Tobacco Documents Online

i r f by Har,unond and Horn of the American Cancer Society volunteers, and a study by Dorn of veterans and Canadian veterans. We had two studies in California-- one of members of the American Legion, whom we selected because their age was such that they were coming into the lung cancer period and also because we could have access. The second was carried out among several occupational groups. So we carried out two of the prospec- tive studies which along with five others were ultimately incorporated into the Surgeon General's report as the seven studies that were most compelling in relationship to cigarette smoking and lung cancer. Larry: You were doing the study on occupational and the smoking at the same time, integrating the two? Breslow: Yes. What we would do was interview the patients with lung cancer about their occupational backgrounds and about their cigarette smoking habits. The methodological advantage of the restrospective or case control type of study is that you can get information on several hy- potheses. In fact, we had a paper on this discussing the advantages and disadvantages of case control versus long-term studies. The advantage of the retrospective case control studies is that the patients already have lung cancer and you can ask them about cigarette smoking, other kinds of smoking, about occupational exposures, or any other factor that you may think worthy of investigation, and you can do this in the same investigation. It is no :norP--dfffi-cult- to--ask- a--€ewmori-quest#ons -once youtve got- to the person°-s - bedside, where this kind of study is usually carried out, and then find a . control and ask similar questions. So we were exploring the occupational hypothesis added in with the cigarette smoking hypothesis at the same time. In that study, we identified several occupations that we regarded as sus- pect and a positive factor in lung cancer. We, of course, also identified cigarette smoking as a factor. The second set of studies we did, the long-term prospective studies, involved assembling large scale populations of men in selected occupations. We went to the unions, to industry and:indicated that there was some reason to believe their occupation was a factor in lung cancer. So we carried out the study by getting from the unions or management the names of about 10,000 persons we could obtain and we simply entered them into our investigation, and ascertained subsequent mortality from lung cancer. There too, we were able to get information both about their particular occupations and about cigarette smoking. Larry: Was the executive branch supportive of this? Breslow: Executive branch of what? Larry: State government. Breslow: I don't think they were even aware of it. Larry: No problems then? Breslow: The only problem I remember was with one man who was a very prominent American Legioneer. He wrote to me expressing outrage that such a fool study was being carried out and that it was a waste of the taxpayer's money by the state, and what possible value could the maiden name of his mother be to any health study. I wrote back to him in a very nice way, enclosing another questionnaire'and also a copy of the California death certificate.\ I pointed out that the questions we had asked on the ques- (4) 1

ENDICOTT: Yes. I know they have a strong problem there now. I just don't know what the relationship is. Another thing that occurred which I think was of major importance was the establishment of IARC in France. ~ IARC) DEVRA: That was during your tenure? What particular stimulation did you give to this or did your office? DEVRA: And did you influence for example the mechanisms they developed for the studies that they did? ENDICOTT: Yes. I took a very active role. DEVRA: And the advisory committee set up and in the appointment of John Higginson?' ENDICOTT: Yes, I think I talked John into going. I played a very active role on the Board of Governors and so on. And tried to support him as best I could with NCI resources. DEVRA: In fact, in the beginning was a large part of their U.S. money NCI money? .r ENDICOTT: At the outset the basic contribution was the State Department. But we constantly supplemented that with contractual money and people. DEVRA: Is that still the pattern? ENDICOTT: I don't know. DEVRA: You're obviously very proud of that. Just about as proud probably as you are of the chemotherapy and national chemotherapy service center. (Carcinogenesis Regulation F, Management) ENDICOTT: Anyhow, I think it was the thing that needed happening and has a good purpose. I think as far as I know they are doing a good job. I kind of agree with "Satch" Page, the baseball player, "you should never look ba,ck, they might be gaining on you." So when I cut my ties, I really cut them.

