FDA Advisers Not So Independent?

More than half of the experts hired to advise the U.S. government on the safety and effectiveness of medicine have financial ties to the drug companies that will be helped or hurt by their decisions, USA Today reported on Monday.

The experts are hired to advise the U.S. Food and Drug Administration (FDA) on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed.

They are supposed to be independent, but USA Today said it found that in 54 percent of the cases, the advisers had a direct financial interest in the drug or topic they are asked to evaluate.

These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug; holding stock in the company; consulting fees or research grants.

Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but the paper said the agency had waived the restriction over 800 times since 1998.

The pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice.

"The advisory committee system allows the FDA to chose from among the best experts while at the same time it protects the panels from conflicts of interest," Jeff Trewhitt of PHARMA (Pharmaceutical Research and Manufacturers of America) told CBS Radio News. "The FDA requires disclosure of any financial interests of potential advisory panel members and the FDA makes the final decision about whether to accept advisory committee recommendations. The agency itself remains in control of the process."

The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved.

USA Today said its own analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through June 30, 2000 found that at 92 percent of the meetings, at least one member had a financial conflict of interest.

At 55 percent of meetings, half or more of the FDA advisers had conflicts of interest, the paper said.

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