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Furthermore, public commentary could help prevent the “capture” of the risk assessment process by interest groups.63
We studied the role of the tobacco industry in the process by analyzing archival data, including written commentary and hearing transcripts, and by interviewing key policy makers involved in each case study.38,58–60
Risk assessments of secondhand smoke In 1992, the U.S. Environmental Protection Agency (EPA) published a risk assessment of environmental tobacco smoke, which concluded that passive smoking is associated with lung cancer in adults and respiratory disease in children.64
The development of the risk assessment was considerably delayed by the tobacco industry’s criticisms of the draft re- port.40 Sixty-four percent (69/107) of submissions received by the EPA during the public commentary period claimed that the conclusions of the draft were invalid; of these, 71% (49/69) were submitted by tobacco industry–affiliated indi- viduals.40 The tobacco industry–affiliated reviewers supported their criticisms of the draft report by the selective citation of non-peer-reviewed literature, especially articles from sympo- sium proceedings.40 Thus, tobacco industry–sponsored re- search that was not published in the peer-reviewed scientific literature was submitted directly to the EPA for review.
In 1997, the California Environmental Protection Agency (Cal-EPA) published the final report of a risk assessment, titled Health Effects of Exposure to Environmental Tobacco Smoke.65
The California risk assessment was more comprehensive than the U.S. EPA risk assessment of passive smoking because it examined the association of secondhand smoke exposure with lung cancer and respiratory illness as well as with cardio- vascular, developmental, reproductive, and childhood respi- ratory effects. The Cal-EPA risk assessment also addressed criticisms brought by the tobacco industry against the U.S. EPA risk assessment.
In an examination of the development of the California risk assessment, Schotland and I found that participation in the public input process was not balanced among all inter- ested parties and was dominated by the tobacco industry.38
Critics and supporters of the risk assessment used different criteria to evaluate the science, which suggests that they were constructing the evidence to support their predefined positions. As was the case with the U.S. EPA risk assessment, the tobacco industry was able to use its funded research to support its arguments against the California risk assessment.
Indoor air regulation During the 1990s, Washington State and Maryland restricted smoking in private workplaces. The U.S. Occupational Safety and Health Administration also proposed a workplace smok- ing restriction, but this failed. Internal tobacco industry docu- ments show that one strategy the industry used to defeat the proposed federal regulation was to “produce data to counter the findings about the adverse health effects of secondhand smoke.”60 Although the tobacco industry used this strategy, among others, in an attempt to defeat the Maryland and Washington regulations, the state regulations were passed.66
Each of these states’ regulatory development processes required a public commentary period. Opposition to the proposed regulations came primarily from the tobacco in- dustry, small businesses, and business organizations—and
appeared to be coordinated.59 Much of the business group opposition was supported by the tobacco industry, although this support was not disclosed in the public commentary.66
Although arguments not related to science were more com- mon than scientific arguments on the whole, arguments about science were used more often by opponents than supporters of the regulations.59 Opponents of regulation, primarily the tobacco industry, cited industry-sponsored sym- posium proceedings or peer-reviewed journal articles of low methodological quality to support their criticisms of the science on which the regulation was based.59
Apparent disagreement among experts during public tes- timony reinforces the uncertainty of the data on which risk assessments or regulations are based. However, the findings from our case studies suggest that the industry-supported experts used different criteria to evaluate the science, differ- ent bodies of evidence to support their claims, and relied on arguments about specific studies rather than emphasizing the body of evidence as a whole. The involvement of tobacco industry lawyers and executives in the design, conduct, and dissemination of research has an impact on how controversy can influence public opinion or policy decisions.
A case example: Tobacco industry creation and dissemination of a study The tobacco industry’s creation of the Japanese Spousal Smoking Study illustrates the industry’s hidden involvement in the design, conduct, and dissemination of research. In 1981, Takeshi Hirayama published an influential study show- ing an association between secondhand smoke exposure and lung cancer.67 The Hirayama study has been the most frequently cited study in regulatory hearings on smoking restrictions.45 In these hearings, tobacco industry represent- atives have argued that the Hirayama study is flawed due to misclassification bias.38,40 Hong and I conducted an analysis of internal tobacco industry documents that showed how the tobacco industry hid its involvement in creating the Japanese Spousal Smoking Study to support its arguments about misclassification bias.51
Although the Japanese Spousal Smoking Study had named Japanese investigators, project management was conducted by Covington and Burling (a tobacco industry law firm), the research was supervised by a tobacco industry scientist, and a tobacco industry consultant assisted in reviewing the study design and interpreting the data.51 The tobacco companies that funded the study did not want any of these individuals named as co-authors on any of the resulting scientific publi- cations. When the study was published, the tobacco industry consultant was the sole author. 68 The publication acknowl- edged “financial support from several companies of the to- bacco industry.”68 This acknowledgement tells the reader little about who was actually involved in the design, conduct, and publication of the study. The hidden roles of the to- bacco company lawyers and scientist raise questions about who is accountable for the research.51
CONCLUSION
The tobacco industry has had a longstanding strategy of funding research and disseminating it through sponsored, non-peer-reviewed publications. These strategies have re-
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mained relatively constant as the industry has progressed from refuting research on active smoking to refuting re- search on secondhand smoke. Tobacco industry lawyers and executives, rather than scientists, have been in control of the design, conduct, and dissemination of this research. Despite the questionable conduct of much of this research, the to- bacco industry has widely disseminated it to lay journalists and policy makers. In addition, the tobacco industry has a record of suppressing and criticizing research that is unfa- vorable to its position.
