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. A Mstoy iiof Cancer Control in the U n ited States 1946-1971 Book One A History of Scientific and Technical Advances in Cancer Control Prepared by the History of Cancer Control Project, UCLA School oi Public Health pursuant to Contract No. NOI-CN-55172, Division of Cancer Control and Rehabilitation, National Cancer Institute; principal investigator, Lester Breslow, M.D., M.P.H. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service National Institutes of Health National Cancer Institute Division of Cancer Control and Rehabilitation DHEW Publication No. (NIH) 79-1517 1

BOOK ONE A HISTORY OF SCIENTIFIC AND TECHNICAL ADVANCES r IN CANCER CONTROL 125

I1CKBLOCI{'S CARTOON JAN "COULP YOU NURRY AAV FINP A CURE FOR CANCER? TNAY WtllD BE SO MUCH EASIER TNAN PRE1dEtAl'lON

TABLE OF CONTENTS (BOOK ONE) Chapter 1. Occupational Carcinogenesis ................ 13i Chapter 2. Carcinogenesis Bioassays ................... 157 , Chapter 3. Tobaccogenic Cancer ........................ 109 Chapter 4. Detection of Uterine Cervix Cancer ......... 197 Chapter S. The Role of Mammography in the Detection of Breast Cancer ........................... Chapter 6. The Detection and Diagnosis of Large Bowel Cancer ............................... Chapter 7. Cancer Treatment ........................... Chapter 8. The Rehabilitation and Continuing Care of the Cancer Patient ...................... r 273 319 3069 423 ' r, 129

I CHAPTER 3 TOBACCOGDNIC CANCER Introduction In 1919, when Alton Ochsner was a junior in medical school at Washington University in St. Louis, a patient with cancer of the lung was admitted to Barnes Hospital, the teaching hospital for Washington University. In a short time, the patient died. Ochsner recalled the incident: Dr. George Dock, who was ar} eminent clinician and pathologist, asked the two senior classes to witness the autopsy because, as he succinctly said, the condition was so rare he thought we might never see another case as long as we lived. Being very young at the time and enamored by the clinical knowledge and judgment of our eminent professor of medicine, I was greatly impressed by this extremely rare condition. (1) hfiien Ochsner recorded these recollections in 1973, he was 77 years of age. Lung cancer--a condition "so rare. ..we might never see another case as long as we lived"--had, in fact, become a modern epidemic of massive proportions. The disease currently kills upwards of 83,000 Americans each year; in 1976 an estimated 65,200 men and 18,600 women died from the disease. (2) As a result of perhaps the most important * Principal Researcher/hYiter: Larry Agran 169 i i O Cr W

twentieth century advance in carcinogenesis, it is now stated with con- fidence that approximately 80 percent of all lung cancer deaths in the United States are caused by cigarette smoking. (3) The Early Evidence After graduating from medical school, A1ton Ochsner went on to become a surgeon and an early leader in lung cancer surgery. He was also among the earliest scientists to explore the relationship between cancer of the lung and the use of tobacco. Seventeen years elapsed before I saw another case of lung cancer, at the Charity Hospital in New Orleans after having come to Tulane University as Professor of Surgery in 1927. There was nothing particularly unusual about seeing a rare case in 17 years, but eight other additional cases were seen in a period of six months which,was extremely unusual. Having been impressed with the extreme rarity of the condition 17 years previously, the sudden increase in incidence represented an epidemic, and there had to be some reason for it. All the patients involved were men; they all smoked cigarettes heavily and had begun smoking in the First World War. I then ascertained that very few cigarettes were consumed before the First World War but during the war and after- ward there had been a tremendous increase. Since there was a parallel in the rise in sale of cigarettes and the appearance of the new disease with a lag of approximately 20 years from 1914 to 1936, I considered that this might be the necessary length of time for a possible carcinogenic agent in tobacco smoke to become evident. The evidence was admittedly very nebulous, but it seemed as if this was the most likely cause. (4) European studies, most notably that of MUller in Germany in 1939, (5) began to show a strong statistical association between lung cancer and smoking. Two years later, in 1941, Ochsner joined with Michael DeBakey in publishing the first American study to stress the cigarette-lung cancer connection. (6) Based on clinical observations of autopsies performed in the United States and in other countries, these researchers found that the incidence of pullranary carcinoma had doubled over the 18-year period studied, 'Vhereas the increase in the incidence of all carcinoma in all U 170 0 I~ 0

