Do you speak at continuing medical education conferences on drug therapy? Do you ever mention off label use? Be concerned. You may wind up in handcuffs. That’s what happened to Dr. Peter Gleason, a Maryland psychiatrist whose career has been destroyed in an episode characterized by the New York Times as illustrative of the “murky” relationship between drug companies and physicians who help promote their medications. Dr. Gleason frequently spoke about off label use of the Jazz Pharmaceuticals product Xyrem, a drug approved for narcolepsy. Although the extent of Dr. Gleason’s promotional activities are concerning this may be a case of over zealous prosecution. Dr. Gleason stated that he was arrested and charged only after he refused to cooperate with the prosecutor’s investigation of the company. Moreover, according to independent legal experts interviewed by the Times, Gleason’s activities were not clearly illegal. Rather, prosecutors were concerned merely that Dr. Gleason “went too far.”
Off label use of drugs is legitimate. The mention of off label drug prescribing is commonplace at drug company supported CME events. This prosecution sets a dangerous precedent. There are no clear legal constraints regarding such activities, and this could happen to any speaker at drug company supported educational events.