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Wednesday 04 January 2006

I've Got the Pill to Drive Myself Sleepless

By: Julian Sanchez

Teresa Nielsen Hayden is a touch miffed at Ralph Nader.

If Ralph Nader is run over by a beer truck and killed, if a very large meteorite falls on the offices of Public Citizen and vaporizes the lot of them, I won't feel sorry. Not the least little bit.

It turns out Teresa had been treating her narcolepsy with Cylert (the brand name of pemoline), a stimulant initially developed for ADHD, but also frequently prescribed off-label to narcoleptics and MS patients suffering from fatigue. Because it increases the risk of liver failure, it's typically something doctors resort to only after other medications fail. Now, under pressure from Public Citizen, the FDA has withdrawn it entirely.

The FDA's reason is that it has determined "the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug." Except, of course, that Teresa Nielsen Hayden obviously thought the benefits outweighed the risk. And, of course, there isn't really such thing as the "benefit" or "risk" of a drug in itself, but only the benefit and risk to a particular patientónot just because of physiological variation between people, but because of how we differently value the same sets of positive and negative effects. A sane FDA would give us the information and let us decide for ourselves which way the balance came out.

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