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http://www.newstarget.com/022036.html

NewsTarget) Earlier this year, the FDA announced a series of
significant changes to its policy on conflict of interest in advisory
panels. Up until now, there have been no rules barring experts with
financial conflicts of interest from participating in the panels,
which recommend to the agency which drugs, diagnostic tests and
medical devices should be approved for use.

The FDA has come under increasing fire lately for its policies toward
conflicts of interest. Because the FDA almost always accepts the
recommendations of its advisory panels, critics have been particularly
concerned that many of the "experts" that make up these panels have
financial ties to the companies that make the products being reviewed.

Under the new rules, no one who has received $50,000 or more in
financial benefits from a company in the previous 12 months --
including direct research grants, stocks and consulting fees -- may
participate in a panel about any of that company's products. People
who have received less than $50,000 in the past year may participate
but not vote.

While welcoming the announcement as a step in the right direction,
many critics claim that the new rules do not go far enough. R. Alta
Charo, a bioethicist from the University of Wisconsin, noted that the
FDA ignored the national Institute of Medicine's recommendation to cap
the number of members with conflicts of interest on any given advisory
panel.

Diana Zuckerman, president of the National Research Center for Women &
Families, said that the new rules fail to take into account more
subtle forms of influence.

"A drug rep who takes someone to a memorable restaurant twice a year
to chat about their research is spending relatively little money but
is building a relationship that is likely to be more influential than
giving a $2,000 honorarium -- perhaps even more than a $50,000
grant...funded by several companies," she said.

Zuckerman also pointed out that simply being barred from voting does
not prevent someone from influencing a panel's decision.

"The votes are often unanimous, because the group comes to a consensus
-- almost always to approve a product," she said.