Introduction

In 1964, U.S. Surgeon General Luther L. Terry appointed an expert committee to submit a report to review and evaluate the current data on smoking and health. The publication of the committee's report, Smoking and Health: Report of the Advisory Committee to the Surgeon General of the United States (U.S. Department of Health, Education, and Welfare [USDHEW] 1964), marked the first of a long series of reports issued by the Office of the Surgeon General to the American people on smoking and health (Table 3.1). This series of reports, released over a 50-year period, comprises a remarkable set of scientific documents that have provided internationally accepted consensus judgments on the scientific evidence implicating smoking in disease causation. In addition, the reports have built a scientific foundation to support tobacco control programs and interventions intended to control the epidemic of tobacco-caused disease (see Chapter 2, “Fifty Years of Change—1964–2014”). The reports have also been invaluable to the scientific community by highlighting what is known in this area and identifying the critical evidence gaps to be addressed with further research. Finally, the methods for reviewing evidence and causal inference have been widely applied in other contexts (Rothman and Greenland 1998).

Table 3.1

Surgeon General's reports on smoking and health, 1964–2012.

The reports of the Surgeon General have developed a formal framework for assessing evidence on disease causation, and the formats of the reports have provided detailed presentations of the scientific evidence underlying each of their conclusions (USDHEW 1964; U.S. Department of Health and Human Services [USDHHS] 2004). The reports have been produced using a balanced and comprehensive review and editorial process to ensure that the evidence, rather than the authors' opinions, defines the conclusions. Across the five decades of reports, the emphasis has been on the evidence base and the scientific validity of the conclusions, and scientific conclusions have been clearly separated from any policy decisions that may result from the findings.

The result of the work undertaken over this 50-year period has been a series of reports that have maintained their utility and credibility despite marked shifts in governmental policies toward tobacco, powerful opposition from tobacco industry interests, and the sometimes heated debates on science and policy that have taken place within the tobacco control community. This chapter covers the production and evolution of the reports during the past 50 years, emphasizing the processes that have sustained their utility.

Development of a Scientific Consensus

Often considered the first report of the Surgeon General on the health consequences of smoking, the 1964 report on smoking and health was actually (as noted in the introduction above) a report of an expert Advisory Committee to the Surgeon General (USDHEW 1964). Although this report is widely viewed as pivotal in establishing with certainty that cigarette smoking causes lung cancer, a similar conclusion with regard to causation had been reached earlier by several scientific reviews and by Surgeon General Leroy E. Burney (see Chapter 2).

Given the rising evidence and to once again critically review the cumulative evidence, the Surgeon General in 1962 convened an independent group of scientists who had not up to that time publicly expressed an opinion on whether smoking caused lung cancer. This group of scientists was asked to review all of the available evidence on possible links between cigarette smoking and disease and to form a scientific judgment on this issue. In addition, the scientists were expected to report back to the Surgeon General with a solid evidence-based foundation for appropriate remedial action by the U.S. Public Health Service (PHS) responding to the emerging epidemic of lung cancer being caused by a highly profitable consumer product, the cigarette.

To ensure transparency, the committee codified the criteria used to reach the conclusion that smoking causes lung cancer. Both the resulting systematic, transparent review and the synthesis of evidence using those criteria were pioneering for the time.

Development of the Criteria for Causation Used in the 1964 Report

The meaning of the word “cause” has a long and rich philosophical history; the term has been applied variably in different scientific contexts. Among these contexts have been the demonstration of causation experimentally in the laboratory, the causal attribution of a specific infectious disease to a specific microbiologic agent, and the understanding of the mechanism(s) leading to a disease. In the years before the creation of the Advisory Committee, the groups which considered the question of cigarette smoking as a cause of lung cancer recognized that these scientific contexts, and the resulting context-specific constructs of causation, could not be readily applied to the question of whether cigarette smoking caused human disease (Blackburn and Labarthe 2012; Glass et al. 2013). Obtaining direct experimental evidence in humans is an ethical impossibility and understanding the mechanisms of disease occurrence involves considering an ongoing, open-ended set of scientific questions. Furthermore, neither of these scientific contexts for defining causation is well suited to examining the effects of human behaviors and exposures on subsequent disease occurrence in populations.

