Tobacco Documents Online

an SAB meeting Dr. Wakeham attended on March 14-16, 1973. The minutes of that meeting are attached as Exhibit 3. 27. 1 personally knew Dr. Wakeham and heard him express his views on the "relevance" of CTR research many times during the 1970s. Dr. Wakeham and his colleague at Philip Morris, Dr. Thomas Osdene, repeatedly expressed the opinion that CTR-funded research work was not sufficiently relevant to tobacco, based on their view that research which did not involve experiments using tobacco smoke was not "relevant" to CTR's mission. The CTR staff and SAB disagreed with, and never adopted, the view of Drs. Wakeham and Osdene. Based on my familiarity with Dr. Wakeham and his views about scientific "relevance," I believe that Dr. Wakeham's rating of " 1" meant he considered the research to be most relevant to tobacco Rg_r sg and that his rating of "5" meant he considered the research to be least relevant. I do not believe that he meant to give a grant application a low score based on its potential for research findings connecting smoking with disease causation. 28. At the time of Dr. Wakeham's memorandum, the SAB had already voted on the applications at issue. Therefore his comments could not have affected the SAB's vote. Exhibit 3 records both the SAB's recommendations and the actions taken by Dr. Hockett, who was then the Acting Scientific Director. Although some of the applications that were not funded had received low ratings from Dr. Wakeham, others that were not funded received high or medium ratings from him. Four of the grant 11 20343071.02

proposals that were funded by CTR received a "5" (the lowest rating) from Dr. Wakeham. Thus, it seems clear that Dr. Wakeham's comments had minimal, if any, influence on the actions of Dr. Hockett. In any case, Dr. Hockett's actions were reported to the SAB at the next meeting in October 1973, by which time Dr. Gardner had replaced Dr. Hockett as Scientific Director. The SAB and Dr. Gardner could have reversed Dr. Hockett's decisions at that time if they disagreed with them. 29. Until I was asked about Dr. Wakeham's note in 1995, 1 knew nothing about it, and I am not aware of any similar communications from tobacco company representatives to anyone at CTR. CTR Grant-in-Aid Research 30. Throughout my affiliation with CTR, recipients of CTR grants-in- aid were encouraged to submit their research findings to scientific journals for publications. Each year, CTR prepared an Annual Report listing the publications during the previous year, as well as current and active grantees. These Annual Reports form the basic record of CTR contributions to scientific research. In my 30 years of work for CTR, I am not aware of any instance in which a grantee was prevented from publishing research results or had his or her research suppressed, undermined or interfered with by CTR. 31. During my 30 years with CTR, the nature of the research funded by CTR evolved significantly. Because CTR administered a grant-in-aid program, the 12 2o3a3o71.02

projects that it funded were selected from applications submitted by researchers and therefore tended to reflect the general trends in the scientific community. Thus, as the methods of basic medical research became more sophisticated, so did the projects funded by CTR. I witnessed a general trend in CTR-funded research from whole- animal studies in the 1950s and 1960s, to cellular-level studies in the 1970s and 1980s, to genetic and molecular-level studies in the 1980s and 1990s. 32. CTR's mission, as I understood it, was to advance scientific knowledge about the causation of diseases that may be associated with smoking. As stated in the minutes of the SAB meeting on December 3-4, 1966, CTR funded projects having a "direct or clearly pertinent bearing on the general field of tobacco use and health." A copy of these minutes is attached as Exhibit 6. In my view, virtually all the research funded as part of CTR's grant-in-aid program was highly relevant to that effort. 33. Throughout the 1970s, CTR funded some research through contracts rather than through grants-in-aid. These research contracts were considered and approved by the SAB. CTR entered into research contracts as a supplement to grants- in-aid in cases where it was not feasible to accomplish certain types of research through grants-in-aid. For example, CTR was interested in developing standard experimental techniques, "smoking machines," animals and materials for animal inhalation experiments. A researcher would not be likely to submit a grant application for that 13 2o3a3a71. 02

