Going Up In Smoke? An FDA Panel & Transparency
5 CommentsBy Ed Silverman // May 17th, 2010 // 9:16 am
Earlier this year, the FDA inaugurated a new panel - the Tobacco Products Scientific Advisory Committee - which was formed to review and evaluate “safety, dependence and health issues” concerning tobacco products. But it wasn’t long before there was criticism that some panel members held conflicts of interest (see here and here).
At issue has been that a few of the members have ties to drugmakers that market or are developing products designed to help people quit smoking. For instance, the panel roster notes that its chair, Jonathan Samet, who is a public health expert at the UCLA, is listed as a member between 2004 and 2009 of Pfizer’s Tobacco Advisory Board, and Pfizer sells Chantix. The resume provided by Jack Henningfield, an adjunct professor at Johns Hopkins University School of Medicine, mentions that he provided expert witness testimony for GlaxoSmithKline, which sells Nicorette.
But not all industry connections are disclosed. The roster, which was updated last week on May 12, does not include the fact that Samet has also received grant support from Glaxo (look here) and Henningfield works for Pinney Associates, which has Glaxo as a client although that isn’t clear from the resume on the FDA site. Meanwhile, Neal Benowitz, a pharmacologist at the University of California at San Francisco, has been a consultant to Pfizer and Glaxo (see this). And Dorothy Hatsukami has consulted for Pfizer and received grant support from Nabi Pharmaceutical, which is developing a smoking-cessation vaccine, but these are not mentioned in her resume.
In explaining its actions, an FDA spokeswoman tells us that panel choices were based on a federal statute, which says non-industry members could not have received any salary or payments from any tobacco manufacturer, distributor or retailer in the previous 18 months. In an email to us, Hatsukami, for instance, noted that she “consulted with Pfizer about 3 years ago and received no honorarium. I have not consulted with Pfizer since that time.” [UPDATE: Benowitz writes in that "the disclosures were made in full by me to the FDA. I suspect that the FDA does not consider pharmaceutical consulting to be a potential conflict with respect to tobacco products since medications are specifically excluded from TPSAC’s considerations]. We await word from the other panel members and the FDA.
There is a wrinkle in all this, however, and that is the FDA’s alleged commitment to greater transparency. Just last month, the FDA issued a new draft guidance that would expand disclosure when a conflict of interest waiver is granted to individuals who participate in its advisory committee meetings (see this). The FDA may be adhering to the letter of the law, but given the ongoing concerns over panel conflicts - and this panel, in particular - the agency is displaying a tin ear. Given the criticism over this issue, it would behoove the agency to work with Congress to find a solution, or its ability to achieve greater transparency may go up in smoke.
Paul
What’s the point of this critique? That experts in a field can only be experts in one setting and nowhere else?
Being on an advisory board for Pfizer or any other company does not “pollute” a scientific expert so that they cannot be used for anything else. That’s exactly the point, you want the best of the best advising everywhere they can. And providing advice in multiple settings is better than only one - drives even more balance.
Ed Silverman
Hi Paul,
Thanks for writing. And no, the point was, as I stated, that the FDA ought to do more to disclose all conflicts - or connections - so that everyone has as much information as possible about the backgrounds and interests of its panels.
That is not the same thing as suggesting that panel members should have expertise in only one area. In fact, I agree with you that added expertise in multiple disciplines or fields can be extremely beneficial.
Whether the FDA found the best panel - or the best available panel - can be open to debate. I simply tried to point out that the FDA has, in the past, taken it on the chin for failing to properly address conflicts - real or perceived - among its panel members and should do more to achieve transparency.
From there, it would hopefully be possible to have a more informed discussion - if one is needed - about the composition of any given panel.
I hope this helps,
ed
MsPiggy
DUH WHAT!
Paul, do you actually believe that there are no competent experts outside of the Pharmaceutical Industry’s greedy grasp that can be found for these supposed unbiased advisory committee’s?
Maybe your just completely ignorant/blinded to the fact that having a “conflict of interest”, whether it does or does not result in actual biased outcomes; gives us the mere disturbing appearance and public perspective of the good old hanky panky shenanigans that the FDA has a deep and long tradition of up holding for their corrupted pharmaceutical industry masters.
Paul, do you also want us to believe that those “Good Drugs” people that you obviously are an apologist for haven’t skewed data, purposely misrepresented drugs, marketed drugs illegally, caused significant health dangers to large segments of the population, buried tainted/negative findings in clinical studies/science, and have not acted unethically/irresponsibly/criminally.
Jeez, maybe you can sell us all some of what your smoking. It obviously has a profound intoxicating delusional effect lol……
annepme
Surely the FDA has heard and likely had to deal with footnores? As the saying goes, when in doubt footnote…
ex-FDA
I’m not surprised. A cosmetic change at the top means nothing. Even if they did want to do anything the FDA is now entrenched with industry stooges who were brought in and intentionally placed in various management layers, all the way down to the lowest level so that no changes away from industry could be effected. Plus almost anyone who would be able to be placed in open positions with a new administration were forced out or removed.
Over the weekend I spoke to several old colleagues from different centers who are still at the FDA. Every single one said nothing has changed.