Tobacco Documents Online

THF. COl:NC1L FOR TORACCo RF.9F.ARC11-U.S.A.. INC. 7u.ruwr,nn n,or.n,twl InvUr,owrn,n ratings are then used to establish a priority ranking among the applications, which I. in consultation with the Council's scientific staff, apply in allocating specific grant awards. The SA0 is informed of the precise awards made by the Council. Most grant applications request a three-year period of support. Grants are awarded, however, for one year at a time. For the second and third years of a typical grant, the researcher must submit what we call a noncompeting renewal application. These applications are reviewed by two SAB members -- generally the same two SAH members who were the principal reviewers of the original grant application. The full SAB then votes whether to recommend the applications for approval. Some applications for grant support involve arean of inquiry about which SAB members believe they would benefit from consultation with experts and specialists outside of the Council in considering applications. In those occasional instances. meabers of the SAB recommend to the Council's scientific statf scientists or physicians who are knowledgeable on the particular subject; these individuals are then asked to assist in reviewing the grant 10 'I•l1E COUNCIL FOR TORACCO RF.REARCIi-U.S.A., INC. Yurn~nru.o Nowoncw,. invrwrmwrron application. These scientists are selected because of theif distinguished credentials and their particular expertise. . If, after Ne completion of the typical three-year grant cycle, a researcher wishes to receive further support from the Council for an extension of the same research project, he or she must submit a competing renewal application. Competing renewal applications are evaluated through the same process by which full original applications are evaluated. In evaluating grant applications, the members of the SIID bring to bear their understanding of the state of scientific knowledge in the areas covered by the grant proposals. The SAB members consider the results of previously reported research in any particular field, which might include research performed by Council-funded investigators, in evaluating whether a particular proposal is meritorious. The SAB does pp,t consider, for any type of grant application (original, noncompeting renewal or competing renewal), whether any of the investigator's prior research produced results thought to be favorable or unfavorable to the tobacco industry. Industry sponsors exercise no control over the decislon to fund a particular grant applicatlon or 11 i

u "~*t with respect to the publication of the results of any sponsored research. Selection of SAB Membere end Other Pe~~gqy~qvp_tp The Council selects for the SAB distinguished scientists who can bring cutting-edge expertise in various areas of biomedical research. The Council seeks to maintain a wide range of expertise on the SAB, so that the appropriate biomedical areas are represented in the grant application process. When a vacancy occurs on the SAB, the Chairman of the Cou.icil and the Scientific Director solicit from SAo members recommendations for a successor. As a general matter, the Chairman of the Council or an SAB member will contact individuals who have been recommended and ask them to attend an SAB meeting to give a prenentation on their research. After candidateu have attended an SAD meetLni, SAD membors arrd the Chairman of the Council will confec to see if there is a consensus to extend an Snvitation to Join the SAB. I am proud of The Council for Tobacco Research and my association with it. The Council has provided vital support to nearly 1,000 independent researchers. Its research program has played a key role in advancing our knowledge of diseases that have been associated with smoking. I thank the Subcommittee for this opportunity to present this brief picture of the Council and its contributions to biomedical research, and I am happy to answer any questions you may have. Mr. WAXMAN. Dr. Glenn, thank you very much for your testi- mony and for being here today. I appreciate your being here and since you are our only witness, if you need to take a short break at any time, let us know. We are going to go through some areas and give you the oppor- tunity to respond to some of these things that have been said and tell us more information about the Council on Tobacco Research. I find your comments about the Wall Street Journal article inter- esting. You didn't commeTlt to them before they did the article and then afterwards they had so many inaccuracies you didn't want to respond. This is your chance and we want to go through some of these is- sues with you. In recent months, we have begun the process of learning more about the tobacco industry. We still, however, need to know more about this Council on Tobacco Research. I want to go back over 40 years. In 1954, the major tobacco companies joined together in issuing a "frank statement to cigarette smokers", a copy of this statement is Exhibit 4, and excerpts of the statement are displayed on the chart, which we would like to have displayed. Are you familiar with this statement? Mr. GLENN. Yes, sir. Mr. WAXMAN. You know at the same time the companies created the Tobacco Industry Research Council, the previous name for your Council for Tobacco Research. Mr. GLENN. Yes. Mr. WAXMAN. I released the staff report today on Hill and Knowlton documents, which were written from 1954 to 1956. These documents provide considorublo insight into the founding of your Council, and I would like to ask you some questions about these documents. In 1953, there was tremendous public interest in the hazards of smoking. In that year, for instance, Dr. Winter of Sloan-Kettering published a major study showing that mice painted with tobacco tars developed fatal cancers. A copy of this report is Exhibit 1. The Sloan-Kettering report received significant public attention at the time. Are you aware of this report? Mr. GLENN. Yes, sir. Mr. WAXMAN. The tobacco industry was very concerned about the Sloan-Kettering report and other similar work coming out in the early 1950's. In fact, on December 15, 1953, an unprecedented meeting of the CEO's of the major tobacco companies took place to respond to these reports. Are you aware of that meeting? Mr. GLENN. Yes, sir. Mr. WAXMAN. I have a memorandum written by Bert C. Goss of the public relations firm Hill and Knowlton as Exhibit 2. Mr. Goss and the founder of Hill and Knowlton, John Hill, attended the De- cember 15 meeting. Mr. Goss' memorandum memorialized what happened. Aro you familiar with his momorandum? Mr. GLENN. I think I am, Mr. Waxman. Mr. WAXMAN. This memorandum is crucial in understanding the strategy of the tobacco industry. In attendance at the meeting were paul Hahn, president of the American Tobacco Company; Joseph J

