CTR Special Projects

As described in chapter 2, the tobacco industry has always maintained that the Council for Tobacco Research (and the Tobacco Industry Research

Committee before it) is an independent organization and that its research projects are awarded following peer review by the Scientific Advisory Board (SAB). The documents show, however, that many of CTR's projects were awarded through a special mechanism. Beginning in 1966, shortly after release of the first Surgeon General's report on smoking and health, in 1964, CTR began to fund "special projects" {1000.01, p. 13}. These special projects were awarded by tobacco industry lawyers, rather than the Scientific Advisory Board, and their primary purpose was to produce research that could be used to defend the industry in court or legislative arenas. The money for the CTR, including special projects, came from pooled contributions directly from the tobacco companies according to market share (see chapter 2).

CTR special projects were sometimes used to fund projects that did not get approved through CTR's traditional peer review process but were still desirable to industry lawyers. This arrangement is described in the minutes of a meeting of the general counsels for the six tobacco companies that funded the projects. The meeting was held on December 17, 1965, and the minutes discuss seven projects recommended by the Ad Hoc Committee for immediate implementation. (The precise functions of the general counsels and the Ad Hoc Committee are not known, but they appear to have been groups of industry lawyers and executives, respectively.) The minutes report the following action on one project: "To be submitted to SAB, CTR; if not approved, the project will be carried out by CTR under its 'special projects'" {2000.04, p. 1}. Thus, if this project could not meet the criteria for funding established by the Scientific Advisory Board, it would still be funded by CTR as a special project based on approval by the tobacco company lawyers.

The type of work conducted through CTR special projects awarded to three investigators—Henry Rothschild, Carl Seltzer, and Theodor Sterling—is described in detail below. As the documents show, these three sets of projects were designed to dispute the scientific findings about the adverse effects of tobacco and to produce research that shifted attention away from tobacco as a cause of disease. These three individuals, as well as many others funded through CTR special projects, also received funding directly through law firm accounts (see table 8.1}, as described in the next section. We discuss these three CTR special projects in depth because they were funded over extended periods of time, they were awarded large amounts of money, and they are mentioned often and in great detail in the documents.

Special Projects Awarded To Henry Rothschild

Henry Rothschild, M.D., Ph.D., has been a professor of medicine at Louisiana State University, New Orleans, since 1972. Between 1977 and 1988 Dr. Rothschild was awarded grants of approximately $250,000 to conduct research on the role of genetics in the causation of cancer (table 8.1). In 1976 Henry Rothschild wrote a letter addressed to "Dear Mister" and sent it to B&W suggesting that his research implicating factors other than tobacco smoke in the causation of lung cancer would be of interest to the tobacco industry {2009.19}. Subsequent correspondence indicates that the tobacco companies were interested in Dr. Rothschild's work and began funding him through CTR special projects in 1977. A 1977 memo from lawyer Timothy Finnegan (at Jacob, Medinger, and Finnegan) to William Shinn (at Shook, Hardy, and Bacon) recommends that Dr. Rothschild be funded to conduct a pilot study "to explore the possibility that peculiar genetic and environmental factors are responsible for this unusual lung cancer pattern [in Louisiana]" {2009.15, p. 1}.

In his progress report about the work conducted in 1977, Dr. Rothschild asks for continued support and states that his work has shown that autopsy and lung biopsy are confirmed in only about 20 percent of deceased patients {2008.04, p. 1}. This finding would be important to the tobacco industry because the industry argues that lung cancer is diagnosed more often than it actually occurs (1). Rothschild also notes that his data will be useful to the industry because "it will allow us to raise several interesting questions concerning the validity of many epidemiologic studies based on Mason and McKay's data" {2008.04, p. 2}.

A 1982 memo from Timothy Finnegan to the counsels for the tobacco companies recommends that Dr. Rothschild be funded through a CTR special project to continue his work related to the genetic aspects of cancer {2015.02}. The 1982–83 funding enabled Dr. Rothschild to complete his work on the association between sugar cane farming and lung cancer. This work did not relate to genetic aspects of cancer, but it supported the tobacco industry's position that environmental factors other than tobacco cause lung cancer. In 1983 Timothy Finnegan again recommended renewing Rothschild's funding for another year to "discover possible genetic markers associated with lung cancers" {2034.02, p. 2}. Rothschild's work was useful to the tobacco industry because it suggested that environmental and genetic factors are associated with lung cancer, thereby shifting attention away from the health dangers of smoking.