, ~ a little in the public policy aspect, but the situation was such that we were pygmies compared to the industry and the prevailing attitudes and habits in Ar,.erica and other countries. Larry: Were you ridiculed? Did you find your views being ridiculed by public testimony? Breslow: I don't recall our being attacked on moral grounds, but the ciga- rette smoking industry began to respond quite early by forming a tobacco research council which did two things; one was to encourage the study of other factors in lung cancer, such as air pollution, etc. The other thing was to employ people like C.C. Little (and others) who did write polemics in the semi-scientific literature about the matter and ridicule it on scientific grounds. Further, they began to publish studies of others who began to look at the evidence critically and advanced notions as to why the evidence was not as compelling. Larry: Did you find that kind of combat f rustrating? Breslow: Oh no. I found it exciting. There were a Tot of statisticians in those days, and others, who began to point out alleged discrepancies in the evidence. I regarded it as an intellectual challenge and the thing to do was to bring forth more evidence and present it more compellingly. .• Larry: How about later when you came up against the intransigence of the industry? I take it your stronger feelings were reserved for those "scientists" whom you believed to sell out as opposed to the vested economic interests. You just figured they were playing their role and it was per- fectly understandable? Breslow: Yes. I can understand why the cigarette manufacturers would employ advertising agents and polemicists to espouse their point of view because that's the kind of society we live in. In example of the evolution of feeling, I recall seeing on television in the 60's, Elmer Hess, the urologist of Erie, Pennsylvania who was then the president of the American Medical' Association, smoking a cigarette while being interviewed by a news man and saying at the same time that cigarette smoking could not possibly cause lung cancer because he smoked cigarettes and he didn't have lung cancer. Approxi- mately one year after that television appearance, I read in 'a newspaper that Elmer Hess had died of lung cancer and I had a peculiar feeling about that. Larry: Graham died of lung cancer didn't he? Breslow: Yes, I knew Evarts Graham quite well. It happened early in 1952 when President Truman appointed the Health Commission on which Graham was appointed to be a member. I joined the staff of the Com- mission and became the study director and, in the course of that work, I had many conversations with Evarts Graham in and around the sessions. I recall his discussing the question of cigarette smoking and lung can- cer several times. We spoke of the medical student, Ernest Wynder, who I guess was still with him. I recall also that Evarts Graham had deeply stained fingertips from long exposure to tobacco in 1952. By that time he had quit smoking. i (6)

He was also at that time, like many of his colleagues, a very vigorous exponent of stopping cigarette smoking. Subsequently he died and the diagnosis was lung cancer. I think, however, that the histologic type of the cancer in his case opened some question as to whether it was associated with smoking. Larry: Did he have a lung removed? Breslow: I don't recall, but that can be no doubt ascertained from Wynder. Wynder would know the complete detail and he might be worth get- ting information from. Larry: Yes, I hope to meet with him over the Christmas vacation if he's out here. Breslow: That's right, he's supposed to be coming out here. Larry: If not, I'll catch up with him. Let's get into the politics of the "64 Surgeon General's report. Dealing with the public policy realm, what were your expectations and did you quickly have to adjust your expectations? From the beginning, did you not expect to get too far too fast? Breslow: I guess my expectations were always moderated by the knowledge and belief that we were going to have to contend with a mammoth,industry and the economic thrusts of that industry in American life. My recollection is that in the late 40's we became interested in the problem; and in the 50's I explored with other :colleagues of mine. Then in the later 50's and early 60's, the prospective studies provided the evidence that later came in. By that time, the Surgeon General's report came along. I recall testi- fying to the Surgeon General's Committee with Bill Cochran and other members of the group who were considering the evidence. That body had been carefully selected to eliminate all of those who had been caught ' up in investigating the situation themselves--everybody of any merit scientifically and involved had already come to some conclusion by that time. So the Surgeon General, in selecting a committee, had to pick people who were unbiased so to speak, which meant that they hadn't investigated the problem, so that their findings would not be subject to challenge by the industry. By that time, the early 60's, my feeling was that the time had come to mount a campaign against cigarette smo- king. I don't remember exactly when, but increasingly I moved in that direc- tion, like a lot of other people in the field did. By the early 60's we felt that the time had come to act. So we looked upon the Surgeon General's report, not so much as a scientific venture, although it was that--it was sort of a summary of the scientific work by a prestigou§ neutral body that could not be attacked because they had personally become involved with the studies-- it was looked upon, not so much as a scientific venture, but as a public policy venture. That would make possible, we felt--I felt and I think others shared this view--the development of public policy in the country. So that was the feeling that I had toward it when it was being developed in '63-64' and was published. And then we found that it could be used for that purpose. So from that point on, I was no longer interested in the investigative aspect of cigar- ette smoking and lung cancer, although increasingly interested in the relation- ship between cigarette smoking and other diseases. That became a matter of scientific investigation. But with regard to cigarette smoking, now the time had arrived to begin a public campaign against cigaretts smoking. (7)

