The 1964 Surgeon General Report Represented a Scientific Consensus

that Smoking Causes Disease a. The Process and Methodology of the Surgeon General's Report 642. In 1961, the Surgeon General created his Advisory Committee on Smoking and

¶Health to perform a comprehensive evaluation of all the existing research regarding cigarettes and disease and offer a definitive assessment. The process of the Committee's formation, its selection, its substantive work, and its findings were designed to represent a model of objective, public scientific and medical inquiry based on a rigorous and systematic assessment of the health implications of smoking. Brandt WD, 99:5-112:1. The findings of the Advisory Committee would become the Surgeon General's Report.

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Surgeon General Luther Terry first drew up a list of some 150 individuals as potential Advisory Committee members. None were known to have taken a public position regarding the relationship of smoking and health. These individuals represented a number of fields and medical specialties from pulmonary medicine to statistics, cardiology to epidemiology. This list was then circulated to the American Cancer Society, the American Heart Association, the National Tuberculosis Association, and the American Medical Association, as well as the Tobacco Institute. Each group was permitted to eliminate any name, without citing any reason. Individuals who had already published on the issue or had taken a public position were also eliminated. The selection process indicated Terry's commitment to a process that would produce a genuine and definitive consensus. Dr. Terry had wanted to ensure that the Report could not be attacked on the basis of its membership. All ten of the members finally selected were eminent physicians and scientists; eight were medical doctors, one was a chemist and the other a statistician. Three of the panelists smoked cigarettes, two others occasionally smoked pipes or cigars. VXA1601844-2232, at 1864-1867 (US 64057) (1964 Surgeon General Report); Brandt WD, 100:8-102:8.
All of the major companies manufacturing cigarettes and other tobacco products were invited to submit statements and any information pertinent to the inquiry. The replies which were received were taken into consideration by the Committee. VXA1601844-2232 at 1870 (US 64057) (1964 Surgeon General Report); Brandt WD, 100:8-102:8.

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Terry's first ten selections all agreed to serve on the Advisory Committee, indicating to him "that these scientists were convinced of the importance of the subject and of the complete support and confidence of the Public Health Service." VXA2511396-1397 at 1396 (US 21376) (Terry, Luther L., The Surgeon General's first report on smoking and health: A challenge to the medical profession, New York State Journal of Medicine, 1254 (1983)); Brandt WD, 102:4-23.
The Report drew on the respective disciplinary strengths of the Advisory Committee members. Walter J. Burdette was a prominent surgeon and chair of the Surgery Department at the University of Utah; John B. Hickman was the Chair of Internal Medicine at the University of Indiana; and Charles LeMaistre was a pulmonary specialist and head of a very large cancer treatment center. The pathologists joining the Committee were: Emmanuel Farber, Chair of Pathology at the University of Pittsburgh; Jacob Furth from Columbia, an expert on the biology of cancer; and Maurice Seevers, Chair of the University of Michigan Pharmacology Department. Louis Feiser of Harvard University was an eminent organic chemist. Completing the Committee were: Stanhope Bayne-Jones, a bacteriologist, former head of New York Hospital and Dean of Yale Medical School; Leonard H. Schumann, epidemiologist at the University of Minnesota; and William G. Cochran, a Harvard University mathematician with expertise in statistical methods. VXA1601844-2232 at 1864- 1867 (US 64057) (1964 Surgeon General Report); Brandt WD, 102:9-23.
Terry divided the preparation of the 1964 Report into two distinct phases. The first phase, the work of the Advisory Committee, was to determine the "nature and magnitude of the health effects of smoking." The Committee sought to arrive at a clinical judgment on smoking. As one public health official explained, "What do we (that is, The Surgeon General of the United States

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¶Public Health Service) advise our patient, the American public, about smoking?" VXA2511346648. The Advisory Committee met together nine times in just over a year. In between these meetings, both Committee members and staff worked to review, critique, and synthesize what had become a formidable volume of scientific work on tobacco. Terry promised that the report on these findings would be followed by phase II, proposals for remedial action, thereby insulating the Committee from the politics that swirled around the tobacco question. Terry recognized that the Advisory Committee could only speak with authority about the scientific nature of the health risks of smoking; he would leave the policy questions to the political process. Brandt WD, 103:23- 104:19.

