Thursday, March 5, 2015

Conflicts of Interest Exposed, FDA Reorganizes Tobacco Advisory Panel

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.


Anonymous said...

Brilliant of the FDA to take this action ,well done the truth will prevail regarding Ecigs.

American Housewife said...

It is about time! Brilliant! I have felt from the begining that there must be special intrest money being paid to someone. Otherwise why would anyone be trying to stop the most successful ceasation device ever invented. Vaping allows people to quit smoking and to reduce their nic levels at their own pace. While using a device that is 95% to 99% less harmful than smoking cigarettes. Maybe the FDA does care about the public after all. Will see.

Michael J. McFadden said...

" ($8 million in 2014 for Dr. Samet,"

Not all that unexpected, but amazing to see it finally revealed.

Look at that statement and then go back in your files over the years to see how researchers and political candidates are reviled as "Big Tobacco Stooges" because of grants or compensations of less than ONE THOUSANDTH of that amount from BigT!

Samet et al should be brought up on outright criminal charges for abuse of the public trust and the enormous public harm they have caused through their promotion of smoking bans based upon misguided or misrepresented research.


Anonymous said...

Thanks for posting Brad. Last July, I predicted Zeller would replace TPSAC Chair Samet due to his conflicts of interest at

Bill Godshall

Anonymous said...

Absolutely reassuring to see ethics utilized in a government agency. We'll done!

Lance Johnson. 35 yr smoker and currently 3 years smoke free with a vaper.

Anonymous said...

ob half done - the Director who did the firing, Mitch Zeller, is himself a former employee of Pinney Associates, the reason for Jack Henningfield's sacking. Zeller survives because he isn't mentioned in the 2011 law suite. He was an employee of Pinney Associates at that time, joining FDA's CTP later.