Summary
The Center for Science in the Public Interest, an advocacy group, says that the FDA violated the Federal Advisory Committee Act, which prohibits researchers with direct financial ties from serving on advisory panels. The FDA says that it followed its procedures and that the conflicts of interest in a recent advisory panel were not problematic.
Original source:
http://quote.bloomberg.com/apps/news?pid=10000006&sid=anvrTAdDIXrU&refer=home
Details
- The U.S. Food and Drug Administration 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 Feb. 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 yesterday that 10 panelists had financial ties to the two companies and a third maker of similar medicines, Novartis AG.
- ``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, in an e-mailed statement yesterday.
- The Center 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 didn't 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 center 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 center said in a statement.
- ``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 yesterday in a telephone interview.
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