The Cigarette Century
Page 27
The best efforts of the voluntary health organizations, the surgeon general, and other public agencies failed to bring closure to this carefully constructed controversy. This situation, in which powerful corporate interests both shaped and clouded a crucial scientific debate, ultimately compelled the surgeon general and the federal government to take unprecedented action. An independent and definitive assessment of the scientific evidence could not be achieved without state intervention. A question that had arisen in doctor’s offices and clinics found its ultimate resolution in conference rooms in Washington. With medicine and public health now buffeted by powerful economic and political forces of commerce, the federal government found it necessary to develop new capacities for the disinterested and independent evaluation of data.
By the 1960s, pressure was building for the U.S. Public Health Service to take some concerted action against smoking. The voluntary health agencies, including the American Lung Association and the American Heart Association, proposed in June 1961 that President Kennedy appoint a commission to “study the widespread implications of the tobacco problem.” 28 Kennedy declined to respond, apparently to avoid alienating southern congressional delegations. There was little corresponding enthusiasm in Congress when Senator Maurine Neuberger (D-Oregon) proposed legislation also calling for a commission. By the spring of 1962 it looked like the issue might be tabled, when Kennedy was asked about the health controversy during a nationally televised press conference. His halting response revealed his surprise:The—that matter is sensitive enough and the stock market is in sufficient difficulty without my giving you an answer which is not based on complete information, which I don’t have, and therefore perhaps we could—I’d be glad to respond to that question in more detail next week.29
Two weeks later, Kennedy’s surgeon general, Luther Terry, announced that he would establish a committee to fully investigate the ongoing questions of smoking and health.30 A native of Alabama, Terry had come to the surgeon general’s office after a long career in the PHS, including most recently eleven years at the National Heart Institute.31
To offer a rigorous and systematic assessment of the health implications of smoking, the Terry committee had to provide a full and open inquiry among independent scientists and medical experts. Terry’s staff created a list of candidates for the advisory committee consisting of some 150 individuals representing fields ranging from pulmonary medicine to statistics, cardiology to epidemiology. The PHS then circulated the list to the American Cancer Society, the American Heart Association, National Tuberculosis Association, American Medical Association, and the Tobacco Institute, the tobacco industry’s PR arm.32 Each group had the right to eliminate any name, without any reason cited. Terry also eliminated individuals who had already published on the issue or had taken a public position.
Not surprisingly, this procedure drew objections. Congressman Clark MacGregor wrote to Terry, “It has been suggested that several members of the commission were appointed on the basis of tobacco industry recommendations. If so, this would immediately suggest a conflict of interest destructive to the necessary unbiased study and recommendations of the commission.”33 But the selection process was actually a mark of Terry’s political savvy. Having anticipated that the industry would seek to discredit any findings that suggested the harms of tobacco, he and his advisors had preempted any chance that the report might be attacked on the basis of the committee’s membership. The group was scrupulously made up of five smokers and five nonsmokers.34 Photos of the committee meeting at the National Library of Medicine show a smoke-filled room with a conference table littered with ashtrays.35 The constitution of the committee demonstrated Terry’s commitment to reaching a genuine and definitive consensus.
The TIRC monitored the selection process carefully. Peter Hamill, a young commissioned officer in the PHS who served as staff director of the committee, maintained consistent contact with the industry representatives, frequently consulting with Robert Hockett, associate scientific director of the TIRC, about the prospective appointees. According to Hockett, Hamill promised him that “one of our nominees, and probably two, will be on the commission.”36 Two committee members, chemist Louis Fieser, who had consulted with Arthur D. Little on its tobacco industry projects, and pharmacologist Maurice Seevers were widely perceived as sympathetic to the industry.37
Prospective committee members were also reviewed by Stanley Temko, the industry’s counsel for the Tobacco Institute, who shared them with Ed Jacob, an attorney who directed the “Special Projects” arm of the TIRC, as well as the ubiquitous C. C. Little. They shot down the nomination of University of Chicago pathologist Clayton Loosli because they understood that “he has become a nonsmoker.” After Little consulted with Jacob and George Allen, president of the Tobacco Institute, they agreed that they would not object to William Cochran and Stanhope Bayne-Jones, but would oppose Esmond Long because of his association with the American Cancer Society. 38 No one turned down an invitation to serve on the committee, indicating to Terry “that these scientists were convinced of the importance of the subject and of the complete support of the Public Health Service.”39
The committee drew on the varied disciplinary strengths of its members. Walter J. Burdette was a prominent surgeon and chair of the surgery department at the University of Utah; John B. Hickam was chair of internal medicine at the University of Indiana; Charles LeMaistre was a pulmonary specialist and director of the chest program at Parkland Hospital in Dallas. The pathologists joining the committee were Emmanuel Farber, chair of pathology at the University of Pittsburgh, and Jacob Furth from Columbia, an expert on the biology of cancer. Maurice Seevers, a noted toxicologist, chaired the University of Michigan pharmacology department. Louis Fieser of Harvard University was an eminent organic chemist. Completing the committee were Bayne-Jones, a bacteriologist, former head of New York Hospital and dean of Yale Medical School; Leonard M. Schuman, epidemiologist at the University of Minnesota; and Cochran, a Harvard University mathematician with expertise in statistical methods. By appointing this distinguished group, Terry assured that the advisory committee would be protected from charges of bias. The committee possessed a full range of experts, with no single discipline dominant.40 Moreover, the methodological diversity of the committee reflected the understanding that determinations of causality required a range of medical and scientific perspectives.
