Curb Your Enthusiasm—Unless You Want to Be Charged With a Felony

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On Saturday The New York Times ran a surprisingly sympathetic front-page story about Maryland psychiatrist Peter Gleason, who was arrested in March for talking too much about Xyrem, the prescription version of the depressant gamma hydroxybutyrate (GHB), which used to be sold over the counter as a nutritional supplement but was banned for most uses in 2000 after being demonized as a "date rape drug." Although the FDA has approved Xyrem only for treating narcolepsy, Gleason says he has found it is also useful as a pain reliever and antidepressant. Under federal law, doctors may prescribe drugs for purposes other than those specifically approved by the FDA, and they are free to discuss the evidence supporting such off-label uses with their colleagues. Drug companies, by contrast, are forbidden to promote off-label uses for their products. Gleason's crime, according to federal prosecutors, was conspiring with the Xyrem's manufacturer to evade that prohibition by giving lectures about the drug for which the company paid him. But doctors routinely give such lectures, which have not heretofore been deemed a felony. Although the Times implies that Gleason's enthusiasm for GHB leads him to underplay its hazards (which were shamelessly hyped by the drug warriors who pushed its prohibition), it correctly notes that prosecutions like this one raise serious First Amendment problems and are apt to have a chilling effect on scientific debate.

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  1. There’s still a First Amendment? I was under the impression that it had been overturned.

  2. Off-topic, but I’m surprised H&R hasn’t covered the so-called “mercy killings” in New Orleans after Katrina.
    Fascinating reading.

  3. To lend anecdote to support the story…a doctor I know had his career’s crowning achievement by getting published in JAMA for giving a drug commonly prescribed for encephalitis (swelling of the brain) to victims of jelly fish bites. The low cost drug proved literally life-saving to people bitten by the jelly fish, as people who were extremely allergic to toxin can, and often do, die.

    He then went on a lecture series, paid by the drug company, to promote this new use of an old drug, despite lack of FDA approval, providing a valuable resource to coastal, and often impoverished tropical island doctors.

    I’m guessing that if the life saving drug was pot, he’d be in prison right now.

  4. Dude,jellyfish don’t bite, they sting.

  5. If there was a paid lobbying effort to begin with to get Congress to allow the drug on the market at all, how was that promotion of an unlicensed use legal? I know it’s legal if you’re just telling it to potential investors in a drug enterprise.

    BTW, I’ve used sodium GHB and its lactone, GBL. I can’t figure out why GHB is the article of commerce instead of GBL, which doesn’t give you all that sodium.

  6. Dude, jellyfish don’t bite, they sting

    Yeah, usually, but man, when they do bite, look out! Encephalitis!

  7. You can also bind to the other common electrolyte, potassium, to get through the blood brain barrier.

  8. Thank you for having this discussion. If you are interested to discuss this story more, or share more personal opinions, anecdotes, etc., please visit the following site:

    http://gleasondiscussion.blogspot.com/

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