358 Cullman of Benson & Hedges; Parker McComas, president of Philip Morris; Whitney Peterson, president of U.S. Tobacco. According to the memorandum, the meeting is the first time these CEO's ever met out of a social context. They are taking this extraordinary step because they agree that the health criticisms are extremely serious and worthy of drastic action. At the meeting they agreed that what is needed is not more science or research but a public relations campaign to counter the mounting evidence of the adverse health effects of smoking. In their own words they decide they should sponsor and I quote, "A public relations campaign which is entirely pro-cigarettes." The plan of action is fleshed out in another Hill and Knowlton memorandum written just 9 days later. This is Exhibit 3, entitled "Preliminary Recommendations for Cigarette Manufacturers." In this memorandum, Hill and Knowlton recommends that your organization be created for explicitly public relations nonscientific purposes. Are you familiar with this exhibit? Mr. GLENN. No, sir. Mr. WAxmAN. The memorandum states and I quote, "The under- lying purpose of any activity at this stage should be reassurance of the public...It is important that the public recognize the exist- ence of weighty scientific views which hold that there is no proof that cigarette smoking is a cause of lung cancer." The memorandum goes on to recommend that to achieve this public relations purpose, the industry should create the Council for Tobacco Research-then called Tobacco Industry Research Commit- tee; and the memorandum further recommends that the very first action of the new organization should be the assurance of a frank statement, like that we talked about earlier. As you can see, your organization was not thought up by sci- entific researchers who perceived a need to know more about health effects of tobacco, it was dreamt up by the public relations experts who perceived the need to calm public fears. It is not fair for me to ask you if you are familiar with all the documents in this subcommittee report. You have not had a chance to study them all thoroughly. Instead, I want to describe for you some of the early activities of the Council for Tobacco Research. I will describe these activities and ask you a simple question, are these activities scientific in nature-as you say is the devotion and goal of the Council-or are these public relations activities? Let me begin with a simple matter of staffing. According to these documents, the Council for Tobacco Research hired 23 public relations experts from Hill and Knowlton in 1954, its first year of operation, and 35 public relations experts from Hill and Knowlton in 1955, which would be its second year of operation. Can you explain why a small organization that is supposed to be purely scientific needs to employ the services of 2 to 3 dozen public relations experts? Mr. GLENN. Mr. Waxman, on the basis of my knowledge I would have to reject that. The Council for Tobacco Research has been the research arm not the public relations arm for the tobacco industry. Mr. WAxmAN. Well, we have Exhibit 10 which shows the budget of the organization at that time. It indicates the charges paid to 359 Hill and Knowlton, which of course no one would argue is a sci- entific organization. This was before you were there at the Council. At that time, they were spending money on 2 to 3 dozen public relations experts. According to these documents, one of the activi- ties of the Council was to turn obscure research findings that were favorable to the tobacco industry into headline news around the country. A good example of thig is Exhibit 13, a confidential public rela- tions report on the activities of the Council and I want to read to you from page 6 of this report. "A report from the New Zealand public health official, published in a British medical journal, attrib- uted the increase in lung cancer incidence to air pollution and not to smoking. Advance information of the date of publication was ob- tained from contacts in New Zealand and England when it ap- peared and it was brought to the attention of the United States press. Stories and editorials on it appeared in many newspapers." Dr. Glenn, is this activity, encouraging the media to write stories about obscure research favorable to the tobacco industry, a sci- entific activity or public relations activity? Mr. GLENN. Mr. Waxman, my answer to that, I have to tell you that in 1954 1 was in the Korean War as a flight surgeon so I may not be au courant with what was happening in the press at that time. I will say that these documents were not made available to me until this young man began passing them here to the witness table. So I really haven't had a chance to review them and I have had no opportunity to develop any response. This is ancient history and I really cannot verify it one way or the other. Mr. WAX1vtpN. Well, I am asking you from the documents I have described, and I have acknowledged the fact that you were not there, if the Council were working on encouraging writers of news- papers to cite obscure scientific articles and they were trying to get favorable articles written, would you consider that, what I have just described, as scientific research activity or public relations ac- tivity? Mr. GLENN. I appreciate the way that you have phrased the question. I was not there. But I can tell you that the Council for Tobacco Research and its research arm have been directed by a Sci- entific Advisory Board of very distinguished people from the begin- n 7. r. WAxmAN. But I am asking you to answer for me whether you consider the activity I described for you scientific in nature or pub- lic relations in nature? Mr. GLENN. Mr. Waxman, the activities of the Scientific Advisory Board and the Council for Tobacco Research have always been dedicated to science. Mr. WAXMAN. Let me- Mr. GLENN. Whatever activities that may have been accom- plished by Hill and Knowlton are beyond my knowledge or recollec- tion. Mr. WAxmAN. Hill and Knowlton was paid a substantial amount of money by the Council. According to these documents, another ac- tivity of the CTR was to commission free-lance authors to write fa- .

