Once available in health food stores, GHB was made a schedule I drug in the year 2000. The ban came over protests of a few plucky doctors and despite over a dozen investigational new drug applications pending with the FDA.
Soon after it was outlawed for recreational use, one niche pharmaceutical company was given exclusive rights to manufacture and market GHB.
Few are aware that the drug described in headlines as ‘fatal’ ‘toxic’ ‘deadly’ and ‘made with paint stripper’ is now FDA-approved and prescribed to children.
Not content with outlawing natural plants, the federal government is now working feverishly to make several chemicals produced naturally in the human body into Schedule I controlled substances.
The current FDA scare campaign against mild mood-elevators like Revivirant, Blue Nitro and Gamma G amount basically to a “drug war” against unauthorized states of mind.
These latest targets of FDA propaganda consist either of gamma-hydroxy butyrate (GHB) or its parent molecule gamma butyrolactone (GBL), both of which are produced naturally in the brain as antianxiety amino acids.
You could buy GHB in your local health-food store before 1991, but since then the DEA has been busting people even for kits” containing its commonly available tabletop ingredients. Distributors were producing brand-name items consisting of GBL until last January, when the FDA demanded they recall them or face arrest.
Like marijuana, GHB and GBL influence the main anti-anxiety brain hormone, GABA (gamma-aminobutyric acid), commonly with mildly pleasant results. Therefore, the DEA is working to put GHB alongside pot on Schedule I as soon as the FDA declares it “medically useless” — in the face of over 30 years of research proving the opposite.
Since its discovery in Europe in 1961, GHB has been used there to lessen withdrawal symptoms for alcoholics and junkies, to aid childbirth, to improve sexual performance and to counter anxiety, depression and sleep disorders. There are currently 15 applications before the FDA for studies on GHB’s various applications in medicine.
GHB periodically catches attention in the American press as a “designer” or “date-rape” drug, in government propaganda barrages which rarely emphasize its genuine dangers when taken along with alcohol, which it potentiates unpredictably.
The truth is it’s not really a party drug, as advertised in FDA-inspired health and science tracts. Athletes use it for enhancing muscle bulk, insomniacs and anxious people use it as a sedative, and it’s increasingly popular with employees subject to workplace drug-testing, as it’s undetectable in urine after just a few hours.
Since GHB users can expect to suddenly “nod off” at unpredictable intervals while high the media readily relay horror stories about “coma victims” showing up in ERs and about date-rape per perpetrators supposedly using it.
Reports of death by GHB OD aren’t very hard to manufacture though. The first such report of a Texas teenager, gained a lot of press before it was found to be baseless, as did the 1997 death of actor River Phoenix, which had nothing to do with GHB
“I have looked at every GHB-related death,” says Dr. Ward Dean, coauthor of GHB: The Natural Mood Enhancer, “and I have always found another cause.”
Since GHB occurs naturally in the body, it can always be reported as “present” in any corpse by any headline-seeking coroner.
Last February, though, in a survey by the federal Centers for Disease Control of GHB-related hospital visits, all the “victims” were reported as released within hours with no long-term effects at all.
‘Table salt is more toxic than GHB,” points out Dr. Dean. Street users do face potential hazards from badly synthesized batches of it, thanks to the US government’s suppression campaign, so overseas sources are preferred.
Dr. Andrew Baer anticipates that the FDA will eventually succeed in having GHB declared medically useless.
“The FDA and DEA are eroding our freedom.” he says.
“You’ve got a few cases of kids abusing it with alcohol and its use in rapes, so we have to make a law.”
Nearly year after this article came out the United States government succeeded in rescheduling GHB.
In an unprecedented move GHB was rescheduled to a Schedule I controlled substance, while simultaneously making expensive FDA-approved GHB schedule III.
Xyrem is currently the only-FDA approved GHB medication available on the American market. It’s used in the treatment of sleep disorders such narcolepsy, but is only prescribed under strict protocols and remains cost prohibitive for patients who don’t have deep pockets or excellent insurance. A prescription for ‘Sodium Oxybate’ (GHB), as it’s generically known, costs U.S. patients $6-12,000 per month.
The maker of Xyrem, Jazz Pharmaceuticals have fought to keep their monopoly on the high-profit medicine, which costs pennies per doses to produce.
When it was first available, Xyrem cost patients just over $2 per dose. Since then, the company has inflated the price for Xyrem an average of 40 percent per year.
Currently there are nine Abbreviated New Drug Applications for Xyrem spin-offs before the FDA. A generic brand is not expected to reach the market until 2023.
In 2010, the FDA rejected an application for the use of GHB in treating Fibromyalgia (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). In the FDA advisory panel public comment session, patients testified how helpful the medication was for them in treating symptoms of fibromyalgia. ME/CFS is a baffling disease that is difficult to treat.
The FDA rejected the use of Xyrem to treat ME/CFS 20-2, not for lack of effectiveness but because they worry that the large patient population meant the drug would end up being funneled to the black market. Later double blind trials confirmed a positive therapeutic response in treating ME/CFS.
Researchers are also interested in its use in treating Parkinson’s Disease, anxiety, depression, sexual dysfunction and a wider range of sleep disorders.
And despite record numbers of alcohol and opioid dependence, U.S. doctors, unlike their colleagues in continental Europe, don’t tend to prescribe GHB as an alcohol or opioid cessation aid.
In most of the European Union GHB is classified as a schedule IV drug, meaning it is considered ‘medically useful’ and has a lower potential for abuse than higher scheduled drugs.
There, GHB is used as a anesthetic agent and is available under the brand name Alcover, where it has an 80 percent success rate in the treatment of alcohol and opioid withdrawals and as an anti-craving agent, facilitating extended periods of alcohol abstinence among the most severe alcoholics.
Drugs on the U.S. market used to treat opioid and alcohol use disorders such as buprenorphine and Naloxone have a disadvantage over GHB because they can be hepatotoxic for patients with liver disease, a problem that obviously affects many in that population.
A 2016 Italian study in the use of GHB for alcoholism concluded that Sodium Oxybate “can be considered one of the most effective drugs in the treatment of AUD (Alcohol Use Disorder), with a good profile in safety.”