! tionnaire were identical in form and arrangement with those on the California dea:h certificate and the purpose was to make it easy to identify the people who died so that we could study the relationship of death to the things we were asking about including cigarette smoking. Ne wrote back and said that he understood and he enclosed his questionnaire. Apart from that incident we had a little, but not very much resistance from the hospitals who were concerned with our talking with patients. Actually, we had very little resistance from the hospital systems. Larry: When you were working on all of this, were you truly struck by the potential enormity of the human tragedy that was involved? Breslow: Yes, I was struck by that curve. Almost every year one could see that it was still going up. In the late 40's and 50's it was the men, and then we became convinced that cigarette smoking was a factor but did not account for all lung cancer because at that time it was also overwhelming- ly clear that a certain portion was due to other environmental exposure, particularly occupational. Then we understood why it was that women did not have lung cancer; that was because they did not take on smoking on a large scale until the 40's, whereas men did so before 1920. Although there was then practically no indication that the curve was rising in women, we pre- dicted that there would be a rise probably in the 60's which was about 20 years later. Larry: In the early 50's, when you and your colleagues around the nation were coming to the same conclusions, was there a sense of despair or optimism about it? In other words, was the expectation positive? Breslow: In those days, my colleagues around the country expressed a feeling of excitement for the investigation. Here was a major epidemic of a new kind that man himself created and the evidence was'now coming that a truly massive epidemic in disease and major killer in men was bound to occur also in women. The feeling that I had in the early days of the 50's was that we've discovered something. The policy implications and such came more slowly. If you examine some of my earlier writings, you may find that my recollection is not completely accurate as to when we began to emphasize the public policy aspect, but I think that as early as 1951 I raised the issue of campaigning against cigarette smoking. How- ever, in 1951, it was only an idea to campaign against cigarette smoking as the evidence had to obviously be more compelling. Larry: Let's say that by,1955 when the consensus among those who cared was pretty clear, and you take that as an important date and then look at the history of the cigarette policy, you have really at least a ten-year hiatus before Congress addressed itself to the issue. J Breslow: I recall writing a paper in 1955 entitled "Occupations and Cigarette Smoking as Factors in Lung Cancer," published in the American Journal of Health. By that time, as you can see, I was quite convinced that cigarette smoking was an important factor in lung cancer. I think that was the word we began to use. We stayed away from the word "cause" because that was a word we realized as not being very acceptable in the scientific com- munity, so we emphasized it as being a"factor" or sometimes a "positive factor." In some earlier papers you would see such words as "association," "relation," "factor," "positive factor," and then "cause," which was sort of the evolution that I recall. To get at your question, by that time, many of us began to involve ourselves (5)

