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518 Journal of Health Politics, Policy and Law before funding. The primary purpose of special projects, according to tobacco industry lawyers, was to develop scientific data that could be used to defend tobacco companies against litigation (Saroldn 1988; Bero et al. 1995). In addition, the special projects allowed the industry to cul-. tivate relationships with scientists who could later be called on to testify . on the industry's behalf (Bero et al. 1995). The Council for Tobacco Research's special projects were often designed specifically to divert attention from tobacco as a cause of disease (Bero et a1.1995). For exam- ple, studies were funded to show that poor nutrition, occupation, or genetic predisposition could cause the same diseases attributed to smok- ing. In addition, the study designs of the special projects were sometimes altered so they would be more likely to produce results that would sup- port the tobacco industry position (Bero et al. 1995). Given general evidence suggesting that industry sponsorship can influ- ence the results or conclusions of sponsored research and specific evi- dence of previous efforts by the tobacco industry to control the direction of the research it funds, we hypothesized that research funded by CIAR might be affected by conflict of interest. The tobacco industry argues that exposure to ETS is too minimal to cause any real damage, and that epi- demiologic studies of passive smoking are flawed and do not prove that ETS is harmful (Tobacco Institute 1986). The industry has an obvious interest in producing scientific data to support these arguments, because policy makers and juries would be more likely to accept them if they were based on hard data. In fact, a confidential report prepared by the Roper Organization (1978: A7) for the Tobacco Institute noted that the industry's best strategy for countering public concern about passive smoking was to fund scienti8c research. The report stated: "The strate- gic and long run antidote to the passive smoking issue is, as we see it, developing and widely publicizing clear-cut, credible, medical evidence that passive smoking is not harmful to the non-smoker's health" Thus the purpose of our study was to analyze the content, quality, and use of research funded by CIAR to determine whether it is funding truly independent research or whether it is financing studies that appear to be motivated by tobacco industry interests. We hypothesized that, although CIAR claims to be objective and independent, the tobacco industry might smoking has not been provedd harmful to health. be funding research through CIAR to support its position that passive

522 Journal of Health Politics, Policy and Law 0 studied an aspect of tobacco, tobacco smoke, or a tobacco-specific sub- stance such as nicotine; or as non-ETS related if it studied general indoor ai= quality and did not specifically mention tobacco. Then we subclassified the topics of the projects into the categories of health effects, exposure, or other. A health effects study evaluated the effects of exposure to a substance, including studies conducted in cells, animals, or humans. An exposure study measured exposure to a sub- stance but did not evaluate the effects of that exposure; these included studies of exposure markers sucb as cotinine (a nicotine metabolite). Studies that did not evaluate either health effects or exposure were clas- sified in the other category. One project, for example, studied whether tobacco smoke is perceived primarily through sight or smell. Table I summarizes our findings on the topics of projects funded by CIAR. Almost two-thirds of CIAR's special-reviewed projects were related to ETS, compared with 30 percent of its peer-reviewed projects. In addition, most special-reviewed projects studied exposure, rather than health effects. Thesefindings suggest that research related to ETS, par- ticularly exposure research, is a high priority for the tobacco industry executives who select CIAR's special-reviewed projects. One of the tobacco industry's main arguments regarding passive smoking is that per- sons are not exposed to sufficient levels of ETS to cause any serious dam- age (Tobacco Institute 1986). It is therefore possible that the tobacco industry is funding research through CIAR's special-reviewed projects to develop data it can use to support this claim. In addition, from a legal per- spective, a study measuring exposure to ETS would be much less dam- aging to the industry than one showing that EfS causes disease; thus it is "safer" for the industry to sponsor exposure research. We also examined the affiliations of CIAR-funded principal investiga- tors (PIs). Based on the information provided by CIAR, we coded the affiliation of each PI as either academic, private sector, or other. They were classified as academic if their stated affiliation was a university or college and as private sector if they were affiliated with a private-sector business, consulting firm, or contracting agency. All other affiliations were classified as other. None of the PIs had more than one affiliation listed. Table 2 summarizes our findings regarding the affiliations of CIAR- funded PIs. Nearly all of the PIspn peer-reviewed projects had academic affiliations, whereas almost 40 percent of the PIs on special-reviewed projects were affiliated with private-sector organizations. Two special- reviewed projects were awarded to the president of Healthy Buildings ® W s.

