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The Administrative State and The Death of Peter Gleason, MD: An Off-Label Case Report

2019; American Academy of Sleep Medicine; Volume: 15; Issue: 03 Linguagem: Inglês

10.5664/jcsm.7700

1550-9397

Ronald E. Kramer,

Medical Research and Practices

Free AccessLetter to the EditorThe Administrative State and The Death of Peter Gleason, MD: An Off-Label Case Report Ronald E. Kramer, MD, FAASM Ronald E. Kramer, MD, FAASM Address correspondence to: Ronald E. Kramer, MD, Colorado Sleep Disorders Center, 3206 Greensborough Drive, Highlands Ranch, CO 80129-1531(720) 350-8976 E-mail Address: [email protected] Colorado Sleep Disorders Center, Highlands Ranch, Colorado Search for more papers by this author Published Online:March 15, 2019https://doi.org/10.5664/jcsm.7700SectionsPDF ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutINTRODUCTIONSleep medicine continues to have a major impact on medical education in this country. Ironically, this impact comes from the courtroom and not the classroom. Best known is the Libby Zion case where malpractice allegations arising from sleep deprivation and shift work caused a national change in trainee work schedules.1 Lesser known is the criminal case of Peter Gleason, MD.2Dr. Gleason, a private practice psychiatrist, was a high-volume prescriber of the narcolepsy drug Xyrem (sodium oxybate, the sodium salt of GHB). He advocated its off-label use and the manufacturer frequently hired him to give promotional lectures stating his off-label opinions.3 In 2006, without warning, Gleason was arrested for his off-label advocacy. He was indicted on four felonies, including health care fraud.2 He faced $1 million in penalties and 28 years in prison. The indictment included allegations against his CME activities that dealt with Xyrem if funded by the manufacturer. His crime was advocating Xyrem for “…fatigue, chronic pain, weight loss, EDS not associated with narcolepsy, depression, bipolar disorders, fibromyalgia, insomnia, and movement disorders such as Parkinson's disease.”2 These uses have a basis in clinical practice and basic science, but being off-label were based on anecdotal and theoretical data.4 Despite this, the FBI publicly stated Gleason's conduct was “…indistinguishable from a carnival snake-oil salesman…”5 Within legal circles, the indictment was considered “creative.”6The indictment included a criminal forfeiture allegation. Designed as a prosecutor's tool to be used against illegal drug dealers, it freezes and isolates a defendant's finances prior to trial.6 In 2010, Gleason acquiesced to a federal misdemeanor and was sentenced to a $25 fine and one-year probation. He was financially destitute and faced state medical board disciplinary proceedings. In 2011, one month after probation ended, he committed suicide. His sister stated his death was from governmental overreach for “truthful speech to fellow physicians about the off-label use of an FDA-approved drug.”6The doctor received some vindication. The sales representative indicted with Dr. Gleason was convicted of felony drug misbranding. With help from national legal foundations, that felony conviction was overturned in 2012 by the Second Circuit Court of Appeals on First Amendment grounds.7 Some would argue that decision unleashed corporate malfeasance and undermines the FDA's authority.The Gleason case set a lasting precedent for promotional lectures, and drug companies routinely refer to the case during promotional speaker training. The Gleason case reined in off-label statements, turning forums into rote presentations of the package insert. To protect themselves, companies require that such presentations be composed of only FDA approved slides presented in a defined order. Speakers cannot make spontaneous statements regarding off-label options.This truth-in-advertising comes with a price. Prior to the Gleason case speakers would modify, add, or delete data from promotional presentations. New side effects, dosing deviations from the package insert, and pediatric use are all topics that cannot be spontaneously opined, even with data on such off-label parameters. Given the banality of promotional presentations, physician attendance has dropped.Published off-label data are frequently presented in case reports, case controls or other poorly designed formats. Some argue that such data are a threat to public safety, but these data represent the “art” of medicine upon which the “science” progresses. Quality off-label data from high-impact, peer-reviewed journals should be openly available at promotional presentations. It could raise journal prestige and impact.With full disclosures, the free exchange of quality medical information among physicians should not be limited by the CME status or funding source of an educational forum.DISCLOSURE STATEMENTThe author, Dr. Ronald E. Kramer takes full and sole responsibility for the content of this manuscript. This study had no industry-sponsored support. The author was on the speaker's bureau for Xyrem from its release in the United States in 2002 until approximately 2014. The author was active on speaker's bureaus for just about all epilepsy and sleep medicine products from 1990-2014. The author has had only one malpractice allegation in his career and that dealt with Xyrem (Bettenhausen v Kramer, No. 1:04-CV-025620-RPM).CITATIONKramer RE. The administrative state and the death of Peter Gleason, MD: an off-label case report. J Clin Sleep Med. 2019;15(3):529–530.REFERENCES1 Asch DA, Parker RMThe Libby Zion case. One step forward or two steps backward?N Engl J Med1988318127717752. United States v Gleason, No. 1:06-cr-00229-ENV - Document 28 (EDNY 2007) CrossrefGoogle Scholar2 Berenson AIndictment of doctor tests drug marketing rules. New York Times websiteAccessed July 24, 2018 https://www.nytimes.com/2006/07/22/business/22drugdoc.html. Published July 22, 2006 Google Scholar3 Tunnicliff G, Cash CDGamma-Hydroxybutyrate: Molecular, Functional, and Clinical Aspects2002New York, NYTaylor & Francis, Inc. Google Scholar4 The United States Attorney's Office, East District of New York websitePsychiatrist Charged with Conspiracy to Illegally Market the Prescription Medication Xyrem, Also Known as “Ghb,” for Unapproved Medical Uses on Behalf of its ManufacturerAccessed July 25, 2018 https://www.justice.gov/archive/usao/nye/pr/2006/2006apr05.html. Published April 5, 2006 Google Scholar5 Silverglate HThree Felonies a Day: How the Feds Target the Innocent2011New York, NYEncounter Books Google Scholar6 United States v Caronia, No. 09-5006 (2d Cir. 2012) Google Scholar Previous article Next article FiguresReferencesRelatedDetails Volume 15 • Issue 03 • March 15, 2019ISSN (print): 1550-9389ISSN (online): 1550-9397Frequency: Monthly Metrics History Submitted for publicationOctober 10, 2018Submitted in final revised formJanuary 16, 2019Accepted for publicationJanuary 18, 2019Published onlineMarch 15, 2019 Information© 2019 American Academy of Sleep MedicinePDF download