The early scientific reviews that examined whether smoking causes human disease used the common, generally understood meaning of the term “cause”: that the disease occurs as a result of exposure to the agent. This meaning was expressed in the 1964 report of the Surgeon General as follows: “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” (USDHEW 1964, p. 21).

The 2004 Surgeon General's report, The Health Consequences of Smoking, described the subsequent refinement of the 1964 language for application in public health and epidemiologic considerations as “The qualitative judgment that an exposure causes a particular disease signifies that in the absence of exposure some fraction of cases or deaths would not occur or would occur at a later age” (USDHHS 2004, p. 10).

The 1964 report of the Advisory Committee clearly stated that the decision that cigarette smoking was a cause of lung cancer in men resulted from a judgment based on a synthesis of all of the available evidence, rather than the outcome of a single scientific study or a single line of evidence. Specifically, the report (USDHEW 1964, p. 20) noted:

Statistical methods cannot establish proof of a causal relationship in an association. The causal significance of an association is a matter of judgment which goes beyond any statement of statistical probability. To judge or evaluate the causal significance of the association between the attribute or agent and the disease, or effect upon health, a number of criteria must be utilized, no one of which is an all-sufficient basis for judgment.

Included in the evidence base for the 1964 report were observational data from epidemiologic studies of human populations. During the 1940s and 1950s, epidemiology was rapidly developing as a scientific discipline, but the observational, as opposed to experimental, nature of epidemiologic approaches led some scientists to question whether such approaches could be used to determine causation scientifically. Others confused epidemiologic analyses with the statistical methods used to describe the data (Shimkin 1979). Cigarette manufacturers and their spokespersons capitalized on this confusion by claiming that only experimental approaches could lead to evidence establishing causation: the evidence used by public health authorities to conclude that smoking caused lung cancer was only “statistical” and therefore not scientific (Brandt 2007; Proctor 2011).

Given the ethical impossibility of conducting human experiments to establish causation and recognizing the validity of epidemiologic methods, the various groups (before the Advisory Committee's report) that examined the question of whether cigarette smoking caused lung cancer had relied heavily on epidemiologic studies as a key part of the evidence base establishing causation. Each review described how the epidemiologic data were examined and considered. The reviews acknowledged that epidemiologic studies lacked the methodologic reassurance and needed careful attention to identify potential methodologic flaws, various biases, and both measured and unrecognized confounding (e.g., lifestyle differences between never smokers and smokers) that might have resulted in the demonstrated association. Each of these reports explained how these factors were considered in assessing the evidence, but the Advisory Committee went further and defined the criteria by which epidemiologic evidence could be examined and synthesized to reach a causal judgment.

The Committee's process for using epidemiologic data in assessing causation included multiple steps. The process involved: (1) establishing that cigarette smoking was associated with lung cancer; (2) examining whether the association could be explained by other factors such as methodologic flaws, bias, or confounding; (3) examining whether there were plausible alternative explanations for the observed association; (4) considering the main points of criticisms raised about the association and its potential causal nature; and (5) ensuring all of the lines of evidence were generally consistent with a causal hypothesis (USDHEW 1964). A similar careful and extensive process for considering evidence of causality had been implemented earlier by Cornfield and colleagues (1959) in their review of smoking and lung cancer: their considerations provided guidance for the methodologic approach adopted by the Advisory Committee in 1964. Subsequent reports of the Surgeon General have used the same approach for examining questions of causality for smoking and specific diseases.

