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Feb. 28 -- The US Food and Drug
Administration (FDA) said it screened doctors and scientists for
conflicts of interest when the agency named a committee to rule on
the safety of pain drugs made by Merck & Co and Pfizer Inc.
A 32-member committee voted on
February 18 that the benefits of Merck's Vioxx and Pfizer's Celebrex
and Bextra outweighed the risk of cardiac damage for patients taking
them. The New York Times reported that 10 panelists had financial
ties to the two companies and a third maker of similar medicines,
Novartis AG. Without their votes, the findings would have been
reversed for Vioxx and Bextra, the newspaper said.
"The advisory committee members
and expert consultants were screened for conflicts of interest
according to the same strict ethics guidelines FDA applies to all
its advisory committees," said Sheila Dearybury Walcoff, the FDA's
associate commissioner for external relations.
The Centre for Science in the
Public Interest, a Washington consumer advocacy group, said it
evaluated affiliations disclosed by the 32 committee members at the
request of the Times, which did not name all of those identified as
having ties to the companies. The analysis found 17 additional
panelists with other links to drugmakers, including three to Merck
or Pfizer that "were deemed to be too old to be relevant," the
centre said.
In a list made available to
Bloomberg, the group named the 27 advisers and their links to New
York-based Pfizer, the world's biggest drugmaker; Whitehouse
Station, New Jersey-based Merck, which withdrew Vioxx September 30;
Basel, Switzerland-based Novartis, maker of the painkiller Prexige;
and other drugmakers.
Inclusion of the 10 with financial
ties to the makers of pain drugs "would appear to be a direct
violation of the Federal Advisory Committee Act, which prohibits
scientists with direct conflicts of interest from serving on panels
offering advice to federal regulatory agencies," the centre said.
The FDA spokeswoman said the
agency followed its rules for complying with US law. As the
committee meetings opened February 16, 17 and 18 in Gaithersburg,
Maryland, an FDA official verbally listed members with connections
to healthcare companies.
"This transparent process requires
the agency to carefully weigh any potential financial interest with
the need for essential scientific expertise," Walcoff said.
"In our view, the FDA clearly
discussed conflict issues at the start of the meeting in a very
clear and forthright manner, so it was public," Pfizer spokesman
Andy McCormick said. "We had no role in the selection of the FDA
panel, and the membership wasn't publicly announced until very close
to the hearing."
"The composition of the committee
is a process that is left completely to the FDA with no Merck
involvement," said Tony Plohoros, a Merck spokesman.
Senator Edward M Kennedy, a
Massachusetts Democrat, said that the report of panel members'
conflicts "emphasizes the need to restore public confidence in the
FDA and its ability to protect the public health and safety of the
American people."
Senate and House Committees have
been probing the FDA's monitoring of drug safety since a Merck study
showed a link to heart attacks and strokes in patients taking Vioxx,
leading to the biggest drug recall ever, and since antidepressants
were linked to elevated suicidal behavior in children.
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