The documents contain an example of how Rothschild's work was used by the tobacco industry. First, the work was used for congressional testimony. In the "Statement of Henry Rothschild, M.D., Ph.D. in response to S.772, the 'Smoking Prevention Health and Education Act of 1983'" (cited by Finnegan as a reason for funding Rothschild), Rothschild said that his work "indicates that genetic factors may play a significant role in this excess mortality from lung cancer" and "If we can isolate such genetic markers, it will be a major step toward unraveling another aspect in the mystery of lung cancer causation" {2034.03, pp. 1, 6}.

The documents on Rothschild show that he kept tobacco company lawyers informed about his work, even offering to let them review scientific manuscripts before the manuscripts were submitted for publication. In an April 17, 1979, letter, for example, Dr. Rothschild asks Timothy Finnegan to review a scientific paper:

Enclosed is a summary of our accomplishments during the past year. A copy of our proposal for the coming year, including the budget, and a preprint of a next to final copy of the paper we would like to submit to the New England Journal of Medicine is also enclosed. (I say the penultimate copy because I await your comments prior to submission ) [emphasis added]. {2034.18}

The paper in question never appeared in the New England Journal of Medicine; the documents do not indicate why. The document demonstrates that a tobacco company lawyer was involved in commenting on a scientific paper before its publication.

In 1979 Rothschild published an article entitled "The Bandwagons of Medicine" (2) in the scientific journal Perspectives in Biology and Medicine . The article's basic premise is that physicians "jump on the bandwagon" of whatever therapies are popular and use these therapies even though there is little scientific evidence of their validity. The article criticizes the overwhelming acceptance of unproven but popular ideas—"the bandwagons of medicine." Historical bandwagons cited in the paper include leeches, homeopathy, tonsillectomy, and anticoagulants. When the article was submitted for publication, it contained the sentence:

Exercise, vitamins, high fiber diet, and the complete elimination of cigarettes are all rapidly gaining acceptance among physicians, though at present time there is no definitive evidence to support their value [emphasis added]. {2009.06, p. 13}

Deletion of the phrase referring to cigarettes was suggested by one of the peer reviewers who read the article for the journal that published it. In

the published article the phrase "and the complete elimination of cigarettes" was deleted (2). The editor's acceptance letter stated:

We will be pleased to publish "The Bandwagons of Medicine". The reviewers and I have only one strong suggestion. We are convinced that it would be wise to eliminate the comment on cigarettes (p. 13). Since smoking is known to be harmful, your qualification 'complete elimination' will not be carefully noted [emphasis added]. {2009.07}

Rothschild apparently sent the manuscript and the editor's comments to Timothy Finnegan, who, in turn, circulated the editor's acceptance letter and page proofs of the article to the counsels for the tobacco companies. Finnegan evidently believed that the statement about cigarettes was an important part of the paper, even though the reference to cigarettes was the only one in the seventeen-page paper.

Of particular interest is the reviewer's comment about 'complete elimination of cigarettes' on page 13 of the manuscript, which makes the point of the paper [emphasis added]. {2009.05}

Thus, the documents reveal that Rothschild cooperated closely with the lawyers in allowing opportunity for editorial input and in reporting on professional editing that affected references to tobacco in Rothschild's work submitted to scientific journals on scientific subjects and that lawyers at the highest levels followed Rothschild's work closely.

CTR Special Projects Awarded To Carl Seltzer

Carl Seltzer was a professor of public health at Harvard University until 1976. He conducted research related to the constitutional and genetic hypothesis favored by the industry. Specifically, Seltzer's work focused on countering the evidence that smoking causes heart disease. Like Rothschild's work, Seltzer's work could be used by the tobacco industry to divert attention from tobacco as a cause of disease.

