The controversy created when arthritis painkillers, Bextra, Celebrex, and Vioxx, were allowed to stay on shelves despite their proven role in increasing the risk of heart disease took a new twist when 10 of 32 advisers on Food and Drug Administration’s advisory committee were found to have consulted for the companies making these drugs. While Merck manufactures Vioxx, Pfizer is the maker of Celebrex and Bextra.
Had the 10 not cast their votes, the vote would have been 14-8 in favour of yanking Vioxx off the market and 12-8 against the sale of Bextra. Of the 10 with ties, 9 favoured the sale of Bextra and 9 the sale of Vioxx. The votes of the 10, however, did not have a significant impact in the committee's decision on Celebrex since it had a unanimous vote of 31 against 1.
On being contacted, eight of the 10 advisers asserted that their past ties had no bearing whatsoever on their votes. The other two were unavailable for comment.
This isn’t the first time that the ‘conflict of interest’ question has been raised in relation to FDA advisory committees. According to Sidney Wolfe of Public Citizen, the FDA has a pretty high threshold for conflict of interest. Citing this issue ‘a serious problem’, Wolfe felt that finding people without vested interests isn’t very difficult.
Strangely, these ties were not disclosed when the committee was convened to take a decision. A statement read out before discussions started said that the topics of the meeting were ‘issues of broad applicability’ adding that ‘unlike issues before a committee in which a particular product is discussed, issues of broader applicability involve many industrial sponsors and academic institutions’.
While acknowledging that there may be a conflict of interest, the statement confirmed that waivers had been issued to panellists and said that the potential conflict stood mitigated due to the general nature of the discussion. The ‘general’ nature of the discussion, however, is questionable considering that the advisory panel was discussing the fate of medicines that were vital to the two drug companies.
Meanwhile, the FDA has decided to monitor drug advertising to consumers more carefully. Though extreme measures like banning ads altogether have been ruled out, FDA’s acting commissioner Lester Crawford said that his agency would aggressively monitor ads that conveniently avoid mentioning the risks while promising unrealistic benefits.
