 6 in Section 2 of S. 1929 states that "present Federal, State, and private initia- tives have been insufficient" in conveying information about.the claimed health consequences of smoking to the American public. Similarly, the FTC Staff Report asserts that "additional action designed to provide consumers with more information about the health consequences of smoking is necessary." (Report at p. 21) For several reasons, this assumption is dubious. In the first place, determination of what constitutes a "sufficient" level of awareness in such a complex area is both difficult and subjective, although it appears to me that, by any standard, the level of awareness about the claimed health hazards of smoking is astonishingly high. A basic question is the amount of information a consumer can reasonably be expected to be aware of in connection with a decision to use any particular product. Many of the questions posed in the surveys cited by the FTC Staff required a detailed scientific knowledge about questions of smoking and health, including a complete awareness of every health problem that has been attributed to smoking, the specific size of the increase claimed in the risk of incurring each problem if one smokes, the percentage of each particular health condition that is attributed to smoking, and the proportion or number of 173 - 4 - people who die from a given health con. viewpoint, what value is there in posst array of information? When one considf of information to which the consumer i: the fact that consumers do not possess capacities, it clearly would seem more sumer to retain in memory the overall i numerous bits of information about the smoking, i.e., that smoking is dangerot information conveyed by the present Suz statement. Proper evaluation of the adec ness also is hampered by the fact that comparison. For example, how does cons smoking and health compare to the infor about the health hazards attributed to automobiles, liquor, and hang-gliders? judgments about the sufficiency of the are highly subjective and cannot serve -K the far-reaching changes embodied in Se Moreover, an examination of t the FTC relies for the proposition that sufficiently aware of the dangers assoc reveals that those studies are defectiv respects.

ARTICLES IN PROFESSIONAL JOURNALS: Roger 0. Blackwell, "Potentials of Contra-Cyclical Advertising," 8usiness and Government Review (September-October 1963), 22-32. Roger D. Blackwell, "Evaluating a Store's Image," OSU Bulletin of Business Research (May 1966), 2-4. Roger 0. Blackwell, "Knowing Your Image," Small Marketers Aids No. 124. Washington Small Business Administration, 1967. Roger 0. Blackwell, "Socio-Economic Variables Affecting Consumer Funeral Decisions," (February 1967), OSU Bulletin of Business Research. 4-6. Roger D. Blackwell, "Price Levels in the Funeral Industry," The Quarterly Review of Economics and Business (Winter 1967), 74-84. James F. Engel and Roger 0. Blackwell, "Affluent Suburbia and the Negro Neighbor," Bulletin of Business Researbh (October 1968), 1-9. J. F. Engel, J. F. Kegerreis and Roger D. Blackwell, "Word-of-Mouth Communication by the Innovator," Journal of Marketing (December 1968), 15-19. D. T. Kollat and Roger D. Blackwell, "Recognizing the Limitations of Customer Traffic Pattern Studies," The New York Retailer (December 1968), 3-7. "Price Levels in the Funeral`fndustry," in Donald S. Watson, Price Theory in Action, Second Edition,(Boston: Houghton Mifflin Co. 1969), 225-265. James Engel, David Kollat and Roger Blackwell, "Personality Measures and Market Segmentation," Business Horizons (June 1969), 61-70. Roger D. Blackwell and James F. Engel, "Attitudes of Affluent Suburbia Toward the Negro Neighbor," Business Topics (July-August 1969). 41-49. James F. Engel, Roger D. Blackwell and Robert Kegerreis, "How Information is Used to Adopt an Innovation," Journal of Advertising Research (December 1969), 3-10. H. E. Spence, James Engel and Roger D. Blackwell, "Perceived Risk in Mail-Order and Retail Store Buying," Journal of Marketing Research (August 1970), 364-369. David T. Kollat, James F. Engel and Roger D. Blackwell, "Current Problems in Consumer Behavior Research," Journal of Marketing Research (August 1970), 327-333. Roger D. Blackwell and James F. Engel, "Comnunicating Religious Truth in a Changing World," in David L. Sparks, Broadenin the Conce t of Marketin , (Chicago: American Marketing Associat on 0. Roger D. Blackwell and Brian Sternthal, "Physiological Measurement of Communi- cations Variables," in David L. Sparks, Broadenin the Conce t of Marketin (Chicago: American Marketing Association, 1970).

179 achieve the goal of informing the public. The little evidence that exists not only fails to support that proposition, but in fact contradicts it. An initial study for the FTC Staff was undertaken in 1980 by Walker Research to assist in the selection of specific warning statements, while another study conducted by Burke Marketing Research examined consumers' recall of various warnings. Importantly, neither study examined the impact of such warnings on consumer awareness. There are accordingly no data to indicate that a rotational system such as that proposed by the bill would meet the objective of providing consumers with "sufficient" awareness about the claimed consequences of smoking, particularly if sufficiency is gauged by the very detailed measures used in the surveys cited by the FTC Staff. What the studies do demonstrate is that consumers are likely to discount warnings that link smoking to specific health problems. In its Summary of Key Findings, for example, the Burke Focus Group Study states: "The messages related to birth control pills and heart attacks tended to confuse the participants, who did not thoroughly understand the synergistic effects which form the basis of the message. Thes two statements relatin to oral contrace tives a so had the least ersonal relevance and were rather easily dismisse as being intended 'for someone else . (Emphasis a ded. The Study thus concludes: t "It seems that the t could have relevance to a of people who could be be very specific media. The to the population as a wh Group Study Analysis at p That same conclusion appe validity to each of the specific di by S. 1929. Thus, even the preliminar tends to support the conclusion tha- warnings would be considered irrele- compared to the present warning sta; every consumer the Surgeon General': dangerous to your health." „ , These findings are partict one of the major premises of the FTC sumably of the present bill: that c information concerning smoking and h relevant. Since it is basic to hume risks apply to "the other person," s be more personally relevant to some be personally irrelevant to most oth individual who sees these diseases a sonally, then the proposed new warni Such individuals are particularly li who may be making the decision of wh, While the decision to smoke is not r, least in the preseqt situation paren

Dr. Roger Blackwell 181 Dr. Roger Blackwell ia Professor of Marketing at the Ohio State University and a Consulting Associate and Director of Management Horizons, Incorporated. His specialty is the analysis of buyer behavior and development of market- ing strategy. Dr. Blackwell is the co-author of the Fourth Edition of Consumer Behavior, the most widely adopted textbook in the field. He has written fourteen books including Market- ing Management, a soon to be released book relating mar keting principles to corporate strategy. Some of his other books inciude Consumer Attitudes Toward Health Care, American Attitudes Toward Death and Funerals, Communi- cations for the Funeral Profession, Laboratory Equipment for Marketing Research, Research in Consumer Behavior, and Strategic Marketing. His Ph.D. is from Northwestern University and he holds B.S. and M.S. degrees from the University of Missouri. He has served as a Visiting Professor of Marketing at Stanford University Graduate School of Business and a visiting lecturer in Canada, Australia, South Africa and several European countries. Dr. Blackwell has won several awards for outstanding teaching at the Ohio State University and he isa a consul- tant to some of America's largest corporations. He has served as an expert witness before the Federal Trade Com- mission and other legal proceedings and his opinions have been quoted in the Wall Street Journai, Forbes, Business Week and other leading business publications. Over fifty articles he has written have appeared in Journal of Market- ing Research, Journal of Advertising Research, Business Horizons and many other publications. ®

169 STATEMEIVT OF DR. PAUL MINIARD I am Paul Miniard. I have a doctorate in marketing from the University of Florida, and since last September have been Assistant Professor of Marketing at the Ohio State University. My specialty is the study of consumer behavior, and I have published articles in that and related fields in such journals as the Journal of Marketing Research, Journal of Consumer Research, and the Journal of Experimental Psychology. For over two years, I have worked with Dr. Roger Blackwell, Professor of Marketing at the Ohio State University and author of, among other things, Consumer Behavior, the most widely adopted textbook in the field. I assisted Dr. Blackwell in reviewing and analyzing the cigarette labeling and adver- tising provisions of S. 1929, the comparable provisions of H.R. 5653, and the FTC Staff Report on the Cigarette Advertising Investigation. On Friday, March 12, Dr. Blackwell appeared before the House Subcommittee on Health and the Environment to provide his analysis of H.R. 5653. He also has prepared testi- mony concerning S. 1929, but because of a longstanding profes- __ sional commitment is unable to be here today, and has asked me to present the attached statement. @ 0 I

173 -4- people who die from a given health condition. From the consumer viewpoint, what value is there in possessing such a complex array of information? When one considers the tremendous amount of information to which the consumer is exposed every day, and the fact that consumers do not possess unlimited processing capacities, it clearly would seem more functional fqr the con- sumer to retain in memory the overall implication of these numerous bits of information about the claimed consequences of smoking, i.e., that smoking is dangerous. That is precisely the information conveyed by the present Surgeon General's warning statement. Proper evaluation of the adequacy of consumer aware- ness also is hampered by the fact that there is no baseline for comparison. For example, how does consumer awareness about smoking and health compare to the information consumers possess about the health hazards attributed to other products such as automobiles, liquor, and hang-gliders? Without such comparison, judgments about the sufficiency of the level of consumer awareness are highly subjective and cannot serve validly as a basis for the far-reaching changes embodied in Section 4 of the bill. Moreover, an examination of the studies on which the FTC relies for the proposition that consumers are not sufficiently aware of the dangers associated with smoking reveals that those studies are defective in several important respects.

support for your efforts in this area will he of assistance to you and the Committee. We would be pleased to provide you with any other assis- tance.

What is certain is that at the moment no final decision be made about whether or the degree to which cigarette 169 STATEMENT OF DR. PAUL I am Paul Miniard. I have e from the University of Florida, and si been Assistant Professor of Marketing University. My specialty is the study and I have published articles in that such journals as the Journal of Market of Consumer Research, and the Journal For over two years, I have w Blackwell, Professor of Marketing at t and author of, among other things, Con widely adopted textbook in the field. in reviewing and analyzing the cigaret tising provisions of S. 1929, the comp H.R. 5653, and the FTC Staff Report on Investigation. On Friday, March 12, D before the House Subcommittee on Healt provide his analysis of H.R. 5653. He mony concerning S. 1929, but because o sional commitment is unable to be here me to present the attached statement. can smoking may cause lung cancer or coronary heart disease, how it interacts with other factors (stress; personality), or how we can best protect the health of our citizens in relation to these diseases. "In ignorance, abstain!" warned the famous French scientist, Claude Bernard; hasty action on the basis of partial knowledge is unlikely to be in the best interests of those most concerned, namely the prospective victims of lung cancer and coronary heart disease. HANS J. EYSENCK -13-

. 185 Roger D. Blackwell, D. K. Hawes & W. W. Talarzyk, "Profiling the Female and Male Bank Card Holders: A Psychographic and Demographic Analysis", Proceedings of A.M.A. Fall Meetings, 1976. Roger D. Blackwell, D. K. Hawes & W. W. Talarzyk, "Consumers' Use of Credit Cards: Results of a Nationwide Study", paper presented at the Southwestern Marketing Association, March 17-20, 1976. Roger 0. Blackwell, "The Diffusion of Diffusion Research," Paper presented to Association for Consumer Research, San Francisco, October 1979. Justin Yoss and Roger Blackwell, "The Role of Time Resources in Consumer Behavior," in 0. C. Ferrell, S. W. Brown and C. 11. Lamb, Jr., (eds.), Conceptuat and Theoretical Developments in Marketing (Chicago: American Marketing ssoc9ation, /~ 28 -295. Roger D. Blackwell, "The Future of Fashion: The Influence of Lifestyles on Textiles and Clothing," Combined Proceedings of the Association of College Professors of Textiles and Clothing, 1979, 59-64. Roger D. Blackwell, "The Consumer Approach to Death Education," Paper pre- sented to Fifth Annual Symposium on Death Education at the Ohio State University, March 1980. Roger D. Blackwell, "The Effects of Lifestyles on Retailing in the 1980's." A.M.A. News (March 3, 1980). ~ Roger 0. Blackwell and JoAnn Schickel Hilliker, "Clothing Decisions: A Decision Process Analysis of Focused Group Interviews," in H. Keith Hunt and Frances M. Magrabi, eds., Interdisci iina Consumer Research (Ann Arbor: Association for Consumer Rese3rch 1980 , 20-2 . Roger D. Blackwell, "Seven Principles of Marketing Education," Marketing News (Chicago: American Marketing Association, May 1980). H. Lee Mathews and Roger D. Blackwell, "Implementing Marketing Planning in Higher Education," in Richard Bagozzi, ed., Marketin in the 80's: Changes and Challenges (Chicago: American Marceting Association, 1980, 1-5. Roger D. Blackwell (with Karen S. Edwards), "The 1980's Ph sician: From Patient Care to Patient Advocate, The Ohio State Medica Journa (September , -479. Roger D. Blackwell, "The Role of Lifestyle Analysis In Retailing Profitability,= Journal of Retailing Research (May 1980). W. Wayne Talarzyk and Roger D. Blackwell, "James F. Engel: Twenty Years of Contributions to Consumer Behavior," Paper presented to Converse Symposium, University of Illinois, May 1981. Roger D. Blackwell, "The Many Hats of Today's Funeral Director," Chapter 6 in Charles Stewart, Funeral Service: Counselin Princi les and Practices (Batesville, Indiana: Batesvi e Management Servi ces, 1981 . Roger D. Blackwell, "The Preparation of Future Marketing Managers," Journal of Marketing Education (Spring 1981), 4-9.

187 The CHAIRMAN. Now, you have indicated that this legislation is unnecessary because over 90 percent of our citizens now know that smoking is harmful. If this is so, it is likely due to the initial warn- ing label required by legislation, or at least in the eyes of some people. Now, how could this effort to inform smokers about specific health consequences be counterproductive, as you say? Mr. HORRIGAN. Mr. Chairman, to support your concern about public health, from a marketing viewpoint, because we are really talking about delivering a message, and that is also your intent, our experience is that there is a great advantage in what we call single mindedness versus clutter. We are not permitted, as you know, to advertise on television, but manufacturers who do, worry greatly about the millions of dollars they spend on spot commer- cials surrounded by other commercials, which causes clutter, and therefore their message is diffused. We believe in single minded- ness in effective marketing. What you in effect have here is a very effective warning that has been proven over the years, and we honestly believe that, in terms of your own sincere intentions, you would add confusion and clut- ter, let alone the chaos that would exist on the manufacturing side. The CHAIRMAN. In your testimony, you state the Comprehensive Smoking Prevention Education Act is, "designed to force smokers to conform and to encourage prohibition of smoking." Now, of course, I think everybody here today has indicated that there is no desire to have prohibition of smoking but a desire to inform the public. Now, I do not know whether this public education effort would be forcing or prohibiting smoking, but that is certainly not our intent. You indicate 30 highly qualified and respected scientists were ready to appear and challenge the scientific findings of our bill. Yet, I think the overwhelming majority of scientists throughout the world accept the conclusions of thousands of researchers and their efforts linking cigarette smoking with disease and death. - Now, how do you account for the striking difference of opinion among these various scientists? Mr. HORRIGAN. First of all, Mr. Chairman, although I have inter- jected myself this morning in these medical proceedings, I will not proceed to answer in a scientific way your question, but I will make this opening statement, that just prior to our appearance here, an eminent physician said that, indeed, there is a controversy that does exist, and that is a fact, after all these years. To answer your question and to add greater perspective, I would like to turn the question over to Dr. Sommers. The CHAIRMAN. Dr. Sommers? Dr. SOMMERS. Mr. Chairman, the key word is "linking." Epidemi- ology, indeed, shows a strong statistical relationship between smok- ing and a variety of diseases, but epidemiology is a scientific tech- nique that can never prove cause and effect. Cause and effect have to be proved by other methods such as animal experiments and in vitro experiments, and that has not been achieved. 95-077 0-82---13

189 more balanced in terms of the points of view that we need to air and look at. I would agree with Mr. Horrigan that this question of science has loomed up large and with Dr. Sommers on the question of cause and effect as opposed to straight statistics. I do not wish to go at that ad nauseam, but it is a critical assumption that we are dealing with science here, and in American public life and in policy formu- lation, when the word "science" is heard, it would suggest we follow instructions, that there are no loose ends, that all has been carefully stitched together, and we must follow the dictates of sci- ence. I do feel this morning, from my vantage point at least, that the testimony has been valuable to question whether we are talking about science or wish or judgment or value, et cetera. Mr. Horrigan, your testimony, I think, can be particularly valua- ble for me and, I would hope, for the committee's record here. I had hinted at the beginning of this hearing today, and you have touched upon it, that, ultimately, those of us on this side of the issue in terms of being in the legislative chamber-and I know Sen- ator Hatch has a great sensitivity to this and a very distinguished record in this area, as a matter of fact-of making sure that bur- dens placed upon industry are commensurate with some gain to the public. The regulatory reform bill that the Senate is going to be taking up shortly hits that one head on. In the past, there has been the tendency of Government, of policy formation here in Washington, in the Senate, and in the House, frequently to dump upon business- es, or to place upon businesses, to use a more neutral phrase, regu- lations that just incredibly hobble an industry with no real genuine corresponding benefit to the public in terms of cost-benefit analysis or anything of this kind. I think, obviously, you are in a very unique position because your industry would obviously bear the burden of this. I had indicated earlier, I suspect other businesses could be affected by it, too, but let's leave that for another time or place. As you see it, this act, this particular piece of legislation, would place substantial, serious burdens upon your industry. I would like for you to comment briefly on that and just some of the illustra- tions of it that you see; and then, second, to weigh that as to what you see would be the gain, if any, to the public on the issue before the House, or the Senate in this case, namely the problem of smok- ing and public health. Where might you advise us we would be if this bill goes into operation? How would you weigh that, coming from a key figure in a key industry. Probably the R. J. Reynolds Co., which we are very proud to have in North Carolina, might very well say the industry, but we will not get into all the partisan loyalties. How would you assess that for me in general terms? It would be valuable for me, and I think it would be valuable for the record to show. Mr. HORRIGAN. Fine, Senator. I am somewhat partisan. My son graduated from the University of Utah, so he cannot be all bad, Mr. Chairman. [Laughter.] He is a skier and a business student.

199 Mr. Chairman and Members of the Committee Page Five other health professionals in communicating the risks of smoking to their patients. The College would recommend that "WARNING: The Surgeon General has Determined that Cigarette Smoking Causes Heart Disease" be amended as follows: "Current scientific evidence indicates that Cigarette Smoking is a Major Risk Factor for Coronary Heart Disease." The College would also recommend that "Current scientific evidence indicates that cigarette smokers are predisposed to sudden death," and "Current scientific evi- dence indicates that there is a significant re- lationship between cigarette smoking and heart disease, cancer or emphysema" be considered. In addition, the College believes that one aspect of the wording of the bill relating to the coordi- nation of research, conduct of research and the authority of the Secretary to carry out the pro- visions of this bill through grants, may need clar- ification to avoid duplication with research on cigarette smoking effects being conducted by NHLBI, NCI and other Institutes at NIH. If coordination means the implementation of a systematic exchange

195 Dear Mr. Chairman and Members of the Committee: I am Dan G. McNamara, M.D., F.A.C.C., Professor of Pediatrics and Chief of the Cardiology Section, Baylor College of Medicine and Texas Children's Hospital. I am also President of the American College of Cardiology, a professional medical spe- cialty society representing over 11,500 physicians, scientists and educators who specialize in diseases of the heart and circulatory system. ACC is dedi- cated to ensuring optimal care for persons with cardiovascular disease and those with the potential for developing cardiovascular disease and, through educational and socioeconomic activities, to contri- bute significantly to the prevention of cardiovas- e

197 Mr. Chairman and Members of the Committee Page Three is hazardous to health. Additionally, as noted, consumers themselves agree that the current warning is inadequate. Why not provide the public with the type and quality of information sought? As the FTC report notes, nearly "two out of every three questioned during the 1978 Roper survey for the Tobacco Institute, believe that the current warning is not "adequate" and indicated they preferred a health warning that describes the specific health risks of smoking." A 1978 Gallup survey of smokers and nonsmokers found that 32% were not aware of the statistical relationship between cigarette smoking and heart attack; that 37% of smokers did not know this relationship; and that among heavier smokers, 40% did not know the increased risk for heart attack associated with cigarette smoking. The 1979 Chilton Study, conducted by the FTC, found that 25% of the general population and 31% of smokers did not know that smoking greatly increased their risk of heart attack despite research that concluded that it doubles a person's risk of heart attack. In addi- tion, consumer knowledge of the relationshio among cigarette smoking, birth control pills and heart I 9 0 0 I

207 - 4 - who quit smoking on their own will stay off cigarettes. Assistance must be provided to the remaining 50 percent if smoking is to be decreased significantly. The AMA is developing an audiovisual presentation on how to quit smoking that will soon be available for physicians to use in assisting patients desiring to quit smoking. If adopted, a change in the warning may create more awareness of the dangers of smoking, and more smokers will want to stop smoking. Programs to assist those who want to quit smoking will be needed even more in that case. Conclusion The AMA supports efforts to increase public awareness of the hazards of smoking. We believe that the best method to decrease smoking is to help people avoid starting the habit. One method to discourage smoking would be a clear indication of the health hazards of smoking. Thus, the AMA supports a more explicit warning on cigarette packages and in advertisements. 0386p

175 -6- were asked whether heart disease "had been found to be associated with cigarette smoking." (Question 42e) Only 9.8% of the teen- agers and 9.3% of the adults interviewed answered incorrectly (i.e., "No" and "Don't know" responses). Later in the interview, these same persons were asked'whether the statement "cigarette smoking is a major cause of heart disease" (Question 52) was true or false. '26.88 of the teenagers and 39.6% of the adults were presumed to be "unaware" of the claim embodied in this statement. Such response variations between questions involving the same disease, but which differ in positing smoking as either the cause of or simply associated with that disease, strongly suggest that many persons classified as "unaware" in fact are aware of smoking's asserted relationship to various health risks. These persons simply do not believe that smoking causes these health problems. Question wording has long been recognized as a critical area in survey research. The FTC Staff Report acknowledges that ". . . conservative sounding statements have been found to be more likely to generate agreement . . . ." (Report at p. 3-3) By the same token, statements employing extreme wording or phrases are likely to inhibit agreement. Thus, the amount of agreement with the statement "smoking is by far the greatest cause of lung cancer" used in the 1980 Roper Study was probably lower than had the statement been phrased "smoking is the greatest cause of lung cancer." Wording ambiguity can also influence the response patterns to a question. Phrases repeatedly appearing increases," and in the Roper Study such as "by far," "greatly

190 But I think, to answer your question, Senator, we are a responsi- ble and a concerned industry. I think we have proven that over the past. If there was substance and reason for what was being pro- posed here, we would be responsive to it, No. 1. No. 2, with regard to the economic impact in terms of pure dol- lars and cents, we have made reference to this with regard to the House of Representatives bill. Yes, it would cost, let's say, roughly, in the range of $40 to $50 million a year, and that is a cost burden that would just continue to be passed on during what we now know to be very difficult times. But even if you put that number aside, the fact that these state- ments are without foundation, without basis, along with the fact that the chaos and the confusion that would result in the market- place for manufacturers to comply with such a law with regard to the statements I made on the number of brandstyles in the market- place, the rotation sequence, the ability of FTC to monitor such a system; we just think that no matter how flexible we are-and we are flexible-it would be a total chaos in the marketplace, adding, of course, to the clutter and the confusion that we sincerely believe would result from a message standpoint. Senator EAST. So the burdens on the industry are, as you see it, considerable and of deep concern to you. On a scale of difficulty of 1 to 10, perhaps, this bill causes you considerable concern, not just casual concern. Mr. HORRIGAN. Considerable. Yes, sir. Senator EAST. What benefit do you see to the public generally from it? I gather from what you have already said you are not sure, from an industry perspective, there will be any increased benefit if the goal, which we all seem to be agreed upon, is public awareness and information about the relative health problems of cigarette smoking. I gather that if we put you through this bill and what the impact would be in terms of government regulation, in terms of potential suits against you-and much of this, I suppose, is unforeseen as to where it might lead-you see little, if any, real, genuine gain to the public in terms of its level of increased awareness and sensitivity to and information about the relative health hazards of smoking? Is that how you see it? In short, you said, now it is working; why place an inordinate burden upon us with no commensurate in- crease in terms of benefit to the public. Is that what we are saying here? Mr. HORRIGAN. That is correct, Senator. There is nothing more dangerous in a marketing company than when a new marketing man comes in and tries to change something that is working. I would love to have a message that has the awareness level of the Surgeon General's basic warning notice. Senator EAST. So the burden upon the industry, not only yours but all involved, the other great companies in this country involved in this business, not only would the burden be great upon you and them but the benefit to the public, at least as you people from the industry see it, would be negligible if not even counterproductive in terms of the confusion of the labels and getting away from the es- tablished pattern of a set label. The cost-benefit does not balance out, as you see it. 191 Mr. HORRIGAN. Precisely. Senator EAST. I have no other questior Senator HATCH. Thank you. Mr. Horrigan, if these statistics are ri are unaware, that 60 percent did not I most cases of bronchitis and emphysem not know that smoking causes lung car know that smoking causes many heart a there are other possible health detrimei just a few hundred, a few thousand or m: be worth putting any labels on the cigar Mr. HORRIGAN. Mr. Chairman, I think those particular numbers, and if I may answer. Mr. MINIARD. The problem here in loo: interpreting that many Americans are hazards of smoking is a problem of in mean. For example, most of these statemen assume that the person is willing to be1 direct causal link between smoking and : seems very likely that people may be aa the alleged relationship, or aware of the cided that in fact it is not a causal relatic To give an illustration of that, one of presume some of this information is base which the same people were asked twc people were asked was whether or not t ease was associated with smoking. For t cent of teenagers and the adults that wE to be uninformed. When we moved to a more causal statE ing causes heart disease, for the same ranging between 27 and 40 percent. So : here is that we are trying to measure kr we assume that a person does not possE agree that smoking causes as opposed to : a particular health hazard. Senator HATCH. I see. Well, we thank you for coming. We a and we will keep the record open so that timony as well. Mr. HORRIGAN. Thank you, Mr. Chairm Senator HATCH. Thank you. It is nice tc With that, we will recess this hearing. [Whereupon, at 12:31 p. m., the commit at the call of the Chair.]

205 - 2 - Commission vith a list of the chemical additives in each of their brands of cigarettes. This information would be protected as a trade secret and used only for research purposes. Comments The United States Surgeon General stated in his recent report, "The Health Consequences of Smoking," that 'Cigarette smoking . . . is the chief, single, avoidable cause of death in our society and the most important public health issue of our time." A decision to smoke should be made with the knowledge that increased health risks are associated with smoking. For this reason the AMA is supportive of efforts to increase public awareness of the hazards. The AMA has been involved in many efforts to increase the public's knowledge of the consequences of smoking. The AMA receives and answers many requests for smoking information. In 1978 the AMA published "Tobacco and Health," an account of the comprehensive research program conducted by the AMA. A pamphlet called "Smoking: Facts You Should Know," a copy of which is attached, has been widely distributed along with two anti-smoking posters. Physicians are urged to alert smokers to the risks associated with smoking. Our comments address only the rotational labeling provisions. We find it very disturbing if, as a recent FTC staff report alleges, approximately ten percent of the population still do not know that cigarette smoking is harmful. Believing a more detailed warning would better inform the public of the harm of smoking, the AMA House of Delegates adopted a report encouraging Congress to require a more explicit warning on cigarette packages. C W Qi ~ ~ ~ N (M

(4) Research on psychosocial influences should not be deemphasized, bu4 projects should be sought which try to evaluate psychosocial and pharma codynamic influences within the same context. (5) Basic research efforts should be focused on the analysis of nicotine self-administration in laboratory animals. The range of conditions neces sary for the establishment, maintenance, and elimination of nicotine se) ~ administration should be studied. (6) Research efforts should be directed toward establishing an adequate~ animal modell of cigarette smoking behavior. (7) Research should be undertaken to establish valid low-cost, and pf~ erably noninvasive measures of cigarette smoking to be used as outcome measures in clinical treatment research. Examples of such measures mcl urinary nicotine or expired-air CO levels. (8) Physiological and psychological changes that occur during repeated administration (tolerance and physical dependence) and upon smoking cesi? sation (withdrawal) should be characterized in detail. The contribution these changes to the clinical phenomenon of relapse to smoking should established. * ;%,> ,,..:r.I.... Well, thank you, Dr. Pollin. A,: j .:•,! ~?:+nd it• you need to leave to go to a tt+. r', i% Fh:,t is right. Vr~ •~.! V•+A.. When is the latest you need to t* !°•:.•. I have at least 20 to 25 minutes, 1V . tir . v i)o you have any questions? z. N • x~.~,c>n. I have only one question. n~.%.•here you talk about adding " w„Fvrous, are you suggesting that tc a.r bt;. rft• r:Idditional labels that we may chc -0iwra-vt -: ~-, -•• word "addictive"? ' l ~+r i•, f.ltihe National Advisory Council, i w.ts 4uhgesting the addition of the w 400 s»-nt tatxrl. I would conclude from the natt now& anat tnw would think it would be important 'UM of any campaign emphasizing i . trt•ttt•ti. ret~->;! •r t•.0 t;Wrxlu. Is that your personal concl• ti# •.. It is. ti%"xlu. Is it the administration's p, A, Ur. Brandt indicated today, the i%4,r of stronger health warnings. T n n1;t%. most optimally achieve that a 1MMP's- ;.: n ,• r'., kwixnu. 'I'hank you. fx+;k%t..V Ur. Pollin, let me ask you thi: * .JM6M'W& •-jr ' rts•rt testimony, and you have cot This report has summarized the Technical Review on Cigarette Smoking an Addiction. Additional information about the meeting may be obtained from Dr. Pierre Renault, NIDA Division of Research. ~~ ~•. tnat tobacco is an addicting sub: !lf~nazs,i s. t drug. why has tobacco escaped be: ~' ~f1.:f a~,(lvtltnl•eS~~ i'`==--• i:mn sure that there is a com 1• e : mnr,r i . ~ p equlppea at tnls point to al n,tw led to indeed a ver diff , y , '•'-t,acco as compared with other s hwe ~ , ~ %7, ci u1JL111gU1Jileu c)acl 1hO N •ou believe that requirii ~ .o be ~,-tnK tffi an eectve method of 40"4* '"o•VP that these types of warnings rtL;tlrettes? rx•l,c•Vce that knowledge of healtl- r! ar. ... oft •~~~~~. ts cieariy not a simple ~'~°~ (•tther know it or don't know th A I the r easons that lead to bel :rndations and multiple levels ol tht i d :a• assemonstrated by "'t ` K h,ch ih .s peraps one of the +truments that man has dev~ ~ML "4, +ti4-M tlresentation of inessages. t)r-sentation of health conse( -=ivtdual because it represent `'O"ch has become so well know 0360'7594

198 il-tc. Chairman and Members of the Committee Page Four attack is low, despite the fact that women who smoke and take birth control pills have approx- imately ten times the risk of a heart attack of women who do neither. 199 ;•1r. Chairman and Members of th Page Five other health professionals in risks of smoking to their pati The College would recommend th Surgeon General has Determined Therefore, the College agrees that the current cigarette warning is not effective relative to the public's need to know and act on the strong scientifically-validated statistical relationship between cigarette smoking and cardiovascular disease. The College agrees with the need to . improve on the type and content of the required cigarette warning labels. Therefore, in reviewing the FTC report and its conclusions, the College endorses the concept of rotational warnings as being more effective than the current warning. The College believes that the labeling approach and specific warnings contained in S. 1929 (as modi- fied below for scientific acceptability) will assist consumers in making conscious, more informed deci- sions about smoking, because they will have more definitive information on the specific health con- sequences of smoking. This type of information, also,will assist cardiologists, other physicians and Smoking Causes Heart Disease" follows: "Current scientific that Cigarette Smoking is a Ma for Coronary Heart Disease." also recommend that "Current s, indicates that cigarette smoke: to sudden death," and "Current dence indicates that there is lationship between cigarette sr disease, cancer or emphysema" 1 In addition, the College_belie• of the wording of the bill relz nation of research, conduct of authority of the Secretary to c visions of this bill through gi ification to avoid duplication cigarette smoking effects heinc ~ NCI and other Institutes at NIf O :neans the implementation ~ N of a :

182 Revised 7/1/81 PUBLICATIONS Roger D. Blackwell The Ohio State University BOOKS Roger 0. Blackwell, James F. Engel and David T. Kollat, Cases in Consumer Behavior, Holt, Rinehart and Winston, Inc., 1969. David T. Kollat, Roger Blackwell and James Engel, Research in Consumer Behavior, 1970. Roger Blackwell, James Hensel, Mike Phillips, and Brian Sternthal, Laboratory Equipment for Marketing Research, Kendall-Hunt, Inc., 1970. David T. Kollat, Roger 0. Blackwell, and James Robeson, Strategic Marketing, Holt, Rinehart and Winston, Inc., 1972. Roger D. Blackwell and W. Wayne Talarzyk, American Attitudes Toward Death and Funerals, Evanston, Illinois: Casket Manu acturers Association, 1974. Roger 0. Blackwell, W. W. Talarzyk & D. C. Beever, Professional Funeral Pricin (Columbus: New Horizons.eublishing, Inc., 19 Roger Blackwell and David Anderson, A Christian A roach to Transcendental Meditation (Columbus: New Hon zons Pub ishing, 9 Roger D. Blackwell, J. F. Engel & W. W. Talarzyk, Contem orar Cases in Consumer Behavior (Hinsdale, Illinois: Dryden Press, Roger D. Blackwell & W. W. Talarzyk, Consumer Attitudes Toward Ph sicians and Malpractice (Columbus: Grid P ishing, 1977). Roger 0. Blackwell and W. Wayne Talarzyk, Communications for the Funeral Profession (Columbus: New Horizons Publishing, 9 9. Roger D. Blackwell, H. Lee Mathews and Carolyn Randolph, Living in Columbus (Columbus, Nationwide Insurance, 1979). Roger D. Blackwell, Books About Death: An Annotated Bibliography (Columbus: The . Ohio Funeral Directors Association, 1980~- J. F. Engel and Roger D. Blackwell, Consumer Behavior, 4th Edition (Chicago: Dryden Division of Holt, Rine art, W nston, st Ed, 196 , 2nd Ed., 1973, 3rd Ed., 1978, 4th Ed., 1982). Roger D. Blackwell, James Robeson and David Kollat, Marketin Mana ement: A Strategic Approach (Chicago: Dryden Press, In press . 183 ARTICLES IN PROFESSIONAL JOURNALS: Roger 0. Blackwell, "Potentials of Contra-Cyclic Government Review (September-October 1963), Roger 0. Blackwell, "Evaluating a Store's Image, Research (May 1966), 2-4. Roger 0. Blackwell, "Knowing Your Image," Small Small Business Administration, 1967. ' Roger D. Blackwell, "Socio-Economic Variables Af (February 1967), OSU Bulletin of Business Re Roger D. Blackwell, "Price Levels in the Funeral of Economics and Business (Winter 1967), 74- James F. Engel and Roger D. Blackwell, "Affluent Bulletin of Business Researbh (October 1968) J. F. Engel, J. F. Kegerreis and Roger D. Blackw, by the Innovator, Journal of Marketing (Dec D. T. Kollat and Roger D. Blackwell, "Recognizin Traffic Pattern Studies," The New York Retai "Price Levels in the Funeral'fndustry," In Donal Action, Second Edition,(Boston: Houghton Mif James Engel, David Kollat and Roger Blackwell, "! Segmentation," Business Horizons (June 1969) Roger D. Blackwell and James F. Engel, "Attitude the Negro Neighbor," Business Topics (July-A: James F. Engel, Roger D. Blackwell and Robert Ke• Used to Adopt an Innovation," Journal of Advw 1969), 3-10. H. E. Spence, James Engel and Roger 0. Blackwell and Retail Store Buying," Journal of Marketi, David T. Kollat, James F. Engel and Roger D. Bla, Consumer Behavior Research," Journal of Mark, 327-333. Roger D. Blackwell and James F. Engel, "Carmunic, Changing World," in David L. Sparks, Broaden (Chicago: American Marketing Associat o~T93 Roger D. Blackwell and Brian Sternthal, "Physiolc cations Variables," in David L. Sparks, Broa (Chicago: American Marketing Association-T9'

154 Cica ;c; -- - - - -c e s e ad.•ertis i -_ .1e- ---:'• tc _- =cr:r.s -r-----:g _^c1u_ 3 ve:icle deca:s, pcs'e- --_ - m.a_cr.z co•s c_ove=s anc peir.t cf p::rc:ase materia:=_ _.* t__--.__ _ta -es, Puer.o -_cc, a --- L'.Sn ter-.torial nossessicr.s. 1. No advertising shall atpe in puhlica_io:s directed _ primarily to those under 21 years of age, including school, college or university mecia (such as athletic, ~ theatrical or other prograr,.s;, comic boo::s orcomic suonlements. - 2. No one depicted in cigarette advertising shall be or appear to be under 25 years of age. 3. Cigarette advertising shall not suggest that sroking is essential to social prominence, distir.cticr., success or sexual attraction, nor shall it picture a persc:, smoking in an exaggerated manner. 4. Cigarette advertising may picture att, ct'_ve, health.• looking persons provided the:e is no suggest'_c.1 tceir attractiveness and good -aealt: is due to cigarette smoking. S. Cigarette advertising shall not depict as a smoker anyone who is or has been well knohrn as an athlete, nor shall show any smoker participating in, or obviously iust having participated in, a physical activity recuiring stamina or athletic conditioning bevon,: that of normal recreation. 6. No sDorts or celebritv testimonials shall be used or those of others who would have special appeal to persor.s under 21.years of age. 7. Persons who engage in sampl=ng shall refuse to give a sample to any person whom they know to be under :1 years of age or who, without reasonable identification to'the contrary, appears to be less than 21 years of age. 8. Sampling shall not be conducted in any public place within two blocks of any centers c= youth activities, suc:^h as playgrounds, schools, college campuses, or f=aternitv or sorority houses. 9. Persons who engage in sampl'_ng shall not urge any adult 21 years of age or over to accept a sample i_ =..e adult declines or refuses to acce7:t such sa=ie. 155 LUNG CANCER, CORONARY HEART DISEA By H. J. ProfeE Instit Univer ,farch 10, 1982 I C, I ;, U--xz--tt

d 191 Mr. HORRIGAN. Precisely. Senator EAST. I have no other questions, Mr. Chairman. Senator HATCH. Thank you. Mr. Horrigan, if these statistics are right that polled Americans are unaware, that 60 percent did not know that smoking causes most cases of bronchitis and emphysema, and even 20 percent do not know that smoking causes lung cancer and 50 percent do not know that smoking causes many heart attacks, even assuming that there are other possible health detriments to smoking, if you save just a few hundred, a few thousand or maybe 100,000 lives, it would be worth putting any labels on the cigarette packages, wouldn't it? Mr. HORRIGAN. Mr. Chairman, I think perhaps we should address those particular numbers, and if I may, I will have Mr. Miniard answer. Mr. MINIARD. The problem here in looking at these numbers and interpreting that many Americans are unaware of these alleged hazards of smoking is a problem of interpretation of what they mean. For example, most of these statements that we have before us assume that the person is willing to believe that there has been a direct causal link between smoking and a certain illness. In fact, it seems very likely that people may be aware of the relationship, or the alleged relationship, or aware of the information, but have de- cided that in fact it is not a causal relationship. To give an illustration of that, one of the studies upon which I presume some of this information is based was the Chilton study in which the same people were asked two questions. One question people were asked was whether or not they agreed that heart dis- ease was associated with smoking. For this question, only 10 per- cent of teenagers and the adults that were tested were considered to be uninformed. When we moved to a more causal statement where we say smok- ing causes heart disease, for the same people, we find numbers ranging between 27 and 40 percent. So it seems that the problem here is that we are trying to measure knowledge in an area where we assume that a person does not possess knowledge unless they agree that smoking causes as opposed to smoking is associated with a particular health hazard. Senator HATCH. I see. Well, we thank you for coming. We appreciate your testimony, and we will keep the record open so that you can submit other tes- timony as well. Mr. HORRIGAN. Thank you, Mr. Chairman and Senator East. Senator HATCH. Thank you. It is nice to have you here. With that, we will recess this hearing. [Whereupon, at 12:31 p. m., the committee recessed, to reconvene at the call of the Chair.] Lk

215 - a- associated with smoking. It is imperative that we make every effort to ensure that those who may choose to smoke are fully cognizant of the risks to their health and the health of others which are being incurred by this action. In addition, we would note that the emerging scientific evidence with regard to the addictive properties of tobacco smoking raises new and additional concerns, and that efforts must be made to convey this information to the American public. As physicians, in particular as specialists in internal medicine and its related subspecialties, we are fully aware of the overwhelming scientific support for the range of specific warnings outlined in the legislation before the Committee. As providers of primary and continuing care to adults, we have a strong interest in preventive health measures and in the mechanisms by which health-related information is conveyed. We support the proposed changes in the present labeling requirements for cigarette packages. As we have stated, given the clear and dramatic health risks associated with smoking, we believe that every reasonable effort should be made to accurately convey to individuals the nature of this health risk. We believe that the specificity of the warnings outlined in the proposed legislation will help to emphasize the risk which individuals take every time they smoke. We also believe that it is vitally important to convey to smokers the fact that quitting smoking will reduce the risks to their health. We are pleased to see that under the proposed legislation both messages would be presented. Some might argue that the information conveyed I a H

180 people who are deciding to smoke that "the Surgeon General has determined that smoking is dangerous to your health." Under the proposed new warnings, the logical conclusion would be that the Surgeon General has no longer determined that smoking is gen- erally unhealthy, but only unhealthy for certain older segments of the population or for pregnant women. As an analyst of consumer behavior and decision making, I am of the opinion that A. 1929 may well have the opposite effect of that which appears to be intended by its sponsors. I am concerned that S. 1929,.no matter how laudable the inten- tions of the sponsors, is not desirable legislation if the goal is to have the general population, and especially smokers, aware of the health hazards that are alleged to occur from smoking. Dr. Roger Blackwell 181 Dr. Roger Btackwell is P. State University and a C of Management Horizons, the analysis of buyer beh: ing strategy. Dr. BlackweIl is the co-s Consumer Behavior, the the field. He has written : tng Management, a eoon t keting principles to corpo books incdude Consumer American Attitudes Towar, cations for the Funeral Pi for Marketing Research. I and Strategic Marketing. His Ph.D. is from Northw B.S. and M.S. degrees f: He has served as a Visit Stanford University Grad visiting lecturer in Canad several European countrie: Dr. Blackwell has won a teaching at the Ohio State tant to some of America's served as an expert witnes: mission and other legal prc been quoted in the Wall St Week and other leading bu articles he has written have ing Research. Journal of A Horizons and many other p

209 L~/,1/( pryEOnRESPIRATORYMERAA' 1720nepUaou.PO.0o.75287.Danas.Tx15235(21G)N63540 ~,/ ..,TA~ERKA"A55aiAn the COMPREHENSIVE SMOKING PREVENTION EDUCATION ACT OF 1981 by . JOHN R. WALTON, RRT PRESIDENT , _ As President of the American Association for R come the opportunity to submit a statement for hensive Smoking Prevention Education Act of 19 professional health care organization represen ers across the nation. Respiratory therapy pr suffering from both acute and chronic respirav emphysema, bronchitis, black and brown lung di! conditions that are treated by respiratory ther vated and exacerbated by cigarette smoking. Tt a great concern for the detrimental effects of their patients. As an Association we are also smoking issue often neglected by other organiza sive smoking. - Passive smoking can be defined as the smoke emi cigar, or pipe (side-stream smoke), and the smc stream smoke) which comes into contact with oth Tobacco is a complex mixture of particles, liqu a variety of toxic and hazardous compounds when nicotine, carbon monoxide, cadmium, nitrogen di dehyde, hydrogen sulphide, are among the most they are non-smokers or smokers. Non-smokers need to be aware of the disturbing higher concentrations of noxious compounds than smoker. For example, side-stream smoke can hav. chree times as much 3-4 benzpyrene, five times . tines as much ammonia as mainstream smoke does.