C ovV vorable articles about cigarettes. These articles would then appar- ently be published under the name of the free-lance author with no acknowledgment of the link to the Council. For instance, Exhibit 9, a report on tobacco industry research committee information activities contains this entry on page 4, "C.B. Colby, free-lance popularizer of science was retained for re- search and possible writing of articles concerning all the hazards of modern life which people are cautioned against and leading to the conclusion that in spite of all the death scares, you still live longer." Is hiring a free-lance popularizer of science urging people to ig- nore death scares a scientific inquiry? Mr. GLENN. That is beyond my knowledge, as you must know. I notice this memorandum, however, is an internal memorandum of Hill and Knowlton. They, indeed, are a public relations firm. But they were independent of and separate from the Council for To- bacco Research to my knowledge. Mr. WAXMAN. I dispute that. We will move on to other Members who have questions and we will come back to some of these points. Mr. Bliley. Mr. BLILEY. Dr. Glenn, could you identify those who serve on the CTR Scientific Advisory Board, what their background is? Mr. GLENN. Yes, sir. Let me go to my notes lest I miss somebody. The Scientific Advisory Board consists of at the present time 15 very distinguished individuals; alphabetically they are, Dr. Leo G. Abood, professor of Pharmacology and Biochemistry at the Univer- sity of Rochester; Dr. Barry G. Arnison, chairman of the Depart- ment of Urology and director of the Brain Institute at the Univer- sity of Chicago; Dr. Drummond Bouden, chairman of the Depart- ment of Pathology, University of Manitoba; Dr. Michael Brennan, director emeritus of the Michigan Cancer Center in Detroit; Dr. Carl O. Croci, director of the Thomas Jefferson Cancer Center, Thomas Jefferson University, Philadelphia; Dr. Raymond Erickson, professor of Molecular Biology, Harvard University; Dr. Joseph Feldman, professor of Immunology and research director emeritus at the Scripps Institute in California; Dr. Gordon Gale, professor of Medicine and Endocrinology at the University of California, San Diego; Dr. W. K Yaclick, professor and chairman of the Depart- ment of Microbiology at Duke University; Dr. Manfred Carnofski, professor of Biochemistry, Harvard University; Dr. Henry Lynch, Creighton University, director of the Department of Preventive Medicine, and the same Lynch to whom I referred previously who is responsible for our most recent understanding of genetic disease for-as the basis for cancer;' Dr. Harmon McAllister, a biochemist and our current scientific director, also a member of the board; Dr. Barry Pierce, chairman emeritus of the Department of Pathology, University of Colorado; Dr. Judith Swain, professor of Medicine, di- rector of the Division of Cardiovascular Disease and Medical Genet- ics at the University of Pennsylvania; and Dr. Peter Vote, formerly chairman of the Department of Microbiology at the Universicy of Southern California, now director of research at the Scripps Insti- tute. ^1 Mr. BLILEY. Isn't the role of the CTR's Scientific Advisory Board comparable to the role of similar advisory boards? Mr. GLENN. Yes, sir. Mr. BLILEY. To your knowledge to what extent have the member companies attempted to influence the research activities of the Sci- entific Advisory Board? - Mr. GLENN. They have never attempted to influence our activi- ties in any way to my knqwledge. Mr. BLILEY. How long have you been in your present capacity? Mr. GLENN. In my present capacity 5 years, 4 years, but associ- ated with CTR for 7 years. Mr. BLILEY. There have been some recent criticisms of CTR largely arising from the Cipollone case. Before the plaintiffs law- yers and the media began their criticisms, there was an interesting article that appeared in the July 1985 edition of the New York State Journal of Medicine, the article quoted among others, Joanne Shellenback, the Director of Press Relations with the American Cancer Society in New York. She said of CTR and I quote, "They are legitimate. We are very critical of the tobacco industry in terms of their advertising prac- tices and many of the things that they do but here is an area where they seem to be doing something by the book in promulgat- ing good research. So I can't criticize them across the board." Do you think that CTR has been unfairly criticized recently? Mr. GLENN. Yes, sir, and I think it is by inference that we are supporting smoking which is certainly the furthest thing from the truth. We are an independent agency, we have the respect of medi- cal investigators and institutions across the country and through- out the world. We are regarded as a good source of funding particu- larly for young people with fresh new ideas and approaches to the questions of basic biomedical investigation that are so fundamental to our understanding of cancer, cardiovascular disease, and others. I think the statement from the American Cancer Society is en- tirely in keeping with the reputation we hold in the medical com- munity. Mr. BLILEY. You mentioned In your written oral statement that three researchers funded in part by CTR have received Nobel prizes in physiology on medicine. Could you name them? Mr. GLENN. Yes, sir. I think I mentioned Dr. Stanley Cohen of Vanderbilt University for his work with epithelial growth factor. The second was Dr. Barry Nazerath of Harvard University, who really was the father of modern molecular biology. And the third Nobel prize winner was Dr. Harold Varmus, currently the Director of the National Institutes of Health. Mr. BLILEY. Beyond the three researchers funded in part by CTR that have received Nobel prizes, can you qive this subcommittee some idea of the quality of the research which has been funded by CTR? Mr. GLENN. Well, I think the quality speaks for itself. As you pe- ruse the annual reports you will see that we have moved to the cutting edge of basic biomedical research. I think the quality is tested by some of the examples I gave in my opening statement of individuals who have made major breakthroughs in our under- standing of basic disease process.

i However, you must understand that our review process and the selection of grantees to be supported is a very critical mechanism. We receive well over 1,000, close to 1,200, inquiries and applica. tions per year. We are able to fund only a minute portion of those total inquiries and applications. So we are really-we really are picking the cream of the crop it would seem. I think our judgment has been borne out by the succession of the investigators. Mr. BLILEY. What is the publication policy of CTR? Mr. GLENN. We encourage all investigators to publish everything that they wish to publish. We have never discouraged publication. I would cite as an example the fact that we were approached by Dr. Edward Campbell of the University of Utah recently. Dr. Campbell is one of our grantees and he is working on the problem of emphysema. He has identified a genetic defect that leads to an alpha 1 antitrypsin deficiency and in those individuals perhaps represent- ing some 3 to 5 percent of patients with emphysema, this enzyme deficiency predisposes them to emphysema. He inquired of us whether he should publish these results, and we said, most certainly you should publish those results. Those are the individuals who are most susceptible to emphysema and cer- tainly those who should be kept away from the risk factors such as smoking. Mr. BLILEY. There has been recent criticism that the research funded by CTR doesn't have anything to do with cigarette smoking and health. Does your experience support this criticism? Mr. GLENN. No, sir, we are supporting very fundamental re- search into molecular and cellular biology, genetics and immunol- ogy