by Allan Brandt
The committee understood that there had been a long-running debate within the medical sciences over the term cause. Was a cause both necessary and sufficient to result in disease? Might there be something that sometimes causes disease? Could a factor be a cause if it was neither necessary nor sufficient? Might there be other factors? As we have seen, these questions were not new. But the resolution of the question—do cigarettes cause disease?—demanded that the committee articulate its methodological and epistemological criteria for arriving at a definitive answer. As a result, the Surgeon General’s Advisory Committee worked to define the specific approaches utilized to reach a causal conclusion. By mid-century, it had become clear that population-based investigations would be critical to the understanding of systemic and chronic diseases. The Surgeon General’s Advisory Committee came to understand the complex interdisciplinary process of determining the causes of chronic disease.
William Cochran took the lead in organizing and drafting the report’s most critical chapter, “Criteria for Judgment,” which laid out the justification for its causal conclusions. What did it mean to say, for example, that cigarettes caused lung cancer? How should cause be distinguished from associated with, a factor, or determinant? The report sought to clarify this issue at the outset, noting that “the word ‘cause’ is the one in general usage in connection with matters considered in this study, and it is capable of conveying the notion of a significant, effectual, relationship between an agent and an associated disorder or disease in the host.” But the committee understood the problem with stating simply that smoking causes cancer.
Sources: Federal Trade Commission; Centers for Disease Control; Richard Peto, Alan D. Lopez, Jillian Boreham, Michael Thun, and Clark Heath, Jr., Mortality from Smoking in Developed Countries, 1950-2000 (Oxford: Oxford University Press, 1994).
CHART 4 Cigarettes sold and tobacco-related deaths in the United States, 1915-2005
Many individuals could smoke heavily throughout their lives and yet not develop lung cancer, just as many individuals might become infected with the tubercle bacillus but never develop tuberculosis. Therefore, they acknowledged the complexity of causal processes in medical science:It should be said at once, however, that no member of this Committee used the word “cause” in an absolute sense in the area of this study. Although various disciplines and fields of scientific knowledge were represented among the membership, all members shared a common conception of the multiple etiology of biological processes. No member was so naive as to insist upon mono-etiology in pathological processes or in vital phenomena.57
Yet the members of the committee did not wish to give too much ground. After all, the critical question, from a public health perspective, was whether smoking increases an individual’s chance of developing a potentially life-threatening disease. Therefore, they concluded:Granted that these complexities were recognized, it is to be noted clearly that the Committee’s considered decision to use the words “a cause” or “a major cause” or “a significant cause,” or “a causal association” in certain conclusions about smoking and health affirms their conviction.58
The tobacco industry would consistently argue for an esoteric and unobtainable definition of cause—one that would have eliminated the known causes of many diseases—but the Surgeon General’s Advisory Committee understood that the public’s health was at stake. In the medical sciences, cause always required inference.
The committee established a clear set of criteria to evaluate the significance of a statistical association. Recognizing that inference requires judgment, the committee sought to define this process specifically, outlining five particular conditions for judging causal relations:Consistency of the Association. Comparable results are found utilizing a wide range of methods and data.
Strength of the Association. The cause and effect has a dose response, the greater the exposure, the more likely the effect.
Specificity of Association. The effect is typically and powerfully associated with the cause. (90 percent of all lung cancers were found to occur among smokers.)
Temporal Relationship of Associated Variables. The cause must precede the effect.
Coherence of the Association. There must be an overall logic to the cause-and-effect relationship.59 The report, for example, demonstrated that the epidemiological findings made sense in light of the animal experiments and knowledge of the pathology of cancer.
