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.”
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.
Dr.Gilbert Ross, M.D. is a board-certified physician in both Internal Medicine and Rheumatology and a Diplomate of the American Board of Internal Medicine. Most recently, he spent 18 years at the American Council on Science and Health in a variety of roles, including Medical Director, Executive Director, and Senior Director of Medicine and Public Health. He received his undergraduate degree in Chemistry from Cornell University’s School of Arts and Sciences in 1968, and received his M.D. from the N.Y.U. School of Medicine in 1972. - View all posts by Gil Ross →