Tobacco Documents Online

To carry out an assignment made by Secretary of Health, Education and Welfare Cohen, the Joint Committee on Tobacco and Health was established by Kenneth M. Endicott, M.D., then director of the National Cancer Institute, in the spring of 1968. The Committee met June 20, 1968, in San Francisco. In his opening statement, -Dr. Endicot': referred to a recent meeting between HEW officials and cigarette industry execu- tivesI who "agreed that there are gaps in our knowledge about tobacco and health." He said that as a result of the meeting "it was decided that a group of experts be asked to identify these gaps, " and that this was the mission of the new Committee. During the two previous years, Earle C. Clements, president of the Tobacco Institute, representing major cigarette manufacturers, had initiated a number of discussions with Secretary Gardner, and much later with Secretary Cohen, to open a dialogue on scientific research needs in the smoking-health controversy. Responding to Dr. Endicott's opening statement at the San Francisco meeting, Mr. Clements iThe meeting was conducted by Secretary Cohen. For a list of those attending, see appendix. -

-2- agreed that "our initial goal in this continuing dialogue is to identify these many gaps." Those present represented government health research agencies, cigarette companies, and the scientific boards which administer the more than $4 million annual smoking and health research funds provided by the companies.2 Since this was the first time representatives of these groups had been together, they devoted part of the meeting to a com- parison of their research efforts. The Committee agreed to a suggestion from the staff of the National Cancer Institute: to establish a subcommittee from among those present, not including cigarette company officials, to prepare a program for the consideration and criticism of the Joint Committee. (. The Joint Committee recessed to permit an initial meeting of the subcommittee, which was charged by Dr. Endicott "to plan how it will prepare an assessment of the state of the art in the field of tobacco and health; an indentification of the important gaps in the different areas of knowledge and recommendations on how to fill these gaps through scientific ~A list of members of the Joint Committee attending the San Francisco meeting is appended. ~ o

-3- ,,3 investigation as well as specifying priorities. Dr. Carl Baker of the National Cancer Institute pre- sided at the subcommittee session.4 He raised the issue of how to deal with the question of association between specific diseases and smoking. It was decided that any document prepared by the subcommittee "should briefly summarize the findings of previous studies to avoid duplica-- tion." but that HEW would "keep this effort separate from its continuing public education campaign''5 (Emphasis added). Thus it was clear at the outset that the forthcoming docu- ment would not reflect conclusions on the part of any of its authors, or the organizations which they represented, as to smoking-disease causation. The intention to "briefly summarize the findings of previous studies" would merely provide leads to further needed research which might or might not help to corroborate such findings. As will be seen, this decision by the subcommittee may have become, in the light of later events, a subject of misunderstanding. 3Excerpted from the minutes of the meeting. 4Names of the nine merabers of the subcommittee are appended. Drs. Loosli and B~ng were not present at the first meeting. Dr. Hickam died in 1970. 5Excerpted from the minutes of the subcommittee session.

At Dr. Jacobson's suggestion, the subcommittee agreed that each group represented would "prepare its own outline of the fields that require further research"6 as a prelude to later development of a single document, and that it would next meet in four to six months. It was hoped that a final document might be submitted to Secretary Cohen by January 15, 1969. The Progress of Drafting As scheduled, the three groups submitted individual drafts to each other in the fall of 1968. The NIH draft listed many topics of needed research, assessing relative priorities. It also referred at several points to work in progress and which should be expanded to develop a "safer cigarette." Finally, it offered a very general outline of a five-year, $75 million budget for NIH smoking-health research contracts, grants and in-house expenditures. The AMA group recommended establishment of a jointly financed laboratory to pursue a half dozen types of investiga- tion of tobacco smoke constituents and their possible physiological effects, as leads to development of a "less O 6Subcommittee minutes.

hazardous" cigarette. The AMA draft reviewed the nature of studies going forward with industry financing under AMA-ERF grants, urged a continuation of mechanisms to permit broad exploration of the smoking-health field by the individual "creative investigator," and stressed that "it seems highly unlikely that the specific approaches to the kinds of gaps to be closed in research on diseases related to tobacco use can be determined by Committee action." CTR's draft set forth a number of smoking-health ques- tions and recommended research which might help to answer them. These ranged from suggestion of the need to study endocrinological factors as a possible explanation of the predominance of pulmonary diseases in males, to development of more sophisticated statistical approaches to determine the relative importance and interdependence of multiple factors associated with coronary heart disease. With these papers before them, members of the sub- committee met for the second time on November 15, 1968. Dr. Hasterlik, was present in the AMA group in place of Dr. Hickam. Dr..McMillan attended for NIH in place of Dr. Kotin. Dr. Jacobson of the CTR group was unable to 7 attend. 7See list of Joint Committee members in appendix for full identifications.

-6- Dr. Baker observed at the outset that he did not believe it would be too hard to meld the documents. He said Dr. Endicott had indicated that budget figures need not be included. The NIH draft was criticized for its conclusions about smoking and disease causation, but Dr. Baker said these were consistent with Public Health Service policy. On the other hand, he criticized the AMA and CTR papers for their failure to set forth clear priorities. Aiming toward a scheduled December 9 meeting of the full Joint Committee, the subcommittee at first agreed to a new approach, contemplating a Single document with an introduction and sections on cardiovascular diseases, drafted by Drs. Bing and McMillan; on cancer, drafted by Drs. Baker and Sommers; and on respiratory diseases, drafted by Drs. Loosli and Hickam. However, after the meeting, it was evidently decided informally that instead of a further effort by these teams, Dr. Baker and his associates would attempt a consolidated draft reflecting as many as possible of the views expressed during the meeting. This draft was sent to other sub- committee members by Dr. Mitchell December 5. Though it

-7- was Dr. Mitchell's intention to solicit comments by phone, the AMA group notified Dr. Endicott that day that it could not prepare adequate comments in time for the December 9 Joint Committee meeting, and that the AMA representatives therefore could not attend. On December 3 Mr. Clements wrote Dr. Seevers of the AMA group urging him to reconsider the decision. Nevertheless, on December 5 Dr. Endicott notified the Joint Committee members that the meeting would have to be postponed. The next day Dr. Endicott wrote to them, stating that at the November 15 meeting of the subcommittee "it was agreed that the document prepared by the National Institutes of Health should be used as the basis for developing the final document, pro- vided that certain segments and statements in the document could be modified or removed to represent the consensus of the group and provided that cer- tain concepts and suggestions contained in the CTR and AMA documents could be incorporated." He expressed hope that Dr. Baker's December 2 draft could be examined by all the subcommittee members by December 16, with Dr. Singer coordinating the comments of the AMA group and Dr. Loosli those of the CTR group. He anticipated that perhaps the subcommittee could meet just before Christmas. Such a meeting could not be scheduled, however, and it became apparent that the project would not he completed prior

i,,~~ to the advent of a new Administratlo~ on January 20. ~- To help assure that the project would be reco~ended '~"-' for continuation under a new Secretary of gg~, Dr Endicott • -,~.. and ~. Clements visited Secretary Cohen on January 2, and ;.'~ reported on the status og the matter. ~..cohan said he -~ still hoped he might receive a final doc~ent before • ~. ( January 20, but asked that in any event he b~ given a • ~:}'~ written status report by Dr. Endicott by January' 15. Either way, he said, he would be in a position to report on this project, among others, to the President and to the Secretary-designate before leaving office. Both Dr. Ma~ston, director of NIH, and Surgeon General Stewart were pr'esent at this meeting, but neither made any comment. Dr. Endicott transmitted his report to the Secretary week later, providing a copy to Mr. Clements on January. " 13 with a covering letter. In his report, Dr. Endicott .... said the three groups within the s.ubcommittee were exchanging " ~'.~ modified draft documents, that they were scheduled to meet : ~.~ "~ again on January 21, and that "it is my expectation that a " . satisfactory, document will be forthcoming which will serve -. as a useful guide in planning research programs." His letter to Mr. Clements said "It is my hope and expectation that the

new administration will encourage and extend the beginnings which have been made with Secretary Cohen. " The January 21 meeting took place, with Dr. McMillan again replacing Dr. Kotln, and Drs~ Bing ~nd Loosll absent. ~ 8 time a modification by the AMJ% group of the December 2 NIH draft was taken up for discussion. While there were further expressions from the participants not unlike those at the November 15 meeting, Dr. Mitchell did dlstr~bute, on January 27, a revision subject to the comments of the partlcipants. On that day, ur. Endicott gave Mr. Clements a copy of the revision for study. At a meeting in Dr. Endicott's office, Mr. Clements observed that the newdraft still contained language which in effect required the cigarette industry to "plead ~uilty" to smoking-disease causation as a part of the statement of gaps in scientific knowledge on the matter, lie reminded Dr. Endicott that this was beyond the scope of the Secretary's directive, and that the weight of scientific evidence was insufficient to justify such a posture by the industry. But he promised that the new draft would receive careful study. On February ].4, Mr. Cl&ments visited the new Secretary of HSW, Robe.~t F~noh. lie provided an oral summary, and left

-i0- a written statement with the Secretary, on the development of the project to identify as future research guidelines the gaps in smoking-health knowledge. Following up on Secretary Finch's interest, there was a further meeting in his office in mid-April, in which Surgeon General Stewart, Dr. Endicott, Mr. Clements, Mr. Ramm, Drs. Sommers and Jacobson and others participated. ~[t was the consensus that a public statement was desirable on the part of the Secretary, noting the existence of the cooperative research project and his endorsement of it. Accordingly, on April 25, the Secretary issued a state- ment to news media describing the project and identifying the participating groups. The statement quoted the Secretary as saying: ~. "I believe that industry and government working together offers great promise of finding the answers we need. I am confident our joint effort will yield a cooperative research program which strongly promotes the public interest." Meeting again on June 6, the drafting subcommittee made further progress, but still did not reach total agreement. This led Dr. Sommers to suggest, in a letter to Dr. Endicott on June 24, that "it would seem desirable to include a statement as