6 half-rate effort. I think we missed the boat in several areas. I don't think we did too brilliantly in the area of personal health services either. I guess it began when we lost "water", and then the "air" followed after that, and it wasn't too long 'ti1 there was an EPA. DEVRA: What do you think contributed to that sort of demise of authority, demise of responsibility? ENDICOTT: I don't know. I've often thought that it was petty squabbling between the engineers and the doctors. DEVRA: That's very depressing. What about the level of competence, in general, of the PHS to handle these major pollution and environmental problems? ENDICOTT: I don't think that was ever really tested because it wasn't until after it was split off that any decent regulatory legislation was written. DEVRA: In that sense then, it was a boon that it was split off? r ENDICOTT: Probably. DEVRA: What about the level of technical and medical competence now within that agency? ENDICOTT: I really shouldn't comment on that. DEVRA: Do you think that if it had remained more integrally a part of the PHS, regulatory powers would have come or not? ENDICOTT: Yes I think it would have. I think there is essentially concern over health issues that would have brought the regulatory power. I think it was our concern over pollution and that kind of thing. DEVRA: Were there people in Congress, specific Congressmen, Senators, who were in this fight or has it been a slow fight? ENDICOTT: No, I think it was largely or as far as I can recall, decisions made in the executive branch. r DEVRA: I was wondering how much influence people like Ralph Nader and others may have had on this? ENDICOTT: Really Nader came along later. DEVRA: Well some of this is Rachel Carson's period, too. ENDICOTT: Yes, I suppose if you had to pick one thing that happened, her book might have been the most important one single thing. I suspect that it was. DEVRA: Were there any other major policy achievements or program achieve- ments before we talk about the resource achievements? There all sort of mixed in.

i 5 an Now there was/unfortunate thing that happened later..... . And the tragedy hasn't played itself out yet. And that was that the decision to split off the National Institute of Environmental Health Sciences. Shannon • had appealed to me personally to help the thing off the ground, and I gave them a big hunk of NCI, including Paul Kotin, and a lot of people. DEVRA: Are they the people who went to the Research Triangle? Left the area? Were strictly attitudinally separated? ENDICOTT: Yes. Now the tragedy is that our toxicology capabilities through the PHS were fragmented. It's even more fragmented now because another mistake was made, that was to launch the FDA as an independent competitor. Now we have three. NCI, NIEHS, and the thing down in Arkansas. DEVRA: That's a piece of the FDA down there? ENDICOTT: Yes. DEVRA: Is it conceivable that there is constant duplication of effort? ENDICOTT: It's almost-certain. DEVRA: What about protection of the public as a result? Since one of these, at least, is a regulatory agency. ENDICOTT: There has been recognition of the problem. Under Ted Cooper's policy board there is a Toxicology Coordinating Committee that tries to coordinate their activities. But it's a mess. Somebody else will have to straighten that out one of these days. DEVRA: What do you think the consequences have been for the public at large? ENDICOTT: I think basically wasteful. Now then the task of defining the chemical risks in the environment is so.enormous that I don't think the great nations can afford to squander their resources in this area by having a myriad independent enterprises. I think this is one area in which some degree of international planning and sharing of tasks is in order. For us to have it fragmented, the way it is, and the U.S. to be alone in this? DEVRA: Are we considered the leaders in toxicology research, internationally? ENDICOTT: I think probably we are. DEVRA: But when it comes to management, we are not setting a very good example? ENDICOTT: We can do a lot better. Unfortunately that's the way it is. but with the spinning off of EPA, the health component of environmental concerns has been substantially weakened. Well, it serves us right. I don't think we were doing an adequate job in the Public Health Service. It was a I ! ;