174 - 5 - Perhaps most significant is that many of the survey measures assessed beliefs rather than awareness. The distinc- tion between belief and awareness is a critical one given the existing controversy over the health threats presumed to be posed by smoking. Consider the likely situation of a survey participant who recognizes that smoking has been foimd to be associated with particular health problems but finds the evidence insufficient for demonstrating that smoking causes these health problems. Thus, the person is aware of the claimed link between smoking and some health problems but does not believe that smoking causes the problems. As stated in the 1980 Burke Mar- keting Research Focus Group Study commissioned by the FTC: "Further doubt about the direct relation- ship of smoking and cancer seems to be related ,to the fact that these persons had known smokers who had lived long lives without contracting cancer and non-smokers who had suffered from that disease." (Burke Study Analysis at p. 4.) Many of the measures employed in the studies asked the respondents to indicate their agreement with or the correctness of statements such as "smoking causes X." Respondents who disagreed with these "supposedly true" statements are categorized as unaware. Alternatively, these respondents may be aware of the medical evidence but have concluded that while smoking is "related" to X, it does not "cause" X. Evidence supporting this alternative explanation is provided by the 1980 Chilton study conducted for the FTC Staff. At one point survey participants 175 -6- were asked whether heart disease "had with cigarette smoking." (Question 4 agers and 9.3% of the adults intervie (i.e., "No" and "Don't know" response these same persons were asked'whether smoking is a major cause of heart dis true or false. 26.8% of the teenager were presumed to be "unaware" of the c statement. Such response variations ' the same disease, but which differ in the cause of or simply associated wit' suggest that many persons classified < aware of smoking's asserted relations) risks. These persons simply do not bf these health problems. Question wording has long bE area in survey research. The FTC Sta: ". . . conservative sounding statement more likely to generate agreement .- By the same token, statements employir phrases are likely to inhibit agreemer agreement with the statement "smoking cause of lung cancer" used in the 198( lower than had the statement been phrz cause of lung cancer." Wording ambigc response patterns to a question. Phre in the Roper Study such as "by far," " ~ W ~ 0 ~ ~ co 00

203 James C. Miller, III Chairman Federal Trade Commission Page Two concerning the competition between the dangers of cigarette smoking and the attractive modeling and glamor of cigarette smoking. The Bethesda Conference Report embodies many of the concerns enumerated in th e FTC Report, specifically the need to have credible information provided in a manner which will be believed and which will provide eicher positive behavior modification or prevent initial negative behavicr. The College believes that there has not been sufficie.^.t tine permitted for us to provide the breadth of i,put `r= the various comoonents of the College, particularlv the Preventive Cardiovascular Disease Ccmmittee, on these recomme.n.dations to allow us to acre fully address this issue, which we consider to be of Dara.:.ount i=zcrtance. P'_ease be assured that our additional views will be rc:•='_ec to vou as soon as oossible. In addition, we will s'c.ara with the FTC our cemments on current and nrceosed lecislazion on this subject. We trust you will find these f..c___ ....-n e: _s of assistance. Please let me or Roger C. Ccurtne,7, J.D., of Goverament Re'_aticns, know if u n--- assistance on this or any other matcer~ Sincerely, Dan G. McNamara, M.D., F.A.C.C. President DGX: cs Enclosure ACC Director 95-077 0-82-14

186 OTHER PUBLICATIONS: Roger 0. Blackwell,"The Public Relations Effects of Pricing Policies'; Public Relations (4th Quarter, 1967), 1-10. Roger D. Blackwell, "The Consumer Image of Funeral Pricing," Ohio Spot Release (July 1967). 6-8. Roger D. Blackwell, "STudent Survey of Funeral Purchase Decisions," Ohio Spot Release, (March 1968), 5. Roger 0. Blackwell, "The Product of the Funeral Director," Journal of Funeral Service (Jan-Feb. 1969), 6-8. Roger D. Blackwell, "Public Relations and the Consumers' Need for Information," Public Relations (First Quarter 1969), 1-9. James F. Engel and Roger D. Blackwell, "Understanding the Consumer: Your Key to Profit in the 1970's," Public Relations (Second Quarter 1969), 1-11. Roger D. Blackwell, "Management of Apartments in the 1970's," Journal of Homebuilding. (December 1969), 84-86. Roger D. Blackwell and James F. En el, "The Image of the Osteopathic Profes- sion," Osteopathic Physician, ~November 1969); 13-20. Roger D. Blackwell and David T. Kollat, "Strategic Marketing to the New Consumer," Building Supply News, (October 1971), 97-101. Roger D. Blackwell and W. Wayne Talarzyk, "Market Segmentation in the Funeral Profession," Mortuary Management (January 1975), 32-33ff. Roger 0. Blackwell and W. Wayne Talarzyk, "The Return-On-Investment Approach to Funeral Pricing," a two-part article in The American Funeral Director, March & April 1977. Roger 0. Blackwell, "Lifestyle Radio: Waves of the Future?" Radioactive (April 1980), 16-17. Roger 0. Blackwell, "The Effects of Changing Lifestyles on Careers in Business," OEA Communique (April-May 1980), 4-6. Roger 0. Blackwell, "Changing Lifestyles," Credit Union Marketing (Summer 1981), 4-8. O W ~ ~ . ~ --0":, O 187 The CHAIRMAN. Now, you have II unnecessary because over 90 perceni smoking is harmful. If this is so, it i: ing label required by legislation, oi people. Now, how could this effort to i: health consequences be counterprodl: Mr. HORRIGAN. Mr. Chairman, tc nublic health, from a marketing vie talking about delivering a message, our experience is that there is a grE single mindedness versus clutter. V know, to advertise on television, but greatly about the millions of dollars cials surrounded by other commerch therefore their message is diffused. ness in effective marketing. What you in effect have here is a v( been proven over the years, and we h of your own sincere intentions, you v ter, let alone the chaos that would exi The CHAIRMAN. In your testimony, Smoking Prevention Education Act i: to conform and to encourage prohil course, I think everybody here today I desire to have prohibition of smokinl public. Now, I do not know whether this 1 be forcing or prohibiting smoking, b, intent. You indicate 30 highly qualified a,, ready to appear and challenge the sc Yet, I think the overwhelming majoi the world accept the conclusions of tl their efforts linking cigarette smoking Now, how do you account for the sl among these various scientists? Mr. HORRIGAN. First of all, Mr. Chan jected myself this morning in these mE proceed to answer in a scientific wa, make this opening statement, that ju here, an eminent physician said that, ir that does exist, and that is a fact, after . To answer your question and to add ~ (ike to turn the question over to Dr. Sor. The CHAIRMAN. Dr. Sommers? Dr. SOMMERS. Mr. Chairman, the key Ology, indeed, shows a strong statistical ing and a variety of diseases, but epide nique that can never prove cause and ef Cause and effect have to be proved animal experiments and in vitro expe been achieved. 4 .~' a5-u~7 0-82---13

171 _ 2 - ,My name is Roger D. Blackwell. I am Professor of Marketing at the Ohio State University, specializing in the analysis of buyer behavior and development of marketing strategy. My Ph.D. degree was earned at Northwestern University, with a concentration in consumer behavior. I have authored or co- authored fourteen books and over fifty articles published in professional or business journals that report research that I and others have conducted concerning the communications pro- cess, consumer decision processes involved in buying and using goods and services, and variables involved in marketing strategy. One of my most recent books is the fourth edition of Consumer Behavior, published this year. The book describes psychological principles involved in buying and consumption and is the most widely adopted textbook in the field. A complete list of my publications is submitted with this statement. This is my personal statement and should not be con- strued to reflect the views of the Ohio State University or any other institution with which I am or have been affiliated. ' I have been asked to analyze Section 5 of S. 1929, which would change the present labeling requirements for cigarette packages and advertisements. The rotational system of warning statements proposed by Section 5 of the bill is similar to a recommendation made last year by the Staff o.f the Federal Trade Commission in a Report on cigarette advertising, and I have evaluated the findings and conclusions of that Report as well. In my opinion, the change proposed by Section 5 is fundamenta: labeling provisions of Section 5 wot ful program of informing consumers a risks of smoking with a program of c counterproductive consequences. All about consumer awareness of smoking the conclusion that people are unive that smoking is hazardous to health. in favor of a course that is not onl to demonstrate, likely to lead to re those apparently intended by the bil The other basic flaw in Se of rotated warnings attributing spec smoking will probably lead to one of either consumers will erroneously be sonally suffer the specific health p warning statements, even though such minority of the smoking and nonsmoki the warnings would be deceptive; or perceive that only a small proportio. risk from the stated health problems that the Surgeon General and other h. decided that smoking is not hazardou. appears that the specific diseases ic warning systems apply primarily to o:

American College of Cardiology Americaa Medical Association Acerican Association For Respiratory Therapy American College of Physicians . American College of Chest Physicians Action on Smoking and Health Bakery, Confectionery and Tobacco Workers International UnionDoeingo M. Aviado, president, Atmospheric Health Sciences, Inc. Cigarette Smoking of Pregnant Women by Bea J. van den Berg Feter L. Berger, professor, Boston University Fndger L. Bick, M.D., medical director, San Joaquin Hematology & Oncology Medical Group :7eodore H. Blau, Ph. D. 'Walter M. Booker, Ph. D., president, Walter M. Booker & Associates, Inc. Oliver Gilbert Brooke, M.D., FRCP, Department of Child Health, St. George's Hospital, London Farbara B. Brown, Ph. D. Victor Buhler, M.D., pathologist, Kansas City, Mo. Jack Matthevs, M.D., Fbteritus Professor of Surgery, University of California at San Diego 3hervia J. Feinhandler, Ph. D., president, Social Systems Analysts, Inc. . r_3vin R. Fisher, M.D., professor of pathology, University of Pittsburgh School of Medicine .. Russell Fisher, M.D., Fbleritus Professor of Pathology, University of Southern California jean Dickinson Gibbons, professor of statistics, University of Alabama Fatherine McDermott Herrold, certified pathologist Artbur Furat, Ph. D., Institute of Chemical Biology, University of San Francisco aichard J. Hickey, Ph. D., senior research investigator, department of statistics, Wharton School, University of Pennsylvania :lmcan Hutcheon, M.D., D. Phil., departments of pharmacology and medicience, Hev Jersey Medical School `.eos 0. Jacobson, University of Chicago Lawrence L. Kupper, professor of biostatistics, School Of Public Health, University of North Carolina at Chapel Hill BSrsm Thomas Langston, M.D., clinical professor of surgery (emeritus), Northwestern University Medical School S. C. Llttlechild, B. Com. Ph. D., professor of commerce, University of Birmingham Eieanor J. Macdonald, professor emeritus, department of cancer prevention, University of Texas System Cancer Center, Houston, Tex. John E. 0'Toole, chairman, Foots, Cone & Belding Communications, Inc. L. G. S. S. Rao, Ph. D., Bellshill Maternity Hospital, Bellshill, Scotland, U.K. Dr. Jsy Roberts, professor and chairman of the department of pharmacology, Medical College of Pennsylvania, Philadelphia Henry Rothchild, M.D., Ph. D., professor of medicine and anatoay, Louisiana State University Dr. Henry I. Russek, practising specialist in the filed of cardiovascular disease Bernice C. Sachs, M.D., Seattle, Wash. G. N. Schrauzer, Ph. D., La Jolla, Calif. Dr. Carl C. Seltzer Sheldon C. Sommers, M.D. Theodore Sterling, University Research Professor at Simon Fraser University, Burnaby British Col mmbia Yoram J. Wind, professor of marketing, Wharton School, University of Pennsylvania Tobacco Institute, theRobert Casad Hockett, research director. Council for Tobacco Research-- U.S.A., Inc. Charles D. Spielberger, Ph. D., University of South Florida, Tampa, Fla. (193)

196 Mr. Chairman and Members of the Committee Page Two cular disease. It is in my capacity as President ..:vrH of the College that this statement is made on _.. ~ ; S. 1929, the "Comprehensive Smoking Prevention Education Act of 1981." One main concern of the College is whether consumers;-' receive sufficient and accurate information on the 5o~ demonstrated relationships between cigarette smoking and cardiovascular disease. The College believes _. : that consumers are provided with insufficient infor-. mation on the demonstrated relationships between cigarette smoking and cardiovascular disease and that this lack of information weakens a physician's role in altering a patient's smoking behavior. As the Federal Trade Commission noted in its "Staff Report on the Cigarette Advertising Investigation" (May, 1981), which we commented on (attached), "substantial portion of the public remains unin- formed about the hazards of smoking," and that FTC tests "indicate that the (current) warning is neither noticed nor read by the vast majority of people." Even though the current warning indicates that the Surgeon General has determined that cigarette smoking I is dangerous to one's health, 17% of all s:^okers and 24% of heavy smokers do not know that smoking 197 'hairman and Members of th. 3.-e Three _5 :zazardous to health. Addit: _i-::sumers themselves agree tha- -irning is inadequate. -;hv not provide the public wit: ;•. ality of information sought? -...-es, nearly "two out of ever<. __=_ng the 1978 Roper survey fc r.stitute, believe that the cui - "adequate" and indicated tt :-alth warning that describes t =_sks of smoking." '% 1973 Gallup survey of smoker; :_und that 32% were not aware c ;~iationship between cigarette -ttack; that 37% of smokers dic ---~Iationship; and that among he ==' not know the increased ris} Isscciated with cigarette smok: 3=udy, conducted by the FTC, fc '_neral oopulation and 31% of < `::at smoking greatly increased -'tack despite research that cc -~:=s a person's risk of hea: consumer knowledge of tht -:7arette smoking, birth contrc

I 219 Senator Hatch and Members of the Committee: I am Dr. Thomas Petty, Professor of Medicine and Anesthesiology, Head of Division of Pulmonary Sciences, University of Colorado Health Sciences Center. I am also the President of the American College of Chest Physicians, a professional medical specialty society of more than 11,000 physicians, scientists, and educators who specialize in diseases of the heart, lungs, and circulatory system. It is in this latter capacity that I express our support for S.1929, "The Comprehensive Smoking Prevention Education Act of 1982." As pulmonary and cardiology specialists, we have seen first-hand the significant health problems associated with smoking and recognize that we are in a unique position to influence our patients to forego smoking in the first place and to stop smoking when health conditions so require. Accordingly, as a society committed to post-graduate medical education, we have viewed the education of physicians (who in turn educate their patients) on the smoking problem as one of our highest priorities. -- In 1968, the College supported in conjunction with the National Clearing House for Smoking and Health,a national forum on office management of smoking. The procedures of this conference were published in CHEST, the official journal of ACCP. -- ACCP joined the National Cancer Institute in the preparation of a correspondence course on smoking and its relationship to chronic obstructive lung diseases and asbestosis. This course was mailed to tens of thousands of primary care I I 0 95-077 0-82--15

176 - 7 - "significantly increases," are very subjective. For example, some people may perceive a 30% risk increase as a significant increase, while others may not. It is interesting to note that the FTC Report cites evidence that people tend to ignore or discount statistical information in making judgments. (Report at pp. 4-14 and 4-15) Given this evidence, it seems inconsistent to employ measures of "statistical knowledge" for assessing the level of awareness concerning the claimed effects of smoking. Measures of this type, however, were frequently employed as indicators of con- sumers' awareness about the asserted dangers of smoking (e.g., "What percent of lung cancer cases are caused by cigarette smoking?" - Chilton 1980; "Smokers are at least ten times as likely to develop lung cancer than non-smokers" - Roper 1980). For these reasons, it would appear that current studies have underestimated consumers' awareness about the health hazards associated with smoking. There is, unfortunately, no way of predicting how much underestimation error exists in these data. But in view of the fact that these same studies consistently report awareness levels in the 80 to 90 percent range, it is fair to conclude that public awareness of the various claims about smoking and health is as a practical matter universal. It would be wrong to conclude that consumers are not adequately informed about the claimed health consequences of smoking simply because many consumers continue to smoke. The FTC Staff Report states several times that smokers are not as 177 - 8 - well informed as nonsmokers, implyinc differences are responsible for the d smoke. That conclusion is flatly ref Study, the very study cited by the FZ supposed difference in the levels of and nonsmokers. The conclusion reach as follows: "Factual knowledge abc consequences of smoking was be significantly related to behavior. No more differen knowledge levels of smokers non-smokers were found to t at the 0.05 level than were by chance." (page 22) This important finding that relationship to smoking behavior reft who smoke do so because they are "uni dangers of smoking. The lack of a re ness and smoking also demonstrates th awareness about the health hazards at unlikely to influence their smoking t the extent that the present bill is t smoking -- and putting aside the ques modification is an appropriate goal f country -- the warning statements prc simply irrelevant. - Given these facts, a change by Section 5 should not be undertaker evidence that the proposed system of

212 STATEMENT OF THE AMERICAN COLLEGE OF PHYSICIANS on S. 1929, the "Comprehensive Smoking Prevention Education Act of 1981" Mr. Chairman and Members of the Committee: The American College of Physicians (ACP) is pleased to have this opportunity to provide its comments on S. 1929, the "Comprehensive Smoking Prevention Education Act of 1981." As you know, the College represents over 54,000 doctors of internal medicine, related non-surgical specialists, and physicians-in-training. The ACP membership includes private practitioners delivering primary health care; medical specialists in such fields as gastroenterology, endocrinology, oncology, and cardiology; medical educators; and researchers. The legislation presently before the Committee seeks to establish a new strategy for educating and providing information to the American public about the hazards of smoking. It would thereby allow members of the public to make more fully informed decisions as to whether they will choose to smoke. The American College of Physicians strongly supports the central purpose of the legislation and believes that 213 -2- such an effort represents an important and ar initiative -- an initiative which we believe health interest of this Nation. - We concur in the scientific finding that ciga important preventable cause of illness and pr In particular, the American College of Physic most recent report of the Surgeon General, "TI Smoking," both warrants and requires the full and policy makers concerned with the protectic We believe the statements that "cigarette smok cause of cancer mortality in the United States single action an individual can take to reduce effectively than quitting smoking" lend strong efforts to more fully infono the public of the smoking. flespite statements of some to the contrary, th dispute with regard to the numerous health haz Cigarette smoking is a major cause of cancers and oral cavity. Smoking is a contributory fac urinary bladder, kidney, and pancreas. It is i bronchitis and emphysema and a major risk factc and arteriosclerotic peripheral vascular diseas to smoking are in excess of 300,000 annually. for one out of four of all cancer deaths and it thirty percent of all cancer deaths are attribu

200 Mr. Chairman and Members of the Committee Page Six of information on the research being supported .,.;. by different agencies, this would be useful. If, however, the purpose is to provide the Office ~ of Smoking and Health with authority to direct the research of Institutes, the College believes ~ it would be counter-productive and undesirable. However, authority to conduct types of research that do not fall clearly under the authority of the categorical Institutes could be appropriate for the Office of Smoking and Heal th. Examples of such would be in monitoring national trends of cigarette consumption in different age groups, surveillance of the composition of tar, nicotine, carbon monoxide and other potentially harmful constituents of cigarettes and maintaining the periodic reporting of new research findings. In addition, the College also believes that the Congress should review all the current material on the connection between cigarette smoking and the costs to society through increased medical costs and reduced productivity in order to provide a basis for furtaer cigarette smoking prevention efforts. 201 Chairman and Members of the ~ ?age Seven I trust that these comments that ;upport for your efforts in this assistance to you and the Committ te pleased to provide you with ar tance.

209 As President of the American Association for Respiratory Therapy (AART), I wel- come the opportunity to submit a statement for the record of S. 1929, the "Compre- hensive Smoking Prevention Education Act of 1981". The AART is a 23,000 member professional health care organization representing respiratory therapy practition- ers across the nation. Respiratory therapy practitioners deliver care to patients suffering from both acute and chronic respiratory diseases. For example, asthma, emphysema, bronchitis, black and brown lung diseases, are among the most common conditions that are treated by respiratory therapy. These conditions are aggra- vated and exacerbated by cigarette smoking. The respiratory therapy community has a great concern for the detrimental effects of cigarette smoking on the health of their patients. As an Association we are also concerned with an aspect of the smoking issue often neglected by other organizations, that is the hazards of pas- sive smoking. Passive smoking can be defined as the smoke emitted from the end of a cigarette, cigar, or pipe (side-stream smoke), and the smoke exhaled by the smoker (main- stream smoke) which comes into contact with others. Tobacco is a complex mixture of particles, liquids, and gases, which combine into a variety of toxic and hazardous compounds when burned. Compounds such as tar, nicotine, carbon monoxide, cadmium, nitrogen dioxide, amnonia, benzene, formal- dehyde, hydrogen sulphide, are among the most dangerous to the individual whether they are non-smokers or smokers. Non-smokers need to be aware of the disturbing fact that side-stream smoke has higher concentrations of noxious compounds than mainstream smoke inhaled by the smoker. For example, side-stream smoke can have twice as much tar and nicotine, three times as much 3-4 benzpyrene, five times as much carbon monoxide, and fifty times as much ammonia as mainstream smoke does.

-5- by the proposed warnings is too graphic, but we would counter that the scientific evidence underlying these warnings is also quite graphic. We believe that the specificity of the warnings and their prominence on the packaging materials will provide an important adjunct to our efforts as health professionals to counsel patients in maintaining sound health and reducing the risk of preventable disease and illnesss. Some have argued that there is not sufficient evidence of the "effectiveness" of the proposed system of rotational health warnings. However, we believe that such an argument is without merit in the face of such substantial and clearcut evidence of adverse health effects and premature mortality, and in view of the tremendous social costs associated with smoking. It is our belief that this preponderance of evidence carries with it a responsibility and in fact a duty to warn the public regardless of whether statistics are presently available which indicate that the public will in fact heed this warning. We also believe that in the interests of sound international health policy -- and in keeping with a longstanding commitment to being cognizant of the health needs of all people -- warnings should appear on all cigarette packages produced and manufactured in this country, irrespective of where they are ultimately offered for sale. In addition, we support the provisions included in the proposed legislation which would require that nicotine, tar, and carbon monoxide levels be disclosed. We also support efforts to require that information be provided to the Federal Trade Commission and the Department of Health 217 and Human Services with regard to those ct manufacture of cigarettes and the quantit'. At the present time it is extremely diffic risks of cigarette additives because of tt Those listings of additives which presentl specific in terms of the types and quantit being used. The presently unknown health must be explored and such an assessment ca scientific community has access to more ca growing national concern with toxic substa with regard to the possible synergistic ef believe that a national compendium of info should be considered if we expect to be ab health risks. In conclusion, Mr. Chainnan, we support eff of the health hazards, including the incre: associated with smoking. As public policy the importance of individual efforts at dii we believe that it is essential that indivi on the risks associated with smoking. It i this Committee will substantially enhance c to convey vitally important scientific infc The American College of Physicians is pleas efforts and is available to respond to any

194 195 Dear Mr. Chairman and Members of the Committee: ..r«« DAN G ucNAMAM, N.D- F~Ma SULW.YE B NNOEBEL. M.0 N~.IN...r F.uN~y ROBERT 0 BRANOENBURG. M D. ........ EBERT MO ~.. wr. JDNN w wALaNAUSEN. MD JMM..N..p.W, .DOLPN M NUnER. JR., M.U JWY. 1....« ANES J EONARO M D CW.vI bw. N Cwxmn GOTTl-EB C FRIESINGER. N. M D. n.r... ALTER N ABELMANN. N D ROBERT 0. 9RANDEMBURG. M.D. DAVID 9 CARMICN.EL.J .. M.D. LAWRENCE S. COHEN. M.O. ROBERT D CONN. M D TNOMAS C 01cNINSON M.D LEONMD S DREIFJS. N D. YAUL J. EBERT. M D. ROBERT S EIIOT, M D. GOTTLJEB C FPIESmGER. U. Y O. B LEONARO NOLMAN. M 0. J. O'NEAL N nRiES M D. ADOLPN Y NtRTER.JR. M 0. PRANCIS J RLOCNE. M.D. BUZANNE B RNOEBEL M D JAMES J LEONARD M D. ROBERT J LUCNL MD DWIGNT C McG00N. M.O OAM G McnA.MARA M D CHARLES B. MULIINS. M 0- WILLIAM W P RMLEY. M D. VICTOR PARSONNET, M.D. JOHN N. PHIILIPS. M D CNAFLES E. RACKLEV M.O. DONALD E 5 UN'DERS JR. M 0. JALR P. SEGAL. u.0. ' BOATS SURAWICZ. ND. JOHN A WALONAUSEN M 0 RNOLD M. WEiSSLER. M0. JONM F. WILL/AMS. JR . N 0 tueMl.. Dlsl« WILLIAM 0 NELLIGAN. CAE awNr E.s.B.. Ur«Nr - WIILIAM D COUGNLA.V. CAE AseIN. Ese1W. BN.cla 00MALD J.JABLONSNI American College of Cardiology HEART HOUSE 9111 OLD GEORGETOWN ROAD BETHESDA. MARYLAND 20814 (301) B97-540D STATEMENT on S. 1929 "Comprehensive Smoking Prevention Education Act of 1981" of Dan G. McNamara, M.D., F.A.C.C. President to Honorable Orrin G. Hatch Chairman Committee on Labor and Human Resources March 16, 1982 I am Dan G. McNamara, M.D., F.A.C Pediatrics and Chief of the Card: Baylor College of Medicine and Te Hospital. I am also President of College of Cardiology, a professi cialty society representing over scientists and educators who spec of the heart and circulatory syst cated to ensuring optimal care fc cardiovascular disease and those for developing cardiovascular di- educational and socioeconomic act bute significantly to the prevent

[F 223 -s- the claims of the tobacco industry that there does not yet exist a scientific causal link between cigarette smoking and major cardio-pulmonary health problems, the evidence is quite clear. Government intervention in the marketplace is desirable when the problem is one of national scope, when the costs of regulation are clearly outweighed by benefit to society, and when the government can perform a function not assumable by the private sector. A visible governmental commitment -- or recommitment -- to the eradication of smoking is clearly required. ne believe that the passage of S. 1929 will do much to assist we practitioners in educating the public regarding health risks involved with smoking cigarettes. We would like to focus on each of the major provisions contained in this legislation. 1. We'support the establishment of a program to inform the public of the dangers to health from cigarette smoking. The voluntary sector cannot bear the entire responsibility for educating the public on the risks of smoking. The high cost of advertising and the volume and influence of cigarette advertising are major deterrents to voluntary efforts. The establishment of an Interagency Committee on Smoking and Health to coordinate research and educational efforts of the Federal Government and private sectors will help to avoid duplication of research already being conducted by NIH or other Federal agencies. It is important that the NHLBI and NCI, as well as the other Federal agencies you have mentioned, be represented on the Interagency Committee. I

211 3 3.•Individuals suffering from asthma can severely aggravate their condition by exposure to cigarette smoke. . . 4. It can damage the action of cilia, the microscopic hairs that line the air- ways of the lungs. 5. In healthy, nonallergic people it has been shown to cause eye irritation, sneezino, coughing, sore throat, hoarseiss, headache, and in some cases more serious side effects. As more research is conducted and the results tabulated the evidence on the neg- ative effects of passive smoking mount. It has already been shown to be extremely toxic, harmful, and carcinogenic. The public must be made aware of the harmful effects of this habit. The blll 5.1929, makes great progress in educating the pub- lic on the specific dangers of smoking. We urge the Senate Committees,when amend- ing this bill,not to neglect the serious and often overlooked are of the passive smoker. In addition, the Office on Smoking and Health must recieve adequate and steadfast government commitment relevant to this entire issue. Committee members and gov- ernment officials must not allow political considerations and pressures from the tobacco industry to negatively sway or change their opinions on an issue and pro- duct that contributes to over 300,000 premature deaths and over 25 billion dollars in lost productivity each year. _ Research and public education must continue and increase markedly if we are to have any hope of reducing the tremendous social expense, irritation, suffering and death from the most preventable cause - cigarette smoking. REFERENCES 1. White,J.S. , Froeb,H.F., "Small Airways Dysfunction in Non-smokers Chronically Exposed to Tobacco Smoke", New England Journal of Medicine, 302: 1980, 720-723. 2. Hirayama, T., "Non-smoking Wives of Heavy Smokers Have a Higher Risk of Lung Cancer", British Medical Journal, 282: Jan. 17, 1981. I I I

218 Testimony of THE AMERICAN COLLEGE OF CHEST PHYSICIANS Submitted by Thomas L. Petty, M.D., F.C.C.P. President regarding S. 1929: "The Comprehensive Smoking Prevention Education Act of 1982" Senate Labor and Human Resources Committee Senator Orrin G. Hatch, Chairman March 16, 1982 219 cator Hatch and Members of the Committee: I am Dr. Thomas Petty, Professor :d of Division of Pulmonary Sciences, Un: alth Sciences Center. I am also the Pree ,.;ilege of Chest Physicians, a professiona= :iety of more than 11,000 physicians, sc' ...o specialize in diseases of the heart, 1L .~em. It is .in this latter capacity that r S.1929, "The Comprehensive Smoking Pre•. As pulmonary and cardiology speci . ::t-hand the significant health problems : recognize that we are in a unique posit --:ents to forego smoking in the first plz .~._n health conditions so require. Accordi ._.^,itted to post-graduate medical educatic education of physicians (who in turn ec c: the smoking problem as one of our highes -- In 1968, the College supportec :7ational Clearing House for Smoking anc `,,rum on office management of smoking. Thc .erence were published in CHEST, the of1 -- ACCP joined the National Cancc -'~ the preparation of a correspondence cou: r-,lationship to chronic obstructive lung d :',is course was mailed to tens of thousandi 95-077 0-82--15

132 But when we say preventable, for example, just throwing in that adjective, which greatly ups the scientific ante here, how do we know, as a matter of science, that it is easier to prevent smoking than other relative health problems? How could we say that with assurance? First I hear scientists in here saying it is addictive and it is verry difficult to give up; then I hear scientists coming in and saying, `Oh, it is the most preventable"; suggesting it is easy and ou just stop doing it. y I am not saying who is right or who is wrong. What I aIn Now , saying is, it strikes me that when you move into an area of this kind, and science seems to be butting heads, and words are being used rather casually, getting back to my fundamental concern about scientific causation, whether, the scientific community arid the medical science community here have not been unwittingly ulled into a great political movement of some kind that has great p political currency with some individuals and groups in parts of thel! country, getting back to the need now to maintain the integrity of;~ science, I query whether we are not getting a little casual here with wording. "Preventable": are there scientific studies showing *- that it is easier to give up smoking than to, say, throw away the ~ saltshaker or to give up sugar or to do this or that or the otheii., thing or to correct driving practices? I am just curious. I am not,; saying what my conclusion would be. I am just troubled with scien:~ tists coming in and proclaiming findings, when in fact, in their sci-,~ entific heart of hearts, they would say, "Oh, well, we don't really~ ` that's politics n that" it . ; e mea qu I think science has a separate responsibility here, and that is tu~ maintain its integrity, maintain its commitment to that which is, demonstrable and provable with data and quantification. When I- see adjectives sprinkled through and I see pieces of legislation here~ with grandiose conclusions of that kind, I wonder if there is the sci:, i- l ~ col entific evidence to back it up or whether it is not just casua clusions that further a cause. ~ What would be your response? This word "preventable" I do find; ..~a< intriguing. I feel that everyone who has MAISTRE Senator East L D , E r .. tempted to respond to that question has acknowledged the credib our position from the standpoint of the quantitative as of it y y of whether it is easier to prevent this or that. Clearly, it is not, ' to easy task to prevent cigarette smoking. We have been trying, h I4 i c wh certain knowledge and involvement in this, since 1962, 'r uestion ted in this it b . q neres ecame The original Surgeon General's Committee that reported in 1 ^ ed the same kind of thought process that you are r i enc exper . ~ through now. If you will go back and look at the committee s 6* clusions, the strong causal relationships were drawn to reflect tM evidence available at that time. Therefore, although the evideA "A& hly s was highly suspicious for cardiovascular disease and hig f we focused of the causality in the ulmonary disease or ious or , p c tionship with lung cancer, primarily because that is where the " o at that time d us to ll ll . g owe y a dence rea add9a b h een as other evidence Progressively, over the years, Indeed, because of the publication of that report, in 1964, 18 lion Americans who had been smoking no longer smoked. ~ 133 %vere carefully followed as cohorts of thc and that today still provides the best e• ing decreases the risk of heart attack. pies by which one can bolster each c based on epidemiologic data. These dat, data, which I consider exceedingly soul this country and prospective data in wl- ied. Both enhance the integrity of the sc Coming to your specific point, unti health education in our schools of hiI t i1 rough 12, in my opinion, that allows i yiiainted with the known facts, there wi yuestion about how preventable this reE cal application. But, theoretically, it shot '1'he tragic consequences extend far be to«•n, we had a very tragic fire involvinp Iam closely associated only a few weeks c;;;arette. Over one-half of the hospital f e,y e, _v day, and over one-half of the fatal ci~arettes. That evidence is irrefutable h oi fires are usually determined. So these factors come together for soma life that should be acceptable to the Am 1ie ve, as a teacher, that young people can Ic'niy associated with cigarettes in terms the truth. I have sufficient respect for coLntry to let them make their own deci: bein,_, ill and of dying they are willing rivht to choose those risks, just as I do. here today, and that was an unnecessar token, I think that it is not a question o: Pre"ention. We are now preventing some . up the habit through better information e Senator EAST. But, you see, in the legis ~~on~rress finds that," meaning a scientific prE've ntable," and you are suggesting tha "I a supposition really is not scientific fact Vor example, let's say we determine i that it is not easy to prevent smoking; th puhlic policy-I am just hypothetically t',,%'<,rnment would acknowledge, well, we ~mtE ing, I'll tell you what let's do. Let's tr ~•ou see, because it isn't preventable t9 c'`'t people to stop. OTHER THINGS ~t~ be easier to get people to chan, t~• tgain, the ones I have worked over t r1i,trition, exercise, the whole phalanx of tl a composite for good health practic "E l I, this is easy to do, it is preventa' ~~`r" more preventable than these other %n`i"'~s show that it is not, why not direct 0360'7600

213 -2- such an effort represents an important and appropriate governmental initiative -- an initiative which we believe is clearly in the public health interest of this Nation. We concur in the scientific finding that cigarette smoking is the single most important preventable cause of illness and premature death in the United States. In particular, the /4nerican College of Physicians believes that the most recent report of the Surgeon General, "The Health Consequences of Snoking," both warrants and requires the full attention of health professionals aod policy makers concerned with the protection of the public health. We believe the statements that "cigarette smoking is the major single cause of cancer mortality in the United States" and that there "is no single action an individual can take to reduce the risk of cancer more effectively than quitting smoking" lend strong suport to this Committee's efforts to more fully inform the public of the health risks attendant to smoking. Despite statements of some to the contrary, there is no scientific dispute with regard to the numerous health hazards presented by smoking. Cigarette smoking is a major cause of cancers of the lung, larynx, esophagus, and oral cavity. Smoking is a contributory factor in cancers of the urinary bladder, kidney, and pancreas. It is a major cause of chronic bronchitis and emphysema and a major risk factor for coronary heart disease and arteriosclerotic peripheral vascular disease. Estimated deaths related to smoking are in excess of 300,000 annually. Lung cancer alone accounts for one out of four of all cancer deaths and it is estimated that at least thirty percent of all cancer deaths are attributable to tobacco use. I ® 4

225 -7 - veriod will aid in efforts to get more up-to-date information to the public in the future. Varied warnings will also promote greater dialogue between physicians and their patients regarding smoking. 3. We strongly concur that advertising information and cigarette packages should be required to identify the carbon monoxide yield of cigarette smoke as well as the content of tar and nicotine. Carbon monoxide is one of the most harmful ingredients of cigarette smoke, in that it reduces the blood's ability to carry oxygen to the cells. Carbon monoxide is particul3rly harmful to pregnant women and may also be a critical factor in coronary heart disease, sudden death, atherosclerosis, and chronic respiratory diseases. 4. S. 1929 should be amended to conform to provisions in the companion House legislation (H.R. 5653) which increase the civil penalties for violation of the new labelling requirements outlined in the bill. In conclusion, we feel that the evidence of the need for a national education effort on the hazards of smoking is over- whelming. Study after study has established the link between smoking and lung cancer, cardiovascular diseases and many other disorders. Consumers do not have all of the facts to make an educated choice between not smoking and smoking. Cigarette manufacturers spend $1.0 billion on advertising their products each year, or 50 times the amount expended on public education The statutory establishment of an Office on Smoking and Health will insure a I 0 0 I 0

131 everi mec of have ificre e 0 on the'`, - il.e .d reassu .izards a, blem ~ the' ,ason,i hese ticular, ~ bi11, r there is the Iited Sta iands of` noking' ~~ ; . ~° ~;._r • , a- = ® 0 ® 0 ~ )r thelr erved o: I 1964 ; 0 0 randaA2 .. vlth the , 6 rlJ ' ' lence -of scieti mt on' No au® I could4` ;ay thO ' believe = will foY1~ t kind of r the ot isclosure lot comi )day. ~" ming lab"e cant redu 0 ® g , :04 at rotati~ disease"o pregnant o might bE - or has alx me famil °ette paclC- s, I do be- Pre it will have a specific impact and aid in an intelligent deci- Wn by those who choose to read it. a The CHAIRMAN. In your opinion, how would scientific research be Wed by having tobacco companies provide information regarding e chemicals used in the manufacture of cigarettes? Now, you 4 lore indicated that that would be very helpful, and we have had ~r. Holbrook's testimony. Dr. LeMAISTRE. In the bill before the Senate, the disclosure, on a iloafidential basis in order to protect trade secrets, would allow at pletst the certain knowledge of what is being added. Those sub- (st.nces then could be the subject of research to find out, as Dr. : jlolbrook so well stated, the consequences of burning them at be- preen 800 and 1,000 degrees-the pyrolysis that changes those products to determine whether they are indeed harmful or not and ~ whether the harm comes from the fact that their consequences ~' effect the lungs, or heart, or contribute to cancer. ' lndeed. that might encourage the tobacco companies to find safer additives. The CHAIRMAN. In your testimony, you indicated what you de- lcribed as special treatment of tobacco companies and products. v How do you account for that? What do you mean by that? Dr. LEMAISTRE. I have no knowledge, as Senator East mentioned earlier, of the political complexities that overwhelm many of us, and I agree with him. Sometimes they are far more complex, with greater variables than we see in the scientific world. I stated my observations on the basis of history. I did not try to attribute cause or effect to that. I do think the record is clear, though, Senator. The CHAIRMAN. Thank you. Senator East? Senator EAST. Thank you, Mr. Chairman. Doctor, I wish to again thank you for coming and helping us in this testimony and hearing. As you have been here this morning, I have pursued this theme to some extent with the other people from the medical community and from the perspective of medical science, concentrating on the trord science here. You used a phrase which we hear a great deal of in this effort to build a base of support for this legislation. The first finding of this bill, under section 2, says that Congress finds that "cigarette smok- ing is the largest preventable cause of illness and premature death in the United States," and you used that phrase, "the largest pre- ventable cause of illness." I am just curious. On this matter of scientific causation, and looking at it in a way that people in the scientific community Would want to look at it, not to have it politicized but to have it be meaningful, how could one say with total assurance and as a scien- tific finding that it is the largest preventable cause of illness? For example, I could see how, conceivably, you might have facts. I am not saying they are there, but one might be able to establish, as a matter of scientific causation, that a particular thing is the largest cause of illness and premature death, because raw statistics might conceivably bear it out in some way-driving, alcohol, salt, Sugar, obesity, nutrition, and so on and so forth-that we might be able to establish that. 0 0 0 0 0 a l

rN 231 favorably to this personality type; therefore, reinforcement of the current franchise is simultaneously achieved.32 The same marketing plan indicates that a primary theme for the promotion of Salem has been to associate the cigarette with the lifestyle of 'young adult males" who,are "masculine, contemporary, confident, self-assured, daring/adventurous, mature."33 Marketing plans for other cigarettes are similar. A Doral campaign sought to project the image of 'an independent, self-reliant, self-confident, take-charge kind of person."34 A Winston man was projected as "a 'man's man who is strong, vigorous, confident, experienced, mature."35 Liggett i Myers' documents show that their Lark ads picturing a balloon high above land sought to give the consumer an association with "lightness and exhilaration."36 L&M's campaign planned to position Lark as a "youthful, contemporary brand that satisfies the lifestyles of the modern smoking public." Its ads emphasize "moments 32 Document A900022 - "Salem 1977 Annual Marketing Plan." 33 Id. 34 Document A900003 - "RJR Statement of 6usinee:s 1977 - Doral Cigarettes." 35 Document A900001 - "Winston Hing 1978 Marketing Plan." 36 Document A900230 -"197< Lark Annual Marketing Plan." 2-14

-6- and Human Services with regard to those chemical additives used in the manufacture of cigarettes and the quantities of such additives. At the present time it is extremely difficult to fully assess the relative risks of cigarette additives because of this lack of basic information. Those listings of additives which presently exist are not sufficiently specific in terms of the types and quantities of substances actually being used. The presently unknown health effects of cigarette additives must be explored and such an assessment can only be undertaken if the scientific conmunity has access to more complete information. Given our growing national concern with toxic substances and our developing knowledge with regard to the possible synergistic effects of certain substances, we believe that a national compendium of information on cigarette additives should be considered if we expect to be able to assess present and future health risks. In conclusion, Mr. Chairman, we support efforts to better inform the public of the health hazards, including the increased risk of premature mortality, associated with smoking. As public policy turns increasingly towards emphasizing the importance of Individual efforts at disease prevention and health maintenance we believe that it is essential that individuals receive complete information ' on the risks associated with smoking. It is our belief that the measure before this Committee will substantially enhance our efforts as health professionals to convey vitally important scientific information to the public. The American College of Physicians is pleased to lend its support to your efforts and is available to respond to any questions which you might have.

226 -a- continuing national education effort on the dangers of smoking and rotational labelling will maximize exposure of millions of Americans to at least a minimum level of information on smoking's health hazards. We heartily welcome the exp~.nded Federal role in addressing the smoking menace to this Nation's health. Mr. Chairman, you and your colleagues are to be commended for recognizing that this problem is one of national scope and deserving of a national legislative and administrative focus. We, as practitioners, educators, and researchers, are pleased to have the opportunity to join hands with the Federal Government to help eradicate the human, social, and economic waste resulting from smoking. 227 TESTIMONY OF ACTION ON SMOKING AND HEF DIRECTOR AND CHIEF COUNSEL, JOHN F. SENATE COMMITTEE ON LABOR AND HUMAl, THE HONORABLE ORRIN G. HA1CH, C SMOKING PREVENTION EDUCATIC Submitted April F i I am happy to appear before you and F@alth (ASH) to strongly suppor Prevention Fducation Act. As you may kno4 is a national nonprofit organization wt arm of the antismoking community. In this involved in virtually all major actions cc advertising. For example, in my individual at the Federal Communicatiorts Commissic that stations make free time available the Fairness Doctrine. Shortly thereaf* major role in upholding the Congressional: advertising. ASH was also instrumenta: off the air and in persuading the Fe complaints against the tobacco industL advertisements. In my individual capacity a, National Law Center of the George Nashh persuade the Federal Trade Commission to a-pon against deceptive ads. Since t numerous proceedings concerning deceptive including a major fact-finding procee effects of advertising. On the basis of this experirequirement of stronger, clearer, mor necessary and long-overdue step. Thi changing, or 'rotating,' warnings wil effective and to bring them forcefully to Because the need for th demonstrated in other testimony and in ma Commission and other agencies, I wil However, I think it is important for depths to which the tobacco industry wi people into smoking and to negate or oth from the serious health problems it pre attaching, as part of my testimony, a p prepared by the Staff of the Federal 'lYad one may rell conjecture -- not made avail The report demonstrates many apparently has nothing but contempt fo people who might be persuaded to do so. report at page 2-16 of the Federal document says,

220 -2- physicians. -- The national media focused on our 1972 Annual Scientific Assembly, when the College established a policy requiring smoking physician-registrants to sit in a special smoking section in the assembly room. This section is no longer utilized because so few of our national convention participants now smoke. Since 1980, new Fellows of the College have been asked to take a pledge that they will use their offices, clinics, and hospital environ- ments as health centers to discourage smoking. -- The College is preparing for publication in CHEST a document describing procedures that the physician should utilize in the office, clinic, and hospital to discourage smoking and to identify the pulmonary specialist's role in smoking cessation.- -- The College is preparing a monograph for distri- bution in October 1982 identifying the responsibility of chest physicians to inquire of all their patients about their smoking habits and to assist patients in smoking cessation. The impact of cigarette-smoking is well documented. It causes approximately 300, 000 deaths annually; this is one out of seven of all deaths in the United States. In 1980 over 80,000 individuals died from smoking-related emphysema and chronic bronchitis; and approximately 200,000 heart attack deaths were attributed to smoking. The Surgeon General's latest report concludes that "cigarette smokers have overall mortality rates substantially greater than those of the non-smokers." The statistics on the impact of cigarette-smoking are staggering and clearly call for relief in the form of the proposed 221 -3- legislation. Regarding lung cancer, t states that: 1. Cigarette smoking is the in the United States. 2. Smokers who consume two lung cancer mortality rates 15-25 time 3. Cessation of smoking red mortality compared to that of the cont 4. The economic impact of 1 approximately $4.25 billion per year i costs, and physician fees. 5. Lung cancer is a prevent estimated that 85% of lung cancer mort if individuals had never taken up smok Over one-third of our member they see in their offices and clinics of smoking vis-a-vis cardiovascular di 1. Smoking is a major contr of heart attacks, sudden death and per 2. Smoking doubles a persor and heavy smokers are three times as 1 attacks and sudden death. 3. Cessation from smoking c cardiovascular disease. 4. The economic costs of ce U.S. is approximately $41.8 billion pc

241 March 24, 1982 STATEMENT of the BAKERY, CONFECTIONERY f, TOBACCO WORKERS INTERNATIONAL UNION to the SENATE COMMITTEE ON LABOR AND HUMAN RESOURCES Re: S. 1929, "The Comprehensive Smoking Prevention Education Act of 1982" The Bakery, Confectionery and Tobacco Workers International Union represents over 160,000 workers in the United States and Canada. Approximately 30,000 of our members are employed in the U.S. tobacco industry. We present this testimony on behalf of all of our members - those who are employed in that industry, as well as those employed in the various aspects of the food production industry. We also speak on behalf of the many workers in the tobacco industry who are not organized and do not, therefore, have a collective voice to represent them at the hearings. We oppose S. 1929, The Comprehensive Smoking Prevention Education Act, for two very important reasons. First, it threatens our industry and our workers with the needless loss of shles, earnings, and ultimately, jobs. Second, it threatens a host of other workers in other indus- tries and the general public with the loss of protection against hazardous environmental and occupational exposures. To put it plainly, this legislation is not what it seems to be. It is not merely a harmless labeling bill, but rather the first step down the road to prohibition. In fact, it is not merely a tobacco and health bill, but rather a red herring that

233 perceive the smoking habit as a"dirty• and dangeroua o++e engaged in only by 'very stupid people."40 The report concludesa Thus, the smokers have to face 'the fact that they are illogical, irrational and stupid. People find it hard to go throughout life with such negative presentation and evaluation of self. The saviours ace the rationat - zation and the repression that end up and result ln a defense mechanism that, as many of the defense sechanisms we use, has its own 'logic', its own rationale. . r • . . . . a Thus, smokers don't like to be reminded of the fact that they are illogical and irrational. They don't wt7t to be reminded by either direct or indirect meiine.. The report proceeds to describe the elements of a good cigarette advertising campaign, in light of its findings, in a chapter entitled, •How To Reduce Objections To A Cigarette.' The basic premise of the report's recommendations is that since there "+re not any real, absolute, positive qualities and attributes in a cigarette,• the most effective advertising is desiqned to "reducs objections" 42 to the product by presenting a picture or situation ambiguous enough to provide smokers with a rationale fur their behavior and a means of repressing their health conrerns about smoking. To provide a rationale for smoking, the ad must project the 40 Document A901268 - May 26, 1975 'What Aave We Learned E'rnm People? A Conceptual Summarization of 18 Focus Cruup lnterviewe On The Subject Of Smoking." 41 Id. at 2, 3 (emphasis in original). 42 Id. at 12 (emphasis in original). 2-16

228 2. Thus, the smokers have to face the fact that they are illogical, irrational and stupid ... . . . ... smokers don't like to be reminded of the fact that they are illogical and irrational. The report also demonstrates that the tobacco industry actively encourages smoking by young people and actively designs campaigns to encourage them to begin smoking. For example, among the atrategies for attracting young 'starters' to cigarette smoking are the following: Present the cigarette as one of a few initiations into the adult wvrld. Present the cigarette as part of the illicit pleasure category of products and activities. 1b the best of your ability, (considering some legal constraints), relate the cigarette to 'pot', wine, beer, sex, etc. Third, this confidential document makes it abundantly clear that the tobacco companies use a variety of means to detract from and undermine the health warning on cigarettes. Oi this point I think the report speaks most forcefully for itself. In addition to including this report as a part of ASH's testimony, Action on Smoking and Health would like to respectfully request and suggest that the Committee demand from the Federal Trade Commission the various documents cited in the report and place them, also, in the record, so that Members of Congress may be fully advised on the tobacco industry's strategy and techniques and the effectiveness of their advertisements prior to a vote on this issue. 229 , ltECEIVED MAR 1 515Rt THIS DOCUM: CONFIDENTIA: FEDERAL TRAI STAFF REI CIGARETTE ADVERT: E Matthew Pro9ras Craig Is Carol Je Nilliam Eleanor Andrew S APPROVEDs Collot Guerard Deputy Assistant Director Division of Advertising Practice Wallace S. Snyder Assistant Director Division of Advertising Practice CONCUR: James Sneed Director Bureau of Consumer Protection

a 221 -3- legislation. Regarding lung cancer, the Surgeon General's report states that: 1. Cigarette smoking is the major cause of lung cancer in the United States. 2. Smokers who consume two or more packs per day have lung cancer mortality rates 15-25 times greater than non-smokers. 3. Cessation of smoking reduces the risk of lung cancer mortality compared to that of the continuant smoker. 4. The economic impact of lung cancer to the U.S. is approximately $4.25 billion per year in lost earnings, hospital costs, and physician fees. 5. Lung cancer is a preventable disease. It is estimated that 85% of lung cancer mortalities could be avoided if individuals had never taken up smoking. Over one-third of our membership are cardiologists; they see in their offices and clinics the devastating implications of smoking vis-a-vis cardiovascular diseases. 1. Smoking is a major contributor to the occurrence of heart attacks, sudden death and peripheral vascular disease. 2. Smoking doubles a persons' risk of heart attack and heavy smokers are three times as likely to suffer heart attacks and sudden death. 3. Cessation from smoking greatly reduces the risk of cardiovascular disease. 4. The economic costs of cardiovascular disease to the U.S. is approximately $41.8 billion per year in lost earnings fl ® 1i

222 -4- and health costs, both Federal and private. Other chronic respiratory diseases are also caused or aggravated by the direct inhalation of cigarette smoke, including chronic bronchitis, asthma, emphysema, pleurisy, pneumoconiosis, bronchiectasis and other disorders. Over 16 million Americans suffer from these diseases. The most salient characteristic of the smoking problem is that not smoking or ceasing smoking is a means of preventing or delaying the onset of the above-mentioned lung and cardio- vascular disorders. This Committee has been apprised of numerous studies that demonstrate increased life expectancy in individuals who stop smoking as compared to those who continued to do so. A twenty-year study(British Medical Journal, 2: 1525-1536, 1976) of over 34,000 physicians in Great Britain showed that deaths from chronic obstructive lung diseases decreased by 24% for those who stopped smoking. The death rate from lung cancer for those who continued to smoke was 16 times higher than non-smokers; after 15 years of abstinence by smokers their death rate from lung cancer fell to only twice the rate of non-smokers. Most recently, an American Study (American Review of Respiratory Diseases, 125:144-51, 1982) documents that cigarette smoking in adults is the most important predictor of obstructive airways disease and its cessation significantly reduces the future de- velopment of the diseases. The use of a simple spirogram (pul- monary function test) markedly enhances the ability to predict obstructive airways diseases. Another study (New England Journal of Medicine, 300: 213-217, 1979), showed that individuals with coronary artery -s- =::e claims of the tobacco industry that tt exist a scientific causal link between cic and major cardio-pulmonary health problem: cuite clear. Government intervention in t 'asirable when the problem is one of natic costs of regulation are clearly outweighe, . and when the government can perform a func by the private sector. A visible governm, recommitment -- to the eradication of smo; .a believe that the passage of S. 1929 wi: ..e practitioners in educating the public - _nvolved with smoking cigarettes. We wou _` the major provisions contained in this 1. We'support the establishmen the public of the dangers to health from :'oluntary sector cannot bear the entire r ~_ducating the public on the risks of smok _`_ advertising and the volume and influen ivertising are major deterrents to volun establishment of an Interagency Committee to coordinate research and educational ef ~overn:nent and private sectors will help research already being conducted by NIH c It is important that the NHLBI and NCI, a a7encies you have mentioned, be represent Z:om.^iittee.

