Indictment of Doctor Tests Drug Marketing Rules

Indictment of Doctor Tests Drug Marketing Rules

(July 22, 2006) -- At first, Dr. Peter Gleason thought his arrest was a joke.

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.’ ”

Ozier Muhammad/The New York Times

Dr. Peter Gleason, 53, promoted Xyrem for purposes other than those approved by the federal government and now faces charges.

Side Effects
Articles in this series are examining how money from drug and medical device companies can influence the ways doctors conduct business and practice medicine.

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.

Some doctors who have researched Xyrem say that Dr. Gleason, in his enthusiasm for the drug, may have understated its very real risks. Still, at least one former F.D.A. official says that the government appears to be overreaching in going after Dr. Gleason and may chill a common and legitimate form of medical discussion. “This is a very, very scary development,” said Daniel E. Troy, a partner at Sidley Austin and the former chief counsel of the F.D.A.

Dr. Steven Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, said the case could “have a chilling effect on physicians, because when we give lectures, we assume that giving an opinion about the use of a drug is not going to get us into legal difficulty.” The F.D.A. and federal lawyers, he said, need to restrict criminal prosecutions to especially egregious cases of off-label promotion.

Continuing to Practice

Dr. Gleason, who is now free on bail and continues to practice medicine, insists that he is not guilty of conspiracy. He says that he was charged only after he refused to help the government build a case against the drug’s maker, Jazz Pharmaceuticals — a sequence of events that court documents seem to support.

Dr. Gleason freely acknowledges that in meetings with other doctors, he advocated Xyrem as a treatment for many conditions, including depression and fibromyalgia, a poorly understood pain disorder.

In a news release about the indictment, an assistant F.B.I. director compared Dr. Gleason to a “carnival snake-oil salesman.”

But the doctor says that based on his own experience giving Xyrem to patients, he believes everything he said about the drug and that his right to express his views are protected by both F.D.A. rules and the First Amendment.

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Last updated: 7/06

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Indictment of Doctor Tests Drug Marketing Rules

Ozier Muhammad/The New York Times