Beginning with the first Report in 1964, the United States Public Health Service has followed the scientific consensus formation approach when producing a Report of the Surgeon General on Smoking and Health. The scientific community forms a consensus on issues of causation by reviewing all of the scientific evidence available; examining that evidence for its strength, consistency, coherence, temporal association and biological plausibility; and then reaching a judgment as to whether the data support a causal relationship between smoking and a disease. Burns WD, 14:13-19.
The Reports go through a careful process to ensure that individual biases play no role in determining the conclusions or statements reached. That process occurs through a set of expert reviews of the Report at various stages in its preparation. Individual scientists, usually outside of the government, are first selected and asked to write chapters on a given topic. Sometimes the entire Report will be devoted to a specific topic, like cancer or heart disease or lung disease. In that case, individuals are asked to write chapters or sections on specific questions that relate to the general issue examined, so that chapters can be assembled to cover the entire topic. The individual authors selected are extremely knowledgeable in the specific area that they are asked to write about. They are directed to consider all of the pertinent scientific literature and to base the chapter's conclusions on the data presented in that literature rather than on the author's personal views. Initial drafts of chapters are prepared for each Report by the individual authors, and the initial drafts are received and then edited into chapters. Id.

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Once the chapters are submitted by the initial author, the editors make all subsequent changes and the chapters are not resubmitted to those authors for their approval of the changes. The chapters are next sent out to a group of expert scientific reviewers for peer review of their scientific accuracy and completeness, as well as for balance, tone and appropriateness of the conclusions drawn from the scientific data. These comments are integrated into the volume, and the entire volume is then sent out to a group of senior scientists in the academic community for further review for its accuracy, balance and tone. The Report is also formally reviewed by each of the agencies of the Public Health Service. Id.
Once these many reviews are completed, the editors again integrate the comments into the text to strengthen its substance. Each Report is then submitted for final formal clearance by the Centers for Disease Control, by the Assistant Secretary for Health, by the Surgeon General, and by the Secretary of Health and Human Services. Once the Report is cleared, it is transmitted as a formal requirement of law to Congress as the official position of the HHS on the issue. It is also released to the public and the press. Id. at 15:3-16:7. In the 1960s and 1970s, it took approximately one year to complete the Report preparation process. More recently, given the vast expansion in the body of smoking and health literature, it has required two to three years to accomplish the task of preparing a Report of the Surgeon General on Smoking and Health. Burns WD, 16:8-11.

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As part of that process, the Advisory Committee established a set of criteria to evaluate the significance of a statistical association. Recognizing that such evaluation requires judgment, the Committee sought to specifically define the process, as rigorously as possible, and set forth five specific conditions for judging causal relations:

a. Consistency of the Association. Nearly all the retrospective and prospective studies produced comparable results, despite the fact that different methods were employed for collecting data.

b. Strength of the Association: the ratio of lung cancer rates for smokers versus nonsmokers. The Committee assessed the significance of the dose effect phenomenon, finding that risk increased with amount smoked. According to the Report:

[A]verage smokers of cigarettes have a 9- to 10 fold risk of developing lung cancer, and heavy smokers, at least a 20-fold risk. Thus it would appear that the strength of the association between cigarette smoking and lung cancer must be judged to be high.

c. Specificity of Association. This criteria, according to the Report:

implies the precision with which one component of an associated pair can be utilized to predict the occurrence of the other, i.e. how frequently the presence of one variable (e.g., lung cancer) will predict, in the same individual, the presence of another (e.g., cigarette smoking).

In a discussion of the specificity of the relationship between any factor possibly causal in character and a disease it may produce, it must be recognized that rarely, if ever, in our biologic universe, does the presence of an agent invariably predict the occurrence of a disease. Second, but not less

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important, is our growing recognition that a given disease may have multiple causes.

In the current case, the specificity of the association was especially strong. The Report explained, "of the total load of lung cancer in males about 90 percent is associated with cigarette smoking."

d. Temporal Relationship of Associated Variables: the Advisory Committee wrote:

Exposure to an agent presumed to be causal must precede, temporally, the onset of a disease which it is purported to produce. . . . [N]o evidence has thus far been brought forth to indicate that the initiation of the carcinomatous process in a smoker who developed lung cancer antedated the onset of smoking.

e. Coherence of the Association: the Advisory Committee concluded:

A final criterion for the appraisal of causal significance of an association is its coherence with known facts in the natural history and biology of the disease.

¶VXA1601844-2232 at 2033-2036 (US 64057) (1964 Surgeon General Report); Brandt WD, 105:6111:7.