-ii- follows: The members of the Subcommittee are not in agreement with all the statements made and do not subscribe to all the research programs and plans outlined, or to the background information believed to justify all the programs included. "As I look at the present document it seems that we may have gotten away from the original direc- tive to try to develop a document reflecting what we could agree were gaps in knowledge and priorities for filling those gaps." Secretary Finch made a further public reference to the project on July 26, 1969, in his letter to the Speaker of the House and to the President of the Senate, transmitting to Congress his Department's annual report on smoking and health as required by law. Referring to his April 25 announcement, he stated: "It had been my hope that the preliminary report of the scientific group might be available for reference in the report which I now transmit to you. I am advised that they have made substantial progress. Their report has not been completed, but it is my hope that it will be at an early date." | In part due to personnel changes within NIH and HEW, and in part because of the apparent "impasse" within the drafting subcommittee, no apparent further progress on the project occurred during the fall and winter of 1969-70. The latest comment on the matter, however, appeared in the report of the Hous~ and Senate conferees on H.R. 6543, the

"Public Health Cigarette Smoking Act, " issued on March II, 1970, and subsequently approved by both Houses of the Congress : "The conferees noted that the Secretary of Health, Education, and Welfare has informed the Congress that discussions have been held between officials of the cigarette industry and the Department...in an effort to identify gaps in knowledge regarding smoking and health. The Secretary is urged to expedite such identification in a cooperative effort between the cigarette industry and the Department in order that priorities may be set for closing these gaps through appropriate research. "

-13- Appendix i. Persons who attended meeting in the office of the Secretary, HEW, May 2, 1968: Secretary Cohen Assistant Secretary Philip R. Lee Surgeon General William H. Stewart Dr. Kenneth Endicott, Director, National Cancer Institute Tim Worth, Officeof Secretary Cohen ~ Earle C. Clements, President, The Tobacco Institute Joseph F. Cullman 3d, Chairman, Philip Morris Edwin P. Finch, President, Brown & Williamson Alexander Galloway, President, R. J. Reynolds Milton E. Harrington, President, Liggett & Myers Fred Haas, General Counsel, Liggett & Myers H. Henry Ramm, General Counsel, R. J. Reynolds Paul Smith, General Counsel, Philip Morris Addison Yeaman, General Counsel, Brown & Williamson 2. Members of the Joint Committee on Tobacco and Health who attended its first meeting in San Francisco, June 20, 1968: National Institutes of Health Francis R. Abinanti, D.V.M., Ph.D. National Institute.of Allergy and Infectious Diseases Carl G. Baker, M.D. National Cancer Institute Kenneth M. Endicott, M.D. National Cancer Institute Paul Kotin, M.D. Division of Environmental Health Sciences

-14- Gardiner C. McMillan, M.D. National Heart Institute Ian A. Mitchell, M.D. National Cancer Institute AMA-ERF Committee for Research on Tobacco and Health: Robert J. Hasterlik, M.D. University of Chicago John B. Hickam, M.D. Indiana University Paul S. Larson, Ph.D. Medical College of Virginia Maurice H. Seevers, M.D. University of Michigan Ira Singer, Ph.D. Council for Tobacco Research: Richard J. Bing, M.D. Wayne State University CTR/m -ERF McKeen Cattell, M.D. Cornell University Leon O. Jacobson, M.D. University of Chicago Clarence C. Little, Sc.D. CTR, Scientific Director Sheldon Sommers, M.D. Columbia University

-15- Tobacco Industry : Earle C. Clements The Tobacco Institute Philip Grant, General Counsel Lorillard Corporation Frederick P. Haas, General Counsel Liggett &Myers Tobacco Co. David K. Hardy, Counsel t.o the Tobacco Institute Shook, Hardy, Ottman, Mitchell & Bacon Cyril Hetsko, General Counsel American Brands, Inc. H. Henry Ramm, General Counsel R. J. Reynolds Tobacco Co. Paul Smith, General Counsel Philip Morris, Inc. Addison Y. Yeaman, General Counsel Brown & Williamson Tobacco Corp. 3. Members of the drafting subcommittee: NIH AMA-ERF Dr. Baker Richard J. Bing, M.D., Dr. Kotin Prof. & Chmn., Dept. of Dr. Mitchell Medicine, Wayne State Univ. School of Medicine Dr. Hickam Dr. Larson CTR Dr. Jacobson Clayton G Loosli, M.D., Ph.D., Prof of Medicine " & Pathology, Univ.~ of So. Calif School of " Medicine Dr. Soldiers