which are the fundamental questions that must be answered before we can address questions of therapy and social habits. Mr. BLILEY. It has been claimed that research has been chan- neled or funneled into CTR special projects so that adverse results could be suppressed from publication by claiming that they were subject to the attorney-client privilege. I understand that many publications resulted from CTR special projects. I also understand that all of the privileged documents were reviewed by speciall master Joel A. Persono who was ap- pointed by Judge Sarokin and who later became a United States magistrate judge. In the special masters report he states, and I quote, "The research projects themselves were conducted by inde- pendent scientists affiliated with a variety of academic and re- search institutions who were not applied by or related to the to- bacco industry. These researchers were permitted to publish the re- sults of their research with credit given to the CTR." Is that consistent with your understanding? Mr. GLENN. Yes, sir. Mr. BLILEY. I also understand that some researchers who re- ceived CTR special projects funding were co-funded by other fund- ing agencies and that a lot of this research waa published in peer review journals and acknowledgment to special project support was re9uested; is that right? Mr. GLENN. Yes, sir. I would point out that special projects were projects that were desirable for our sponsors. However, our sci- entific director reviewed these projects for scientific accuracy, for methodology, edghe CTR then served merely as the funding agen- cy for such projt However, your first-initial statement is correct. Some 250 peer- reviewed articles were published as a result of the various special projects that were accomplished. Mr. BLILEY. Some of what people are claiming here today doesn't make sense. If a researcher was being funded by both the Federal Government and a CTR Vecial project grant, how could CTR pre- vent publication? Mr. GLENN. We couldn't, Mr. Bliley. You can't prevent a bio- medical investigator from doing anything he wants to do. He cer- tainly will publish at his discretion. We wouldn't presume to tell him not to publish. On the contrary, we have encouraged publica- tion. Mr. BLILEY. Would you submit a list of publications and presen- tations which are believed to have resulted from CTR special projects for the research? Mr. GLENN. Would I submit such a list? Mr. BLILEY. Obviously, you can't do it today but the record will be open, and I am sure the Chairman will keep it open for that. Mr. GLENN. It is available to you, Mr. Bliley. We have submitted our annual reports for the last 30 years, which I am sure that much of it to people who are in different professions and even to me on occasion must look like Greek, but I think if you will ask competent biomedical investigators, authorities in the field to re- view the research reported in these annual reports you will see the very high quality of the research that has been done. Mr. WAxIvIAN. Will you submit to this committee for the record a list of all the research funded under the special projects? Mr. GLENN. Yes, sir, we will cooperate with you in any way. [The following information was received:] As I explained in my testimony, Council Special Pri, ects were research projects that the Council's sponsors wished to fund. Tr. at 46. These research projects were funded by the sponsors, and were administered by the Council, separately from the grant-in-aid program. We have ppared a list of all Council Special Projects for which the Council has a file. That listre includes the following information for each such project (where such information is available from the Council's files or from published sources): (a) the name of the principal investigator or investigators; (b) the institution or institutions With which the principal investigator or investigators were associated; (c) the title or subject matter of the Council Special Project; (d) the dates of funding of the Council Special Project; (e) the total amount of funding provided by the Council; and (f) a list of the publications that apparently resulted, or may have resulted, from the Council Special Pro,'eet Some of the publications identified on the list appear in the Council a Special Projects files; others have been collected from other sources. In a number of instances, it is not clear whether a particular publication resulted from Council Special Project funding. My statement at the May 26 hearing that 250 peer-reviewed articles are believed to have resulted from Council Special Projects was based on my information about the number of publications that either were in the Council's files or have been col- Icctcd from other sources. Several clnriffcations should be made to that statement FIrst, our list scts forth over 400 articles or presentations that resulted or may have resulted from Council Special Projects; so far. I understand, copies of about 250 of these articles or presentations have been obtained, and that underytanding was the source of my statement at the hearing. Second, most but not all of these 250 articles or presentations were peer-reviewed. Third, abstracts relating to Council Special Projects publications were not included in the Council's Annual Reports. We expect to provide this list to you promptly after we have reached an under- standing with the subcommittee staff with respect to procedures for the subcommit-

I n i E tee's handling of such materials provided by the Council. In the interim, I respect- fully request that this letter be included at pages 47 and 106 of the May 26 tran- script. Mr. WAXMAN. Thank you. Mr. BLILEY. Thank you, Mr. Chairman. Last question, Mr. Chairman, if I may. I further understand the documents related to CTR special projects research including proposals, interim reports, final reports, and publications have been produced to plaintiffs counsel in discov- ery in some cases. Is that correct? Mr. GLENN. That is correct. Mr. BLILEY. Thank you, Dr. Glenn. Thank you, Mr. Chairman. Mr. WAXMAN. Thank you, Mr. Bliley. Mr. Synar. Mr. SYNnrt. Thank you, Mr. Chairman. Welcome, Dr. Glenn. Let me go back to something Mr. Waxman was questioning you about. The Wall Street Journal on Thursday, February 11, stated the Council's role has never been just research and it was largely a creature of Hill and Knowlton, the public rela- tions firm. Do you deny that? Mr. GLENN. Yes, sir. Mr. SYNAR. How does that square with the fact that in a 1954 memo, Exhibit 10 in front of you-do you have it? Mr. GLENN. Yes, sir. This is the first time I have seen it, Mr. Synar. Mr. SYNAR. All right. That is interesting, Dr. Glenn. Usually when you take over a cor- poration as someone who is going to run it, one of the first respon- sibilities is to learn the history of the corporation and to learn the corporation's inner workings over the years. You are telling us you have not taken that time to do that? Mr. GLENN. Mr. Synar, I have taken over a number of organiza- tions in my career and I am well aware of the procedure. This is a Hill and Knowlton internal document. Mr. Sntax. But it is from the founder of Hill and Knowlton to the chairman of the CTR. The paragraph says, attached are budget estimates for oper- ations of the Tobacco Industry Research Committee during the cal- endar year 1955, which would be the first year of its creation. Then it goes into the next paragraph, as you can see, the budget for the staff operations provides for 35 different staff members of the Hill and Knowlton Corporation. Now, doesn't that fly in the face of your answer to Mr. Waxman that the Hill and Knowlton operation was separate from CTR, since the budget shows that it was fully funded by CTR? Mr. GLENN. Mr. Synar, I am not sure of the thrust of your ques- tion. Mr. SYNAR. Were