type of work because it might not be useful to the researcher in the absence of funding for follow-on experiments using the materials or techniques developed. In addition, a grantee would be unlikely to undertake a large-scale, long-term inhalation experiment because of the large capital investment and overhead required. Early consideration by the SAB of contract type research is reflected in the minutes of the SAB meetings of September 23-24, 1967, at page 4, and March 2-4, 1968, at page 4. Copies of these minutes are attached as Exhibits 7 and 8. 34. CTR entered into contracts with commercial research laboratories to get this type of work done. Among the commercial laboratories used for these purposes were Dr. Freddy Homburger's Bio-Research Consultants, Inc., the Mason Research Institute, and Microbiological Associates, Inc. 35. Research contracts differ from research grants-in-aid in several significant ways. A grant-in-aid, in effect, is an award to the researcher, and the grantee is free to follow new research directions as they arise. A grantee's research findings, and the reports of those findings, belong solely to the grantee. By contrast, a contract researcher is legally obligated to follow the research directions set by the funding party in the contract. The research findings and reports of those findings legally "belong" to the funding entity. Accordingly, research contracts typically provide that the researcher can publish only with the consent of the funding entity. CTR's research contracts so provided. 14 20343071.02

-CTR's Relationship to the Tobacco Companies 36. I am aware that some people claim that CTR held itself out as totally independent of the tobacco companies, and I find that claim to be odd. [ believe that the scientific community and the government (and anyone else who knew anything about CTR) were well aware at all times that the CTR consisted of and was owned by its member tobacco companies. Thus, it could never be completely independent from its members, and it-would be impossible for CTR to pretend that it was. 37. The ultimate ownership of CTR by its member companies was open and obvious. From the time I started with CTR in 1964 until 1990, the Chairman of CTR was a former tobacco company executive. From the time I joined CTR until 1969, the Chairman was Timothy Hartnett, formerly of Brown & Williamson. From 1969 to 1975, the Chairman was Henry Ramm, formerly of R. J. Reynolds. From 1975 to 1980, the Chairman was Mr. Yeaman, formerly of Brown & Williamson. From 1981 until 1991, the Chairman was William Hobbs, formerly of R. J. Reynolds. 38. Nonetheless, CTR operated throughout my tenure a grant-in-aid program that was not dominated or controlled by the tobacco industry. This was possible because CTR was set up with an SAB and a Scientific Director who did not come from the tobacco industry and who followed their own scientific prerogatives. Because of the SAB and Scientific Director, CTR charted its own course with regard to grants-in aid and contracts. 15 20343071.02

39 I was aware during my tenure at CTR that some tobacco company personnel (a) criticized CTR for funding research that was not "relevant" to smoking and health, (h) complained that CTR-funded research was not sufficiently helpful to them and in some instances was harmful to them, and (g) proposed changes in CTR that would have given the tobacco companies impact into CTR's research program. I have recently reviewed a number of documents reflecting those criticisms. 40. Some of these criticisms are explained by the fact that most tobacco company scientists are chemists, and in many instances they lacked sufficient familiarity with the biomedical research being funded by CTR to understand its relevance. And it is true that much CTR-funded research, by focusing on fundamental questions of disease causation, was not likely to provide any findings that would be useful to the tobacco companies in the short-term. It is also true that much CTR- funded research could and did lead to findings implicating tobacco in disease causation. I am not surprised that tobacco company employees may have proposed that the companies take control of CTR's grant-in-aid program. I view those proposals as confirmation of CTR's independence. Notwithstanding these industry criticisms, I am not aware of any industry control over the SAB's research program during my 30 years of affiliation with CTR. 41. One issue on which tobacco company executives frequently expressed their views during the 1960s and 1970s was "directed" research. This issue 16 20343071.02

was also debated by the CTR Staff and the SAB. In the 1960s and 1970s, some of CTR's sponsors expressed the view that CTR should have a more "directed" research program. I understood this to mean a more product-oriented research program conducted primarily through contracts. The term "directed" research referred to scientific research that was more narrowly focused on predetermined topics, not to research whose outcome was predetermined. 42. The members of the SAB, Drs. Little and Gardner (the Scientific Directors in the 1960s and 1970s) and other members of CTR's scientific staff expressed varying views about the value of directed research. However, there was at all times a unanimous (or nearly unanimous) point of view among the SAB and the scientific staff that research did not have to directly involve tobacco to be relevant to smoking and health. The CTR staff and the SAB believed that research into the etiology of diseases associated with smoking was necessary in order to discover the nature of tobacco's relationship with those diseases. Such research did not directly involve tobacco products, but it was, and is, absolutely essential to understanding disease causation. I strongly shared that view, and still do today. 43. Furthermore, the prevailing view among members of the SAB (as well as among the scientific staff of CTR) was that CTR should remain principally a granting organization, with contracts used for research where appropriate. A granting organization can fund only research projects for which it receives applications. Thus, 17 20343071.02

