Many FDA Experts Have Drug Industry Ties

But votes on drug approvals wouldn't change much if they withdrew from advisory panels, study finds

Amanda Gardner

Amanda Gardner

Updated on April 26, 2006

TUESDAY, April 25, 2006 (HealthDay News) -- Experts sitting on powerful health advisory committees at the U.S. Food and Drug Administration often have conflicts of interest with drug companies and other vested interests, a new study shows.

These conflicts rarely result in the individual in question voluntarily withdrawing from the committee, the researchers noted.

However, the study also showed that, even if the experts had excused themselves, voting outcomes probably would not have changed.

The study authors, most of them from the nonprofit watchdog organization Public Citizen's Health Research Group, still expressed the hope that, "ideally, all panels of scientific experts advising a federal decision-making body would be free of financial conflicts of interest with the affected companies."

The findings appear in the April 26 issue of the Journal of American Medical Association.

The findings were hardly news to experts, however.

"This should come as absolutely no surprise," said Dr. A. Mark Fendrick, a professor of internal medicine at the University of Michigan School of Medicine and professor of health management and policy at the University of Michigan School of Public Health in Ann Arbor.

"Only if adequate funding came from the not-for-profit sector would we expect to see key opinion leaders without conflicts of interest," said Fendrick, who studies the clinical and economic impact of innovation in health care.

"On the one hand, this highlights the fact that conflicts of interest can be found in a lot of different arenas," added David Magnus, director of the Stanford Center for Biomedical Ethics. "It's also pretty clear that the amount of influence is modest."

Every year, the FDA's Center for Drug Evaluation and Research (CDER) approves 25 to 30 new drugs and, in so doing, often incorporates the advice of advisory committees composed of outside experts.

In January 2002, the FDA imposed a new policy to disclose potential conflicts of interest for advisory committee members. Members and voting consultants are now required to disclose financial interests they have currently, have had or are negotiating to have. Such conflicts include investments, employment, patents and development agreements.

The new guidelines have helped matters, but, the authors stated, there's still room for improvement.

The recent saga of cox-2 inhibitor prescription painkillers is a case in point.

According to an article published last February in the New York Times, 10 of the 32 FDA advisory committee members who voted at that time to allow the continued sale in the United States of the three painkillers -- Bextra, Celebrex and Vioxx -- had previously acted as consultants for the drugs' manufacturers. If these members had not voted, the recommendations would have been for Bextra to be withdrawn and Vioxx to not be returned to the market, the Times said.

As it was, panel advisors with company ties voted overwhelmingly for Bextra to stay on the market and for Vioxx to return to pharmacy shelves. Celebrex would not have been affected.

Both Bextra and Vioxx remain off U.S. drug store shelves, however. Vioxx was pulled in September 2004, after studies linked long-term use to cardiovascular trouble. Similar data prompted the withdrawal of Bextra from the market in April 2005. Celebrex remains available to consumers.

For this study, the authors analyzed agendas and transcripts from all FDA drug advisory committee meetings listed on the Web site as taking place between January 1, 2001 and December 31, 2004.

A total of 221 meetings held by 16 advisory committees were included in the analysis. In almost three-quarters (73 percent) of the meetings, at least one committee member or voting consultant disclosed a conflict, yet only 1 percent of committee members disqualified themselves from participation.

In all, 28 percent of advisory committee members and voting consultants disclosed a conflict, the most common of which were consulting arrangements, contracts or grants and investments.

Some of the financial interests were considerable. Nineteen percent of consulting arrangements were worth more than $10,000, 23 percent of contracts/grants exceeded $100,000, and 30 percent of investments were over $25,000.

While recusal of these members would not have changed voting outcomes, it would have narrowed the margin of approval, the researchers said.

"Advisory committee members with such large conflicts of interest should be recused from the meetings in which these conflicts exist," the authors wrote.

Others said the data may not be telling the whole story, however.

"Probably, there's a lot more influence on the kinds of panels they don't have data on, for example, panels considering a class of drugs or treatments would not fall into regulations of requiring disclosure and hence were not included," Magnus pointed out.

More information

The U.S. Food and Drug Administration has more on the current drug approval process.

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