autopsies.kas relatively slight." (7) Noting the parallel increase in cigarette sales over the same period, the study concluded, "It is our definite conviction that the increase of pulmonary carcinoma is due largely to the increase in smoking, particularly cigarette smoking, which is universally associated with inhalation." (8) Dr. Michael Shimkin has written of epidemiologists in these terms: Epidemiologists are a mixed lot and come from many walks of medical, sociological, and economic persuasions. They include statisticians who refuse to be browbeaten by clinicians, physi- cians who acquire a nodding acquaintance with statistics, and geographic pathologists who learn to distinguish pathology specimens from people. There are also macroepidemiologists, who consider it beneath their dignity to deal with populations of less than 100,000, and microepidemiologists, who look for intuitive insights in unusual small clinical experiences. (9) Intuition. Pathology. Statistics. E4ch was important as the cigarette controversy emerged as the leading field in cancer epidemiology shortly after World War II. Interestingly, amid an atmosphere con- ducive to scientific inquiry, Washington University contributed more than its fair share of prominent personalities to the fray. Of course, Alton Ochsner was himself a product of Washington University. But there were others. Dr. Evarts Graham, who in 1933 performed the first success- ful pneumonectomy for cancer of the lung, was Ochsner's professor of surgery in his senior year. Some years after his graduation, when Ochsner first postulated that the increase in lung cancer was due to cigarette smoking because of the parallel between the sale of cigarettes and the increasing incidence of the disease, he was chided by Graham. Graham, who was a very heavy cigarette smoker, said, "Xes, there is a parallel be- ' tween the sale of cigarettes and the incidence of cancer of the lung, but there is also a parallel between the sale of nylon stockings and the in- cidence of cancer of the lung." (10) Ochsner recalled further: , 171 O ~ ~ C ... I

A few years later Dr. Graham wz-ote to me and reminded me (of the incident] and said that he would have to "eat crow" because a young man, a sophomore student at Washington University, had taken his jDr. Graham's] cases of cancer of the lung and studied them and the results of this-study convinced Dr. Graham that there was a relationship between cigarette smoking and cancer of the lung. This young sophomore student was Ernst Wynder. . . . (11) In 1950, Graham and Wynder together published the results of their epidemiological study. (12) In their investigation, they employed a retrospective method of study: They interviewed patients already known to have lung cancer and, inquiring about their smoking habits, they then compared these responses to the responses of patients without.lun,g cancer. The results indicated that proportionately more heavy smokers were found among the lung cancer patients than the control group population; fewer light and non-smokers were found among the cancer patients than among the controls. 'Graham and Wynder concluded: ~ "Extensive and prolonged use of tobacco, especially cigarettes, seems to be an important factor in the inducement of bronchogenic carcinoma." (13), Persuaded by the evidence, Graham altered his personal'smoking habits, decreasing his cigarette consumption to six per day=-two-after each-meal: Then, in 1953, when Graham and Wynder were able to prove that the tar from cigarette smoke when applied to the surface of animals produced skin cancer, (14) Graham quit smoking altogether. But it was too late. A few years later lle wrote to Alton Ochsner, "Because of our long friendship, you will be interested in knowing-that they found that I have cancer in both my lungs. As you know, I stopped smoking several years ago but after having smoked as much as I did for so many years, too much damage had been done." (1S) Wynder recalled the tragic irony of Graham's death. 172

When he was dying I went to St. Louis. He was laying (~ic3 in an oxygen tent. I remember he pointed to a little sign on the oxygen tent where it said "No Smoking." lie said, "I should have listened." He wrote me a very moving letter stating that fate had really done him badly for all the work he had done on lung cancer. (16) On March 4, 1957, Dr. Evarts Graham, the first person to surgically remove a human lung, was himself dead from lung cancer. Important as it was as an epidemiological study, the Wynder-Graham investigation was but the beginning of a great mid-century scientific debate. Serious questions remained, not the least of them directed to the techniques employed in the Wynder-Graham study itself. The questions were raised not only by the tobacco interests that were ob- viously threatened by the study's conclusions, but also by scientists of considerable reputation. Dr. Lester Breslow, currently Dean of the School of Public Health at UCLA, was a state public health epidemiologist in California in the late 1940s when he first encountered Ernst Wynder at work on the Wynder-Graham study. About 1947-48--in that period--we were visited in Berkeley by a medical student named Ernst Wynder. He came in with an obviously very strong conviction that cigarette smoking was a factor in lung cancer. Wynder had undertaken what we later be- gan to call a retrospective or case control study of the matter. He came by to let us know that he was going to be visiting the hospitals in the Bay Area to interview patients and controls in regard to their smoking practices. - We thought he was a pretty brash young man. ..and asked whether a member of our staff, named Hoaglin, could accompany him around to the hospitals just to see what he was doing. Hoaglin came back with a horrible story of poor technique, a very sloppy approach to the interviewing.. And so we decided we ought to do a proper kind of study. We were quite astonished with the results, which were almost identical with those Wynder was obtaining by what had appeared to us as very biased and sloppy techniques. (17) It was this remarkable similarity of results that made early con- verts of Breslow and others. But still more was needed before a con- sensus among scientists would emerge on the matter. Breslow's early 173