When Seltzer retired from the Harvard University School of Public Health on June 30, 1976, he continued his research on "constitution and disease" at the Peabody Museum at Harvard. The Peabody Museum is a natural history museum, which is an odd place to do tobacco and health research. Nevertheless, during his retirement Seltzer was awarded grants of more than $750,000 from 1976 to 1990 through CTR special projects and Special Account 4 (table 8.1). A 1976 letter from Donald Hoel of Shook, Hardy, and Bacon describes the arrangements made with Dr. Seltzer and the Peabody:

Dr. Stephen Williams, Director of the Peabody Museum, has indicated that appropriate arrangements can be made. Such arrangements would be quite similar to those previously maintained at the Harvard University, School of Public Health. The total cost for one year's support from July 1, 1976, through June 30, 1977, would be $50,000. This sum includes a 15 percent "overhead" allocation to the Peabody Museum. Dr. Seltzer's salary, secretarial assistance, purchase or leasing of certain equipment, telephone service, etc., would be paid from the balance of these funds. {2004.01}

An April 4, 1979, memo from Hoel to the counsels for the tobacco companies approved an increase in Dr. Seltzer's annual grant from $60,000 to $70,000 to cover, in part, "increased travel expense for lectures" {2004.09}. As described below, Seltzer traveled extensively to speak about his work and stimulate controversy about the association between tobacco and heart disease.

A 1979 letter from Donald Hoel to the counsels of the tobacco companies describes a trip that Carl Seltzer made to New Zealand and Australia

[to] meet with scientists, science writers and some industry people concerning his research and opinions on smoking and heart disease. ... Personal reports from colleagues in Australia and New Zealand indicate that Dr. Seltzer's visit "was a great success." {2004.12}

Eight news clippings and radio transcripts covering Seltzer's visit are attached to the letter. The clippings—with titles such as "Smokers—Take Heart," "Doctor Slams Link between Smoking and Heart Disease," and "Smoking Does Not Cause Heart Disease"—describe Seltzer as a doctor from Harvard University. Only one small clipping discloses that Seltzer was "in Australia at the Tobacco Institute's invitation" {2004.13}. This type of press coverage that is favorable to the tobacco industry is significant because it demonstrates how the industry was quietly paying for scientists to publicize its position that tobacco is not dangerous. Scientists such as Seltzer, who were well-known researchers or had connections to prestigious institutions, lent a patina of legitimacy to the industry's claims that tobacco is not harmful. Seltzer was valuable to the tobacco industry, in part, because it could exploit his connection with Harvard University in press coverage.

Seltzer criticized scientific studies that found an association between tobacco and adverse health effects, and his efforts were monitored by the lawyers. An April 4, 1983, letter from Patrick Sirridge of Shook, Hardy, and Bacon to the counsels for the tobacco companies describes

Seltzer's activities—especially his analysis of a landmark study that found an association between smoking and heart disease (3, 4).

Dr. Seltzer has been very active in the past year analyzing literature dealing with coronary heart disease (CHD) and advancing his views on the smoking and CHD issue. In particular, he spent a great deal of time reviewing the results of the Multiple Risk Factor Intervention Trial (MRFIT). In this regard, the Journal of the American Medical Association [which published the MRFIT study] recently published his letter [5] commenting on the MRFIT findings. Dr. Seltzer also presented his views about smoking and CHD and MRFIT in a written statement to the Waxman Subcommittee. {2004.21, p. 1}

A 1984 memo from Ernest Pepples to I. W. Hughes, J. Alar, and T. Humber illustrates that researchers funded through special projects were asked to respond to data presented in the lay media as well as in the scientific literature. Seltzer was asked to respond to unfavorable press on tobacco that was aired on the MacNeil/Lehrer television news program. The memo states:

At B&W's request through Horace Kornegay [chairman of the Tobacco Institute], Carl Seltzer wrote the attached letter to Robin MacNeil taking issue with Dr. Castelli's [an investigator in the Framingham study] comments on the January 11 MacNeil/Lehrer program. My guess is MacNeil will send it to Castelli for rebuttal or he will just chuck it in the waste can. {2004.23}

