The New York Times on Saturday profiled Maryland psychiatrist Peter Gleason, who federal authorities arrested in March 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." Federal prosecutors allege that Gleason received large fees from Jazz Pharmaceuticals to promote the narcolepsy medication Xyrem as a treatment for depression and pain relief, uses not approved by FDA. Federal prosecutors allege that Gleason conspired with Jazz to recommend Xyrem for potentially dangerous uses. According to the Times, the case has "put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines." Pharmaceutical companies, which cannot directly market medications for uses that FDA has not approved, often sponsor seminars or continuing medical education classes and pay physicians to make presentations to promote their products for both approved and off-label uses. The Gleason case "could establish limits on what doctors can do to help companies sell their drugs," the Times reports. Steven Nissen, interim chair of cardiovascular medicine at the Cleveland Clinic, said that 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" (Berenson, New York Times, 7/22).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Xyrem.
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