work, (18) like Ochsner's and Grahan: and Wynder's, was a retrospective study with all its attendant problems. According to Breslow: It seemed to me that the retrospective approach to the matter--the case control studies--were vulnerable methodologically on the grounds of bias of samples. The people already had the disease; they were selected people who were being interviewed; aad it is very difficult, if not impossible, to get perfect controls. You depend upon what the patient recollects and is willing to tell you and the accuracy of what he says about his smoking habits. There were a lot of reasons why one could doubt the significance of these retrospective studies. The issue was only going to be resolved by what we later came to call prospective studies. (19) The Emerging Consensus r Soon after L'he Wynder-Graham study was published in 1950, a number of prospective studies were organized throughout the country. The prospective method examines the smoking habits of a sizeable population-- apparently healthy--and then follows that group over a period of years in which -":te rateG and causes* of mortality are recorded. In this way, the problerrs or retrospective falsification or the failure of memory or the selection of improper controls are avoided. The most inf-'lue.itial pros.pective study in the United States was that undertaken by Drs. E. Cuyler Hanmond and Daniel Horn. (20) With the assistance of American Cancer Society volunteers, Hamrrond and Norn tracked 187,783 American men to determine what effect, if any, smoking habits had upon mortality. The results, published in the Journal of the American Medical Association in March, 1958, (21) confirmed the findings of the retrospective studies. In fact, all of the prospective studies of the late 1950s--including the 1956 study of British doctors by Doll and Hill (22) and the 1959 Dorn study of 200,000 U.S. war veterans with government life insurance policies--(23) showed that the total death rate for cigarette smokers was 174

rctiraatel)' 70 i~rcCnt }:ig,ur that for nLn crK):crs7 l,uig cancers, and cancers of other sites, accounted for a disproportionately high nwnber of the excess deaths. In all of the studies, as the amount of cigarette consumption increased, so did total mortality rates. In terms of public health policy, an especially significant finding in the Hammond-Horn investigation was that the mortality risk from smoking decreased as the number of years of smoking cessation increased. (24) By the mid-1950s, dispute among scientists investigating the cigarette-cancer connection was waning. A consensus on the causal con- nection was clearly taking shape. The cigarette, first described as possibly "associated" with lung cancer and, later, as a "factor" in the disease, was now described with increasing confidence as the over- riding cause of the twentieth century lung cancer epidemic. In fact, in this period of rapidly mounting scientific evidence, Surgeon General ' Leroy Burney, urged by NCI's Dr. Michael Shimkin, had a statement pre- pared in 1957 concerning the cigarette-lung cancer connection. For well over 2 years, Dr. Burney's statement remained mired in the federal health bureaucracy, subject to countless revisions and clearances. (See Book Two, Chapter 5.) It wasn't until November, 1959, that the statement was finally published--as an article in the Journal of the American Medical Associa- tion. (25) Entitled "Smoking and Lung Cancer: A Statement of the Public Health Service," the article declared: 'The weight of evidence ... implicates smoking as the principal etiological factor in the increasing incidence of lung cancer." (26) Interestingly, the Surgeon General's statement received little publicity; and its overall impact on public policy was negligible. 175

.In 1962, the Royal College of F'hysiciwis in Loi:don stated their conclusion on smoking and cancer causation in the plainest of terms: 'The strong statistical association between smoking, especially of cigarettes, and lung cancer is most simply explained on a causal basis." (27) The report of the Royal College of Physicians went on to raise the spectre of a second stage in the lung cancer epidemic--the toll it was yet to take among women. Because women did not develop smoking habits quantitatively comparable to those of men until after World War II, it was hypothesized that the full effect of cigarettes on the female lung cancer rate could not be assessed for some years, in view of the time period ordinarily required before cancer manifests itself. The Surgeon General's Report on Smoking and Health In January, 1964, two years after the Royal College of Physicians' report, the Surgeon General's Advisory ConQnittee on Smoking and Health published what was to become the definitive American statement. (28) In arriviing at its conclusions on the effects of smoking, the committee experts evaluated three kinds of scientific evidence: (1) animal studies in which the effects of smoke, tars, and toxic irritants were measured; (2) clinical and autopsy studies of smokers and non-smoke'rs, such as the Ochsner-DeBakey study; and (3) epidemiological studies, both retrospective and prospective. Second only to its impact on the smoking-health con- troversy, perhaps the most critical contribution of the Advisory Cornnittee's report was to gain lasting acceptance for epidemiology as a bona fide science that could no longer be dismissed as "mere statistics." While epidemiology had been recognized for some time as useful in the study of acute disease, the 1964 Surgeon General's report established epidemiology's 176

',)L1! 11)' 1l.`r 1e :ly.aL1o;1 01 L Chapter 9 of the Advisory Committee's report was titled simply "Cancer." The chapter's 136 pages consisted of an exhaustive review of the epidemiological evidence not only with respect to tobaccogenic lung cancer, but for other organ sites as well, such as the mouth,.:,, larynx, esophagus, urinary bladder, and stomach; other chapters in the report reviewed epidemiological evidence linking cigarettes to non- neoplastic respiratory diseases, cardiovascular diseases, and other conditions. Dealing directly with the question of ascribing causation based on a statistical association between a factor such as cigarette smoking and a disease such as lung cancer, the Committee wrote: Causal Si 'ficance of the Association. -- As already stated, statistical me s cannot esta lis proo of a causal relation- ship in an association. The causal significance of an association is a matter of judgment which goes beyond any statement of statistical probability. To judge or evaluate the causal r significance of the association between cigarette smoking and lung cancer a number of criteria raust be utilized, no one of which by itself is pathognomonic or a sine ug_a non for judgment. These criteria include: (a) The consistency of the association (b) The strength of the association (c) The specificity of the association (d) The temporal relationship of the association (e) The coherence of the association (29) Fmploying these criteria, the Committee concluded that: 1. Cigarette smoking is causally related to lung cancer in men; the magnitude of the effect of cigarette smoking far outweighs all other factors. The data for women, though less extensive, point in the same direction. 2. The risk of developing lung cancer increases with duration of smoking and the number of cigarettes smoked per day, and is diminished by discontinuing smoking. (30) While making no specific policy proposals, the report went on to call for "remedial action" to reduce the health hazard posed by cigarette smoking. 177