204 STATEMENT of the AMERICAN MEDICAL ASSOCIATION to the Labor and Human Resources Committee U.S. Senate Re: S. 1929 - Comprehensive Smoking Prevention Education Act March 16, 1982 The American Medical Association takes this opportunity to comment on S. 1929. The bill states its purpose is "to provide a new strategy" to educate and provide information to the American public that will allow individuals to make informed decisions concerning smoking." The bill would accomplish this by replacing the current general health warning found on cigarette packages with seven specific health warnings. One of the seven specific health warnings would be required on all cigarette packages and in advertisements. The warnings would be rotated among -brands so that each brand would use all warnings within a fifteen-month~ period. S. 1929 would also require the "tar," nicotine and carbon monoxide levels to be disclosed on packages and advertisements. Cigarette manufacturers would be required to provide the Federal Trade 205 -2- Commission with a list of the chemical addi of cigarettes. This information would be pr used only for research purposes. _ Comments The United States Surgeon General state realth Consequences of Smoking," that "Cig< chief, single, avoidable cause of death i :nportant public health issue of our time." A decision to smoke should be made with health risks are associated with smoking. supportive of efforts to increase public awa: The AMA has been involved in many effo knowledge of the consequences of smoking. aany requests for smoking information. "Tobacco and Health," an account of the cc conducted by the AMA. A pamphlet called Know," a copy of which is attached, has b with two anti-smoking posters. Physicians E the risks associated with smoking. 11 Our comments address only the rotatior find it very disturbing if, as a recent approximately ten percent of the populati cigarette smoking is harmful. Believing a better inform the public of the harm of Delegates adopted a report encouraging C explicit warning on cigarette packages.

185 Roger D. Blackwell, Brian Sternthal and James Hensel, "Pupil Dilation: What Does It Measure?" Journal of Advertising Research, Vol. 10 (August 1970),15-19. Roger D. Blackwell, "The Product of the Funeral Director", "Management Planning for Growth Oriented Funeral Firms," "Socio-economic Variables Affecting Funeral Purchase Decisions", "Professional Pricing by Funeral Firms", and "Improving Funeral Firm Performance Through Better Consumer Analysis (with J. F. Enge1)", all reprinted in Sam P. Douglass, ed., Funeral Homes: Le al and Business Problems (New York: The Practicing Law Institute 197 , 153-207. David T. Kollat, Roger D. Blackwell and James F. Engel, "Current Status of Consumer Research, Developments in the 1968-1972 Period", Paper Presented to Association for Consumer Research, November 5, 1972, Chicago. Roger D. Blackwell, David T. Kollat and James F. Engel, "A Research Approach to Consumerism", Paper Contributed to American Institute for Decision Sciences, Fourth Annual Meeting, New Orleans, November 1-3, 1972. Roger D.Blackwell, James F. Engel and David T. Kollat, "A Multifunctional Analysis of Multimediation Models of Consumer Behavior", Paper presented to Association for Consumer Research Annual Convention, Boston, 1973. Roger D. Blackwell, David T. Kollat and James F. Engel, "Determining Consumer and Customer Wants", in Steuart H. Britt (ed.), Marketin Mana er's Handbook. Chicago: The D'rtnell Corp., 1973, 21 - . Douglass K. Hawes, W. Wayne Talarzyk, and Roger D. Blackwell, "Consumer Satisfactions from Leisure Time Pursuits", in M. H. Schl-inger (ed.), Advances in Consumer Research Vol. II. Chicago: Association for Consumer Research, , 8 - . Roger 0. Blackwell, "Strategic Planning in Marketing: Discussion", in Ronald C. Curhan (ed.), 1974 Combined Proceedin s of the AMA. Chicago: American Marketing Association, 1974. 476-4 77. Roger D. Blackwell, Douglass K. Hawes and W. Wayne Talarzyk, "America's Use of Credit Cards: A Nationwide Study of Female and Male Attitudes", Bulletin of Business Research, Vol. 50, No. 2 (February, 1975), 5-8. Roger 0. Blackwell and W. Wayne Talarzyk, "Gistner Funeral Home" Case #9-575-711, Intercollegiate Case Clearing House, Harvard Graduate School of Business Administration, 1975. Roger D. Blackwell, D. K. Kawes 5 W. Y. Talarzyk, "Attitudes Toward Use of Credit Cards: Do Men and Women Differ?" Baylor Business Studies, Nov-Dec. 1976, Jan. 1977, 57-71. Roger 0. Blackwell, "John Howard and Marketing Theory and Metatheory", in Alan R. Andreason and Seymour Sudmen (eds.), Public Polic and Marketin Thought, (Chicago American Marketing Associatio- , - . Roger D. Blackwell, D. K. Hawes & W. W. Talarzyk Male Bank Card Holders: A Psychographic and Proceedings of A.M.A. Fall Meetings, 1976. Roger D. Blackwell, D. K. Hawes & W. W. Talarzyk Credit Cards: Results of a Nationwide Study" the Southwestern Marketing Association, Marc Roger 0. Blackwell, "The Diffusion of Diffusion to Association for Consumer Research, San Fr Justin Voss and Roger Blackwell, "The Role of Ti Behavior," in 0. C. Ferrell, S. W. Brown and Conce tual and Theoretical Develo nts in M Marketing Assoc ation, 1979, 28 -295. Roger D. Blackwell, "The Future of Fashion: The Textiles and Clothing," Combined Proceedings Professors of Textiles and Clothing, 1979, 5'. Roger D. Blackwell, "The Consumer Approach to D& sented to Fifth Annual Symposium on Death Ed University-, March 1980. Roger D. Blackwell, "The Effects of Lifestyles o~ A.M.A. News (March 3, 1980). ~ Roger 0. Blackwell and JoAnn Schickel Hilliker, ' Decision Process Analysis of Focused Group Ir Hunt and Frances M. Magrabi, eds., Interdisc (Ann Arbor: Association for Consumer Researct Roger D. Blackwell, "Seven Principles of Marketir News (Chicago: American Marketing Associatior H. Lee Mathews and Roger D. Blackwell, "Implemen~ Higher Education," in Richard Bagozzi, ed., h Changes and Challenges (Chicago: American Mar Roger 0. Blackwell (with Karen S. Edwards), "The Patient Care to Patient Advocate, The Ohio 7~ . 980 , 4 -4 9. Roger 0. Blackwell, "The Role of Lifestyle Analy; Journal of Retailing Research (May 1980). W. Wayne Talarzyk and Roger D. Blackwell,.'James Contributions to Consumer Behavior," Paper pr University of Illinois, May 1981. Roger D. Blackwell, "The Many Hats of Today's Fur in Charles Stewart, Funeral Service: Counsel` (Batesville, Indiana: Batesv e Management ~ Roger D. Blackwell, "The Preparation of Future M, of Marketing Education (Spring 1981), 4-9.

Thus, an attempt to reach young smokers, starters, should be based, among others, on the following major parameters: - Present the cigarette as one of a few initiations into the adult world. - Present the cigarette as part of the illicit pleasure category of products and activities. 1. f t • f • t • - In your ads create a situation taken from the day-to-day life of the young smoker but in an elegant manner have this situation touch on the basic symbols of the growing-up, maturity process. - To the best of your ability, (considering some legal constraints), relate the cigarette to 'pot', wine, beer, sex, etc. - Don't communicate health or health-related points.45 B&W adopted many of the ideas contained in this report in the development of a Viceroy advertising campaign. Thus, in a document entitled, "Viceroy Strategy," BiW notes repeatedly that its advertising campaign must provide consumers with a rationalization for smoking and a"means of repressing their health concerns about smoking a full flavor Viceroy."46 The following excerpts from 'Viceroy Strategy' are representative and indicate that in BiW's view, the other cigarette companies also have developed advertising 45 Id. at 31. 46 Document A015538 -"Viceroy Strategy," March 3, 1976, V.C. •Broach, Group Project Manager, B&W (emphasis in original). 2-18 95-077 0-82-16

214 -3- It is important to emphasize that at this time, despite the advances made in the treatment of certain cancers, the five year survival rate for lung cancer is less than ten percent. Despite advances in our ability to perfonn early diagnosis and treatment we have not significantly altered this survival rate. The best preventive measure with regard to cancer of the lung is not to smoke -- this means that those who smoke should stop, and that those who do not smoke should not start. Lastly, important evidence has been accumulated on the effect of maternal smokina on pregnancy outcomes and the well-being of infants, and there is emerging evidence on the adverse impact of smoking on healthy non-smokers. This latter evidence challenges any statement that smoking is solely a matter of individual choice. The fact that new evidence is being developed on the impact of smoking on health must not diminish the fact that there already exists a substantial body of irrefutable scientific evidence with regard to the health hazards and increased premature mortality associated with smoking. It should be emphasized that there is clear scientific consensus as to the veracity and import of this existing evidence. In view of the cost to society -- in both human and economic terms -- which smoking represents and in view of the recognized need to be more diligent as a society in our efforts at health promotion and disease prevention, the American College of Physicians believes that every reasonable effort should be made to alert the public to the range and magnitude of the risks 215 - a- associated with smoking. It is imperative tl to ensure that those who may choose to smoke i risks to their health and the health of other! this action. In addition, we would note that with regard to the addictive properties of tot additional concerns, and that efforts must be to the American public. As physicians, in particular as specialists in its related subspecialties, we are fully aware scientific support for the range of specific w legislation before the Committee. As provider care to adults, we have a strong interest in p and in the mechanisms by which health-related We support the proposed changes in the present cigarette packages. As we have stated, given health risks associated with smoking, we belie effort should be made to accurately convey to this health risk. We believe that the specificity of the warning legislation will help to emphasize the risk wh time they smoke. We also believe that it is v to smokers the fact that quitting smoking will health. We are pleased to see that under the messages would be presented. Some might argue

N 229 ; RECEIVED MAR 115 W THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION FEDERAL TRADE COMMISSION STAFF REPORT ON THE CIGARETTE ADVERTISING INVESTIGATION BY: Matthew L. Myers Program Advisor Craig Iscoe Carol Jennings William Lenox Eleanor Minsky Andrew Sacks APPROVED: Collot Guerard Deputy Assistant Director Division of Advertising Practices Mallace S. Snyder Assistant Director Division of Advertising Practices CONCUR: James Sneed Director Bureau of Consumer Protection May, 1981 nm

206 - 3 - In testifying before the Subcommittee on Health and Scientific Research of the Senate Committee on Human Resources in 1978 on a similar labeling provision contained in S. 3115, (95th Congress) the Disease Prevention and Health Promotion Act of 1978, the AMA endorsed the rotational label warning concept. We recommended at that time that if adopted the rotational labels "should be evaluated after a period of use to see if there has been any substantial difference in the public's awareness of health problems associated with cigarette smoking." We still believe the effectiveness of the labels should be evaluated. A more explicit warning, while an improvement, will not be a complete solution. The 1980 Surgeon General's Report on Smoking and Women reveals that smoking is increasing among teenagers. The AMA is concerned about teenage smoking and does not believe a change in the warning alone will fully deal with the problem. Educational programs that emphasize the harmful aspects of smoking from a teenager's point of view should be pursued, and the use of "role models" in cigarette advertisements should be eliminated. Issues of concern to an adult, like a decrease in life expectancy, may not influence a teenager's decision to smoke. More information is needed on youth smoking, such as why they begin to smoke, why they quit smoking, and what method is most effective in urging teenagers to quit smoking. Once this information is available efforts to reduce teenage smoking can be better directed. .Even those who are aware of the dangers of smoking may have difficulty quitting because of the addictive qualities of cigarettes. The recent Surgeon General's report shows that up to 50 percent of those 207 - 4 - who quit smoking on their own will stay of be provided to the remaining 50 percent 9 significantly. The AMA is developing an a to quit smoking that will soon be availe assisting patients desiring to quit smoking warning may create more awareness of the smokers will want to stop smoking. Prograr quit smoking will be needed even more in th: Conclusion The AMA supports efforts to increase p of smoking. We believe that the best met help people avoid starting the habit. On, would be a clear indication of the health AMA supports a more explicit warning c advertisements. 0386p

243 -3- is required to carry. It also explains why the bill opens the door to a massive overload of litigation. If these prohibitionist effects succeed in depressing sales by just one percent, the ad- verse impact would be significant. Based on data from a recent Wharton study of the tobacco industry's contribution to the U.S. economy, we estimate that the loss for just nine of the states (California, Illinois, Kentucky, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas) would be more than 10,000 jobs and more than $170 million in wages. One-fifth of this loss would come from tobacco farming, manufacturing, retail sales, and suppliers; the remainder would result from the ripple effect on the rest of the economy. - Further economic hardship would result from the loss of export markets and of American jobs that depend on exports. This bill goes far beyond existing legislation by requiring warning labels on cigarettes produced in this country for export. Could American cigarettes carrying a health warning label compete with cigarettes which bear none? Can there be any doubt of the result on sales and on American jobs? The American Cancer Society, a major lobbying force for this legislation, wants to cause more than a one percent drop in smoking. Several years ago, they launched their Target Five campaign, aimed at a 25% decrease in smoking in five years. And, it must be recog- nized that in Sweden, the source of this bill, the government's stated goal is to achieve a smoke-free nation by the year 2000. . We seriously question the wisdom of buying the Swedish import for Americans. We seriously question the wisdom of disrupting a health industry and creating more unemployment in a recession.

245 -s- The Committee which wrote the report considered the possibility of trying to make such calculations, but rejected the idea because "it involves making so many assumptions that the Committee felt that it should not attempt this..." That restraint is as needed now as it was then. We believe the findings in this bill are unsubstantiated and will be misused to the detriment of millions of workers exposed to occupational hazards. We oppose this bill and its findings to show our solidarity with: o Coal miners whose black lung disease has been blamed on smoking. o Textile workers whose brown lung disease has been blamed on smoking. o Asbestos workers whose lung diseases have been blamed on smoking. And the list includes uranium workers, chemical workers, metal workers, shipyard workers, and many others. Public Health Service and the voluntary health organizations should honestly abandon the blame-the-victim approach and get at the truths of what is causing disease. Earlier this year, the Congress heard testimony from two scientists who reported that "at least 11 percent and more likely 21 percent" of lung cancer in the U.S. can be attributed to air pollution. They noted that the proportion of adult smokers has decreased and that cigarettes now contain half the tar content of 20 years ago, yet lung cancer rates continue to climb. "To us this indicates that something else is at work," the scientists said. But to the supporters of this bill, it's all cigarette smoking. Recently, the National Wildlife Federation reported that "responsible scientists believe air pollution is responsible for m

188 ~ ;A The CHAIRMAN. You suggested that this causal link between smoking and disease has not yet been established; yet all official reports from our Government for the last 14 years and at least one major World Health Organization report published in 1981 indicate loud and clear consensus. Now, do you think that there would be any controversy if the to- bacco industry did not question these studies? Dr. SOMMERS. I repeat, sir, that I accept a statistical relationship. I do not accept a cause-and-effect relationship. I do not think any- thing the tobacco industry did has, is, or would affect the natural course of science except that politicization makes it difficult for sci- ence. The CHAIRMAN. Let me ask you this. As I understand it, the to-bacco industry has done extensive scientific research on the effects of tobacco smoking. Has that research all been made public? '. Mr. HORRIGAN. You are correct, Mr. Chairman. We spend in excess of $10 million a year through no-strings-attached medical re- search. Those grants are awarded to eminent scientists, and the re- sults of their research are published. I believe Dr. Sommers, who heads up the Scientific Advisory Board and directs this activity, could give some additional information. Dr. SOMMERS. The Council for Tobacco Research, with a budget in excess of $7 million a year, accepts applications from anyone wishing to study in the field of tobacco and health. The Scientific Advisory Board considers the application. It awards the funds. If they meet the criteria of excellent science, the grants are usually for 3 years and are renewable. There is no control exercised by the council or by the tobacco in- dustry upon the findings. They are freely published anywhere that the investigator wants, and anything that is found is to be pub- lished. The CHAIRMAN. Mr. Horrigan, you stated that the Swedish rota- tional warning system or scheme was not effective and that ciga- rette consumption has actually risen since the new system was im- plemented. But I have before me the latest statistics on cigarette smoking in Sweden-this comes from the Swedish Institute. For men, the number of daily smokers has declined from 43 per- cent in 1976 to 31 percent in 1980. For women, the number of daily smokers has declined from 35 percent in the midseventies to 26 percent in 1980. Would you care to comment on these statistics? Mr. HORRIGAN. I Will, Mr. Chairman, because we have the same experience in the United States. The incidence rate of smoking is declining, so that when you relate the trend with regard to the in- cidence rate of smoking, we are experiencing that same phenom- enon or development here in the United States, for both sexes. The CHAIRMAN. Thank you. 189 more balanced in terms of the points c- and look at. I would agree with Mr. Horrigan that loomed up large and with Dr. Sommei and effect as opposed to straight statis that ad nauseam, but it is a critical asst with science here, and in American pub lation, when the word "science" is h follow instructions, that there are no k carefully stitched together, and we mu: ence. I do feel this morning, from my vant testimony has been valuable to questi( about science or wish or judgment or va Mr. Horrigan, your testimony, I think ble for me and, I would hope, for the had hinted at the beginning of this he touched upon it, that, ultimately, thos issue in terms of being in the legislative ator Hatch has a great sensitivity to th record in this area, as a matter of fact dens placed upon industry are comme the public. The regulatory reform bill that the r up shortly hits that one head on. In ti tendency of Government, of policy forrr in the Senate, and in the House, frequei es, or to place upon businesses, to use a lations that just incredibly hobble an in corresponding benefit to the public in tc or anything of this kind. I think, obviously, you are in a very u industry would obviously bear the bur( earlier, I suspect other businesses coul, let's leave that for another time or plac, As you see it, this act, this particula place substantial, serious burdens upon for you to comment briefly on that an tions of it that you see; and then, secor you see would be the gain, if any, to th the House, or the Senate in this case, n ing and public health. Where might yc this bill goes into operation? How woi from a key figure in a key industry. F Co., which we are very proud to havE very well say the industry, but we will loyalties. How would you assess that I would be valuable for me, and I think record to show. Mr. HORRIGAN. Fine, Senator. I am graduated from the University of Uta Mr. Chairman. [Laughter.] He is a skier and a business student. Senator East? Senator EAST. Thank you, Mr. Chairman. Gentlemen, I wish to thank you for coming and helping us this morning on this very important matter. I would, Mr. Chairman, like to underscore what I said at the beginning of these hearings, and Mr. Horrigan has also mentioned, that I would trust we might, in order that we can give this matter the serious due that it de- serves, have additional hearings so that they could be, frankly,

80 common cause of chronic, low-grade elevation of carboxyhemog bin. tte smokers compensate in a very i gare c As a matter of fact, ted carboxyhemoglobin levels, by l eva r these e teresting way fo creasing the number of red cells that their bone marrow mak pacity is en- h a e oxyg The body assesses the fact that t P f r his. a duced ana, in a way, lt, a"~ ===r- --- Senator EAST. I appreciate your comment on thP ^rrl ana br -- - here that I woula Ju5L, z5il=lr•.r =_-- - to the attention of the Chair is that=we make sureltha~v as e¢ burdens of thts xma ijrlljv,vu ur-== ~- ~- to additives that we might make sure that we not impose burd t articular thing, 1 tha p on upon them that the state of science, k the scientific knowledge on l ac do it; we not permit them to particular pomt to au A. the law and science into a bad u in b g r I think we Again, But it is not to gainsay y ute disre t i . p o n g both there and brin point that we ought to always be'willing rPlations of ad tave ya any other area, to purbuc •- ----- y t is on the individual or societ l health impac what their genera a whole. I again do not want our good intentions to get ahead us to do in this or s ll ow dge will a what our scientific knowle other area. Dr. HOLBROOK. Senator, I think I can reassure`yhucrtha~G is a tine measurement periuraiCU .__ ___-i --------- - Senator EAST. But, as you have indicated, the difficulty with i noted at the oul h ave as we that-again, back to our problem, of variables and isolating them bl em it is a pro with Dr. Koop- determining precisely the health impact upon the individual or nt i t s+^ ~ ciety as a whole, then. It is_ not simple„ acknowled>;e~ isp Our control ot an Lne ~al1au-, osition. "" su p l d p on ea there, so we are going a great I just want to make sure that, in the governmental policy, P0, i d w e 1 eQs policy arena, we do not let^our~ wi11 susain. a h; ano nt from what our scIenLUIL: 11~11V••=--b- --- - us continue to probe the scientific correlations in the laborato an with it bu~ c b es + wte T release that information, and do the^ force it beyond wnat Lne UdlliV I found your testimony helpful to remind us of that. Thank Mr. Chairman. The CHAIRMAN. Thank you, Senator East. Thanks, Dr. Holbr We apprec>.ated your Le5U111V1=,r• a distinguished s les LeMaistre Ch , ar Our next witness is Dr. tist and physician who is currently serving in two major positi M D s T f c exa ~ He is president of the University o an t nt?the Coal _~~ -~ - - - tal and '1'umor insULutG, a==- a large group of voluntary and pri lth on Smoking or Hea , agencies who have determined to work together in smoking pre tion education. So, Dr. LeMaistre, it is good to see you again and nice to testimony . you here. You may proceed with your 81 ~r{tT} ~iF:~T OF CHARLES A. LeMAISTRE, M.I I, t'ft-~ ITl' (1F TEXAS M. D. ANDERSON HOS t,%-TCrI "1'E. ON BEHALF OF COALITION NF. M1'll l1• [.r M:.tsTeE. Thank you very much, Mr. C1 ~! ~::, ii rman, members of the committee, : ._•r, t, . t r:o: LeMaistre, president of the Univei An"<<•!-r, Hospital and Tumor Institute. Today d:ot• hill 1929 on behalf of the American Amrr:.-an I.ung Association, and the Americar _:,)1 iior health, education, and youth leac >,p tro rf-wiv organized Coalition on Smoking or ( i.: r'l; r t ion's most prestigious agencies hat Iarr.• ,r• Washington and throughout the Natioi tlw consequences of smoking to America srrv•: r; t he coalition's blueprint for action is rn, +: blueprint explains that the coalitio .W .• "; ;,)him~ prevention through education. cx.., oI the uniting of the concerned privr tr:;ncr „i this coalition and the tremendous p I,+•>": ~1*%'t'ut Surgeon General's report on "' qwrK.-., „i :imoking," the legislation before th sne rr rn„rt• timely. In particular, we commen( Wi t•, r,r0>% ute information not now available ai thn at•i;,tN „t the American public to make an ar a+v»l„n to smoke or not to smoke. These c ta0he m:rae i) _v younger Americans, are of critica lr.i:n ot our 1'~ation. 4 i=•a !:.i ~ i • niready heard this morning and pr( +msaut tnt• consequences of past poorly informed sjs+ famniar. A 1981 estimate of the Departn ttsmAn ~•rvrces states the results very succinc ftiv Aau•rican deaths annually-roughly the po " e%tv „t the State of Texas, Austin-health i Afta•runn, ;,nnually; an annual cost of $41 billi glswndrwrtw and lost economic productivity. I"n Ie any reasonable doubt about the : Poo& •n»,xrnc; is the single most preventable c. 41hj 64nxi- mcst preventable cause of death in V%**'r tnnuw,nd studies now link cigarette smo **"V"rIn* 61•neral have repeatedly documented rw r tiuit cigarette smoking causes cancei thh .• 4-opagus, urinary bladder, mouth, t°mki 'ung causes emphysema and chror la t° +.nii ij ocn(;s a maor risk factor f r h r o ear 6s:rt•x,n,; is associated with retarded fet: rur miscarriage and prenatal death. =t.'• message is still not reaching sor. rl'-de earlier that many smokers are . ~" r''~ar;-+ „i cigarette smoking, but the Fede: ' 'tatt r4•Gwrt in May of 1981 pointed out, a V'" '- ''R.•rti are unaware of the existence ( o3s0'7s08

210 - 2 - Perhaps one of the most hazardous compounds emitted by a burning cigarette is carbon monoxide. This colorless, ordorless gas is created by incomplete com- bustlon,and both car exhaust and tobacco smoke put it into the air. When inhaled the carbon monoxide gas "bumps" oxygen molecules out of the redblood cells, preventing oxygen from attaching to the cell and forming a new compound called carboxyhemoglobin. Carbon monoxide also remains in the bloodstream and is dif- ficult to remove. After three or four hours, half of the excess carbon monoxide is still in the bloodstream. A study done in 1980 by James R. White, Ph.D. and Herman F. Froeb, M,D, evaluated the long term effects of passive and voluntary smoking on the small airway func- tions in 2100- middle aged subjects.l The findings showed that regardless of sex, non-smokers chronically exposed to tobacco smoke have-lower flow rates of exhaled air than non-smokers not exposed. In addition, values in passive smok- ers were not significantly different from those in light smokers and those who did not inhale. One of the most recent and most shocking research studies has been published in Japan. Conducted Takeshi Hirayama, M.D. of Tokyo's National Cancer Center Re- search Institute, 91,540 non-smoking wives aged 40 years and above were followed for 14 years. 2 The study showed that non-smoking women married to heavy smoking men (20 or more cigarettes a day) were up to four times as likely to die of lung cancer as women married to non-smokers. Other studies have shown that: 1. Children with a smoking parent or parents have nearly twice as many res- piratory illnesses as compared to those children of non-smoking parents. 2. Exposure to passive smoke can hasten the onset of angina in people with heart disease. 211 -3- 3.•Individuals suffering from asthma can sever by exposure to cigarette smoke. 4. It can damage the action of cilia, the micr ways of the lungs. 5. In healthy, nonallergic people it has been sneezino,coughing, sore throat, hoarsenss, serious side effects. :;s more research is conducted and the results tab ctive effects of passive smoking mount. It has a toxic, harmful, and carcinogenic. The public mus effects of this habit. The bill S.1929, makes grr lic on the specific dangers of smoking. We urge ing this bill,not to neglect the serious and ofte smoker. In addition, the Office on Smoking and Health mus ;overnment commitment relevant to this entire iss ernment officials must not allow political eonsid, tobacco industry to negatively sway or change the duct that contributes to over 300,000 premature d in lost productivity each year. -search and public education must continue and i, have any hope of reducing the tremendous social e and death from the most preventable cause - cigar REFERENCES ~. uhite,J.S., Froeb,H.F., "Small Airways Dysfurn Exposed to Tobacco Smoke", New England Journa 2. Hirayama, T., "Non-smoking Wives of Heavy Smol Cancer", British Medical Journal, 282: Jan. I~

234 iaage that cigarettes provide the smoker with social acceptance, an acceptable means of rewarding himself or herself, a stimulant, a tranQuilizer, a better self-image, etc. With regard to health issues, the report recommends: "Start out from the basic assumption that cigarette smoking is dangerous to your health - try to go around it in an elegant manner but don't try to fight it - it's a losing war."43 One chapter of the report describes how the company can introduce "'starters' to the Viceroy brand, a discussion which focuses almost exclusively on how to persuade young people to smoke., The report assertss For the young smoker, the cigarette is not yet an integral part of life, of day-to- day life, in spite of the fact that they try to project the image of a regular, run-of-the- mill smoker. For them, a cigarette, and the whole smoking process, is part of the illicit pleasure category...In the young smoker's mind a cigarette falls into the same category with wine, beer, shaving, wearing a bra (or ur osel not wearing one), declaration of ndependence and striving for self-identity. For the young starter, a cigarette is associated with introduction to sex life, with courtship, with smoking 'pot' and keeping late studying hours.44 The •starters' to cigarette smoking: chapter then recommends a strategy for attracting young 43 Id. at 17. 44 Id. at 29-30 (emphasis in original). 2-17 235 Thus, an attempt to reach young smok be based, among others, on the follo - Present the cigarette as one into the adult world. - Present the cigarette as part pleasure category of products . : - In your ads create a situatior day-to-day life of the young : elegant manner have this situ< the basic symbols of the grow: process. - To the best of your ability, ( some legal constraints), relat to 'pot', wine, beer, sex, etc - Don't communicate health or he B&W adopted many of the ideas contair development of a Viceroy advertising camF entitled, "Viceroy Strategy," BcW notes r advertising campaign must provide consumc for smoking and a "means of repressing th smoking a full flavor Viceroy."16 The f 'Viceroy Strategy' are representative and view, the other cigarette companies also 45 Id. at 31. 46 Document A015538 - "Viceroy Strategy," ,Broach, Group Project Manager, B&W (empha ~ 95-077 0-82--16

Lung Diseases, March 5, 1982 Page 2 t g I n s s e e d a f 1 I s and familial or genetic predisposition. The author of this submission intends to discuss his personal research investigations and those of others questioning the conclusion that smoking is either "the major cause" or "the most important cause" of chronic obstructive lung diseases. Briefly, his reasons are as follows: (a) Animal experiments have failed to reproduce pulmonary emphysema from long-term exposure to cigarette smoke, although this has been successfully done so for sulfur oxides, nitrogen oxides and other inhalants. (b) Functional and histopathological studies in humans show uncertain and inconsistent effects of cigarette smoking that do not support the -causal relationship between cigarette smoking and chronic obstructive lung disease. (c) Epidemiologic studies suggest the association of chronic obstructive disease with several risk factors, such as levels of outdoor and indoor pollution, alcohol consumption,

I 251 Lung Diseases, March 5, 1982 Page 4 factor has limited the usefulness of Surgeon General Re?crts as scientific documents. a. ExDerimental Pulmonarv Emnhvsema in the Doc. The 1981 report of the Surgeon General (7) states that "there are no•published studies that acceptably show in an animal model that the development of emphysema is induced by cigarette smoking. ... One study in which dogs received smoke directly through chronic tracheotomies reported the development of emphysema (Auerbach, Hammond, Kirman, Garfinkel and Stout (1967)]. The lesions were not conclusive and the results have not been confirmed by others.' The initial series of studies conducted by the author and his colleagues dealt with the effects of cigarette smoke in dogs (8-17). These studies failed to show that inhalation of cigarette smoke caused pulmonary emphysema. It is therefore not surprising that there has been no confirmation of a single study reporting the development of experimental emphysema. It should be noted that the single positive study, although questioned in the 1981 Surgeon General's Report, was highlighted in earlier Reports (including 1979) and may have been responsible for the impression that cigarette smoking is an established cause of pulmonary emphysema. 95-077 0-82--17

246 -6- about 50,000 excess deaths, seven million sick days, and 15 million days of restricted activity per year." But to supporters of this bill, it's all cigarette smoking. The lung cancer rate for white men along the coastal sections of Northern Florida, South Carolina and Georgia are among the high- est in the nation. The National Cancer Institute says it may be the result of exposure in the booming shipbuilding industry during World War II. A Florida State University study attributes it to ~i airborne chemical pollutants from industrial plants in New York and Illinois. But to the supporters of this bill, it's all cigarette smoking. The New York Times has recently looked at the growing contro- versy over whether environmental or lifestyle factors cause cancer. The former chief epidemiologist of the American Cancer Society, and others associated with the industrial establishment, believe that cancer-causing pollutants are relatively minor factors compared to factors such as smoking, diet, alcohol, and even sexual and reproductive behavior, a view that is consistent with the bill's "f ind ing s" . But the New York Times also reported that other scientists believe that factors other than smoking are involved; they are worried about "poisons escaping from smokestacks, toxic waste dumps, . -.~ nuclear reactors." They are worried that "black men smoke less than whites, yet have higher lung cancer have...more hazardous jobs." But the supporters of the bill have it's all due to smoking. Politics makes strange bedfellows. Act has been introduced by a member with - ,h rates, perhaps because they no similar worries; to them, The House version of this a 100% AFL-CIO voting record; 247 -7- S. 1929 has been introduced by a man we can't split the difference. We tc And in doing so, I would like to by the AFL-CIO Executive Council in 1 Some employers have exploit of the combined effects of smoki exposure to toxic substances and would be unnecessary to control substances, if workers stopped s The AFL-CIO is opposed to a to infringe on individual rights smoke or of those who don't. We of scientific data concerning smr toxic substances to serve as a r: to take necessary steps to preve: toxic substances in the workplac( adversely affect their health. We are impressed by the foresigh' stating two years ago the fundamental legislation today.

232 of post-tension and relaxation."37 The Eve smoker has been portrayed as a "sophisticated, up-to-date, youthful and active woman who seems to have distinct ideas about what she wants.•38 .P:F V. EFFORTS OF SOME CIGARETTE ADVERTISEMENTS TO DIVERT ATTENTION 1'•l AWAY FROM THE A HE LTH HAZARDS OF SMOKING Many cigarette advertising techniques appear to denigrate or undercut the health warning. Information obtained from subpoenaed documents indicates that, at least in the case uf several advertising eampaigns, these techniquea have been carefully planccd. For example,•documents from Brown i Williamson (BCW) and one of its advertising agencies, Ted Bates and Company, Inc., set forth the development of an advertising strategy for Viceroy cigarettes designed to suppress or minimize public concern about the health effects of smoking. The documents show that, at the request of Ted Bates, a marketing and research firm conducted a number of focus group interviews on the subject of smoking in order to assist the ad agency in developing a marketable image for Viceroy cigarettes.39 The final report summarizing the results of this research asserts that many smokers 37 Document A900251 - "1973 L&M Marketing Plan." 38 Document A900245 - "1974 Eve Portfolio Test.• 39 Document A011345 -"An Action-Oriented Research Program For Discovering And Creating The Best Possible Image For Viceroy Cigarettes," prepared for Ted Bates Advertising in March 1975 by N. Rennan, Marketing and Research Counselors, Inc. 2-15 ±f) 233 perceive the smoking habit as a "dirty" anc only by "very stupid people."40 The repor+ Thus, the smokers have to face 'the fac• illogical, irrational and stupid. Peo; to go throughout life with such negati' and evaluation of self. The saviours : zation and the repression that end up : defense mechanism that, as many of the we use, has its own 'logic', its own r Thus, smokers don't like to be reminde they are illogical and irrational. Th be reminded by either direct or indire The report proceeds to describe the el advertising campaign, in light of its find entitled, "How To Reduce Objections To A C premise of the report's recommendations is any real, absolute, positive qualities and cigarette," the most effective advertising obiections" 42 to the product by presentir. ambiguous enough to provide smokers with a behavior and a means of repressing their t smoking. To provide a rationale for smoki 40 Document A901268 - May 26, 1975 "What I People? A Conceptual Summarization of 18 The Subject Of Smoking." 41 Id. at 2, 3(emphasis in original). 42 Id. at 12 (emphasis in original). 2-16 ~ ~ ~ ~ ~ ~ ! V1~

253 Lung Diseases, March 5, 1982 Page 6 d. Comoarative Studies with Air Pollutants. Dogs, rats and mice are useful experimental models for the study of toxicity of air pollutants. Animals exposed to low levels of products of fuel combustion show impaired lung function and pathological lesions characteristic of pulmonary emphysema and bronchitis. The studies are described in the new series of Criteria Documents that have been prepared by the Environmental Protection Agency on ozone and photochemical oxidants (23), nitrogen oxides (24) and sulfur oxides with particulates (25). This author questions the logic of finding cigarette smoke "the major use" of pulmonary emphysema when primary air pollutants have been shown to cause pulmonary emphysema in experimental animals, and with the same models, cigarette smoking has not. B. Human Studies on Pulmonary Function and Histoaatholoaic Changes in Cigarette Smokers. The Chapter on chronic obstructive lung diseases in the 1979. Surgeon General's Report (pages 6-7 to 6-52) starts by defining the terms chronic bronchitis and pulmonary emphysema. For each definition,• there is a positive statement on structural or pathological alterations such as hypertrophy of

242 -2- could be used to divert attention from efforts to undermine other health policies and programs. Mr. Chairman, this bill masquerades as labeling legislation, but there is an issue behind the issue. The hidden issue is whether national policy should shift from education to prevention, from choice to coercion. This Committee will have to decide between those two roles for the government. Should the government continue to give people information so they can make their own free choice? Or should it aggressively persuade individuals to modify their behavior until they stop? Present U.S. policy calls for the public to be informed, the measure of effectiveness being the extent of public awareness. Awareness stands at an astonishingly high level of 90 percent, verging on universal acceptance according to behavioral scientists. The neo-prohibitionist strategy of this bill calls for prevention, and is based on the theory that if people reject the government's admonitions, they cannot really be informed -- and, therefore, must be reformed. The new measure of effectiveness shifts from knowledge to conformity. Even on these terms, the present policy of education is working: The prevalence of smoking has dropped to 35 percent, the lowest ever recorded by the Gallup Poll. But apparently, it is not enough that awareness is at its highest level, and smoking, the disapproved behavior, is at its lowest point. That more prevention is nevertheless prescribed betrays the neo-prohibitionist motivation that lies just under the surface. This motivation explains why the bill loads packages and advertising with more warnings and lists than any other product 243 -3- is required to carry. It also explains door to a massive overload of litigation effects succeed in depressing sales by j verse impact would be significant. Base Wharton study of the tobacco industry's economy, we estimate that the loss for ji (California, Illinois, Kentucky, New Jer: Carolina, Ohio, Pennsylvania, Texas) wou: jobs and more than $170 million in wages. would come from tobacco farming, nanufact suppliers; the remainder would result frc the rest of the economy. ,.,. Further economic hardship would resu markets and of American jobs that depend goes far beyond existing legislation by r on cigarettes produced in this country fo cigarettes carrying a health warning labe which bear none? Can there be any doubt and on American jobs? The American Cancer Society, a major legislation, wants to cause more than a o. Several years ago, they launched their.Ta: at a 25% decrease in smoking in five year: nized that in Sweden, the source of this 1 stated goal is to achieve a smoke-free na? We seriously question the wisdom of 1 for Americans. We seriously question the a health industry and creating more unemp]

255 Lung Diseases, March 5, 1982 Page 8 a. Resoiratorv svira*_o^.s and oulmonarv functional chanaes. The section on the natural history of chronic obstructive lung disease (pages 6-10 to 6-11) ends with the qualifying statement that pathological data are the most specific and sensitive parameters relating to pulmonary emphysema or chronic bronchitis. It is further stated that "the relationship of early respiratory symptoms to subsequent development of lung disease is unclear' and that "longitudinal studies demonstrating that individuals with abnormal tests of small airways function are at greater risk for lung disease are unavailabie'. Respiratory symptoms and small airway functional tests therefore are not necessarily indicators of adverse effects or pathological processes. That smokers show abnormal lung -function-has not been uniformly observed. In addition to a single study mentioned in the Surgeon General's Report, tZiere are five other publications during the late 1970's that were not cited (29-33). b. Clearance Mechanisms. The discussion of mucociliary transport (page 6-32) is another example of selective citations from the literature showing negative aspects of cigarette smoking, and omission of conflicting results. Articles that show smoking accelerates bronchial clearance in humans have been omitted. The studies of Albert q I 0

257 Lung Diseases, March 5, 1982 Page 10 "An inconsistency for the primary role of elastin alteration as a mechanism for inducing pulnonary emphysema has been a failure to demonstrate alterations in elastin content or composition in human emphysema. Morphologically, elastin fibers have appeared disrupted and diminished, yet most data from human lungs (Johnson and Andres 1970; Pierce and Hocott 1960; and Pierce et al 1961) with the exception of that of Briscoe and Loring (1958), have shown no reduction of parenchymal elastin content by gravimetric techniques." The above comments can be reinforced by the 1976 observations of Ruhn et al (38) that hamsters treated with elastase intratracheally and developing emphysema also show normal elastin content. Even lung fluid samples collected from smokers and nonsmokers showed no difference in proteolytic enzyme content (38a). C. Epidemiologic Studies. Increased mortality from pulmonary emphysema and/or chronic bronchitis among smokers compared to nonsmokers is

238 A third set of documents obtained from Brown and Williamson - reveal that in 1976, Brown and Williamson introduced a new brand of cigarette named Fact. The Brown and Williamson documents indicate that the company believed that Fact cigarettes were a new product which reduced the amount of harmful gas in the cigarette smoke inhaled by the consumer. Therefore, Fact was initially advertised as a brand with the unique ability to filter certain gases.50 However, initial sales of Fact were not considered satisfactory by erorn and Williamson, so in 1977 it temporarily halted all advertising and promotion of the cigarette while it developed a new market strategy.51 49 (Footnote Continued) smokers. In a 1978 document discussing Rool cigarettes' strengths and weaknesses, B&W also admits that one of Kool's strengths "rides on the connotation that menthol has health overtones.' (Document A006981 - Memorandum from R.L. Johnson to F.E. McGowan, B&W, March 13, 1978.) In addition, BSW states that one of the strengths of its ltool Super Longs is that "menthol and 'tar' delivery has synergistic therapeutic implications." (Id.) B&W intends to exploit this false belief. In its document describing Kool's objectives through 1981, BiW states that its strategy will be to provide product safety reassurances while enhancing the satisfaction and refreshment perception. (Document A035669 -"Rool Three-Year Objectives," August 15, 1978.) In fact, mentholated cigarettes tend to have a high "tar" and nicotine content. 50 Document 7244 -"Fact 1976 Concept Description and Potential and Marketing Plan.• 51 Document 3~523 -"Fact 1977 Repositioning and 1978 Marketing Plan Summary. _ 2-21 239 In April 1977, Brown end Williamson's Keyes-Gardner, Inc., presented Brown and marketing and strategy recommendations fc cigarettes.52 The ad agency proposed twc distinguish Fact from other cigarettes: 1 protection through selective gas filtrati satisfaction in a low tar cigarette."53 atrategy focusing on better health protec itthmling lorer levels of gas, Post-Reyes- A secondary opportunity to distingui: of tar number claims is by capitalizi unique selective gas filtration. Thi ' roduct ime e" advert~sing and wou1C r t a rea po nt of difference. It the cigarette health issue beyond tar However, this would require establist ful health hazard in cigarettes becaL very low consumer awareness or comprc problem. The Agency believes one of the introductory advertising for Fact educate health concerned consumers at This failure to establish the gas prc aelective filtration promise was meai of the target audience. However, if educated regarding this problem, the promise may still be powerful, parti, health conscious.54 52 Document 35524 - Brown & Williamson, ' Strategy Recommendations for the Reintro, April 18, 1977. (The same document was & Gardner, Inc. - Document 714569). 53 Id. 54 Id., at 3. 2-22

247 -7- S. 1929 has been introduced by a man with a zero AFL-CIO rating. We can't split the difference. We totally oppose both bills. And in doing so, I would like to point to a report adopted by the AFL-CIO Executive Council in 1980: Some employers have exploited scientific studies of the combined effects of smoking with occupational exposure to toxic substances and conclude that it would be unnecessary to control exposure of these substances, if workers stopped smoking. The AFL-CIO is opposed to any coercive efforts to infringe on individual rights of individuals who smoke or of those who don't. We also oppose misuse of scientific data concerning smoking and exposure to toxic substances to serve as a rationale for failure to take necessary steps to prevent worker exposure to toxic substances in the workplace, which are shown to adversely affect their health. We are impressed by the foresight of the Executive Council in stating two years ago the fundamental basis for rejecting this legislation today. I 0

236 strategies designed to cause repression of consumer health concerns about smoking: full flavor smokers perceive cigarette smoking as dangerous to their health...Given their awareness of the smoking and health situation, they are faced with the fact that they are behaving illogically. They respond to this inconsistency by providing themselves with either a rationalization for smoking, or, by repressing their perceptions of the possible dangers involved. To date, major full flavor brands have either consciously or unconsciously 'coped' with the smoking and *health issues in advertisin b a ealin to -Tepreaa on. (emphasis adde . The marketing efforts must cope with consumers' attitudes about smoking and health, either providing them a rationale for smoking a full flavor VICEROY or providing a means of repressing their concerns about smoking a full flavor VICEROY. [emphas,is in original.) a a a a a a . a . BiW documents also show that it translate attract young •starters' into an advertising 237 feels good, smoke it.... 47 adults in situations that the vast majority c would experience and in situations demonstrat and easy, hedonistic lifestyle.'48 Other documents submitted by BiW show thz attempted to capitalize upon the erroneous cc there is s health benefit to smoking menthol, Documents pertaining to the marketing of Roo that the company is aware of the consumer mii relative safety of menthol cigarettes and ut development of advertising strategies for Ito 47 These strategies were employed in a six-n conducted in three test cities in 1976. The the campaign was approximately ten times thf dollar amount for a six month period. (Doc. from M.M. Matteson to V.C. Broach, July 14, 48 Document A080115 - 'Viceroy Marketing/Ad• January 26, 1976. 19 In 1976, BaW held four focus group discu smokers' responses to a new Kool 120mm ciga participants were menthol cigarette smokers the participants told B&W that they switche health considerations or from a general fee cigarettes are less dangerous. According t image' has accrued to mentholated cigarette 'Low Tar Longs Project - Creative Agency As characterizing the health image of inentholz B&W admits its knowledge that menthol is of Advertising Objective - To communicate effectively that VICEROY is a satisfying flavorful cigarette which young adult smokers enjoy, by providing them a rationali- xation for smoking, or, a repression of the health con- cern they appear to need. BiW then describes'its plan to accomplish its advertising objective. Three advertising strategies would be used: 1. 2. The 'satisfaction' campaign provides a rationalization: VICEROY is so satisfying that smo ers can smoke fewer cigarettes and still receive the satisfaction they want.... The 'tension release' campaign provides a rationalization: VICEROY'S satisfying flavor can help the smoker in a tense situation.... 3. The 'feels good' campaign appeals to the smoker by re ressin the concerns he may have about smoking by 7ustification: If it feels good, do it; if it 2-19 2-20

