FDA Drug Advisers Have Financial
Conflict of Interest
In two recent articles on September 25, 2000 by both
Reuters News and USA Today came reports that that 54 percent
of the experts the FDA asks for advice on which medicines should be
approved for sale had a direct financial interest in the drugs or topics
they were evaluating.
These financial conflicts or interest typically include stock ownership,
consulting fees or research grants.
Federal law prohibits the FDA from using experts with financial
conflicts of interest, but the FDA has waived the restriction more than
800 times since 1998. Although the FDA does reveal when financial
conflicts exist, since 1992 it has kept the details of any conflict secret
so it is not possible to determine the amount of money or the drug company
involved.
The USA Today article stated, "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."
USA TODAY conducted an analysis of financial conflicts at 159 FDA
advisory committee meetings from Jan. 1, 1998, through last June 30. The
following are listed in the article as their findings:
- 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 conflicts.
- At the 102 meetings dealing with the fate of a specific drug, 33%
of the experts had a financial conflict.
Larry Sasich of the advocacy group, "Public
Citizen", concluded by saying, "The industry has more
influence on the process than people realize."
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