f Viewed historically, it is now apparent that the report had the remarkable effect of really*settling the scientific issue whether cigarettes indeed caused lung cancer. How was it that this second Surgeon General's report proved so effective when the Burney report- initiated in 1957 and published in 1959--had been so ineffective? Several reasons emerge. First, the passage of time itself was a key factor. Between 1957 and 1964, the findings of some of the large prospective A epidemiologic studies were being published, confirming earlier work, and solidifying the growing scientific consensus on tobaccogenic cancer. Second, in both its design and scope, the 1964 report was a far more impressive document. Fmp.loy3ng a sizeable staff, the Advisory ' Committee took more than a year to exhaustively review virtually all of the evidence at hand regarding the.smoking-health issue generally, and the cigarette-cancer issue specifically. The full document, almost 400 pages long, reflected the,kind of ct..e. that would enable the report to withstand the scrutiny and criticism that would inevitably follow its release. The third reason for the effectiveness of the 1964 report, as compared with the-1959 Burney report, can be attributed to what might be called the managerial factor. From beginriing to end, Surgeon General Luther Terry sought to assure maximum impact of the report's findings--- whatever they might be. The report was not to be his per se, but rather the report of an "expert committee," acknowledged by the President, thereby gaining enormous stature. (31) Dr. Terry selected the 10-member Advisory Committee in a way to virtually guarantee that there would be no subsequent charges of bias. He insisted that no one could be a member of the Advisory Comnittee if he had been publicly identified with any 178

position on the smoking-health question. (32) ASoreover, he astutely allowed the Tobacco Institute to veto any proposed nominees to the . Advisory Committee. (33) In this way, the Surgeon General managed to bestow upon the Advisory Committee the tobacco industry's implicit en- dorsement as to its objectivity. Throughout the investigation, all meetings and staff work were conducted in a politically protected en- vironment, based at the National Library of Medicine. (34) Dr. Terry forbade the Corrmittee members to speak to politicians or the press. In exchange, he secured assurances from President Kennedy and HEW Secretary Ribicoff (and, later, Anthony Celebrezze) that the Committee could carry out its work insulated from any political influence. (35) Consistent with these precautions, there were no leaks or any other disclosures to sap the final report of its desired impact. Finally, when Dr. Terry released the report on January 11, 1964, it was with the utmost fanfare--a carefully staged press conference to carry the message to the American public. (36) In the Aftermath of the Surgeon General's Re2rt, 1964-65 With the release of the Advisory Committee's report on January 11, 1964, the purely scientific phase of the cigarette controversy had largely run its course. Almost immediately, the controversy shifted to the political realm--a clash between public health considerations on the one hand and private economic interests on the other. The stakes were evidentt from the outset. The mere issuance of the Surgeon General's report, coupled with the attendant publicity, produced a short-run, one-month decline in cigarette sales of more than 15 percent. (37) But more sig- nificant than this temporary impact was the fact that the report's release 179 . . ~ , ~. . ~ :

signalled the nation's err;)arkation along a twisting pathway in search of an appropriate cigarette policy. It is now clear that at several points along that pathway- -stretching from 1964 to 1971--advocates for the public's health stumbled across the elements of a truly effective program in cancer control education, only to have the Congress inter- vene to block the emerging policy and then redirect it along predictably unproductive lines. In the winter and spring of 1964, there was no requirement that the Congress act in response to the Surgeon General's report. In fact, it is likely that no action at all would have been forthcoming had it not been for the maverick-like conduct of the Federal Trade Commission, 91 particularly its Chairman, Paul Rand Dixon, and commission member, Philip Elman. Citing the Surgeon General's report, and then citing its authority to regulate comnerce so as to eliminate unfair and deceptive trade practices, in a classic document of administrative law, the FTC proposed a trade regulation rule which would have required in every cigarette advertisement (radio, television, billboards, and print media) and on every pack, box, and carton of cigarettes, the prominent in- clusion of one of the following warnings: (1) CAUTIO:V--CIGARETTE SMOKING IS A 1ElLTH HAZARD: The Surgeon General's Advisory Committee on Smoking and Health has found that "cigarette smoking contributes substantially to mortality. from certain specific diseases and to the overall.death rate;" or (2) CAUTION: Cigarette smoking is dangerous to health. It may cause death from cancer and other diseases. (38) The fact that the regulation would have required the labeling of one of these warning statements on every pack, box, and carton of cigarettes was not nearly as signiticant as the requirement that the statement accompany any advertising, including broadcast advertising. A disclosure statement 180