you- Mr. GLENN. Hill and Knowlton documents are hot in our files. Mr. SYNAIt. The point is Hill and Knowlton was basically CTR, were they not? Mr. GLENN. No, sir, on the contrary from the beginning CTR was composed of independent scientists serving on a Scientific Advisory Board. Mr. WAxMAN. If you would yield to me, that document was writ- ten to the head of the Council for Tobacco Research. I don't. know why it wouldn't be in your files, but it was written by Hill and Knowlton to your committee and I presume paid for by the Council. Mr. GLENN. Mr. Waxmon, I think you are presuming a lot. This is a confidential memorandum internal to Hill and Knowlton. It mentions the CTR but it is not in our files and there was no way I can know that nor do I know who paid for this. Mr. WAxMAN. This one does not indicate that it is confidential. Mr. GLENN. I am sorry. Mr. WAXMAN. It doesn't indicate- Mr. GLENN. Are we looking at Exhibit 9? Mr. WAxMAN. No, 10. Mr. SYNAR. Exhibit 10. Mr. GLENN. Again, I can't speak to this because I have never seen it until this moment, but it would appear to me to be a Hill and Knowlton internal document. Mr. WAxMAN. Would you confirm for us that Mr. Timothy Hart- nett was the chairman of the Council for Tobacco Research? Mr. GLENN. I can't confirm that to you, no, sir. Mr. WAXMAN. Have you ever heard of him? Mr. GLENN. No, sir. Mr. WAxMAN. You never heard of him. OK. Mr. Synar. Mr. SYNAR. Dr. Glenn, you are proud of your scientists on your board. Have any of these Nobel prize winners done research in the area of tobacco or how it affects health? Mr. GLENN. The Nobel prize winners? Mr. SYNAIt. Yes, that serve on your board. Mr. GLENN. The Nobel prize winners that I mentioned, Mr. Synar, are former grantees of the Council for Tobacco Research. Mr. SYNnIt. Let me move on. A review of the Council- Mr. WAXMAN. Just before we go too far I do want to indicate for the record that the annual report, 1963-1964, from the scientific di- rector of the Council for Tobacco Research indicates that Timothy V. liartnett is the chairman, W. T. IIowe is the executive director, and Clarence Cook Little is the scientific director. Mr. GLENN. I was not aware of Mr. Hartnett. Doctor-Clarence Cook Little was the first scientific director, very distin •uished man, president of the University of Minnesota, founded thear Harbour Library, credited with establishing the basis for fundamental lab- oratory animal research. Mr. WAxMAN. I am sure Mr. Hartnett was also quite distin- guished. He was chairman of the Council and did receive that memo from Hill and Knowlton. Mr. Synar. Mr. SYNAR. Dr. Glenn, answer my question, did any of these grantees, the Nobel ~rize winning crew, do research on tobacco and how it affects health. Mr. GLENN. Mr. Synar, every one of them has done fundamental research to help us understand underlying disease process. t~ t bib,.

Mr. SYNAR. I didn't ask you that. Mr. GLENN. I know you didn't ask me that, Mr. Synar, but what you asked me was very naive. Mr. SYNAR. Did they do research in tobacco research and how it affects health, yes or no? Mr. GLENN. Yes. Mr. SYNAR. Will you provide that for the record? We would like to see it. Mr. GLENN. I would be glad to provide the papers published by these Nobel prize winners. Mr. SYNAR. In the area of tobacco and how it affects health. [The following information was received. Documents referred to hereinafter in these responses have been retained in subcommittee files.] As I testified on May 26, the Council has funded three investigators who have won Nobel Prizes: Dr. Baruj BenaceralT of Harvard University, Dr. Stanley Cohen of Vanderbilt University and Dr. Harold E. Varmus of the University of California at San Francisco. Dr. Benaceraff, who was awarded the Nobel Prize in 1980, received a Council grant from 1972 through 1974 for investigating "Control of Specific Cellular and Hu- moral Immune Responses to Neoplastic and Non-neoplastic Tissues." Item A in the Appendix•includes three publications acknowledging the Council's support of Dr. Benaceraffs research. Dr. Cohen, who was awarded the Nobel Prize in 1986, received a Council grant from 1987 through 1993 for investigating "The Role of Lipocortin in the Cellular Re- sponse to EGF." Item B in the Appendix includes six publications acknowledging the Council's support of Dr. Cohen's research. Dr. Varmus, who was awarded the Nobel Prize in 1989, received a Council grant from 1984 through 1986 for investigating "Functional Analysis of Cellular Oncogenes Activated During Tumorigenesis." Item C in the Appendix is a publica- tion acknowledging the Council's support of Dr. Varmus' research. As I explained to the subcommittee on May 26, the Council-funded research by these Nobel laureates was basic biomedical research aimed at improving our under- standing of fundamental disease processea-which is the kind of research that is now believed to further scientific understanding of the effects of tobacco use on health. Dr. Benaceraff conducted pioneering research into the humoral immunological response of the host when presented, attacked or Invaded by can- cerous vowths. His work has provided important insights into how regulatory mechanisms may operate in defense of the host organism. Dr. Cohen etudi.ed cell growth factors and their role In regulating growth and ditferentietton. His investiga- tion oC genetie wntrola of growth factors opened the door to our understanding of meehenisms by whieh normal cells beeome eancerous. Dr. Varmus pioneering work with oncogenes made importent eontributione to our ovcrell underotanding oC how healthy cells beeome transformed into cells that can no longer control their growth and therefore become cancerous. Mr. GLENN. Mr. Synar, one does not have to specifically inves- tigate tobacco as a product- Mr. SYNAR. Dr. Glenn, you just said under oath that they did have expertise in research in tobacco and health-related issues with respect to tobacco. Is that correct? Mr. GLENN. Fundamental understanding of basic cellular and molecular biology is the basis for understanding scientific truth which will then let us understand the specifics of a vehicle such as tobacco. Mr. SYNAR. That is a very convenient way to say that they are not conducting tobacco-related research, isn't it, Dr. Glenn? Mr. GLENN. No, Mr. Synar, it is not. VVI Mr. SYNAR. Let's go on to the review of the Council for Tobacco Research published in the July issue of the American Journal; Ex- hibit 19, if the staff will provide that to the Doctor. Doctor, let me quote from Exhibit 19 from the American Journal. "Most of the CTR-funded grant supports biomedical research not related to health consequences of smoking. In a recent survey of principal investigators ft knded by the CTR grants in 1989 almost 80 percent of the respondents indicated that none of their research, current or past, examined the health effects of smoking. "Furthermore, the vast majority of industry-supported research that addressed the health affects of smoking produced findings con- sistent with the Surgeon General's conclusion that smoking is a major cause of numerous diseases." Are you aware of those findings, Dr. Glenn? Mr. GLENN. I am aware of Dr. Warner's article. Mr. SYNAR. Do you agree with the central conclusion? Mr. GLENN. What is his conclusion? Mr. WAXMAN. The conclusion that the CTR research is not relat- ed to the health consequences of smoking. Mr. GLENN. What was the- Mr. SYNAR. That is what the statement is, that the CTR research is, quote, "not related to the health consequences of smoking." Do you agree with that? Mr. GLENN. No, sir. Mr. BLILEY. Can these documents be made available to the mem- bers? We don't have them. Mr. WAXMAN. We will get them to you immediately. Mr. SYNAR. Do you know Dr. Brennan? Is he not a member of your Scientific Advisory Board? Mr. GLENN. Yes. Mr. SYNAR. In