USA today, 9/25/00, published an article regarding a conflict
of interest in regard to drug approval.  Questioning if a drug is safe
and benefits the end user parallels asking if the drugs and procedures
adhered to for labor and delivery in hospitals benefits the mother and
baby.
Judy Ritchie

http://www.usatoday.com/news/washdc/ncssun06.htm

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."

**************************************************************************

             ***********************************************
The LACTNET mailing list is powered by L-Soft's renowned
LISTSERV(R) list management software together with L-Soft's LSMTP(TM)
mailer for lightning fast mail delivery. For more information, go to:
http://www.lsoft.com/LISTSERV-powered.html