Carl Seltzer's two-page letter to Robin MacNeil, dated January 31, 1984, states:

I found some of Dr. Castelli's statements relative to smoking and heart disease to be biased, flawed, and inaccurate. {2004.25, p. 1}

Seltzer's letter critizes the Framingham heart study, which evidently had been discussed in the interview. This study, the largest population-based study of heart disease epidemiology, had found that smoking is a cause of heart disease (6, 7). In an hominem attack on the scientist rather than the science, Seltzer claims that Castelli deliberately misled the "American public":

I merely wanted you to get some idea of deliberate inaccuracies in the Castelli statements to you and the public, and in the flaws in the works of the Public Health Service's Framingham Study. {2004.25, p. 2}

In the letter to MacNeil, Seltzer devotes a paragraph to describing his own qualifications in an effort to establish that he is a credible, independent scientist. Seltzer does not state that his work has been supported

by the tobacco industry during these years, nor does he mention that B&W's lawyers asked him to write the letter to MacNeil.

CTR Special Projects Awarded To Theodor Sterling

Theodor Sterling is a university research professor at Simon Fraser University in Burnaby, British Columbia. In addition to receiving money through the university, Dr. Sterling also formed a private consulting firm that received funding through CTR special projects. Between 1973 and 1990 CTR special projects provided over $5 million to support Sterling's work, with additional funding through Special Account 4 (table 8.1). The focus of Dr. Sterling's tobacco research has been on examining factors that could potentially confound the association of tobacco smoke and adverse health effects. For example, he has studied the influence of occupational hazards and genetics on lung cancer. This work has been useful to advance the "constitutional hypothesis" of disease (i.e., that cancer is caused by genetic makeup, not smoking) favored by the tobacco industry and provides a distraction from the evidence on the adverse health effects of tobacco.

Documents from tobacco industry lawyers reveal that Dr. Sterling's work became increasingly important to the industry over time because it was used to dispute scientific findings about the adverse effects of tobacco. Dr. Sterling's long history of funding by the tobacco industry illustrates the scientific issues that were important to the industry at different times.

A February 27, 1980, letter {2020.06} from William Shinn of Shook, Hardy, and Bacon to the general counsels of the tobacco companies describes the way in which Sterling was funded both through the university and through his consulting firm, the range of his funded activities, the tobacco industry's use of his work, and the lack of a competitive review procedure to receive continued funding. The projects funded in 1979–80 were directed at refuting the evidence that environmental tobacco smoke is dangerous (see chapter 10). Dr. Sterling's projects were designed to critique published work on environmental tobacco smoke and to draw attention to occupational and other lifestyle factors that might confound an association between environmental tobacco smoke and disease. As described in the lawyer's memo, Dr. Sterling's work was presented at congressional hearings, at scientific meetings, and in scientific publications to support the industry's position that exposure to environmental tobacco smoke should not be regulated.

Dr. Sterling is presently quite busy in at least nine areas. These include: preparation of a review of health effects due to indoor combustion of organic material requested by the National Academy of Sciences; preparation of a paper to present to the American Lung Association on the possible relationship between occupation, smoking and lung disease; completion of work on familial disease among women whose husbands are exposed to irritating dust and fumes; an investigation of the change in employment patterns of women since the 1930's; a study of smoking habits and employment patterns among blacks; completion of an analysis of errors in the [Harold E.] Dorn/[Harold A.] Kahn Study [a study of smoking and mortality among US veterans]; analysis of the use of magnetic techniques to measure long-term lung clearance of particles in smokers and nonsmokers; and an examination of preliminary data from a study of indoor pollutants from gas stoves.

Dr. Sterling has continued to be helpful in frequent consultations about the smoking and health controversy. He testified at Congressional hearings on public smoking in October, 1978; has given several technical papers at professional meetings recently; and has prepared a number of manuscripts, some of which have been published.

...