The charge Terry set for the committee was one stage of a two-part process. The assignment of the advisory committee was to arrive at a clinical judgment—to determine the “nature and magnitude of the health effects of smoking.”41 As one public health official explained, “What do we (that is, the Surgeon General of the United States Public Health Service) advise our Patient, the American public, about smoking?”42 These findings would be followed by phase II, proposals for remedial action. This separation into two phases kept the committee away from the political morass that circled around the tobacco question. Terry astutely recognized that the advisory committee could speak with authority only about the scientific and medical issues; he would leave the policy questions to the politicians. This is not to suggest that the report was not a political document. Its main purpose was to provide sufficient medical authority to generate new public policies.43
What Terry sought—and ultimately got—was a political document that was scientifically unimpeachable. Without it, the regulatory agencies and the Congress would lack the basis, in the face of industry-generated “controversy,” to create powerful public health policies relating to smoking and health. But while the committee was working, the PHS continued to express frequent concerns about its role and authority in relation to the medical profession. Bayne-Jones would somewhat defensively point out that the report made no attempt “to advise anybody to [do] anything.”44 The job of the committee (on behalf of the PHS) was to answer a single, strictly empirical question: is smoking harmful? That they were able to do so was a major accomplishment, bringing to an end the notion that
there remained a persistent, unresolved scientific controversy.
At its first meeting, in November 1962, the committee decided that it would base its assessment on a comprehensive review of the now considerable existing data; new research would greatly delay the announcement of any conclusions, and given more than a decade of substantial peer-reviewed science, there was already exhaustive data on which to make such a judgment. Over the next year, the committee met eight more times. In between these meetings, both committee members and staff worked concertedly to review, critique, and synthesize the formidable volume of scientific work on tobacco.
William Cochran proved to be the committee’s central figure, subtly negotiating and leading members through the complex statistical arguments concerning causality. He wrote the pivotal chapter on statistics in the final report and made crucial contributions to the chapter on “Criteria for Judgment.” He also collected all the prospective findings that had been reported in the literature and integrated their analyses. In this way, he was able to assure their consistency and at the same time test their significance. In doing this large-scale integration, Cochran helped to develop the essential underpinnings of what would come to be called meta-analysis in statistics and epidemiology. The whole was greater than the sum of its parts; the results of numerous studies possessed far more statistical and analytic power than any single study.45 Not only had each new study confirmed earlier findings, the collective data, as Cochran conclusively demonstrated, was especially robust.
Burdette initially drafted the chapter on lung cancer, but after members of the committee objected that he had not done justice to the epidemiological findings, the chapter had to be completely rewritten. Burdette apparently considered resigning but was persuaded by his fellow members to stay on. The loss of any committee member during the process would have shattered the necessary unanimity. The chapter that appeared in the report contained sections written by Burdette as well as Schuman and others. As a result, the committee’s work rested on the complex interpersonal and intellectual process of disciplinary respect, trust, and negotiation. Bayne-Jones, the senior member of the committee and a seasoned administrator and negotiator, had to use all of his considerable military and administrative experience to ensure that the process led to scientific consensus.
Given the diversity of scientific training and temperament, tensions within the group were a constant. Farber, a pathologist, apparently worried about the use of the term cause. A strict constructionist whose work was dependent on visualizing pathology, he nonetheless came to be convinced that smoking could legitimately be called a cause of lung cancer. The ultimate agreement that the language of causality was not only appropriate but crucial, fundamentally shaped the committee’s final report. Bayne-Jones later explained that the members had concluded that the “monomorphic conceptions of Koch and others [to determine causality] were too strict” to accommodate the multiple causes of complex diseases.
Louis Fieser, the distinguished Harvard organic chemist, smoked throughout the meetings, up to four packs a day. Committee members warned him to cut down while they sifted through hundreds of studies demonstrating the serious harms of smoking. He didn’t, even though he signed on to the committee’s conclusions. With this evidence of the effects of nicotine before his eyes, Maurice Seevers, the committee’s expert in pharmacology, still refused to accept the idea that smoking was addictive by current standard definitions. He conceded that it was habit-forming and smokers might experience withdrawal. But the prevailing definitions of addiction centered on the social impacts of drug use. Since it was widely perceived that cigarettes had no “social pathologies” like alcohol, marijuana, or heroin, the committee followed Seevers’s lead. The addictiveness of smoking would ultimately be the subject of the surgeon general’s report of 1988, which documented the addictive properties of nicotine.
