July 25, 2006
Doctor indicted for off-label drug promotion: NY Times
A Maryland psychiatrist arrested in New York has been charged with promoting a drug for purposes other than those approved by the FDA, The New York Times reports. Prosecutors at the US Attorney’s office in Brooklyn in March charged Dr. Peter Gleason for going too far at hundreds of speeches and seminars where he was rewarded with generous fees for advising other physicians that Xyrem, a narcolepsy drug from Jazz Pharmaceuticals, could be prescribed for depression and pain relief, uses not approved by the FDA. The case could establish limits on what doctors can do to help companies sell their drugs. 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 FDA and lawyers, Nissen said, need to restrict criminal prosecution to especially egregious off-label promotion. Gleason, now free on $150,000 bond, continues to practice medicine and insists that he is not guilty of conspiracy. He said he was charged only after he refused to help the government build a case against Jazz. Gleason said that based on his own experience of giving Xyrem to patients, he believes everything he said about the drug and his right to express his views are protected by both the FDA rules and the First Amendment. As he awaits trial, Gleason is supporting himself by working as an in-house doctor on short-term contracts. For a brief period he worked at a Maryland hospital before being let go. He told the Times he had been fired because of the indictment.