the grant-in-aid process, by its very nature, limited to the ability of CTR to "direct" research or even its research program. 44. Nevertheless, until the late 1970s some members of the SAB were interested in trying to provide more focus to CTR's research program. Most of them were interested in funding research focused on the effects of tobacco smoke inhalation on laboratory animals, as part of a research program in which basic research through grants-in-aid predominated. This initiative was referred to as "planned" or "directed" research, as shown in the minutes of the SAB meeting of May 16-18, 1969, at page 5. A copy of these minutes is attached as Exhibit 9. As shown there, such research was to be "planned" or "directed" by the SAB, not by the tobacco industry. As part of this effort, the SAB formed a Planning Committee, whose task was to map out areas of research on which the CTR should focus its funding. This activity is reflected in the minutes of the SAB meeting of September 12-14, 1969, a copy of which is attached as Exhibit 10. 45. As part of the directed research effort CTR entered into a number of contracts, most of which related to the study of smoke inhalation by laboratory animals. These contracts culminated in a mouse inhalation study under contracts with Microbiological Associates, Inc. ("MAI") from the 1970s until about 1981. Ultimately, however, CTR did not alter its basic non-directed research approach. It remained in essence a grant-making organization, which awarded grants to applicants 18 20343071.02

and tried to interest high-quality investigators in submitting grant applications. It has not funded any contract research since the MAI project was concluded. 46. The issue of "directed" research was often discussed by employees of the tobacco industry. Some tobacco company representives expressed concern that such "directed" research, executed through contracts, would somehow compromise the independence of CTR's SAB-directed research program. However, as I have indicated, contracts were firmly within the jurisdiction of the SAB and "directed" research was "directed" by CTR and independent researchers, not the industry. These discussions are reflected in the following documents which I have reviewed and which are attached to this affidavit: (a) notes which appear to reflect a meeting of the Executive Committee of CTR in November 30, 1970, attached as Exhibit 11; (b) a December 6, 1977 letter from Mr. Heimann of American to Mr. Yeaman, then Chairman of CTR, attached as Exhibit 12; (c) Mr. Yeaman's December 9, 1977 response to Mr. Heimann, attached as Exhibit 13. 47. I believe these documents accurately reflect the attitude about CTR that I frequently heard expressed by people in the tobacco industry: that it was vital that CTR's SAB-guided research program be independent of control by the companies. These statements also confirm my distinct recollection that in the late 1960s and the 1970s tobacco industry executives differed among themselves as to what CTR could and should do while maintaining the independence of its research program. 19 20343071.02

48. The text for a speech given by Mr. Yeaman, then CTR's President and Chairman, at the December 10, 1975 meeting of the CTR Board of Directors, accords with my recollection of Mr. Yeaman's attitudes about CTR's relationship with the tobacco industry. A copy of this speech is attached as Exhibit 14. According to page 3 of Exhibit 14, Mr. Yeaman stated: "Give us your policy directions and we'll follow them within the limits of scientific integrity.... But don't look over our scientific shoulder." Based on my numerous conversations with Mr. Yeaman, I believe Mr. Yeaman meant that the CTR sponsor companies were free to propose general guidelines about matters like means of funding research CTR should use (such as contracts vs. grants) or what general subject-matter areas CTR should try to fund research in (such as animal inhalation, cancer, or heart disease), but that the SAB and the Scientific Director must be left alone to make funding decisions and would not do anything that was misguided or lacking in scientific integrity. 49. A memorandum dated October 12, 1967 from Dr. Osdene to Dr. Wakeham (both of Philip Morris) describes a meeting at CTR on September 25, 1967. A copy of that memorandum is attached as Exhibit 15. Although I had not seen this document until recently, I participated in the activities to which I believe Dr. Osdene refers. When Dr. Osdene quoted Dr. Hockett (on page 1) as stating that "CTR is moving into an era of active collaboration with the industry," I believe he was referring to CTR's efforts to collaborate with the Industry Technical Committee to develop 20 20343071.02