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FDA conflicts of interest (USA Today)

On 25 Sep 2000, at 15:24, Biotech Activists wrote:

Biotech Activists (    Posted:

               09/25/00- Updated 12:24 AM ET

                FDA advisers tied to industry
                By Dennis Cauchon, USA TODAY

                More than half of the experts hired to advise the
                government on the safety and effectiveness of medicine
                have financial relationships with the pharmaceutical
                companies that will be helped or hurt by their
                decisions, a USA TODAY study found.

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

                The experts are supposed to be
                independent, but USA TODAY found
                that 54% of the time, they have 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.

                The conflicts typically include stock ownership,
                consulting fees or research grants.

                Federal law generally prohibits the FDA from using
                experts with financial conflicts of interest, but the
                FDA has waived the restriction more than 800 times
                since 1998.

                These 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 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.

                A USA TODAY analysis of financial conflicts at 159 FDA
                advisory committee meetings from Jan. 1, 1998, through
                last June 30 found:

                 At 92% of the meetings, at least one member had a
                financial conflict of interest.

                 At 55% of meetings, half or more of the FDA advisers
                had conflicts of interest.

                 Conflicts were most frequent at the 57 meetings when
                broader issues were discussed: 92% of members had

                 At the 102 meetings dealing with the fate of a
                drug, 33% of the experts had a financial conflict.

                "The best experts for the FDA are often the best
                experts to consult with industry," says FDA senior
                associate commissioner Linda Suydam, who is in charge
                of waiving conflict-of-interest restrictions.

                But Larry Sasich of Public Citizen , an advocacy
                group, says, "The industry has more influence on the
                process than people realize."

                    Front page, News, Sports, Money, Life, Weather,
                     Copyright 2000 USA TODAY, a division of Gannett

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