Report: Many FDA Drug Advisers Tied to Firms

W A S H I N G T O N, Sept. 25 -- More than half of theexperts hired to advise the U.S. government on the safety andeffectiveness of medicine have financial ties to the drugcompanies that will be affected by their decisions, USA Today reported today.

The experts are hired to advise the U.S. Food and DrugAdministration (FDA) on which medicines should be approved forsale, what the warning labels should say and how studies ofdrugs should be designed.

They are supposed to be independent, but USA Today said itfound that in 54 percent of the cases, the advisers had adirect financial interest in the drug or topic they are askedto evaluate.

These conflicts include helping a pharmaceutical companydevelop a medicine, then serving on an FDA advisory committeethat judges the drug; holding stock in the company; consultingfees or research grants.

Hundreds of Waivers

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

The pharmaceutical experts, about 300 on 18 advisorycommittees, make decisions that affect the health of millionsof Americans and billions of dollars in drugs sales. With fewexceptions, the FDA follows the committees’ advice.

The FDA does reveal when financial conflicts exist, but it haskept the details of such disclosures secret since 1992; it is not possible to determine the amount of money or the drug company involved.

USA Today said its own analysis of financial conflicts at159 FDA advisory committee meetings from Jan. 1, 1998, throughJune 30, 2000 found that at 92 percent of the meetings, atleast one member had a financial conflict of interest.

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