He [Sterling] has offered to prepare a detailed proposal for the extension, but I am not too concerned about this since we could continue under the old agreement [emphasis added]. {2020.06, pp. 1–2}

One of the main purposes of CTR special projects funding was to attempt to discredit independent scientific findings about tobacco. A letter from William Shinn at Shook, Hardy, and Bacon to the counsels for the tobacco companies requesting their approval of Sterling's funding credits their funding arrangements with Sterling as enabling the companies to obtain fast responses from Dr. Sterling to dispute scientific results that were not favorable to the industry. In contrast to research grants, which usually focus on a specific topic, the lawyers' correspondence indicates that Dr. Sterling's special projects funding was used to criticize the work of other scientists, such as Cohen's study showing that smoking adversely affects people's ability to eliminate dust from their lungs (described below).

A February 4, 1981, letter from William Shinn of Shook, Hardy, and Bacon to the counsels for the tobacco companies states:

As in the past, Dr. Sterling has used the support received from his grant to develop proposals for other projects. The flexibility inherent in the current arrangement has also provided Dr. Sterling with the ability to respond quickly to new scientific developments.

... Dr. Sterling analyzed Cohen's article [8], which appeared in Science , May, 1979, and concluded that Cohen's claim that smokers have impaired long-term clearance capabilities compared to nonsmokers' is open to challenge because of his faulty experimental design. Dr. Sterling interested

Dr. Glicksman and colleagues at Brown University in this problem. Subsequently, both Dr. Sterling and Dr. Glicksman presented papers highly critical of Cohen's work at a recent conference. ... Dr. Sterling has been informed that Cohen and colleagues have apparently ceased this type of experimental work. In view of the many claims about the possible interaction of smoking and occupational exposures, Sterling's critical response to Cohen's work seems particularly important [emphasis added]. {2022.06, pp. 1–2}

Cohen and his colleagues (8) had human volunteers inhale a dust that could be traced because of its magnetic properties over a long period of time. They showed that after one year smokers had eliminated only half of the dust from their bodies, whereas nonsmokers had eliminated 90 percent of the administered dose. This work had potentially important implications for setting exposure limits to toxic dusts in occupational and in environmental settings.

Shinn's letter recommending approval of Sterling's funding contains a comment revealing the lawyer's interest in maintaining that Sterling was an independent scientist and not a representative of the tobacco companies:

Dr. Sterling is an independent scientist, of course, and as we have stated in earlier grant requests, there are to be no restrictions attached to his research work. Dr. Sterling's findings are his own, and we are free to agree or disagree with them. {2022.06, p. 3}

A March 1, 1982, memo from Patrick M. Sirridge at Shook, Hardy, and Bacon to the counsels for the companies requesting their approval for further funding of Sterling indicates that the lawyers were directly managing at least some of Sterling's work:

It is further recommended that the extension of Theodor D. Sterling, Ltd. commence May 1, 1982, because of unforeseen expenses due mainly to additional requests from our office [emphasis added]. {2037.04, p. 1}

Sirridge's acknowledgment that unforeseen expenses had been incurred by Sterling because Sterling was responding to additional requests from Shook, Hardy, and Bacon presents an ironic contrast with Shinn's insistence a year earlier that Sterling was an independent scientist. Sirridge repeats the point made by Shinn that the companies' funding arrangement with Sterling enabled him to respond quickly, apparently to requests from the lawyers. For example, one special request involved responding to publications on environmental tobacco smoke:

In January, 1982, Dr. Sterling prepared written comments in response to a paper presented by James E. Repace [of the US Environmental Protection

Agency] at the ASHRAE (American Society of Heating, Refrigeration and Air-conditioning Engineers) in Houston. ... Dr. Sterling's oral presentation at the Houston meeting and the written comments which will be published in the ASHRAE Transactions this summer provide the first public criticisms of the deficiencies in Repace's scientific methodology. Further, Dr. Sterling pointed out that Repace's reliance on studies such as Hirayama's [Takahishi Hirayama published a paper in 1981 demonstrating that environmental tobacco smoke increases the risk of lung cancer in nonsmokers] was misplaced and that his conclusions were at variance with many published reports and Dr. Sterling's own research on indoor air pollution.

