On August 8, 2008 psychiatrist Peter C. Gleason pleaded guilty in U.S. District Court for the Eastern District of New York (Case 1:06cr-00229-ENV).  He was charged by the U.S. Attorney with “misbranding” the drug Xyrem.

According to the United States Code, Title 21, Section 352 (f), a drug is misbranded if its labeling is false or misleading or does not contain adequate directions for the drug’s use or adequate warning against its use where such could be dangerous to the user’s health.

Xyrem was initially FDA approved to treat patients with narcolepsy (recurrent uncontrollable desire to sleep) who experience episodes of cataplexy (a condition marked by abrupt attacks of muscular weakness, associated with narcolepsy).  It was later approved for treatment of excessive daytime sleepiness in patients with narcolepsy.  The active ingredient in Xyrem is gamma hydroxybutrate (GBH), a powerful and fast-acting central nervous system depressant subject to abuse as a recreational drug (GBH is known as the “date rape drug”).  Side effects of the drug include confusion, depression, vomiting, headache, bedwetting and sleepwalking.  Abuse of the drug could cause seizures, coma and death.  The drug carries the FDA’s strongest (“black box”) warning.  Additionally, Xyrem was designated a Schedule III Controlled Substance, meaning it could not be sold, distributed or provided to anyone other that for its prescribed use.

According to the U.S. Attorney’s charge, between 2003 and 2006, Dr. Gleason was paid tens of thousands of dollars by Orphan Pharmaceuticals to appear at speaking engagements and promote their drug Xyrem for “off-label” indications (medical conditions other than those that the FDA approved the drug to treat), including fibromyalgia, weight loss, insomnia and chronic fatigue.  By promoting the drug for “off-label” indications, he thus misbranded the drug, as its labeling would not then “contain adequate directions for the drug’s use or adequate warnings” relative to off-label uses.

Dr. Gleason pleaded guilty to misbranding, in that he “did knowingly and intentionally introduce into interstate commerce…Xyrem, that was misbranded within the meaning of 21 U.S.C. § 352 (f), in that [he] was marketing Xyrem for medical indications that were not approved by the FDA when [he]…well knew and believed, Xyrem’s labeling lack adequate directions for such uses and adequate warnings against such uses where such uses could be dangerous to the user’s health.”

His sentence is pending. ¹