Thursday, June 3, 2010

Four Members of FDA Tobacco Products Scientific Advisory Committee Have Received Pharmaceutical Money; Industry Influence Grows - Michael Siegel

My previous post reported that the FDA appointed GlaxoSmithKline to sit on its Tobacco Products Scientific Advisory Committee, by virtue of its appointment of a Glaxo consultant and expert witness to the panel.

Today, I report that the influence of the pharmaceutical industry on FDA policy will be even greater than I suggested yesterday, because three additional members of the Committee have also received pharmaceutical money.

First, the chair of the Committee - Dr. Jonathan Samet - has received grant support from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - is funded by GlaxoSmithKline and Pfizer.

Second, an additional panel member - Dr. Dorothy Hatsukami - has received grant support from a pharmaceutical company to study the nicotine vaccine for use in smoking cessation.

Third, an additional panel member - Dr. Neal Benowitz - co-authored a study on the use of Chantix in smoking cessation which was funded by Pfizer and has also served as a Pfizer consultant. In particular, Dr. Benowitz served as a Pfizer consultant on how to develop a scientific base to support the use of Chantix in smoking cessation. Benowitz has also consulted for GlaxoSmithKline and Nabi Pharmaceuticals.

The Rest of the Story

The FDA Tobacco Products Scientific Advisory Panel is a virtual smorgasbord of tobacco and pharmaceutical financial interests. This is hardly what I imagine President Obama had in mind when in his inaugural address he called for "science to be restored to its rightful place."

The FDA has now given a seat on the panel to GlaxoSmithKline, Pfizer, and Nabi Pharmaceuticals, alongside the tobacco companies, through their paid consultants or grantees.

There is no way this panel can objectively consider tobacco product regulation and policy - based purely on the science - in the midst of such a potpourri of pharmaceutical financial interests and conflicts of interest.

The conflicts of interest of two of the panel members were highlighted in an article in today's Wall Street Journal.

Given that the FDA has already been under siege for complaints about the undue influence of politics over science, due to the influence of industry, it is unclear why the Agency would want to compound the problem by crafting a highly conflicted panel to advise it on tobacco issues. There is enough bias in this field to begin with; we don't need to add to it by appointing a panel with numerous members who have severe, personal financial conflicts of interest.

The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats).

This means that 7 of the 12 seats on the panel are now industry seats:

Big Tobacco: 3
Big Pharma: 4
Total Industry Seats: 7

The tobacco and pharmaceutical industries must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors.

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