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- 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.
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- 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.
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- Number of drug experts available is limited
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- 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.
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- The conflicts typically include stock ownership, consulting
fees or research grants.
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- 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.
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- 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.
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- 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.
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- A USA TODAY analysis of financial conflicts at 159 FDA
advisory committee meetings from Jan. 1, 1998, through last June 30 found:
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- At 92% of the meetings, at least one member had a financial
conflict of interest.
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- At 55% of meetings, half or more of the FDA advisers
had conflicts of interest.
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- Conflicts were most frequent at the 57 meetings when
broader issues were discussed: 92% of members had conflicts.
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- At the 102 meetings dealing with the fate of a specific
drug, 33% of the experts had a financial conflict.
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- "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.
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- But Larry Sasich of Public Citizen , an advocacy group,
says, "The industry has more influence on the process than people
realize."
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