of the kind proposed by the FTC threatened to destroy the appeal of radio and television advertising, an appeal of such enormous dimensions that the industry was pumping nearly $200 million per year- -four-fifths of its advertising expenditures- -into these media. Faced with the impending FTC actiori, the tobacco lobby, whose principal lobbyist was former Congressman Earle C. Clements (D-Kentucky), turned to the Congress for help. (39) In substantial measure, the industry received all the help it needed with the Federal Cigarette Labeling and Advertising Act of 1965. (40) In this act, Congress blocked the FTC's proposed regulations and required instead that as of January 1, 1966, all cigarette packages, boxes, and cartons sold in the U.S. must bear the statement: "Caution: Cigarette Smoking May be Hazardous to your Health." Beyond this inconspicuous side-panel requirement, the Congress refused to require that the mildly worded warning statement accompany radio and television advertising- -the key to the promotion of cigarette sales. In fact, the labeling act ex- pressly banned the FTC, and any state or local agencies,_from taking any action in this regard for a period of four years. Senator Frank Moss (D-Utah) later lamented that the 1965 legislation effectively sus- pended the entire apparatus of federal and state regulatory authority in exchange for nine innocuous words on the side-panel of cigarette packages. Representative John ;,ioss (D-Calif.) voiced his opposition in these terms: This legislation puts the Federal Government in the position of saying that cigarette smoking constitutes a serious health hazard, but that traditional guardians of public health, the state and local authorities, cannot act to protect their citizens if they believe a warning statement in cigarette advertising would do so. (41) .• 181

The warning requirement, he said, does little to act as a remedy to curb the cigarette health hazard. . . A more realistic and responsible approach. ..would be to warn the non-smoking consumer of the health hazard before the product is purchased--rather than remind the individual who already smokes and after he has the product in his possession, that it may be harmful to his health. ...We must first concern ourselves with public health and welfare, not legislate to the whims of a special interest. (42) When thq labeling requirements went into effect on January 1, 1966, there was no significant impact on cigarette sales; per capita con- sumption increased slightly in 1966, (43) By way of separate legislation, the Congress took other action in the cigarette field in 1965. As a means of maintaining the staff which had served the Surgeon General's Advisory Committee, the Congress appropriated $2 million to the Public Health Service to establish a ' .~ National Clearinghouse on Smoking and Health. (44) Lodged in the Cancer Control Program in the Division of Chronic Diseases, the Clearinghouse undertook responsibility for gathering and disseminating information on smoking and health including, later on, the preparation and promotion of anti-cigarette media messages. Under the direction of Daniel Horn, who had contributed to the pioneering scientific work on tobaccogenic cancer, the Clearinghouse, tiny as it was, nevertheless represented the only programmatic evidence of a national effort to discourage cigarette smoking. The Banzhaf Decision and CoM essional Re-entry, 1967-71 In mid-1967, a year and a half after the labeling act took effect, a young attorney named John Banzhaf III filed a Fairness Doctrine complaint with the Federal Corrumnications Commission. In his canrplaint, he called upon the FCC to make a finding that cigarette corrmercials per se con- 182

stituted statements depicting one side of a controversial issue of public importance and that, accordingly, the Federal Comamications Act required the FCC to order stations to provide "equal" time for the pre- sentation of the "other side" of this public controversy. In a land- mark decision, the FCC agreed with much of Banzhaf's argument and re- quired broadcasters to accord a "substantial" amount of air time-- although not "equal" time--to the "other side" of the cigarette con- troversy. (.4S) With this decision, the nation was launched on a three-and-a-half- year experiment in public health education by way of anti-cigarette commercials. Affirmed by the courts in 1968, (46) the FCC action was interpreted to mean that radio and television stations had to provide roughly one free anti-cigarette message for every five pro-cigarette messages. (47) Translated into aggregate terms, this meant that by 1969 and 1970, approximately $40 million per year in broadcast time-- free of charge--was accorded to the American Cancer Society, the Tuberculosis Association, and other non-profit organizations in order to present hard-hitting anti-cigarette messages. It was a unique era in broadcast advertising, giving rise to a host of creative anti-cigarette messages. For example, there were the messages depicting a pleasant scene: people having fun, enjoying life. Then one of the people would light up a cigarette and the voice-over caption would follow: "This is life. .... This cuts it short." Another spot message was a parody of the Marlboro man. A tough-looking, gun-toting cowboy pushed his way into a saloon," inhaling a smoky cigarette. Then he began to cough uncontrollably, and was pushed aside by a clean-cut, non-smoking cowboy. Then the word "cancer" zoomed up on the television screen and the voice-over announcer 183

