April 25, 2006

US FDA panel industry ties common, study says

By Lisa Richwine

WASHINGTON (Reuters) - Nearly 30 percent of U.S. Food and
Drug Administration advisers reported financial conflicts of
interest but their votes did not sway recommendations for or
against a specific drug, a consumer group said on Tuesday.

Sometimes advisers with conflicts voted for a drug under
review and other times against it, said a study by Public
Citizen's Health Research Group.

If all the experts with a conflict had been excluded, it
would not have changed the overall vote tally in favor of or
against a drug, it concluded.

The FDA often turns to panels of outside experts for advice
on whether to approve a new drug and other matters. The agency
is not required to follow the panels' recommendations but
usually does.

Financial links between the panel members and drug makers
have come under scrutiny, with calls for the FDA to find
advisers without industry connections.

Public Citizen's Health Research Group, which often
criticizes the FDA, evaluated the financial ties of experts who
participated in 221 advisory panel meetings from 2001 through

Of nearly 3,000 panel members, 28 percent of them disclosed
a financial relationship within the previous year with the
company that made a drug under discussion or a competitor, the
study said.

The most common ties were consulting arrangements, research
contracts or grants, and stock holdings or other investments.

Nineteen percent of consulting arrangements involved
payments of more than $10,000, 23 percent of contracts or
grants exceeded $100,000 and 30 percent of investments topped
$25,000, the study said.

One percent were recused from panel deliberations because a
conflict was considered excessive.

Seventy-three percent of meetings involved at least one
participant with a financial conflict, according to the study,
which was published in the Journal of the American Medical


FDA spokeswoman Susan Bro said the agency carefully weighs
any potential conflicts with the need for expertise. "The FDA
is committed to a strict code of ethics and transparent
process," she said in a statement.

The study authors said the potential for conflicted members
to sway a meeting's outcome remained and suggested those with
conflicts involving large sums of money be banned.

"Ideally, all panels of scientific experts advising a
federal decision-making body would be free of financial
conflicts of interest with the affected company," they wrote.

The findings were based on FDA meeting transcripts. An FDA
staff member explains each panelists' financial conflicts at
the start of each meeting.

The analysis did not include a closely watched meeting in
February 2005 on the future of COX-2 painkillers such as Merck
& Co. Inc.'s withdrawn drug Vioxx. Others have reported that
removing panelists with ties to the manufacturers could have
impacted some votes at that meeting.