In its report, the Advisory Committee formally presented a set of criteria by which epidemiologic data could be used to define the causation of human disease: (1) the consistency of the association (replication of findings across different studies and populations), (2) the strength of the association (magnitude of the increased risk associated with exposure), (3) the specificity of the association (presence of a unique exposure-disease association), (4) the temporal relationship of the association (exposure comes before effect), and (5) the coherence of the association (support for the association from other lines of evidence) (USDHEW 1964).

These criteria were included in the widely recognized criteria for interpreting epidemiologic evidence in public health presented by Sir Austin Bradford Hill in 1965 (Hill 1965). The Bradford Hill criteria added four additional criteria, most notably the presence of a biologic gradient (dose-response relationship) in the evidence. The other three included plausibility (subsumed under coherence in the Surgeon General's criteria), experiment, and analogy.

Detailed discussions of these criteria, how they evolved, and how they are applied in reviewing epidemiologic evidence are presented in the 1964 report (USDHEW 1964) and the 2004 report (USDHHS 2004); that discussion will not be repeated here. Rather, the public health significance of formally expressed criteria for the use of epidemiologic evidence in defining causality is the focus of the present discussion. Historically, the articulation of these criteria marked a turning point in the utilization and acceptance of epidemiologic evidence. It laid the foundation for the current widespread use of epidemiologic evidence to define disease causation and identify methods for disease prevention and education of the public. These criteria, and their use by the Advisory Committee in reaching a judgment that smoking caused lung cancer in men, established an approach that remains in use for causal inference based around epidemiological and other evidence.

Methods for Reviewing the Evidence and Developing Conclusions

The reports of the Surgeon General have continued to play a role in defining the science that underlies efforts in tobacco control by certifying the causation of various diseases and expressing the state of the science on the effectiveness of tobacco control interventions, approaches, and policies. The success of the series of reports reflects the processes used for reviewing and presenting the evidence and for the development of the conclusions. The processes used for subsequent reports evolved from the process used in the 1964 report of the Advisory Committee.

The 1964 report, at 387 pages, was substantively longer than the independent reviews that had preceded it. As a consequence, it was able to offer a much more detailed presentation of the evidence in the text rather than simply providing references to the individual studies in support of the conclusions.

The depth of the evidence presentation in the Advisory Committee's report in 1964 can be seen readily in subsequent reports, and this comprehensive approach has been one reason for the reports' continuing credibility. An editorial standard evolved that required the conclusions of individual sections of the report to be based on discussions of the literature presented in the text that were coupled with relevant study results presented in the text, tables, and figures of those sections. This approach, of presenting the totality of evidence in sufficient detail to allow the reader to evaluate it, contrasted with the general approach of the time for written reviews, which relied heavily on syntheses of evidence by authors with literature citations for the publications reviewed. In the Surgeon General's reports, presentation of the critical findings from the relevant studies, coupled with discussion of the methods used to generate the evidence in the text of the report, has allowed readers to assess the validity of the conclusions directly rather than requiring them to conduct a time-consuming search of the cited publications. This transparency has strengthened the reports' findings in the face of the inevitable criticisms.

In synthesizing the evidence on exposure to secondhand smoke and disease, meta-analysis has been used, both in the Surgeon General's reports and in other evaluations. Generally, the term “meta-analysis” refers to the systematic analysis and quantitative summarization of the findings of multiple studies containing evidence to address the same question (Greenland 1987; Egger and Davey Smith 1997; Institute of Medicine 2011). In a meta-analysis, the data are the summary findings of the studies identified through a systematic review and not the data at the individual level. Meta-analysis has been used to summarize the evidence on exposure to secondhand smoke, primarily because the associations are generally much weaker than they are for active smoking. Meta-analysis was not used in the 1986 report, but it was applied to multiple outcomes in the 2006 report, The Health Consequences of Involuntary Exposure to Tobacco Smoke, and is used in this report.

