Indictment of Psychiatrist Tests Drug Marketing Rules.

As reported in the New York Times, part of a much longer story. The Psych in question was promoting theraputic uses of a known date rape drug.

In the early afternoon of Monday, March 6, half a dozen men in suits surrounded Dr. Gleason, a Maryland psychiatrist, at a train station on Long Island and handcuffed him.

“I said, ‘Well, this is a gag,’ ” Dr. Gleason recalled in a recent interview. “They said, ‘No, this isn’t.’ ”

Dr. Gleason, 53, was taken aback because he was arrested, and later charged, for doing something that has become common among doctors: promoting a drug for purposes other than those approved by the federal government.

But prosecutors say that Dr. Gleason went too far. At hundreds of speeches and seminars where he was rewarded with generous fees, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. In doing so, he conspired with the drug’s manufacturer to recommend it for potentially dangerous uses, the prosecutors claim.

The case has put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines. Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drug’s sales, so companies often skirt the rules by sponsoring seminars where doctors are paid to make presentations promoting their drugs, including the “off label” uses.

For doctors, these and other payments they receive for discussing drugs can be very lucrative. Dr. Gleason acknowledges that he received more than $100,000 last year alone from Jazz Pharmaceuticals, which makes Xyrem, the narcolepsy drug he has promoted.

His case could establish limits on what doctors can do to help companies sell their drugs. But any precedent could be complicated by the history of Xyrem, which differs in one important way from other drugs. Because the active ingredient in Xyrem is gamma hydroxybutyrate, or GHB, an illegal street drug with a history of use in date rape and of overdose hazards, Xyrem is listed as a federally controlled substance, with distribution tightly monitored. [...]

F.D.A. rules allow doctors to prescribe federally approved drugs for any purpose, even if it is not indicated on the medicine’s label. But drug companies are tightly constrained in what they can say about their medicines. Companies can promote drugs only for their federally approved purposes — their so-called “on label” use. [...]

In 2000, after highly publicized cases in which young women died or were raped after GHB was slipped into their drinks, Congress designated the drug a Schedule I controlled substance, in the same class as heroin. [...]

The indictment also charges that Dr. Gleason committed fraud against insurance companies by advising doctors to leave blank an area on the Xyrem prescription form that asked for a disease diagnosis. Dr. Gleason acknowledges that he told doctors not to offer a diagnosis but says he never told them to lie if they were asked for one.