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. r CONFERENCE AT THE- OF FICE OF i. E SECRETARY OF HEALTft, EDUCATION • AND WELFARE - May 2, 1968 4-o P. M. . Present: Secretary Wilbur J. Cohen Earle C.'Clements Dr. Philip R. Lee Joseph F. Cullman, 3rd : Dr. William H. Stewart Edwin P. Finch Dr. Kenneth M. Endicott Alexander Galloway Mr. Tim Worth (Apparently.a Milton E. Harrington Secretary)' Fred Haas . ' H. Henry Ramm ~ Paul Smith Addison Yeaman Secretary Cohen opened the meeting by asking Senator Clements to say a few words. The Senator stated that at the previous meeting the industry's viewpoint had been presented and that all industry.people present, as well as representa- tives of companies not present, had been completely briefed on what transpired at the meeting held April 1. Messrs. Yellen and Grant of P. Lorillard Company were expected to be present at today's meeting,-having accepted 1 .the invitation to come, but a matter arose that required their presence in New York. One of the major companies had declined the invitation to be present. -The Senator informed the Secretary as to this,,not in derogation of that company's position, in the hope that the Secretary would not regard 0 this as a serious matter. Ul N W W 1-+

2 ;The Senator assured the Secretary that the results of the meeting would be reported to the comftanz.es not present. The Senator recalled.that at the previous meeting .~ ~ the Secretary had recited his experience with a number of- groups particularly ooncerned with pollution_and found as a result of frank discussions with a large number of chief executives of the companies involved progress was made. The Senator said that the cigarette industry was in his judgment prepared to proceed on all things that are worth-. .while and to endeavor to achieve mutual confidence with health authorities of the government. In absence of confi-, dence the association would not accomplish much for either From his previous discussions the Se~ator"harl inferred ., •that the Secretary regarded research as very important. Perhaps this meeting could proceed to aiscuss this area on a policy level. However, the industry does not want to be put in the same position as it was in connection with the Surgeon General's.Advisory Committee report. In spite of statements p ~ made to the contrary, the industry really had.nothing to do V N td with the appointment of members of the Advisory Committee, ta N

1 3 being given the opportunity only to strike names from a list of.some three hundred submitted. The statements sub- . sequently made about the industry's'participation in the .selection of the Advisory Co:mzittee were not of the kind t . ,.: that-permitted develtipment of confidence by the industry in its dealings-with government. Presumably it is not the . purpose of this meeting to discuss details of research but Secretary Cohen stated that his background for thirty- four years seems to have been devoted to solving insolvable problems. In view of his experience he is an optimist and firmly believes that human beings have a capacity for solving ._the insolvable. Whenever there are strong differing points , of view it is helpful to have full discussian and rind some areas of agreement and to break down the areas of disagree- ment. .In dealing with leaders of industry in similar matters which involved water and air pollution, the Secretary had found that there were areas for cooperation.in working to- gether with industry and government. The Secretary stated

i 4 that he received an awful lot of advice and was the most advised man in Washington, having over two hundred advisory co:n,-nittees: He conceives his responsibility as a generalist whose function it is to examine all advice on the basis of _ its overall affect on society and the general welf-are., He endeavors to approazh problems with humility and under- .standing. His responsibility, the Secretary stated, he regards as falling within four separate and inter-related areas: Research HEW is a very vast research organization which grows out of its commitment to safe- guard public health. "' Information to Congress. HEW is required to make periodic reports to Congress. It has a budget of some $14 billion and must report on its stewardship. The Cigarette Labeling Act requires an annual report about the cigarette indus~ry and;it would be proper to discuss what might be in that report. Recommen-dations to Congress in changes in legislation. The Cigarette Labeling A_-t requires HEW to report to Congress any recommendation it has in changes in legislation. The staff has been reviewing this matter and this also would be an appropriate subject for further discussion.

• I 5 Public education on health matters. It is the responsibility of HEW to bring to public knowledge information _as to health matters. Responsibility is ''felt especially with respect to children and youth and this relates particularly as to what should be said to young people about smoking. It would be proper to discuss this area of health education. ~_ , The Secretary stated that'he was willing to start today's discussion in the area of research and that the other three.-areas ca-a be discussed at'subsequent meetings. The Senator 'stated that if there is a comniunity of interest in research, how cooperation can be achieved might be a matter for discussion. The Senator referred to the Lung Cancer Task Force and stated that this was a NI1i oriented body, not connected with the industry, and that there are areas of research other than luri~ cancei,- in which :the industry is involved. The important thing, the Senator .said, is to see if mutual confidence could be developed whereby the structure of research can be understood by all concerned. The Secretary stated that Dr. Endicott was pre-- Y•

