NEW YORK - The US Food and Drug Administration says 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 and Pfizer.
A 32-member committee voted this month 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 panellists 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 Time.
The analysis found 17 extra panellists with other links to drug-makers, including three to Merck or Pfizer that "were deemed to be too old to be relevant", the centre said.
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 advise to federal regulatory agencies", the centre said.
The FDA spokeswoman said the agency followed its rules for complying with US law.
Pfizer spokesman Andy McCormick said the FDA clearly discussed conflict issues at the start of the meeting.
"We had no role in the selection of the FDA panel, and the membership wasn't publicly announced until very close to the hearing."
Merck spokesman Tony Plohoros said: "The composition of the committee is a process that is left completely to the FDA with no Merck involvement."
- BLOOMBERG
