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GHB - Gamma-HydroxyButyrate
The Story Behind the Story

GHB — Gamma-HydroxyButyrate — is a naturally-occurring component of mammalian
biochemistry. It is both a metabolite and a precursor of the neurotransmitter gamma
aminobutyric acid (GABA). GHB is also known among scientists and physicians as sodium
oxybate, sodium oxybutyrate, gamma-hydroxybutyrate sodium, 4-hydroxybutyrate, and
gamma hydrate, as well as by its commercial European trade names Alcover™,
Gamma-OH™, and Somatomax PM™.

Millions of GHB molecules exist in everyone’s body, where they are intimately involved in
the normal functioning of the brain. Without GHB, our nervous systems would not
function properly.

GHB was discovered and first synthesized in the early 1960s by Dr. Henri-Marie Laborit,
a brilliant French physician. A decade earlier, Laborit had demonstrated that the drug chlorpromazine (sold in the US as Thorazine®) could be used to suppress the symptoms
of schizophrenia and other psychoses. It was the discovery of chlorpromazine in the
early 1950s — and eventually other antipsychotic drugs — that revolutionized the
treatment of schizophrenia. Prior to chlorpromazine, “psychosurgery” was a standard
treatment for severe schizophrenia. Psychosurgery is a euphemistic name for a debilitating, brain-scrambling surgical procedure known as a prefrontal lobotomy in which the frontal
lobe of the brain was severed from the rest of the brain. With the advent of chlorpromazine, this barbaric procedure ended. It also allowed many victims of schizophrenia to
“escape” from the virtual imprisonment of mental institutions.

For his pioneering work with chlorpromazine, Professor Laborit was nominated for the Nobel Prize. Although he did not win, in 1957 he was awarded the Albert Lasker Medical Research Award, which is known informally as the “American Nobel.”* Until the day he died in 1995 at age 81, Laborit continued to publish research about GHB, to use it himself at least three times a week, and to recommend it to friends and colleagues. He always maintained that his work with GHB and chlorpromazine were his two greatest scientific accomplishments. In the four decades since GHB was discovered, Laborit and other scientists have thoroughly and systematically explored its role in the biochemistry of humans and other mammals. During this time, GHB has been used safely and
successfully in Europe and the United States as a pediatric anesthetic, an aid to childbirth, and a treatment for alcohol and opiate withdrawal symptoms. It is the treatment of choice for narcolepsy and associated cataplexy. With few exceptions, researchers have also found GHB supplements to be extraordinarily safe and highly effective for treating insomnia, alleviating anxiety and depression, and enhancing cervical dilation during childbirth.

In Europe, GHB is readily available. It is sold “over the counter” in some countries and by
prescription in others (e.g., Italy and France). The effects of GHB in varying doses have been studied in depth in both laboratory animals and humans. Scientific investigations have demonstrated GHB’s potential to alleviate the symptoms of more than a dozen diseases and clinical syndromes.

Because of its unique mode of action, its incredibly rapid absorption, its powerful
antianxiety/antidepressant activity and its high level of safety, some researchers have suggested that GHB should be the treatment of choice for potentially suicidal patients.1

Before the current clamp-down on GHB use, pharmaceutical companies had filed 15 investigational new drug (IND) reports with the FDA (see box). INDs constitute an early step in the procedure pharmaceutical companies must follow to obtain FDA approval before marketing a medication. IND studies typically include the results of preclinical and toxicology reports to demonstrate that the drug is safe for clinical trials in humans. An FDA-approved IND is a green light for the pharmaceutical company to begin large-scale clinical trials. Although an IND is far from a guarantee that a substance is safe enough, effective enough, and economically viable enough to make it all the way to market,
approved INDs are not to be taken lightly.

The FDA’s drug approval process is so long and so costly that companies file INDs only when they believe their product has a good chance of surviving the tortuous drug approval process mandated by FDA regulations. This is especially true in the case of a substance that may have “psychoactive” properties (as GHB does). Even a hint of possible danger — an overdose risk or potential for abuse is often enough for the product to be thrown down the laboratory drain. Such products seldom, if ever, make it to the IND stage, let alone have 15 separate INDs filed. No pharmaceutical company likes throwing away money (not to mention its credibility) on useless or dangerous substances that are likely to be rejected. At an average approval cost of $250 to $350 million per drug, pharmaceutical companies have collectively bet many millions on GHB’s safety and efficacy.