an article, "Pack of Lies", a BBC documentary, Dr. Brennan is quoted as saying that during his service on the Sci- entific Advisory Board, "very little of the CTR research is related to determining the relationship of smoking to ill health." Dr. Brennan goes on to say in this BBC documentary that, "cer- tainly less than Vio of the funds awarded are awarded for the sci- entific study of tobacco-related effects." Is Dr. Brennan correct? Mr. GLENN. He is correct in the sense that we-I have spent mil- lions of dollars in the past in supporting studies where experi- mental animals were exposed directly to tobacco smoke and that sort of thing. It was very unrewarding. As the Surgeon General's report will point out to you, there has never been an instance in which lung cancer was observed in animals exposed to intense to- bacco smoke. It was an unrewarding avenue of research and we focus now on molecular and cellular aspects, as I have explained. That is what Dr. Brennan was alluding to. Mr. SYNAR. So the quote that, certainly less than one-tenth of the funds of the CTR awarded are awarded for specific study of to- bacco-related effects; you are saying only 10 percent of the budget has anything to do with tobacco? Mr. GLENN. When he says specifically related to tobacco prod- ucts, he is talking about research with nicotine, talking about-

Mr. SYNAR. No, he didn't say specific tobacco-related products, he said tobacco-related effects. Mr. GLENN. That would include nicotine. Mr. SYNAR. Are you familiar with your Council report of 1993? Mr. GLENN. I am. Mr. SYNAR. Out of the 296 studies in your index, where you fund- ed about $19.5 million in grants; as I see from the index or.Jy 10 or about 10 of the projects have anything to do with tobacco. Do you dispute that? Mr. GLENN. No, sir. Mr. SYNAR. So you don't devote much research to cigarettes or the death of the 434,000 Americans a year, do you? Mr. GLENN. Because, Mr. Synar, medical research in general has taken the turn towards basic fundamental understanding of cell regulation and deregulation. Until we understand these processes, we cannot explain any diseases. And our research is at the fore- front, along with that of the National Cancer Institute and the Na- tional Institutes of Health and the various other private funding agencies. Mr. SYNAR. Dr. Glenn, has the Council for Tobacco Research con- ducted vr financed research that has found that smoking cigarettes or using oral tobacco increases the likelihood of a person developing lung cancer or heart disease? Mr. GLENN. I didn't hear your question, sir. Mr. SYNAR. Has the CTR conducted or financed research that has found that smoking cigarettes or using oral tobacco increases the likelihood of a~person getting lung cancer or heart disease? Mr. GLENN. Yes, sir. Mr. SYNAR. Will you provide that for the committee? Mr. GLENN. Yes, air, it is provided in the annual reports that you already have at hand. Mr. SYNAR. Dr. Glenn, has the Council for- Mr. WAxMAN. Just a moment, we want to receive specifically fr ~eywill hold the rrecord op ns butf we want a specific r spo se to that question. Mr. SYNAR. You will provide that full report? Mr. GLENN. Yes, sir. [The following information was received:] At the hearing, I was asked about studies funded by the Council that found that tobacco use increased the likelihood of disease. With all due respect, this request is extremely naive, and therefore very difficult to respond to meaningfully. Modern scientific studies into the etiology of chronic diseases typically focus on narrow ques- tions, the answers to which contribute to a broader understanding of disease proc- esses. However, ae a general matter, each such study, standing alone, does not atate that smoking does or does not make the chronic disease more likely. The reported research findinge have implications for the relationship between smoking and dis• ease that are far more subtle, complex and cumulative. Conaequently, in many instances, it is difficult to determine-and it ultimately iq a subJCcllve tnatter--w}retlrer a publicntknr In d-;mnad lo havn foturd nn iucrcanrd likelihood of disease. Indeed, I believe that any two persona who might review Ulc full set of publications resulting from the Council's grants in response to this re• quest would come up with different sets of documents. As I stated on May 26 in response to this request, abstracts of publications resulting from CTR grants and contracts have appeared in the Council s annual reports, and we can make the pub- lications themselves available to the subcommittee for its review. With these qualifications, we are providing in the boxes marked "Box I" and "Box 2" copies of over 375 publications resulting from Council-funded research that could be considered to indicate that tobacco use may increase the likelihood of developing diseases or conditions that have been associated with smoking. (These documents were selected from the Council's files of publications resulting from Councilgr ante. Those files are not complete since not all publications have been provided by the researcher or located in the Council.) We have used our best efforts to compile for the subcommittee a complete set of such publications, in light of the difficulties re- ferred to above. In addition, yls order to reduce the burden on the subcommittee, we are not providing copies of publications that simply rely on or refer to previous re- search findings associating smoking and diseases, and in a number of instances we are not providing copies of publications that are preliminary to, or repetitive of, pub- lications that are being provided. Mr. SYNAR. Dr. Glenn, has the CTR conducted or financed any research into the matter that nicotine is addictive or has an addict- ive quality to it? Mr. GLENN. We have sponsored a very large amount of research into nicotine. We have been very concerned about the question of addiction. We have funded researchers who have established the habituation of nicotine. We have not been able to establish addic- tion. Indeed, we asked Dr. Jerome Jaffe, Director of the Addiction Center at the National Institute of Drug Abuse to address our Sci- entific Advisory Board on this question in 1989. Dr. Jaffe and our Scientific Advisory Board had a lengthy exchange. Dr. Jaffe was unable to assign properties of addiction as they are classically defined to nicotine. We have continued to pursue the question and are doing so now. Indeed, a large part of this conference that is taking place here in Washington today deals with nicotine and nicotinic receptors. I think the committee should know that the central nervous system, the function of the central nervous system and myoneural junctions depend upon two sorts of chemical receptors. They are classified as muscarinic and nicotinic. Perhaps the word "nicotinic" is unfortunate but nicotine and nic- otine analogs we derive from the various foods that we eat, to say nothing of nicotine that might be in tobacco is critical to normal neural function in the human being. Mr. SYNAR. Just a couple things on that very one point. Dr. Jaffe is a member of the National Institute on Drug Abuse that did find that nicotine is addictive, is he not? Mr. GLENN. Dr. Jaffe is-was at the time he appeared before us the Director of the Addiction Center for the National Institute of Drug Abuse. Mr. SYNAR. All right. Now beyond Dr. Jaffe, let me repeat this question very clearly. Have you conducted or financed research that has found nicotine is addictive or has an addictive quality to it? Mr. GLENN. We have definitely established that there is habituation to the use of nicotine. We have not established addic- tion. Mr. SYNAR. Will you provide for the record all of the reports and studies with respect to nicotine and its addictiveness? Mr. GLENN. Yes, sir. Mr. SYNAR. Thank you.