Through these five principles, the assessment of causality became part of a consistent and rational scientific explanation. These criteria are now the basic orthodoxy for integrating quantitative techniques with other data to make a causal inference regarding disease. Although the criteria themselves had been used in the past, they had never been so systematically and categorically articulated.60
As committee member Leonard Schuman later explained in an interview, what struck the committee was the “consistency of the findings” on lung cancer. Over the thirty case-controlled studies the committee examined, “the strength of the associations” was undeniable, “regardless of the methodology, regardless of the controls, regardless of the characteristics of the case samples . . . the outcome was the same.”61 The surgeon general’s report effectively ended any remaining medical and scientific uncertainty concerning the harmfulness of smoking. Their conclusion did not mean that important scientific questions about tobacco no longer needed examination, but the essential question, systematically and thoroughly investigated for more than a decade, had been definitively resolved. The core skeptics—now almost exclusively tied to the industry—had been marginalized and delegitimated. At the press conference announcing the committee’s findings, Terry was asked whether he would now advise a patient to stop smoking. His answer was an unequivocal “yes.”62
Those committee members who smoked were now confronted with their conclusions. Terry, another cigarette smoker, had switched to a pipe just weeks before the 1964 report was released. He explained, “I became increasingly more convinced that cigarettes were not good for me and frankly that I was not setting a good example for the American youth and the American public.”63 Schuman, who had also continued to smoke during the work of the committee, followed Terry’s example and announced that he had smoked his last cigarette. In spite of the findings, as well as the urgings of his fellow committee members and the entreaties of his wife and daughter, Cochran relied on his own statistical analysis to support his decision to continue smoking. Having smoked for a long time, he could not become a statistical nonsmoker, only a former smoker. Quitting now, he reasoned, would reduce his chances of succumbing to lung cancer from 40 percent higher than a nonsmoker’s to 24 percent. “I think the comfort of my cigarettes is worth that 16 percent chance,” he explained. He nonetheless conceded that he would probably cut down, and he noted that “I certainly intend to see that my children never start.”64
In the year following the release of the report, Fieser, the heaviest smoker on the committee, was diagnosed with lung cancer. Following the removal of a lung, he wrote to his former colleagues, “You may recall that although fully convinced by the evidence, I continued heavy smoking throughout the deliberations of our committee and invoked all the usual excuses. . . . My case seems to me more convincing than any statistics.”65 Suffering as well from emphysema, heart disease, and bronchitis, all linked in the report to smoking, Fieser now relinquished his cigarettes once and for all. He wrote to Cochran, urging him to quit as well. “I recommend total nonsmoking, for it certainly makes you feel better,” Fieser told his Harvard colleague. “I have not smoked since August 27th and do not find abstinence particularly painful.”66 Disease and looming mortality fractured denial with a power that the most intimate acquaintance with the data could not match.
For the industry, the report offered an opportunity to change course by beginning to warn its patrons about the risks of using its product. Instead, the industry chose to maintain the strategy it had adopted in 1953: insist that there is no proof that tobacco causes dise
ase; disparage and attack all studies indicating such a relationship; support basic research on cancer largely unrelated to the hypothesis that smoking and cancer are linked; and support research on alternative theories of carcinogenesis. These four principles would continue to guide the industry, which was now firmly under the control of its legal counsel.
Although the Surgeon General’s Advisory Committee cited a wide range of evidence beyond statistical and epidemiological findings, critics—especially those representing the tobacco industry—continued to portray the causal link as but a mathematical aberration. Given the definitive findings of the surgeon general’s report, the cigarette companies were forced to redouble their efforts to maintain the smoke screen of “scientific controversy” and “uncertainty.” They quickly developed a policy, determined by their legal staffs, to neither deny nor confirm the findings. In public, they continued to insist on the need for more research; the “merely statistical” nature of the surgeon general’s conclusion; and their eagerness for their customers to “keep an open mind.” They agreed to emphasize the “much” that was not known and to maintain that experimental evidence to demonstrate causality was still lacking. Little yet again offered his now traditional perspective:After ten years, the fact remains that knowledge is insufficient either to provide adequate proof of any hypothesis or to define the basic mechanisms of health and disease with which we are concerned. It is true now as it was in 1954 that continued research in all areas where knowledge is deficient offers the best hope for the future.67
And thanks to Little and the TIRC, prominent news sources would continue to report the “controversy.”68 The industry had constructed a standard of “proof ” that it knew could never be met. This was not a clash of scientific epistemologies or research methods; it was a calculated PR approach, brilliantly conceived and executed for inventing controversy. Sustaining the product in the face of overwhelming knowledge of its dire harms called not for more science but for a public marketing strategy.
Tobacco researchers often expressed frustration with the industry’s self-interested construction of “proof.” Wynder noted that calls for experimental evidence negated the potential for any conclusion: “If you doubt statistics . . . you have already cut off every possible road to coming to an answer to the problem before you even start it.”69 Others reached similar conclusions. As A. Bradford Hill explained in 1965:All scientific work is incomplete—whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. That does not confer upon us a freedom to ignore the knowledge we already have, or to postpone action that it appears to demand at a given time.
Who knows, asked Robert Browning, but the world may end tonight? True, but on available evidence, most of us make ready to commute on the 8:30 the next day.70
The authoritative voice of the Surgeon General’s Advisory Committee and the subsequent surgeon general’s reports left the industry with little room to maneuver. Little’s repeated insistence on scientific uncertainty was wearing thin. In the face of the surgeon general’s report, the decade-long strategy of denial and distortion of the medical evidence would receive new scrutiny within the industry.71
Industry researchers and executives tacitly acknowledged the scientific consensus even before the release of the first surgeon general’s report. Even though their public position remained unchanged, industry executives internally expressed great concern about the government’s report. It constituted the most significant crisis for tobacco companies since 1953, when they created the TIRC. With its key defenses in disarray following the report’s release, the TIRC sought to construct a response. Its first act was to change its name. The TIRC now became the Council for Tobacco Research (CTR). At the same time it broke its tie of more than a decade with Hill & Knowlton, which continued to maintain the Tobacco Institute account. At the TIRC meeting in which the name change was approved, tobacco executives urged Little to take the offensive in critiquing the report. Little outlined what he saw to be the chief problems in the review, centering attention on issues of measurement (inhalation, whole smoke versus condensates, and socioeconomic differences in lung cancer rates), and he was encouraged to raise these issues with Terry and the PHS. Bowman Gray of R.J. Reynolds, as he had done in the past, urged a more aggressive response to the “attack” of the surgeon general. Rather than using the TIRC and the Scientific Advisory Board to promote “more research,” he argued for a sustained counteroffensive. According to the minutes of the meeting, Edwin P. Finch, president of Brown & Williamson, chided the TIRC leadership and “expressed disgust . . . at the fat-assed attitude of Hartnett and company”—which, according to American Tobacco executive Robert Heimann, “had gone on for ten years.”72
Others, however, questioned the decade-old industry approach of maintaining “controversy.” A number of analysts now concluded that this formulation could only alienate the public and weaken the industry’s credibility. After more than a decade of denial and obfuscation, the report offered the industry an opportunity to set a new course, to accept the risks of its product, intensify its research into modifying these risks, and sharply reconfigure its promotion and marketing. These alternative strategies received significant comment and analysis within the inner circles of tobacco executives and scientists.