259 Lung Diseases, March 5, 1982 Page '_2 important conclusion is that smokers do not have~ a higher incidence of chronic obstructive lung diseases than nonsmokers or exsmokers when the adults were grouped according to income and educational backgrounds. Education and income were inversely related to prevalence of obstructive lung diseases even after controlling for sex, age and smoking. c. Alohalantitrynsirr deficiency. The summary L 2 1 t 0 c t statement in the 1979 Report that individuals with severe deficiency have the onset of symptomatic chronic obstructive lung disease probably "abbreviated by smoking" was based on selected citations. Two publications in Chapter 6 were not accurately quoted. Chan-Yueng et al and Morse et al did not only examine subjects with mild deficiency but also individuals with severe antitrypsin deficiency which did not deteriorate with smoking. Kidokoro et al (43) concluded in their study of subjects with severe deficiency that "variables other than age and cigarette smoking, influence the severity of emphysema." d. Other aenetic and familial factors. The limited discussion in the .1979 Report needs expansion due to increasing evidence of familial aggregation of chronic obstructive lung disease. The studies of familial orevalence of lung disease conducted by Cohen et al clearly indicate that there is a familial factor unrelated to cigarette smoking and

224 - 6 - We believe that the bill should be amended to establish. by statute the Office of Smoking and Health within HHS so that there may be a permanent focus for Federal activities in this area. Smoking and its health problems are too significant to -.- # be subject to the economic or political climate. The Office of _ Management and Budget, in its effort to reduce domestic spending, has tried to zero-fund the Office twice. Thanks to the efforts of Secretary Schweiker, the Office has retained its strength and integrity. A Congressional mandate for the Office will assure continuing public education on the hazards of smoking, and will demonstrate Congress' commitment to a healthier America. 2. We also support the provision that would require the rotation of five new warning labels to appear on cigarette :_ packages and in advertising. The Federal Trade Commission recently determined that "current cigarette advertising practices '.. ~ may mislead consumers by omitting material facts about the health risks of smoking". The report indicated that consumers do not know enough about the harmful effects of smoking and often underestimate the risks of suffering from health problems related to smoking. The current warning label is overexposed and too non- specific as to the health hazards of smoking. We feel that disease- specific warning labels tailored to varying populations (such as pregnant women) will more effectively inform consumers about the health problems associated with smoking. Rotating the labels so that the label statements will appear an equal number of times on each brand of cigarettes and advertising during a fifteen month 225 - 7 - =:od will aid in efforts to get more the public in the future. Varied wa ,:_ater dialogue between physicians and 3. We strongly concur that a 3 cigarette packages should be requir :..onoxide yield of cigarette smoke as we :-td nicotine. Carbon monoxide is one o _r:gredients of cigarette smoke, in that ,_lity to carry oxygen to the cells. .irticularly harmful to pregnant women ._,ctor in coronary heart disease, sudde :d chronic respiratory diseases. 4. S. 1929 should be amended :n the companion House legislation (H.R t:c civil penalties for violation of th outlined in the bill. In conclusion, we feel that t `_or a national education effort on the •:?elming. Study after study has establ and lung cancer, cardiovascular disease Consumers do not have all of the facts between not smoking and smoking. Cigar $1.0 billion on advertising their produ times the amount expended on public edu establishment of an Office on Smoking a

240 Oorever, the agency also noted the weakness of this proposed strategy: This strategic option assumes yas will become a major health issue. To ensure it becomes an issue will require - an educational approach in introductory advertising. It Ss questionable whether any cigarette manufacturer should be publicizing a new health hazard for cigarette smokers. The desire to.avoid spelling out the gas hazard in adver- tising cogld severely weaken the effectiveness of this approach SS. Ultimately, Brown and Williamson documents indicate that it elected not to educate the public about the health hazards associated with the gases in cigarette smoke and not to focus the Fact ad campaign on the low gas issue. The reason for Brown and Williamson's decision is explained in a document entitled "Fact 1977 Repositioning and 197! Marketing Summary: Until the problem of gas becomes public knowledge through government investi ation or media covera e, a low gas benefi rill rema n of little strategic value. [emphasis .AA.A1;6 . . . The rationale is restated in a memorandum from the representative of the Brown and Williamson 'Brand Group" which had overall responsibility for Fact: we do not support definition in advertising of the problem of gas in order to specifically communicate its consumer benefit and distinguish it from low "tar". To supply such definition would require overt references to the alleged ciliatoxic and cardiovascular ill effects of smoking. The possible ramifications of this in the Legal, Regulatory, and Policy areas are appalling...a likely result of such 55 Id., at 6. 56 Document 35523 -'Fact 1977 Repositioning and 1978 Marketing Plan Summary." 2-23 241 March 24, V STATEMENT of the BAKERY, CONFECTIONERY & TOBACCO WORKERS INTf to the SENATE COMMITTEE ON LABOR AND HUMAN I Re: S. 1929, "The Comprehensive Smoking Prc Act of 1982" The Bakery, Confectionery and Tobacco V Union represents over 160,000 workers in the Canada. Approximately 30,000 of our members U.S. tobacco industry. We present this testimony on behalf of those who are employed in that industry, as in the various aspects of the food productic speak on behalf of the many workers in the t are not organized and do not, therefore, ha~ to represent them at the hearings. We oppose S. 1929, The Comprehensive Sr Education Act, for two very important reasor First, it threatens our industry and ot needless loss of sales, earnings, and ultim~ Second, it threatens a host of other wc tries and the general public with the loss c hazardous environmental and occupational exI To put it plainly, this legislation is be. It is not merely a harmless labeling bi first step down the road to prohibition. Ir merely a tobacco and health bill, but rathei

260 Lung Diseases, March 5, 1982 Page 13 antitrypsin deficiency that is involved in chronic obstructive pulmonary disease (44). Familial aggregation of chronic bronchitis independent of cigarette smoking, sex, respiratory illness history, residence in common household, geographical distribution and antitrypsin variants has also been reported by Tager et al (45) in 1978. There has also been revived interest in the concept of a congenital or developmental etiology of pulmonary emphysema (46). 'Additional research directed at the basic cause of emphysema may lead to the identification of additional genetic factors that result in developmental abnormalities leading to adult pulmonary emphysema. e. Infections. A recent report on the Tecumseh study reveals that acute infection may play an independent role in the pathogenesis of chronic respiratory disease (47). For serologic infection rates for three viruses and M. Dneumoniae in males, the incidence of bronchitis is higher for nonsmokers (23%) than in smokers (8.8%). Lebowitz and Burrows (48) arrived at a similar conclusion, i.e. acute respiratory illness is a major risk factor in the etiology of chronic obstructive •lung disease. f. Alcohol consumption. Since 1977, there have been:~'s:• -several reports that consumption of alcohol is associated with ° 263 Lung Diseases, March 5, 1982 higher incidence of chronic bronc.`. study, Lebowitz (52) has cor.cl independent risk factor for chroni There are also earlier observa rats causes pulmonary cellula immunologic reaction, and increasE (53-55). D. CONCLQDING It is the opinion of the au cigarette smoking is not "th obstructive lung diseases, such as opinion is based on the author's interpretation of literature on.the additional research is needed different risk factors for chronic important in a causal sense. ~ ~.J . ~ ~ ~ ~ ~ .

256 Lung Diseases, March 5, 1982 Page 9 et al on accelerated clearance in donkeys have been cited, but their article on human clearance stimulation in smokers (34) has been omitted, thus giving readers the impression that the phenomenon has only been seen in donkeys. Camner, who pioneered in clearance studies in man and whose technique has been adapted by many clinical pulmonary physiologists, has been overlooked. The basic concept that has evolved from Camner's work is that adrenergic stimulation increases mucociliary transport (35), an effect to be expected from cigarette smoking. Patients with predominant pulmonary emphysema but withcut chronic bronchitis are reported to have no impairment of mucociliary transport (36). Therefore, it is unlikely that smoking, by accelerating airway clearance, would contribute to the paEfiogenesis bf emyphysema. c. Proteolytic lung damace. The hypothesis that cigarette smoke causes a protease-antiprotease imbalance and in turn potentially leads to pulmonary emphysema is based on a group of selected observations. There is no discussion as to why the hypothesis has not been generally accepted. Turino (37), the first researcher to show that proteolytic enzymes_ influence the pulmonary mechanics in vivo, has noted flaws in the hypothesis that emphysema is caused by the imbalance of protease and antiprotease: 257 Lung Diseases, March 5, 1982 "An inconsistency for the prim alteration as a mechanism fo- emphysema has been a failu: alterations in elastin contei human emphysema. Morphologica: have appeared disrupted and c data from human lungs (Johnson Pierce and Eocott 1960; anc with the exception of that of F (1958), have shown no reduc elastin content by gravimetric The above coaiments can be reinforced by of Kuhn et al (38) that hamsters intratracheally and developing emphy elastin content. Even lung fluid smokers and nonsmokers showed no di. enzyme content (38a). C. Ecidemiologic StudiE Increased mortality from pulr chronic bronchitis among smokers cor.

230 explicit and varied. Their constant repetition in advertising which reaches vast numbers of Americans of all ages must be viewed as significantly contributing 'to the portrayal of the desirability of smoking.30 Thus, the dominant themes of cigarette advertising are that smoking is associated with youthful vigor, good health, good looks and personal, social and professional acceptance and success, and that it is compatible with a wide range of athletic and healthful activities. One theme is conspicuously absent from all cigarette ads. Although these ads contain the required general warning, they make no mention of the numerous and specific adverse health consequences of using the advertised product.31 /IV. ADVERTISING THEMES AS DESCRIBED BY THE MANUFACTURERS' ~ MARKETING PLANS The cigarette companies' documents reinforce the findings of the staff about the themes of cigarette advertising. For example, R.J. Reynolds' 1977 marketing plan for Salem states explicitly that: Motivational research has identified the phenomenon of image projection as a highly motivating force. Therefore, through the association of SALEM, and its brand styles rith emulatable personalities and situational elements that are compatible with the aspirations and lifestyles of contemporary young adults, this important target segment will be attracted to the brand. Importantly, older smokers also relate 231 favorably to this personality type; reinforcement of the current franct simultaneously achieved.32 The same marketing plan indicates that a pri promotion of Salem has been to associate the lifestyle of "young adult males' who are "ma confident, self-assured, daring/adventurous, nians for other cigarettes are similar. A L project the image of •an independent, self-r take-charge kind of person."34 A Winston me nan's man who is strong, vigorous, confident :nature.'35 Liggett i Myers' documents show that the balloon high above land sought to give the c -Lth "lightness and exhilaration."36 L&M's position Lark as a'youthful, contemporary b lifestyles of the modern smoking public." I 32 Document A900022 -'Salem 1977 Annual Mar 33 Id. 34 Document A900003 -'RJR Statement of Busi :igarettes." 30 1964 Cigarette Rule, supra, 20 Fed. Reg. at 8342. 31 To the best of our knowledge, cigarette companies never have provided health information, other than the required warning and 'tar' and nicotine figures, in their advertisements. 2-13 a! 35 Document A900001 -'Winston King 1978 Mar 36 Document A900230 - "1974 Lark Annual Mark 2-14

237 feels good, smoke it.... 47 BiW documents also show that it translated the advice on how to attract young 'starters• into an advertising campaign featuring young adults in situations that the vast majority of young people probably would experience and in situations demonstrating adherence to a"free and easy, hedonistic lifestyle.'48 Other documents submitted by BiW show that the company has attempted to capitalize upon the erroneous consumer perception that there is s health i>enefit to smoking mentholated cigarettes. Documents pertaining to the marketing of Rool cigarettes demonstrate that the company is aware of the consumer misperception about the relative safety of menthol cigarettes and utilizes it in the development of advertising strategies for Rools.49 47 These strategies were employed in a six-month media campaign conducted in three test cities in 1976. The advertising allotment for the campaign was approximately ten times the normal advertising dollar amount for a six month period. (Document A015486 - Memorandum from M.M. Matteson to V.C. Broach, July 14, 1976, emphases added). 48 Document A080115 -'Viceroy Marketing/Advertising Strategy,' January 26, 1976. 49 In 1976, BiW held four focus group discussions to gauge menthol smokers' responses to a new Rool 120mm cigarette. The majority of the participants were menthol cigarette smokers. In a number of cases, the participants told BiW that they switched to menthol either for health considerations or from a general feeling that menthol cigarettes are less dangerous. According to B6r1, a"pseudo-health image" has accrued to mentholated cigarettes. (Document A080675 - 'Low Tar Longs Project - Creative Agency Assignment,' 1977.) By characterizing the health image of mentholated cigarettes "pseudo," BiW.admits its knowledge that menthol is of no health benefit to (Continued) 2-20 0 0 0

263 Lung Diseases, March 5, 1982 Page 16 histamine during inhalation of cigarette smoke and anoxemia in the heart-lung and intact dog preparation. Arch Environ Health, 1966, 12, 605-711. 13. Folle LE, Samanek M, Aviado DM: Cardiopulmonary effects of tobacco and related substances. II. Coronary vascular effects of cigarette smoke and nicotine. Arch Environ Health, 1966, 12, 712-716. 14. Samanek M, Aviado DM: Cardioou Lmonary effects of tobacco and related substances. III. Pulmonary vascular effects of cigarette smoke and nicotine. Arch Environ Health, 1966, 12, 717-724. 15. Aviado OM, Palacek F: Pulmonary effect of tobacco and related substances. I. Pulmonary compliance and resistance in the anesthetized dog. Arch Environ Health, 1967, 15, 187-193. 16. Palacek F, Aviado DM: Pulmonary effects of tobacco and related substances. II. Comparative effects of cigarette smoke, nicotine and histamine on the anesthetized cat. Arch Environ Health, 1967, 15, 194-203. 17. Palacek F, Oskoui M, Aviado DM: Pulmonary effects of tobacco and related substances. III. Inhibition of synthesis of histamine in various species. Arch Environ Health, 1967, 15, 204-213. 18. Palacek F, Palecekova M, Aviado DM: Emphysema in immature rats: condition produced by tracheal constriction and papain. Arch Environ Health, 1967, 15, 332-342. 19. Ito H, Aviado DM: Pulmonary emphysema and cigarette 20. smoke: experimental induction and use of bronchodilators in rats. Arch Environ Health, 1968, 16, 865-869. Aviado DM, Watanabe T: Functional and biochemical effects on the lung following inhalation of cigarette smoke and constituents. I. High- and low-nicotine cigarettes in mice. Toxicol Apol Pharmacol, 1974, 30, 185-200. u• Watanabe T, Aviado DM: Functional and biochemical effects on the lung following inhalation of cigarette smoke and constituents. II. Skatole, Acrolein, and Acetaldehyde. I

239 0 t In April 1977, Brown and Williamson's advertising agency, Post- Keyes-Gardner, Inc., presented Brown and Williamson with its marketing and strategy recommendations for the reintroduction of Fact cigarettes.52 The ad agency proposed two possible strategies to distinguish Fact from other cigarettes: 1) "More complete health protection through selective gas filtration," 2) "More taste and satisfaction in a low tar cigarette."53 About the proposed strategy focusing on better health protection as the result of fnhaltrg lower levels of gas, Bost-Reyes-Gardner, Inc. wrote: A secondary opportunity to distinguish Fact from the mass, of tar number claim is by capitalizing on the product's unique selective gaa filtration. This would demand • roduct 1ma e• advert~sing and would provide the brand w t  rea po nt of difference. It would mean expanding the cigarette health issue beyond tar to encompass gas. However, this would require establishing 'gas" as a meaning- ful health hazard in cigarettes because currently there is very low consumer awareness or comprehension of the gas problem. The Agency believes one of the major problems with the introductory advertising for Fact was that it failed to educate health concerned consumers about the dangers of gas. This failure to establish the gas problem meant that Fact's selective filtration promise was meaningless to the majority of the target audience. However, if smokers are effectively educated regarding this problem, the selective gas filtration promise may still be powerful, particularly among the very health conscious.54 52 Document 35524 - Brown & Williamson, "Marketing Advertising Strategy Recommendations for the Reintroduction of Fact Cigarettes," April 18, 1977. (The same document was also submitted by Post-Keyes & Gardner, Inc. - Document 714569). 53 Id. 54 Id., at 3. 2-22 I

261 Lung Diseases, March 5, 1982 ?age 1.4 higher incidence of chronic bronc=itis (49-51). _*n the Tucsor. ttudy, Lebowitz (52) has concluded that alcoholism is an independent risk factor for chronic obstructive luns disease. There are also earlier observations that alcohol feeding in rats causes pulmonary cellular changes, depression of iamunologic reaction, and increased susceptibility to infection (53-55 ). : . D. CONCLUDING REMARKS It is the opinion of the author of this submission that cigarette smoking is not "the major cause" of chronic obstructive lung diseases, such as pulmonary emphysema. This opinion is based on the author's own research studies and his interpretation of literature on the subject. It is clear that additional research is needed to determine which of the different risk factors for chronic obstructive lung disease are important in a causal sense. _ .

273 0 dealt generally with the evaluation of risks in everyday life; my presentation only mentioned smoking in passing, but it placed the smoking issue in a wider context of the quest for risk reduc- tion.) Consequently, I have a good measure of familiarity with the various arguments made in the course of this controversy. As to the bills under consideration here, I have no doubts whatever about the sincere intentions of the sponsors. What concerns me is the manner in which such legislation, if enacted, could be used by the anti-smoking forces. My concern is that this would be another step in a long-term campaign of stig- matizing and even criminalizing smoking. First, smoking is stigmatized as a disease; then, smokers are physically segregated; finally, smoking would be viewed as abnormal behavior, to be eventually eradicated or suppressed in all but the most private locations (to be engaged in, if at all, by consenting adults in the privacy of their bedrooms). 3ut what concerns me even more is what this development says about the role of government (in this case, the Federal government) in our lives. It seems to me that those who favor or are considering this legislative proposal should give seYious thought to two matters -- the general cultural context and the issue of govern- ment power. . The General Cultural Context The campaign against smoking is not an isolated phenomeaon; rather, it must be seen in a much wider context of i - 3 -

270 -3- ]qoked at the incidents of non-severe congenital anomalies. We found that, while the incidence of these non-severe birth defects among children of h.avy smokers (more than 20 cigarettes per day) was slightly more than among children of non-smokexs, the incidence among children our light smokers (less than 20 cigarettes per day) was equal to that of the children of non-smokers. These observations, again, do not support the statement in the proposed Bill that cigarette smoking by pregnant women may result in birth defects. In conclusion, our data do not support the statements in the proposed Bill. 'tc 27 PETER L. 4 Worthinc Brookline, M Tel. (617) I am a sociologist, cur Boston University. The following does not necessarily represent tYh which I am affiliated. (A brief My attention was first by an article in the New York T subsequently obtained the texts o my opinion, constitute a further for some time now, interested me me as a citizen; that is, the anti-smoking movement and its a• smoking activity. I have no comaetence questions at issue. However, I c to the broader social and culture and it seems to me that it rai: questions about the scope and pu- on which any citizen has the righ What first interested aggressiveness with which anti-s their campaign. It annoyed me a should say that I smoke cigars ar. are the major targets of the anti

275 irrational to be concerned with health; of course it's not. But in the mind-set at issue, there is a tendency to deny that human life, by its very nature, is risky, and to assume that a life- style of passivity would eradicate all risks. As Wildavsky put it well, however, the greatest risk is to take no risks at all. moreover, the ultimate human risk is death, and that, alas, cannot be avoided. Thus, the utopia of a risk-free existence finally denies the root fact of our mortality. All these attitudes are prominent in the anti-smoking movement. Reading the latter's literature, one gets the impression that, if we only stopped smoking, we would live forever. For example, there is the recurring phrase of "unnecessary deaths" (allegedly caused by the "smoking epidemic") -- a ve rl curious and revealing phrase since, in the end, death is the final necessity for all of us. I do not want to be misunderstood on this point. I'm not saying that everyone who favors public policies directed against smoking is motivated by such considerations. I am saying that these are themes in the ideology of the anti-smoking -move- ment. I'm also saying that these themes are debilitating both to individuals and to society as a whole. Individuals and sccieties that dwell on the fearful dangers besetting them will ter.d to avoid risks of any kind, which is not a healthy posture in the face of the challenges of life. There is another very important point to be made about the general context of this issue: There are significant class differences both in the general themes just described and - 7 -

244 -4- We question the wisdom of setting up a new anti-smoking bureaucracy with unspecified spending authority when other essential health and social programs are being slashed. Mr. Chairman, we do more than "seriously question the wisdom" of this bill -- we reject its folly. Now, let us turn to the second major ground for our opposition. Section 3 deals with so-called findings. These blame every major chronic disease on smoking, and thereby create a smoke-screen for the occupational and environmental factors involved. The very first one states that "the Congress finds that cigarette smoking is the largest preventable cause of illness and premature death in the United States and is associated with the unnecessary deaths of over three hundred thousand Americans annually." At first glance, it is difficult to conceive of a statement more alarming, more compelling, more demanding of remedial action. It calls for nothing short of outlawing tobacco. But on reflection, this finding is curiously phrased; the words have an Alice-in-Wonderland quality. Their meaning is hard to pin down. For example, if cigarette smoking is the "largest preventable cause of illness," what are the second and third largest preventable causes? What are the "non-preventable" causes? Is smoking "preventable" while environmental pollution is not? If these statements of findings had to be substantiated, as the FTC requires advertising statements to be, I doubt they would sur- vive. The bill says flatly that smoking "is associated with" over 300,000 deaths a year. Yet, the first Surgeon General's Report in 1964 stated that: The total number of excess deaths causally related to cigarette smoking in the U.S. population cannot be accurately estimated. 245 -s- The Committee which wrote the repor of trying to make such calculations, but "it involves making so many assumptions i that it should not attempt this..." That restraint is as needed now as i We believe the findings in this bill will be misused to the detriment of milli to occupational hazards. We oppose this ' show our solidarity with: o Coal miners whose black lung diset blamed on smoking. o Textile workers whose brown lung d been blamed on smoking. o Asbestos workers whose lung diseas blamed on smoking. And the list includes uranium workers workers, shipyard workers, and many others and the voluntary health organizations sho blame-the-victim approach and get at the ti disease. Earlier this year, the Congress heard scientists who reported that "at least 11 p 21 percent" of lung cancer in the U.S. can pollution. They noted that the proportion decreased and that cigarettes now contain h: 20 years ago, yet lung cancer rates continu~ indicates that something else is at work," i But to the supporters of this bill, it' Recently, the National Wildlife Federat "responsible scientists believe air pollutio

267 Lung Diseases, March 5, 1982 Page 20 52. Lebowitz MD: Respiratory synptoms, and disease related to alcohol consumption and ssoking. Am J Boidemiol, 1977, 106, 248. 53. Rossi MA: Alcohol-induced pulmonary changes in rats. ExDerientia, 1975, 31, 573-575. 54. Palmer DL: Alcohol consumption and cellular immunocompetence. Larynaoscofle Supol, 1978, 88 Part 2, 13-17. 55. Hurley DL: Infectious complications of alcoholism. ' Postgrad Med, 1977, 6, 160-162. 95--077 0-82-18

259 suggested by seven prospective studies summarized in the 1979 Report (page 6-10). However, these studies are far from being consistent and tend to suggest that many risk factors including cigarette smoking need to be considered in studying the etiology of chronic obstructive lung disease. a. Air Pollution. The role of air pollution as a risk factor in chronic obstructive lung disease has been the subject of several publications not cited in the 1979 Report. Studies in Tucson, Arizona (39) and in Busselton, Australia (40) showed that an urban environment may contribute to thp normal increase in closing volume with age and to the incidence England than in the United States has been cited as a cause of the lower ventilatory functional measurements among British males (41). b. Socioeconomic Status. The presented in the 1979 Report (page 6-39) by Higgins of residents of Tecumseh, Michigan. prevalence of chronic bronchitis for various groups ranged from 12.3 for professionals and managers to 30.0 for laborers. An uncited 1977 survey by Lebowitz (42) is more accurate because the diagnosis of emphysema and chronic bronchitis was confirmed by medical examination. His most t: Lung Diseases, March 5, 1982 important conclusion is that smoke: incidence of chronic obstructive 1; or exsmokers when the adults were grc and educational backgrounds. E inversely related to prevalence of even after controlling for sex, age a C. A1Dhalantitryosin def statement in the 1979 Report tha deficiency have the onset of symptc lung disease probably •abbreviated selected citations. Two publications accurately quoted. Chan-Yueng et only examine subjects with mild defic with severe antitrypsin deficiency with smoking. 1Cidokoro et al (43) co: subjects with severe deficiency tha- and cigarette smoking, influence the : d. Other genetic and familic discussion in the .1979 Report increasing evidence of familial obstructive lung disease. The stuc of lung disease conducted by Cohen et there is a familial factor unrelate

266 Lung Diseases, March 5, 1982 Page 19 41. Holland WW, Gilerdale S: The epidemioiogy of chronic bronchitis. Commun Health, 1975, 6, 2737-2778. '42. Lebowitz MD: The relationship of socio-environmental factors to the prevalence of obstructive lung diseases and other chronic conditions. J Chron Dis, 1977, 30, 599-611. 43. Ridokoro Y, Kravis TC, Moser KM, Taylor JC, Crawford IP: Relationship of leukocyte elastase concentration to: severity of emphysema in homozygous alpha -antitrypsin-deficient persons. Am Rev Reso Dis, 1977, 115, 793-803. 44. Cohen BE, Chase GA: Familial aggregation of chronic, obstructive pulmonary disease. Epidemiologic and genetic approaches. Lung Biol Health Dis. 1978, 11 „ 201-255. 45. Tager I, Tishler PV, Rosner B, Speizer FR, Litt M::. Studies of the familial aggregation of chronic bronchitis and obstructive airways disease. int J EDidemiol, 1978, 7, 55-62. 46. Rilburn RH: New clues for the emphysemas. Editorial. Am J Med, 1975, 58, 591-600. 47. Monto AS, Ross HW: The Tecumseh study of respiratory illness. X. Relation of acute infections to smoking, lung function and chronic symptoms. Am J£Didemiol, 1978, 107, 57-64. 48. Lebowitz MD,- Burrow B: The relationship of acute respiratory illness history to the prevalence and incidence of obstructive lung disorders. Am J Epidemiol, 1977, 105, 544-554. 49. Saric M, Lucic-Palaic S, Horton RJM: Chronic non-specific lung disease and alcohol consumption. Environ Res, 1977, 14, 14-21. 50. Heinemann 30: Alcohol and the lung. A brief review. J Med , 1977, 63, 81-85. 51. Emirgil C, Sobol BJ: Pulmonary function in former alcoholics. Chest, 19977, 72, 45-51. 267 Lung Diseases, March 5, 1982 52. Lebowitz MD: Respiratory sy:apt alcohol consumption and smok 106, 248. 53. Rossi MA: Alcohol-induced F Exoerientia, 1975, 31, 573-575. 54. Palmer DL: Alcohol cc immunocompetence. Laryngoscor 13-17. 55. Hurley DL: Infectious comF • Postgrad Med, 1977, 6, 160-162. 95-077 0-82-18

277 .k !d on as t- the .^.ev and power, but of education that supposedly legitimatizes their claims to "know better". The bottom line of this pretension is always "We know what is best for you and, therefore, we have the right to tell you how you should live." In everyday situations, the response of working-class people to such elitist interventionism tends to be quite forceful (and frequently unprintable). Cultural themes are typically related to vested interests of one sort or another. The Temperance Movement kept thundering against the vested interests of the liquor merchants, but in time it was quite correct to speak of "Temperance interests". Similarly, the anti-smoking movement keeps attacking the "smoking interests" .(which are, of course, identical with the tobacco interests); but by now one may also speak of "anti-smoking interests" -- that is, the vested interests of those who stand to gain (be it in terms of privilege or power) from the campaign against the regulation of, or the litigation involving smoking. Vested interests, inevitably, have different interpretations of available data. How the evidence may look to an absolutely disinterested observer (say, a non- smoking scientist from outer space) is an altogether different question, but one that, I think, has little to do with the political dynamics of the situation here and now. (One may add', that verl few people indeed have either the time or the com- petence to go through the by-now massive body of scientifrc literature on the subject and to form an objective view of their ® - 7 -

i 227 ACTION ON SMOKING AND HEALTH 2013 H St., N.W. • Washington D.C. 20006 •(2021 659<310 TESTIMONY OF ACTION ON SMOKING AND HEALTH (ASH), BY ITS EXECUTIVE DIRECTOR AND CHIEF COUNSEL, JOHN F. BANZHAF III, BEFORE THE SENATE CONMITTEE ON LABOR AND H[MAN RESOURCES, CHAIRED BY THE HONORABLE ORRIN G. HA1CH, ON THE CONPREHENSIVE SMOKING PREVENTION EDUCATION ACT (S. 1929) Submitted April 2, 1982 I am happy to appear before you on behalf of Action on Smoking and Ff=alth (ASH) to strongly support The Comprehensive Smoking Prevention Fducation Act. As you may know, Action on Smoking and Health is a national nonprofit organization which serves as the legal action arm of the antismoking community. In this capacity it has been directly involved in virtually all major actions concerning cigarette smoking and advertising. For example, in my individual capacity I filed the complaint at the Federal Communications Commission which led to the requirement that stations make free time available for antismoking messages under the Fairness Doctrine. Shortly thereafter ASH was formed and played a major role in upholding the Congressionally-imposed ban on cigarette advertising. ASH was also instrumental in forcing "little cigar" ads off the air and in persuading the Federal Trade Commission to file complaints against the tobacco industry concerning various cigarette advertisements. In my individual capacity as a Professor of Iaw at the National Iaw Center of the Ceorge Washington t4iiversity I was able to persuade the Federal Trade Commission to adopt corrective advertising as a weapon against deceptive ads. Since that time I have participated in numerous proceedings concerning deceptive advertising at the Commission, including a major fact-finding proceeding concerning the permanent effects of advertising. On the basis of this experience it is my judgment that the requirement of stronger, clearer, more specific health warnings is a necessary and long-overdue step. This, coupled with the idea of changing, or "rotating," warnings will do much to make them more effective and to bring them forcefully to the public's attention. Because the need for these warnings has been amply demonstrated in other testimony and in many stu3ies by the Federal Trade Commission and other agencies, I will not dwell on this aspect. However, I think it is important for the Congress to appreciate the depths to which the tobacco industry will descend to try to lure young people into smoking and to negate or otherwise distract their attention from the serious health problems it presents. 1b dramatize this, I am attaching, as part of my testimony, a portion of a confidential report prepared by the Staff of the Federal Trade Commission and -- for reasons one may well conjecture -- not made available to Congress or the public. 1fie report demonstrates many things. First, the industry apparently has nothing but contempt for people who use its product or people who might be persuaded to do so. For example, a tobacco industry report at page 2-16 of the Federal Trade Commission's confidential document says, 0

278 own. It would seem to follow from this obvious fact that most people, on either side of the controversy, will base their res- pective positions on something other than rigorously considered scientific judgment.) These general considerations are relevant in that they lead to the following questions for those who favor this legis- lation: Do they want to further an overall attitude of unrealistic risk-avoidance in the society? Do they want to stig- matize people and lifestyles that deviate from what is considered proper and wholesome in the elite milieus of the society? More specifically, should public policy and law impose upper-middle- class values and lifestyles on the rest of the population? It seems to me that both realism and democratic values incline one toward negative answers to all three questions. In sum: I don't believe that what American society needs right now is a new version of creeping Prohibition. The Issue of Government Power Americans are rightly proud of living in a pluralistic society. In such a society, there will always be conflicts between discrepant values and lifestyles, and evangelism of one's own values and lifestyles is protected by the First Amendment. Also, there will always be conflicting vested interests in such a society, and the idea that these can all be resolved into harmony is utopian and undemocratic. The matter becomes very serious, however, when one ideological party seeks to utilize the powers - 8 - 279 of government in elevating its o interests to monopoly status. In • Federal government, this is doubly and Federal legislation is involv consideration here, there is "an i. issue of government power. important issue. In my The cultural theme of : necessarily lead to an expansion of there are other ways by which indi• themselves from the risks they fea government is increasingly looked guarantor of all desiderata in humz that government should be expected risks they want to avoid. In the e: Since many of the risks individuals a result of their own actions, gover people from themselves -- a curious cratic ideals. Ivan Illich recently pointed oL increasingly taking on the characte becomes mater et magistra, "mother a all nurture and all instruction. Th function of the state is particularl: under consideration here. Surely, General's report on the alleged peri- - 9 -

248 Comments on H. R. 4957 -- Proposed S. 1929 "Comprehensive Smoking Prevention Education Act of 1981" Domingo M..Aviado, M. D. President, Atmospheric Health Sciences, Inc. P. 0. Box 307, Short Hills, New Jersey 07078 Adjunct Professor of Pharmacology University of Medicine and Dentistry of New Jersey Consultant and Former Member of the Clean Air Scientific Advisory Committee, Environmental Protection Agency The proposed bill, H.R. 4957, states that "Congress finds that ... smoking is the major cause of chronic obstructive lung diseases such as emphysema" (Section 2 (2)]. The statement paraphrases one sentence in the introduction of the Chapter on non-neoplastic bronchopulmonary diseases of the 1979 Report of the Surgeon General on Smoking and Health, which reads 'cigarette smoking is the most important cause" (1). a careful examination of the chapter raises questions about the validity of that statement because of the complexity of the causation of chronic obstructive lung diseases in general and of pulmonary emphysema in particular. Although there are a multiplicity of suspected pathogenic mechanisms and of etiologic factors, the Surgeon General's Report refers only to those relating to cigarette smoking with an incidental discussion of outdoor pollution, indoor pollution, infections Lung Diseases, March 5, 1982 249 and familial or genetic predisposit. submission intends to discuss investigations and those of others c that smoking is either "the major cz cause" of chronic obstructive lunc reasons are as follows: (a) Animal experiments have pulmonary emphysema from 1 cigarette smoke, although successfully done so for su oxides and other inhalants. (b) Functional and histopath humans show uncertain and in cigarette smoking that do not relationship between ciga chronic obstructive lung dise (c) Epidemiologic stud association of chronic obs several risk factors, such as and indoor pollution, a

283 machinery of the state, the viability of the private insurance system, and even the economic well-being of the society (the latter a sort of offense against the Gross National Product). When one puts the concept of "social costs" in these terms, one becomes (or should become) pensive, for there is a totalitarian thrust to this logic. After all, what actions of mine do not entail "social costs" in the aforementioned sense? I think one must answer: Very few indeed. Thus, my lazy and self-indulgent lifestyle endangers my health (with all the alleged risks to society enumerated above); my child-raising patterns (so say various experts) risk making neurotics or juvenile delinquents out of my childrer.; my hobby of tinkering with household machinery endangers the livelihood of plumbers and mechanics, not to mention my gardening tastes which are a standing offense to the aesthetic sensibilities of my neighbors -- and so on. In other words, once the conceot of "social costs" is acceoted as a rationale for government interference with orivate individual behavior, it is difficult to see just where such interference would stop. This point is so important that a further analogy is appropriate. In the current controversy, there is ccr.stant mention of the alleged economic costs of smoking, this supposedly justifying anti-smoking efforts by government. The manner in which these alleged costs are calculated strikes me as rather fanciful (the figures depend on all sorts of presupoosit:cns, medical as well as economic, that seem cuestionable) but let that 95-077 0-82-19

250 Lung Diseases, March 5, 1982 Page 3 occurrence of previous infections, familial predisposition and genetic susceptibility. A. Exverimental Animal Studies on Pulmonarv Emohvsema. From 1948 to 1977, the author and his colleagues conducted smoking-related research at the University of Pennsylvania School of Medicine where he was a Professor of Pharmacology. The nature of this investigation was guided in part by comments in the 1964 Surgeon General's Report on Smokina and Health which suggested the need for definitive data on the relationship between cigarette smoking and auInb,,:rww ;?.I. ...;J.thcuVtb p.5-ght A° the z.uxhor's publications were mentioned in the 1967, . 1968, 1969 and 1971 Surgeon General's Reports, the coverage was brief and out of co ntext (3-6). Over thirty of his articles on cigarette smoking and over a hundred articles published in the 1970's on related subjects were not mentioned.The government writers cannot be criticized entirely, however, because they have been examining only "Smoking and Health" rather than conducting a global review of all suspected risk factors of chronic obstructive lung diseases. Yet this isolated emphasis on one Y Lung Diseases, March 5, 1982 251 factor has limited the usefulness of scientific documents. a. ExDerimental Pulmonary E 1981 report of the Surgeon Genera no•published studies that acceptably that the development of emphysem. smoking. ... One study in which dog. through chronic tracheotomies re- emphysema [Auerbach, Hammond, Rirr (1967)). The lesions were not con( not been confirmed by others.• The initial series of studie: and his colleagues dealt with the e: cbgs (6-17). These studies failed tcl cigarette smoke caused pulmonary e not surprising that there has been nc study reporting the development of should be noted that the single questioned in the 1981 Surgec h'-ghlighted in earlier Reports (inclu been responsible for the impressio an established cause of pulmonary emp 95-077 0-82--17

27 cultural and social developments in this society. Specificallv, ~ it is part of a pervasive quest for security on the part of large numbers of Americans (who, incidentally, share this trait with people in other Western societies). There is a mind-set in this that cannot be unfairly described as institutionalized hypo- chondria: Life is full of hidden dangers and risks, many of them imposed on the innocent citizenry by rapacious forces beyond- their control; this is intolerable; citizens must, therefore,` " organize to combat these evil forces and, wherever possible," enlist government in this battle. The obverse of this vision of an infinitely dangerous environment is a utopia in which dangers and risks are reduced to a minimum if not eliminated altcgether. The combination of these two themes, one hypochondri- acal and the other utopian, makes for a curious ambivalence of timidity and aggression. On the one hand, people with this mind-set see themselves constantly surrounded by terrible perils, many of them deliberately caused or exploited by forces perceived as enemies; on the other hand, the same people beccme increasingly combative, aggressive and single-minded in the pursuit of their own goals. One can find this constellation of attitudes in a con- ' siderable variety of public issues. But, logically enough, health is a favored focus of these concerns. It is also logical (at least in a pyZ chological sense) that individuals greatly concerned about their own health should be attracted to the anti-smoking movement. Now, I am not saying that it - 4 - _:rational to be concerned with he _.n the mind-set at issue, there ie ___e, by its very nature, is risk~ stvle of passivity would eradicate _= well, however, the greatest ris ..,_eover, the ultimate human risk -annot be avoided. Thus, the uto- "_nally denies the root fact of -=titudes are prominent in the ant ::e latter's literature, one gets t -;=cpped smoking, we would live for recurring phrase of "unnecessar "smoking epidemic") -- a very 3_nce, in the end, death is the finj I do not want to be misun c sayina that everfone who favor =?a.ast smoking is motivated by sucr `•`•at these are themes in the ideolo -ent• I'm also saying that these th -~ci•riduals and to society as a whol = 3= dwell on the fearful dangers b =-'Oid risks of any kind, which is nc =1ce of the challenges of life. There is another very impo = e general context of this issue: --°ferences bcth in the general th, - 7 -

280 tM public has been bombarded with negative communicatiorn about this practice, including the warning notice printed, under penalty of law, on all cigarette packages. It is now alleged that the message has not sufficiently registered and that it ought to be reinforced. One detects here the note of irritation familiar to all teachers whose pupils fail to learn the proper lessons. Such irritation, I suppose, is quite justified when children refuse to learn arithmetic or grammar. In this case, though, it carries the disturbing implication that the American public actually consists of child-like individuals. But what is the evidence for this? As far as I know, the only evidence is that smoking has not declined to the degree that anti-smoking activities would wish. But is it not plausible to argue that adults, with all the information available to them, make their own decisions -- including decisions as to what risks to take? There is something very disturbing about the notion that government in a democracy has a "magisterial" function. It becomes even more disturbing when government pushes its 'teachings" ever more aggressively as people don't take to it in the opinion of the "teachers". A democracy presupposes that its citizens are responsible adults; therefore, when that same government engages in activities that treat citizens as recalcitrant children, they have a right to be offended. The proposed policy of rotational warnings has precisely this character of infantilization: "Now, Johnny, since you haven't learned your lesson, you will •, hundred times . . . - t4acistr< The most troublesome implicit threat of an ever-deer influences in the private lives person will deny that, in a mc protect individuals from risks government denies me the right unaware others. It is quite a d protect me from risks incurred b own actions. An analogous case may drive my car, I obviously risk government, quite rightly, seek government examines and licenses dangerous driving, mandates vari so on. No reasonable person wi: behavior a violation of the indr another matter, though, when gov against the possible risks of my faced in the debate over involu: Should government not only insi: functioning devices that protect and the like), but also devices want them or not, protect me, th without which I cannot start the

CnisnAnrs Arn f)on(irnuir, tn Ynnr I In;dtN

271 March 5, 1982 PETER L. BERGER 4 Worthington Road Brookline, Mass. 02146 Tel. (617) 738-5703 I am a sociologist, currently a University Professor at Boston University. The following is a personal statement, which does not necessarily represent the views of any institution with which I am affiliated. (A brief vita is enclosed.) My attention was first drawn to H.R. 4957 and S. 1929 by an article in the New York Times on January 30, 1982; i subsequently obtained the texts of the two bills. The latter, in my opinion, constitute a further step in a development that has, for some time now, interested me as a sociologist and disturbed me as a citizen; that is, the growing militancy of the anti-smoking movement and its attempts.to control or limit smoking activity. I have no competence with regard to the medical questions at issue. However, I do claim competence with regard to the broader social and cultural context of this development, and it seems to me that it raises some rather fundamental questions about the scope and purposes of democratic governance on which any citizen has the right to claim competence. What first interested me in this matter was the aggressiveness with which anti-smoking activities carried on their campaign. It annoyed me as a smoker (though perhaps I should say that I smoke cigars and pipes, not cigarettes, which are the major targets of the anti-smoking groups). No one likes

Lung Diseases, March 5, 1982 Page 5 b. Exoerimental ?ulmonarv Emai:vsema in the Rat. In 1967, the author and his collaborators developed an experimental model for producing pu lmonary emphysema in rats (18). Unlike other models reported permitted functional measurements in addition histopathologic observations signifying pulmonary emphysema. The exposure of animals to cigarette smoke did not cause pulmonary emphysema (19). Other investigators have also used the same model and have confirmed essentially its acceptability for the study of pulmonary emphysema. c. Exaerimental Pulmonary Emohvsema in the Mouse. In 1974, the author and his collaborators developed a technique for measuring lung function in the mouse that could not be performed previously (20-22). Chronic exposure to cigarette smoke simulating the dosage of smokers did not cause pulmonary changes signifying emphysema. It is a disappointment to the author that the only study comparing high and low nicotine cigarettes on pulmonary function of mice was overlooked in the 1981 Report of the Surgeon General entitled The Changing Cigarette (7). It is possible that the study was ignored .because of the unexpected observations that the lungs seem to adapt to repeated exposure of cigarette smoke. Lung Diseases, March 5, 1982 253 d. ComDarative Studies with ~ rats and mice are useful experimental toxicity of air pollutants. Animals expc products of fuel combustion show imF pathological lesions characteristic of pL bronchitis. The studies are describe Criteria Documents that have " beer Environmental Protection Agency on o2 oxidants (23), nitrogen oxides (24) ar particulates (25). This author questic cigarette smoke "the major use" of pu: primary air pollutants have been shc emphysema in experimental animals, and G cigarette smoking has not. B. Human Studies on Pulmonary : Histopathologic Changes in Cigare• The Chapter on chronic obstructi, 1979. Surgeon General's Report (pages defining the terms chronic bronchitis an( For each definition, there is a structural or pathological alterations si

202 James C. Miller, III Chairman Federal Trade Commission Page Two n.w WN D- 4a+4w1V\ M-0. hplMlF(IM 1YLwl+( l rtN0t1lL YA. r.Maw. ... .Lw.. 1qU11T O. rMN001Wf10• Y.D- n.. a..u.r 14N• A r1eR. Y0- . ...,.. JOMN l WKCNW7j11. M.O, .wr a.a...n A00V!/ v. I.UR[P, JA_ 4.D. /rw r•...ww ,we. J- ~tav..0. M-0. Q.nww• hr..1 0«w..« :OrTI!rr C. tarS+N6i.9. II. M.D. TIVM.« warC1 ~. M(L N. M.D. ~orMr 0. eILNGr4ru.0. M.D. WYIO S. G/IU/CNJ(~-:~.. M.D. 4W.r!~Cr fC'.NLM t0rlNr D. CC.'.N. u.D. r1+0>L4 C. 01C<INSON. Y.O. ,A0t4.0 2. ONrIFUl. 4,0. ..ul• . (r(M. M.0. Grs.T s. tUOT. v.D. OOrruU 0. ../1sINGra. ". a.0. r. L!G,,.D .CVJ.N. 'J 0. I. 0'NrAI .UM.wFirS. V.D. •001M1 V -... J.0. ,au.C'.s :. <LCCkr. ~J.O. SUUNrsE 7. -OrSrL up. W.(S J. LL0NUl0. 'J 0. 0,0rrar J. :uGu. v 0. ^::~Gwr C. MeOCON. •J.D. O.n .. v.N.M./. v D. CN..IIS !. 'JUUIW. V ]. 'MI~t,114 • . .MIr•1 V.0 a.NSONN(r '40. M»M ..IiuR. 'J a Cr.Plr: (. i.CKlr! '! D. DOn..: c. •. D. J.cx + aca. M D J0w•+ . naOM.uSEM ~ 0. .Onv x+luus a . •J ). t.«-•« 0-+« D..... (~« . o~.« ..._ ..:.•..._+ a . e,«rl... D..«... American College of Cardiology December,•1,0, 1981 James C. Miller, III Chairman Federal Trade Commission Sixth Street and Pennsylvania- Avenue, N.r•a. Washington, D.C. 20580 Re: File Number 792-3204 Dear lKr. Chairman: The American College of Cardiology, a orofessiona'_ medical specialty society reorssentinc over 11.CC0 physicians, scientists and educators who sreciaLize in diseases of the heart and circulatory system, is pleased to provide initial comments, with respect to the Staff Re~rt ec t*_ C_carette ?•dvertising Investication or t;•e Federal Trade Cor,n•issze.•, May 1981. The College believes the FTC has prov:ded a ase'-a' and constructive contribution to the healtc•. :a_ar::s of cic- aretta smoking. :nclosed :s the Bet`:esda Conferen_a Re- port on the "Prevention of Ccronar: Sear: Disease", which the College hopes you will find instructi•:e oc our commitment to prevention i•^n suc:l areas as c1Car2tte smoking. The conference, held Septem;er 27-29, 193C in Bethesda aaryland at the American Co'_lace of Car4iclc- gy, focused on the potential for physicians to do r,..'•- more in the coronary heart disease prevention ef'orz, especially in concert with allied health ^ v-sss:onaa The College endorses the reccm.~endatior.s ofthis cencar- ence report. •• i would like to note that the mission of the -amer'_c_- College of Cardiology is to ensure optinal ca_e 'or~ persons with cardiovascular disease or the ?ote:L: a'- =o= developina itr and ultimatel.:, t`:rouc^ acprcpriateeducs': tional and sociceconcmic activities, to contribu_e s'_° , ficantly to the prevention of cardiovascular dlsea52. The Be tzesda Cor.ference Reoort not=_d t: c'_zare_te s^eking is one o: t••_ major - ronar;. _, :=c_crs. Pace 25 det_i1s ccnc__ns ^ic _-'^tad _ ._:z '•_ 3_cc== 203 concerning the competition between thE smoking and the attractive modeling a: smoking. The Bethesda Conference Report embodie enumerated in the FTC Report, specific have credible information provided in be believed and which will provide eit* modification or prevent initial negati The Coilece believes that there has no tine neraitted for us to provide the b the various comoonents of the College, Preventive Cardiovascular Disease Ccmm: recom•mendations to allow us to more fu: issue, which we consider to be of para: •'_ease be assured that our additional - to you as soon as possible. In additic wit5 the FTC our comments an current a: on this subject. We trust you will f-1- - of assistance. ?'.ease let me or Roger C. Courtney, J.L C: GOvernAlent Relatlo'!s, know if •. -__ assistance on this or any other matzer? Sincerely, :a-^• G. Kc^7amara, N.D., F.A.C.C. President Enclosure

279 of government in elevating its own values, lifestyles and interests to monopoly status. In view of the vast powers of the Federal government, this is doubly serious when Federal policy and Federal legislation is involved. In the matter under consideration here, there is "an issue behind the issue" -- the issue of government power. In my opinion, that is the most important issue. The cultural theme of risk reduction does not necessarily lead to an expansion of government power. After all, there are other ways by which individuals may want to protect themselves from the risks they fear. But, in an age where government is increasingly looked upon as the provider and guarantor of all desiderata in human life, it is only logical that government should be expected to protect people from the risks they want to avoid. In the end, this produces a paradox. Since many of the risks individuals fear are actually incurred as a result of their own actions, government is expected to protect people from themselves -- a curious inversion of classical demo- cratic ideals. Ivan Illich recently pointed out that the modern state is increasingly taking on the characteristics of the church; it becomes mater et magistra, "mother and teacher," the source of all nurture and all instruction. The "magisterial" or teaching function of the state is particularly evident in the legislation under consideration here. Surely, since the first Surgeon General's report on the alleged perils of smoking, the American - 9 - 0 I

294 I am a member of numerous professional societies, s including the International Society on Thrombosis and Haemostasis„~ ;;>£ and the American Society of Hematology, and serve as editor for -- . . several journals in my field. I have written over 100 published " articles on various aspects of the field of hematology. I have long been interested in the subject of blood coagulation and its possible relationship to heart attacks and': cardiopulmonary disease in general. Recent reports have appeared"; in the literature describing alleged isolation and biological'l properties of certain brown pigments from cured tobacco leaf,., cigarette smoke condensates, and saline extracts of smoke. These pigments have been generally referred to as "tobacco glycoprotein" (TGP). Becker and co-workers have reported tha*_, TGP produces allergic skin reactions, induces the formation of , antibodies, and activates early clotting factors. Based upon these rather simple experiments, with respect to early blood clotting factors, Becker and co-workers have drawn far reaching conclusions that TGP therefore must also activate the remainder of the clotting system, clot lysing system, and complement system. However, there is no evidence for this sequence of events in either the Becker articles or in subsequent work. In spite of this lack of evidence, these authors have hypothesized that these possible sequential pathological events represent the ci 295 pathophysiological link betweer cardiopulmonary disease which has be To investigate more carefu al., our group, in collaboration wi by the previous published methods c 7roup found that the final produc nrocedure of Becker contains an contaminant that is introduced by f .noears to be a side product of the ..sed to form the gels for sepa -on*_aminant, polymethylmethacrylat orthopedic and dental surgery and t been implicated in allergic reactio •.:e subjected the contaminant to th clo*_ lysing, complement, and kinin Eound that the contaminant complex early coagulation Factor, Factor XI completely erroneous impression th However, it was found to have no ac currently used by the Bureau activation of the blood clotting sctivation of numerous of the earl :.ikewise, there was no activation c effect on the complement system, -3-

281 ® learned your lesson, you will write it on the blackboard one hundred times . . . ." Magistra indeed! The most troublesome aspect here, however, is the implicit threat of an ever-deeper penetration of governmental influences in the private lives of individuals. No reasonable person will deny that, in a modern society, government must protect individuals from risks imposed by others. That is, government denies me the right to impose risks on unwilling or unaware others. It is quite a different matter for government to protect me from risks incurred by me alone as a consequence of my own actions. An analogous case may be instructive here. When I drive my car, I obviously risk injuring other people. The government, quite rightly, seeks to limit this risk. Thus government examines and licenses drivers, imposes penalties for dangerous driving, mandates various safety devices in cars, and so on. No reasonable person will consider such regulation of behavior a violation of the individual's rights. it is cuite another matter, though, when government sets out to protect me against the possible risks of my own driving. This issue sur- faced in the debate over involuntary safety devices in cars. Should government not only insist that cars contain properly functioning devices that protect others (such as brakes, lights, and the like), but also devices that, regardless of whether I want them or not, protect me, the driver (such as safety belts without which I cannot start the car, and the like)? There has

My name is Rodger L. Bick; I am the medical director of i San Joaquin Hematology & Oncology Medical Group. I am also assistant professor of medicine, specializing in hematology I medical oncology, at the School of Medicine of the UCLA iter for the Health Sciences in Los Angeles. I am on the :nical faculty for hematology and oncology of the Wadsworth a. Hospital in Los Angeles, and hold adjunct teaching positions the Wayne State University Specialized Center for Thrombosis ;earch in Detroit and at the Wesley Medical Center and _versity of Kansas Medical School in Wichita. I received my medical degree from the University of .ifornia at Irvine School of Medicine in 1970. In 1973 and '4, I was the Director of the Hemostasis/Thrombosis Research -oratory, Chief of Hematology/Medical Oncology, and Director of '.ical Education at the Rern County General Hospital in ersfield, California. From 1974 till 1977, i worked for the Area Hematology Oncology Medical Group and Bay Area atology Oncology Clinical and Research Laboratories in Santa .ica. From 1980 to date, I have been an associate professor of ied Health Professions and of Nursing and Health Sciences at ifornia State University in Bakersfield.