® 532 'Journal of Health Politics, Policy end Law. ® can use to influence policy. The motivation behind CIAR's peer-reviewed projects is less clear. It is possible-that the industry is using them to deflect attention away from ETS as an indoor air pollutant, because most of them are -not related to ETS: . In addition, it is possible 'that peer- reviewed projects are being funded to gain good publicity and improve the industry's credibility. Influencing Policy Our analysis of the use of CIAR-funded research suggests that the tobacco industry is using CIAR to develop scientific data it can cite in legislative settings to influence policy related to ETS. For example, data from two of CIAR's special-reviewed projects were presented at OSHA hearings on its proposed indoor. airi quality standard, and data from a third special-reviewed project were presented at a congressional hearing related to the proposed ban on smoking on commercial aircraft. In all three cases, these data'were used to s~pport the tobacco industry position that smoking.should not be regulate4. Although the tobacco industry applears to be funding research through CIAR's special-reviewed projects i an attempt to influence policy on ETS, the impact of this strategy ma~ be minimized by the lack of peer review associated with these projects. For example, the Oak Ridge National Laboratory study shows hQw lack of peer review appears to have led to a poor study design with al high potential for bias. Participants were selected for the study by a marf eting research firm with ties to the industry, and laboratory tests were c~nducted by scientists employed by R. J. Reynolds. Given these sorts of c~mpromises in study design, policy makers may be unwilling to accept the conclusions of the study, which support the tobacco indust ry position that workplace smoking should not be regulated. In addition, the congressional su~ ommittee report on the HBI study suggests that data from one of CYARRrs special-reviewed projects appear to have been dramatically altered. It }s not clear from the subcommittee report whether HBI acted independently or with the approval of its tobacco-industry sponsors. However~' it is likely that policy makers will examine testimony and research resuQts presented by HBI with a partic- ularly critical eye in the future Is r4

Industry-Funded Research and Conflict of Interest: An Analysis of Research Sponsored by the Tobacco Industry through the Center for Indoor Air Research Deborah E. Barrrnes and Lisa A. Bero University of California, San Francisco Abstract The Center for Indoor Air Research (CIAR) was created by three United States tobacco companies itt 1988. Its stated mission is to fund high-quality, objective research related to indoor air, including studies of environmental tobacco smoke (ETS). Because CIAR is financed by the tobacco industry and funds research related to tobacco, it fosters an inherent conflict of interest. We consider whether this conflict of interest has affected the content, quality, or use of research funded by CIAR. We hypothesize that the tobacco industry might be using CL4R to develop sci- entific data to support its position that ETS is not harmful to health. CIAR funds two types of projects: "Peer-reviewed" projects are awarded after peer review by a group of scientists, whereas "special-reviewed" projects are awarded directly by tobacco industry executives. CIAR's special-reviewed projects are more likely than its peer- reviewed projects to be related to ETS, to support the tobacco industry position, and to be used by the industry to argue tbat smoking should not be regulated in public places. Our findings suggest that the tobacco industry is funding special-reviewed projects through CIAR to develop scientific data that it can use in legislative and legal settings. The industry may be financing peer-reviewed projects through CIAR to enhance its credibility, to provide good publiciry, and to divert attention from ETS as an indoor air pollutant. CIAR's stated mission of funding high-quality, objective research has been compromised by conflict of interest, and at least some of CIAR's projects are being used to promote the tobacco industry's agenda. 'this study was fundedghrough the Cigarette and Tobacco Surtax Fund of the State of Califor- nia through the TbbaocR-Related Disease Research Progntm of the University of California (awards 2KT0078 and 4RT0035). We thank all of our friends and cotlea;uea at the Institute for Health Policy Studies who provided Invaluable insight as we prepared this article. Presented in pan at the American Public Health Association meeting in Washinatoa. DC, 2 October 1994. JournaJ offfealrh Politics. Policy anQ law. Vol. 21. No. 3, Fall 1996. Copyright O 1996 by Duke University Prees.