A number of industry leaders recognized that in light of the overwhelming accrual of scientific and medical studies of smoking’s harms, the strategy created by Hill & Knowlton in 1953 had become exceedingly threadbare. It was a new era, and the sale and marketing of cigarettes demanded new thinking. In July 1963, Brown & Williamson’s chief counsel, Addison Yeaman, offered this confidential assessment:Whatever qualifications we may assert to minimize the impact of the Report, we must face the fact that a responsible and qualified group of previously non-committed scientists and medical authorities have spoken. One would suppose we would not repeat Dr. Little’s oft reiterated “not proven.” One would hope the industry would act affirmatively and not merely react defensively.
In calling for an active response, Yeaman asked that other tobacco industry executives accept that the cigarette had been categorically shown to be a serious risk to health:Certainly one would hope to prove there is no etiological factor in smoke but the odds are greatly against success in that effort.73
He proposed a wholly new approach:I suggest that for the new research effort we enlist the cooperation of the Surgeon General, the Public Health Service, the American Cancer Society, the American Heart Association, American Medical Association and any and all other responsible health agencies or medical or scientific associations concerned with the question of tobacco and health. The new effort should be conducted by a new organization lavishly financed, autonomous, self perpetuating, and uncontrolled save that its efforts be confined to the single problem of the relation of tobacco to human health.74
The TIRC, given its history, would not be in a good position to perform this task. Yeaman acknowledged that since its inception, the TIRC had principally acted as a public relations unit:The TIRC cannot, in my opinion, provide the vehicle for such research. It was conceived as a public relations gesture and (however undefiled the Scientific Advisory Board and its grants may be) it has functioned as a public relations operation. Moreover its organization, certainly in its present form, does not allow the breadth of research—cancer, emphysema, cardiovascular disorders, etc.—essential to the protection of the tobacco industry.75
This proposal never came to pass. Denial of the relationship between smoking and disease had been deemed a crucial element of the industry’s legal defense against liability litigation, and any shift in this position was viewed as potentially enhancing the litigation risk. Yeaman soon assumed the helm of the TIRC (now CTR) and never changed its course. The organization continued to argue that there was still a controversy and continued to fund research unrelated to the question of smoking and health. The central problem with the industry’s position—and cover-up
s in general—was that there was no easy exit strategy. Having steadfastly denied the harms of smoking in the face of scientific data for a decade, the industry lawyers saw no alternative but to continue.
Still, the position of insisting on a “continuing controversy” had itself become a source of internal controversy. In 1967, an R.J. Reynolds executive, J. S. Dowdell, noted that “the industry has little, if any, positive evidence” to refute the findings that cigarettes cause disease.76 After more than a decade of TIRC research, no evidence to contradict the knowledge of smoking’s harm had been produced. In 1968, William Kloepfer, Jr., vice president of public relations for the Tobacco Institute, wrote to Earle Clements, the institute’s president, to say that that the industry’s consistent denial of harm and risk might now be untenable:Our basic position in the cigarette controversy is subject to the charge, and may be subject to a finding, that we are making false or misleading statements to promote the sale of cigarettes.77
There was much to be said for Kloepfer’s assessment. The industry’s very efforts to limit its legal liabilities were augmenting those liabilities.
Helmut Wakeham, the director of research and development at Philip Morris, advocated a similar shift in strategy starting in 1970. In May of that year, he wrote to Clements expressing doubts about the industry approach in the aftermath of the report. He cautioned, “I think we have spent too much time and energy being ‘negative’ on the subject of smoking and health, undermining our public image,” and went on to warn that the industry’s focus on controversy could have contradictory elements:Our medical research support efforts through C.T.R. and A.M.A. have been confusing and contradictory in the public eye because we have on the one hand proclaimed these endeavors to be aimed at “finding the truth about smoking and health” and at the same time denied the existence of a problem.