Although meta-analysis has proven useful for summarizing the evidence and quantifying the risks of exposure to secondhand smoke as precisely as possible, the findings of meta-analyses and, particularly, information on whether an association found in the meta-analysis was statistically significant, have not figured directly in the causal inferences presented in the reports of the Surgeon General. The results are most useful for providing a single, combined estimate of the risk for calculating the associated burden of disease and, potentially, for exploring why results vary from study to study.

The practice of presenting the relevant evidence needed to support the conclusions also has helped to ensure the validity of the conclusions as has the tiered approach and peer review process of the chapters. In the Surgeon General's reports, the initial author of an individual section is tasked with reviewing and assembling all of the relevant evidence available and presenting it in the text and related tables and figures with a level of detail sufficient to support the conclusions. Based on that presentation, the author then considers and discusses what conclusions the evidence supports. This comprehensive review process helps reduce inaccuracies that may occur when authors synthesize the evidence and reach conclusions based on their recall of what the literature shows, rather than on the evidence actually contained in that literature.

Passing the section on to the editors allows a different group of people to consider the evidence presented to evaluate the basis for the conclusions and to revise them, if appropriate. Similarly, as the chapters and reports proceed through the various review stages, the reviewers can independently consider the evidence presented as they consider the accuracy, completeness, balance, tone, and language of the conclusions. In providing their comments, the reviewers can focus on the evidence presented, consider whether the review of that evidence is complete, and judge whether the conclusions are supported by the evidence.

The intense criticisms of the reports by the cigarette manufacturers and their representatives prior to the late 1990s (see Chapter 2) helped to strengthen the process of developing conclusions for the reports. The anticipation of criticism motivated the development of conclusions that were firmly based on evidence without speculation. Before its elimination as a result of the 1998 Master Settlement Agreement, the Tobacco Institute (a representative of cigarette manufacturers) conducted a well-funded and highly visible public relations campaign to denigrate the quality of the science in each Surgeon General's report and question the validity of their conclusions (Kluger 1996; Brandt 2007; Proctor 2011). Based on the historical pattern of challenges to the Surgeon General's reports (see Chapter 14, “Current Status of Tobacco Control”) the authors, editors, and reviewers of the reports assumed that every conclusion might be challenged and, therefore, each had to be solidly and fully supported by sufficient evidence. The result was that, as conclusions were drafted and reviewed, there was an intense focus on the quality and robustness of the evidence. Conclusions were structured to be unassailably grounded in a foundation of evidence and the language of the conclusions was “conservative” such that the strength of evidence was not overstated. As the evidence foundation advanced, conclusions were strengthened.

This effort to achieve scientific transparency by laying out the evidence foundation for the conclusions has defined with clarity the state of the scientific evidence on disease causation, the effectiveness of efforts in tobacco control, and the consequences of changes in public policy. In addition, it has provided solid support for evidence-based public policy decisions on tobacco issues, has identified the areas where scientific certainty exists as separate from those areas where uncertainty remains, and has been a principal reason for the enduring credibility of this series of reports.

Process of Ensuring Consensus and Strength of the Peer Review

In a series of governmental reports, such as those of the Surgeon General which have both great visibility and a substantial impact on public policy, protections are needed to resist influences that could distort the process of forming a consensus and affect the conclusions.

As a report is in development, a myriad of factors may come into play: political pressures; pressures from a variety of individuals and groups to have the conclusions conform to their preexisting policy positions; the recognition that some conclusions can influence decisions on research funding; and even the well-intentioned belief of authors of sections of the report that the final conclusions should substantiate positions they have adopted based on their own research. Without a process to insulate the report's conclusions from such influences, the conclusions might be perceived as based on the politics and pressures of the moment rather than on a consensus of scientific opinion.