265 Lung Diseases, March 5, 1982 Page 18 m 32. Seppanen A: Comparison of different kinds of tests in tc:e evaluation of lung function among healthy smokers and nonsmokers. Ann C1in Res, 1977, 9, 275-280. 33. Wicht CL, De Kock MA, Van Wyk Kotze TJ, Pienaar GJ, Stevn PG, Vad De Wal B'ri, Vermaak JC, Weich EirH: An epidemiological study of the diffuse obstructive pulmonary syndrome. S Afr Med J SuDC1, 1977, 1-15. 34. Albert RE, Peterson HT Jr., Bohing DE, Lipomann ML: Short-term effects of cigarette smoking on bronchial clearance in humans. Arch Environ Health, 1975, 30, 361-367. 35.. Camner P, Strandberg F, Philipson K: increased mucociliary transport by adrenergic stimulation Arch Environ Health, 1976, 3, 79-82. 36. Mossberg B, Philipson K, Camner P: Tracheobronchial clearance in patients with emphysema associated with alphal-antitrypsin deficiency. Scand J Res Dis, 1978, 59, 1-7. 37. Chrzanowski PJ, Turino GM: Experimental emphysema concepts and questions. Bull Eur Phvsiooath Reso, 1977, 13, 471-477. 38. Kuhn C, Yu SY, Chraplyvy M, Linder HE, Senior RM: The induction of emphysema with elastase. II. Changes in connective tissue. Lab Invest, 1976, 34, 372-380. 38a. Harris JO, Olsen GN, Castle JR, Maloney AS: Comparison of proteolytic enzyme activity in pulmonary alveolar macrophages and blood leukocytes in smokers and nonsmokers. Am Rev Resn Dis, 1975, 111, 579-586. 39. Lebowitz MD, Burrows B: Tucsorr epidemiologic study of obstructive lung disease. II. Effects of in-migration factors on the prevalence of obstructive lung disease. 40. urban smokers and non-smokers. Bull Eur Phvsionath Resp, 1978, 14, 127-135. Am J Epidmiol, 1975 „ 102, 153-163. Woolcock AJ, Leeder SR, Armstrong JG, Peat JK, Coman M, Cullen KJ: The single breath nitrogen tests in rural and 0 n

= L`L?f v iT:E: PUBLICATIC\S (cont.) Bick, RL: Malignancy's Effect on Hemostasis: Cor..plex questions finding answers. Diag. Dialog, July 21, 1980, Vol. 2, \o. 5. Bick, RL: Malignancy's Effect on Hemostasis: Part II. Diag. Dialog. September 8, 198,0, Vol. 2, No. 6. Bick, RL: Dissemir.ated Intravascular Coagulation: A Clinical/Laboratory Study of 48 patients. Annals of the New York Academy of Sciences, 370:843, 1981 - Contributions to Hemostasis. Bick, RL: Hereditary Hemorrhagic Telangiectasia and Disseminated Intrarascular Coaguiation: A New Clinical Syndrome Annals of the New York Academy of Sciences, 370:851, 1981 - Contributions to Hemostasis. Bick, RL: Disseminated Intravascular Coagulation (DIC). Part I. Pathophysiolcgy and Diagnosis Practical Cardielugy, 7:145, 1981. Bick, RL: Disseminated Intravascular Coagulation (DIC). Part II: Therapy of DIC and the Manifestations of Related Syndromes. Practical Cardiology, 7:152, 1981. Bick, RL: Clinical Significance of Fibrino(geno)lytic Degradation Products (FDP) Testing Lab-Lore, 9:683, 1981. Bick, R.L. . . Hereditary Hemorrhagic Telarigiectasia and Disseminated Intravascular Coagulation: A New Clinical Syndrome. Vasc. Surg. 15:394, 1981.

255 mucous secreting apparatus and epithelial metaplasia as well as more classic histopathological evidence of inflammation for bronchitis; and abnormal enlargement of the air spaces distal to the terminal nonrespiratory bronchiole accompanied by destructive changes of the alveolar walls for emphysema. These definitions are completely ignored in the changes and enzymatic contents are regarded as pathological or adverse signs of chronic bronchitis or pulmonary emphysema. The definition of adverse and nonadverse effects has been vigorously debated in recent years by the National Academy of Sciences (26) and the World Health Organization (27, 28). The National Academy of Sciences defines adverse effects as responses that are irreversible; the reversible effects are regarded as adaptation or defense mechanism of the lung in response to the inhalant. The predominant opinion is to establish irreversibility as a prerequisite •to the definition of an adverse effect. In terms of tobacco use, most of the functional effects described in the 1979 Surgeon General's Report are reversible, not adverse in nature, and are indicative of physiological and biochemical adaptation of the, lungs. . - I Lung Diseases, March 5, 1982 a. ResDiratorv svmotoms and chanaes. The section on the natu: obstructive lung disease (pages 6-10 tc qualifying statement that pathologic specific and sensitive parameters r emphysema or chronic bronchitis. It "the relationship of early respiratory development of lung disease is unclear studies demonstrating that individuals w small airways function are at greater r unavailable". Respiratory symptoms and : tests therefore are not necessarily effects or pathological processes. -- That smokers show abnormal lung ": uniformly observed. In addition to a si the Surgeon General's Report, t-here are f during the late 1970's that were not cite b. Clearance Mechanisms. mucociliary transport (page 6-32) i selective citations from the literatu aspects of cigarette smoking, and or, results. Articles that show smoking clearance in humans have been omitted.

301 C,?.HICu'!J!( 'dIT.;E: L. 3'.CK, `d, D. PtiBLIUTIC`S (ccnt.): Bick, RL, Adams, T, Schmalhorst, WR: Bleeding times, platelet adhesion, and aspirin. Am. J. Clin. Pathol. 65:69, 1976. Bick, RL: Alterations of hemostasis associated with cardiopulmonary by"2ass. Thromb. Res. 8:285, 1976. Bick, RL: Adriamycin and fibrinolysis. Thremb. Res. 8:467, 1976. Bick, RL, Fekete, L. Murano, G, Wilson, WL: Duanomycin and fibrinolysis. T.:romb. Res. 9:201, 1976. Bick, RL, Fekete, L,.Kovacs, I: A new two-stage functional assay for antithrombin III (heparin-cofazter) clinical and laboratory evaluation. Thromb. Res. 6:745, 1976. Wilson, WL, Andrews, NC, Frelick: RW, Nealon, TF, Bick, RL, :dams, T: PreliTinary -eport on the use of CCAU (NSC-79037), Adrianycin (NSC-123127), and Hexamethylmelamine (NAC-13R75) in r,arrinoma of the lung. Cancer Treat. Rept. 60:269, 1976. Fekete, LF, Bick, RL: Laboratory modalities for assessing hemostasis during cardiopul^cnary bypass. Semiaars in Thromb. and Hemostasis 3:83, 1976. Bick, RL, Dukes, ML, Wilson, WL, and Fekete, LF: Antithrombin III as a diagnostic aid in disseminated intravascular coagulation. Thromb. Res. 10:721, 1977. Bick, RL: Complement levels in disseminated intravascular coagulation. Am. J. Clin. Path. 68:93, 1977. Bick, RL: Alterations of hemostasis associated with malignancy: etiology, pathophysiology, diagnosis and management. Sem. Thromb. and Hemostasis, 5:1, 1978. -5-

264 Lung Diseases, March 5, 1982 Page 17 Toxicol Anol Pharmacol, 1974, 30, 201-209. 22. Ito H, Watanabe T, Shore SR, Aviado DM: Functional and biochemical effects on the lung following inhalation of cigarette smoke and its constituents. III. Serum antitrypsin and bronchomotor responses in rats. Toxicol 23. 24. 25. IV, Health Effects. 1980. Anol Pharmacol, 1975, 35, 403-411. II. S. Environmental Protection Agency: Air Quality Criteria for ozone and other ohotochemical oxidants. Vol. I and II, 1978, EPA-600/8-78-004. U. S. Environmental Protection Agency: Air oualitv criteria for oxides of nitroaer.. Vol I to IV. 1978. U. S. Environmental Protection Agency: Air cualitv criteria for oarticulate matter and sulfur oxides. Vol. 26. National Academy of Sciences: PrinciDles for evaluatinc chemicals in the environment. Washington, 1975, 124-126. 27. World Health Organization: Princioles and methods for evaluatina the toxicitv of chemicals. Part I. Environmental Health Criteria 6. Geneva, 1978, 31-33. 28. World Health Organization: Methods used in establishinc oermissible levels in occuoational exDosure to harmful agents. Technical Report Series 601, Geneva, 1977, 33-36. 29. Robinson M, Lonsdale D, Macrae K, Guz A: The flow/volume curve breathing air or helium-oxygen: an analysis of bias, dispersion, and correlation in 10 indices and a comparison of non-smokers with asymptomatic smokers. Bull Eur Physiooathol Reso, 1977, 13, 96P-97P. 30. Chinn DJ, Lee - WR: Within- and between- subject variability of indices from the closing volume and flow volume traces. Bull Eur Phvsiooath ResD, 1977, 13, 789-802. 31. Williams DE, Miller DE, Taylor WE: Pulmonary function studies in healthy Pakistani adults. Thorax, 1978, 33, 243-249. 265 Lung Diseases, March 5, 1982 32. Senpanen A: Comparison of diffe evaluation of lung function nonsmokers. Ann Clin Res, 1977, 33. 34. 35.. Wicht CL, De Kock MA, Van Wvk Kc PG, Vad De Wal BW, Ver epidemiological study of the dif syndrome. S Afr Med J Suool, 19 Albert RE, Peterson HT Jr. Short-term , effects of cigare clearance i n humans. Arch En 361-367. Camner P, Strandberg K, mucociliary transport by adr Environ Health, 1976, 3, 79-82. 36. Mossberg B, Philipson R,".Cam clearance in patients with alphal-antitrypsin deficiency. 59, 1-7. 37. 3a. 38a. 39. 40. Chrzanowski PJ, Turino GM: concepts and questions. Bull 13, 471-477. Kuhn C, Yu SY, Chraplyvy M, Linc induction of emphysema with connective tissue. Lab Invest, : Harris JO, Olsen GN, Castle JR, t proteolytic enzyme activity macrophages and blood leukc nonsmokers. Am Rev Reso Dis, 19" Lebowitz MD, Burrows B: Tucsor obstructive lung disease. II. factors on the prevalence of c Am J Enidmiol, 1975 „ 102, 153-1E Woolcock AJ, Leeder SR, Armstronc Cullen KJ: The single breath : urban smokers and non-smokers. R-eso, 1978, 14, 127-135.

I 285 a I feel optimistic about the good sense of Americans in resisting this sort of totalitarian encroachment. They showed good sense in resisting Prohibition, made its enforcement imprac- tical, and finally forced repeal. But, in the meantime, a great deal of damage was done. For one, there was an enormous expansion of organized crime -- perhaps inevitable in retrospect, if government criminalizes a large area of private behavior. It seems, though, that the lessons of Prohibition have been forgotten. Be this as it may, it is very important to be alert to the totalitarian implications of all comparable intrusions of government into the private behavior of individual citizens. Most Americans, across the entire political spectrum, recognize the need for welfare-state measures in modern society (political disagreements are really not about the welfare state as suc:^h any longer, but about its extent, its mechanisms and its costs). But the accumulation of risk-reducing demands on government must bring about a quantum leap in the conception of the welfare state -- a leap precisely in the direction of an all-embracing . totalitarian understanding of the role of government. If the behavior of individuals is to be politically proscribed or regu- lated because it is claimed to carry "social costs" in the aggregate, then virtually no area of private life is immune to government intervention. Again, I would not like to be misunderstood: I am not saying that the legislation under consideraticn here is totalitarian either in intent or even in its immediate H m

305 CL'RdICULI!?S \'II:E: 6.=°4 L. 6rKS/CYJ.P;ERS/NLk\'UALS (cont.): Bick, RL: Primary hyperfibrino(geno)lytic s;rdromes, C`:apt. 9 in Basic Concepts of Hemostasis and Thronbosis, .'•',..s.io, G. a;:d Bick RL (eds.) CRC Press, Boca Raton, FL 1980. Bick, RL: Acquired circulating anticoagulants and defective in ^alig:~.nt para- protein disorders, Chapt. 10 in Basic Concepts of Hemostasis and Thrombosis, 1Surar.o, G. and Bick, 2L ;eds.) CRC Press, Boca Raton, FL 1980. Bick, RL: Alterations of henostasis associated with malig-ancy, Chapt. 11 in Basic Concepts of Hemostasis and Thrombosis, )furar.o, G. and ?ick, RL (eds.) CRC Press, Boca Raton, FL 1980. Bick, RL: Hypercoagulability and thrombosis, Chapt. 13 in Basic Concepts of Hemostasis and Thrombosis, ~turano, G. CRC Press, Boca Raton, FL 1980. Bick, RL: Anticoagulant and antiplatelet therapy. Chapt. 14 in Basic Concepts in Hemostasis and Thrombosis, Murano; G. CRC Press, Boca Raton, FL 1980: Murano, G. and Bick, RL:. Throlnbolytic therapy, Chapt. 15 in Basic Concepts in Hemostasis and Thrombosis, Murano, G. CRC Press, Boca Raton, FL 1980. and Sick, RL (eds.) and Bick, RL (eds.) and Bick, RL (eds.) i Bick, RL: Disseminated intravascular coagulation and related syndromes, Chapt. in Perspectives in Hemostasis and Thrombosis, Fareed, J., Messmore, H, Fenton, J.W. and Brinkhous, IQ•1 (eds.) Pergamon Press, New York 1981. Bick, RL: Disseminated intravascular coagulation and related syndroc•es; in Preparation (textbook) CRC Press, Boca Raton, FL 1982. Bick, RL: Hemorrhagic problems associated with cardiac surgery. In Preparation, Chapt. in Textbook of Hemostasis and Thrombosis, Ratnoff, OD, and Forbes (eds.) Grune 8 Stratton, New York 1982. ~

309 CiRR1CJLU?I VIT.>E: -._. :=3 L. B'CK, M.D. ABSTRACTS (ccnt.): Bick, RL, and Wilson, WL: 4ultiple myeloma and second malignancies: A three year follow-up of forty patients. Blood, Vol. 52, No. 5, 240, November, 1978 Bick, RL, and Fekete, LF:• Hereditary hemorrhagic telangiectasia and associated thr:.xbahemorrhagic defects. Blood, Vo. 52, No. S, 179, 1978. '- Fekete, LF, and Bick, RL: The developwent and evaluation of a new coagulation standard for protiWes, PTT's and all coagulation factor assays. Blood, Vol. 52, No. 5, 181, 1978. Bick, RL: Biological antithrombin III levels. J.A.M.A., January 23, Vol. 239, No. 4, 1978 Bick, RL, Fekete, LF: Alterations of hemostasis during cardiopulmonary bypass: A comparison between membrane and bubble oxygenators. Trans. Am. Soc. Clin. Path. October, 1979, Las Vegas, Nevada. Bick, RL, and Fekete, LF: Hereditary hemorrhagic telangiectasia and associated thrombohemorrhagic defetts. Blood, 54:745, 1979. Bick, RL, and Skondia, V: Piracetam: results of a preliminary in vivo trial as a platelet suppressant. Blood, 54:635, 1979. Bick, RL, Fekete, LF, Dukes, ML, Gaal, PG, Smith, R: Hereditary hemorrhagic telangiectasia and associated thrombohemorrhagic defects. Am. J. Clin. Path. Vol. 73, #2, p. 300, 1980. Bick, RL and Fekete, LF: Alterations of hemostasis during cardiopulmonary bypass (CPB): A comparison between membrane and bubble oxygenators. Am. J. Clin. Path. Vol. 73, 02, p. 300, February, 1980. -13-

295 pathophysiological link between cigarette smoking and cardiopulmonary disease which has been reported. To investigate more carefully these claims by Becker et al., our group, in collaboration with Dr. Stedman, extracted TGP by the previous published methods of Becker and co-workers. Our group found that the final product obtained by the isolation procedure of Becker contains and consists primarily of a contaminant that is introduced by the methods of separation and appears to be a side product of the photo-polymeri2ation reaction used to form the gels for separation. (Relatives of this contaminant, polymethylmethacrylates, are widely used in orthopedic and dental surgery and traces of these compounds have been implicated in allergic reactions and clot formation.) When we subjected the contaminant to the aforementioned coagulation, clot lysing, complement, and kinin generation assay systems, we found that the contaminant complexed with small amounts of an early coagulation Factor, Factor XII, giving the superficial and completely erroneous impression that activation was occurring. However, it was found to have no activity on thrombogenic assays currently used by the Bureau of Biologics for detecting activation of the blood clotting system. Nor was there any activation of numerous of the early coagulation Factors tested. Likewise, there was no activation of the fibrinolytic system, no effect -on the complement system, and no effect on the kinin

311 CURRICULUM VITAE: ROUGER L. BIC.I', M.D. ABSTRACTS: (cont.) Bick, RL, and McClain, BJ: A clinica( comparison of chronogenic, fluorometric, and natural (fibrinogen) substrate assays•for determination of antithrombin-III. Thrombos. Haemostas. 46:364, 1981. Bick, RL, and Faulstick, D: Antithrombins and coronary artery disease. Thrombos. Haemostas. 46:372, 1981 8ick, RL, Arbegast, NR, and Schmalhorst, WR: Alterations of hemostasis during cardiopulmonary bypass (CPB): a cor..parison between membrane and bubble oxygenators. Thrombos. Haemostas. 46:392, 1981. Bick, RL: Disseminated intravascular coagulation: a clinical/laboratory correlation in 48 patients. Thrombos. Haemostas. 46:395, 1981. Bick, RL, Skondia, V, and Fritch, D: Hypercoagulability in diabetes and its correction by an antiplatelet drug: Piracetam. Thrombos. Haemostas. 46:439, 1981. Bick, RL and McClain, BJ: A clinical comparison of chromogenic, fluorometric, and natural (fibrinogen) substrate assays for determination of antithrombin III. Am. J. Clin. Path. 77:238, 1982. Bick, RL: Disseminated intravascular coagulation: a clinical laboratory correlation in 48 patients. Am. J. Clin. Path. 77:244, 1982. LETTERS PUBLISHED: Bick, RL Anhalt, J: Needle malaria N. Eng. J. Med. p. 856, April 1971. Bick, RL, Anhalt, J: Malaria in drug addicts J.A.M.A. 216:1036, 1971 Bick, RL: Prothrombin complex concentrates and chronic liver disease. Thrombos. Res. 7:825, 1975. Bick, RL: Antithrombin III and factor VIII in patients with neoplasms. Am. J. Clin. Path. Vol. 69, No. 2, 1978. -15-

272 to be depicted as a victim of debilitating vice or awa'_king threat to public health, and the segregation ir.creasingly imposed on smokers in various public places is frequently demeaning. What also intrigued me, though, was why some anti-smokers were so aggressive about this matter. I could not quite believe that they were all that concerned about me (and other practitioners of this custom). After all, a lot of other things that I and others do are also claimed to be bad for health, yet no comparable furor surrounds them -- and I began to suspect that more complicated motives and interests were involved. I expressed these misgivings in the attached article, "Gilgamesh on the Washington Shuttle," published in Worldview magazine in November 1977. While this matter has not been a major focus of my pro- fessional activities (which, in recent years, have centered on the problems of Third World development), I have maintained an interest in the issue of smoking, contemporary culture and public policy. In the summer of 1979, for example, I attended the Fourth World Conference on Smoking and Health, held in Stockho Lm under the auspices of the World Health Organization (no doubt an appropriate location considering that the Scandinavian countries have the most stringent anti-smoking policies anywhere). I sub- sequently served as consultant to a study of the anti-smoking movement in Britain and the United States conducted, by Professor Aaron Wildavsky of the University of California at' Berkeley. In 1981 I gave a presentation at the Conference on Consumer Policy at the Wharton School in Pennsylvania. (This - 2 - 2' dealt generally with the evaluati presentation only mentioned smoki smoking issue in a wider context tion.) Consequently, I have a gc the various arguments made in the As to the bills under doubts whatever about the sincer what concerns me is the manner : enacted, could be used by the ant that this would be another step i matizing and even criminalizing stigmatized as a disease; then segregated; finally, smoking wc behavior, to be eventually eradi, the most private locations (to t consenting adults in the privacy concerns me even more is what tt role of government (in this case, lives. It seems to me that thos this legislative proposal should matters -- the general cultural c ment power. The General Cultural Context The campaign against phenomenon; rather, it must be a

307 Cu:~:CU L,~ ~t 1 _r-.ic^: --=4 L :BSi'R.aCTS (cont.): Bick, RL, Sch•:alhorst, hR, Adams, T, Arbagast, N: Hemorrhagic syndromes associated with cardiopu:-:_7ary b-pass pathogenesis, diagnosis, and manage.ent. Trans. XII World Congress Int. Cardiovas. Soc. p. 7, 1975 Bick, RL: Prothrombin complex concentratbs and chronic liver disease. Thromb. Diath. Haemorrh. 34:875, 1975. Bick, RL, Schmalhorst, hR: Blood component therapy in disseminated intravascular coagulation. Clin. Res. 23:269, 1975. Bick, RL, SciL-nalhorst, WR, Arbegast, N: The hecnorihagic diathesis created by cardiopulaonary b,-,sss. Am. J. Clin. Path. 63:588, 1975 Bick, RL: Fibrinolytic enzymes in metastatic cancer Am. J. Clin. Path. 65:266, 1976 oick, RL, Fekete, LF, Wilson, WL: Treatment of disseminated intravascular waguietion with antithrombin I11. Trans. Am. Soc. Hematol. 167,1976. Bick, RL, Klein, CA, Fekete, LF, Wilson, WL: Alterations of hemostasis associated with malignant paraprotein disorders. Trans• Am. Soc. Hematol. 163, 1976. Fekete, LF, Wilson, WL, Bick, RL: The large scale preparation of clottable fibrinogen-free, high purity, . high potency factor VIII concentrate. Trans. XII Congress World Fed• of Hemophilia, New York Thrombosis and Hemostasis, 38:348, 1977 Bick, RL, Fekete, LF, Wilson, WL: Clinical use of platelet adhesion Trans. VI int. Congress on Thrombosis and Hemostasis Philadelphia, 1977. - Bick, RL, Dukes, ML, Fekete, LF, and Wilson WL: Antithrombin III as a diagnostic aid in disseminated intravascular coagulation. Trans. VI. Int. Congress on Thrombosis and Hemostasis, Philadelphia, 1977.

302 CURRICULUM VITAE: RODGER L. BICF:, ?I.D. PUBLICATIONS (cont.): Bick, RL: Antithrombin III: diagnostic and therapeutic implications. Presented at the Annual Blood Coagulation Symposium (•lanual), J. Penner, (Ed.) Ann Arbor, Michigan, 1978. Bick, RL: Disseminated intravascular coagulation and related s,,ndroaes: etiology, patho- physiology, diagnosis and management. Am. J. Hematol. Vol. 5, 03, 265, 1978. Bick, RL:' Vascular disorders associated with thrombohemorrhagic phenomena. Sem. in Thrombosis and Hemostasis, Vol. V, No. 3, 167, 1979. Nalbandian, RM, Henry, RL, and Bick, RL: Thrombotic thrombocytopenic purpura: An extended editorial. Sem. in Thrombosis and Hemostasis, Vol. V. \o. 4, 216, 1979. Bick, RL, Fekete, LF: Cardiopulmonary bypass hemorrhage: aggrevation by pre-op ingestion of anti- platelet agents. Vascular Surgery, Vol. 13, No. 4, p. 277, July-August, 1979. Bick, RL: Monitoring heparin therapy. Diagnostic Dialog, Vol. I, \o. 4, August, 1979. Bick, RL, Marcum, JD: vo., Yalebrand's disease. Diagnostic Dialog, Vol. 1, No. 5, November 1979. Bick, RL: Monitoring heparin therapy. Kern County Medical Societ,v, The Bulletin, Vol. XXVI, No. 12, 1979. Bick, RL: In vivo platelet inhibition by piracetam. Lancet, Vol. II, p. 752, 1979. Bick, RL, Bick, MD, and Fekete, LF: Antithrombin III (AT-III) patterns in disseminated intravascular coagulation. Am. J. Clin. Path. 73:577, 1980. -6- 3( PUBL?CATIC]S (cont.) Bick, RL: Malignancy's Effect on Hemostasis: Complex Diag. Dialog, July 21, 1980, Vol. 2, No. S. Bick, RL: Malignancy's Effect on Hemostasis: Part II Diag. Dialog. September 8, 198A, Vol. 2, No Bick, RL: Dissemir.ated Intravascular Coagulation: A C: Annals of the New York Academy of Sciences, Henostasis. Bick, RL: Hereditary Hemorrhagic Telangiectasia and D: A `:e» Clinical Syndrome Annals of the New York Academy of Sciences, 4emostasis. Bick, RL: Disseminated Intravascular Coagulation (DIC; Diagnosis Practical Cardiolugy, 7:145, 1981. Bick, RL: Disse^:inated Intravascular Coagulation (DIC' stanifestations of Related Syndromes. Practical Cardiology, 7:152, 1981. Bick, RL: Clinical Significance of Fibrino(geno)lytic Lab-Lore, 9:683, 1981. Bick, R.L. Hereditary Hemorrhagic Telarigiectasia and Di A New Clinical Syndrome. Vasc. Surg. 15:394, 1981.

282 been strong resistance to the latter extension of government regulation, both in the Congress and in the american public. There has been strong feeling to the effect that it is my busi- ness and my business only, if I do not protect myself against the risk of going through the windshield in a collision. Now, it is not my intention to take a position, one way or another, on the issue of involuntary driver-safety devices in automobiles. But I do want to comment on a concept that has been introduced into that debate and that_is relevant to the present controversy as well -- the concept of "social costs". it is one of those ideas which, at first glance, seems eminently sensible -- until one starts thinking it through to its logical consequences. Here is what the concept refers to: To be sure, if I risk serious injury or death as a driver, it is myself that I injure or kill. Nevertheless, there are costs to society. Society (be it directly through the state or indirectly through rising insurance costs) has to bear the burden of my hospitalization and medical treatment; society (again, through state or private insurance mechanisms) has to assume costs yment or disability; if I'm permanently resulting from my unemplo, disabled or die, society has to concern itself with the welfare of my dependents or survivors; and the economy has to adjust to .my diminished or terminated productivity. From this perspective, I risk far more than my own, life or limb in an automobile accident; rather; I risk imposing burdens on others, to the point of threatening (in whatever measure) the viability of the welfare 283 machinery of the state, the viabilit system, and even the economic well-t :atter a sort of offense against the when one puts the concept terms, one becomes (or should become =otalitarian thrust to this logic. mine do not entail "social costs" in think one must answer: Very few in( self-indulgent lifestyle endangers rr s:leged risks to society enumerated =atterns (so say various experts) r :uvenile delinauents out of my child: ,v:_a household machinery endangers th, mechanics, not to mention my "gardern standing offense to the aesthetic ser. -- and so on. In other words, once t: ~ acceoted as a rationale for gove private individual behavior, it is d= auch interference would stoD. This point is so important aporopriate. In the current controv ^:ention of the alleged economic costs ;ustifying anti-smoking efforts by gc which these alleged costs are calcul, 'anciful (the figures depend on ali medical as well as economic, that seer. - 12 - ` i - 13 - 95-077 0-82-19

262 Lung Diseases, March 5, 1982 Page 15 E. BI3LIOGRaPH° 1. Report of the Surgeon General: Smoking and Health, 1979, 6-7. 2. Report of the Surgeon General: Smokinc and Health, 1964, 259-313. 3. Report of the Surgeon General: The Health Consequences of Smoking, 1967, 117. 4. Report of the Surgeon General: The Health Consecuences of Smoking 1968 Suoolement, 76. 5. Report of the Surgeon General: The Health Consecuences " of Smoking, 1969 Supplement, 50. 6. Report of the Surgeon General: The Health Consecuences of Smoking, 1971, 135-230. 7. Report of the Surgeon General: The Health Consequences of Smoking The Chancinc Cigarette, 1981, 142. 8. Aviado DM, Samanek M: Bronchopulmonary effects of tobacco and related substances. I. Bronchoconstrictor and bronchodilation: influence of lung denervation. Arch Environ Health , 1965, 11, 141-151. 9. Samanek M, Aviado DM: Bronchopulmonary effects of tobacco and related substances. II. Bronchial arterial injections of nicotine and histamine. Arch Environ Health, 1965, 11, 152-159. 10. Samanek M, Aviado DM, Peskin GW: Bronchopulmonary effects of tobacco and related substances. III. Axon reflexes elicited from the visceral pleura. Arch Environ Health, 1965, 11, 160-166.. 11. Samanek M, Aviado DM: Bronchopulmonary effects of tobacco and related substances. IV. Bronchial vascular and bronchomotor responses; their suggested defense . function. Ar ch Environ Health, 1965, 11, 167-176. 12. Aviado DM, Samanek M, Folle LE: Cardiopulmonary effects of tobacco and related substances. I. The release of Lung Diseases, March 5, 1982 histamine during inhalation anoxemia in the heart-lung Arch Environ Health, 1966, 12, 13. Folle LE, Samanek M, Aviado D. of tobacco and related substa. effects of cigarette smoke a: Health, 1966, 12, 712-716. 14. Samanek M, Aviado DM: Cardiooi and related substances. III. of cigarette smoke and nicoti 1966, 12, 717-724. :5. Aviado DM, Palacek F: Pulmona 40 16. 17. 18. 19. 20. 21. related substances. I. resistance in the anestheti Health, 1967, 15, 187-193. Palacek F, Aviado DM: Pulmonar related substances. II. Comp smoke, nicotine and histamine Arch Environ Health, 1967, 15, Palacek F, Oskoui M, Aviado tobacco and related substan: synthesis of histamine in vario: Health, 1967, 15, 204-213. Palacek F, Palecekova M, Ac immature rats: condition constriction and papain. Arch F 332-342. Ito H, Aviado DM: Pulmonarv smoke: experimental inductior. in rats. Arch Environ Health, 1 Aviado DM, Watanabe T: Function on the lung following inhala constituents. I. High- and 1 mice. Toxicol Apol Pharmacol, 1 Watanabe T, Aviado DM: Function. on the lung following inhala constituents. II. Skatole, Ac_

276 specifically in the area of smoking. Lower-income people are more likely to smoke more than upper-income people; conversely, the anti-smoking movement (as are other movements concerned with health and risk reduction of all sorts) is overwhelmingly upper-income in its constituency. Putting this in more sociological terms, the anti-smoking campaign is an initiative coming from the upper-middle-class, while its putative beneficiaries are concentrated in the working class. Put in non-sociological terms, this is but another case of evangelism, in which the better-off classes in our society are trying to impose their own lifestyles on those who are less well off. There is a long history of this, going all the way back to the early 19th century. The most ambitious case, of course, was Prohibition -- and the long Temperance Movement that preceded it. Here too, well-meaning middle-class people were trying to convert and eventually coerce their social "inferiors". :n allusion to George Bernard Shaw's famous play, we might call this kind of cultural imperialism the "Major Barbara complex". Needless to say, working-class people resent this sort of meddling, and they resist it. The same tensions between well-meaning yet aggressive missionaries of a "nice" lifestyle on the one hand and those who are supposed to be the beneficiaries of these efforts on the other hand can be found in the contem- porary smoking controversy. It also goes without saying that the upper-middle-class missionaries have greater resources at their disposal in this cultural welfare -- not only resources of money - 6 - 277 and power, but of education that su claims to "know better". The bottoi always "We know what is best for yoc right to tell you how you should 1ii the response of working-class pec interventionism tends to be quite unprintable). Cultural themes are typi: interests of one sort or another. Z thundering against the vested intere but in time it was quite correct interests". Similarly, the anti- attacking the "smoking interests" . identical with the tobacco interest: speak of "anti-smoking interests" interests of those who stand to gain or power) from the campaign against =itigation involving smoking. Veste different interpretations of availat .may look to an absolutely disintere smoking scientist from outer space) iuestion, but one that, I think, h Political dynamics of the situation t:at very few people indeed have ei petence to go through the by-now m --:erature on the subject and to for - 7 -

297 San Fra-:ci.sco, r_a;if_rr'_s .:rri?d S!21/;2 :;N : "r. -_ry: . -cra .._,..rec .. ul, fa;if-•.._`a °'7h cC` ;1, .ra, ,..._ .:-is :.<i:y,?f i: et _.. - . . _ .. ._-_~. i;v 'r~ 2 9'l n - .r-:1 = y: ~,_ly i9 1' e^:?;2, .__._.:.:.p: ol CLa _-cer .or ... - a 9_..:.: , Cali__rnia __ .'_.i1 ife7c ..;,by -'li.: ...p: 7g'6 - Sa'~?c-.lr ;?'•6. d1' _._. 91. `I " _, 1 .i a L?St -vt .-.._._ _ ~ .. rs r :.{ b7. i', -1 Jf adi: ne , _ .. ay _d `or ... . ..._:ng ._ _e.ch, _ 4z 1 cz <dici.e, 'sS. ?o _-.._or :i----'-- .. .-1 . . .zr.•, ....r -.y --.:=a1 7S• ° - ... e, -..S '-.t __._r,e. _ -:_t ee c•r :.; a zl - < ital, ?z'< d, Caii.cri;a, C~iefr -e~_tclc e?:cal C^ :y, }'=:n _ ty ._ : .. , a1, .. c d. =slSfor.^ia, .'•uiy 1973 - `ay :9.'4. D::•r tor of . dical Ed:;cati.m: Ke:1 C: z%ty Ca:iEornia, Ju1y 1?'3 - 51ay io-4. trA T

284 pass here. Let me instead propose that excessive and imaroper eating constitutes a health hazard. Let me suggest that there is a "cholesterol epidemic" in America. If so, let us look at the individual aspects of this first, and then at the possible policy implications. I habitually overeat, and I eat the wrong things. Cholesterol builds up in my body. In consequence, I greatly increase the risk of suffering a heart attack or a stroke. And, if the aforementioned logic is accepted, I incur this risk not only for myself but for others as well; indeed, I'm a walking bundle of potential "social costs". and now imagine the govern- ment interventions that suggest themselves in this case: Rotational anti-cholesterol warnings on all food products; prohibition of advertising of cholesterol-rich foods; intrusive government propaganda on matters of diet; government regulaticn of all meals served in public places and prohibition of certain types of cuisine (say, Italian restaurants); perhaps tax tl incentives for health restaurants and food establishments; mandatory physical exercise for workers in government or govern- ment-subsidized enterprises (in the manner of Maoist China); and so on. Absurd? Maybe (I hope so). But not if one takes the concept of "social costs" seriously as a guide to legislation and public policy. What is missing so far is an anti-cholesterol movement, arrayed militantly against the "cholesterol interests" and with enough political clout to put items from the above list on the agenda. Given the cultural climate ! tried to describe before, this may only be a matter of time. 285 I feel optimistic about the resisting this sort of totalitarian e good sense in resisting Prohibition, it tical, and finally forced repeal. But deal of damage was done. For one, expansion of organized crime -- perhaF if government criminalizes a large ar< seems, though, that the lessons of °orqotten. Be this as it may, it is to the totalitarian implications of a government into the private behavior Most Americans, across the entire pol the need for welfare-state measures i: disagreements are really not about th longer, but about its extent, its mec: the accumulation of risk-reducing de bring about a quantum leap in the con-. -- a leap precisely in the directi totalitarian understanding of the ro behavior of individuals is to be pol' lated because it is claimed to carr aggregate, then virtually no area of government intervention. Again, I would not like to saving that the legislation under totalitarian either in intent or

323 C'.J.'.RICUL'uM CI?kE: ?.^GER L. BICK, SI.D, MEMBERSHIPS: International Society of Haemotology International Society on Thrombosis and Haerostasis Thrombosis Council-American Heart Association American College of Angiology (Fellow) International College of Angiology (Fellow) American Association for the StudY of Neoplastic Disease. American Association for Clinical Research Central Oncology Group (Clinical Investigator) i974-1975 American Society of Mammologists Nigerian Haematology Society Southwest Oncology Group (Clinical Investigator) 1976-Nov. 1977. California College Honor Society American Cancer Society International Association for the Study of Lung Cancer (Founding Member) Federation of American Societists American Geriatrics Society (Founding Fellow) Professional Education Committee, American Cancer Society, Los Angeles Unit Research and Grant Peer Review Committee, American Heart Association Consultant: American Tobacco Research Council Chairman: Professional Education Committee, American Heart Association, Kern County Unit Member: Professional Education Committee: American Cancer Society, Kern County Unit -26-

329 THOROUGH REVIEW OF HISTORICAL FACTORS, CURRENT THEORIES AND RESEARCH, QUALITY OF THE RESEARCH AND PUBLICATIONS PERTAINING TO DEPENDENCE, ADDICTION, LABORATORY AND APPLIED RESEARCH AND CULTURAL ASPECTS OF SMOKING BEHAVIOR. IN ADDITION TO THIS LITERATURE REVIEW, I HAVE ALSO COMMUNICATED WITH ACTIVE RESEARCHERS WORKING IN THE AREA. I AM PRESENTLY WRITING THE SECTION ENTITLED "SMOKING BEHAVIOR" THAT WILL BE PUBLISHED IN THE VL& FNCYCLOPEDIA QE PSYCHOLOGY. IT IS MY UNDERSTANDING THAT PROPOSED BILL HR 5653 WOULD MANDATE A WARNING ON CIGARETTE PACKAGES STATING THAT CIGARETTE SMOKING IS ADDICTIVE. I WILL ADDRESS MYSELF TODAY TO THAT CONCLUSION. FOR ALMOST 400 YEARS THE SMOKING HABIT HAS BEEN AN ISSUE NEVER LACKING PROPONENTS AS WELL AS OPPONENTS. SOME WHO SMOKE SEEM UNABLE TO GIVE UP THE CIGARETTE HABIT AT LEAST DURING CERTAIN STAGES OF THEIR LIVES. OTHERS CAN QUIT WITH APPARENT EASE. FEW SPECIFIC AREAS OF APPLIED PSYCHOLOGICAL RESEARCH HAVE RECEIVED GREATER ATTENTION THAN THE CIGARETTE SMOKING HABIT. DESPITE THIS INTENSE SCIENTIFIC FOCUS ON THE BEHAVIORAL AS WELL AS PHYSIOLOGICAL ASPECTS OF CIGARETTE SMOKING, NO GENERAL AGREEMENT AMONG SCIENTISTS EXISTS AS TO THE QUESTION OF WHETHER CIGARETTES OR THEIR CONTENTS ARE ADDICTIVE. THE BEHAVIOR AND RESPONSES OF CIGARETTE SMOKERS ARE QUITE DIFFERENT THAN THOSE OBSERVED IN INDIVIDUALS WHO ARE -2- I

317 C'JSn1CU::uN V1T4E: L. Sice, V.D. SCIENTIFIC FRESEN-ATIC]S 6 IN~I?EJ Disseminated Intravascular Coagulation and Re:ated S}^4=a.es (Se-.`.nar) California Society of Pathologists, San Francisco, CA., 1978 Current Status of Henostasis, Thror..basis and Antiplatelet Agents A..,erican Heart Association Annual Meeting, Sacra_-.ento, CA., 1979 Difficult Diagnostic Problems in He-..cstasis and Thror.bosis; D'.rector A,:.erican Society of Clinical Pathologist (National Se:.inar), \er Drleans, 1979 Current Concepts of Hemosiasis and Thror~bosis; Director ;r..erican Society of Clinical Pathologist,(National Ser_inar), Ne. Orleans, 1979 Modern Concepts and Evaluation of Hemostasis and Th:o:.bosis; Director American Society of Clinical Pathologist, (National Se-inar), Ne+. Orleans, 1979 Disseminated Intravascular Coagulation and Related Syndroa.es; Director Aa,erican Society of Clinical Pathologist, (National Secinar), New Orleans, 1979 Modern Laboratory Evaluation of Heapstasis and Thrombosis; Director Anerican Society of Clinical Pathologist, (National Seminar), New Orleans, 1979 Current Concepts in Hemostasis and Thro-bosis, Director California Society of Pathologists, Annual Meeting, San Francisco, CA., 1979 Disseminated Intravascular Coagulation and Related Syndromes A:.eri.can Society of Clinical Pathologist (Regional Educational Se^inar) Lincoln, Nebraska, 1979 Hypercoagulability • Colorado Association for Continuing Medical Laboratory Education, Colorado, 1979 Current Concepts of Hemostasis and Thrombosis; Director American Society of Clinical Pathologist (Regional Education Program), Lincoln, Nebraska, 1979 Modern Concepts and Evaluation of Hemostasis and Thror3osis; D'.rector American Society of-Clinical Pathologists, Fall Meeting, Las Vegas, Oct., 1979 Difficult Diagnostic Problems in Hemostasis and Thror..bosis; Director American Society of Clinical Pathologists, Fall Meeting, Las Vegas, Oct., 1979 -21-