The flexibility inherent in Dr. Sterling's ongoing project enables him to respond within a short time to scientific developments. His willingness to prepare written comments on Repace's paper with only a few weeks notice is a good example. Dr. Sterling also responded to the publication of Hirayama's article early last year with a highly critical letter to the British Medical Journal , a copy of which is enclosed as Appendix D. Most recently, Dr. Sterling has prepared responsive materials on the scientific aspects of legislative proposals (Waxman and Hatch bills) pending in Congress [emphasis added]. {2037.04, p. 2}

Sirridge then points out that Sterling's work will be useful for stimulating controversy about the health effects of environmental tobacco smoke:

[Sterling] has written an extensive critical review of the literature on indoor by-product levels of tobacco smoke which is scheduled for publication in March. This paper will serve as a useful critique of previous studies in this area, as it points out their deficiencies and emphasizes the need for more careful work ... [emphasis added]. {2037.04, p. 2}

In 1984, at the request of Ernest Pepples, B&W vice president for law, Sterling began to receive funding directly through the law firm of Shook, Hardy, and Bacon to continue his work reviewing epidemiological studies that demonstrated a link between smoking and disease {2037.01}. In a January 24, 1984, letter to Sirridge at Shook, Hardy, and Bacon, Pepples agrees that Sterling should be funded at the budget levels set forth but also states:

I do not think, however, that we should continue burdening CTR with such programs, and instead suggest that they be handled as law firm projects. {2037.01}.

Table 8.1 shows that in 1985 Sterling began to receive funding through Special Account 4, which was administered by the law firm of Jacob and Medinger.

In 1984, two years after Sirridge wrote the memo describing the usefulness of Sterling's work {2037.04}, that work continued to be useful to

the industry by stimulating controversy and refuting scientific findings about tobacco. A January 23, 1984, memo from Patrick Sirridge of Shook, Hardy, and Bacon to the general counsels of the tobacco companies summarizes some of Dr. Sterling's accomplishments for the tobacco industry:

He [Sterling] has also been concerned with selectivity in reporting in government reports such as the Surgeon General's. His conclusions have been presented at scientific meetings. ... Dr. Sterling and members of his staff have appeared before scientific and professional groups such as BOCA, ASHRAE [American Society of Heating, Refrigeration and Air-conditioning Engineers], and the California Energy Commission. ...

During the past year, Dr. Sterling attended international meetings in Geneva and Turin to present reports on environmental conditions in office buildings. Based on his research results, Dr. Sterling reported that there was no difference in the prevalence of complaints about health or environment among smokers and nonsmokers working in offices where smoking was permitted versus those where it was prohibited. Dr. Sterling continues to publish papers in scientific journals and make presentations at scientific meetings. ... Dr. Sterling has also provided assistance in responding to the 1982 and 1983 proposed legislation regarding new warning labels. He appeared before Congressman Waxman's Committee in 1982 and submitted statements in 1983. {2015.04, p. 2}

BOCA, ASHRAE, and the California Energy Commission are organizations involved in creating ventilation standards for buildings that are directly affected by environmental tobacco smoke. Sterling's presentations had the potential to influence regulation of environmental tobacco smoke exposure directly. The meeting in Geneva was a tobacco industry–sponsored symposium (9). Like those of other industry-sponsored symposia, the published proceedings of the Geneva conference featured the work of industry-funded scientists and contained articles that support the tobacco industry's position that tobacco smoke is not harmful (9). The industry-sponsored symposia are often cited by the industry as if they are peer-reviewed scientific journal articles that support the industry's position (1).

Sterling and Harold Perry were also funded under a CTR special project from 1978 through February 1982 to conduct an environmental study entitled "Retrospective Analysis of Environmental Contacts of Patients with Respiratory Cancer, Other Cancers, and Other Diseases" {2020.01}. In 1980 Sterling was funded under a CTR special project to conduct a study of indoor environments ("Feasibility Study on Office

Environments" {2022.10}). Robert Northrip (of Shook, Hardy, and Bacon), in a letter to the general counsels recommending funding, states:

It is our opinion that this work could be extremely useful in view of the intense activity we are witnessing in both legislatures and referendums to restrict indoor smoking. {2020.03, p. 2}

This study led to the development of a proposal entitled "Office Building Syndrome," with the purpose of examining

[the] dependence of this syndrome on building design and ventilation features, and investigating the syndrome's relationship, if any, to life-style factors, such as smoking. {2022.03, p. 1}

Theodor Sterling and his son, Elia Sterling, were coinvestigators on the $200,160 special project {2022.02}.

