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 Ten
of the 32 Food and Drug Administration (FDA) drug advisers whose
total votes favored the controversial painkillers Celebrex, Bextra
and Vioxx had financial ties to the industry. According to public
records and disclosures in medical journals, the 10 advisors had
recently consulted with the drugs’ makers.
Although most (8) of the 10 members said
their ties did not influence their votes, had they not voted the
advisory committee results would have been as follows:
- 12 to 8 to withdraw Bextra from the market
- 14 to 8 to keep Vioxx off the market
However, the advisors with company ties voted 9 to 1 to keep Bextra
on the market and 9 to 1 to bring Vioxx back to the market. Their
votes did not significantly influence the decision to keep Celebrex
on the market.
It’s commonly known that researchers who work with industry
serve on FDA advisory panels; the agency says it works to balance
expertise with potential conflicts of interest. However, the FDA
often keeps such ties secret from the public and experts say studies
have shown that money does influence scientific judgments.
The 10 advisors had worked in some capacity for Merck, Voixx’s
maker, Pfizer, which makes Celebrex and Bextra, or Novartis, which
is applying to sell Prexige, a similar drug.
Three votes were taken for each drug. Out of the 30 votes cast
by the 10 advisers in question, 28 voted to continue marketing all
three drugs. Comparatively, out of the 66 votes cast by the remaining
22 members of the panel, only 37 voted in favor of the drugs.
The FDA said that the committee members were “screened for
conflicts of interest according to the same strict ethics guidelines
FDA applies to all its advisory committees.''
Merck, which pulled Vioxx from the market in the biggest drug recall
to date, has not determined whether they will reintroduce the drug.
San
Francisco Chronicle
February 25, 2005
Bloomberg
February 26, 2005
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