http://seattletimes.nwsource.com/html/nationworld/2003147820_fda24.html

FDA's use of outside experts with conflicts is under scrutiny

By ANDREW BRIDGES
The Associated Press

WASHINGTON - Outside experts who advise the government on drugs and
other regulated products often have financial ties to industry,
creating the potential for conflicts of interest.

Some members of Congress and critics of the Food and Drug
Administration Bar say these scientists should be barred from review
panels. The agency says that's not possible, because so many scientists
whose expertise the government relies on have ties to industries under
FDA regulation.

But pressured by Congress, the agency is trying to bring its
decision-making more into the open, by spelling out how and why it
grants waivers for outside experts that allow them to serve as FDA
advisers.

Eventually, new guidelines - plans for which are being announced
today - should clarify its actions when an expert might have a
conflict of interest, said Dr. Scott Gottlieb, the FDA's deputy
commissioner for Medical and Scientific Affairs. Few details about the
proposed guidelines were available.

The FDA says that simply eliminating all outside reviewers with
potential conflicts would deny the agency access to advisers with the
expertise and experience it seeks.

"We probably couldn't recruit department chairmen. It would hinder us
from recruiting all but junior faculty members," Gottlieb said.

A congressional critic called that claim "absolutely untrue," adding
that anything short of barring advisers with conflicts would be a
"charade."

"It just doesn't make any sense to me. When you have this problem -
conflicts of interest on critical panels - the solution is eliminate
the conflict. It's simple and easy to do," said Rep. Maurice Hinchey,
D-N.Y.

That blanket approach is too restrictive, while the FDA's is too
permissive, said Dr. Peter Lurie, author of a recent study on the issue
that appeared in the Journal of the American Medical Association.

"They should ... beat the bushes to find people with as few conflicts
as possible," he said.

Outside advisers, although independent, often have ties to the drug,
vaccine, medical device and other industries regulated by the agency.

The FDA turns to its advisory committees for outside advice. The agency
is not required to follow the recommendations of its outside advisers
but usually does.

In April, a study found that more than one-fourth of the experts relied
on for advice on drugs, including whether to approve new
pharmaceuticals, had a financial conflict.

Only 1 percent of these reviewers were excluded from serving on FDA
advisory panels because of those conflicts, which can include tens of
thousands of dollars in corporate grants, contracts and consulting
fees, according to the study by the consumer-advocacy group Public
Citizen.

The FDA routinely grants panelists waivers to participate and vote in
advisory committee meetings even when they do report conflicts of
interest.

Those conflicts typically are minor and often arise because the
panelists, many of them academics, either work for universities that
have received industry support or supervise others who have, Gottlieb
said.

The FDA is moving to clarify when and how it grants waivers, laying
out, for instance, whether it would approve panelists with a
"scientific" relationship with a company, but not do so when their work
filled a more marketing function, Gottlieb said.

The guidelines also could codify how those decisions to grant waivers
are made - a process now done on a case-by-case basis.

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TC