The documents show that Sterling has continued to receive funding through CTR and law firm special projects through at least 1993. The publication of Sterling's criticisms was part of a broad industry strategy to stimulate controversy about the adverse health effects of environmental tobacco smoke (1, 10, 11). Sterling's publications also gave the tobacco industry supportive material that could be cited in testimony before Congress, in court, in the medical literature, and in response to government documents in support of their position that the links between active and passive smoking and disease were "controversial."

Microbiological Associates

Although lawyers appear to have been primarily involved with CTR's special projects, in at least one case they became involved with a project that had been awarded as a contract through CTR. The contract was approved by the Scientific Advisory Board, but CTR had control over the data and publication of the results. The documents describe a contract during the 1970s with Microbiological Associates to conduct studies on the effects of cigarette smoke in mice.

Microbiological Associates was conducting inhalation studies, in which mice were placed in small chambers and breathed smoke-laden air for part of the day. Other studies were short-term biological tests to determine the carcinogenicity of cigarette smoke condensate. Tobacco industry lawyers were unaware that CTR had been funding the biological tests until 1977, when one of the scientists at Microbiological

Associates (a Dr. Gardner) requested additional funding from CTR to study smoke fractions in the biological tests. The ultimate purpose was to identify the compounds within tobacco smoke that are responsible for its carcinogenic effects.

The lawyers were apprehensive about this work because its results might give rise to lawsuits if the tests showed that certain elements in tobacco smoke were carcinogenic and also because the tests might constitute a breach of antitrust laws (discussed in chapter 7). These concerns are described in a memo from Ernest Pepples of B&W to Addison Yeaman, another B&W lawyer, dated March 10, 1977.

I did not understand until I talked with Arthur Stevens [CEO of B&W] that CTR in the last several years has tested cigarette smoke condensate fractions in the following tests: (1) in the Ames microbiological screen for mutagenic activity; (2) for possible tumorigenic activity in a tissue culture assay; and (3) for promoting activity by using subcutaneous injections in mice. The fractions were originally produced by someone at the USDA for CTR under what has been called the "Stedman procedure." Most of the assay work has been carried out at Microbiological Associates.

Let me say parenthetically that years of cherishing Dr. [Robert] Hockett's [of the CTR] oft quoted comment about mice tests—the wrong animal, the wrong tissue, etc.—I confess that I was somewhat jarred by the revelation to me about tests on mice through the CTR [emphasis added]. {1817.02}

Pepples says that he has discussed the tests with several other tobacco industry lawyers, and none of them knew that CTR was engaged in this sort of work.

We all think these tests are so significant that members of your [CTR] Board and people who attend the scientific sessions as I have off and on for the last couple of years should be better informed. Pursuing the thought just a bit further, these tests are so-called red light tests . They have been developed for use by FDA and other agencies in possibly identifying harmful ingredients and substances in products which are available to the consuming public. At best they show only a probability of trouble but they are used as a signal in such things as whether Red Dye No. 7 or cyclamates or hexachlorophene should be yanked off the market. I do not have to tell you what Senator [Edward] Kennedy [D-MA] would do with a finding by a CTR grantee of red lights in one of these tests as it applies to cigarette smoke fractions . We would never be able to explain that we were only replicating or confirming some other person's work. No matter what our explanation happened to be the fact of the red light in our own hands would be a serious burden to the tobacco industry if it came out in legislative hearings or in litigation [emphasis added]. {1817.02}

One of the short-term tests being done at Microbiological Associates was a test to see whether tobacco smoke caused chromosomal abnor-

malities in laboratory animals. Such a study had been done by the Food and Drug Administration in its investigation of cyclamates (see chapter 7). Pepples recommended that the inhalation program at Microbiological Associates should continue until completion, but that the short-term biological tests should not be funded through CTR {1817.03, p. 1}.