If one would have had to deal with it and to deal with it effectively it would have to be economically: that is, combat the automobile, and not by exhortation--what wasn't done very much, but by building a good transit system. Well now, 20 or 30 years later we are getting around to the point that we have to have a rapid transit system. Too bad in America things are based so much on short range returns in industry, both to those who ire exacting a profit from industry and also those who are employed in the in- dustry. This leads to a poor quality of life, whether it's health or trans- portation. We have not yet arrived at the point socially in this country where planning is effective. Social values are always put second behind narrow, short range economic interests. Cigarette smoking is a very good example. The Los Angeles transport system is another good example. Larry: This is very useful. I appreciate this. If there is anything special that I may have forgotten,:.now would be a good point. Breslow: No, I think only to round out the thing, that I advocated at the First World Congress on Cigarette Smoking in New York City, I can't remember the exact year, that we would one day have to approach the matter economically. The sooner we got around to that the better. One day, the people determining public policy in the country, whether in politics or other ways of influencing public policy, would have to get around to the economic approach. I would still like to see th at. I will still advocate that as nationally the central thrust of endeavor. It's perfectly obvious that in the U.S. Congress, for example, there are just enough states, not very many if you count them, (one way three, another way six states and quite small states compared to California and New York), that hold up progress on the cigarette smoking issue because of their parochial, locally important industry. Until that issue is tackled and the Congress is willing to deal effectively with those few states, and their interests, then I don't think we are going to have very much progress. The Congress should come to the point of dealing with those states fairly. Their grandfathers, their fathers started out growing tobacco for cigarettes. You can't'blame them for becoming caught in an industry that is producing deaths. Larry:- I take it that you considered view is that in addition to the moral questions that might be involved, that approach would be a very cheap buy-out on our part. Breslow: Oh yes. Larry: I mean the amount that would be necessary to deal with any hardship would be very small, indeed, when compared to the economic savings if nothing else. Breslow: That's right. As a matter of fact, I am just now engaged in endeavor- ing to recruit someone to our school of public health who is particularly compe- tent and interested--a very serious petson--who would make this one of the central aspects of his work. If we are successful with that recruitment, I will be delighted. Larry: That would be great. Well, again this is very helpful. I will no doubt want to get back to you with some specifics that I may have omitted or documents that I may want to request. Breslow: My emphasis on the industrial and economic side--I don't mean in any way, however, to take away from my committment to education. Because I think we need to approach that as well. (9)

15a ENDICOTT: When Jim Shannon decided to transfer "cancer control" out of NIC and NIH, Rod Heller - Director of NCI - was strongly opposed to the move. He developed an organizational entity - The Field Investigations and Demonstrations Branch - to continue "cancer control" activities in NCI under the leadership of Ray Kaiser. When I succeeded Rod Heller, one of my first official acts was to abolish Ray Kaiser's Branch. I did so in order to get the activities back into the mainstream where more rigorous scientific standards could be assured and where the activities could feed out of the more generously financed "pots" of research and research training. The Branch contained a powerful intramural group in epidemiology and Biometry whose skills were urgently needed to develop better and larger efforts in research on etiology and prevention. Having had a favorable experience in the field of chemotherapy by combining intramural research with a big contract program, I decided to try the same thing in etiology and prevention first under Mike Shimkin and then under Paul Kotin.

DEVRA: Were they distressed since they were producing this? ENDICOTT• • Oh yes. They were distressed but so far as I could see they did not make any effort to suppress the evidence. In fact, I'm sure that he and Abbott took the initiative and carried the evidence to the FDA and laid it on a desk. He came and asked me what he ought to do, and that's what I advised him to do. DEVRA: Of course the battle is still going on. ENDICOTT• The research was his, and the credit is all there. (Aflatoxin) DEVRA: What about the aflatoxin one? What did your people do? ENDICOTT: There again the best one to talk to would be Paul Kotin. DEVRA: That happened while he was there? ENDICOTT• Yes. He provided quite substantial resources DEVRA: ...to the fish meal people? ENDICOTT: Yes. Ran the thing down, pinned it down as I remember it to peanut meal. Paul Kotin was in full charge of that. He kept me informed, but I wouldn't want to take any of the luster away from him. DEVRA: One thing I remember is that happened fast? ENDICOTT: It did, indeed. He can move fast and did. DEVRA: Faster in some ways certainly than some of these others that have been diddling around for the last 5 or 6 years. ENDICOTT: I really hated to see Paul leave. (Prevention) DEVRA: What role did the NCI during your leadership play in stimulating greater attention to mobilizing forces focused on prevention of cancer generally. We've talked a little about etiology, but beyond that, in the development of integrated, etiologic resources, what happened? ENDICOTT: From a resources standpoint, the main thing we did, I think, was internal and it really amounted-to putting dollars and space and slots into the area. I can't really point to anything. i 13 I