HUGE NEW NEWS::
From USA Today
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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 conflicts.
At the 102 meetings dealing with the fate of a specific 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." |