269 -2- an ss.rntioeal ard not .>re='-aental: this signifies that not the 90.sra.r, but th. Mom.n -~e:ves decide whether or not to smoke .#&qaat... SA. ,ros.n Ln :: cs. separate groups might be different, not M;f La t.`uir saoking haL.iv, t7ut also in various other known or unknown pArs..^tsyatica. This a. ~Odclogical problem, coined by Dr. J. Yerushalmy M p,%* procl.m of s.lf-se:ac~_i-n, has to be taken into consideration if we smwear. Use pr.gnancy out_-aoe cf women who do smoke with the pregnancy Kteo.e of voo.n who do not sxke. I would like to r^-a:z.e the results of our studies to date that p/ate to the statements •-+++ce^ing pregnancy in the proposed Bill. Cn birth weight. As ear_y as in 1962 Dr. Yerushalmy reported an lecz.as.d proportion of :.,^r `:;..h weight infants among the offspring of saaxinq pregnant women as ==-a red with the offspring of non-smoking pr.y-iant women. The obse_~d association may indicate a cause-and-effect r.lationship but it may a:.so be influenced by differences between smokers ar.: -ten-smoKers in chara=e=s-.ics other than smoking. A later study lyd.ad showed that a var-=ety of other maternal characteristics, such as socioeconomic status, ma=er_a.i age and ethnic background, influence the association between szti;ci..^g during pregnancy and birthweight of offspring. Cantrollir.g for a number =f -_"nese variables reduces the crude difference in the birthweight of the ofsr-i.ng of both groups of women. Terushalmy's later work on maternal smoking was aimed at developing rtlvdologies and desigm_i-mg studies to test the causal hypothesis against the alternative hypothesis that inceased incidence of low birth weight is due to the differences :De:+ee.n smoking and non-smoking pregnant women. • One .uch study evaluated the f--e:,uency of low birth weight among the offspring of mothers who began smo<<-g after the birth of the infants. It was found that women who subsequently became smokers also had a high incidence of low birth weight babies durirg the period before they started to smoke. This finding cannot be explained by the causal hypothesis and underscores the need for a larger study to confirm or refute this finding. On abortion and stillbi--,.h. Our statistical study, comparing for each week of gestation the risk of fetal death for smoking and non-smoking pregnant women, failed to find a difference between the two groups. These results, based on the pregnancy outcome of 15,000 pregnant women, do not provide evidence that smokinq during pregnancy raises the risk of spontaneous abortion and stillbirth. On birth defects. We recently published the results of our evaluation of the incidence of congenital anomalies (or birth defects) among the 14,735 children born to women who never smoked, to women who were past smokers or to women who smoked during pregnancy. The children were offspring of mothers enrolled in the Child Sealth and Development Studies. Our data did not show a difference in the incidence of severe congenital anomalies among children of smoking women and children of women who never smoked. We also T

328 STATEMENT OF THEODORE H. BLAU, PH.D. SUBCOMMITH~F~S NOFBT~RESEIJTA~IVE~VIROfJMENT THANK YOU MR. CHAIRMAN FOR THE OPPORTUNITY OF APPEARING BEFORE YOUR SUBCOMMITTEE. MY NAME IS THEODORE H. BLAU. I HOLD THE DOCTORATE IN PSYCHOLOGY, RECEIVED FROM THE PENNSYLVANIA STATE UNIVERSITY IN 1951. I HAVE BEEN IN INDEPENDENT PRACTICE OF CLINI- CAL PSYCHOLOGY AND CONSULTING PSYCHOLOGY IN TAMPA, FLORIA, SINCE 1953. FORMERLY, I WAS PROFESSOR OF PSYCHIATRY AT THE MEDICAL SCHOOL OF THE UNIVERSITY OF SOUTH FLORIDA. I HOLD A DIPLOMATE IN CLINICAL PSYCHOLOGY FROM THE AMERICAN BOARD OF PROFESSIONAL PSYCHOLOGY AS WELL AS THE DIPLOMA FROM THE AMERICAN BOARD OF FORENSIC PSYCHOLOGY. I AM A MEMBER AND PAST PRESIDENT OF THE AMERICAN PSYCHO- LOGICAL ASSOCIATION AND AM CURRENTLY PRESIDENT OF THE AMERICAN PSYCHOLOGICAL FOUNDATION. I AM ALSO A MEMBER OF THE EVALUATION RESEARCH SOCIETY AND HAVE CONDUCTED EVALUATION STUDIES FOR PRIVATE CORPORATIONS AS WELL AS EVALUATION RESEARCH FOR VARIOUS BRANCHES OF THE U.S. MILITARY AND THE GOVERNMENT. I AM THE AUTHOR OF ONE BOOK, A NUMBER OF CHAPTERS AND APPROXIMATELY FIFTY ARTICLES. FOR SEVERAL YEARS, I HAVE BEEN INVOLVED IN AN EVALUATION OF THE RESEARCH AND CURRENT STATE OF KNOWLEDGE ABOUT THE PSYCHO- LOGICAL ASPECTS OF CIGARETTE SMOKING. THIS EVALUATION INCLUDES A 329 THOROUGH REVIEW OF HISTORICAL FACTORS, C RESEARCH, QUALITY OF THE RESEARCH AND PU DEPENDENCE, ADDICTION, LABORATORY AND AP ASPECTS OF SMOKING BEHAVIOR. IN ADDITIO REVIEW, I HAVE ALSO COMMUNICATED WITH AC IN THE AREA. I AM PRESENTLY WRITING THE BEHAVIOR" THAT WILL BE PUBLISHED IN THE _ PSYCHOLOGY, IT IS MY UNDERSTANDING THAT PR[ MANDATE A WARNING ON CIGARETTE PACKAGES : SMOKING IS ADDICTIVE. I WILL ADDRESS MY: FOR ALMOST IIOO YEARS THE SMOKIt NEVER LACKING PROPONENTS AS WELL AS OPPOA SEEM UNABLE TO GIVE UP THE CIGARETTE HABI STAGES OF THEIR LIVES. OTHERS CAN QUIT W SPECIFIC AREAS OF APPLIED PSYCHOLOGICAL R GREATER ATTENTION THAN THE CIGARETTE SMOK INTENSE SCIENTIFIC FOCUS ON THE BEHAVIORA ASPECTS OF CIGARETTE SMOKING, NO GENERAL EXISTS AS TO THE QUESTION OF WHETHER CIGA. ARE ADDICTIVE. THE BEHAVIOR AND RESPONSE ARE QUITE DIFFERENT THAN THOSE OBSERVED I'

310 C_2RiC:^'u'm VITAE: --=R L. 'A.D. A9STR4CTS (cont.): Fareed, J., Messmore, HL, and Bick, RL: Quality Control and Standardi:ation of \ewer Methods in Henostatic Testing Presented - International Society of Pathology, 1980. Bick, RL: Disseminated intravascular coagulation and related s;'ndi'o-es: etiology, pathophysiology, d~agnosis and management. In The Year Book of Cancer, 1980 (R.L. Clark et al Eds.) Year Book Medical Publishers, Inc. , Chicago, ILL 1980, p303. Bick, RL, Stedman, RL, Kronick, PL, and Hillman, E: Studies related to tobacco glycoprotein: a claimed activator bf coagula*ion, fibrinolysis, complement, kinin, and a claimed allergen. Clinical Research, Vol. 29, No. 2, 178A, 1981. Bick, RL, Skondia, V, and Fritch, D: Hypercoagulability in diabetes ar.d its correction by an antiplatelet d ug: Piracetam. Clinical Research, Vol. 29, No. 2, 400 A, 1981. Bick, ?.L: Hereditary hemorrhagic telangiectasia and disseminated intravascular coagulation: a new clinical syndrome Thromb. Haemostas. 46:9, 1981. Bick, RL, Fareed, J, and Skondia, V: Pirl',etam: a new platelet suppressing drug. Thromb. Haemostas. 46:67, 1981. V: and Skondia MK Nix RL , , , , Bick, The effect of piracetam in preventing recurrent deep venous thrombosis. Thrombos. Haemostas. 46:91, 1981. Bick, RL, Arbegast, NR: A comparison of chromogenic, fluorogenic, and fibrinogen substrate assays for determination of plasma heparin. Thrombos. Haemostas. 46:214, 1981. Bick, RL, Stedman, RL, Kronick, PL, Hillman, E, and Fareed, J: Studies related to tobacco glycoprotein: a claimed activator of coagulation, fibrinolysis, complement, kinin, and a claimed allergen. Thrombos. Haemostas. 46:231, 1981. 3: CURRICULUM VITAE: ABSTR4CTS: (cont.) Bick, RL, and McClain, BJ: A clinical comparison of chromogenic, fluo- substrate assays.for determination of anti- Thrombos. Haemostas. 46:364, 1981. Bick, RL, and Faulstick, D- Antithrombins and coronary artery disease. Thrombos. Haemostas. 46:372, 1981 Bick, RL, Arbegast, NR, and Schmalhorst, Wf Alterations of hemostasis during cardiopulrr membrane and bubble oxygenators. Thrombos. Haemostas. 46:392, 1981. Bick, RL: " Disseminated intravascular coagulation: a c 48 patients. Thrombos. Haemostas. 46:395, 1981. Bick, RL, Skondia, V, and Fritch, D: Hypercoagulability in diabetes and its corr Piracetam. _ Thrombos. Haemostas. 46:439, 1981. Bick, RL and McClain, BJ: A clinical comparison of chromogenic, fluor substrate assays for determination of antit Am. J. Clin. Path. 77:238, 1982. Bick, RL: Disseminated intravascular coagulation: a c patients. Am. J. Clin. Path. 77:244, 1982. - LETTERS PUBLISHED: Bick, RL Anhalt, J: Needle malaria N. Eng. J. Med. p. 856, April 1971. Bick, RL, Anhalt, J: Malaria in drug addicts J.A.M.A. 216:1036, 1971 Bick, RL: Prothrombin complex concentrates and chroni Thrombos. Res. 7:825, 1975. Bick, RL: Antithrombin III and factor VIII in patient Am. J. Clin. Path. Vol. 69, No. 2, 1978. 14 qX' -15

319 q1 CO:RICULJM VI?.E: -1CDGER L. BICK, ';.D. SCIENTIFIC PRESE\TnTIOSS/I VITED SPEAKER/KCRi:S;OP DIRECTOR (cont.): Congenital Coagulation Defects and von Willebrand's S)^:3rome Traveling Consultant in Hematology/Medical Oncology, Tripler Arry Medical Center, Honolulu, Hawaii, June, 1980. Disseminated Intravascular Coagulation and Related Syndromes. Traveling Consultant in Hematology/Medical Oncology, Tripler Arsy Medical Center, Honolulu, Hawaii, June, 1980. Hypercoagulability, Anticoagulant Therapy, and Thrombolytic Therapy Traveling Consultant in Hematology/Medical Oncology, Tripler ,1rmy Medical Center, Honolulu, Hawaii, June, 1980. Current Concepts of Heparin Therapy (Surgical Grand Rounds) Mercy Hospital, Miami, Florida, September 1980. Disseminated Intravascular Coagulation (Medical Grand Rounds) Mercy Hospital, Miami, Florida, September 1980. Hemostasis and Bleeding Disorders in Problem Patients (Grand Rounds) Mt. Sinai Medical Center, Miami Beach, FL September 1980. Clinical :pplications of `4cassring Antithrombin III Levels; With f.mphasis.on its Relationship to Monitoring Heparin Therapy. (Florida Soc. Pathologists) Mt. Sinai Medioal Center, Miami Beach, F1 September 1980. Current Concepts of Heparin Therapy Valley Medical Center, Fresno, CA September 1980. Disseminated Intravascular Coagulation Valley Medical Center, Fresno, CA September 1980. Disseminated Intravascular Coagulation and Related Syndromes American Society of Clinical Pathologists, Fall Meeting St. Louis, October, 1980. Difficult Diagnostic Problems in Hemostasis and Thrombosis American Society of Clinical Pathologists, Fall Meeting St. Louis October 1980. Modern Concepts and Evaluation of Hemostasis and Thrombosis American Society of Clinical Pathologists, Fall Meeting St. Louis October 1980. Monitoring Heparin Therapy 8 Mini-Heparin Therapy (Grand Rounds) Dameron Hospital Association, Stockton, CA February 1981. . -23- II

299 CG ;11',.?f 6IT.- ?RICA?E P;..CTICE CQon*.): San ,'_a-.ain ia \,~:e-ber 1977 to -ire_ent. FATE.`:TS P=OC_wD: A. B. A *Set~ od `or t:`.e ; -e Scsle A :.et':od for the L-ge y- aie igh Pot -=y FactorV[II ' .- C. A:'e*_`.-~d for .' e rge ccale --sctic;:'t--n .. : . .t___=`_:z _ :3 . .. . . , LF. r;'31--.>7P;\S: Co-S'i':r for Sea -'.zrs _a 2ick, :lt, Giolli, ;iC, R: . . e f r e c t s o f _ - - Y - . . a . . . - - ~ -d tie .l sl of = ..:eLr.:.s- ..^s .ats. 3i,.•k, RL = .-P, RC, •.,.eh_}n E: 1 -'. . t5 C i _.ltia ~ . 1970. 'ick, RL, J: c!, RT ron, E: A ., .:c to t`e d'._, :-s .,t 9:23,1972 :'ed:~CO~'tteTJ r Ezc~; BL, 3`sti•,p, aC, and i. Fi'?r: oI}tic acti•:ity ;n ac:t: .r. J. CI`1. ~..th. 57:3E9, 1972. -_ck, :ZL, '',=-;scn, C,_ etrics-G;-.c- 3y 39:213, 19=2. ?ick, PL, :. .alt, J, S,hza: orst, -a: - atralia ..,r._sei: A coz.;sri_:n ot =._. at high r:sk •`^.r he-=-titis. 1.,. J. C L'n. .^_be, :9-2. . :tc, iL, l^.r, i[ _,_t -<r, N: J.'Csr___ as. ?--,rg. _ :SE9, 1973. Pises, P, ?ick, RL: HyparfiSrirol>sis in cirr.`,asis am. J• Gaetr:,e:.tsro'_o;y 50:=00, :y 3. 95-077 0-82-20

306 C,RICULi:kf V'_TAE: BOOKS/CN_4PTERS/M4\UALS (colt.): Bick, RL: Hemostasis in transplantation surgery. In Preparation = for Textbook of Hemostasis and Thronbosis, Ratnoff, OD and Fcrhes (eds.) Grune 8 Stratton, Tew York 198Z. ABSTR4CTS: Bick, RL, Shanbrom, E, Bishop, R: Fibrinolytic abnormalities in m;•eloproliferatiti•e disorders. Clin. Res. 21:264, 1970 Thompson, WB: RL Bick , , Fibrinolytic abnormalties in various clinical states Am. J. Clin. Path. 156:130, 1971. Bick, RL, Bishop, RC, Warren, M, Stemmer, E: Changes in f'brinolysis and fibri.n.olytic en:ymes during extraco:p creal circuiation.~ Trans. Am. Soc. Hematol. 109, 1971. Bick, RL, and Adams, T: Fibrinolytic abnormalities in myeloproliferative disorders. Clin. Res. 21:264, 1973. Bick, RL, Schmalhorst, WR, Crawford, L, Holtermann, M, Arbegast, `R: Platelet adhesion defects during cardiopulmonary bypass. Clin. Res. 22:383, 1974 . Bick, RL, Schmalhorst, WR, Crawford, L., Holtermann, M. Arbegast, NR: Primary hyperfibrinolysis during cardiopulmonary bypass. Clin. Res. 22:383, 1974. Bick, RL, Arbegast, N, Holtermann, M, Crawford, L, and Schnalhorst, W: Platelet function abnormalities in cardiopulmonary bypass Circulation 50:301, 1974. Bick, Rl., Schmalhorst, WR, and Shanbrom, E: Abnormalities in platelet function induced by cardiopulmonary bypass. Transact VII World Congress of Cardiology Supp. 1974, Buenos Aires. -10- Cii'.:~ :CJLL'd 11TAr".: :.BS:'iACTS Ccont.): 3( Bick, RL, Schmalhorst, hR, Adams, T, .L^begas He:^orrhagic syndromes associated with cardio pa*_hcgenesis, diagnosis, and management. Trans. XII World Congress Int. Cardiovas. So• Bick, RL: Prothrombin complex concentrat'es and chronic T!-.romb. Diath. Haemorrh. 34:875, 1975. Bick, RL, Schmalhorst, {vR: Blood component therapy in disseminated intra Clin. Res. 23:269, 1975. Bick, RL, ScfLmalhorst, WR, Arbegast, N: The henorrhagic diathesis created by cardiopu Am. J. Clin. Path, 63:588, 1975 Bick, RL: Fibrinolytic enzymes in metastatic cancer xm. J. Clin. Path. 65:266, 1976 B- RL, F`;,ete, LP Wilson, WL: TrcacmO.,nt of disseminated irr-avascular coagu: Trans.Am.^Soc. Hematol. 167, 1976. _ Bick, RL, Klein, CA, Fekete, LF, Wilson, WL: Alterations of hemostasis associated with mali '"rax>. Am. Soc. Hematol. 163, 1976. Fekete, LF, Wilson, WL, Bick, RL: The large scale preparation of clottable fibri high potency factor VIII concentrate. Trans. XII Congress World Fed. of Hemophilia, Thrombosis and Hemostasis, 38:348,.1977. _ Bick, RL, Fekete, LF, Wilson, WL• Clinical use of platelet adhesion Trans. 'vI int. Congress on Thrombosis and Hemo: Philadelphia, 1977. Sick, RL, Dukes, ML, Fekete, LF, and Wilson WL: Antithrombin III as a diagnostic aid in dissemi Trans. VI. Int. Congress on Thrombosis and Hemc Philadelphia, 1977.

330 ADDICTED TO HEROIN AND OTHER SUBSTANCES THAT ARE DEMONSTRABLY ADDICTIVE. THE SCIENTIFIC LITERATURE DEMONSTRATES THE FOLLOWING: THERE IS APPARENTLY NO DIFFERENCE IN THE SEVERITY OF CESSATION RESPONSES BETWEEN LIGHT SMOKERS AND HEAVY SMOKERS. RESEARCH ALSO HAS SHOWN THAT THESE EFFECTS ARE FELT MORE SEVERELY BY THOSE WHO REDUCED BUT DID NOT STOP COMPLETELY THAN BY THOSE WHO ABSTAINED TOTALLY. A THIRD ASPECT REPORTED BY VARIOUS RESEARCHERS IS THAT SMOKING CESSATION EFFECTS ARE RELATIVELY MILD AND IN SOME CASES NON-EXISTENT. THEY ARE OF A NATURE WHICH MIGHT BE EXPECTED TO FOLLOW THE LOSS OF PSYCHOLOGICAL REWARDS FROM ANY LOVED OBJECT TO WHICH A PERSON WAS LONG ACCUSTOMED AND WHICH COULD BE CONCEIVED OF AS FORMING A PART OF THE INDIVIDUAL SELF-IMAGE. IT HAS BEEN REPORTED THAT MANY SMOKERS ARE ABLE TO REFRAIN FROM SMOKING FOR RELATIVELY LONG PERIODS OF TIME FOR PRACTICAL. SAFETY OR RELIGIOUS REASONS AND TO DO SO WITHOUT APPARENT DISCOMFORT. SOME EXAMPLES ARE COAL MINERS WHO MAY NOT SMOKE AT THE PITFACE. ORTHODOX JEWS WHO GIVE UP SMOKING AT SUNDOWN ON FRIDAY AND CEASE SMOKING UNTIL SUNDOWN ON SATURDAY, AND SO FORTH, SUCH BEHAVIOR DOES NOT FIT CONVENTIONAL VIEWS OF ADDICTION. WHEREAS THE EFFECTS OF USE AND WITHDRAWAL ARE CONSISTENT AND PREDICTABLE WITH KNOWN ADDICTIVE SUBSTANCES DESPITE A WIDE -3- 331 RANGE OF USES, DESCRIPTIONS OF TOBACCO VARIED AND INCONSISTENT. IN THIS REGA: THE USE OF CAFFEINE RATHER THAN ALCOH01 REPORTED (COSTA, 1980) THAT THE CONTINI MORE RELATED TO A WIDE RANGE OF PSYCHO: PLEASURE, STIMULATION, SENSORY MOTOR ME OF NEGATIVE AFFECT THAN AN ADDICTION FF THE UNITED STATES DEPARTMENT THAT 95 PERCENT OF THOSE PEOPLE WHO QUI OWN, THIS IS NOT ONLY A PHENOMENA IN S WITH DEMONSTRABLY ADDICTIVE SUBSTANCES EXPLORED. - CLEARLY, MANY AREAS OF SMOKIN UNEXPLORED INCLUDING WHY SOME SMOKE VER CAREFULLY CONTROLLED ANIMAL STUDIES MUS DESCRIPTION OF THE SMOKING HABIT CAN BE WITH RHESUS MONKEYS HAS BEEN REPORTED ~. JAPAN AND RESEARCHERS AT THE SOUTHWEST HAVE REPORTED CONDITIONING LABORATORY B. THESE DEVELOPMENTS SUGGEST THAT WE MAY i SMOKING IN A PROPERLY CONTROLLED LABORA' CONTROLLED ANIMAL EXPERIMENTS WITH RELIi ADMINISTRATION OF TOBACCO CAN BE DEVISEI -4- 9b-o77 0-82--22

336 - 3 - The most accurate and appropriate statement that can be made is that cigarette smoking has been identified as one of the many risks or associated factors that may cause or aggravate cert- tain commonly occurring diseases. We are still not able to say whether all relevant risk factors and associations have been iden- tified and consequently, it is practically impossible to control for their effects in experimental studies. While attempts have been made to evaluate certain factors individually, research has not reached the point of being able to say a particular factor is causative.. The scientific fact of the matter is that no one knows why someone like an industrial worker develops cancer of the lung. Is it because he or she is a smoker or because he or she is an industrial worker? Should cigarette smoking be used as a•scape- goat" or should meaningful efforts be made to afford protection to the industrial worker? Having devoted a large part of my research career to functional underlying processes that might contribute to certain diseases of the heart, I am particularly concerned with those parts of the Bills that seem to ask Congress to decide what specifically causes coronary artery disease. In all sincerity, I raise the question: If smoking has been scientifically shown to be a cause of heart disease, what 337 - 4 - are the established mechanisms? As a believe that such mechanistic data are on causation are possible. Diet, whether deficiencies or exc• emotional stress, genetic factors,autc where cancer is concerned) must each bc possible cause of disease; but not one ficient responsibility to justify cong: contained in the Bills being discussed In summary, I strongly disagree wi because they misrepresent the present e The Bills are asking Congress to give t dict on the causes of complex diseases is either conflicting or has yet to"be A'. C VI M~ W ~~ V 1 .-•% . ~

331 RANGE OF USES, DESCRIPTIONS OF TOBACCO EFFECTS ARE EXTREMELY VARIED AND INCONSISTENT. IN THIS REGARD, TOBACCO USE IS MORE LIKE THE USE OF CAFFEINE RATHER THAN ALCOHOL OR OPIATES. IT HAS BEEN REPORTED (COSTA, 1980) THAT THE CONTINUANCE OF SMOKING APPEARS MORE RELATED TO A WIDE RANGE OF PSYCHOSOCIAL MOTIVES SUCH AS PLEASURE, STIMULATION, SENSORY MOTOR MANIPULATION, AND REDUCTION OF NEGATIVE AFFECT THAN AN ADDICTION FACTOR. THE UNITED STATES DEPARTMENT OF H.E.W. REPORTED IN 1977 THAT 95 PERCENT OF THOSE PEOPLE WHO QUIT SMOKING DO SO ON THEIR OWN. THIS IS NOT ONLY A PHENOMENA IN SHARP CONTRAST TO EXPERIENCE WITH DEMONSTRABLY ADDICTIVE SUBSTANCES BUT ONE WHICH REMAINS TO BE EXPLORED. CLEARLY, MANY AREAS OF SMOKING BEHAVIOR ARE AS YET UNEXPLORED INCLUDING WHY SOME SMOKE VERY HEAVILY AND SOME DO NOT. CAREFULLY CONTROLLED ANIMAL STUDIES MUST BE DONE BEFORE SCIENTIFIC DESCRIPTION OF THE SMOKING HABIT CAN BE EXPECTED. PROMISING WORK WITH RHESUS MONKEYS HAS BEEN REPORTED (KIYOSHI AND YANAGITA) IN JAPAN AND RESEARCHERS AT THE SOUTHWEST RESEARCH INSTITUTE (ROGERS) HAVE REPORTED CONDITIONING LABORATORY BABOONS TO SMOKE CIGARETTES. THESE DEVELOPMENTS SUGGEST THAT WE MAY BE ABLE TO STUDY CIGARETTE SMOKING IN A PROPERLY CONTROLLED LABORATORY SETTING. UNTIL SUCH CONTROLLED ANIMAL EXPERIMENTS WITH RELIABLE MODELS OF SELF- ADMINISTRATION OF TOBACCO CAN BE DEVISED AND CONDUCTED AS THEY 9&-077 0-82--22

337 - 4 - are the established mechanisms? As a research scientist, I believe that such mechanistic data are necessary before conclusions on causation are possible. Diet, whether deficiencies or excesses, lack of exercise, emotional stress, genetic factors, auto-immune factors (particularly where cancer is concerned) must each bear its responsibility as a possible cause of disease; but not one of these can be given suf- ficient responsibility to justify congressional action of the type contained in the Bills being discussed here today. In summary, I strongly disagree with the proposed Bills because they misrepresent the present state of scientific knowledge. The Bills are asking Congress to give the Nation a scientific ver- dict on the causes of complex diseases when much of the evidence - -• is either conflicting or has yet to be presented. -

342 Rush reported similar'findings to Davies in an equally well- The• next 2 years will, it is hopf conducted study (Rush D, J. Obstet. Gynecol. Br. Cmmwlth. questions about the relationship: 81, 746, 1974). Rush also found that an effect of smoking intake and between psycho-social on birth weight was confined to women of lower social class This will lead directly to a lar€ (Rush D., Am J. Dis Children 129, 430, 1975). More recently survey of pregnancy outcome with these findings have been confirmed by Papoz et al, who found *.o data collection techniques, an no effect of smoking on birth weight in Parisian women of - of factors important in birth siz upper social class (Papoz L. et al, in: Maternal Nutrition The techniques used, particularly in Pregnancy, Ed. Dobbing J. London: Academic Press, 1981). collection of social and nutritio thoroughly developed and tested i I have been involved in research during the last two years to try to clarify these issues. This research has been - supported by the American tobacco industry. It involves a team approach (epidemiological, obstetric, pediatric, nutritional and psychological) to the investigation of pregnancy outcome in a hospital providing maternity services to a typical urban community with widely varying socio- economic conditions. The initial 18 month period has been involved with a pilot study of an unselected group of 160 women, examining the feasability of employing various study instruments to evaluate social status, psychological health and nutrition. The results are in the process of : analysis. -5- March 8, 1982 -6-

333 AND DURATION, AS DO EFFECTS FOLLOWING ABSTINENCE FROM TOBACCO SMOKING. I, MYSELF, SMOKED CIGARETTES FOR 24 YEARS, TWO TO THREE PACKAGES A DAY FOR THE LAST TEN YEARS OF THE HABIT. I STOPPED AT THE AGE OF 35 AND HAVE NOT SMOKED SINCE. I WAS SOMEWHAT UNCOMFORTA- BLE FOR A SHORT PERIOD OF TIME, BUT WAS NEVER HIGHLY UNCOMFORTABLE. THE CRAVING NEVER REACHED THE LEVEL I HAVE EXPERIENCED OR OBSERVED IN MEDICAL WEIGHT LOSS PROGRAMS. IN SHORT, ALTHOUGH CIGARETTE SMOKING IS A COMMON AND PERVASIVE HABIT, I CAN FIND NO CONVINCING BASIS IN THE SCIENTIFIC LITERATURE OR IN MY OWN PROFESSIONAL CLINICAL EXPERIENCE TO JUSTIFY LABELING IT OR TREATING IT AS AN ADDICTION. -6-

340 at variance with the prevailing views I became interested in carrying out further research in the subject. A review of the literature of the effects of smoking in pregnancy is contained in the U.S. Public Health Service report "Smoking and Health" (1979, 79-50066). This report marshals a large body of evidence to link smoking with low.birth weight. However there is a strong minority body of opinion which holds that the effects observed in humans are mainly mediated through social status or nutrition. The hypotheses here are as follows: 1. Women of low socio-economic status have been known for many years to have smaller babies than more privileged women. Smoking is a class linked practice. There are now far more smoking women in lower than in upper social class groups in Western societies. The link between smoking and low birth weight may therefore not be causal but mediated through other social•factors. 2. Smokers may be more likely than non-smokers to have small infants because of their personality or their genetic predisposition to respond unfavorably to stressful events. -3- 341 3. The effect of smoking c( nutrition; it is possib' or worse than non-smoker cause of the associatior reduced birth size. ' Evidence in favour of one or ano has been obtained by a number of 15-20 years: Yerushalmy produced evidence tha- to a particular type of reproducl J, Am. J. Obstet. Gynecol. 73, 8C Am J. Epidemiol. 93 443, 1971). Silverman's research supported th D.T. Am. J. Epidemiol. 105, 513, Davies et al, in a substantial an concluded that much of the effect was mediated through poor materna and was likely to have been of nu D P et al, Lancet 1, 385, 1976). -4-

334 335 - 2 - : i II~~ l f •' I . ,~ ~ ~i f fi i n oe 1 HCOKER S .. Cl~:7?S ~R l-R ia ER f , , . . . . . ~ ... ilrl e_ : .c_s . . . . . . Sr,c_:-,.'rrce r~-- - s:C_• , N 'J _ 'C S^7:6 E -- _,. . c ,]021 1~l.6!VO STATEMENT OF WALTER M. BOOKER, PH.D. My name is Walter M. Booker. I am President of Walter M. Booker and Associates, Inc., an incorporated biomedical group in Washington, D.C. I am also Professor Emeritus of Pharmaco- logy at Howard University where I was Chairman of the Department of Pharmacology for 20 years. My post graduate professional training consists of a Master's Degree in Cellular Physiology and Biochemistry from the University of Iowa and a Ph.D. in Physiology and Pharmacology from the University of Chicago. I also spent a postgraduate year as a Senior Fulbright Scholar in Belgium and Sweden, studying with two Nobel Laureates. I hold membership in numerous scientific societies including the American Society of Pharmacology and Experimental Therapeutics, the American Physiology Society, the American College of Clinical Pharmacology, and the American College of Cardiology of which I am a Fellow. The views I am expressing in tt upon my training and experience as z fields of pharmacology and physioloc endeavors included studies on the ef of nicotine on the heart and the aut system. My main concern with the Bills and S 1929, is that they propose cor findings that have not been clearly to note that both Bills make such s: smoking is the number one cause of . heart disease deaths *are attributa: opinions are undoubtedly based on s is by no means unanimity in the sci smoking can be incontrovertibly lab Despite what those in the legi the cause or causes of cancer of tF unknown. Both smokers and nonsmoke diseases often associated with cige don't know why.

335 - 2 - The views I am expressing in this statement area based upon my training and experience as a scientific researcher in the fields of pharmacology and physiology. In these areas my research endeavors included studies on the effects and mechanisms of action of nicotine on the heart and the autonomic (sympathetic) nervous system. My main concern with the Bills under consideration, HR 4957 and S 1929, is that they propose congressional action based on findings that have not been clearly established. It is important to note that both Bills make such summary statements as: "Cigarette smoking is the number one cause of lung cancer" and one-third of heart disease deaths "are attributable to smoking." While such opinions are undoubtedly based on some published information, there is by no means unanimity in the scientific community that cigarette smoking can be incontrovertibly labeled as causal. Despite what those in the legislative arena might believe, the cause or causes of cancer of the lung (and other organs) remain unknown. Both smokers and nonsmokers contract cancer and other diseases often associated with cigarette smoking, and we still don't know why.

313 CURRICULUM VITAE: :=5_R L. ?._CK , '1.D. SCIE!tTIFIC PRESE\ZATISNS/I\TITED SPEA}-n,'NC:.}:::='JP DIREI"TCR: Therapy for metastatic solid tWmors. Presented for UCLA Postgraduate Internal Medicine Seminar: Current Trends in Internal Medicine, January, 1974. Malignant th;r•,oma: A review of 20 cases. Presented to American College of Physicians, New York, 1974. Hemostatic Defects Induced by Cardiopulmonary Bypass. Presented to International College of Angiology, Montreal, 1974. Hemostatic defects induced by cardiopmlmonary bypass. Presented to the American Association of Clinical Pathologists, Washington, D.C., 1974. Control of bleeding associated with cardiopui,.anary bypass: Panel member. National Meeting of the Southern Thoracic Society, Williamsburg, Virginia, 1974. Special Symposium Participant: "Side Effects of antihemophilia Concentrates". World Federation for Hemophilia, Helsinki, Finland, 1975. Hemorrhagic Syndromes Associated with Cardiopulmonary Bypass: Pathogenesis, Diagnosis, and Management. International Cardiovascular Society (;'aarly meeting), Edinburgh, Scotland, 1975. Bleeding Associated with Cardiopulmonary Bypass. Cardiology Grand Rounds, UCLA, 1975. Bleeding Problems in the O.R. Special UCLA Lecture series; Department of Surgery, Kern County General Hospital, Bakersfield, California, 1975 A Systematic Approach to the Diagnosis of Bleeding Disorders. UCLA, Santa Monica Hospital II Annual Family Practice Refresher Postgraduate Course, UCLA, 1975. Program and Workshop Director: Recent Concepts and Evaluation of Disorders of Hemostasis, American Society of Clinical Pathologists, 1975. Platelet Adhesion, Bleeding Times, and Aspirin Presented to the American Society of Clinical Pathologists, Chicago; 111. 1975. Prothrombin Complex Concentrates and Disseminated Intravascular Coagulation. Presented to the World Federation of Hemophilia, Helsinki, Finland, 1975. Recent Concepts and Evaluation of Disorders of Hemostasis and Thrombosis. American Society of Clinical Pathology National Workshop, September, 1975. -17- BJII

321 CL'2RICULL?t VITAE: RC:`°_R L. BICK, :d.D. SCIENTIFIC PRESE\TATIONS/I\VITED SPEAKER/WORKS&CP DIRECTOR (cant.) A Hereditary Hemorrhagic Telangiectasia and Disseminated Intravascular Coag•,a ation: A New Clinical Syndrome. VIIIth International Congress on Thronbosis and Haecostasis Toronto, Ontario, Canada July 1981. Piracetam: A\ew Platelet Suppressing Drug. VIIIth International Congress on Thrombosis and Haemostasis Toronto, Ontario, Canada July 1981. The Effect of Piracetam in Preventing Recurrent Deep Venous Throe,bosis. VIIItK International Congress on Thrombosis and Haemostasis Toronto, Ontario, Canada, July 1981. A Comparison.of Chromogenic, Fluorogenic, and Fibrinogen Substrate Assays for the Determination of Plasma Heparin VIIIth International Congress on Thrombosis and Haemostasis Toronto, Dntario,' Canada, July 1981. Studies Related to Tobacco Glycoprotein: A Claimed Activator of Coagulation, Fibrinolysis, Complement, Kinin, and a Claimed Allergen. VIIIth international Congress on Thrombosis and Haemostasis Toronto, Qntario, Canada, July 1981. Clinicians and New Methods in Coagulation Testing Annual Meeting of the American Association of Clinical Chemists (Invited Speaker), St. Louis, Missouri July 1981. A Review of'Hemostasis and Thrombosis The Colorado Association for Continuing Medical Laboratory Education Dillon, Colorado July 1981. Hemostasis, Coagulation, Disseminated Intravascular Coagulation and Proteolysis American Society of Clinical Pathologists Atlanta, Georgia September 1981 Hemostasis, Coagulation, Disseminated Intravascular Coagulation and Proteolysis American Society of Clinical Pathologists Silver Springs, Maryland, September 1981 Clinical Applications of AT-III Surbaban Hospital, Silver Springs, Maryland Grand Rounds September 1981 DIC and Bleeding Problems Associated with Open Heart Surgery National Naval Medical Center Grand Rounds Bethesda, Maryland September 1981 -25- 8 0 I

332 HAVE BEEN WITH MORPHINE, COCAINE AND ALCOHOL, THE CONCEPT OF TOBACCO ADDICTION WILL PROBABLY REMAIN A HYPOTHETICAL CONCEPT ONLY PARTLY UNDERSTOOD GJARVIK, 1977). AND SO, GENTLEMEN, AT THIS TIME THE SCIENTIFIC DATA DO NOT SUPPORT THE STATEMENT: CIGARETTE SMOKING IS ADDICTIVE. I WOULD NOW LIKE TO DISCUSS VERY BRIEFLY MY CLINICAL EXPERIENCE WITH SMOKING. DURING THE PAST 30 YEARS, I HAVE WORKED AND CONTINUE TO WORK WITH PEOPLE WHO SMOKE CIGARETTES. IN REVIEW- ING MY EXPERIENCE WITH THE THOUSANDS OF PEOPLE THAT I HAVE SEEN PROFESSIONALLY, MANY OF WHOM ARE HEAVY SMOKERS, SOME CONTINUED, SOME QUIT WITH STRESS, AND SOME QUIT WITH LITTLE OR NO STRESS. THESE PATIENTS IN NO WAY ACTED LIKE THE PATIENTS THAT I HAVE SEEN WHO STRUGGLE TO BE RELEASED FROM THE ADDICTIONS OF OPIATES OR ALCOHOL. CIGARETTE SMOKERS ARE VERY ATTACHED TO THEIR SMOKING BEHAVIOR. THEY ARE OFTEN ANNOYED OR DISTRESSED WHEN THEY ARE NOT ALLOWED TO SMOKE. HOWEVER, I HAVE NOTED EQUALLY STRONG ATTACH- MENTS TO TENNIS, JOGGING, CANDY, ROCK MUSIC, COCA-COLA, MEMBERS OF THE OPPOSITE SEX, AND HAMBURGERS IN MY ADOLESCENT AND ADULT PATIENTS. WITH CHILDREN, ONE SEES VERY STRONG ATTACHMENTS TO PLAYMATES, PARENTS, CERTAIN ARTICLES OF CLOTHING, TV, BLANKETS AND TEDDY BEARS. REMOVAL FROM THESE ACTIVITIES, PERSONS OR OBJECTS CAN RESULT IN AGITATION, SLEEPLESSNESS, IRRITATION, DEPRESSION AND OTHER UNCOMFORTABLE SYMPTOMS. THEY VARY CONSIDERABLY IN INTENSITY -5- 333 AND DURATION, AS DO EFFECTS FOLLOWING A SMOKING. I, MYSELF, SMOKED CIGARETTES PACKAGES A DAY FOR THE LAST TEN YEARS 0 THE AGE OF 35 AND HAVE NOT SMOKED SINCE BLE FOR A SHORT PERIOD OF TIME, BUT WAS THE CRAVING NEVER REACHED THE LEVEL I H IN MEDICAL WEIGHT LOSS PROGRAMS. IN Sh SMOKING IS A COMMON AND PERVASIVE HABIT BASIS IN THE SCIENTIFIC LITERATURE OR I CLINICAL EXPERIENCE TO JUSTIFY LABELING ADDICTION. -6-

316 CuRRICULT-I VIT:E: R'' er L. °_ick, '+..D; SCIE\71FIC FRESE\T>TICNS 6 IUVITED C REC:DR (c^.~ Recent Concepts and Deyelopments in E:alcatir.g Discrders of °e:cstasis and Thrombosis American Society of Clinical Pathologists, Chica3o, 1978 Modern Concepts and Evaluations of HeWostasis and Thrombosis; Director American Society of Clinical Pathologists, San Diego, 1978 Disseminated Intravascular Coagulation and Related Syndro-es; Director American Society of Clinical Pathologists, San Diego, 1978 Difficult Diagnostic Problems in Hemostasis and Thrombosis; Director American Society of Clinical Pathologists, San Diego, 1978 Basic Mechanisms of Hemostasis Grand Rounds (All Staff), Northridge Hospital, Korthridge, CA, 1978 Current Status of Mini-heparin Grand Rounds (All Staff), Northridge Hospital, Northridge, CA, 1978 Hypercoagulability and Thrombosis Grand Rounds (All Staff), Northridge Hospital, Northridge, CA, 1978 Modern Concepts of Hemostasis and Thrombosis; Director American Society of Clinical Pathologist (Naticnal Secinar), St. Louis, Missouri, 1978 Difficult Diagnostic Problems in Hemostasis and Thrombosis; Director American Society of Clinical pathologist, (National Seminar), St. Louis, Missouri, 1978 jlntithrombin III: Theory and Clinical Applications Annual Hemostasis Workshop; John Penner - Director; Ann Arbor, Michigan, 1978 Disseminated Intravascular Coagulation and Related Syndromes; Director American Society of Clinical Pathologist, St. Louis, Missouri, 1978 (National Seminar) Course in Hemostasis to Laboratory Technology Students California State College at Bakersfield, Bakersfield, CA., 1978 Disseminated Intravascular Coagulation and Related Syndromes Canadian Society of Pathologists, Ontario, Canada, 1978 Current Concepts of Hemostasis and Thrombosis American Society of Clinical Pathologists (Continuing Education Comaittee- Seminar) Chicago, Illinois, 1978 317 rjc:iCJL:1.M 61TAE: SCIENTIFIC PRESENTATICNS B I>T1TED Disseminated Intravascular Coagulation and California Society of Pathologists, San Fr Current Status of Henostasis, 7Tror,.b.sis a A.-erican Heart Association Annual Meeting, Difficult Diagnostic Problems in Hesostasi :,:.erican Society of Clinical Pathologist ( Current Concepts of Hemostasis and Throcbo ;rerican Society of Clinical Pathologist,( Modern Concepts and Evaluation of Hemostas knerican Society of Clinical Pathologist, DisseRSnated Intravascular Coagulation and L-erican Society of Clinical Pathologist, Modern Laboratory Evaluation of Heapstasis A:-,erican Society of Clinical Pathologist, Current Concepts in Hemostasis and Thrombo California Society of Pathologists, Annual Cisseminated Intravascular Coagulation and A-erican Society of Clinical Pathologist ( Lincoln, Nebraska, 1979 Hypercoagulability Colorado Association for Continuing Medica Current Concepts of Hemostasis and Thrombo A:,erican Society of Clinical Pathologist ( '.ebraska, 1979 11odern Concepts and Evaluation of Hemostas S:.erican Society of-Clinical Pathologists, Difficult Diagnostic Problems in Hemostasi k-erican Society of Clinical Pathologists, -21-

322 C~RRICCLGN VITAE: :'OI'ER L. SICK, 'f,D. SCIENTIFIC PRESE\7ATIONS/IN1'ITED SrEAKER;tiGRkS i0P DIRECTOR (cont.): Modern Concepts and Evaluations of Hemostasis and Thronbosis American Society of Clinical Pathologists and College of American Pathologists Fall Meeting, Las Vegas, Nevada, October, 1981 Difficult Diagnostic Problems in Hemostasis and ThreWbosis American Society of Clinical Pathologists and College of American Pathologists Fall Meeting, Las Vegas, Nevada, Dctober, 1981 New Methods in Coagulation Testing - Scientific Exhibit American Society of Clinical Pathologists and College of American Pathologists Fail ;•leeting, Las Vegas, Nevada, October 1981 Review Course in Coagulation American Society of Clinical Pathologists, CAY'b1-CCE Joint ASCP Project Los Angeles, CA November, 1981 ZSa C:;'.RICUL'uy VITAE: ME`7SERSHIPS: 3 International Society of Haeootology International Society on Thrombosis a Thrombosis Council-American Heart Ass American College of Angiology (Fello International College of Angiology (: American Association for the StudY of American Association for Clinical Rese Central Oncology Group (Clinical Inves American Society of Mammologists Nigerian Haematology Society Southwest Oncology Group (Clinical Inv California College Honor Society American Cancer Society International Association for the Stud) Federation of American Societists American Geriatrics Society (Founding Professional Education Committee, Ameri Research and Grant Peer Review Committe• Consultant: American Tobacco Research ( Chairman: Professional Education Commit Kern County Unit Member: Professional Education Committe County Unit

341 i 3. The effect of smoking could be mediated through nutrition; it is possible that smokers eat less or worse than non-smokers, and that this is the cause of the association between smoking and reduced birth size. Evidence in favour of one or another of these hypotheses has been obtained by a number of workers over the past 15-20 years: Yerushalmy produced evidence that smoking was an "index to a particular type of reproductive outcome" (Yerushalmy J, Am. J. Obstet. Gynecol. 73, 808, 1957; Yerushalmy J, Am J. Epidemiol. 93 443, 1971). Silverman's research supported these conclusions (Silverman D.T. Am. J. Epidemiol. 105, 513, 1977). Davies et al, in a substantial and well documented study, concluded that much of the effect of smoking on fetal growth was mediated through poor maternal weight gain in pregnancy and was likely to have been of nutritional origin (Davies D P et al, Lancet 1, 385, 1976). -4- 0 tj ~ ~ CD ~ N

9 343 The next 2 years will, it is hoped, be devoted to answering questions about the relationships between smoking and food intake and between psycho-social stress and birth size. This will lead directly to a large scale epidemiological survey of pregnancy outcome with very careful attention to data collection techniques, and multivariate analysis of factors important in birth size and pregnancy outcome. The techniques used, particularly in relation to the collection of social and nutritional data, will have been thoroughly developed and tested in the initial studies. March 8, 1982 -6- I 0

I 345 © Scientific Societies: Member of Nutrition Society Physiological Society Neonatal Society British Paediatric Association European. Society of Paediatric Gastroenterology a- Nutrition Paediatric Research Society. Other Scientific Member of European Advisory Co®ittee on feeding of Activities: low birth-weight infants, organised by the European Society of Paediatric Castroenterology and Nutrition. t. Is 3 f

9 ty ute s an 339 which was organized by the European Society of Paediatric Gastroenterology and Nutrition. In addition, I am a member of the following scientific societies: Nutrition Society, Physiological Society, Neonatal Society, British Paediatric Associition, European Society of Paediatric Gastroenterology and Nutrition, and Paediatric Research Society. I have been an invited speaker and have presented numerous papers at scientific meetings, and I am the.author of numerous scientific publications. My interest in smoking and fetal growth dates from the early 1970s when I carried out a study on ethnicity and birth size. This involved careful matching of pregnant women for factors such as social status and income, combined with accurate assessment of gestation. Such information is difficult to obtain in large scale epidemiological surveys but is very important in assessing the outcome of pregnancy. When we analyzed our results we found that, after controlling for maternal age, height, gestation of pregnancy, parity, socio-economic status and race, and infant sex, smoking appeared to have little or no influence on birth weight and other measures of fetal growth. (Alvear J & Brooke OG, Archives of Disease in Childhood 53, 27, 1978; Brooke O.G., Lancet 1, 1158, 1977). Since this unexpected finding was -2-

