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Luchtenborg et al. that while non-filtered cigarettes increased the risk for colon cancer (OR 1.59; 95% CI, 1.15-2.21; P(trend) = 0.001), filtered cigarettes did not increase colon cancer risk (OR 1.05; 95% CI, 0.79-1.39; P(trend) = 0.98).

Instead of this insane regulatory approach, the FDA should scrap the requirement for product applications and should simply promulgate basic safety standards that ensure minimum, uniform requirements for product safety. If the agency allows for a 12-month grace period, we could expect to see these requirements actually take effect within two years.

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.

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