The National Clearinghouse for Smoking and Health prepared the initial series of reports (1967–1976) which followed the 1964 Surgeon General's report. The scientific and technical staff of the clearinghouse, a forerunner of the current Centers for Disease Control and Prevention's Office on Smoking and Health, was responsible for both drafting and editing the volume. The 1971 report, The Health Consequences of Smoking, was a comprehensive review of all of the available evidence, but the other reports in the 1967–1976 period were intended to review the evidence on the relationship of smoking to cancer, cardiovascular disease, and COPD that had been published since the previous report, with additional chapters focusing in more depth on specific topics. The “in-house” preparation of the volume was counterbalanced by a multilevel review process. Each draft chapter was reviewed by experts, external to the clearinghouse, from the academic community and select PHS agencies who were asked to evaluate the accuracy and completeness of the chapter. After the reviewers' comments were incorporated into the draft chapters, the chapters were assembled into a draft report. That version of the report was sent to a larger group of experts, broadly knowledgeable in smoking and health, who were asked to comment on the balance, tone, and accuracy of the volume and its conclusions. The draft report was also submitted for review to those agencies within PHS that were involved with tobacco issues. Revisions were made in response to these comments, and the volume was then submitted for formal clearance and release as the official position of PHS on the science of tobacco and health. As required by law, it was also transmitted to the U.S. Congress. This complex, multilayered peer review helped to ensure not only that the science in the volume was accurate but also that the positions expressed on the science were the prevailing view of the scientific community at the time and represented concurrence without being unduly influenced by any one individual or group.

Beginning with the 1979 Surgeon General's report on smoking and health and continuing to the present, an additional layer of insulation was added by selecting a set of editors for each volume who were drawn from the academic and scientific communities and, when selected, were not employees of the federal government. These editors have been tasked with ensuring the accuracy of the scientific content of the reports and providing additional independent oversight for the process of incorporating reviewers' comments. These independent editors, rather than the authors, have been responsible for making the final decisions on incorporating reviewers' comments into the text, thereby creating a layer of objectivity regarding reviewers' comments as they are considered and preventing the views of any single author from controlling the conclusions.

The evolution of this production process demonstrates that it is possible for a governmental review of a scientific topic of high societal interest and relevance to be conducted in a way that ensures independence and scientific accuracy for the resulting scientific conclusions.

Separation of Scientific Conclusions and the Formation of Policy

The findings of the reports of the Surgeons General have been the basis for a wide-ranging set of policy decisions and consequently some may consider the reports as offering policy recommendations. The overall intent of the reports, however, has been to provide a clear evidence foundation for scientific judgments on the diseases caused by smoking, the factors influencing smoking initiation and cessation, the effectiveness of smoking and tobacco control interventions, and the results of tobacco control programs and changes in public policy. The characterization of the state of the science on these issues remains the mission of the reports of the Surgeon General and is their principal enduring value. Although it is hoped that these scientific judgments will be used in the formation of public policy, and the reports have often examined the evidence on the effects of public policy decisions, the content of the reports has been limited to the state of the science on these issues. The reports have avoided defining or recommending specific public policies, leaving those decisions to the entities responsible for policy formation, including the Secretary of HHS and the various components of that department. The conclusions of the report have been intentionally framed to state what could be concluded scientifically from the evidence and to lay out the implications of those conclusions for the population.

The separation of scientific conclusions from policy recommendations, initially adopted because policy decisions and implementation occurred at organizational levels well above that of the National Clearinghouse for Smoking and Health, has helped to ensure the ongoing credibility of this series of reports. Public policy decisions are, and often must be, made before the evidence supporting them is complete. These reports have been the benchmark on the status of the evidence for decision-making.

By preserving its exclusive focus on the scientific foundation and avoiding the inclusion of policy recommendations by the scientists involved with the report, the reports of the Surgeon General have preserved their credibility and somewhat insulated the report development process from the need for scientific certainty among those responsible for forming public policy. Correspondingly, the recognized independence of the reports' conclusions has resulted in a solid and enduring foundation that supports those who are tasked with defining and implementing public policy.

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