318 CCRRICULG!t S'I`:AE: I 3_Jier L. 9ici., M.D. SCIE\TIFIC :RESE:'7aTTO.':S 8 I!C:ITED D:;,ECi.^R cc,nt.) Dissecinated intravascular Coagulation and Re!ated Syndro,^es; Dire:.tor American Society of Clinical Pathologists, Fall Sleeting, Las Vegas, Oct., 19-9. Modern Laboratory Evaluation of Hemostasis and P:rocbosis; Director i American Society of Clinical Pathologists, Fall Meeting, Las Vegas, Oct., 19'9. Review Course in Coagulation American Society of Clinical Pathologists, Winter Meeting, San Diego, CA - January, 1980 Difficult Diagnostic Problems in He*:ostasis and Thrombosis, Winter Meeting American Society of Clinical Pathologists, San Diego, California, January, 1980 Disseminated Intrsvascular Coagulation American Society of Clinical Pathologists, Winter Meeting, San Diego, CA January, 1980 Modern Concepts and Evaluation of Hemostasis and Tnroc.Sosis, Spring ?:eeting American Society of Clinical pathologists, Atlanta, Georgia, March, 1980 Difficult Diagnostic Problems in Hemostasis and Thrombosis, Spring Meeting American Society of Clinical Pathologists, Atlanta, Georgia, March, 1980 Disseminated Intravascular Coagulation and Related S}ndromes, Spring Meeting American Society of Clinical Pathologists, Atlanta, Georgia, March, 1980 Clinical Applications of Plasma, Heparin Levels, Antithrombin-III, Plasminogen, and Alpha-2-antiplasmin, San •Leandro Doctors Hospital, April 1, 1980 Disseminated Intravascular Coagulation (Grand Rounds Presentation) Stritch School of Medicine, Loyola University, Maywood, Illinois, May, 1980 Monitoring Heparin Therapy (Surgical Grand Rounds) Stritch School of Medicine, Loyola University, Maywood, Illinois, May, 1980 ~. Hereditary Hemorrhagic Telangiectasia and Associated Thrombohemorrhagic Defects Wayne State University, School of .`ledicine, Detroit, Michigan, May 1980 Disseminated Intravascular Coagulation: A Clinical/Laboratory Correlation in 48 Patients Wayne State University, School of Medicine, Detroit, Basic Mechanisms of Hemostasis and Thrombosis Michigan, May 1980 Traveling Consultant in Hematology/Medical Oncology, Tripler Army Medical Center, Honolulu, Hawaii, Jur,e, 1980 Hereditary and Acquired Vasci..lar Defects and Hereditary and Acquired Platelet Function Defects Traveling Consultant in Hemoe.tasis/Medical Oncology, Tripler Army Medical Center, Honolulu, Hawaii, June, 1980 Ik 319 CCRR?CU:.UD1 %'I"AE: SCIENTIFIC PRESE\TATIONS/I:VITED SPEAK-ER/nCF Congenital Coagulation Defects and von Wille Traveling Consultant in Hematology/Medical C Honolulu, Hawaii, June, 1980. Disseminated Intravascular Coagulation and F Traveling Consultant in Hematology/Medical Center, Honolulu, Hawaii, June, 1980. H,vpercoagulability, Anticoagulant Therapy, Traveling Consultant in Hematology/Medical c Honolulu, Hawaii, June, 1980. Current Concepts of Heparin Therapy (Surgic +!erc.• Hospital, Miami, Florida, September . Disse-inated ;ntravascular Coagulation (Med' Mercy Hospital, Miami, Florida, September : Hemostasis and Bleeding Disorders in Probler Mt. Sinai Medical Center, Miami Beach, FL . Clinical pplications of !tcasuring Antithro: :ts Relationship to Monitoring Heparin Ther Kt. Sinai Mediaal Center, Miami Beach, F1 . Current Concepts of Heparin Therapy Valley Medical Center, Fresno, CA Septembe . Disseminated Intravascular Coagulation L'alley Medical Center, Fresno, CA Septemb Disseminated Intravascular Coagulation and American Society of Clinical Pathologists, St. Louis, October, 1980. Difficult Diagnostic Problems in Hemostasis 4merican Society of Clinical Pathologists, St. Louis October 1980. Modern Concepts and Evaluation of Hemostasi american Society of Clinical Pathologists, St. Louis October 1980. Monitoring Heparin Therapy 8 Mini-Heparin " Dameron Hospital Association, Stockton, CA . -23-

® 353 STATEMENT OF BARBARA B. BROWN, Ph.D. I am Barbara B. Brown, former Chief of Experiential Physiology, Veterans Administration Hospital, Sepulveda, California. I received my Ph.D. in Pharmacology from the University of Cincinnati College of Medicine in 1950. I have over 30 years research experience, primarily in the fields of pharmacology, psychopharmacology, neurophysiology and psycho- physiology. I began my research activities as a technician in the pharmaceutical firm of The Wm. S. Merrill Co. (subsidiary of Merrill-Richardson) and later became Head of the Department of Pharmacolcgy. After leaving Merrill, I served as Research Neuro- pharmacologist at Riker Laboratories in California and as Consulting Neurophysiologist at Psychopharmacology Research Laboratories. I was also an associate clinical professor of pharmacc'ogy at the University of California Center for Health Sciences in Los Angeles and at the Department of Psychiatry and Human Behavior at the University of California -- Irvine, and also lecturer at the Department of Psychiatry at UCLA. As Chief of Experiential Physiology Research at the VA Hospital in Sepulveda, I was one of the pioneers in the development of the concept of biofeedback. In the past few years, much of my professional activity has centered around attempting to analyze the role of mental activity (brain information processing systems) in health and illness. To date, I have published four books and several theoretical articles on this subject. 11 0

338 Statement Smoking and Fetal Growth by Oliver Gilbert Brooke, M.D. FRCP Department of Child Health St. George's Hospital London SW 17 I am a graduate in Medicine of London University, attaining my basic medical degree in 1966. I received an MD degree (British medical equivalent of PhD) from London University in 1974. I am a pediatrician by training, with specialist interest in newborn medicine and nutrition. My present position is Reader in Pediatrics at St. George's Hospital (equivalent of full Professor in the United States) and I am head of Neonatology. Among other positions I have held, I have served as Scientific Officer of the Medical Research Counsel, Tropical Metabolism Research Unit at the University of the West Indies (1969-1972); Member of the Scientific Staff of the Division of Human Physiology, National Institute for Medical Research, Hampstead (1972-1973); Paediatric Registrar and Senior Registrar in Paediatrics at St. Mary's Hospital, London (1973-1976). I am a member of the European Advisory Committee on Feeding of Low Birth-weight Infants 339 which was organized by the Europea: Gastroenterology and Nutrition. Ii of the following scientific societ: Physiological Society, Neonatal Soc Association, European Society of Pf and Nutrition, and Paediatric ReseE an invited speaker and have present scientific meetings, and I am the.a scientific publications. - _ My interest in smoking and fetal gr 1970s when I carried out a study on size. This involved careful matchi for factors such as social status a accurate assessment of gestation. difficult to obtain in large scale but is very important in assessing When we analyzed our results we fou: for maternal age, height, gestation socio-economic status and race, and appeared to have little or no influ< other measures of fetal growth. (A: Archives of Disease in Childhood 53 Lancet 1, 1158, 1977). Since this i -2-

300 YIT1.c: r':3LIC.TiC':S ^t.): B' ct RL 3is`op ?C Tse, D, -. _..broa, E: F:ctor V: A sspiifiel o:je staae --say :.si-g ;_. -.__-_c -:,1, 3.itr. 2. Path. 15?:511, I:'3 Sick, RL, =.da^s, T, Goi.";:ert, LS: A PreV1oUS L.-Y. Cr0't:-d C'33U1atiCn "liyies-StcCen s~T.droire. . . Ci-.n. 7,es. 21:264, 1973 Si.k, RL, Sc..-alhorst, WA: az zbo:ytic *_.`:erapy :ai.h = _.a _.. t_ .-..,_, t Va=c. Surg. 8:152, 1974'. 4L: Sick , -:d t_ca..ernt .7ad. C^'.~;:te_po_nt 6::8, 19+4. 3i ck, T: 3i. ?cc4 ±L, . . _~, T, a-.i , __tk, K: S.::gi.-1 _ 'ostasis . th a J.A.?L A. 2:9:153, 1974. Bi •k n s T LS: :e : ..shcs-Sto': ea i-itr. ._t4. 3d. 153:.:0, :9'4 Blck, ;L: Fi' ri^oiytic ~=-tia1 in ._ra :'~. ...th. 3d. lii:-07, 1974 Sick, RLN, '.4, C:.:°ord, ?late_rt f:-,.ti.n _ iitSes in `s. Circ'ji.,.__n =3. •,k 17 t c., ,.st 77 in -.r:rx ~.+c_r.-..te: use in s of c.`. ic :;;er '.ise=_se. Am. J. D:;?s. Z0:'=1, 1975 .-_t RL, C-:w..:d, L. : .-.-_n, , _.-s, T, Sick, RL, 5:` __? rst, h'R, L: 3L:_.a a=sri-s:ad r.tr -ascui:r c_ _on T.saf' si_•n, 16:561,- 19'6 301 C_aRICU'_:^a VITAE: ^;;9LIC:TICYS (cont.)• Bick, RL, Adams, T, Schmalhorst, WR: Bleeding times, platelet adhesion, and aspirin Am. J. Clin. Pathol. 65:69, 1976. Bick, RL: Alterations of hemostasis associated with card Thronb. Res. 8:285, 1976. Bick, RL: - Adriamycin and fibrinolysis. Thromb. Res. 8:467, 1976. ~' Bick, RL, Fekete, L. Murano, G, Wilson, NL: Duano"tycin and fibrinolysis. Throc.b. Res. 9:201, 1976. , - Bick, RL, Fekete, L,.Kot'acs, I: A new two-stage functional assay for antithroml clinical and laboratory evaluation. Thromb. Res. 8:745, 1976. Wilson, WL, Andrews, NC, Frelick. RW, Nealon, 1 Preli^inary re_ort on the use of CC?.U (\SC-790: Hexamethvlmelamine. (,tiGf.-]~R75) in careino^;a_of Cancer Treat. Rept. 60:269, 1976. Fe;ete, LF, Bick, RL: Laboratory modalities for assessing hemostasis Semi&ars in Thromb. and Hemostasis 3:83, 1976. Bick, RL, Dukes, ML, Wilson, WL, and Fekete, LF Antithrombin III as a diagnostic aid in dissemi Thromb. Res. 10:721, 1977. Bick, RL: Complement levels in disseminated intravascular Am. J. Clin. Path. 68:93, 1977. Bick, RL: Alterations of hemostasis associated with malig diagnosis and management. Sem. Thronib. and Hemostasis, 5:1, 1978. -5- -4-

363 reevaluation and restructuring of research into smoking motivation and behavior should be commenced. Because of my research, I feel strongly that the reasons people choose to smoke have constitutional origins and this must be taken into account when the advisability of a government cessation campaian is discussed. Conclusion House bill 5653 should not become law, because its scientific underpinnings are weak and unconvincing. Page 1. 0 ~ Q+ ~ ~ ~ ~ 95-077 0-82-24 ~ 0 0

355 physi- the basic -ets the cigarette .~: psycho= - life-"t! ly ople ic king,• y, The most convincing study ever conducted on the origins of smoking behavior was the decades-long study of'constitutional oredispositions to smoking by Seltzer. Using tests to develop psychological and physiological reaction profiles, Seltzer was able to predict who among pre-teens and young teenagers would be smokers when adults. His predictions were about 85% accurate. fl Since a major objective of science is to predict events accurately, and Seltzer's work is an outstanding example of achieving this objective, it is unfortunate that the implications of his studies have not been actively pursued. My own research did not come from considering Seltzer's work, but rather from a continuing interest in the electrical activity of the brain. A report of my research study on smokers and human EEG activity appeared in the December 1968 issue of Neuropsychologia, an international journal on neurology. The study compared a variety of EEG measures, along with behavioral characteristics, among light, moderate, and heavy smokers, former smokers and nonsmokers. Each subject was studied one full day, under various control and test conditions, for EEG patterns and reactivity. Results of the study were both unexpected and dramati-C. I discovered striking differences between the brain wave patterns ,Page 3

generating system. Further, we found that there was no effect of this contaminant on the normal clot inhibiting proteins found in human blood. Our studies strongly suggest that TGP isolated by the general published procedure of Becker and co-workers consists of a contaminant which is introduced during the separation process and contributes to, or more likely, is entirely responsible for the biological activites noted by Becker and co-workers. The presence or absence of a substance in tobacco smoke and certainly unproven. It is obviously of importance to examine the significance, if any, of tobacco glycoprotein; however, a good deal of controversy does exist and it has been impossible to duplicate previous findings. In this one instance it appears that erroneous and superficial observations have led to far reaching hypotheses which cannot be confirmed by carefully performed studies. This author's plea would be for adherence to confirmed scientific fact, rather than emotion, in attempting to study and delineate the biological effects, if any, of cigarette smoking on the blood coagulation complement or kinin systems. My own research and review of the scientific literature lead me to the conclusion that whether and how smoking might cause heart attacks or cardiopulmonary disease remain open questions. 297 can Fra-:cisco, r•a;if-rr.-'s rit.a] S'a s: arried ._....er x'-_a Ca:if , ' S a_ata: ~ni.=rsi,y of : 3''0 - a et .. _-:r: . cs. "'c.•-ia 't .. n. eg c, a n. .'~!'y':911 -'' .]'2,,~= p: Cai:`ornia a-.d iil 'C; p_ t9t6 - Sa, C `307 - - =:d ;' .'.d icg r '.aic` r.e, i367. • -°,rt•!i r ar~i: -o -.2AiCai .-'.,i ...: -:5 -... 7a1 r ._<e_rch __ ~ %-1iy 1973 - ',;y :9.'4. :'or of ',, a] d at:cn: Ker~ Cc er; 1973 -'day 1974. %I

315 CL"~IC L°:1 Y:TAE: Pc-'.er L. .lck, M.D. SCIES?IFiC PKESENT.AT:ONS F, I.\lITEO SFF`K-E3': ^13EC^R (=t.) Current Concepts of Hamostasis; Clinical and La~oratory E:aications of ThromSohemorrhagic Phenomena; Director Arrsric3n Society of Clinical Pathologists, Corrission on tiedical Laboratory Personnel Regional Education Program, Los Angeles, 1977 Modern Concepts and Evaluation of Hemustasis and Thror•bosis; Director American Society of Clinical Pathologists, Fall ~'eeting, Las l'egas, Nevada 1977 Disseminated Intravascular Coagulation and Related Syndromes; Director American Society of Clinical Pathologists, Fall Meeting, Las Vecas, Nevada, 1977 Difficult Diagnostic Problems in Hemostasis and Thrombosis; Director American Society of Clinical Pathologists, Fall Meeting, Las Vegas, Nevada, 1977 Recent Concepts and Developments in Evaluating Disorders of He^ostasis and Thrombosis - AMA/CMA, Palm Springs, 1978 Second Annual Southern California Blood Clotting Symposium American Society of Clinical Pathologists, Santa Monica, 1978 :'odern Concepts and Evaluation of Hecostasis and Thrr„bcsis; Director " American Society of Clinical Pathologists, March, Dallas, 1978 Disseminated Intravascular' Coagulation and Related Syndromes; Director American Society of Clinical Pathologists, Flarch, Dallas, 1978 Difficult Diagnostic Problems in Hemostasis and Thrombosis; Director American Society of Clinical Pathologists, March, Dallas, 1978 Current Concepts of Hemostasis and Thrombosis, Workshop Director American Association of Clinical Chemistry, San Francisco, 1978 Modern Concepts and Evaluation of Hemostasis and Thrombosis; Director American Society of Clinical Pathologists, Fall Meeting, St. Louis, 1978 Disseminated Intravascular Coagulation and Related Syndromes; Director American Society of Clinical Pathologists, Fall MeetinV, St. Louis, 1973 Difficult Diagnostic Problems in Hemostasis and Thrombosis; Director American Society of Clinical Patholoaists, Fall Meeting, St. Louis, 1978 Current Concepts of Hemostasis: Clinical and Laboratory Evaluation F ]hrombohemorrhagic Phenomena American Society of Clinical Pathologist, Regional Cont. Medical Education Program, August, Charleston, South Carolina, 1978 -19- 0 95-077 0-82-21 i 0 0

361 all research on smoking and health, particularly reports that suggest hazardous effects. This often amounts to a media blitz. Further, official warnings are constantly reinforced by anti-smoking commercials and advertisements on radio, magazines, and TV. Advertising by stop-smoking institutes, courses, clinics, e*_c., constitutes additional media coverage and anti-smoking campaigning. Finally "educational" programs are a fairly perma- nent part of many school programs. A recent TV news report showed first graders signing oaths that they would never smoke and orally repeating the oath virtually every day. Such a strong effort, which is probably representative of many educational orograms, goes beyond merely an education purpose and approaches behavior thought control. Warning Labels or Even if i agreed with the bill's findings and supported the belief that public awareness of health hazards was inadeauate, I would still disagree with the proposed change in health warnings. As a society, we are extremely uninformed abcut the basis for behavior that we have termed risk-taking. It should be obvious that the extraordinary sums of money spent on behavioral research, its almost complete failure to discover the causes of these behaviors, and its near failure to prevent such behaviors carry a message. One of the outstanding flaws is the failure of Page 9

a 359 kind of excess energy -- and smoking provides on acceptable outle7: by which that energy can be discharged. Smokinq and Health Studies The bill's "findings" on smoking and health reflect the government position which is promulgated in the Surgeon Generals' Reports. These Reports are based on highly selective reviews of that literature. The behavioral section of the 1979 Report, for example, admitted this very scientifically uncharacteristic approach. Many excellent "dissenting" reports are ignored. Frequently, when differing reports are cited, they are either inadequately or inaccurately reported. One wonders if occa- sionally the Reports' authors might not have been biased because of the government's policy on smoking. Unbiased reviews -- and unbiased research -- cannot be fostered in such an atmosphere. Many research studies cited in the Reports contain serious errors, such as questionable criteria for selecting subjects, poor experimental design, weak criteria for evaluation of results, conclusions not warranted by the data, use of error- ridden or inconsistent public records for information on death and disease, and the abuse of statistics. One of the weaknesses of these studies that most concerns me is the failure of the epidemiological studies to Page 7 u

320 CCRRICULL~4 VITAE: 3~~SER L. 3ICK, M.D. SCIE\TIFIC PRESENT.4TIONS/INAITED SPEAKER/HORKSHOP DIRECTOR (cont.): -:'L ' Syndromes of DIC American Dade Rocky Mountain Hemostasis Conference Denver, Colorado March 1981. Current Controversies About Heparin Therapy American Dade Rocky Mountain Hemostasis Conference Denver, Colorado March 1981. Modern Concepts and Evaluation of Hemostasis and Thrombosis American Society of Clinical Pathologists, Spring Meeting San Diego, CA March 1981. Difficult Diagnostic Problems in Hemostasis and Thrombosis American Society of Clinical Pathologists, Spring Meeting San Diego, CA March 1981. The Need for Tests of Hypercoagulability American Dade Hypercoagulability Seminar Miami, FL March 1981. Disseminated Intravascular Coagulation and Relatcd Syndromes Washington State Society for Medical Technology, Spring Seminar Spokane, Washington April 1981. • Antithrombin-III • California Blood Bank System Annual Meeting Los'Angeles, CA April 1981. Antiplatelet and Mini-Heparin Therapy Methodist Hospital of Southern California Arcadia, CA May 1981. Hemostasis Coagulation, DIC and Proteolysis American Society of Clinical Pathologists, Regional Educational Program Los Angeles, CA June 1981. Acquired AT-III Deficiencies that Occur with Surgery; Surgical Grand Rounds The Medical College of Wisconsin, Milwaukee, Wisconsin, June 1981. AT-III and DIC: Hematology Conference Rounds _ 3 The Medical College of Wisconsin, Milwaukee, Wisconsin, June 1981. 1z Antithrombin-III/Heparin Interrelationships and Methods of Testing for AT-III Pathology Monthly Concerence, Milwaukee, Wisconsin, June! 1981. :~ -24- 321 .=:CULUz1 VITAE: ::?iFIC 2RcSE\;ATIO.'S/I\VITED SPEAKER/ItiORKSii': editary Hemorrhagic Telangiectasia and Disser .r: Clinical Sy'ndrome. :.'th ;nternational Congress on Thrombosis and cto, Ontario, Canada July 1981. cetam: A New Platelet Suppressing Drug. h International Congress on Thrombosis and :z)nto, Ontario, Canada July 1981. Effect of Piracetam in Preventing Recurrent ':Ith International Congress on Thrombosis and -;nto, Ontario, Canada, July 1981. -parison of Chromogenic, Fluorogenic, and Fi ,vs for the Determination of Plasma Heparin ;t Internatim;al Congress on Thrombosis and .,rto, Ontario,'Canada, July 1981. es Related to Tobacco Glycoprotein: A Claim nolysis, Complement, Kinin, and a Claimed A .::th ;nternational Congress on Thrombosis and -oato, Ontario, Canada, July 1981. ..-.icians and New Methods in Coa.gulation Testin :..:al Meeting of the American Association of Cl ... Louis, Missouri July 1981. +'. iew of Hemostasis and Thrombosis c Colorado Association for Continuing Medical ..:'.on, Colorado July 1981. :.,ostasis, Coagulation, Disseminated Intravascu s=erican Society of Clinical Pathologists .anta, Georgia September 1981 --ostasis, Coagulation, Disseminated Intravascu -rican Society of Clinical Pathologists -•..er Springs, 'Maryland, September 1981 •.-.:_al Applications of AT-III •r'aban Hospital, Silver Springs, Maryland Gra >^?•eober 1981 ='C and Bleeding Problems Associated with Open H ",-ona1 Naval Medical Center Grand Rounds .':esda, Maryland September 1981 -25-

268 March 8, 1982 Cigarette Smoking of Pregnant Women A note regarding the "Comprehensive Smoking Prevention Education Act of 1982" HR 5653 S. 1929 My name is Bea J. van den Berg. Currently I am director of the Child Health and Development Studies, a research unit of the School of Public Health of the University of California at Berkeley. I received my medical doctor's degree in the Netherlands and in 1965 I joined the research staff of the Child Health and Development Studies that were designed and directed by the later Dr. J. Yerushalmy, professor of Biostatistics at the University of California at Berkeley. My CV is enclosed with the copy of my statement. I am here to express my concern about the statements made in the proposed 'Smoking Prevention Education Act of 1982" regarding an increased risk of spontaneous abortion, stillbirth, premature birth, child weight deficiencies and birth defects in pregnant women who smoke. For many years I have been involved in research regarding pregnancy and pregnancy outcome, and research results do not support these statements. Our studies were among the very first to identify the lower birth weight of babies born to smoking mothers as compared with that of non- smoking mothers. However, our studies did not indicate an increased risk of abortion and still births among smoking pregnant women nor are our studies supportive of the stated increased risk of birth defects. For almost two decades, at the Child Health and Development Studies, we have studied the pregnancy outcome of women who smoked cigarettes during pregnancy, in comparison with women who never smoked or who stopped smoking before or early in their pregnancy. These studies were based on interviews, early in their pregnancies, of scme 15,000 women who were members of Kaiser Foundation Health Plan, and who enrolled in the Child Health and Development Studies. Extensive information was obtained from the medical records of the mothers during their pregnancy and delivery and from the medical records of the children from birth to at least age five. Our studies are prospective and observational; prospective because the smoking data were assembled before the outcome of the pregnancy was known. This approach avoids a possible recall bias that might occur when the mothers are interviewed after the termination of the pregnancy. An unfavorable pregnancy outcome might affect the mothers' recall of any event that occurred during her pregnancy, including smoking habits. Our studies 269 -2- are observational and not experimentalj t'. researcher, but the women themselves decic cigarettes. The women in these separate r only in their smoking habits, but also in charactenistics. This methodological pro! as the problem of self-selection, has to : compare the pregnancy outcome of women whc outcome of women who do not smoke. I would like to summarize the resulte relate to the statements concerning preqnc On birth weight. As early as in 196: increased proportion of low birth weight : smoking pregnant women as compared with tt pregnant women. The observed association relationship but it may also be influencec and non-smokers in characteristics other t indeed showed that a variety of other matc socioeconomic status, maternal age and et` association between smoking during pregna: Controlling for a number of these variabl, the birthweight of the offspring of both Yerushalmy'a later work on maternal : methodologies and designing studies to te: the alternative hypothesis that increased due to the differences between smoking anc such study evaluated the frequency of low of mothers who began smoking after the bi: that women who subsequently became smoker: low birth weight babies during the period finding cannot be explained by the causal need for a larger study to confirm or ref. On abortion and stillbirth. Our sta- week of gestation the risk of fetal death pregnant women, failed to find a differen, results, based on the pregnancy outcome o provide evidence that smoking during preg: abortion and stillbirth. On birth defects. We recently publi. of the incidence of congenital anomalies children born to women who never smoked, to women who smoked during pregnancy. Th enrolled in the Child Health and Developm. show a difference in the incidence of sev children of smoking women and children of : I to

308 C'JRdICULu!t VIT?F: ,_?c.R L. Fil'K, '.D. x95T4ACTS (ccnt.): Dick, RL, Dukes, ML, Fekete, LF: Antithrombin III for diagnosing and nonitoring dissemir.ated intravascular coagulation. Trans. First Florence Conference on Hemostasis and 77irocbosis Florence, Italy 1977. Bick, RL, Fekete, LF, Wilson, WL: Platelet adhesion in clinical medicine. ' Trans. First Florence Conference on Hemostasis and Thrombosis Florence, Italy, 1977. Sick, RL, Arbegast, N'R, Fekete, LF, and Wilson, 1+'L: Heparin neutralization following cardiopulmonary b}pass., Clin. Res. 25:209, 1977. Dick, RL: Disseminated intravascular coagulation. ' Am. J. Clin. Path. 68:93, 1977 Sick, RL, Dukes, ML, Wilson, WL, Fekete, LF: Simple assay for plasma heparin introduced. J.A.M.A. Jan. 2, Vol. 239, No. 1, 1978. Dick, RL, and Fekete, LF: The development and evaluation of a new coagulation standard for protimes, PTT's, and all coagulation factor assays (`CCP). Blood Vol. 52, No. S, 321, 1978. . RL, and Wilson, WL: Bick , Multiple myeloma and second malignancies: a three year follow-up of forty patients. Blood 52:496, 1978. Sick, RL, Dukes, ML, Wilson, WL, Fekete, L: Antithrombin III patterns in disseminated intravascular coagulation: use for diagnostic and subsequent monitoring of anti-coagulation therapy. Am. J. Clin. Path. Vol. 69, No. 2, 203, 1978. Sick, RL, Dukes, ML, Wilson, WL, Fekete, LF: A new heparin assay for assessing heparin reversal during cardiopulmonary bypass. Am. J. Clin. Path. Vol. 69, No. 2, p. 204, February 1978. 309 C":;F?CJL;Df "%-IT"aE: :BS TR4CTS (ccnt. ) : Bick, RL, and Wilson, WL: Sfultiple myeloma and second malignancies: A thre patients. Blood, Vol. 52, No. S, 240, November, 1978 Bick, RL, and Fekete, LF:- Hereditary hemorrhagic telangiectasia and associ defects. Blood, Vo. 52, No. 5, 179, 1978. Fekete, LF, and Dick, RL: ine development and evaluation of a new coagulat .TT's and all coagulation factor assays. Elood, Vol. 52, No. 5, 181, 1978. Bick, RL: Biological antithrombin III levels. J.A.M.A., January 23, Vol. 239, No. 4, 1978 Bick, RL, Fekete, LF: Alterations of hemostasis during cardiopulmonar) membrane and bubble oxygenators. Trans. Am. Soc. Clin. Path. October, 1979, Las L Bick, RL, and Fekete, LF: Hereditary hemorrhagic telangiectasia and associ defetts. Blood, 54:745, 1979. Bick, RL, and Skondia, V: Piracetam: results of a preliminary in vivo tria Blood, 54:635, 1979. Bick, RL, Fekete, LF, Dukes, ML, Gaal, PG. Smit} Hereditary hemorrhagic telangiectasia and assoc: defects. Am. J. Clin. Path. Vol. 73, #2, p. 300, 1980. Bick, RL and Fekete, LF: Alterations of hemostasis during cardiopulmonar; between membrane and bubble oxygenators. Am. J. llin. Path. Vol. 73, #2, p. 300, Februar, -12- -13-

312 q:RkIC,_:LiiM VIT.:E: 3 CLRRICUL'J.1f VITAE: SCIE\TIFIC PRESE\TATIS3/I\'IITED SPEAK i SCIE.N;T1IFIC PRESEN TATIONS/I\l'ITED SPEai:ERiiN'04tSHJP DIRECTOR: The effects of pinealectomy and environmental lighting on the gonadal, thyroid, and total body weight of female Long-Evans Rats. Presented to Am. Assoc. Anatomist, New Orleans, 1968. Simplified measurements of fibrinolytic potential in myocardial infarction. Presented to Am. Med. Association Multidiscipline Forum. Fibrinolytic activity in various clinical states. Presented to Am. Soc. Clin. Path., Las Vegas, Sev. 1971. Australia Antigen: A comparison bf three detection aethods in a population of high risk for hepatitis. Hyperfibrinolysis in cirrhosis. Presented to Am. Coll. Physicians, Regional Meeting, Los Angeles, CA., 1972. The special problem of disseminated intravascular coagulation in malignancy Presented to Am. Cancer Society, Regional Meeting, 1972. Mechanisms of anemia in malignancy. Presented to American Cancer Society, Regional meeting, 1972. Prothrombin complex concentrate: use to control the hemorrhagic diathesis of chronic liver disease. Presented to Am. College of PhysiFians, Regional Meeting, Palm Springs, CA., 1973. Heparin therapy for disseminated intravascular coagulation Preeented-to UCLA 3rd Annual Anesthesia Postgraduate Seminar, UCLA, 1973. A systemic approach to the diagnosis of bleeding disorders. Presented for UCLA Postgraduate Seminar in Internal Medicine: Current Trends in Internal Medicine, January, 1974. A systemic approach to the diagnosis of anemias. Presented to UCLA Int. Medicine Seminar. Current Trends in Internal Medicine, January, 1974. Current therapy for leukemias and lymphomas Presented for UCLA Internal Medicine Postgraduate Seminar; Current Trends in Internal Medicine, January, 1974 -16- Therapy for metastatic solid t::..ors. Presented for UCLA Postgraduate Intern Current Trends in Internal Medicine, J Malignant th;r.,oma: A review of 20 cas Presented to American College of Physi Hemostatic Defects Induced by Cardiopu Presented to International College of : Hemostatic defects induced-by cardiopa: Presented to the American Association c Washington, D.C., 1974. Control of bleeding associated with cai National Meeting of the Southern Thorac Special Symposium Participant: "Side E: World Federation for Hemophilia, Helsir Hemorrhagic Syndromes Associated with C Pathcgenesis, Diagnosis, and Management Society (;•early meeting), Edinhurgh, Sc Bleeding Associated with Cardiopulmona: UCLA, 1975. • - Bleeding Problems in the O.R. Special Surgery, Kern County General Hospital, A Systematic Approach to the Diagnosis Santa Monica Hospital II Annual Family Course, UCLA, 1975. Program and Workshop Director: Recent of Hemostasis, American Society of Cli Platelet Adhesion, Bleeding Times, and Presented to the American Society of CI 1975. Prothrombin Complex Concentrates and Di Presented to the World Federation of He Recent Concepts and Evaluation of Disor American Society of Clinical Pathology

360 account for biological variation. In the behavioral area, this translates to the fact that the reasons for smoking differ in different kinds of oeople. The sum of psychological, consti- tutional, experiential, motivational factors is never the same for all smokers. There simply is no one, single condition of smoking behavior (incidentally, no single factor accounts for the high rate of recidivism in most stop-smoking programs). Moreover, studies that classify the one pack a day dilettante smoker (one who doesn't care whether he smokes or not, but does so for social reasons) along with the pack a day smoker who sincerely enjoys his smoking but limits it to a pack a day are extremely bad studies from the standpoint of subject selection. Congress must remember that science is not infallible. Both scientists and scientific reports have normal distribution curves of quality. Very few are excellent; most are just average. Awareness In regard to awareness, I strongly disagree with the implication in House bill #5653 that the American public is still too ignorant of the hazards that have been associated with cigarette smoking. I can think of no health claims in the past 20 years that have received more intensive and pervasive media coverage and governmental attention. The media regularly cover Page 361 all research on smoking and health, suggest hazardous effects. This of Further, official warning anti-smoking commercials and advert and TV. Advertising by stop-smokin etc., constitutes additional media campaigning. Finally "educatior.al" nent part of many school programs. `irst graders signing oaths that th repeating the oath virtually every wnich is probably representative of goes beyond merely an education our --hought control. ;Jarning Labels Even if i agreed with the tne belief that public awareness of I would still disagree with the prc 'arnings. As a society, we are ext --asis for behavior that we have ter -~bvious that the extraordinary sums research, its almost complete failu ='•:ese behaviors, and its near failu carry a message. One of the outsta

362 scientists or interested people to encourage studies of personality factors (not neuroticism scores which relate more to e neuroses than normal behavior), studies on the role of the environment, studies on the role of psychosocial influences (again~ the normal rather than the abnormal ones), studies on the role of the human intellect on behavior, and the role of everyday stress on smoking behavior. te Congress must understand that even the so-called experts• just don't know enough about why people behave the way they do in:`. a variety of areas, and how that behavior relates to the individuals' health. We need for example tests built on the characteristics of normal people; we must study the normal range .. of behavior, rather than the abnormal. The majority of smoking . behavior studies have used conditioned learning theory. Condi- tioned learning is an automated, primitive kind of behavior (obviously, since most of the studies are done in rats and pigeons). This theory is unable to explain a behavior as complex as smoking. . Smoking habits have changed, but only a minute part of that change is due to anti-smoking campaigns. People likely to smoke may be people who have excess "cerebral" energy, and our society in recent years has provided them with a variety of other acceptable outlets for that energy. Before any governmental program to reduce cigarette smoking should be considered, a total Page 10 363 _aevaluation and restructuring of res, ~ behavior should be commenced. Be- ,-ronaly that the reasons people choo -astitutional origins and this must I a advisability of a government cess~ ^Clusion House bill 5653 should not b =:entific underpinnings are weak and

1 a A 365 and health and with the general medical literature pertaining to this subject. I.testified before the Committee on Interstate and Foreign Commerce in 1969 in regard to proposed legislation concerning cigarette labeling and advertising. At that time, I told the Committee that my knowledge of the medical literature, my own investigations and my laboratory experience established "my firm conviction that neither cigarette smoking nor any other etiological agent has been shown to be the cause of cancer of the lung." I have seen no research reports in the intervening 13 years which would change that view. I am pleased to have the opportunity to give you my views on the present legislative proposals embodied in S. 1929 and H.R. 4957. I am most disturbed by the finding included in both of these legislative proposals that cigarette smoking is the major cause of lung cancer. Such a statement is, in my view, not supportable by the pathological and clinical observations I have made during my practice, nor by my review of the medical literature. I am disturbed to see such findings in proposed federal legislation because I believe it is deceptive and misleading to the public and the medical community. The pressure to find causes and cures of cancer and other chronic diseases is considerable, and it should be. The problem, however, is that this pressure creates great temptation to seize upon easy answers. It is always important to realize that objectivity is vitally necessary for scientific progress. The cause or causes of lung cancer are unknown, and a Congressional finding to the contrary does not alter that situation. -2- I

367 in the lung. Secondary lung cancer, often called metastatic, is cancer that has spread to the lung from another body site. I have all too frequently found in my own work that tumors clinically considered as primary in the lung are often metastatic and result from cancerous growths in other parts of the body. One of the reasons why primary lung cancer may be frequently diagnosed when it is not present is that physicians depend primarily on chest x-rays as the technique for diagnosing it. In this regard, it should be noted that chest x-rays present fewer problems in interpretation than x-rays of any other organ or part of the body except the skeletal system. This is because the air in the lungs provides an excellent contrast medium so that disease states are more readily detected. We find, therefore, that it is easier to observe on x-ray an abnormality in the chest rather than, for example, the liver. Even then, however, one cannot always tell from an x-ray whether an area of density in the lung is a nonmalignant or malignant growth, and if malignant, whether or not it originated in the lung. There are of course, techniques other than x-rays for diagnosing lung cancer. Biopsy and sophisticated scanning techniques (CAT scan), two other routinely used methods, do not always allow for distinguishing between secondary and primary tumors. It should be stressed that primary lung cancer is simulated by secondary tumors arising from other organs of the body with sufficient frequency to challenge the diagnostic accuracy of many -4-

Present Appointment: Medical Education: Prizes: Other Degrees and Diplomas• Senior Lecturer in Child Health and Honorary Consultant Paediatrician. St Georqe's Hospital Medical School, Cranmer Terrace, London,. SW17 lat and 2nd M.H., Tinqs CoIleqe. London University. M.H., B.S. (1966), St Georqe's Hospital, Londoa Uri•rersity. Brackenbury Prize in Medicine, St Georqe'a Hospital Medical School, 1965. MRCP (London) 1968. M D (London) 1973. Thesis title: 'Malnutrition and Body Temoerature in Jamaican Habies".. FRCP (London) 1980. Previous Aooointments: 1966-67 - House Physician to Medical Unit, St George's _ Hospital, London, SW1 - Senior House Officer to Neurological Unit, Atkinson Morley's Hospital, London, SW20 1967-68 - House Surgeon to Mr Riddell, St George's Hospital London, SW17 1969 - House Physician to Prof. Hywaters, Hammersmith Hospital and Royal Postgraduate Medical School. 1969-72 - Scientific Officer, Medical Research Council, Tropical Metabolism Research Unit, University of the West Indies, Jamaica. 1972-73 - Member of Scientific Staff, Division of Human Physioloqy, National Institute for Medical - Research, Hamostead. 1973-74 - Paediatric Registrar, St Mary's Hospital. London, W2. 1974-76 - Senior Registrar in Paediatrics. St Mary's Hospital, London, W2. 2 34€ Scientific Societies: Member of Nutritior Physiolog Neonatal British F European Other Scientific Activities: Paediatri Member of European low birth-weiqht in Society of Paediatr

365 Statement of Dr. Victor Buhler My name is Victor Buhler and I am a pathologist living in Kansas City, Missouri. I am certified by the American Board of Pathology in both pathologic anatomy and clinical pathology. I have held faculty appointments at the University of Kansas School of Medicine and the University of Missouri-Kansas City School of Medicine. I have served as the President of the College of American Pathologists, the Missouri State Medical Association, the Missouri Society of Pathologists and the Kansas City Society of Pathologists. I am a Fellow of the American Society of Clinical Pathologists, the American College of Physicians, the American College of Pathologists, and a member of the International Academy of Pathology and the American Association for the Advancement of Science. I participated upon invitation by President Johnson in the White House Conference on Health in 1965. At the present time, I am associated with a group of pathologists serving one major hospital and several community hospitals in the Kansas City area, with primary responsibility for the Liberty Hospital, Liberty, Missouri. I have become familiar over the years with many of the articles cited in the various Surgeon General's reports on smoking and health and with the general medice this subject. I testified before the Foreign Commerce in 1969 in regard to cigarette labeling and advertising.. i Committee that my knowledge of the mec investigations and my laboratory expe: conviction that neither cigarette smo: agent has been shown to be the cause have seen no research reports in the : would change that view. I am pleased give you my views on the present legi: in S. 1929 and H.R. 4957. I am most disturbed by the these legislative proposals that ciga cause of lung cancer. Such a stateme supportable by the pathological and c made during my practice, nor by my re I am disturbed to see such findings i because I believe it is deceptive and and the medical community. The press of cancer and other chronic diseases should be. The problem, however, is great temptation to seize upon easy a to realize that objectivity is,vitall progress. The cause or causes of lur Congressional finding to the contrary -2-

7 r 357 either productive or nonproductive, i.e., satisfl a predetermined objective or not. I studied a small group of heavy smokers to learn whether their brain waves would show any effects from short periods of abstinence or any effects when they resumed smoking after abstinence. The heavy smokers who habitually smoked 2.5 to 5 packs of cigarettes per day were asked to refrain from smoking at least 12 hours prior to beginning the experimental recnrding session. We then intentionally prolonged the recording period in an attempt to increase the "need" to smoke, presumably making the EEG recording experience more stressful. After this, these heavy sm..oker subjects were allowed to smoke to satiation, and were allowed to smoke ad lib. throughout the remainder of the recording (about 2 more hours). The results of this sub-experiment were quite surprising. First, no differences in brain wave patterns were found after the subjects had smoked to satiation as compared to patterns found after 12 hours of abstinence from smoking. Second, no changes in brain wave patterns were found at those times when the subjects were actually smoking cigarettes. And third, when the subjects were finally told that they could smoke after the abstinence period, only 1 of the 9 expressed any particular desire or need to smoke. One interpretation of this is that the novelty Page 5

371 by the different methods of specimen procurement, fixation, storage, and staining techniques. In addition, the reported frequency of certain cell types will depend upon the source of the specimens; sputum cytology, for example, yields very different results from specimens taken at surgery, which in turn differ from those taken at autopsy. Most important of all, however, is the fact that there seems to be virtually no solid evidence to link cigarettes with these reported changes. Until more rigorous scientific standards are applied, this change in cell type frequency, if it is real, remains unexplainable and of unknown significance. Based on my years of experience as a pathologist and on my reviews of the smoking and health literature, I must disagree strongly with the proposed Congressional finding that cigarette smoking is the major cause of lung cancer. - Victor B. Buhler, M.D. -8-

Cl.°.-.RICULL^f CI.T..E: BCr:KS:'CRaPTERS;`:i~ .aLS: Sick, RL: Editor and '!ain .cuthor Modern Concepts and Evaluations of Hemcstasis ~-:nd Fhr,=bcsis American Society of Clinical Pathologists Publicstion, Chicago, I1'__;ois, 1975 (.G0 pa3es' Guest Editor: Seminars in Hemostasis and I'hrombosis, October 1916. Alterations of hemostasis associated with cardiepul^enary bypass; pa:`.crh>•<_iology, prevention, diagnosis and management. R.L. Bick, Chapter 2: Laboratory modalities for assessing ?,emostasis 3uring cardi:pul-:.nary bypass. Sick, RL and Fekete, LF. - lick, RL: Editor and Main Author Difficult Diagnosis Problems ip Hemostasis and Thrombosis American Society of Clinical Pathologists Publication. Chicago, Ill. 1976 (300 pages) RL: Bick , Current Concepts of Hemostasis and Thrombosis: Clinical and Laboratory Evaluation American Society of Clinical Pathologists Publication. Chicago, I11.. 1976 (600 pages)- Bick, RL: Recent Concepts and Developments in Evaluating Disorders of HeTcstasis and Thrombosis American Society of Clinical Pathologists Publication Chicago, Ill. 1976 (700 pages) Bick, RL: Bleeding and Thrombosis in Malignancy. Chapter in Care of the"Cancer Patient. Tom Nealon (ed.), W,B. Saunders, X976. Bick, RL: A systemic approach to the diagnosis of bleeding disorders. Chapt. 4 in Basyp Concepts of Hemostasis and Thrombosis. Murano, G. and Sick, RL (e=s.) CRC Press, Boca Raton, FL, 1980. Bick, RL: Vascular disorders, Chapt. S in Basic Concepts of Hemostasis an3 Thrombosis. Murano, G. and Bick, RL (eds.) CRC Press, Boca Raton, FL 1980. Sick, RL: Hereditary plasma protein disorders. Chapt. 7 in Basic Concepts of Hemostasis and Thrombosis. Murano, G, and Sick, CRC Press, Boca Raton, FL 1980. RL (eds.) Sick, RL: Disseminated intravascular coagulation (DIC) and related syndromes, Chapt. 8 in_ Basic Concepts in Hemostasis and Thrombosis. Murano, G. and Bick, RL. (eds.) CRC Press, Boca Raton, FL 1980. -8- CL<4:LUL--'» VT:iE: BXKS/Cf..1PTER5/,%Lk\'UALS (cont. ) : Bick, RL: Primary hyperfibrino(geno)lytic syndromes, C:> Basic Concepts of Hemostasis and Throsbosis, CRC Press, Boca Raton, FL 1980. Bick, RL: Acquired circulating anticoagulants and defect protein disorders, Chapt. 10 in Basic Concepts of Hemostasis and Thrombosis, '; CRC Press, Boca Raton, FL 1980. Sick, RL: Alterations of hemostasis associated with mali Basic Concepts of Hemostasis and Thrombosis, ` CRC Press, Boca Raton, FL 1980. Bick, RL: H,vpercoagulability and thrombosis, Chapt. 13 Basic Concepts of Hemostasis and Thrombosis, ' CRC Press, Boca Raton, FL 1980. Bick, RL: A.nticoagulant and antiplatelet therapy. Chapt Basic Concepts in Hemostasis and Thrombosis, ' CRC Press, Boca Raton, FL 1980: Murano, G. and Bick, RL:. Throlnbolytic therapy, Chapt. 15 in Basic Concepts in Hemostasis and Thrombosis, CRC Press, Boca Raton, FL 1980. Bick, RL: Disseminated intravascular coagulation and re Perspectives in Hemostasis and Thrombosis, Fa and Brinkhous, tat (eds.) Pergamon Press, New York 1981. _ Bick, RL: Disseminated intravascular coagulation and re (textbook) CRC Press, Boca Raton, FL 1982. Bick, RL: Hemorrhagic problems associated with cardiac Textbook of Hemostasis and Thrombosis, Ratno Grune F, Stratton, New York 1982.

