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Mon, Nov-20-06, 06:15
http://www.internetwks.com/pauling/fdaconflict.html
FDA ADVISERS TIED TO INDUSTRY By Dennis Cauchon
USA TODAY
09/25/00 - Updated 12:24 AM ET
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."
***
TC
FDA ADVISERS TIED TO INDUSTRY By Dennis Cauchon
USA TODAY
09/25/00 - Updated 12:24 AM ET
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."
***
TC