Until November 8, 1990, GHB was sold legally in the US, mostly in health food stores. On that day, the Food and Drug Administration (FDA) issued a press release in which it declared GHB to be a dangerous and “illegally marketed drug,” with serious abuse potential, that was being “promoted as a legal psychedelic.” The only evidence the FDA offered in support of its allegations of danger was an assertion that “more than 30” unconfirmed reports of “nausea, vomiting, severe respiratory problems, seizures, and coma” had been made. The FDA provided no scientific evidence that GHB
 was dangerous, nor did it establish the legal basis for GHB’s “illegality.” They also failed to mention anything about GHB’s 30-40-year record of safety.

With no more legal authority than this press release, the FDA, along with the Drug Enforcement Administration (DEA) and the US Department of Justice, began arresting and prosecuting manufacturers and distributors of GHB. Articles began appearing in newspapers and magazines referring to GHB as a 1) new, 2) potentially lethal, 3) certainly toxic, 4) hallucinogenic, 5) designer drug, with 6) high abuse potential and 7) no legitimate medical uses.

According to these stories, GHB causes epileptic seizures and leaves unwitting or careless users in a coma or even dead. GHB was also said to be an ideal “date-rape” drug. “GHB abuse” in Europe has been a non-issue since GHB was discovered in the early 1960s. In fact, one of its major uses in Europe was, and continues to be, to help alcohol and heroin addicts safely kick their habit. This strange dichotomy raises several interesting questions:

Could this “highly dangerous” substance in the US be the same GHB that European consumers, physicians and clinical researchers have been using safely all this time? Could this be the same natural substance that has been found to be safe and effective for a host of serious and debilitating conditions? Could this “lethal designer drug” be the same one used in France and Italy as a nontoxic aid to childbirth and as a pediatric anesthetic? How can it be that US law enforcement agencies, drug regulation bureaus, and unquestioning news media have come to view GHB as a dangerous new designer / narcotic / hallucinogen / date-rape drug that warrants the same legal standing as heroin and crack cocaine? How is it possible that European scientists find GHB safe, effective and non-habit-forming, for a wide variety of uses, while Americans find it dangerous, addictive and clinically useless?

It is worth noting that the voices of scientific reason have been noticeably quiet during the current media furor over GHB. Stories about GHB raise alarms by quoting local or national police agencies and regulatory bodies, opportunistic politicians trying to rid their community of yet another “drug menace,” or grieving relatives who have little choice but to accept at face value what the police and politicians have told them about the “dangers” of GHB.

With the possible exception of one brief TV network news report, no knowledgeable or prominent GHB researchers or physicians who prescribe GHB for their patients are ever quoted in these scare stories. The nearly 40 years of solid scientific research on GHB is treated as though it didn’t exist.

And that’s the way the FDA, DEA, and Justice Department seem to like it. They have worked diligently to suppress public knowledge about the existence of the 15 INDs that have been filed with the FDA. These documents contain thousands of pages of data showing that GHB is one of the safest, least toxic and least addictive psychoactive substances ever studied. Yet when attorneys for defendants in GHB prosecutions tried to gain access to these documents in court, the government lawyers dismissed the INDs as “irrelevant” — and then proceeded to present “expert” witnesses to testify to GHB’s alleged toxicity and addictive properties.

Fortunately, the US Court of Appeals eventually saw through this ruse and ordered the INDs admitted into evidence. This action resulted in the reversal of convictions in several cases, and raised questions about prosecutorial misconduct on the part of the lead US Justice Department attorney in charge of prosecuting the GHB cases. The IND data clearly show that the testimony of the government’s “expert” witnesses — to the effect that GHB is a dangerous, addictive substance with no known clinical utility — has absolutely no basis in fact.

While the US government-sponsored, media-driven attitude toward GHB has been based on ignorance, disinformation and hysteria, the European attitude has generally been based firmly in science and clinical experience. But, references from the scientific literature confirming GHB’s safety never appear in the FDA’s agenda-driven press releases and news reports that seem designed more to scare than to inform. Until now, though, these slanted press releases and news reports have been virtually the only source of information about GHB available to the general public in the US.

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