1 ) n Mr. WAxIrtAN. Mr. Synar's question was have you financed stud- ies on nicotine and nicotine addiction. You then answered that you have concluded it is habituating. Have you financed studies? Mr. GLENN. I misspoke, Mr. Waxman. I didn't conclude, the in- vestigators concluded. We funded the projects. Yes, sir, extensive. Mr. WnxMArr. You will give us details of those studies. Mr. GLENN. Yes, sir. Mr. WAxMAIV. In fact, the studies themselves? Mr. GLENN. Yes, sir. [The following information was received:] The two boxes of documents marked "Box 3" and "Box 4" contain copies of over 660 publications resulting from Council-funded research that appear to examine the effects of nicotine. (As explained above, the set of publications Crom which these doc- uments were selected is incomplete.) Again, we have used our best efforts to compile for the subcommittee a complete set of such publications. As I mentioned during my testimony on May 26, during the week of my testimony the Council sponsored an important seminar on central nervous system receptors, including the receptors that respond to nicotine and its analogues. Item I in the Ap- pendix includes copies of the program from that seminar and of the abstracts pre- sented at that seminar. Mr. WAXMAN. Mr. Greenwood. Mr. GREENWOOD. Thank you, Mr. Chairman. Good-morning, Dr. Glenn. Mr. GLENN. Good morning, Mr. Greenwood. Mr. GRSErrwGOD. In all of my questions I am going to be refer- ring to the February 11, 1993, Wall Street Journal article. The article notes that the Supreme Court last year said smokers can sue, accusing the industry of deliberately hiding or distorting smoking dangers. Can you inform us as to what the record of those suits has been, the number of such suits filed, and whether your organization been a defendant in those suits? Mr. GLENN. In the two suits mentioned in this article? Mr. GREENWOOD. I am asking a more general question. Has your organization been sued as a result of the Supreme Court's ruling that the industry has deliberately been hiding or distorting smok- ing dangers? Have you been a defendant in such a suit? Mr. GLENN. The Council for Tobacco Research has been named defendant in a number of tobacco-related actions. Mr. GREENWOOD. Can you tell us about the status of those cases? Have any drawn to conclusion yet? Mr. GLENN. There have never been adverse findings against the Council for Tobacco Research. Indeed, in the Cipollone case the court found that activities of the Council for Tobacco Research were essentially irrelevant to the action at issue there. Subsequently Judge Sarokin issued a statement relative to the Haynes case in which we were not named as a defendant citing some 1,500 secret documents of the CTR as reported in the press. That simply was not true. The 1,500 documents must belong to somebody e se because they certainly didn't belong to us. Mr. WAXMAN. So you are saying in one case the court found for the Institute as the defendant, is that what you said? Mr. GLENN. Yes, sir. Mr. WAXMAN. And have there been cases where the courts have found for the plaintiffs? 0/1 Mr. GLENN. Not against the Council for Tobacco Research, no, sir. Mr. GREENWOOD. OK There has been a lot of questioning about the freedom of the researchers who have been funded by the Insti- tute, freedom to pursue their research as they would be directed scientifically and freedom to publish. Are those assurances contrac- tually guaranteed to the researchers? Do they have contracts with the Institute that say`blearly, you are in charge of directing the course of this research and, second, you are entirely free to pub- lish? Mr. GLENN. There was no contract per se but in the grant award letter every grantee, there is a paragraph to the effect you are en- couraged to publish your results. We look forward to receiving re- prints of your publications and that message is reiterated to grant- ees repeatedly. Mr. GREENWOOD. Have you made those letters available to the committee yet? Mr. GLENN. I can-I am not sure that we have, Mr. Greenwood. I would be happy to provide them. Mr. GREENWOOD. If you would give us a sample of those. (The following information was received:) Item D in the Appendix is a copy of a form letter, with attachments, that is pro- vided by the Counci) to successful grant applicants. One of these attachments, "Im- portant Procedural Information for Granteee", refers specifically to publicatione by grantees. Item E in the Appendix is the Council's Statement of Policy, which ie sent to all grant applicants. The Statement of Policy makes It clear that the Council ex- pecte granteee to report their findings in medical and scientific journale, and re- quests that any publications acknowledge the Council's support. Our Statement of Policy also says, in very clear terms: "The Council desirea to have scientists work with the greatest freedom, without domination of any kind. It will make no attempt to direct the administration of a pro~'ect once started, to influ- ence its course or to control ite reeulte ..." That ie the Council'e fundamental pol- icy: to give complete scientific freedom to ite grantees, and to let the chips fall where they may. Mr. GREENWOOD. The question of the independence of the re- searchers that receive yourgr ants further comes into question in the Wall Street Journal article. I will quote, "for both men defying conventional wisdom has been rewarding; Dr. Seltser says he has received well over $1 million from the Council, Dr. Sterling got $1.1 million for his special projects works, the 1977 to 1982 court records show." Can you inform this committee how the level of the grants com- pares with normal practice? Were your grants particularly high? Was there any attempt by the Institute to make sure that sci- entists were not so well paid for their research that they felt they would be inclined to feel that they couldn't receive grants as lucra- tive elsewhere? Mr. GLENN. Most of our grants are much smaller in nature. The average Frant from the Council for Tobacco Research is of the mag- nitude ot $75,000 to $80,000 per year for 3 years. However, there are projects that are deemed of such importance that we have given prolonged funding to them. The classic example of this is the research done by Dr. Lynch in the epithelium cancers. We have supported Dr. Lynch for many years because the NIH did not see fit to do so. It is now proving to be a gold mine of basic information about genetic disorders and their relation to disease.

