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Crystal E. Tan,
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Thomas Kyriss,
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Stanton A. Glantz
mail
Background
Spurred
by the creation of potential modified risk
tobacco products,
the US
Food and Drug Administration (FDA) commissioned the
Institute of
Medicine (IOM) to assess the science base for tobacco “harm reduction,”
leading to the 2001 IOM report
Clearing the Smoke. The
objective of this study was to determine how the tobacco industry
organized to try to influence the IOM committee that prepared the
report.
Methods and Findings
We
analyzed previously secret tobacco industry documents in the
University
of California, San Francisco Legacy Tobacco Documents Library, and IOM
public access files. (A limitation of this method includes the fact that
the tobacco companies have withheld some possibly relevant documents.)
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 provide information on exposure and
disease markers, clinical trial design for safety and efficacy, and
implications for initiation and cessation, tobacco company lawyers,
consultants, and in-house regulatory staff shaped presentations from
company scientists. Although the available evidence does not permit
drawing cause-and-effect conclusions, and the IOM may have come to the
same conclusions without the influence of the tobacco industry, 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 equivalence”) without
prior
regulatory approval. Some principles from the IOM report,
including elements of the substantial equivalence recommendation, appear
in the 2009 Family Smoking Prevention and
Tobacco Control Act.
Conclusions
Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.
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