During the following few weeks as I was being vetted for service, it became apparent that Merck was going to sponsor subscriptions for a review journal that I edit. I told the FDA of this sponsorship and was promptly told that this was an insoluble conflict as my “employer” would benefit from the approval of the drug. Would that I could benefit too, but I never heard any mention of sharing in the profits that would result from the increase in paid subscriptions.
Despite the flattering notion that my opinion of a new NSAID might matter enough to make a difference as to whether or not this drug was licensed and administered to millions of patients, I was actually relieved that I would not have to serve on this FDA Advisory Committee. Going into these deliberations, it was clear that this drug stood little chance of approval; the mention of the name of Merck and COX2 inhibitor in the same sentence is to the watchdogs of the pharmaceutical world what Enron is to Sarbanes and Oxley. Whatever the merits or toxicities of this drug and no matter how many patients were involved in the studies, it seemed a remarkable move on the part of Merck to apply for approval of a new COX2 inhibitor so soon after the Vioxx debacle.
My relief in being asked to step down from the panel was that, if I voted for approval of Arcoxia and the vote was in any way close, I knew that I would be criticized in the press. The press, or at least the New York Times (my hometown paper), portrayed the members of the FDA panel that voted to keep Vioxx on the market as virtual pigs feeding at the trough of the pharmaceutical establishment. Indeed, one of the non-physician members of that panel (who was on the losing side of that vote) has subsequently been quoted in the press and has written that, not only were most of the people who voted in opposition to his opinion on the take from the pharmaceutical industry, but that the remainder had an insoluble conflict of interest that arose from the fact that they took care of patients.
The cost of community service may soon become too onerous for most people to participate. In addition to the time taken from other pursuits, the cost of public service now includes the potential for legal action.