:l• 542 Joumal of Health Politics, Policy and law. White, L. G•'.'n.d. Ethical Coruideroti,oru of Accepting Financial Support from the Tobacco lnduatry.. New York: American Council on Science and Health. Witt, M. D., and L: O. Gostin. 1994. Conflict of Interest Dilemmas in Biomedical Research:'Journal of the Americon Medical Asaociation 271(7):547-551. Wolinsky, H. 1985. When Researchers Accept Funding from the Tobacco Industry, Do Ethics Go up in Smoke? New York State Journal of Medicine 85(7):451-455. ®

520 Journal of Health Politics, Policy and Law group of individuals with reputations for expertise and scientific lead- ership in the disciplines relevant to indoor air research. ... After the SAB establishes the research agenda, the Center announces to "the sci- entific community at large that research applications in response to the agenda are being accepted. The review of proposals and their selection for funding is accomplished in a scientifically rigorous and objective manner. Applications are reviewed first for scientific quality by the applicant's peers selected from the group listed in Appendix B [of the RFA). The SAB, in turn, reviews the applications and peer evalua- tions, and develops recommendations on the selection of applieations- Studies recommended by the SAB are subject to final approval by the Board of Directors. (Center for Indoor Air Research 1994: 3) The RFAs also state that investigators funded by CIAR are encouraged to publish their findings in the peer-reviewed literature (Center for Indoor Air Research 1994). CIAR's review process is similar to the grant- approval processes used by many foundations, although all of CIAR's projects are funded as contracts rather than as grants. Although CiAR's publications state that its projects are funded through the peer-review process previously-described, we found that some projects receive a special-review process. CIAR publishes a brochure that lists the projects it has funded to date (Center for Indoor Air Research 1992b). They are classified as "research," "applied;' or "other;" but the differences ecrtbparr ries are not explained. Through inter- views with staff members e were informed that research proj- ects tion n c investigations funded through the peer- iew process described in CIAR's publications; applied and other projects are more goal-oriented studies by the board of directors without receiving peer revie (Marquardt 1993 ). ' s we noted, CIAR's board of directors consists pn atives of the charter tobacco companies. None of CIAR's publications mention that some of its projects are awarded through a special-review process. We tried to confirm the information about CIAR!s special-review process by writing a letter to the executive director of CIAR, Max Eisen- berg. We explained in detail our understanding of the special-review process used for applied and other projects and asked for confirmation or clarification of the process. In response, we received only a note stating "For your information;' along with a packet of CIAR's informational brochures.. However, one recipient of an applied project, Roger A. Jenk- ins (1995), of Oak Ridge National Laboratory, testified at length regard- ing ing app leal R.] fort wh. CIy I pro Co lec to , inf- Re pef fro l CI, mc try usE pul Co Wi wr ulz re: E1 tbl de uK

e to envirotunen- rsons who do not :ause lung cancer !ase (Glantz and "eases the risk for ) and various res- rotection Agency harmful effects of e National Acad- xal (U.S. Depart- )2, the U.S. Envi- -i Group A human 92). The growing is led to increased ionsmokers from :wed journal con- :d [indoors) with ?). This study was avhich was created nission is to fund icluding studies of ~ that CIAR is an : that CIAR's proj- .ve manner" based and that this peer rch. . . is recom- 1994: 3). ctly related to its nay influence the .991; Blank 1992; In particular, the nvestigator to pro- ). For example, the . study design that zsor could encour- ie final publication -stigators may feel i findings that are :illman et al. 1991). Barnes and Bero  industry-Funded Research 517 In particular, investigators may fear that future funding will be denied if they publish unfavorable data (Hillman et al. 1991). Several studies on the effects of industry sponsorship indicate that these concerns about conflict of interest are justified. One showed thai research funded by the chemical industry is more likely than govem- ment-funded research to conclude that occupational exposure to cbemi- cal agents is not harmful (Swaen and Meijers 1988). Another study found that research sponsored by the pharmaceutical industry is more likely than research funded through other sources to favor the new drug being evaluated (Davidson 1986). Similarly, a third study showed that research sponsored by pharmaceutical companies almost always concludes that the sponsor's drug is equivalent or superior to comparison drugs, even when the data do not completely support this conclusion (Rochon et al. 1994). These studies provide compelling evidence that industry funding may influence the type of research condueted and the conclusions drawn from the data. • History has also shown that, when scientific findings are particularly damaging, industry may try to conceal, manipulate, or deny the findings. The asbestos industry, for example, funded external contract research on the health effects of asbestos from the 1930s to the 1950s (Lilienfeld 1991). According to internal memos, these studies suggested that expo- sure to asbestos could cause asbestosis and lung cancer. However, the study results were suppressed, and the industry denied that asbestos was hazardous to health (Lilienfeld 1991). Similarly, the lead industry has denied or minimized evidence suggesting that lead in paint is a common cause of disease in children (Rabin 1989). The tobacco industry has a history of financing scientific research that it claims is independent but is actually designed to fulfill the industry's needs (Bero et al. 1995). In 1954, U.S. tobacco companies created the Tobacco Industry Research Committee, which was later renamed the Council for Tobacco Research-U.S.A., Inc. The industry stated publicly that the council's purpose was to fund independent scientific research on the health effects of smoking and that, to ensure the'objecdvity of the research, projects would be selected based on peer review by an inde- pendent science advisory board (Council for Tobacco Research 1992). However, internal tobacco industry.documents reveal the existence of a "special projects" division within the Council for Tobacco Research (Freedman and Cohen 1993; Bero et al. 1995). Special projects were funded based on the recommendations of tobacco industry lawyers, rather than the science advisory board, and were not peer reviewed

.rd some members r their projects. quality of research : the quality of the the proposals sub- ity of publications 'unded research by urent Contents for ided two lists that I resulted from its , 1993c). Ten more ng were identified a total of seventy- •ticles (15 percent) 'alifornia, Califor- ore were not avail- I five of these arti- stitutional reports, 3 percent), both of :hored by a PI on a 92). Therefore we ilted from CIAR- next section. sociated with pub- ms have been asso- shed data; Rochon a (Bero et al. 1992) .larly, articles pub- iiewed, have been ; (Bero et al. 1992, nerally have been .viewers (Chalmers based on industry- ts (Davidson 1986; al. 1994; Cho and Barnes and Bero  lndustry-Funded Research 525 To assess factors associated with publication quality, we coded the peer-review status, type of publication, and source(s) of funding acknowl- edged for the articles that resulted from CIAR-funded projects.. An article was coded as peer reviewed if the journal in which it bad been published stated it was peer reviewed, published a list of reviewers, or required man- uscripts to be submitted for review before publication; otherwise, it was coded as non-peer reviewed. Type of publication was coded as symposium article, original research article, review, or other based on how the article was described in the table of contents. All articles published in symposia were classified as symposium articles, regardless of whether they were original research articles or reviews. Source(s) of funding acknowledged were coded as tobacco if the stated sponsor(s) was a tobacco company, the Tobacco Institute, CIAR, or the Council for Tobacco Research; as multi- ple if both CIAR and a nontobacco source of funding were acknowledged; as other if an organization other than CIAR was acknowledged; and as none if no source of funding was acknowledged. We also evaluated the conclu'sions.of the articles to determine whether those resulting from CIAR-funded research tend to support the tobacc industry position that ETS is not harmful to health. An article was clas sified as pro-industry if it concluded that there is no evidence that ETS is associated with adverse health effects, that the evidence is inconclu- sive, that confounding variables are responsible for health effects attrib- uted to ETS, that studies on ETS are.statistically flawed, or that the level of exposure to ETS is not high enough to cause health problems. In addi- tion, articles that made policy recorrimendations consistent with tobacco industry proposals, such as accommodating both smokers and nonsmok- ers in restaurants or workplaces, were classified as pro-industry. An arti- cle was considered neutral if it did not discuss the health effects of ETS. An article was considered anti-industry if it concluded that ETS is asso- ciated with adverse health effects or if it made policy recommendations consistent with tobacco-control efforts. These categories have been used previously (Bero and Glantz 1993; Bero et al. 1994) and are based on the written statements of the tobacco industry (Tobacco Institute 1986). High-quality publications were considered those that were published in peer-reviewed journals, those that presented original research findings and had not been published in symposia, and those that acknowledged a source of funding other than the tobacco industry. We used the chi-square statistic to test the hypothesis that articles resulting from peer-reviewed projects would be more likely than articles resulting from special- reviewed projects to be associated with these high-quality characteristics.

