260319 Tobacco Company Influence on the FDA-Commissioned IOM Report, Clearing the Smoke

Monday, October 29, 2012

Crystal Tan, MS , Center for Tobacco Control Research and Education, University of California, San Francisco, San Francisco, CA
Thomas Kyriss, MD , Thoracic Surgery, Schillerhoehe Hospital, Gerlingen, Germany
Stan Glantz, PhD , Department Medicine, School UCSF School of Medicine, San Francisco, CA
Background: Spurred by potential modified risk tobacco products, the Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 report Clearing the Smoke. Methods: Analyzed >1000 documents in the University of California, San Francisco Legacy Tobacco Documents Library. Results: Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to share ideas and information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers and in-house regulatory staff manipulated the presentation of data from company scientists and consultants. The companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalents”) without prior regulatory approval. Some principles from the IOM report, including the substantial equivalents recommendation, were incorporated into the Family Smoking Prevention and Tobacco Control Act. Conclusions: Tobacco companies strategically interacted with the IOM to win their favored scientific and regulatory recommendations. Policymakers should recognize that the industry's desire to “collaborate” on scientific issues is driven by political and financial motives rather than aspirations to high-quality science and interferes with effective public health policymaking.

Learning Areas:
Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
1. Describe how the tobacco companies organized to influence an Institute of Medicine report that would determine scientific and regulatory standards for potential modified risk tobacco products. 2. Identify recommendations made by the tobacco companies that were ultimately incorporated into the IOM report, Clearing the Smoke, as well as the Family Smoking Prevention and Tobacco Control Act. 3. Explain that scientific research by tobacco companies may be presented in a misleading or deceptive way to satisfy their political and financial motives.

Keywords: Tobacco, Policy/Policy Development

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a medical student and researcher at the Center for Tobacco Control Research and Education at the University of California, San Francisco. My research interests include public health policy, and I have pursued my current project by analyzing previously secret tobacco company documents available on the UCSF Legacy Tobacco Documents Library.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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