Tuesday, March 17, 2015

Anti-Smoking Group and Advocate Want Conflicted Scientists to Sit on FDA Tobacco Advisory Panel

Recently, the FDA announced that in compliance with a court ruling, it would re-constitute its Tobacco Products Scientific Advisory Committee (TPSAC) by eliminating members with significant conflicts of interest by virtue of their previous financial relationships with pharmaceutical companies.

Apparently, the four TPSAC members who were removed from the Committee (or who had already left the Committee) were Jonathan Samet, Claudia Barone, Joanna Cohen, and Suchitra Krishnan-Sarin.

In response, the Campaign for Tobacco-Free Kids and Dr. Stan Glantz blasted the FDA for complying with the court decision. Apparently, they would like to see scientists with Big Pharma conflicts of interest sitting on a federal advisory panel that makes policy regarding the very drugs produced by these companies.

The Campaign for Tobacco-Free Kids wrote: "It is deeply troubling that the FDA today removed several extraordinarily qualified members of its Tobacco Products Scientific Advisory Committee (TPSAC) based on a misguided and overreaching court ruling that is under appeal. The FDA’s action demonstrates that the court decision and FDA’s overly cautious interpretation of that decision will deprive the agency of advice from many of the nation’s foremost and most credible scientific experts and undermine the FDA’s ability to do its job. It is essential that the FDA both aggressively pursue its appeal of the court decision in question and, in the interim, apply that ruling in a way that does not impair its tobacco advisory committee."

Glantz wrote: "Last week the FDA fired or forced the resignations of several highly qualified and respected scientists from its Tobacco Products Scientific Advisory Committee because of an overly cautious reaction to a misguided court decision  Like its decision to discount the health benefits of reduced smoking by the "lost pleasure" smokers experience when they stop or do not start smoking, this action sets a terrible precedent not only for tobacco control but public health in general."

The Rest of the Story

Both the Campaign for Tobacco-Free Kids and Dr. Glantz appear to have a misunderstanding of federal law. According to the Federal Advisory Committee Act, all federal advisory panels (including TPSAC) must be "fairly balanced in terms of the points of view represented and the functions to be performed," and its members cannot have severe financial conflicts of interest such that the committee's assessments, reports, or recommendations and decisions will be "inappropriately influenced . . . by any special interest."

Following this law, a D.C. district court ruled that the presence of the above members of TPSAC violated federal law because these members had significant financial conflicts of interest with Big Pharma.

It is essential that federal expert and advisory panels not contain members with significant conflicts of interest with corporations such as pharmaceutical companies because these conflicts of interest may influence, or have the appearance of influencing the recommendations and decisions of these panels. Do we really want a scientist who worked for Pfizer to make decisions about the use of a drug produced by Pfizer? Do we want a researcher who received grant funding from GlaxoSmithKline to make recommendations regarding whether a drug manufactured by that very company should be approved?

Both the Campaign for Tobacco-Free Kids and Dr. Glantz appear to misunderstand the importance of eliminating these conflicts of interest. Their arguments are based on the contention that the scientists in question were of the highest integrity and that they could contribute significantly to the panel. But it is not the integrity nor the potential contributions of these scientists that is in question. The only thing in question is whether they have conflicts of interest that, according to federal law, should preclude them from serving on a federal panel that will likely make decisions that affect the financial status of the very companies with whom these scientists have had financial relationships.

Here is a brief summary of the apparent financial conflicts of interest we are talking about:

Dr. Samet: According to the original complaint filed by Lorillard and R.J. Reynolds: "During the last decade, Dr. Samet has received grant support for research and writing from GSK on at least six occasions, including in 2010. In addition, he formerly led the Institute for Global Tobacco Control, which is [was] funded by GSK and Pfizer. Moreover, until 2009, Dr. Samet received regular honoraria from Pfizer for his service on the Pfizer Global Tobacco Advisory Board."

Dr. Barone: According to her C.V., Dr. Barone and two of her colleagues received a $400,000 educational grant from Pfizer, covering the period 2010-2013.

Dr. Cohen: According to her C.V., Dr. Cohen works for the Institute for Global Tobacco Control. She is now the director. The problem is that the Institute for Global Tobacco Control apparently received funding from GlaxoSmithKline and Pfizer. However, that funding appears to have been received before Dr. Cohen came to the Institute. Thus, I cannot understand in this case why Dr. Cohen should be precluded from serving on TPSAC.

Dr. Suchitra Krishnan-Sarin: According to a 2011 C.V., Dr. Krishnan-Sarin received a GRAND award from Pfizer covering the years 2011-2013. Also listed is Pfizer funding for a clinical trial conducted in 2003-2004.

While Glantz and the Campaign for Tobacco-Free Kids argue that the removal of conflicted members will impede the work of the FDA, the assurance that federal expert panels and advisory boards be free from financial conflicts of interest actually enhances the work of these bodies by eliminating a major potential source of bias and by ensuring that there is no appearance of a conflicted panel.

In summary, I see no reason that Dr. Cohen should not be able to serve on the TPSAC panel. However, the other three members do have significant financial conflicts of interest that should preclude them from serving on TPSAC.

Finally, this has nothing to do with the integrity, character, or potential value to the committee of the conflicted scientists. The only issue here is the conflicts of interest.

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