said, "Cigarettes--they're killers." Perhaps the most forceful of the anti-cigarette messages on television was the one in which William Talman, the actor who played Hamilton Burger on the Perry Mason series, introduced his family and then revealed that he had lung cancer. He then urged smokers to quit and non-smokers not to start. By the time this particular anti-cigarette message was on the air, William Talman was dead from lung cancer. While the FCC facilitated the era of anti-cigarette messages, it is interesting to note that this novel venture.in public health education had its beginnings in the voluntary sector, not the public sector. Indeed, both in its origin and in its content, the anti-cigarette campaigr_ was r almost exclusively a product of the voluntary sector. And even within that sector, some traditional voluntary health agencies, most notably the American Cancer Society, were unwilling to back the initial Banzhaf complaint. (48) During the years 1967-1970, the Banzhaf decision had a major impact on per capita cigarette consumption. After years of virtually unin- terrupted growth in per capita consumption, there was a slight fall-off in 1967--4280 cigarettes for every U.S. resident 18 years of age and older as compared with 4287 in 1966. (49) In 1968, per capita con- sumption fell again--to 4186 units. (50) In 1969, when monitoring and public pressure was assuring widespread compliance with the Banzhaf decision, anti-cigarette messages were in full swing; and per capita consumption suffered its most severe drop-off, down to 3993 units. (51) In 1970, a further decline was registered, down to 398S cigarettes. (52) (See Figure 1,) . r, 184

During 1969, Congress re-entered the picture. Its 1965 legislation prohibiting FTC regulation of cigarette advertising was scheduled to expire on June 30, 1969. Seizing this opportunity, Congress intervened in the cigarette controversy for the second time. It enacted the Public Health Cigarette Smoking Act which included two principal provisions. First, in a minor concession to the flood of scientific evidence con- cerning the deleterious effects of cigarette smoking, the Congress changed the cigarette side-panel label to read: "Warning: The Surgeon General Has Determined That Cigarette Smoking Is Hazardous To Your Health." The second provision, which appeared to be a victory for • public health advocates, was to ban radio and television cigarette advertising effective January 2, 1971. Privately, however, the cigarette manufacturers favored a radio-television advertising ban. (53) They believed--as it turns out correctly--that such a ban would serve to undo the anti-cigarette campaign tied to the Banzhaf decision. With the banning of pro-cigarette commercials, radio and television broad- casters were no longer under a legal obligation to present the "other side" of the controversy. Accordingly, on January 2, 1971, the anti- cigarette messages virtually vanished from the airwaves. The country's three-and-a-half-year experiment in mass media anti-smoking education dried up almost overnight. Meanwhile, in 1971, cigarette promoters managed to shift $150 million of their more than $200 million per year in radio and television expenditures into other outlets, principally newspapers, magazines, and billboards. (54) The effect of all this upon per capita consumption was dramatic. After an historic four-year decline in consumption, an upward trend re- turned in 1971. In that year, per capita consumption rose to 4037 from ... ~- ~ r 185 ~' c ~_ ~r

the previous year's 3985. (55) In 1972, the figure went to 4043; (56) and in 1973 leaped sharply to 4147. (57) By 1973, per capita cigarette consumption was approaching the 1963 peak figure of 4286. (S8) (See Figure 1.) FIGURE 1 Cigat ettes 4400 ' 4300 4200 4100 4000 3900 3800 3700 ;i6UU 3500 3400 3300 ._..r Annual Per Capita Cigarette Consumption* Surgeon Gcneral's Report ()an. 10, 1964) r (June 2, 1967) , Radio-TV Ad Ban takes effect , also ending anticigarette ad campaign (Jan. 2. 1971) 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 Source: U.S. Department of Agriculture •For the yrar 1960 and subscqucnt years. per capita consumption fiRures maintained by the goveinnient were cali idated by divid ing the total nurnher of cil;arette% ennsumed by the number uf Americans eighteen yearsot older. 1 n rarlivi veai.. the cdculation had been hased on the numher of Ameriuns filteen years or older. Labeling Act takes effect (Jan. I, 1966) r, Banzhaf Decisitm (FCC), requiring anticigarette ads 186

The Federal Trade Commission was so alarmed at the turnaround in cigarette sales that it recommended to the Congress in 1971--and repeatedly in the years since--that funds be allocated to HEW to enter the marketplace and purchase radio and television time for anti-cigarette messages, in order to effectively re-establish the public health education program which flourished from 1967-1970. (59) Paralleling the legislative reversals, the National Clearinghouse on Smoking ar.d Health also suffered a series of setbacks in the late 1960s. In 1967, the Clearinghouse went the way of its parent unit, the Cancer Control Program, and was shifted to the Regional Medical Programs Service, an organizational switch which made little sense in terms of the Clearinghouse's work but was indicative of its posture as a programmatic foster child, seemingly unwanted because of the powerful congressional opposition which was part-and-parcel of its operations. In 1971, the Clearinghouse was moved again, this time to. the Center for Disease Control; meanwhile, its budgeted appropriatj.ons were de~lining. In November of 1974., the Clearinghouse was physically re- located from the Washington, D.C.Jarea to Atlanta, Georgia. At the same time, its line item budget, less than $1.S million in fiscal year 1974, was removed. With the loss of funding and with the move to Atlanta, the Clearinghouse was effectively reduced to a programmatic nonentity. Dr. Horn, the Clearinghouse's Director since its inception, resigned. In evaluating the Congress' role as handmaiden to the tobacco interests, Dr. Ernst Wynder observed: The fundamental law of the politician is first to be elected. If you don't get elected, you can't do anything. If you took a position that you thought smoking was the worst thing, and you came from a tobacco-growing state, you would never get elected. So that's how you have the tobacco bloc. LM 0 ~.~ ~ 187 ~ ' 0 ~ . ~~ 0 ~ . ,

