Monday, February 25, 2013

Pharmaceutical Consultant Appointed to Head FDA Center for Tobacco Products, Creating an Immediate and Inappropriate Conflict of Interest

According to an article in the Winston-Salem Journal, the current head of the FDA's Center for Tobacco Products - Dr. Lawrence Deyton - is stepping down and will be replaced by Mitch Zeller, who heads a firm that does consulting work for Big Pharma.

According to the article: "What could make Zeller’s appointment controversial is he currently serves as an executive with Pinney Associates, a pharmaceutical consulting firm that does work for GlaxoSmithKline, the top seller of nicotine-replacement therapy products." ...

"In October 2010, the consumer health care division of GlaxoSmithKline requested that the FDA take Reynolds’ dissolvable tobacco products out of test markets. GlaxoSmithKline sells nicotine-replacement therapy products Nicorette and NicoDerm. In August, U.S. District Court Judge Richard Leon denied the FDA’s attempt to have the manufacturers’ lawsuit dismissed."

The Rest of the Story

In my view, this is an inappropriate appointment because it creates an unacceptable conflict of interest, thus mixing corporate politics with science and federal regulatory policy. This is precisely the type of appointment that President Obama promised to avoid when he stated in his first inauguration speech that it was time to take politics out of science.

Washington D.C. has become a virtual revolving door between corporate lobbyists/consultants and politicians/policy makers. This revolving door was what President Obama stated he would close in order to reduce corporate influence in the capital.

Now, however, we have an extreme example of conflict of interest and corporate influence. A pharmaceutical consultant is taking over a center of the very agency which regulates pharmaceuticals!

The conflict of interest is particularly inappropriate because one of the very first orders of business of the Center for Tobacco Products under Zeller's leadership will be promulgating regulations for the products that will compete with pharmaceuticals for the smoking cessation market: namely, electronic cigarettes and some other alternative nicotine-delivery devices. These regulations will have a major impact on the profits of GlaxoSmithKline, the top seller of nicotine replacement drugs and what appears to be the primary (if only) pharmaceutical company for which Zeller did consulting work.

This is tantamount to inviting GlaxoSmithKline to come to Rockville and issue its own regulations to govern its competitors.

The fact that Zeller is stepping down from his position at Pinney Associates to take this position is irrelevant, as it doesn't negate the conflict of interest.

Zeller has acknowledged that he "provides consulting support to GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment."

How can the FDA possibly appoint an individual with this severe a conflict of interest to head the center of the agency that will regulate GlaxoSmithKline's competitors?

To be clear, I am not questioning Zeller's other qualifications for the position. He is - otherwise - an outstanding choice for the position because of his extensive experience and leadership in the tobacco control movement and his prior service for the FDA itself. Unfortunately, however, the conflict of interest is unacceptable.

An article in the Wall Street Journal highlighted this conflict of interest:

"Mr. Zeller, an attorney and former official in the FDA's Office of Tobacco Programs from 1993 to 2000, helped build the first nationwide program to reduce youth access to tobacco. He was an executive at the American Legacy Foundation, an anti-smoking organization, from 2000 to 2002 before joining consultants Pinney Associates, where he advised pharmaceutical companies such as GlaxoSmithKline on smoking cessation products." ...

"Michael Siegel, a professor at Boston University's School of Public Health, thinks Mr. Zeller will likely take "a much more hard-line approach" in his dealings with tobacco companies but voiced concern that the incoming official has been paid to advise pharmaceutical companies in recent years. Dr. Siegel said that represented a conflict of interest as the FDA mulls how to regulate e-cigarettes, which are viewed by many researchers to be far less harmful than combustible cigarettes and a potential rival to FDA-approved quitting aids such as nicotine patches. An FDA spokeswoman said the agency "assiduously" complies with ethics standards, including recusals if there is any potential conflict of interest."

The FDA response is ridiculous. If the head of a major center at the agency needs to recuse himself from the chief decisions to be made by the center, then he simply shouldn't be heading the center.


No comments: