As a result of the decision, the FDA will not be able to rely upon the findings and conclusions of the TPSAC menthol report. In addition, the Court instructed the agency to reconstruct TPSAC by replacing any members who have conflicts of interest. Dr. Samet is the only current TPSAC member who appears to be implicated by this instruction.

This is the equivalent of a cigarette company refuting the required warnings that are made on a cigarette package. The cigarette companies are free to fight the cigarette warning labels as they are being considered, but once a federal body requires those warnings, the companies must not act to undermine the required warnings. In this case, Pfizer's actions are more grievous than those of a cigarette company undermining a package warning because the black box warnings are required by a federal regulatory safety agency, rather than by a Congressional act. More specifically, the black box warnings are an official part of the formal approval of the marketing and sale of the drug. The company may not sell the drug without the warning. By publicly undermining and refuting the warning, the company is essentially violating the terms of the drug's approval.

The black box warning, then, advises physicians to observe patients being put on Chantix for "suicide-related events," including "suicide."

Earlier this week, I that the 2014 Surgeon General's fails to disclose the conflicts of interest of its authors, many of whom have received money from pharmaceutical companies which manufacture the very products about which the report opines. I also how this is particularly problematic, since the report itself complains about how historically, tobacco-funded scientists failed to disclose their conflicts of interest. I concluded that the 2014 Surgeon General's report is violating the very ethical principles that it attacks the tobacco company for violating in the past, and I note that while there has been substantial progress in the past 50 years in the area of disclosure of conflicts of interest, somehow that progress has evaded the producers of the Surgeon General's report itself.

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