Say goodbye to a Wolfe in sheep s clothing

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While experts are frequently excluded from health and science panels due to conflicts of interest that result from concerns about industry funding, the FDA has made an unusual decision: to eject a panel member because of an intellectual conflict of interest.

Dr. Sidney Wolfe, head of the Public Citizen Health Research Group, was removed from a meeting of the FDA s Drug Safety and Risk Management Advisory Committee by the head of the FDA s Center for Drug Evaluation and Research, Dr. Janet Woodcock. This panel had been called upon to discuss the risks and benefits of certain newer types of birth control pills that contain the hormone drospirenone, the most popular of which are Bayer s Yaz and Yasmin. Dr. Wolfe has previously come down solidly against these pills, posting in his group s newsletter and website that these drugs are unacceptable for use because they can raise blood potassium to dangerous levels and cause significant increases in the risk of blood clots. Upon reading such postings, however, the FDA decided that holding such a strong and outspoken opinion on the topic would prevent Dr. Wolfe from participating objectively in the advisory committee s ruling.

Dr. Wolfe, of course, has opposed the FDA s decision, saying, If intellectual conflict of interest means being informed and subsequently having opinions on a drug, many more members of advisory committees, even without a financial conflict of interest, would have to be excluded because they know too much. The resulting committees would be noticeably less well-informed.

ACSH's Dr. Elizabeth Whelan agrees that Dr. Wolfe should be excluded from the committee, noting that with such well-documented bias, he would be unlikely to change his mind even on the basis of strong counter-evidence. But she adds, Dr. Wolfe s expulsion from the committee confirms what ACSH has maintained for a long time: Conflicts of interest should not be restricted to financial issues. Career-long adherence to a particular point of view also warrants disclosure and the possibility of being barred from objective panels. A 2008 ACSH publication, Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest, observes that people who are not allowed to participate on FDA committees because they received industry funding are often the very same people who have the most expertise on important issues; thus the committees will be hindered by their exclusion. Dr. Wolfe is making exactly the same point, says Dr. Whelan. He s just applying it to his own personal situation.