Scientific Standards for Studies on Modified Risk Tobacco Products (2012) / Chapter Skim
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2 Governance and Conduct of Studies
2 Governance and Conduct of Studies
Pages 45-72
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From page 45... ...
Consequences of improper conduct, such as the falsification, manipulation, or destruc tion of research findings, not only result in a loss of trust and credibility, but also can result in significant harm. It is critical that all data sub mitted in support of modified risk tobacco product (MRTP)
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From page 46... ...
This chapter begins with a brief retelling of the history of tobacco research. The next section explores how the absence of governance and a history of improper conduct have resulted in a situation where the tobacco industry currently lacks the ability to independently produce and disseminate comprehensive and credible data about tobacco products.
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From page 47... ...
. On July 18, 1957, John Blatnik led 6 days of Congressional hearings on filtered cigarette advertising,2 the first of its kind in exploring the marketing of tobacco products (Harris, 2011)
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This modification was advantageous for tobacco companies because less dense cigarettes burn more quickly when left in smoking machines, meaning that the measured tar yields were reduced by virtue of decreasing the number of puffs taken. Filter ventilation, however, was the key feature that drove cigarette elasticity.
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These data encouraged some in tobacco control that harm reduction was possible if smokers could be convinced to adopt use of smokeless tobacco (Kozlowski, 2007) , while others raised serious concerns about unintended consequences (Tomar et al., 2009)
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. Other tobacco products have also been promoted as having potential for harm reduction.
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In addition to the recognized tobacco-specific journals Tobacco Science and Beitraige zur Tabakforschung [Contributions to Tobacco Research] , tobacco industry scientists and consultants served on editorial boards of a number of scientific journals, including Indoor and Built Environment, Inhalation Toxicology, Regulatory Toxicology and Pharmacology, Mutagenesis, and the Journal of Clinical Epidemiology (Bitton et al., 2005; Garne et al., 2005)
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From page 52... ...
designed to cast doubt on the health risks of smoking. Kessler noted in the findings of fact that Defendants attempted to and, at times, did prevent/stop ongoing research, hide existing research, and destroy sensitive documents in order to protect their public positions on smoking and health, avoid or limit liability for smoking and health-related claims in litigation, and prevent regulatory limitations on the cigarette industry.
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. If data generated for the FDA by tobacco companies is perceived to lack credibility, the FDA could in general, and the Center for Tobacco Products (CTP)
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. Prior to the FSPTCA, commercial tobacco products were not regulated by the FDA (White et al., 2007)
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The FSPTCA places the CTP in a difficult position. The center will now be regulating tobacco companies as product sponsors, without the longrun institutional knowledge of these companies that is gained through decades of regulation and oversight.
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This hypothesis gains credence from studies of tobacco industry research, including research done by some of the largest and most established companies, where independent researchers have found significant problems with governance. In one examination of more than 73 different studies with human subjects conducted by R.J.
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This poses a significant problem to product sponsors, because the tobacco industry currently lacks expertise and experience in conducting behavioral and addiction research in high-risk populations. Recognizing the risks involved, some tobacco companies appear resistant to the notion of conducting the research themselves.
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Alternatively, if the CTP requires any substantial part of the portfolio of research supporting an MRTP application to con sist of actual published research, it may be difficult for sponsors to meet this standard. If a governance framework is created that fosters credible and trustworthy tobacco research, journals may be willing to reconsider acceptance of tobacco industry–sponsored manuscripts.
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From page 59... ...
In addition to the basic protections afforded by the Common Rule, the committee identified several ethical issues in tobacco research worth particular attention. The first issue is the risk of conducting clinical trials of MRTPs or other tobacco products in populations with a high risk for tobacco initia 6 Food and Drug Administration Amendments Act of 2007 , Public Law 110-85, 121 Stat.
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the individual does not want to quit using tobacco products or the individual wants to quit using tobacco products, but is unable to quit, (3) the MRTP candidate is not more hazardous than conventional tobacco products, and (4)
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When investigators are conducting research involving these high-risk groups, they should be particularly cautious about the inclusion of individuals who lack the capacity to provide meaningful consent. TOWARD A TOBACCO RESEARCH GOVERNANCE ENTITY To improve the credibility of the studies in support of an MRTP application under Section 911, tobacco product sponsors and the CTP should consider facilitating the creation of a third party or third parties for the conduct and oversight of these studies.
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The Health Research Committee also oversees research investigators and their work. Independently of the Health Research Committee, the Health Review Committee evaluates research produced by HEI-funded investigators and interprets the meanings of such research for policy makers.
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In particular, it may be problematic for individual tobacco companies to contribute funds to a TRGE if those funds will be used to fund research that potentially benefits a competitor's product more than its own product. As such, it will be important to distinguish between two different types of research: (1)
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From page 64... ...
Unregulated or unstructured industry funding could potentially contribute to a perception of bias, so it is quite possible that the funding from tobacco companies and potential MRTP sponsors could be structured in a tax-like manner. The HEI model of regular, equalized contributions from members of the industry -- with expected contributions independent of research and no bargaining over HEI governance between contributions -- would be a useful model for consideration.
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From page 65... ...
can deeply shape the research outcome. If research funding were provided through a TRGE, the competition might create additional incentives to cleave to robust research design models.
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. Consistent with the HEI model and with other forms of research governance at universities and hospitals, the TRGE could perform scheduled or random data audits and other forms of site-specific research investigation.
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Where independent research entities are used, any independent institute • should have as its mission the performance of high-quality studies to determine the risks of modified tobacco products; • should be governed by individuals appointed by an organization independent of the tobacco industry and with sufficient scientific stature to inspire public confidence; and • should receive "core funding" from a tax on tobacco products that will maintain its basic functions, while individual studies will be funded by the interested companies. REFERENCES Ashley, M
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2007. The role of sensory perception in the development and targeting of tobacco products.
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2007. Effect of smokeless tobacco product marketing and use on population harm from tobacco use: Policy perspective for tobacco-risk reduction.
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2005a. Lessons from the history of tobacco harm reduction: The National Cancer Institute's smoking and health program and the "less hazardous cigarette." Nicotine & Tobacco Research 7(5)
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From page 71... ...
Tobacco Control 14(4)
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