The 1964 Surgeon General's Advisory Committee's assessment of causality was based on a coherent and logical set of criteria, which have become the basic methodology for causal inference concerning disease since issuance of the Report. Brandt WD, 104:20-108:21.

¶b. The Conclusions

The 387-page 1964 Surgeon General's Report, citing 7,000 articles, came to the following conclusions:

Cigarette smoking is associated with a 70 percent increase in the age-specific death rates of males. The total number of excess deaths causally related to cigarette smoking in the U.S. population cannot be

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accurately estimated. In view of the continuing and mounting evidence from many sources, it is the judgment of the Committee that cigarette smoking contributes substantially to mortality from certain specific diseases and to the overall death rate.

Cigarette smoking is causally related to lung cancer in men; the magnitude of the effect of cigarette smoking far outweighs all other factors. The data for women, though less extensive, point in the same direction.

The risk of developing lung cancer increases with duration of smoking and the number of cigarettes smoked per day, and is diminished by discontinuing smoking.

¶VXA1601844-2232 at 1884 (US 64057) (1964 Surgeon General Report); Brandt WD, 108:22-111:7.

The 1964 Report carefully evaluated the animal studies that had been conducted up to that time:

Condensates of tobacco smoke are carcinogenic when tested by application to the skin of mice and rabbits and by subcutaneous injection in rats.

Bronchogenic carcinoma has been produced in laboratory animals by the administration of polycyclic aromatic hydrocarbons, certain metals, radioactive substances, and viruses. The histopathologic characteristics of the tumors produced are similar to those observed in man and are predominantly of the squamous variety.

¶VXA1601844-2232 at 1884, 1994-1997, 2016 (US 64057) (1964 Surgeon General Report); Brandt

¶WD, 108:22-111:7.

The 1964 Report found much higher death rates among smokers, as compared with nonsmokers; these rates increased with consumption:

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The death rate for smokers of cigarettes only, who were smoking at the time of entry into the particular prospective study, is about 70 percent higher than that for nonsmokers. The death rates increase with the amount smoked. For groups of men smoking less than 10, 10-19, 20-39, and 40 cigarettes and over per day, respectively, the death rates are about 40 percent, 70 percent, 90 percent, and 120 percent higher than for nonsmokers. The ratio of the death rates of smokers to nonsmokers is highest at the earlier ages (40-50) represented in the studies, and declines with increasing age. The same effect appears to hold for the ratio of the death rate of heavy smokers to that of light smokers. In the studies that provided this information, the mortality ratio of cigarette smokers to nonsmokers was substantially higher for men who started to smoke under age 20 than for men who started after age 25. The mortality ratio was increased as the number of years of smoking increased. In two studies which recorded the degree of inhalation, the mortality ratio for a given amount of smoking was greater for inhalers than for non- inhalers.

¶VXA1601844-2232 at 1888-1889 (US 64057) (1964 Surgeon General Report); Brandt WD, 108:22111:7.

The 1964 Report also reached conclusions as to coronary heart disease:

Although the causative role of cigarette smoking in deaths from coronary disease is not proven, the Committee considers it more prudent from the public health viewpoint to assume that the established association between cigarette smoking and coronary disease has causative meaning than to suspend judgment until no uncertainty remains.

¶The 1968 Report went a step further, concluding that

[b]ecause of the increasing convergence of epidemiological and physiological findings relating cigarette smoking to coronary heart disease it is concluded that cigarette smoking can contribute to the development of cardiovascular disease and particularly to death from coronary heart disease.

¶VXA1601844-2232 at 1885 (US 64057) (1964 Surgeon General Report); ATC1081418-1542 at

¶1430 (US 65351) (1968 Surgeon General Report).

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From both a clinical and a public health perspective, the 1964 Report concluded that stopping smoking lowered an individual's risk of disease and health:

Cigarette smokers who had stopped smoking prior to enrollment in the study had mortality ratios about 1.4 as against 1.7 for current cigarette smokers. The mortality ratio of ex-cigarette smokers increased with the number of years of smoking and was higher for those who stopped after age 55 than for those who stopped at an earlier age.

¶VXA1601844-2232 at 1888-1889 (US 64057) (1964 Surgeon General Report).

The 1964 Surgeon General's Report on Smoking and Health is widely considered by historians to be one of the most significant documents in the history of twentieth century public health. Brandt WD, 99:5-112:1.