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.
6 comments:
Brilliant of the FDA to take this action ,well done the truth will prevail regarding Ecigs.
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.
" ($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.
- MJM
Thanks for posting Brad. Last July, I predicted Zeller would replace TPSAC Chair Samet due to his conflicts of interest at
http://www.e-cigarette-forum.com/forum/fda-regulations/585516-judge-leon-strikes-again-rules-fda-tpsac-had-conflicts-interest-quashes-menthol-report-orders-fda-reconstitute-tpsac.html
Bill Godshall
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.
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.
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