And the way Congress works, because of seniority, tobacco states supply the committee chairmen. They say, 'bkay, now you work for me in this area and I'll work for you in that area." ...That's why so many of these blocs are successful perpetuating their particular line of propaganda. (60) Statistical underpinning for Wynder's political observation rests with the fact that an estimated 600,000 farm families, heavily con- centrated in the Southeast, derive part or all of their livelihood from tobacco sales. (61) To further illustrate his point about the dynamics of special interest politics, Wynder noted his own experience in challenging the meat and dairy interests on the question of cholesterol and, in the case of fatty meats, on the question of diet-related colon and breast cancers : The meat industry of course is very powerful, and so is the dairy industry. All together, they are infinitely more powerful than the tobacco industry. It is interesting, without mentioning names, I went to see one Congressman once--from one of the tobacco states. Ne said, "You must understand that I have to do what I do because otherwise I can't be elected. But nutrition, I'll help you all the way." Some time later I saw a Senator from one of the dairy states who said, "I am certainly anxious to help you in the tobacco area. But the dairy area, leave it alone." (62) Reflections on the History of Tobaccogenic Cancer In reviewing the steps leading to the current near-unanimity re- garding the carcinogenicity of tobacco, there are no discrete points that can properly be labeled dramatic breakthroughs. Instead, the history re- veals a process of evidentiary accumulation: first, the relatively small- scale clinical studies; then a series of retrospective epidemiological studies; and, finally, a number of large-scale prospective studies. 188

. The 1964 report of the Surgeon General's Advisory Committee on Smoking and Health had the effect of rendering a scientific judgment on the significance of the evidence at hand. Largely.because of Surgeon General Terry's adroit political management, the Advisory Committee's conclusion on cigarette-lung cancer causation had maximun scientific impact. . The period 1964-1971 placed the cigarette controversy in an in- tensely political arena. Congressional policymaking was dominated by special interest lobbying, with the tobacco lobby able to exert enormous influence through the traditional avenue of Southern committee chairmen. The result was a feeble congressional response in 196S to the Surgeon General's 1964 call for prompt "remedial action" to meet the serious health hazard posed by cigarettes. . After the almost accidental discovery of a successful anti-cigarette policy--through the Federal Communication Commission's 1967-1970 applica- tion of the Fairness Doctrine to radio-TV cigarette advertising--the Congress was once again able to reassert its primacy in the cigarette policy field, to the ultimate detriment of the public's health. There was no presidential leadership forthcoming to promote a more health- oriented legislative response in these critical years. Nor, for that matter, was there leadership forthcoming from the National Cancer Institute where, apparently, considerations of long-range congressional funding of research took precedence over the need to develop a more effective cigarette-cancer control policy. ... 189

i Chronology cf Significant Events in the History of Tobaccogenic Cancer Mid- 1930s Dr. Alton Ochsner suspected cigarette smoking as a causative factor in an observed clinical "epidemic" of lung cancer. 1939. Muller published one of a number of European studies indicating 1941 a statistical association between cigarette smoking and lung cancer. Drs. Alton Ochsner and Michael DeBakey published the first 1950 American study, based on clinical observations from autopsies, which stressed the cigarette-lung cancer connection. Drs. Ernest Wyrider and Evarts Graham published the results arly 1950s of their retrospective epidemiological study, concluding that cigarette smoking "seems to be an important factor in the inducement of bronchiogenic carcinoma." A number of retrospective studies followed the Wynder-Graham effort, with investigators observing strikingly similar r, 1953 findings. Graham and Wynder produced skin cancer in animals by applying Late the tar from cigarette smoke. The results from a series of prospective epidemiological 1950s studies are published, (the Doll and Hill study of British doctors--1956, the Hammond-Horn American Cancer Society study--1958, the Dorn study of U.S. War Veterans--1959). The strong relationship between prolonged cigarette smoking and lung cancer was found in each of the studies. 1959 After more than a year of internal review, Surgeon General Leroy Burney published a statement in the Journal of the American Medical Association implicating smoking as the principal etiological factor in the increasing incidence of lung cancer. 1962 The Royal College of Physicians in London published their report concluding that cigarette smoking was causally related to lung cancer. 1964 Surgeon General Luther Terry released the report of his Advisory Committee on Smoking and Health, concluding that cigarette smoking was causally related to lung cancer in men. 1965 The Congress blocked pending Federal Trade Commission regulations controlling cigarette advertising, adopting instead a mild cautionary statement to appear on cigarette package side- panels. 190

1967 The era of anti-cigarette messages in radio-TV broadcasting began with the FCC's Fairness Doctrine decision. capita cigarette consunption began to decline. Per 1971 The Public Health Cigarette Snoking Act took effect, banning radio-TV pro-cigarette advertising and simultaneously ending the anti-cigarette media campaign. Per capita consurrption began to rise.

