A range of obvious conflicts of interest has led to the replacement of several FDA Tobacco Products Scientific Advisory Committee (TPSAC) members.
Federal judge Richard Leon ruled last July that “The presence of conflicted members on [TPSAC] irrevocably tainted its very composition and its work product” and “the Committee’s findings and recommendations…are, at a minimum, suspect, and, at worst, untrustworthy.” (here).
Today, Mitch Zeller, director of the FDA Center for Tobacco Products, announced (here) that, “As a result of the expanded [conflict of interest] criteria outlined in Judge Leon’s ruling, each voting TPSAC member was rescreened and four members – Chairman Jonathan Samet, Claudia Barone, Joanna Cohen, and Suchitra Krishnan-Sarin – have resigned or their terms on TPSAC have been terminated.” Pebbles Fagan, Gary A. Giovino and Thomas E. Novotny are new committee members; the chair remains vacant.
Judge Leon ruled that Samet was conflicted because he “received grant support from [pharma giant] GlaxoSmithKline at least six times, including in 2010. He also led the Institute for Global Tobacco Control, funded by GSK and Pfizer. Dr. Samet also testified for lawyers suing tobacco-product manufacturers…he was designated to testify in two pending tobacco cases.” I have noted that Claudia Barone also had a conflict of interest because of a Pfizer grant in 2013 that preceded her 2014 TPSAC appointment (here).
I have reported that Dr. Samet and Krishnan-Sarin also had conflicts due to their having received substantial grants from the anti-tobacco NIH ($8 million in 2014 for Dr. Samet, $5.8 million for Krishnan-Sarin). Current TPSAC members with major NIH funding include Kurt Ribisl ($9.2 million in 2014), Thomas Eissenberg ($3.9 million), Richard O’Connor ($0.5 million) and Warren Bickel ($0.4 million)(here).
Experts can be influenced by substantial financial support from organizations committed to a tobacco-free society, a euphemism for the obliteration of the tobacco industry (an objective that is at odds with the principle of regulation). To avoid even the appearance of impropriety, those who are funded by the American Cancer Society, the American Heart Association, the American Lung Association, the National Institutes of Health, the Centers for Disease Control and Prevention, or the Robert Wood Johnson Foundation should be ineligible for TPSAC membership.