373 372 V' n. "~i {`j So, yes, some of the grants have run to very large numbers sim- ply because of the protracted nature of support. Mr. GREENWOOD. When you provide a grant to a university or to a research laboratory, does the Institute control the amount of grant that can be taken by the individual researchers for their sal- aries? Mr. GLENN. Yes, sir. We do. We regard-in general, the salary of the investigator is to be a responsibility of the institution. We try in as many instances as possible to limit financial support to support personnel such as lab technicians, to the purchase of sup- plies, experimental animals, publication costs, so forth. So it is unusual for an investigator to receive any or even a sig- nificant part of their salary from the grant. Mr. GREENWOOD. OK. Another quote from the Wall Street Journal article, "Today Dr. Hamburger adds that Mr. Jacob-and I assume Jacob is from the law firm-told him he would never get a penny more if the paper was published without making the changes." This went to the issue of a study that was done by Dr. Ham- burger years later at the Rose Cipollone tobacco liability trial in Federal Court in New Jersey. The issue is whether the researchers could use the term "cancer." Apparently the allegation in the arti- cle is that the law firm representing the Institute did not want the researchers to use the term "cancer", they wanted them to use more obscure medical terminology. Dr. Hamburger allegedly re- sisted that and claims he was told by Mr. Jacob that his refusal would end his funding. What is your response to that allegation? Mr. GLENN. First of all, I didn't know Dr. Hamburger and I didn't know Mr. Jacob. But I do know the circumstances. Dr. Hamburger was a grantee of the Council for Tobacco Re- search. He was working on the induction of lung tumors in ani- mals. His work was very nonproductive. He was able to produce only a superficial change in the epithe- lium of the lung never any tumors. As a consequence, the Sci- entific Advisory Board declined to extend his funding. lie was fund- ed I think for some 6 years. But the work was nonproductive and they did not renew his grant. I think his statements may reflect some bitterness at the fact that his funding was not continued. He was not successful in get- ting funding from an)r other agency. Mr. GREENWOOD. How do you respond to that part of his allega- tion that says that he was asked not to use the term "cancer" in his research but to use- Mr. GLENN. Because our Scientific Advisory Board could not con- firm that he had induced cancer; only superficial chanpes. Mr. GREENWOOD. Another quote from the article, 'By 1968 the Council had begun putting researchers under contract for many studies. This gave it the right to control both the studies design and publication of the results." I believe in response to an earlier question that I asked, you indi- cated that there were not contracts, they were in fact grant letters. There seems to be an inconsistency. Mr. GLENN. No. Contract research was done. It was not a promi- nent part of the activity of the Council for Tobacco Research. As I am informed, there were some contract studies in years past. There are none today. In years past, there was a major contract with microbiological as- sociates, and some several million dollars were spent in exposing laboratory animals directly to tobacco smoke in an effort to prbduce tumors. It was an unsuccessful effort. It went on for a number of years and finally the Scie~ntific Advisory Board, which had over- sight over this contract research, decided that it was inappropriate to continue with the research and the contract was terminated. It ran through its end. It simply was not renewed. Mr. G1tE1;Nwoou. Did that contract contain within it terms speci- fying the relative amount of freedom of the researchers to direct the research or their freedom to publish? Mr. GLENN. Yes, sir, as a matter of fact a major publication re- sulted from that Micro-Biological Associate's research work. Mr. GREENwooD. So the contract did specify that the researchers were in control of the direction of the research and were free to publish their findings as opposed to the contract specifying that the Council would determine the course of their science and whether or not they could publish, is that correct? Mr. GLENN. Yes, sir. To my knowledge there never was no re- striction. I think a number of publications by Micro-Biological Asso- ciates resulted from that work. Mr. GREENWOOD. Could you make a copy of that contract avail- able to this committee? Mr. GLENN. Yes, sir. [The following information was received:] Item G in the Appendix includes copies of each of the Council's contracts with Microbiological Associates, Inc. ("MAI"), together with contract renewals. The Coun- cil spent some $12 million under the MAI contracts on a large-scale, long-term study of the efCects of smoking inhalation on mice. I was mistaken when I told the subcommittee that these contracts contained no restriction on publication by MAI. The Council has had no research contracts during my tenure, and I had erroneously assumed that the Council's Qolicies with reapect to publicntiun hy coutract researcl~era .vern the aame aa its `~ol~ciet with rerpect to publtcnUan by bratlttlte. tilnct n1y ttnUaloqv, 1 hava Itarned thnt tht 71tAI c.~ntracts provided that t!m l ouncil'.r prior written approval was required for AtAI to publish its research findings. Such Provisions are customary in research eontracts. It is my undcrstandin~ that the results of thc mqjor inhnlntion etudy performed by MAI were published in complete and unedited form. In eddition, b1AI published dozens of articles based on its Council-Cunded research. Item 11 in the Appendix is a list of 89 publications or abatracts that appear to have resulted from the Council's support of MAI, at least 73 of which acknowledge support from the Council. Mr. GREENWOOD. Finally, Mr. Chairman. Another quote from the article: "But lawyers from Jacob Mettinger told Micro-Biological the project would go no further. When a contract is canceled given these kinds of results, Dr. Henry says, reasonable scientists might conclude the liability issue must have suddenly become apparent to this group." You already disputed the use of the terminology contract being canceled, you said it simply was not renewed. Was it in fact the case that the decisions about whether such a contract would be continued was made by lawyers from Jacob Mettinger or was that decision made by the Council? Mr. GLENN. To my knowledge-again, Mr. Greenwood, I was not thert-but to my knowledge what I have been told, Scientific Advi- V..' S, L