. t :. Dr. Endicott referred to the Lung Cancer Task Force and stated that the problem of lung cancer goes beyond the tobacco industry. There are a number of things that have -tv-•be.exatnined that have nothing to do with tobacco. As an example he stated it is important to improve the cure rate of lung cancer which is now only 5%. Clearly, there t~ . . :. are factors other than cigarettes that produce lung cancer. These include, a~nong others, chromate dusts, asbestos, uranium mining and the coking industry. Another area for 1 research is concerned in exploring those factors relating to the susceptibility of the individual hosts since out of any large population sample only a portion of those ex- posed to the same contaminants get lung cancer. The problem of control is usually to identify w:lat there is in the en- vironment:that causes a disease and them to remove them. .In both atmospheric pollution and cigarette snloUng complex mixtures are involved and the problem is to identify the villains and to bring them down to safe levels. The ultimate test is the effect on human beings, but since it may take some thirty or more years for human beings to develop lung cancer it is necessary to find some other biological test system that can be used for experimentation.• The first . ~.

. . y 7 task is to determine which of the variety of available test systems are trustworthy enough to work with. Even after experimentation with test assay systems the final proof -wi11 lie with tests on humans which may take 50 years or more. The state of the art in terms of biologie al test systems is much more advanced in lung cancer than it is -_-: 9 in emphysema, bronchitis, and coronary heart disease. The _.present program (apparently referring to Less Hazardous Cigarette Work Group) is starting with lung cancer. However, other Institutes than the Cancer Institute are involved-- the National Heart Institute being one--and they will par- ticipate in the program. Agreement has been reached at the National Institutes of Health that the less hazardous cigarette program will be managed and directed by Dr. Paul Kotin. Dr. Kotin is worrying most now as to how to find funds for the program. Those participating in thb' program from NIH know nothing about such things as growing tobacco and how to make f ilters. Persons in NIH are howzver expert in biological assay and their participation will be in this regard in an effort to determine whether the industry is proceeding in the right or wrong direction in modification of its products. Dr. Endicott understood that the individual

. 8 ;-: cigarette companies wanted to remain independent of each other and in position to produce their own individual kinds of cigarettes. Dr. Lee stated that competition had been the history of the cigarette'industry and that he felt it was important to inAintain this competition, particularly in the develop- ment of improvements in cigarettes. Mr. Ramm stated that one of the difficulties-apparently is the difference in fundamental viewpoint between the government and the industry. The government assumes that it has been proved that.cigarettes cause lung cancer and perhaps other diseases. The position of the industry is that proof of causation is lacking and it is first necessary to determine whether causation exists before determination can be made as to methods to be adopted to' improve•th5 product. ; . Stewart stated that there is no question on the basis of evidence that cigarettes are hazardous. Mr. Yeaman stated that the industry regarded proof of causation as a serious question and that nobody wanted more O M to explore this and find the answer than did the cigarette N . cD industry. Dr. Stewart respondedy by saying, you refer to ~W

9 :-, the matter as a"question" where I say it .is a "problem". He added that.there is no evidence that cigarettes do not cause lung cancer. Mr. Harrington stated that each of the com2anies had done extensive research work and that the industry could , .coop,erate by furnishing--say to Dr. Kotiri--the results of . ;~ this- research which would result in an econom'ic saving if nothing else. Whatever information Liggett & Myers has they will be glad to supply. Dr. Endicott stated that he had had similar Offers from other con-panies and that he could assure all concerned that any information w:zich might be submitted on a confidential basis would be kept i.n confi- dence. Secretary Cohen said that it is possible to work out methods to assure confidentiality. Dr. Endicott said that NIH had worked with the pharmaceutical people for ten ~• • ? 15 years and much of the information submitte;I by that industry had been of a confidential nature and- that there had been no leaks. . ~ N Mr. Finch statea'that companies in the industry had N . ca already discussed among themselves the matter of handling ~ any method of making a safer ci.garette---should it be found

most serious gap is the lack of an animal system in which lung cancer can be reproduced as it is in man. _What is nice in experimental work is the ability to produce in ex- .perimental animals diseases identical to those in humans. However, even though an animal system has not been found r amentally following exposure similar to-that received by I that present cigarettes are not safe--and they all had agreed informally to share such information with each other. Mr: Galloway stated that if the companies-arid the government cannot trust each other then we cannot work together.' The Secretary then inquired as to whether there were voids and gaps in knowledge that needed to be.filled. Dr. Endicott responded that there are very large gaps in know- ledge, the most serious being in the areas of emphysema and cancer in other cites. With respect to lung cancer, the man, the evi.dence in man Yiimselff is so strong that one has to assume a cause and effect relationship between smoking and lung cancer. The problems relating to,cardio-vascular diseases and emphyse:.na are much more*difficult.