.rtise and scientific lead- • research. . . . After the ter announces to the sci- ations in response to the osals and their selection , rigorous and objective ;cientific quality by the d in Appendix B [of the rtions and peer evalua- election of applications. to final approval by the search 1994: 3) y CIAR are encouraged ature (Center for Indoor s similar to the grant- although all of CIAR's •ants. :s projects are funded bed, we found that some ublishes a brochure that or Indoor Air Research ied;' or "other;" but the plained. Through inter- med that research proj- ided through the peer- )ns: applied and other firectly by the board of rdt 1993). As we noted, ' representatives of the blications mention that 31-review process. CIAR's special-review )r of CIAIZ, Max Eisen- of of the special-review ked for confirmation or ived only a note stating ' CIAR's informational project, Roger A. Jenk- stified at length regard- i Barnes and Bero  Industry-Funded Research 52t ing the funding process used for his project. He stated that CIAR had approached him with a proposal for the project, and that be and his col- leagues had developed the study methodology with input from CIAR, R. J. Reynolds, and Bellomy Research (a marketing research firm). There- , fore, we believe that the information we received by telephone interview,............-......... which characterized applied and other projects as being awarded by CIAR's board of directors without undergoing peer review, was accurate. Because CIAR's applied and other projects receive a special-review process, and because we hypothesized that they might be similar to the Council for Tobacco Research's special projects, we refer to them col- lectively as "special-reviewed" projects throughout this article. We refer to CIAR's "research" projects as "peer-reviewed" projects. Based on information in CIAR's tax forms, which we obtained from the Internal Revenue Servim, we determined that CIAR awarded $11,209,388 for peer-reviewed projects and $4,022,723 for special-reviewed projects from 1989 to 1993.1 , For our analysis of the content, quality, and use of research funded by CIAR, we hypothesized that CIAR's special-reviewed projects would be more likely than its peer-reviewed projects to, support the tobacco indus- try position, and that the results of special-reviewed studies would be used by the tobacco industry to lobby against regulation of smoking in public places. Content of Research Funded by CIAR . We conducted a content analysis of CIAR-funded research to determine what projects and which investigators are being funded. We were partic- ularly interested in determining what percentage of CIAR-funded research is related to ETS. As we noted previously, research related to ETS has a high potential for being biased. by con8ict of interest, because the tobacco industry could use the results in legal and legislative settings. CIAR provided information regarding projects it had funded from Jan- uary 1988 to October 1993, including the title of each project, the name and affiliation of each principal investigator, the date the project was originally funded, and a one-paragraph description of the purpose of the project (Center for Indoor Air Research 1992b, 1993a). Based on the description, we classified the topic of each project as ETS related if it i. Figures do not include awards made in 199o beanse tax forms were oot avallabe from the Internal Revenue Service.

research to argue tobacco industry istry continue to ;ree that the case iewed projects to ipecial-reviewed i has little to lose ise most of them directly affect its :urs because the dly sound, unbi- :ss of how those ,ther hand, has a is best spent on can overtly or in various ways d Gostin 1994). t it believes will consciously or eir findings in a gators who rely ible to industry I be imposed to .1 (Hillman et al. hren (1994) has ded through an is try and inves- unded research :, which should entific freedom indings. tprofit corpora- nd the tobacco Barnes and Bero ' Industry•Funded Research 535 industry. In addition, all of CIAR's projects are funded through contracts, rather than grants, and CIAR's RFAs explicitly state that funded investi- gators are encouraged to publish their findings in peer-reviewed journals. CIAR has also taken additional steps to mini*niie the role of its sponsors in the funding process. In particular, it has given the primary responsi- bility of project selection to an independent group of scientists who serve on its science advisory board. Our analysis suggests that the projects funded through peer review by the advisory board are of high quality and have not been unduly influenced by conflict of interest. However, our analysis also suggests that Chren's proposal does not necessarily minimize conflict of interest in industry-sponsored research. In particular, we found that the tobacco industry developed a system for circumventing CIAR's peer-review process to fund projects that would serve its needs. The studies funded through CIAR's special-reviewed projects appear to be those that had the highest potential to produce data that could be either harmful or beneficial to the industry, because most of them were related to ETS. It seems likely that the tobacco industry funded these studies through its special-review process to retain control of selection of the principal investigators and study design. If other industries were to create organizations similar to CIAR for funding external research, it seems possible that they might be similarly tempted to fund particularly sensitive studies through a special process. implications for Disclosure Our study raises several important issues'related to disclosure. None of CIAR's publications disclosed that one-third of its projects are funded through a special-review process. In fact, CIAR's most recent publication of supported research no longer separates its projects into the categories of research, applied, and other (Center for Indoor Air.Research 1995). If we had received this new brochure, we probably would not have thought to ask whether all of CIAR's projects are funded based on the peer- review process described in its publications. CIAR should clearly describe the funding process for its special-reviewed projects in all of its publications. In addition, special-reviewed projects should be clearly labeled in its publications to indicate that they were selected by tobacco industry executives rather than through a process of peer review. Similar disclosure statements should be made in all publications resulting from CIA.R-funded research. Journal editors and policy makers have increasingly called for researchers to.disclose any potential conflicts 9024/031