Peter Gleason was a psychiatrist who devoted much of his professional life to caring for what government officials call “underserved populations.” He would have been thrilled to learn that on Dec. 3 in New York, a three-judge panel of the U.S. Court of Appeals for the Second Circuit issued a ringing opinion that vindicated the conduct for which he was indicted and arrested in 2006.
Unfortunately, Gleason did not live to see this welcome reversal of the federal government’s crusade against him and the promotion of Xyrem—a drug widely used by physicians, including Gleason, to treat a number of medical conditions beyond what the federal Food and Drug Administration approved it for. Hounded for years, he saw his career and finances ruined by the relentless war waged against him by FDA bureaucrats and Justice Department prosecutors. Gleason committed suicide on Feb. 7, 2011.
The doctor’s troubles stemmed from lectures he gave attesting to the efficacy of Xyrem, a pharmaceutical originally developed for use in narcolepsy but found by physicians to be effective against a number of conditions, including fibromyalgia and chronic fatigue syndrome. The FDA had not given formal approval for these so-called “off-label” uses since the manufacturer had not submitted an application covering those ailments.
Obtaining FDA approval for a new drug is time-consuming and expensive. Once a drug is approved for a certain use (which its FDA-approved “label” describes), physicians often discover, through use of the drug as well as through further research and field experience, other conditions for which the drug is a safe and effective remedy. Manufacturers rarely go through the FDA approval process for such additional uses of already-approved drugs due to the expense. FDA regulations forbid them to promote these “off-label” uses.
Yet such uses are widely practiced by experienced physicians. They know, for instance, that Neurontin, approved to treat seizures, can also relieve neuropathic, or nerve, pain. Avastin, approved to limit new blood-vessel growth in tumors, ameliorates age-related muscular degeneration. Aspirin is widely deemed a miracle drug because of its uses beyond pain relief, largely discovered by trial and error.
Unlike manufacturers, physicians are not restricted by federal law from prescribing an FDA-approved drug for an off-label condition. They are perfectly free to communicate the results of their experience to fellow physicians, or to publish in medical journals. Such communications have long been recognized to be protected by the physicians’ professional prerogatives and free-speech rights.
So how was it that Gleason was indicted on a conspiracy charge of communicating to his fellow physicians that he found Xyrem effective for off-label medical conditions such as chronic pain and bipolar disorder? Gleason, it turns out, often revealed his experiences with Xyrem to audiences of physicians during paid appearances at events sponsored by its maker, Orphan Medical—a common practice within the medical community. The prosecutors’ convoluted legal theory was that even if Gleason himself was free to recommend Xyrem, he had lost his First Amendment right to communicate his medical knowledge because he had become an agent of sorts for the manufacturer and “conspired” with employees of the company, who had to stick to promoting only FDA-approved uses.
No wonder Gleason was shocked when he found himself surrounded and handcuffed by six federal agents who were waiting for him at a train station on New York’s Long Island on March 6, 2006. When prosecutors could not convince Gleason to cooperate against the drug manufacturer—he did not feel that either he or Orphan Medical had violated the law—they indicted him, triggering a downward spiral that wreaked havoc on his medical practice.
Gleason was not a wealthy man, but whatever assets he had accumulated during his working life were placed in limbo when the feds included in the indictment a “criminal forfeiture allegation.” This sought to force him to turn over to the government “any property, real and personal, that constitutes or is derived, directly or indirectly, from gross proceeds traceable to the commission of offenses.” Virtually all of Gleason’s income and assets were derived from his medical practice. Thus prevented from hiring private counsel of his choice, he required free legal representation from the Federal Defenders Service, tasked with representing indigent defendants.
The ordeal of fighting a federal indictment, a daunting process even for the wealthy, exhausted Gleason, with whom I corresponded when I included his case in a book I was writing about how federal bureaucrats and prosecutors go after innocent defendants for innocuous behavior. He grew increasingly dispirited and finally decided to accept an offer that he felt he could not refuse. He pleaded guilty to a misdemeanor alleging his conspiracy with Orphan Medical and was sentenced to one year of probation and a $25 fine.
But Gleason’s career was ruined and his pride decimated. He had difficulty holding a hospital or clinic job, and his medical license was placed into question. He was despondent the last time I spoke with him, and he subsequently took his life by hanging himself.
Just under two years later, Gleason’s posthumous vindication was achieved by his co-defendant, Alfred Caronia, a sales representative for Xyrem’s manufacturer, Orphan Medical (later acquired by Jazz Pharmaceuticals JAZZ -0.21% ), who had refused to make a deal with the feds. With the aid of aggressive legal counsel and the “friend-of-the-court” backing of two public-interest organizations, Mr. Caronia won the point that Gleason had many times argued to anyone who would listen: The First Amendment protects the right of physicians, drug manufacturers, sales representatives and anyone else who wishes to convey truthful, factual information about the beneficial uses of drugs in the relief of illness and pain.
What the appeals court affirmed in ruling for the defendants on Dec. 3 seems so obvious now. But it’s too late for Peter Gleason. And too late for the feds to apologize, if they were so inclined.
Mr. Silverglate, a Boston lawyer, is the author of “Three Felonies a Day: How the Feds Target the Innocent” (Encounter Books, 2009).
A version of this article appeared Dec. 26, 2012, on page A13 in some U.S. editions of The Wall Street Journal, with the headline: A Doctor’s Posthumous Vindication.