Incidentally, the Reynolds/Lorillard lawsuit seeks to have Drs. Benowitz, Henningfield, and Samet dismissed from the FDA's TPSAC (Tobacco Product Scientific Advisory Committee) panel because of these conflicts of interest. While these conflicts do not preclude the participation of these scientists as authors of the Surgeon General's report, they absolutely must be disclosed to the public.

In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.

Perhaps the FDA Center for Tobacco Products' slogan should be: "CTP: Protecting the Public from Cigarettes that Smell Wrong."

Because this research was funded by the federal government (by the Army Research Office, to Cornell), it is subject to the human subjects research requirements. In addition, the involvement of two researchers at academic (federally-funded) institutions requires that the research be approved by an Institutional Review Board. Apparently, the research was approved by an academic IRB, a decision which I publicly question, for the above reasons.

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