The final action taken on the research at Microbiological Associates is described in a memo from Ed Jacob, of the Jacob and Medinger law firm, to Pepples. The memo is dated June 22, 1978, and is titled "Current Status of CTR's Consideration of Microbiological Associates Contract Proposals."

Following the visit by the SAB [Scientific Advisory Board] Task Force and staff to Bethesda regarding status of Microbiological Associates (MA) contract and later discussions between SAB and staff, CTR has now proposed the following action to MA with regard to the MA proposals for the contract year July 1, 1978 through June 30, 1979:

The studies that CTR declined to fund include short-term biological tests. Although the documents do not indicate the reasons for CTR's decision, the decision is consistent with Pebbles's recommendation. Ed Jacob's memorandum on CTR's final action was transmitted to eight industry lawyers (at both tobacco companies and outside firms) in a memo

describing it as "a most interesting report" {1820.02}. The degree of industry lawyer participation and interest in CTR's action on the Microbiological Associates work is particularly noteworthy because the work at Microbiological Associates was funded through CTR's Scientific Advisory Board, not through its special projects division.

Addiction Research Foundation: A Case Study Of A Special Project The Industry Was Not Interested In Funding

The documents contain at least one instance in which an applicant for funding considered the lawyers as the court of last resort in attempting to procure tobacco industry funding for research. In December 1976 the Addiction Research Foundation, directed by pharmacologist and Stanford University professor Avram Goldstein, M.D., submitted a formal grant application to CTR requesting $400,000 for the purpose of constructing a new research facility. The Addiction Research Foundation had been studying the mechanism of opiate addiction, and the new facility would enable it to expand its work to include the mechanism of nicotine addition.

Dr. Goldstein was told by CTR that it would consider proposals "directly related to tobacco and health, but that it was not in a position to provide funds for structuring the Addiction Research Foundation" {1913.08}. He then pursued funding from individual tobacco companies. Correspondence alerting the individual companies that Leonard Cornell of the Addiction Research Foundation would be contacting them was circulated by Shook, Hardy, and Bacon to Brown and Williamson, American Brands, Liggett & Meyers, Lorillard, Philip Morris, R. J. Reynolds, and US Tobacco. The letters stated that Cornell would be writing the tobacco companies to request funding and that CTR had already rejected the Addiction Research Foundation's application for funding. Cornell did approach the individual companies seeking funding. Only Lorillard responded to his letter, and it issued a terse denial of funding that offered no reason for its decision.

In a final attempt to receive funding from the individual companies, Cornell wrote William Shinn, attorney at Shook, Hardy, and Bacon, on August 9, 1978. Cornell argued that the tobacco industry should be interested in funding the Addiction Research Foundation because the foundation's work could be directed to developing a "safe cigarette"—i.e., a cigarette that "could create the nicotine effect that smokers enjoy without the toxicity of nicotine" {1913.04}.

Perhaps the term 'addiction' turns them [the tobacco companies] off. That is no obstacle. We're willing to establish the tobacco research under a separate name: 'The RJ Reynolds Program ...' or whatever. {1913.04, p. 2}

Although Cornell wrote that his appeal was "attuned to the needs and desires of the tobacco industry in terms of public relations and accelerating profits" {1913.04, p. 2}, he did not realize that the tobacco industry would not fund any proposals that acknowledged that nicotine is addictive.

The document shows that Shinn transmitted Cornell's letter to the general counsels for several tobacco companies as well as to other outside lawyers {1913.04}, but the lawyers showed no interest in approving Cornell's request. The tobacco companies refused to fund the Addiction Research Foundation because of their starting assumption about nicotine; at the same time, BAT's internal research program had come to similar conclusions about nicotine and addiction fourteen years earlier (see chapter 3). The reason that the Addiction Research Foundation did not receive support from the industry is summed up in a memo from C. L. Waite to H. R. Kornegay (of the Tobacco Institute):

Mr. Cornell's foundation actually assumes tobacco (nicotine) is addictive and costs the U.S. citizen 42 billion dollars a year! He also believes tobacco causes 300,000 premature deaths each year. And he wonders if this is why we might not be interested. {1913.01}