Thursday, March 24, 2011

Chair of TPSAC Claims that Committee's Recommendation is Clear; Defense of Committee's Cop-Out is Uncompelling

The chair of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC), in an article in the New York Times, defended the Committee's cop-out (its failure to issue a recommendation on whether the FDA should ban menthol cigarettes) by putting forward the weak and untenable argument that the Committee did in fact issue a recommendation that the FDA ban menthol cigarettes.

According to the article: "While the eight-member group led by Dr. Samet did not recommend a specific policy to phase out or ban menthol cigarettes, that was never its role, he said in the interview, emphasizing the word “scientific” in its formal title, Tobacco Products Scientific Advisory Committee. Further, Dr. Samet disagreed with statements by some stock analysts and public health advocates that the panel did not make a clear recommendation. It did, he said, in the conclusive statement in its 231-page report: “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” “To me that speaks quite clearly to what our recommendation is,” Dr. Samet said. “I think the major issue is probably a failure to understand the role of this committee and what the F.D.A. does as a regulatory agency. I think the statement about removal is what the public health recommendation is, and I think how one achieves that outcome depends on the strategies available to the F.D.A. under the law.”"

The Rest of the Story

Sorry to have to break this news, but the statement "Removal of menthol cigarettes from the marketplace would benefit public health in the United States" is not a recommendation, but a scientific conclusion. A recommendation must suggest an action or provide advice. The TPSAC's "recommendation" does not do either of these.

To show how ridiculous it is to argue that the conclusion of the report is a recommendation, consider the following statement, which mirrors the conclusion of the TPSAC report. As you will see, this statement is not a recommendation, because it does not put forward, suggest, or advise a particular action. This conclusion is compatible with taking action or not taking action.

Example #1: Removal of all cigarettes from the marketplace would benefit the public's health.

This is a true statement. Invariably, if all cigarettes were removed from the marketplace, it would benefit the public's health. But making such a statement does not imply that one is offering a recommendation that cigarettes be prohibited. One could draw this conclusion, yet believe that prohibition of cigarettes would have disastrous social and economic consequences, and therefore one could actually advance the opposite recommendation: Congress should not ban cigarettes.

The conclusion is a scientific one. It does not imply a particular policy action. One could make the statement and also believe that Congress should ban cigarettes. One could make the statement and also believe that Congress should not ban cigarettes. Clearly, it is a conclusion and not a recommendation.

That this is a conclusion rather than a recommendation is also clear from investors' response to the report. If this were a recommendation for a menthol ban, Lorillard stocks would not have jumped up a whopping 14% in just two days after the report's release.

Ultimately, what concerns me most about the panel's failure to make a recommendation is simply that this was a huge cop-out. By failing to tell us what it really thinks, the Committee is doing a major disservice. You don't issue a report that doesn't make a recommendation, and then try to use media interviews to actually make a recommendation. If you have a recommendation, then just tell us. This is a cowardly action.

At this point, I would settle for any recommendation from the Committee. Ban menthol, don't ban menthol, lower menthol levels, phase out menthol, regulate menthol levels, do nothing. To simply punt the issue back to the FDA is not only a cop-out but an abrogation of the Committee's Congressionally-mediated responsibility.

While I don't know for sure why Dr. Connolly resigned from the Committee, my guess is that he was unhappy with the Committee's apparent unwillingness to recommend a ban on menthol cigarettes or a gradual phase-out of these products. I give him credit for getting off the committee before having to have his name tied to a cop-out report.

The FDA is not going to ban menthol cigarettes and any doubt about this was erased with the TPSAC report. Had the Committee come out with a strong and unequivocal recommendation that the FDA ban menthol cigarettes, it would have at least raised the possibility that the FDA could follow through with such an action. But this report gives the Agency the excuse it needs to refrain from making a politically dangerous move. The Agency is off the hook.

Just yesterday, a new research article came out which concludes that menthol cigarettes are actually less harmful than non-menthol cigarettes, because they pose a lower risk of lung cancer. The study also found that menthol smokers smoke less than non-menthol smokers. Combined with the TPSAC's weak-willed action, this pretty much puts a death knell in the chances for a ban on menthol cigarettes.

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