Fixer Upper The problem with fixing something in full public view is that everyone can get a good long look at just how broken it is. So…let's watch as the FDA tries to fix itself. Putting lipstick on a pig Doctors and scientists picked for FDA expert panels typically have ties to drug companies. This is no secret, but the average Joe is probably not aware that experts who review the safety and efficacy of new drugs sometimes have very lucrative connections to drug companies that make the products they're reviewing. The FDA recently announced new rules that would change all that. Well…SOME of that. Under the new rules, anyone who's received more than $50,000 from a drug or medical device company whose product is under review will not be allowed to serve on the review panel. Those who receive less than $50,000 during the prior year will be able to serve on panels, but won't be allowed to cast a vote. So what's the logic here? Influence can be bought for $50,000, but not for, say, a paltry $48,000? And even without casting a vote, you know they have a voice. Why else would they be on a review panel? But it gets even better…there may be exceptions! The New York Times reports that waivers to the rules are possible if approved by the FDA commissioner. But Randall W. Lutter - the acting deputy commissioner - told the Times that such waivers "would probably be rare." Probably? Is Mr. Lutter actually going out of his way to make these new rules seem completely toothless? Hidden panel Mr. Lutter also told the Times that the new rules would affect a "significant number" of experts who are currently advisers for the agency. But he wouldn't say exactly how many would be affected. And who can blame him? The number would probably be uncomfortably revealing. In the e-Alert "Hidden Panel" (3/7/05), I told you about an FDA advisory panel that voted to allow the pain-killing drugs Vioxx, Celebrex and Bextra to stay on the market. According to CBS News, 10 of the 32 panelists had financial ties to Pfizer (the maker of Celebrex and Bextra), Merck (the maker of Vioxx) or Novartis, a company that had submitted an application with the FDA for a new brand in that class of drugs. CBS reported that the 10 "connected" panelists voted 9 to 1 to allow sales of Vioxx. And that was AFTER Merck had pulled Vioxx off the market because research showed that heart attack and stroke risks were doubled when taking the drug! A little culture How could so many "experts" ignore such a glaring safety issue? The answer - or part of it - was revealed in February when former FDA advisers, appearing before a congressional hearing, told lawmakers that the culture of the agency tended to suppress dissent. Dr. David Ross, a former safety reviewer, told Reuters Health that FDA scientists were not only pressured to keep safety concerns quiet, they were also reprimanded when they voiced concerns. At the hearing, FDA Commissioner Andrew von Eschenbach, M.D., stated that he wished to provide an environment where FDA staff members could express their opinions freely. But Dr. Ross singled out a meeting last summer in which he says von Eschenbach compared the FDA to a football team, adding that dissent belonged in the locker room, not on the field. The commissioner added that employees who took dissent out onto the field would be "benched or traded." Dr. Ross says he took that comment as intimidation. But to continue Dr. von Eschenbach's metaphor, when you're playing football at the pro level, you've got to return intimidation with double intimidation. And if intimidation doesn't work, and if you can't get one of those handy waivers, you better figure out how to make due with financial perks of less than $50,000 per year from each of the drug companies you're affiliated with. | 
