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FDA considers reforming use, selection of advisory panels

Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.

To help it make crucial decisions that can affect millions of patients, the FDA relies heavily on the recommendations of scientists who oversee large clinical trials, study drug side effects, and determine which medicines to prescribe. But each step in the advisory panel process has been tinged by controversy of late, including who is selected, and how many advisers can have financial ties to the drug and device manufacturers whose economic futures ride on panel recommendations.

Dr. Andrew von Eschenbach, the FDA's commissioner, said recently the agency is rethinking how and when it calls such panels, and which scientists are selected to participate.

The FDA's move toward internal reform comes even as Congress this week passed sweeping drug safety reform legislation. The bill, which awaits President Bush's signature, includes a compromise that would place new conflict-of-interest restrictions on advisory panel participants. It would require the FDA to decrease the number of participants with conflicts by 5 percent a year.

The FDA has resisted rigid caps on how many scientists with financial conflicts of interest are allowed to serve on advisory panels. The agency says it is already difficult to find enough scientists with expertise in specific areas within the FDA and its sister health agencies, the National Institutes of Health and the Centers for Disease Control and Prevention. It maintains the expertise of outside scientists is desperately needed, even if many of them earn income from the drug and device companies the FDA regulates.

Still, some want the FDA to work harder to assemble more independent panels to guide policy and regulatory decisions.

"When members of the advisory committee have conflicts of interest, it not only hurts the public, but it also destroys the credibility of the committee's recommendations," said US Representative Edward Markey, Democrat of Malden. "The FDA should not allow individuals with conflicts of interest to vote on decisions and the FDA should significantly limit conflicted individuals' participation, in order to preserve the integrity of the process."

Susan F. Wood, who two years ago left the FDA's Office of Women's Health to protest the agency's handling of an emergency contraception application, is not convinced that finding panelists without conflicts is as difficult as the agency contends. By Wood's calculation, the nation has more than 100,000 medical faculty and researchers.

"Even if you concede some very large proportion of the qualified scientists and physicians out there do have financial conflicts of interests, all FDA needs is less than 500 people," she said.

"It may take outreach. It may take a more active and engaged FDA," Wood said. "There truly are people out there who are unconflicted - if we just look."

Wood and others who share her view say limiting the number of advisers with conflicts could boost public confidence in FDA decision-making.

Research conducted by Public Citizen, a Washington, D.C. consumer advocacy organization, however, found that advisers with financial conflicts rarely swing panel votes.

But Dr. Steve Nissen, a prominent cardiologist at the Cleveland Clinic, said the FDA can skew advisory recommendations by selecting certain scientists to serve on panels, and through the way it compiles background documents used to brief panels.

More troubling: It can be difficult for doctors on the panel who have been prescribing a drug for years to come to terms with revelations of new and unforeseen side effects associated with the treatment they have long trusted.

"They have to recognize that people who are very, very close to a field may have trouble accepting the possibility that a drug they've been using for many years was harmful," Nissen said. "There is more conflict of interest in all of this than simply financial."

Material from Bloomberg News was used in this report. Diedtra Henderson can be reached at dhenderson@globe.com.

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