May 28, 2013

Stanton A. Glantz, PhD

Tobacco Company Efforts to Influence the FDA-Commissioned Institute of Medicine Report Clearing the Smoke

Crystal Tan, Thomas Kyriss, and I just published a new paper in PLoS Medicine using industry documents to further illuminate how the tobacco companies work to influence the policy process that tells a cautionary tale for the FDA and others considering how to interact with tobacco companies.

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.

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.

Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.

Read the full paper in PLOS Medicine at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001450 and the accompanying commentary by Tom Novotny at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001457

Comments

Comment: 

In my review of the IOM report, published in Nicotine & Tobacco Research (2002), S191-S193, I remarked that none of the staff or technical writers provided a statement about conflict of interest. While I am sure that that the chair of the committee report, Professor Stuart Bondarant, conducted himself in a professional and objective manner, it should have been noted that he had served on the AMA Committee on Smoking and Health, participating in the 1964–1972 AMA collaboration with the tobacco industry to distribute nearly twenty-five million dollars of company money in AMA research grants.
 
Norbert Hirschhorn MD

Comment: 

In my review of the IOM report, published in Nicotine & Tobacco
Research (2002), S191-S193, I remarked that none of the staff or
technical writers provided a statement about conflict of interest. While
I am sure that that the chair of the committee report, Professor Stuart
Bondarant, conducted himself in a professional and objective manner, it
should have been noted that he had served on the AMA Committee on
Smoking and Health, participating in the 1964–1972 AMA collaboration
with the tobacco industry to distribute nearly twenty-five million
dollars of company money in AMA research grants.
 
Norbert Hirschhorn

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