Please let me take my medicine

|
The NYT reports on the not-very-edifying spectacle of patients having to beg the FDA to return a drug to the market. The drug in question, Tysabri, is substantially more effective than the other available drugs but also has been linked to a rare (and potentially fatal) brain infection
The testimony came on the first day of a two-day meeting of an F.D.A. advisory panel considering whether and how Tysabri might be returned to the market. At a time when the F.D.A. has been criticized for being lax on drug safety, the testimony underlined that there are patients with severe diseases who are willing to take risks and want to be able to decide for themselves.

"We understand the risks of using experimental drugs," Pamela Clark of Salt Lake City told the committee, "but we also understand the risks of doing nothing." She said Tysabri had allowed her to walk to a duck pond with her two 5-year-old sons and stand up long enough to cook dinner.

Tysabri, developed by Biogen Idec and Elan, is considered a significant advance in the treatment of multiple sclerosis, a neurological disease that affects about 400,000 Americans and can cause paralysis, fatigue, blurred vision and cognitive problems.

But in Febuary 2005, three months after its approval, it was withdrawn from the market because of a link to progressive multifocal leukoencephalopathy, or P.M.L., a rare but deadly viral brain disease. It was found that three people who took the drug in clinical trials, one in 1,000, developed P.M.L.; two of them died and the third was severely disabled.

To their credit, the panel has recommended that Tysabri be returned to the market, but it could certainly have gone the other way. In general, its not clear to me that the FDA should be in the business of making this kind of cost/benefit decision. Once it's been established that a drug works and the risks are clear--or clearish--it seems that it would be appropriate to allow those who have demonstrated informed consent to be able to make their own risk/reward tradeoff rather than having the decision be centralized.