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Wednesday, April 23, 2008

Pay offs at FDA: Drug approval and green light for danger

Cash greases the wheels of FDA approvals now more than ever with the new legislation passed in 2007 -----

Another doctor's comments

Ask any doctor, and he'll tell you that speed and safety rarely go hand-in-hand. As a recent study indicates, it's just as true for the drug approval process as it is for a surgical procedure.

Researchers at Harvard detected a disturbing correlation between the drugs that received lightning-fast FDA approvals and the drugs that ultimately needed to be pulled off the market due to safety issues.

Forgive me if I'm not surprised.

Back in 1992, Congress imposed approval deadlines on the FDA – and you'll never believe why. Drug companies agreed to pay millions in fees to the FDA to enable the money-strapped agency to hire more reviewers that would help to clear the gigantic logjam of drug applications. In return for this payment, the FDA agreed to speed the approval (or rejection) of 90 percent of all potential drugs within a year of the application's submission – or they'd have to refund the money. What's more, the FDA has only six months to approve drugs that are considered to be "lifesaving" or otherwise "high priority."

Outrageous? You bet. This is a Federal agency that's charged with the unbiased review of the safety of food and drugs for public consumption… and yet they entered into a lucrative financial arrangement WITH THE VERY COMPANIES WHOSE PRODUCTS THEY ARE INTENTED TO MONITOR.

According to the Harvard study, the FDA is 3.4 times more likely to approve a drug in the two months leading up to a deadline. Like any government agency, the FDA doesn't want to be in the business of giving money back, so it's finally spurred into action once a possible refund is hanging over its head.

Dr. Steven Nissen, chief of cardiology at the Cleveland Clinic, was among the first to raise concerns about drugs like Vioxx, Bextra, Rezuilin, and Baycol – all of which were approved just in time to meet their approval deadline, but were all ultimately pulled off the market. Nissen called the Harvard study a "wake-up call," adding that it "puts the FDA in a very difficult situation when they're trying to make complex decisions under these very, very tight deadlines; we've got to reevaluate now whether that's good public policy."

I can save the reevaluation time: it's horrific public policy. And it's a blatant conflict of interest for the FDA. Approve the drugs fast or lose the cash!? It's the worst possible example of my tried and true dictum to "follow the money."

Of course, the FDA's policy with this – as with everything else – is deny, deny, deny. FDA drug chief Dr. Janet Woodcock said, "The FDA won't approve a drug if we are not ready. And we have the option of denying approval altogether if there is any question about safety."

Thanks for the info, Dr. Woodcock – we all know that the FDA "has the option" to deny approval. That's the whole point of having an approval process in the first place. The question is whether or not the agency is exercising that option judiciously (or at all), and for the right reasons. The fact that she even phrases it as "having the option" gives me chills.

Unfortunately, I'm not sure that this raised alarm will ultimately do any good. As the economy slackens, federal budgets dwindle. Those processing fees paid by the deep- pocketed Big Pharma companies are not likely to be supplanted by tax money or reallocation any time in the near future. And last year, Congress reaffirmed the deadline system, so it's unlikely to make it back into any serious floor debate any time soon.

Besides … there's money to be made. And as always, the public good will take a back seat to the almighty dollar.

Fast to point out too-fast FDA approvals,

William Campbell Douglass II, M.D.

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