GHB, Conspiracy, and Suicide
How one man's fight to elevate a sleep and fibromyalgia aid cost him his life as the FDA turned a societal dilemma over "crossover" drugs into a nightmare crime.
On March 6, 2006, Dr. Peter Gleason, a Maryland psychiatrist known for caring for “underserved populations,” left a lunch presentation at a doctor’s office in Great Neck, NY, that he was doing for a drug he strongly believed in, Xyrem, and headed to the train station to go home. It was a typical presentation for him: he extolled the benefits of the drug, including off-label uses, and he was paid by the drug manufacturer, Jazz Pharmaceuticals. Gleason had been hired by Jazz because of his enthusiasm for the drug. He felt, based on results he’d seen in his own practice, that Xyrem was a safer and more effective medication for treating insomnia and chronic pain (among other conditions) than the more commonly prescribed drugs for those diagnoses.
When Gleason got out of the car at the station, he was immediately surrounded by federal agents, handcuffed, and put into an SUV. He was driven to the Great Neck police station where the feds allegedly pressured him to cooperate with them in their investigation into a conspiracy by Jazz Pharmaceuticals to market Xyrem for off-label and potentially dangerous uses. Gleason protested, insisting he had done nothing illegal and that all of his claims were based on solid empirical evidence. He refused to get involved in any case against Jazz. He was released later that afternoon.
It's the worst withdrawal there is…Most detox takes four to five days. GHB can mean 10 to 14 days of really bizarre and psychotic behavior. The withdrawal itself can be lethal.
“Off-label” use refers to the prescribing of a medication for conditions that it was not intended to treat. Drugs for high blood pressure are frequently prescribed off-label to treat migraines; certain antidepressants may be prescribed off-label to treat pain or insomnia; some antihistamines have been prescribed to treat anxiety. In the most basic example, aspirin, which is marketed as an analgesic, is now universally recommended to prevent and treat heart attacks. None of these drugs are labeled for their alternative uses, but it is common practice for doctors to prescribe them to treat these conditions.
The FDA prohibits drug companies from promoting their own products for off-label uses. The companies are allowed, however, to pay doctors to do presentations and attend conferences in which they speak to other doctors about the drugs. Typically the doctors giving these presentations will offer their experience with the medication, often including off-label uses. Dr. Gleason was requested frequently and the compensation he received for doing these presentations quickly became his primary source of income, far surpassing what he earned from his medical practice.
So why was Gleason arrested if he was engaging in a legal and common practice? Prosecutors for the government claimed that Gleason went too far in promoting the drug - that he suggested its use for disorders which neither the labeling nor empirical research could support. Gleason believed that Xyrem had a wide range of uses including treating the persistent pain and exhaustion from conditions such as fibromyalgia and chronic fatigue syndrome. Officially, Xyrem was only approved for treatment of excessive daytime sleepiness in people with narcolepsy and for cataplexy, a disorder where muscles have periods of weakness or paralysis. When Xyrem was approved for these disorders in 2002 and 2005, the FDA made sure that the drug was very closely monitored and had a “black box” warning which detailed dangerous side effects and cautioned that Xyrem had the potential for abuse and addiction. The FDA additionally categorized Xyrem as a schedule three narcotic and specified that only one pharmacy in the United States could prescribe it. Patients who take the drug must be enrolled in a patient registry (the Orwellian-sounding “XYREM Success Program”) and receive their medication by mail.
The reasons for the restrictions and close monitoring? Xyrem, or sodium oxybate, is also known as GHB, a drug of abuse that has been implicated in addiction, overdose, date rape, and death. Before Xyrem was FDA approved, GHB was categorized as a schedule one narcotic, alongside drugs such as heroin and ecstasy which are described as having “no currently accepted medical use and a high potential for abuse.”
GHB has a structure similar to GABA, a neurotransmitter that calms the brain. Both GABA and GHB occur naturally in the body, but when GABA is taken orally, it doesn’t have an effect on the already existing GABA levels in the brain, presumably because it cannot cross the blood brain barrier. So instead, GABA facilitating drugs are used to increase GABA activity in the brain. Drugs in this category include the benzodiazepines like valium, and some sleeping medications such as ambien.
GHB, on the other hand, can be taken orally and it does affect the brain, binding not only to the GABA receptor, but also to a specific GHB receptor. In 1960, GHB was first synthesized and used as anesthesia because of its ability to induce a coma-like state without compromising life-sustaining cardiovascular and respiratory functioning. It sometimes caused seizure-like activity, however, so it was soon abandoned for that use.
It gained popularity again in the 1980s as a food supplement. Steroid devotees such as “Steroid Guru” Dan Duchaine started pushing the supplement after hearing about a Japanese study that said that GHB-assisted sleep triggered the body to create extra growth hormone. Research has since shown that any increase in growth hormone attributed to GHB is tiny; it’s more likely that the drug gained popularity because it allowed bodybuilders to achieve a more restful sleep after a day pumped full of steroids and other questionable supplements. Initially the bodybuilders were elated. They were sleeping better, their workouts were providing better results, and the drug seemingly had no side effects. It was marketed with names like Verve and Invigorate and was available over the counter at vitamin shops. The packaging claimed that it would help you build more muscle mass, lose body fat, sleep well, and have great sex. It was believed to be nontoxic and non-addictive. Since GHB occurs in tiny amounts naturally in the body, people assumed it couldn’t be harmful.
Enthusiasts soon discovered that in addition to helping with workouts, the drug also acted as a hallucinogenic and euphoric. As restrictions on steroids tightened, the use of GHB became more common, until reports of overdoses began to catch the attention of poison control centers. As a result of increasing deaths related to GHB, in 1990 the FDA prohibited the sale and manufacture of the drug.
By this time, many of the enthusiasts had become addicts. Just like other drugs that are suddenly made illegal, GHB went underground but remained popular, maintaining its hold in the bodybuilding community and also gaining popularity as a club drug. People figured out how to easily make their own GHB at home. And the FDA’s ban wasn’t comprehensive enough: there were still loopholes that allowed certain GHB analogues to be sold over the counter. These analogues, also sold as natural supplements, had chemical structures that turned into GHB after ingestion. Additionally, because of its euphoric and central nervous system-depressing effects, GHB began to be known, along with the now completely illegal Rohypnol, as a date rape drug.