366 Our only hope for progress in the fight against this dread disease is in innovative medical research, not legislative pronouncements. My view that cigarette smoking has not been proven to be a cause of lung cancer is based on my personal knowledge of the sources for the epidemiological evidence frequently used to support this theory. Epidemiological studies, for the most part, are based on mortality data derived from statements of physicians or others who sign death certificates. in approximately 80 percent of deaths, no post-mortem examinations are done to verify the information on the death certificate regarding the primary or underlying causes of death. Even when autopsies are performed, the results often are not available until after the death cer- tificates have been completed. The recorded causes of death, then, are primarily based on the clinical diagnoses, and it has been my experience as a practicing pathologist that these are frequently incorrect. If death certificates reflected the results of completed autopsies, the statistics would have a much higher degree of validity. At the present time it must be understood that 80 percent or more of all death certificates cannot be considered as having been scientifically validated. Consequently, I have grave doubts about the statistical associations which have been derived from data which is subject to serious flaws. --In addition, the data in statistical studies of lung cancer do not distinguish between primary lung cancer and secondary lung cancer. Primary lung cancer is a malignant tumor originating -3- 367 in the lung. Secondary lung cancer, o: cancer that has spread to the lung froi have all too frequently found in my ow: considered as primary in the lung are from cancerous growths in other parts < One of the reasons why prima frequently diagnosed when it is not pr depend primarily on chest x-rays as th it. In this regard, it should be note fewer problems in interpretation than : or part of the body except the skeleta the air in the lungs provides an excel that disease states are more readily d that it is easier to observe on x-ray rather than, for example, the liver. cannot always tell from an x-ray wheth the lung is a nonmalignant or malignan whether or not it originated in the lu There are of course, technic diagnosing lung cancer. Biopsy and sc (CAT scan), two other routinely used rr for distinguishing between secondary e should be stressed that primary lung c secondary tumors arising from other oz sufficient frequency to challenge the ~ W ~ a ~ c~

369 smoking leads to lung cancer oversteps scientific bounds. Through my own experience, I cannot confirm that significant cell or tissue changes in the lung occur more frequently in smokers than in non-smokers. Certainly there are smokers without changes, and non-smokers with changes. As a pathologist, I find the arguments on "pre-cancerous" lesions to indict smoking as a cause of lung cancer to be uncon- vincing and indeed inconsistent with my own clinical observations. I might add that, contrary to the reports that one often hears, it is impossible for the pathologist to determine from both gross and microscopic examination of lung tissue whether the person is a smoker or. a non-smoker. I am equally unconvinced by the evidence provided by animal experimentation. As the Congresaional Record shows, I twice described to Congressman Tim Lee Carter the critical weak- r.esses in one of the few inhalation experiments that have supposedly produced cancer -- the Auerbach beagles study. That experiment suffered from severe design defects, and the photomicrographs published with the article would not permit most pathologists to reach the conclusions stated by the authors. I described to Congressman Carter the essential failure of tobacco smoke inhala- tion experiments to induce lung cancer in animals. That comment is still valid today: no inhalation studies have shown that tobacco smoke inhalation causes lung cancer. Other experimental -6- y I 8

352 Clinical papers and correspondence Recurrent meningitis. Brooke, Ford and Mackintosh (1970). Brit.Med.J. 4, 218. Nalnutrition and body temperature. Brooke (1972) . Brit.Mad.J. 2, 164_ Lscherichia coli meningitis and congenital tuberculosis in the same intant. Brooke, Dow and Hanid (1977). Iancet, 1, 599. Unusual cause of birth asphyxia - & posterior lingual polyp. Brooke, Nesbitt and Wilson (1977). Brit.Med..J. 1, 777. Makinq tiny infants lovable. Brooke (1980). J.Hat.rnal and Ch1d.Slth. 5, 116. Cazttraindications to iasmizatioa. Brooka (1980). Br.1Mad.J. 2, 58. Book Reviews "A colour atlas of paediatrics" (Dynski-Klein). Br.J.Obst.f,ynaecol. 82, 767. 'Proteia-energy malnutrition". (Alleyna, Bay, Picos, Stansfield & Whitehead). Arch.Dis.Child. 52, 595. "Pediatric nutrition in developmental disorders". J.Human.Nutr. 34, 64. "HUman Growth" vol.1,(Fal)mer & Tanner). J.Human.Nutr. 33, 239. "Human Growth" vol 2.(Plakner & Tanner). J.Human.Nutr. 33, 303. "Human Growth" vols. 1 &2 (Fal)mer & Tanner). Lancet 1, 1169. "Human Growth" vol.3. (Palkner & Tanner). Iancet 2, 775. 10 (Palmer & Ekvall). ., tY 353 STATEMENT OF BARBARA I am Barbara B. Brown, form ^ysiology, Veterans Administration H -a!ifornia. I received mv Ph.D. in P .'niversity of Cincinnati College of M 3 _vears research experience, primari ^harmacology, psychopharnacology, neu -.`.ysiology. I began my research acti .:.armaceutical firm of The (+Tm. S. Mer ,rrill-Richardson) and later became ,-srnacolcgy. After leaving Merrill, rarmacologist at Riker Laboratories - nsulting Neurophysiologist at Psyc: Laboratories. I was also an associa- ?.armacc-ogy at the University of Ca ..c_ences in Los Angeles and at the D, 4.•_aan Behavior at the University of ._cturer at the Department of Psychi =xperiential Physiology Research at :.ras one of the pior.eers_ in the dev =:o`eedback. In the past few years, activity has centered around attempt ^-ental activity (brain information F 1-•d illness. To date, I have pub liE --.eoretical articles on this subject 11

349 0 Original Scientific Publications 1. Mechanism of action of a-adraaergic receptor blocking agents in angina pectoris. Wilson, Brooke, Lloyd and Robinson (1969). Brit.Med.J. 4, 399. 2. Effect of ergotamine and ergomettine on forearm venous compliance in man. Brooke and Robinson (1970). Brit.Med.J. 1, 139. 3. Iron absorption and pyrexia. Be:esford, Neale and Brooke (1971). Lancet 1, 568. 4. The influence of malnutrition on the post-prandial metabolic rate and respiratory quotient. Brooke and Ashworth, (1972). Brit.J.Nutr. 27, 407. 5. Iafluence of malnutrition on the body temperature of children. Brcoke (1972). Brit.Ned.J. 1, 331. 6. Hypothermia in malaourished Jamaican children. Brooke (1972). Arch.Dis.Childh. 47, 525. 7. Therssn•egulatory instability in kernicterus. Brooke (1972). it.Znd.Med.J. 21, 253. 8. A simple metabolism csambar allowing aceurate determinations of evaporative water loss in large babies. Brooke (1972). M.Ind.Med.J. 21, 202. 9. Specific dynamic action in malnutrition. Ashworth, Brooke and Watarlow (1972). Proceedings of the first international symposium on energy balance in man (ed. Apfelbaun and Mlller), Paris, Masson. 10. Pasting hypoqlycaemia due to increased glucose utilisation and inappropriately high j++g,l in. Rerr, Brooke and Robinson (1972). Ped.Ras. 1 399. 11. The metabolic rate of malnourished children. Brooke and Cocks (1973). J.PhysioL. (LOnd.) 231, 18P. 12. Evaluation of a method for measuring urine temperature. Brooke, Collins, Fox, James and Thconton (1973). J.Physiol. (Lcad.) 231, 91P. 13. Rasponse of malnourished babies to cold. Brooke, Harris and Salvosa (1973). J.Physiol. (Lcnd.) 233, 75. 14. Thermal insulation in malnourished Jamaican babies. Brooke and March (1973). Arch.Dis.Childh. 48, 901. 1S. Response of malnourished babies to heat. Brook. and Salvosa (1974). Arch.Dia.Childh. 49, 123. 16. The importance of routine urine cultures in malnourished children. Brooke and Xerr (1974). J.1rop.Pediat. 19, 348. 17. Resting metabolic rate in malnourished babies in relatio,z to total body potassiun. Brooke and Cocks (1974). Acta.Paed.Scand. 63, 817. 18. Sarum and liver triglycerides in malnourished Jamaican children with fatty livrs. Flores, Seakina and Brooke (1974). Am.J.C1in.Nutr. 27, 610. 19. Measurements of deep body temperature from the urine. Fox, Brooke,Collins, Bailey and Healey (1975). J.C1in.Sei..fol.Bic1. 48, 1. UO ;4

of the experimental situation acted as an effective substitute for smoking for this brief period of time. The sustained and marked differences in brain wave activity between smokers and nonsmokers are very probably unrelated to the pharmacologic aspects of smoking. When nicotine is administered to animals, or when the effect of smoking is measured, a stimulant effect is only briefly noted. If the continuing action of nicotine and smoking, especially in "smoking" doses is a tranquillizing one, then the fast EEG patterns of the habitual smokers cannot very well be a result of their smoking activity. The remaining conclusion, then, is that there is a constitutional difference between people who tend to smoke and those who do not. My studies, and those of Seltzer, comprise powerful evidence that constitutional factors can predispose to smoking behavior or some equivalent behavior that effectively diffuses the excess "cerebral" energy (such as the "high" that runners or joggers enjoy). -This does not mean that shaping factors such as genes, home environment, individual experiences, etc., predispose specifically to smoking behavior, but that these factors predispose to a behavior that can discharge excess "cerebral" energy and at the same time be socially acceptable. In other words, people likely to smoke are people who have this particular {ind of excess energy -- and smoking prc by which that energy can be discharged. Smoking and Health Studies The bill's "findings" on smok: government position which is promulgatec Reports. These Reports are based on hic that literature. The behavioral sectior example, admitted this very scientifica: approach. Many excellent "dissenting" x Frequently, when differing reports are c inadequately or inaccurately reported. sionally the Reports' authors might not cf the government's policy on smoking. unbiased research -- cannot be fostered Many research studies cited i: serious errors, such as questionable cr. subJects, poor experimental design, wea: of results, conclusions not warranted b, ridden or inconsistent public records f disease, and the abuse of statistics. One of the weaknesses of thes concerns me is the failure of the epide

deaths certified as primary lung cancer without autopsy exclusion In my judgement, the failure of epidemiological studies to distinguish between primary and secondary lung cancer in their statistical analyses raises serious questions about causal inter- pretations of statistical associations. Some advocates of the smoking causation hypothesis have said that lung tissue from smokers exhibits certain abnormalities that they describe as "pre-cancerous." They conclude then that cigarette smoking causes these changes which eventually will lead to lung cancer. Let me say first of all that based on my examina- tion of thousands of lungs in microscopic detail that no one can determine whether or not a lesion described as "pre-cancerous" will progress into cancer. .Metaplasia (changes of one type of tissue to another type), hyperplasia (increases in cell numbers), and dysplasia (atypical cytologic changes in cells) can be seen in lungs of both smokers and non-smokers. All of these kinds of changes are rather common and should not be considered as pre-cancerous. In fact, the weight of scientific evidence is that these lesions will not progre'ss to cancer. Metaplasia, common in older individuals, occurs frequently in the trachea or windpipe, and yet tracheal cancer is extremely rare. Any study of autopsy cases that suggests that metaplasia, hyperplasia, or dysplasia provides evidence that 369 smoking leads to lung cancer oversteps s my own experience, I cannot confirm that tissue changes in the lung occur more fr in non-smokers. Certainly there are smo non-smokers with changes. As a pathologist, I find the a: lesions to indict smoking as a cause of ] vincing and indeed inconsistent with my c I might add that, contrary to t often hears, it is impossible for the pat from both gross and microscopic examinati the person is a smoker or. a non-smoker. I am equally unconvinced by the animal experimentation. As the Congressic twice described to Congressman Tim Lee Cas nesses in one of the few inhalation experi produced cancer -- the Auerbach beagles st suffered from severe design defects, and t published with the article would not permi reach the conclusions stated by the author. Congressman Carter the essential failure o: tion experiments to induce lung cancer in z is still valid today: no inhalation studie tobacco smoke inhalation causes lung cancer -6-

r R t M 373 a causal relationship with cancer of the lung. This interest has been stimulated by my operation on more than 8,000 patients, many of whom suffered from cancer in various parts of the body, including lung cancer. In 1965, I submitted statements to the House of Repre- sentatives and the Senate in which I said that I did not believe that lung cancer had been shown to be caused by cigarette smoking, and that any conclusion to the contrary was not justified. J1y opinion today remains firmly the same. There are aumerous complexities in the behavior and cause of cancer in all parts of the body. I believe that, when we learn how and what causes cancer, we might well find that cigarette smoking has little or nothing to do with the genesis of carcinoma of the lung. That the smoking and health controversy continues is demon- trated by many studies and findings that cannot be explained by a smoking causation hypothesis. I would like to mention just a few of these. 1. Persons who have never smoked get cancer of the lung that is indistinguishable from those cancers that are reported in smokers. A recent study has shown a significant and increasing incidence of cancer of the lung in non-smokers. 2. In the early 1960's researchers, without regard to smoking in the population, predicted that the death rate in lung cancer would level off in the next decade or so. Studies since then have supported their prediction. -2- I

314 CUiR?CL•'__"•f VIT.aE: SCIESCIFIC PRESEN-fATTG':S/PvVITED S?EAiTR;iiCdKSHCP DIKECT^_R (cont.) Fibrinolytic Enzymes in Metastatic Cancer. Presented to the American Society of Clinical Pathologists, Naticaal Meeting, Chicago, Ill., September, 1975. Recent Advances in Laboratory Aspects of Internal '.Iedicine: von 1•:il'_ebrand's Disease, Disseminated Intravascular Coagulation and Primary H~2erfibrino(geno)- lytic Syndromes. Palm Springs, CA., Dctober, 1975. Hemorrhagic Syndromes Associated with Cardiopulmonary Bypass. An approach to Differential Diagnosis and Management. Presented to the American Thoracic Society, 1975. Director: Modern Concepts and Evaluation of Thrombosis and Hemostasis lation Seminar C . oagu American Society of Clinical Pathologists, National Meeting, Dallas, Texas, 1976. - Director: Special Diagnostic Problems in Hemostasis and Thrombosis: Advanced Coagulation Seminar. American Society of Clinical Pathologists, National Meeting, Dallas, Texas, 1976. Modern Concepts and Evaluation of Hemostasis and Thrombosis: Two Day Seminar, UC at Santa Barbara, California, 1976. Director: Recent Concepts and Evaluation of Hemostasis and Thrombosis: American Society of Clinical Pathologists, Regional Center, Long Beach, Cal$brnia, 1976. Director: Recent Concepts and Evaluation of Hemostasis and Thrombosis. American Society of Clinical Pathologists, National Meeting, Los Angeles, .California, 1976. Director: Difficult Diagnostic Problems in Hemostasis and Thrombosis (Advanced Seminar) American Society of Clinical Pathologists, National Meeting, Los Angeles, California, 1976. Director: Recent Concepts and Evaluation of Hemostasis and Thrombosis, American Society of Clinical Pathologists, Regional Center, Chicago, Illinois, November, 1976. - 315 CU:RIC-UL;;'1 VITAE: =c:^er t. SC:-NTIFIC PRESENTA.T:Q:<S 8 I\l'ITED S7E=lE<, Current Concepts of Hemostasis; Clinical a, of ThromSohemorrhagic Phenomena; Director lanericdn Society of Clinical Pathologists, ~ Personnel Regional Education Program, Los P.- MoJern Concepts and Evaluation of Hemostasi, American Society of Clinical Pathologists, f 1977 Disseminated Intravascuiar Coagulation and ' American Society of Clinical Pathologists, F Nevada, 1971 Difficult Diagnostic ProbTems in Hemostasis American Society of Clinical Pathologists, F Nevada, 1977 Recent Concepts and Developments in Evaluati and Thrombosis • X1A/C'4A, Palm Springs, 1978 Second Annual Southern California Blood Clot American Society of Clinical Pathologists, S t:odern Concepts and Evaluation of 4a qstasis P.,,erican Society of Clinical Pathologists, k Disseminated Intravascular' Coagulation and R American Society of Clinical Pathologists, F1 Difficult Diagnostic Problems in Hemostasis American Society of Clinical Pathologists, N. Current Concepts of liemostasis and Thrombosi American Association of Clinical Chemistry, Modern Concepts and Evaluation of Hemostasis American Society of Clinical Pathologists, F Disseminated Intravascular Coaoulation and R American Society of Clinical Pathologists, F Difficult Diagnostic Problems in Hemostasis American Society of Clinical Pathologists. F Current Concepts of Hemostasis: Clinical and Thrombohemorrhagic Phenomena American Society of Clinical Pathologist, Re Program, August, Charleston, South Carolina, ~ W ~ Q ~ ~ ~ 95-077 0-82-21 ~

0 347 4 papers presented at Scientific Meetings 1. "Znfluence of Malnutrition on central body temperature". Brooke, 1971. 16th Scientific Meetinq of the Standing Advisory Co®ittee for Medical Research in the British Caribbean, Barbados. 2. "Defective thermoregulation in malnourished Jamaican babies". Brooke, 1972. 17th Scientific Meeting of the Standing Advisory Committee for Medical Research in the British Caribbean, Nassau. 3. "Specific dynamic action in malnutrition".. Ashworth, Brooke & Waterlow, 1972. 1st International Symposium on Energy Balance in Man, Paris. 4. "The metabolic rate of malnourished chi]dren". Brooke & Cocks, 1973.' Physiological Society Meeting, Medical Research Council_ Mill Hill, London. 5. "Evaluation of a method for measuring isine temperature". Brooke, Collins, Fox, James & Thornton, 1973. Physiological Society Meeting, Royal Postgraduate Medical School, London. 6. "Resting metabolic rate in malnourished children and its relationship with total body potassium". Brooke, 1974. Colloquium on protein-calorie malnutritic SV International Pediatric Congress, Buenos Aires. 7. "High calorie feeding in protein-calorie malnutrition". Ashworth, Brooke & Wheeler, 1974. Colloquium on protein-calorie malnutrition, 7¢v International Pediatric Congress, Buenos Aires. 8. "Ethnic differences in neonatal anthropometric measurements". Brooke, 1975. Neonatal Society Meeting, Nottingham University. 9. "High energy feeding in low birt's-waight infants". Brooke, 1975. Neonatal Society Meeting, St Thomas' Hospital, London. 10. "High energy feeding in immature infants" . Brooke'& Alvear, 1976. 2nd European Nutrition Conference, Munich. 11."Thermoregulation in Malnourished ChiIdren". Brooke, 1976. Hth International Symposium of Paediatric Work Physiology, Bisham Abbey,Eagland. 12. "Influence of acidosis on energy absorption in immature infants". Brooke,1977. 48th Annual Meeting of British Paediatric Association, York. (plenary session). 13. "The role of the neonatal paediatrician in preventing visual handicap". Brooke, 1977. National Conference on Development and Handicap, Nottingham University. 14. "Postprandial energy expenditure in small-for-dates and immature infants". Alvear & Brooke, 1977. European Society for Paediatric Gastroenterology and Nutrition, Dtrecht Meeting. 15. "Specific Dynamic Action in infants of low birth-weight". Alvear & Bxooke, 197' Physiological Society Meeting, St George's Hospital, London. 16. "Postprandial metabolism in low-birth-weight infants". Brooke, 1978. 49th Annual Meeting of British Paediatric Asscciation, York. (section on Nutrition and metabolism). 17 "Energy cost of growth, in healthy immatvze infants". 9rooke & Alvear, 1978. European Society _`or Paediatric Gastroenterology and :7utrition, Paris Meeting. 95-077 0-82--23

356 and brain electrical responses to sensory stimulation of heavy smokers as compared to those of nonsmokers. Results for the average smokers and for the former smokers were between the other two groups. intermediate The outstanding characteristics of smokers' EEG patterns are a high frequency, rhythmic, high amplitude, sustained activity. It looks like alpha activity but is twice as fast Alpha is commonly referred to as the brain wave correlate of relaxed wakefulness and is always contrasted with the nonrhythmic; low amplitude, very fast EEG activity that is commonly correlated with alert behavior. After comparing smokers' patterns with those of former smokers, with those of individuals in various emotional or physical states such as fatigue, etc., I decided that the best explanation for this distinctive EEG frequency is that it represents an inherent tendency for people who smoke to have a level of "alertness" higher than the average and also apparently excess brain electrical activity. These absolute physiological findings can be interpreted in either of two ways: one, that the high frequency, rhythmic activity is associated with information processing that is concerned with specific elements or thoughts, or that it is helter-skelter, poorly productive, non-linear mental activity. either case, the smoker consistently shows an excess of (for lack of a better term) "cerebral" energy. "Cerebral" energy can be :-~ier productive or nonproduct I studied a small gro .r ther their brain waves would ::ods of abstinence or any ef i;^er abstinence. The heavy sm. ?acks of cigarettes per day w< '_east 12 hours prior to begii 3s=on. we then intentionally ..-. attemot to increase the "neec recording experience more st _r subjects were allowed to ..:c•.,ed to smoke ad lib. through ~.-,ut 2 more hours). The results of this su __ -zsing. First, no differenc --:nd after the subjects had smo ~-terns found after 12 hours of - -nanqes in brain wave pattern. e subjects were actually smokii ":e subjects were finally told t: 1:-s'lnence period, only 1 of the - r.eed to smoke. One interprete

374 3. Cancer is rarest in those parts of the body most in contact with cigarette smoke, for example, lip, tongue, trachea and larynx. Tracheal cancer continues to be an extremely rare disease, even though the trachea, which is part of the respiratory tract, is more exposed to tobacco smoke than the lung. The larynx is also more exposed to tobacco smoke than the lung; nevertheless, the incidence of laryngeal cancer has remained relatively stable duriag the last quarter century and has not followed the reported increase in lung cancer. 4. Lung cancer often originates in areas of the lung that have little or no contact with tobacco smoke, that is, in the peripheral areas of the lung, rather than in the hilar, or central, region. 5. Although there is no reason to suppose that there is greater exposure of tobacco smoke at the site of any given cancer in the lung, lung cancer usually appears as a solitary lesion. Metastatic cancer, on the other hand, such as that which spreads in the lung field. Moreover, once a lobe containing cancer of the lung has been removed, a second primary cancer of the lung rarely develops, although the lung fields have been exposed to the same cancer. One theory that is being investigated is that the immune ~ system has a lot to do with the development of this disease. -3- ME 7. Efforts have failed to p: reported to be statistically assoc: animals exposed to smoke. 'One stuc hamsters exposed to cigarette smokE exposed. 8. Some studies find that i chemicals the smokers have a lower non-smokers. For example, chloromethyl ethers. this has It is clear that the smoking not been resolved. It is also clea be the total answer to cancer of th All of us who are interested have one thing in common - we are a for the prevention of cancer, which lives today. The problem won't be : of disease. The problem can only bc Of the various theories and factors date. -4-

354 Given my extensive background in pharmacology, physi- ology, and behavior, I disagree with the conclusions and the basic generalizations of House bill 5653. This bill misinterprets the meaning of the reported statistical associations between cigarette smoking and certain diseases. It fails to understand the psycho- logy of the multiple influences that determine individual life- , styles and the acceptance of their risks, and it completely ignores a fundamental and unresolved question: why do people smoke? Further, the bill misapprehends the level of public awareness of the widely publicized "health hazards of smoking," and it relies on the incorrect premise that revised warning labels' could substantially affect that public awareness. Smoking Behavior - Most important is the failure of the bill to address the" many unknowns in smoking behavior. A great many perceptive people have observed that smoking behavior is a complex behavior determined by the interaction of several influences, namely, constitutional predispositions, environmental factors, experi- ential (psychosocial) influences, individual psychophysiologic reaction tendencies, and chemical factors. No single factor determines smoking behavior, nor do all interacting factors influence smoking behavior all the time. 3P The most convincing stud of smoking behavior was the decade: oredispositions to smoking by Selt2 psychological and physiological rea able to predict who among pre-teens smokers when adults. His predictio. ' ~ll Page Since a major objective of accurately, and Seltzer's work is ar. achieving this objective, it is unfo ,f his studies have not been activel My own research did not cor •.:ork, but rather from a continuing in '-tivity of the brain. A report of my research stuc activity appeared in the December 1961 an international journal on neurology. .'ariety of EEG measures, along with be among light, moderate, and heavy smoke nonsmokers. Each subject was studied c^ntrol and test conditions, for EEG pz Results of the study were bot discovered striking differences betwe

379 s.J. Feinhandler, Ph.D. 4th March 1982 - 4 - "I've tried not smoking and found these days to be laden with anxiety. With that choice, I prefer smoking." The second approach defines the benefits of smoking in terms of the value added to smoking by the uses to which it is out in achieving certain desired ends. The Sources of Value We have observed the use of tobacco in fulfilling a wide variety of personal and social needs. Smoking has value for people because of this role. - Lighting a cigarette in response to pleasant or enjoyable experiences, such as the company of friends or at the end of a ;ood meal, is cited frequently. In this instance smoking is said to heighten the experience and enhance good feelings. The pleas- ure and relaxation many associate with the use of tobacco often derives from the sensorimotor aspect of smoking: taste, hand- ling, visualization of smoke and inhaling and exhaling. One -espondent explained: "If I really desire a cigarette nothing can replace it. Its not the nicotine. Its the feeling of the smoke going up and down that I enjoy. It is a unique experience. A pleasurable feeling." People feel that smoking serves to reduce the emotional consequences of negative situations -- when experiencing feelings of fear, anxiety or distress. One informant characterized cigar- ettes as "a constant companion I carry for comfort." Smoking plays an important part in the everyday ordering of individual lives. Smoking after a meal is a common practice, witnessed everyday in American society. "I normally stop eating, light a cigarette and then I know that mealtime is over. If I don't have a cigarette, then I feel compelled to eat at least one more thing." Here the act of smoking serves to mark the end of an event. As a structuring mechanism, the act of smoking brings with it a sense of predictability and familiarity which allows individuals to achieve a sense of security. Smoking serves to impose structure on events which appear to have little or no structure of their own. "I smoke when I have to wait. Its something that helps me get through the waiting." Cigarettes can aid in the organization of thought. "If I am writing I will stop and have a cigarette to collect my thoughts." Smoking is also viewed as a break from activities, a time in which to relax. "When I work steadily in one place for a long time, smoking is like a little rest period. A five minute break from what I am doing." 95-077 0-82-25 0 w ~ 0 ~ ~ a 0

291 s u / wOtnlrvnw /,ralVt6ault1aN . S,wt6 Karaa'!»,vrtnuNnl, in.(ivithtals WIN/ rarty a hundred thcwsand dollars in attachc cases, and other people with nervous-maling life-stylcs. mostly males, mostly smokers. But never mind: Justice is blind. Sa the other day I was on the shuttle, joining the desperate rush tnward the new Jim Crow .rctinn in dN• hack of the plane ncar the anilets, Whvse they keep the oa ygea equipmcnt and the old cnpie%of Rrsinr.u Week. I tost the race to the last smokci s scat to a rat ytwng man in a seersucker sah, with ten ballpoint pens stuck in his shin pocket and clutching tN•o aitaehc cascs (an agent for both the South Korean and the North Korean gnv. ernments?). Consequently I was forced to sit in rigid abstinence in the enormously enlarged nonsmokers' section (the man next to me, smiling sheepishly, smoked funivelr-e was tempted to emulate him, but I'm a Iaw.abiding citizen; also I'm given to anxieties, and the stewardess-pardon, the flight attendant-bore a strik- ing resemblance to Bella Abtug...). I suffered (it so happens that I'm also given to fear of flying-Erica long hasn't done a thing for me-but that's another story). As everyone knows, suffering is conducive to insight. And so somewhere over Chesapeake Bay (the plan,e suddenly larched and the engines didn't sound quite right for a moment there) I had what my teacher Alfred Schutz used to call an "aha experience." I think I know now what is going on in this department of our culture: Anrisreoking is the eew anri-Sernitisre. And, like the old anri- Senritism, it has:V ,:e wfrh the qrest for immonality. T recognize that, as first reading, these propo- sitions may lack plausibility. I suggest that the propositions be scrutinised by following. a very simple analytic proccdure (Wissenichafr again): The antismoking utitude is one item in tbe consciousness of a specific group of people; it should be seen in relation to orher items ia that consciousness. At that point, I conund, my propositions gain plausibility. But first: Who are these people? Thar question is easily answered: we are talking about the aforementioned New Class- the people who consider themselves intellectuals but who are better described as that new segment of the upper middle class that derives its living (and ipso facto its material and ideological interests) from the so-called knowled:e industry. Daniel Bell and Irving Kristol have given us the basic sociological understanding of this class. It is a minority in the American population but, because of its relation to the educatian and mass communications systems, a very influcntial one. It is both the matrix and the principal clientele of most of nur recent movements of cultural innovation, from the "new consciousness" to the "ne.v politics." Many recent events on the American scene make much better scnse if one sees them as pan of a class struggle (in quite classical Marxist terms) between this New Class and the old upper middle class (Kristol calls the latter, torr cwn, the business class). The outcome of this class struggle has not yet been decided, but there is little doubt that both the cultural and the political power of the New Class has been on the rise. Not all elements of the consciousness of this class are tc(rvaro to dN• anti.u-kinf iwN:. hut .wptining number arc. These are all rclated to an overwhelming sensa nf corruptinn and pollution from which the society a is to be clean.ed. Ask this simple question: What are other causes to which the antismokers are likely to be ~anrartrd? Thrtr is, Muhahly mnst impnnam nf all, Ihe varitws cau%es cs(Ntuvd by the cnvnunmenlalisl move- mcm. It hcFan with Ralph Nra(cr's war against the sutamohite. It finds its fiwcmoa expression today in the campaign against nuclear energy. Modern industrialism (and, in the ctmsciousnetis of tlN: New Class, especially its capitalist version) is perceived as a gigantic death- machine, destroying the earth, poisoning the atmo- sphcre, spreading every sort of plague. Then there are the causes related to the various health movements. ..~~ .i Commercially produced foods arc supposed to poison us, and the only salvation is in the return to some form of organic nutrition. The drugs produced by the phar- maceutical industry (with the possible exception of hallucinogenic ones) are also death-dealing, and the medical establishment has been an accomplice in this conspiracy to destroy us (Ivan lllich-perhaps nniotemionally -has hclped to IeFitimate this panieular hy(NN:Iu,nJrial. And thcn thete is tIN; unmg affinity of this same class 6x e.er% con,eicable type of thenpy, from the conventional services of the psychoanalyst to the latest products of the California personal-liberation industry. Other elements could be mentioned, but these three will do for the present pur- pose. What do they have in common? Hypochondria is as good a term as any. But one could also put it differently: What is said here is that all of us would lead long and 0 I I I

389 STATEMENT OF EDWIN R. FISHER, M.D. I am Edwin R. Fisher of Pittsburgh, Pa. I am currently professor of pathology at the University of Pittsburgh School of Medicine and director of laboratories at the Shadyside Hospital in Pittsburgh, Pa. In addition, I am a consultant in pathology at the Veterans' Administration Hospital in Pittsburgh and the Brownsville General Hospital of Brownsville, Pa. I am a 1947 graduate of the University of Pittsburgh School of Medicine. I received postgraduate train- icg at the Cleveland Clinic, Cleveland, Ohio, and the National Institutes of Health, Bethesda, Maryland. I was certified by the American Board of Pathology in both anatomic and clinical pathology in 1952. I am a member of the honorary medical society Alpha Omega Alpha and Sigma Xi, the honorary society for scientific advancement. I was the recipient of the Parke-Davis Award in Experimental Pathology in 1963 and the Man of the Year in Medicine in the city of Pittsburgh in 1966. ...,I am a member of many scientific societies, including the American Association of Cancer Research and the American Society for the Study of Arteriosclerosis.

289 Peter L. Berger 4 Worthin ton Road g Brookline, Masa. 02146 Biog: aphical Data Td (617) T!6 - $7Ci ---°------------ Personaliar Born 1929 in Vienna, Austris. - U.S. citizen 3:arried, two sons Edveationr B.A.(Philosophy), Wagner Collsge, 1949 ri.A.(Sociology), Hew School for Social Research. 1950 Pb.D.(Sociology),Hew School for Social Research, 1954 Academic Careerr Researdf Director, Evangelical Academy, Bad Boll, G.rmany. 1955-56 Assistant Professor, 19oman•s College, University of North Carolina, 1956-58 :-nI* Associate Professor, Hartrord Theological Seminary, 1958-63 Associate Professor, then Professor, Graduate Faculty, _ New School for Social Research, 1963-70 Professor, Rutgers University, 1970-79 Professor, Boston College, 1979-81 University Professor, Boston University, l981- Hator Boo§st Invitation to Sociolorrvr A Humanistic Persvective, 1963 The Social Construction of R alit-r A?Y'eatise the Sociolor.v of Knowledr;e (with Thomas ucxaann),196E The SacrecjrCanovv, Elements of_a Socioloaieal Theorv of Reliaion, 1967 A Rumor of Araelss L~odern Societv and the Rediscovery o_f the SuDernatural, 1969 The Homeless Minds 1-Toderni ation and Consciousness, with Brigitte Berger and Hansfriad Kellner , 1973 Pv^amids af Saeriticer Political Ethics- and Social Ch, 1975 The Heretical Iarerativer Contemflcrars Possibilities Qf Rnli ious A°firmation, 1979 Socio1ocv Reintervretedr An ~ssav on blethod and Yocation, 19161 Honors etcr Doctor of Laws, honoris causa, Loyola IIniversity, 1970 V Ja ier usa i , g s ca Doctor of Humane Letters, honor College, 1973 President, Society for the Scientific Study of Religion, 1966-68 Prasident, Eastern Sociological Society,'•1975-76 Member, Council on Foreign Relations, 1971- Crusnrlr.rs Aro r)nnrl,nuu.•. In Yuur _C~I_',CS'iCl(Ia(.~_~Cr 7C1L!~IC'~ "`.h.ICI[IG:?I'r~i`rC:~ Dale Dale Vree A FASCIS] OUR FUTi

346 3 Invited contributions at scientific meetinqs: S_ V Internatianal Pediatric Conaress, Buenos Aires, 1974. Co-ordinator of Colloqutum on Protein~alorie Malnutrition, and urvited speaker. 8th International Svmposium on Paediatric Work Physioloqy,_Bisham Abbey, 1976. Invited speaker. Nationa' Conference on Development and Handicap. Nnttingham Dniversity, 1977. .Iavited speaker. Conference on Neonatal Medicine, Institute of Obstetrics, Queen Charlotte's Hospital, 1979. Invited speaker. A~sl Colleqe of Physicians Paediatric Conference, 1979 "Nutrition in Paediarrics". Invited speaker. Nutritlon Society Symoosium on Nutrition in the Mother and Child, Royal Society of Medicine, 1979. Invited speaker. Conference on the Biology of Development, Hopital Necker, Paris, 1980. Iavited speaker. _ 8yI International Pediatric Concress, Barcelona, 1980. Contributor to Symposium on Neonatal Nutrition Annual Conference of Royal College of Radiologists, London, 1980. Invited speaker. 4 347 Paners presented at Scientific Meetings "Influence of Malnutrition on centrai body 16th Scientific Meeting of the Standing Adv Research in the British Caribbean, Barbados "Defective thermoregulation in malnourished 17th Scientific Meeting of the Standing Adv Research in the British Caribbean, Nassau. "Specific dynamic action in malnutrition".- 1st international Symposi= on Energy Balanc "The metabolic rate of malnourished chi]dr.er Physiological Society Meeting, Medical Resee "zvaluation of a method for measuring urine °ox, James & Thornton, 1973. Physiological `sedical School, London. i. 'Resting metabolic rate in malnourished chil total body potassium". Brooke, 1974. Collc XIV International Pediatric Congress, Buenos "High calorie feeding in protein-calorie sal :7heeler, 1974. Colloquium on protein-calori Pediatric Congress, Buenos Aires. "Ethnic differences in neonatal anthropometr- vecnatal Society Meeting, Nottingham Univers. 9. 'High energy feeding in low birt's-wei,rht infz Neonatal Society Meeting, St Thomas' Hospita_ 1."'hermorequlation in Malnourished Children". th International Symposium of Paediatric Wor -•• 'Influence of acidosis on energy absorption i 48th Annual Meeting of British Paediatric Ass =3- '"he role of the neonatal paediatrician in pr 3rooke, 1977. National Conference on Develop. Jniversity. :3. "POstprandial energy expenditure in small-for Alvear & Brooke, 1977. European Society for 1 and Nutrition, Dtrecht Meeting. 5"SPecific Dynamic Action in infants of low bi ?hysioloqical Society Meeting, St George's Bos •O- "POstprandial metabolism in low-birth-weight - 43 t` Annual Meeting of British Paediatric A_ssc '+utrition and Metabolism). "High energy feeding in immature infants" . E Z-nd European Nutrition Conference, Munich. '°ner;y cost of growth, in healthy iamtatLZe ir. "curopean Society for Paediatric Gastroenterolc O W ~ _QY ~ ~ 7 0-82-23 ~ ~ ~,-_u

® I 375 7. Efforts have failed to produce the kind of lung cancer reported to be statistically associated with smoking in tests on animals exposed to smoke. One study has shown that a group of hamsters exposed to cigarette smoke lived longer than those not exposed. 8. Some studies find that in workers exposed to certain chemicals the smokers have a lower incidence of cancer than the non-smokers. For example, this has occurred in workers exposed to chloromethyl ethers. It is clear that the smoking and health controversy has not been resolved. It is also clear that cigarette smoke cannot be the total answer to cancer of the lung. All of us who are interested in this controversial subject, have one thing in common_- we are all anxious to see a discovery for the prevention of cancer, which inexplicably claims so many lives today. The problem won't be solved by legislating the cause . of disease. The problem can only be solved by continued exploration of the various theories and factors suggested by the research to date. -4- 1

372 STATEMENT OF JACK MATTHEWS FARRIS, M.D. My name is Jack Matthews Farris. I am Emeritus Professor' of Surgery at the University of California at San Diego. I practiced surgery in the Los Angeles area for more than 25 years as Staff Surgeon at the Good Samaritan Hospital, Los Angeles; Chief of Surgical Service at the Harbor General Hospital, Torrance, California; and Chief of Surgical Services at the California Hospital Medical Center, Los Angeles. I also served as Senior Consultant to Surgery for the Veterans Administration, for whom I directed the surgical activities at several of their institutions in California. I am on the Board of Directors and Board of Trustees of the Scripps Clinic and Research Foundation, and was on the Board of Directors for the Medical Research Association of California. I am a member of numerous medical societies where I have served on advisory committees. I have published approximately 73 papers in scientific journals and have contributed several chapters for surgical textbooks. My full Curriculum Vitae and list of publi- cations are submitted with this statement. Throughout the past 25 years, I have followed with interest the evidence for and against the thesis that cigarette smoking has 3 a causal relationship with cancer has been stimulated by my operati< many of whom suffered from cancer including lung cancer. In 1965, I submitted staten sentatives and the Senate in which that lung cancer had been shown to and that any conclusion to the con My opinion today remains fi: numerous complexities in the behav parts of the body. I believe that causes cancer, we might well lind t little or nothing to do with the ger That the smoking and health trated by many studies and findings smoking causation hypothesis. I wc few of these. 1. Persons who have never s that is indistinguishable from thos in smokers. A recent study has sho incidence of cancer of the lung in : 2. In the early 1960's resec smoking in the population, predictec cancer would level off in the next c then have supported their predictior -2-

5.J. Feinhandler Consulting Experience (cont'd): Dates Client 3/72-12/72 Mass. Committee on Criminal Justice 3/71-9/72 Division of Drug Reha- bilitation, Comm. of .vass. 4/71-6/72 Beth Israel Hospital 385 5/71-7/71 Boston University School of Medicine, Division of Psychiatry 4/70-12/70 Harvard University Program on Technology and Society 9/70-B/71 Barss, Reitxel and Associates 11/6B-10/69 Harold Cabot Co. 1/67-6/67 Boston State Hospital 5/66-7/66 Harvard University School of Education 3/65-9/65 Charles MacArthur Harvard University Health Services Professionally~ Related E xperience: Responsibility Evaluation of methadone day-care program Evaluation of Marathon House, a drug rehabilitation program Department of Labor study of job improvement - Proposal for comprehensive treatment program for alcoholism Designed and conducted survey of public attitudes on technology Consultant, Office of Education libr•ary program evaluation . Studies of consumer cognition and behavior Design of treatment and research in alcoholism Curriculum develop- ment on East Africa Study of smoking, behavior and cognition Leading therapy group of alcoholics Leading therapy group of wives of alcoholics Leading therapy group of married couples Leading "T" group of Psychology Trainees (graduate students) Evaluating referrals on closed circuit Telediagnosis System Curriculum development Assistant Editor, The Deltan Courses :aught: -Syracuse University: Introductory Anthropology Introductory Sociology Introductory and Intermediate Statistics Demography

methods of exposure, such as skin painting, fail to realistically approximate actual human exposure, so that the results of these experimental models must be viewed with suspicion. Another important aspect of the smoking and lung cancer question involves the histological (cell type) classification of tumors. Some have suggested that the newer cigarettes, generally those with lower tar and nicotine yields, are responsible for the emergence of different frequencies of the various cell types. Squamous cell carcinoma is the type of cancer that has generally .been associated with cigarette smoking. It is less frequently found in non-smokers and in women, for reasons that are not yet known. Recently, a few reports have suggested that the relative frequency of squamous cell cancer is decreasing, while that of adenocarcinoma, the type formerly found more commonly in women and non-smokers, may be increasing. I find the interpretation that these new patterns are caused by recent changes in cigarette manufacture to be highly questionable. First, I believe that the few isolated reports lack sufficient information about such rudimentary factors as nutritional status, occupational.exposure, or ethnic background. Consequently, they do not provide, in my view, a reliable measure of the changes in the general population. Further, of a more technical nature, but of cardinal importance to the pathologist, is the cellular variation produced -7- 37 by the different methods of specimen storage, and staining techniques. Ir. frequency of certain cell types will the specimens; sputum cytology, for e results from specimens taken at surge from those taken at autopsy. Most important of all, howev seems to be virtually no solid evidenc these reported changes. Until more ri are applied, this change in cell type remains unexplainable and of unknown s: Based on my years of experier my reviews of the smoking and health li strongly with the proposed Congressiona smoking is the major cause of lung canc -a-

390 I am the author of 490 scientific publications in American and international journals and textbooks. I have served on the editorial boards of the journal Cancer and of the American Journal of Clinical Pathology as well as the Board of Scientific Directors of Ellis'Fiscbel Cancer Hospital, Columbia, Mo., and the Board of Reviewers for the American Society of Atherosclerosis and am the project pathologist for the National Surgical Adjuvant, Breast and Colon Projects of the National Cancer Institute. I should first like to direct my remarks to personally conducted experiments concerning the possible atherogenic ef- fects of nicotine per se. Atherogenesis is the process which results in the disease which we commonly regard as hardening of the arteries, technically called atherosclerosis. We have also conducted such experiments with actual cigarette smoke which, of course, includes the relationship of carbon monoxide to the atherosclerotic process. Reprints describing these experi- ments are being submitted as part of this statement. In these experiments it was clearly demonstrated in the rabbit that realistic doses of either nicotine or cigarette smoke failed to initiate, exacerbate, or otherwise influence the atherogenic process in that species. -2- 39 You will notice that I used the doses". I think that is very importa studies which have exhibited minor or the use of an equivalent dose of 800 in man. This is such a large number find It difficult to find the time to Another point which r would lik One could justly say you found nothin: experience in the rabbit apply to man' experiment in the laboratory caa do i: look and perhaps what we should look : With those two points in mind, : It might be well to emphasize that tt other study of any scientific validiv uhat indicates that nicotine adversel, 'low. Indeed, most of the studies re~ actually accentuates and enhances corc relating adverse effects of cigarette that is, persons who suffer chest pair a:teriosclerotic heart disease, shoulc indicating that cigarette smoke is eti arteriosclerotic process. Of course t a person with angina should not be doi smoking causes the condition which mat The answer is it hasn't been demonstrs -3-

® .C Y 351 39. Energy metabolism in the neonate and the malnourished child. Brooke (1980), in Topics in Paediatrics 2, Nutrition in Childhood, ad. Wharton, Tunoridqe Wells: Pitman Medical. 40. Growth in British Asians: longitudinal data in the first year. Brooke & Wood (1980). J.Human.Nutr. 34, 355. 41. Lysozyme, IgA, Lactoferrin and carbonic anhydrase Levels in the milk of mothers of preterm and term infants. Brooke, Carter, West & Wood (1980). Atch.Dia.Child. 55, 652. 42. Vitamin D and plasma maqnesium in pregnancy. Brown, Brooke & Haswell (1981). Clin.Chim.Acta (in press). 43. Comparison of protein concentrations and energy in breast milk from preterm and term mothers. Hibberd, Brooke, Carter & Wood (1981). J.Human.Nutr. (in press). Review Articles, Chapters etc Is National Dried Milk really dangerous? Brooke (1976). Nutrition and Food Science. Znfant feeding - the perennial problem. Brooke (1978). Practitioner. 221, 314. 44, 2. t4ien can amniocentesis help? Brooke (1978). Drug and Therap.Bull. 16, 81. "Chanqes at Birth and Physiological Maturation in the Newborn Period and During later Childhood". Brooke (1980), in "Developsent,Growth and Ageing", ed. Carter, Londona Croom Helm. Vitamin D supplements in pregnancy. Brooke (1981). J.Maternal and Child Health. 6, 18. Corresoondence containing oriqinal.scientific data. Pat absorption from two infant milks. Brooke (1976). Arch.Dis.Child. 51, 159. Energy content of milks fed to infants. Brooke and Barley (1976). Lancet, 2, 799. Effect of smoking on fetal growth. Alvear and Brooke (1977). Lancet, 1, 1158. Vitamin D deficiency in Asian immigrants. Brooke, Brown and Cleeve (1979). Br.Med.J. 2, 206. Vitamin D supplements in Asian women. Brooke and Brown (1980). Br.Med.J. 1, 1054. B

391 You will notice that I used the designation "realistic doses". I think that is very important. There have been some studies which have exhibited minor or questionable changes with the use of an equivalent dose of 600 or more cigarettes a day in man. This is such a large number that I think man would find it difficult to find the time to smoke them. Another point which I would like to emphasize is this. One could justly say you found nothing in the rabbit but can_the experience in the rabbit apply to man? What the scientific experiment in the laboratory can do is indicate where we should look and perhaps what we should look for in the clinical setting. With those two points in mind, I should like to continue. It might be well to emphasize that there is no pharmacologic or other study of any scientific validity or acceptability to me that indicates that nicotine adversely affects coronary blood flow. Indeed, most of the studies reveal that this agent actually accentuates and enhances coronary blood flow. Accounts relating adverse effects of cigarette smoke on angina patients, that is, persons who suffer chest pain, probably as a result of arteriosclerotic heart disease, should not be interpreted as indicating that cigarette smoke is etiologically related to the arteriosclerotic process. Of course there are many things which a person with angina should not be doing. The issue is whether smoking causes the condition which manifests itself as angina. The answer is it hasn't been demonstrated. -3-

381 S.J. Feinhandler, Ph.D. 4th March 1982 - 6 - this would work, is silly and wastes a lot of money. All it does is to threaten the credibility of the laws of our country. Like prohibition, it would create a black market. It becomes common practice to break the law. It would make law-breakers out of people that are otherwise considered good citizens. Cigarettes are even less dangerous than alcohol because they don't have the potential to create deviant behavior." The Attribution of Deviance Current attempts to regulate the smoking process are seen as part of an effort to define smoking as deviant behavior. Many people recognize that the attribution of deviance is extended to the smoker himself. "I began to smoke at 24; there was nothing terrible about it then. There was no publicity. I can hardly enjoy it now. I feel very weak minded." "It seems to me that people are now trying to make moral judgements on smokers and the government is backing them. They try to put guilt on the smoker and it is the smoker who suffers." Noteworthy in this respect are recent efforts to encourage businesses to discriminate against smokers in hiring and the establishment of a psycho-diagnostic category, "smoking behavior disorder". Ant!-smoking groups and government are felt to be active in this effort. Smoker and nonsmoker alike view the efforts of anti-smoking groups as deviant rather than viewing smoking as such. They question the motivation of people in these groups and attribute to them either Messianic or power seeking desires. Government attempts to restrict customary behavior are similarly questioned. People thus fee1that government demonstrates hypocrisy, inappropriate exercise of power and undue manipulation of individual rights. "I really think that the government and the people who are anti-smokers like to point fingers. It makes them feel good. 'I'm not doing that, therefore I must be better than they are. I must be a better person'. There is no difference between smokers and nonsmokers. To categorize smokers or nonsmokers is ridiculous. We have enough discrimination in the U.S. now. Why try to create more. But i