Wednesday, March 02, 2005

MS Patients Pay for Vioxx Overreaction

The Wall Street Journal has a saddening editorial about one bit of fallout to the media and congressional overreaction to Merck's pulling Vioxx from the market. Link. (requires subscription)
Still don't think political frenzies have consequences? Consider the weird and troubling inversion this week regarding the promising new treatment for multiple sclerosis, Tysabri.

The biotech partners Biogen and Elan pulled their drug from the U.S. market following just two reports (including one fatality) of serious complications possibly linked to the compound. Meanwhile, officials at the FDA went out of their way to defend Tysabri. Steve Galson of the agency's Center for Drug Evaluation and Research said the FDA "continues to believe Tysabri offers great hope to MS patients." Added drug evaluator Douglas Throckmorton, "It makes meaningful differences in people's lives."

Welcome to the twilight zone of pharmaceutical development post-Vioxx, in which the natural hyper-caution of regulators is exceeded only by the hyper-caution of terrified drug makers. Perhaps Biogen and Elan possess some information that the rest of us don't. But on the face of it the Tysabri withdrawal appears to be an overreaction that will harm MS patients in the near term, and all of us who depend on a healthy drug-development culture over the long run.

Tysabri had received accelerated approval from the FDA just three months ago because clinical trials had shown it to be twice as effective as alternative therapies in preventing flare-ups of MS, which is a degenerative and eventually fatal disease. Tysabri is also easier to take than alternative treatments, and tolerated by a subset of MS patients who can't take the others at all.

But for the indefinite future everyone will have to do without because two of the thousands of patients who've received Tysabri developed a rare neurological disorder. Those two patients happened to also be on another immuno-suppressive MS treatment called Avonex. There is no reason to believe that Tysabri has caused this disorder when used alone.

Unfortunately, it is hard to blame the manufacturers, given the tort suit history of the industry. A drug can save tens of thousands of lives, but the one person harmed by it can win a settlement in the tens of millions of dollars. One person harmed can wipe out the profits on the tens of thousands of sales that helped people. We can never expect absolute 100% perfection, but juries do not weigh the overall good a drug does, they are only asked to weigh the harm done to the plaintiff. This area needs tort reform as much as class action suits do.


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