Since its inception in 2010, the FDA s Tobacco Products Scientific Advisory Committee (TPSAC) has been populated by highly conflicted experts. Although it s powerless, still some rules need following. Federal Judge Leon agrees; FDA s Zeller does not.
Last July, Federal District Court Judge Leon ruled on a lawsuit brought (in 2011) by some tobacco companies, who had alleged that the makeup of the TPSAC (Tobacco Products Scientific Advisory Committee) was unfair, consisting of several members with actual or perceived conflicts of interest. The members so identified included the Chair, Jonathan Samet, and Neal Benowitz, Jack Henningfield, and Greg Connolly. These members all had ties to industry with their own stake in the issue of tobacco and cessation, or had expressed clearly their own opinions about matters likely to come before that committee or both. (As an example, Jack Henningfield was an executive of Pinney Associates, whose main client was (and still is) Glaxo SmithKline (GSK), maker of a variety of nicotine replacement therapies (NRT).
The Judge agreed, and told the FDA to re-constitute its TPSAC: ask to resign or terminate 4 members, and hire 3 to replace them. Finally, the FDA s Center for Tobacco Products head, Mitch Zeller, announced that committee members Chairman Jonathan Samet, Claudia Barone, Joanna Cohen, and Suchitra Krishnan-Sarin--have resigned or their terms on TPSAC have been terminated.
But never accuse Zeller of going down with a...not a fight, exactly, but a whine at least: This is a loss for the FDA and for public health. Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service; however, in light of Judge Leon's ruling, we do not believe we are able to exercise our discretion to consider this option at this time.
ACSH s Dr. Gil Ross had this perspective: You bet you are not able to exercise your discretion Mitch, to fight a federal judge, especially given the sorry truth that the TPSAC was packed from the start with conflicted members. Many of them never had any claim to objectivity, having expressed clear opinions on subjects of importance coming before the panel, and often working hand-in-glove with makers of ineffective NRT products or lawyers involved in tobacco-related litigation.
But wait what about CTP Czar Zeller himself? Maybe he s flying a bit too close to the sun too, since his employment right before coming to FDA was here it is again as a high-level employee of Pinney Associates. I wonder what would have happened if he had been at the CTP in 2011 when the lawsuit was filed? Perhaps his name would have been amongst those terminated from the tobacco center. Maybe that could still happen.