When data on risk appear to be controversial, users of the data should investigate the sources of the controversy. Does the controversy exist only because the findings of inter- est group funded research are contrary to data collected by others? Is the controversy supported primarily by evidence published in interest group supported publications? Is the controversy supported primarily by research publications of low scientific quality? Is the controversy perpetuated in the lay press through citation of interest group affiliated indi- viduals? Are the data that suggest a controversy presented to policy makers only by the interest group? Policy makers should apply these questions to all situations in which a for- profit company has an interest in creating controversy about the risks of its products.
The tobacco industry’s methods for influencing the de- sign, conduct, and publication of research may be similar to those of other corporate interests. For example, studies ex- amining the association of pharmaceutical industry funding and research outcomes suggest that such funding produces studies with outcomes that are favorable to the sponsor.22,43,69
Reasons for this observed association of funding and out- come are not clear.7 Therefore, biased outcomes may be the result of how the research questions are asked, how the research is actually conducted, and whether the results are published (or not published). Food industry funding for research has also been shown to produce outcomes favor- able to the sponsor.71,72
The release of millions of internal tobacco industry docu- ments has given the public health community insight into the inner workings of the tobacco industry and revealed its previously hidden involvement in manipulating research.16
However, analogous information is not available for most corporate interests. Among the few other analyses of inter- nal industry documents, Markowitz and Rosner describe how the chemical, asbestos, and lead industries manipulated re- search about the harms of their products.73–75 Their analysis reveals that these industries used many of the same strate- gies as the tobacco companies to create controversy about the health effects of tetraethyl lead, asbestos, polyvinyl chlo- ride, and other chemicals.
Funding sources for all published research, as well as the roles of the sponsor, should be fully disclosed. The tobacco industry has a long history of hiding the involvement of its lawyers and executives in the design, conduct, and dissemi- nation of research. If internal tobacco industry documents had not been made available to the public, much of what is known about the industry’s manipulation of research would have remained undiscovered.
Disclosures should not be limited to the roles of funders at all stages of the research process. Personal financial ties between investigators and corporate interests (such as con-
sulting fees, stock ownership, and honoraria) should also be fully disclosed. Personal financial ties are increasing76 and are associated with favorable research outcomes for the cor- porate interest, even if the corporate interest is not funding the research.22 Experts who criticize research describing the harms of a company’s product should also fully disclose their financial ties with the company. These complete and accurate disclosures should be found in scientific publica- tions (including research articles, letters to the editor, and editorials), citations in the lay press, and testimony in policy or legal settings.
Our findings also have implications for how experts should be selected to participate in the risk assessment process. As suggested by others, professional competence and diversity of political views, disciplines, opinions, and attitudes are important.77 However, consideration should also be given to affiliation or interest group bias. Encouraging transparency regarding the roles of interest groups in developing and disseminating data on risk will not prevent their involve- ment in the process. However, transparency will make it easier to determine which strategies, if any, an interest group has been using to influence the data.
Detailed and accurate financial disclosures of research funding and financial ties are necessary, but not sufficient, for safeguarding the integrity of the research record. A pos- sible benefit of disclosure is that it might discourage scien- tists from entering into financial relationships that could detract from the perceived integrity of their research. An- other possible benefit is that transparency might improve public trust in the industry-supported research.78 Krimsky, however, has described disclosure as a “rationalization for creating more serious conflicts.”79 He points out that disclo- sure is a “public relations” response to dealing with corpo- rate influence on research and not a way of potentially decreasing the effect of the corporate sponsor on research integrity.
A number of scholars have argued that there should be a total ban on clinical investigators’ financial ties to compa- nies.79,80 Such bans would eliminate the need for oversight committees to “manage” conflicts of interest and protect against even the appearance of conflict. Schafer supports the “sequestration thesis,” which would eliminate direct cor- porate sponsorship of research and financial ties of investi- gators.81 Sequestration could be achieved by forming inde- pendent research institutes that operate independently of the companies that provide funding for the research. Shamoo and Resnik, however, have noted that elimination of financial ties with industry and corporate funding may not be realistic in today’s environment.82 Some investigators advocate “self regulation,” voluntary compliance with professional society guidelines, or adaptation of the federal conflict of interest policy to clinical trials funded by private sponsors.83
Some academic institutions, particularly schools of medi- cine and public health, have instituted bans on tobacco industry funding (e.g., Harvard University, University of Sydney).84 Some funding agencies (e.g., the Legacy Founda- tion) have developed policies that require such bans as a condition of receiving funding from an organization.85 Pro- hibitions on tobacco industry funding for research are sup- ported by the industry’s history of deception about its role in the design, conduct, and dissemination of research. Such
