-Caveat Lector-
-------- Original Message --------
Subject: FDA conflicts of interest (USA Today)
Date: Mon, 25 Sep 2000 23:36:02 -0500 (CDT)
From: MichaelP <[EMAIL PROTECTED]>
Organization: ?
To: undisclosed-recipients:;
http://www.usatoday.com/news/washdc/ncssun06.htm
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
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."
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