Notes : Chapter 3 (1) Ochsner, A.: My first recognition of the relationship of smoking and lung cancer. Prev. Med. 2:611-614. (2) Cancer Facts and Figures. New York, American Cancer Society, 1976. (3) See note (2) at S. (4) See note (1) at 611. (S) Muller, F.H.: Tabakmissbrauch und Lungencarcinom. Z Krebsforsch 49:57-85, 1939. (6) Ochsner, A., DeBakey, M.: Carcinoma of the lung. Arch. Surg. 42:209-258, 1941. (7) See note (6) at 210. - {. (8) 'See note (6). (9) Shimkin, M.B.: Adventures in cancer epidemiology. Cancer Ries. 34:1525-1535, 1971, at 1527. (10) See note (1) at 613. (11) See note (1) at 613. (12) Wynder, E.L., Graham, E.A.: Tobacco smoking as a possible etiologic factor in bronchiogenic carcinoma.. J.A.M.A..143: 329-336, 1950. (13) See note (12) at 336. (14) Wynder, E.L., Graham, E.A., Croniger, H.B.: The experimental production of carcinoma with cigarette tars. Cancer Res. 13:855-864, 1953. (15) See note (1) at 614. (16) Interview with Dr. Ernst Wynder, President of the American Health Foundation, by Larry Agran of HCCP, April, 1976, New York City. (17) Interview with Dr. Lester Breslow, Dean of the UCLA School Of Public Health, by Larry Agran of HCCP, November 25, 1975, Los Angeles, Ca. (18) Breslow, L., Hoaglin, L., Rasmussen, G., et al: Occupations and cigarette smoking as factors in lung cancer. Am. J. Pub. Health 44:171-181, 1954. 192

(19) See note (17). (20) Hammond, E.C., Horn, D.: Smoking and death rates--report on forty-four months of follow-up of 187,783 men. J.A.M.A. 166: 1159-1172 (Part I, Total Mortality), 1958: and J.A.M.A. 166: 1294-1308 (Part II, Death Rates by Cause), 1958. (21) See note (20). (22) Doll, R., Hill, A.B.: Lung cancer and other causes of death in relation to smoking. Brit. b'ad. J. 1071-1081, November 10, 1956. (23) Dorn, H. F. : Tobacco consumption and mortality from cancer and other diseases. U.S. Pub. Health Rept. 74:581-593, July, 1959. (24) See note (20). (25) Burney, L.: Smoking and lung cancer: a statement of the Public Health Service. J.A.M.A. 171:1829-1837,'November 28, 1959. (26) See note (25). (27) ~_Smok~i_nS_.a.~nd Health. Report of the Royal College of Physicians. London, 1962. ~ (28) Smokin and Health: Re ort of the Adviso Committee to the urgeon General of the Public Heal Se ryrnce. U.S. Dept. of HEW, 1964. (29) See note (28) at 182. (30) See note (28) at 196. (31) Trade Regulation Rule for the Prevention of Unfair or DeceRtive A3vertisin`and -Labelin of Ci arettes in Relation to the Health azar o Smo inQ. an Acco an in tatement o Basis an _Puipo..se of Ru1e. Fe ral ra Commission, une , 1 4, at 8-24. (32) See note (31). (33) See note (31). (34) Interview with Dr. Luther L. Terry, former Surgeon General of the U.S.Public Health Service, by Myrna Morganstern of HCCP, April, 1976, New York City. (35) See note (34). (36) See note (34). 193

(37) Statistical S lement to Federal Trade Commission Re ort to ongress Pursuant to the Public Heal Cigarette mo ing Act, 1974, at 4. (38) See note (31) at Appendix D. (39) Health Warning Required on Cigarette Packs. Con pr~essional Quarterly Almanac 344-351, 196S. (40) 15 U.S.C. Sections 1331-1339 (Supp. 1966). (41) See note (39). (42) See note (39). (43) Annual Report on Tobacco Statistics: 1973. U.S. Dept. of Agriculturel, April, 1974, at 33. (44) See note (39). (45) Applicability of the Fairness Doctrine to Cigarette Advertising. 9 F.C.C. 2d 921, 1967. (46) Banzhaf v. FCC,405 F.2d 1082, 1968. (47) National Broadcasting Co., Inc., 16 F.C.C. 2d 947 , 1969. (48) Whiteside, T.: Sellin Death: Ci arette Advertisi n and Public Health. New Yor , veri t, 1971. (49) See note (43). (50) See note (43). (51) See note (43) . (52) See note (43). (53) House and Senate Disagree on Cigarette Ad Bill. Congressional Quarterly Almanac 883-890, 1969. (54) Statistical S DD lement to Federal Trade Corrnnission Report to Con ress Pursuant to e PublicHealtFi i arette mo n Act, a le 7), 1973. (55) See note (43). (56) Annual Re ort on Tobacco Statistics: 1975. U.S. Dept. of Agriculture, April, 1976, at 28. (57) See note (56) . 194

(S8) See note (56). (S9) Federal Trade Commission Rc ort to Congress Pursuant to the Public ealt Ci~arette mo ing Act, ce er 31, 19710-11. (60) See note (16). (61) Tobacco in the National Economy. 1975. "(mi.meo) U.S. Dept. of Agriculture, (62) See note (16). r . r, 195