FDA Panels: Conflicts of Interest?

Study Traces Industry Ties Among Experts Who Make Drug Recommendations

From the WebMD Archives

April 25, 2006 -- Close to 30% of all outside experts who vote on FDA advisory panels have financial or other relationships with the industries they judge, though few recuse themselves because of those apparent conflicts, a study released Tuesday concludes.

The FDA regularly relies on expert panels to advise it on whether to approve drugs, vaccines, medical devices, and other products for U.S. sales. Such panels are involved at some point in the consideration of most high-profile products, including recent deliberations on the safety of drugs for attention deficit disorder, the emergency contraceptive pill Plan B, and arthritisarthritis drugs like Vioxx.

Panelists are required to disclose their potential conflicts of interests to the agency and the public. But those reports rarely stop experts from voting on the fate of drugs from which they potentially may profit.

The report shows that 73% of 221 advisory meetings between 2001 and 2004 included at least one member with a disclosed financial conflict. Twenty-eight percent of all experts reported a conflict, though only 1% declined to participate because of it, concludes the study, published in The Journal of the American Medical Association.

Researchers say their analysis shows that no committee decisions would have been different if all conflicted experts had declined to vote. But they also found that members were 10% more likely to vote for or against a product if they had ties to its manufacturer or a competitor.

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Impact of Financial Ties

Peter Lurie, MD, a study researcher, says the study found a "clear impact" of financial ties on experts' votes, but that the impact is "not very large." But he added that committees are clearly influenced by conflicts that could affect the way regulators decide to police drugs.

"No amount of distortion in the behavior of these people is acceptable. We don't accept it in juries and we shouldn't accept it in advisory committees that affect many more people," says Lurie, deputy director of Public Citizen's Health Research Group, an FDA watchdog and longtime critic of both the agency and the health care industry.

A 2002 FDA directive tightened rules on advisors' disclosure of financial conflicts. The study found slightly fewer conflicts after the ruling.

Still, many ties, in the form of research grants, consulting fees, or stock holdings, were tens of thousands of dollars in value. Five percent of experts reporting conflicts said they held more than $50,000 in stock in a company under consideration or a competitor.

Need for Expertise

FDA officials have stressed the need to use the country's best experts in clinical trials and medical product safety. Most of those experts have ties to industry either directly or through research, and the agency maintains that excluding all advisors with conflicts would rob the public of the most qualified reviewers.

FDA spokeswoman Kimberly Rawlings says in an emailed statement that the agency reports all conflicts of interest to the public at advisory committee hearings and on the Internet two weeks before hearings.

"The agency carefully weighs any potential financial interest with the need for essential scientific expertise. Only in this way can the agency protect and advance the highest standards of public health," the statement says.

Steven Nissen, MD, a Cleveland Clinic cardiologist who has participated in several high-profile advisory panels, says there is "no question" that financial conflicts influence committee votes. He says the FDA "struggles" with the issue of how to balance expertise with public scrutiny of the agency's impartiality.

Still, he cautions that the public should not demand that the agency become overly strict about conflicts. "Holding everyone's feet to the fire on this is the right thing to do, but you don't want to get only the wrong people on the committees," Nissen tells WebMD.

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Nissen points to a September 2005 committee review of the diabetesdiabetes drug Pargluva, in which experts recommended approval of the drug. The committee's only cardiologist, Jorge Plutzky, MD, recused himself from the proceedings because of financial ties to industry, though the FDA stalled Pargluva's approval a month later when Nissen and other cardiologists published data questioning its safety.

"He was the only cardiologist who could have stepped up and said 'there's something wrong here,'" Nissen says of Plutzky. "If he had stayed, we never would have had to go through all that."

Plutzky did not return calls requesting an interview.

WebMD Health News Reviewed by Ann Edmundson, MD, PhD on April 25, 2006

Sources

SOURCES: The Journal of the American Medical Association, April 25, 2006. Peter Lurie, MD, deputy director, Public Citizen's Health Research Group. Kimberly Rawlings, spokeswoman, FDA. Steven Nissen, MD, medical director, The Cleveland Clinic.
© 2006 WebMD, Inc. All rights reserved.

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