. y stated that perhaps a method of priorities-could be worked out to fill existing gaps in knowledge. Mr. Cullman stated the governm--nt is spending money in aL-_t,ac.'r.ing the industry and the industry is spending money in attacking the posi- tion of the government and that it would be better to spend these funds on.research. F The Secretary said that in'connection with preparing the proposed budget of HEW, it would be helpful to have a specification of the areas of gaps in knowledge so that an evaluation could•be done to determine, among other things, the cost, who is available to do the research and the time required. It would then be helpful to determine what re- search could be done in the public sector and w:zat in the private sector. If the matter could be approached in this way it would be an indication of good faith andt tl~e ability -to work together in the future. Dr. Endicott stated that something in this area was already underway in view of in- dustry's participation in the Less.Hazardous Cigarette Working Group. Industry viexrpoint and information are being fed in to this Group which comprises good technical people. Their recommendations can be pr.esent-ed, to others in the industry.

I Mr. Ramm stated that'perhaps there is an area of ' .agreement between government and the industry in spite of a differing opinion as to whether lung cancer causation has or has not been proved. The industry is sponsoring reseqrch to see if there can be found an'=animal assay sys- tem as a means of determining wizether or not lung cancer is caused by smoki_ng. The government on the other, hand, starting with the assumption that smoking does cause lung cancer, is interqsted in finding the same kind of assay material for the purpose of determining.which elements in cigarette smoke should be eliminated to produce "safer ciga- rettes. Both the government and the industry are in this connection interested in the same type and kind of research, even though for different purposes, and it.should be possible ,, r r The Secretary stated that if there are areas of research which industry and NIH experts believe are not being developed rapidly enough perhaps'these could be discussed. HEjJ would try to get funds to conduct such research'and perhaps in- -dustry could assist in funding the expense. The Senator

. . ; The Senator •stated that if there is to be cooperation he thought it must be worked out on a policy level through Mr. Ranm stated that one of the difficulties with the ` Less' Hazardous Cigarette Working Group was its very na-ne, ~ since this implied that present cigarettes are hazardous-' and assumed a position contrary to that held by the industry. The Secretary said that there is no reason why the name can not be changed and asked what the group should be called. -He said it could be called Subcommittee B, if need be. Mr. Ramm stated that he was not in a position to sug- gest a name and that this was perhaps a matter for government determinati_on. Dr. Endicott stated that members of the industry could set their minds at ease about the Lung Catic~er Tasl~Force as probably this group will have only a few more meetings and then will be disb anded. He stated that in lieu of getting work done at medical schools he thought it would be advisable O to contract work'out and stated that efforts were already N .. C1' undertgay to have a competent contracting firm establish ~ itself in the Research Triangle in North Carolina in pr_ox-- N

• I imity imity with Dr. Kotin's operations there. Dr. Endicott thought that.this would not involve difficulties as it would be neCessary to contract work out in areas other than those in- Mr. Ramm inquired whether it would be possible to:arrange, ~ ' for a meeting of.the Scientific Advisory Board of CTR and the members of the conunittee administering tobacco and health research program of the AMA with representatives of NIII. Mr. Ramm stated that the SAB and the AMA committee comprise very outstanding men and the A,~LA Committee in addition to in- • cluding Dr. Kotin includes two members who wzre _Q:Z the Surgeon General's Advisory Comniittee. Mr. Raiitin pointed out that two of, the members of the SAB, including Dr. Loosli, were nrese:ltly in Europe exploring research being conducted in various centers there. The Secretary stated that he thouolt thati this would be possible 'and asked Dr. Endicott how it could be brought abou~. Dr. Endicott stated that he WOuld ask Dr. Baker to get in touch with the chairman of both the indus try groups and see what coul_d be done. , Mr.. -Cu.ll,nau stated that most of the industry had felt harassment by government and instead of harassment there

should be cooperative effort. He stated that he would like to pursue the other subjects suggested by the Secretary. only on one problem and that if any member present had any additional thoughts on today's discussion they were free to send him a note setting forth those thoughts. He said that if there was anything the industry wanted to say about the report that HEW submitted to Congress-last year, he would be glad to receive this information. However, any comments about the report should be submitted no later than June 1, since the staff was presently at work in preparing the re- port required to be submitted by July 1. ;The Secretary stated that today's meeting had touched The Senator inquired whether the Secretary would invite the industry representatives to the nekt.ineeting. The .Secretary stated the next meeting would be arranged on re- quest of the industry. '