During the year the committee was at work, the prominent skeptic Joseph Berkson wrote repeatedly to Cochran, pointing to what he saw as fundamental flaws in the statistical arguments. Cochran offered a sympathetic ear but nonetheless moved the committee forward. To assure that the group fully reviewed Berkson’s position, Cochran invited him to prepare a written statement summarizing his critique. Cochran and colleagues carefully reviewed this statement and ultimately dismissed it. By 1963, Berkson’s critiques had been repeatedly rebutted. Berkson would soon join the last remaining hard-core skeptics on the tobacco industry payroll, where he became a paid consultant.46 While no one questioned his sincerity, it had become clear that his doubt was impervious to evidence.
For the seventy million regular smokers in the United States, the report of the committee’s findings confirmed their worst fears. It told them that the death rate from lung cancer was 1,000 percent higher among men who smoked cigarettes than among nonsmokers. The report also found chronic bronchitis and emphysema to be of far greater incidence among smokers, and it found that rates of coronary artery disease, the leading cause of death in the United States, were 70 percent higher among smokers. In short, cigarette smokers placed themselves at much higher risk of serious disease than did nonsmokers.47
The tobacco industry and its TIRC had no intention of waiting passively for the Surgeon General’s Advisory Committee to report its assessment. Rather, they worked assiduously to attempt to shape the process and conclusions. In the first instance, they had sought, wherever possible, to influence the selection of the committee members. Once the Committee was selected and its staff appointed by the PHS, the industry generously offered the services of the TIRC for consultation and research support. In his contacts with committee members and staff, Little reiterated that he hoped the final report would direct attention to ongoing gaps in scientific knowledge.48 Throughout 1963, Little and his assistants at TIRC, Robert Hockett and William Hoyt, had frequent correspondence and meetings with the committee’s medical coordinator, Peter Hamill, who eagerly sought their counsel and advice.
Hamill’s job was to coordinate the collection of the data and the organization of the inquiry. Little wrote at one point that “I feel that he really would appreciate our taking a more active part behind the scenes.”49 In November 1962, as the work of the committee was getting underway, Hamill wrote to Little expressing his hope that the TIRC would play an important role. “I am very optimistic about the services which you can render this study,” Hamill said. “In the ensuing months I will undoubtedly be taking from you much more than I will be giving, but I hope you will not be offended by having your brains picked.”50 He called the TIRC to invite Little and Hockett to attend the committee meetings as observers. His superiors quickly nixed this idea, and Hamill called to correct the “mistake.”51
As Hamill took on the nearly monumental task of administering the work of the committee, he demonstrated little understanding of the previous decade of scientific and political combat. Further, he did not seem to have grasped the complexities of assuring an unbiased and objective process. As the study was commencing, for example, he met with Charles Kensler, who had worked on the Liggett contracts at Arthur D. Little for nearly a decade. Afterwards, Hamill urged that the PHS hire ADL as a consultant on statistics.52
Following a visit with C. C. Little, Hamill also wrote Assistant Surgeon General James Hundley, liaison to the advisory committee, urging him to permit Little to consult with the committee. “Dr. Little and his staff did not appear to be desperately trying to protect tobacco or to create jobs for themselves,” he argued, and “they seemed overwhelmingly pleased with our activities and seemed most desirous to help in any way possible.” All but overwhelmed with the committee’s workload, and strikingly naive about the TIRC, Hamill failed to see Little’s generous offers of help as attempts to gain influence.
Hamill was no doubt eager to assure the industry representatives that they would get a fair shake from the committee. He admired Little as a “great man of science,” and Little reciprocated by offering a room at the Harvard Club whenever Hamill might be visiting New
York on committee business. This offer Hamill gladly accepted. After meeting with Little at the TIRC offices in New York in 1963, Hamill wrote a note to the files explaining: “My impression of Dr. Little is that he is one of the most estimable men I have ever met. For the past four years I’ve heard rumors that he was the soul of integrity, and also that he had been one of the true giants in the biological sciences, but that he was nearing his dotage and was a mere figurehead in the TIRC. . . . [M]y impression was that the first two items were entirely correct but the last two items were not quite accurate.”53 As the report was nearing completion, Hamill was placed on medical leave, relieved by the more experienced and appropriately detached Eugene H. Guthrie, who guided the committee through the complex discussions and debates leading to its unanimous conclusions. According to Bayne-Jones, Hamill had suffered a breakdown under the weight of work and anxiety.54 Hamill later denied this.55 Nonetheless, after August 1963, he was no longer involved in the work of the committee.
Following the release of the report, Hamill would pay yet another ill-advised visit to Little at the TIRC headquarters in New York. According to Little, Hamill “expressed real disappointment in the quality of the Report” and told him that “he does not believe in any specific effect of tobacco in causation of the various diseases.” Little concluded, “I have a strong feeling that this is a man of whom we probably can and should make use.”56