Just after the US Food and Drug Administration said the benefits of COX-2 inhibitors, Merck & Co’s Vioxx (rofecoxib), and Pfizer’s Celebrex (celecoxib) and Bextra (valdecoxib), outweigh the risk of cardiac damage [[21/02/05a]], the agency finds itself at the centre of a conflict-of-interest storm concerning the make-up of the advisory panel that backed the controversial drugs.

A study by the USA’s Center for Science in the Public Interest, which was commissioned by the New York Times, has revealed that 10 of the 32 panel members had strong links to either Pfizer, Merck or Novartis, which is currently developing its own COX-2 inhibitor Prexige (lumiracoxib). The links come in the form of consulting fees, speaking honoraria and research grants. In addition, the CSPI said that 17 other panel members received research or financial support from other pharmaceutical firms.

It is being suggested that without the ballots of these 10 members, the panel would have voted in favour of withdrawing Bextra and keeping Vioxx, which was voluntarily withdrawn by Merck [[01/10/04a]], off the market. At the hearings, the panel voted 31-1 to keep Celebrex on the market, 17-13 (with two abstentions) in favour of Bextra and 17-15 to allow Merck to sell Vioxx again.

The FDA acknowledged that there may be potential conflicts of interest in this case, but stated that because of “the general nature of the discussions before the committee, these potential conflicts are mitigated.” It added that it screened members of the panel for conflicts of interest and “this transparent process requires the agency to carefully weigh any potential financial interest with the need for essential scientific expertise.”

Nevertheless, the FDA’s comments, and its decision to set up a new independent drug safety board in a bid to improve transparency [[16/02/05a]], are unlikely to quieten critics who believe that the agency, and the way it operates, is inherently flawed.