GHB Report to the California Legislature

GHB Report to the California Legislature

by Steven Wm. Fowkes


What is GHB?

GHB (gamma-hydroxybutyric acid) is a natural metabolite of human metabolism. It is a carbohydrate, found extensively throughout the human diet (all animal-flesh foods contain GHB). GHB is biologically synthesized from gamma-aminobutyric acid (GABA), a structurally similar amino acid that is also widespread in human metabolism and diet. GHB is also biologically converted back into GABA.

GHB was first synthesized in 1961 by Dr. H. Laborit, a French researcher. In the brain, the highest amounts are found in the hypothalamus and basal ganglia [Gallimberti, 1989]. Dr. Laborit found that GHB exhibited a range of effects beyond those expected from GABA (which is established as a basic inhibitory neurotransmitter). GHB has come to be used in Europe as a general anesthetic, a treatment for insomnia (sleeplessness) and narcolepsy (a daytime sleeping disorder), an aid to childbirth (it enhances cervical dilation), a treatment for alcoholism and alcohol withdrawal syndrome, an anti-anxiety and anti-stress agent, and for many other uses. GHB is currently available by prescription in the US through compounding pharmacies. It has no formal drug status with the FDA (although 15 INDs are pending).

What is the legal status of GHB?

Federal law (the Food, Drug & Cosmetics Act) now classifies GHB as a food and dietary supplement.

Prior to 1994, GHB could be classified as a food and/or a drug. The Dietary Supplement Health & Education Act of 1994 created a new category of “dietary supplement,” items of which, according to law, were to be regulated as foods. This category was defined to include: 1) vitamins, 2) minerals, 3) amino acids, 4) nutrients, and 5) herbs, and extracts, concentrates and metabolites of all of the above. Since GHB is 1) a nutrient and 2) a metabolite of the amino acid GABA, it meets two separate legal qualifications for status as a dietary supplement.

The dietary supplement status of GHB is of no influence on whether the FDA does or does not approve GHB as a drug. And according to the new law, approval of GHB as a drug would not affect its status as a dietary supplement. The only way for the FDA to revoke GHB’s status as a dietary supplement is 1) to establish, in an open rulemaking procedure, that it poses an unacceptable risk to public health, or 2) to declare that it is an imminent risk to public health, which must be subsequently confirmed in an open rulemaking procedure.

Why is the FDA avoiding this approach?

Is GHB a Drug?

The category of dietary supplement specifically excludes items already classified as drugs prior to 1994. However, GHB was never classified as a drug by the FDA. The FDA did declare GHB to be a drug in press releases, media interviews, and expert-witness court testimony prior to 1994. However, these declarations have no force of law. They do not not meet regulatory requirements for formal action by the agency.

GHB is not the only dietary supplement to be so treated by the FDA. On countless occasions, the FDA has attempted to declare that vitamins, herbs, amino acids and other nutrients were drugs. The FDA has also declared that dietary supplements were food additives and adulterants. Such actions have been declared illegal and improper by numerous courts, and all of these were severely restricted or directly forbidden by law in 1994.

The loss of the FDA’s power to declare nutrients to be drugs may be one of the reasons they are trying to influence the courts, the DEA, local coroners, media reporters and state legislatures to criminalize GHB.

GHB’s Day(s) in Court

The FDA’s national press release of 8 November 1990, which declared that GHB was a drug, marked the beginning of a series of law-enforcement actions and court cases. At that time, GHB was being sold in health food stores on an over-the-counter basis. With that press release, the FDA and federal and local police began to threaten businesses with legal prosecution for selling GHB. They arrested business owners and told them that they would be prosecuted unless they testified against their wholesale suppliers.

The FDA succeeded in driving the GHB business underground. They began legal proceedings against GHB distributors and manufacturers. They charged them with labeling and drug violations. The FDA provided expert witnesses who testified as to the serious dangers of GHB. During the trials, the Federal prosecutor and FDA blocked the court’s and defense’s access to GHB INDs which were represented to “contain no relevant information.” The GHB distributors and manufacturers were convicted and sent to prison.

When this issue was reviewed in Federal District Court on appeal, this decision was overruled and the lower courts were instructed to admit the INDs. There were 15 INDs. All of them flatly contradicted the FDA’s expert witnesses. The universal opinion of the INDs was that GHB was non-toxic and non-addictive, and had an extremely wide margin of safety. This opinion was amply supported by the FDA-approved GHB-dispensing protocol within the decade-long narcolepsy studies. The study subjects received a large container of bulk GHB, told what dose to take, and instructed to come back for more when they needed it. There were no problems whatsoever with this protocol. There were no addiction problems. There was no toxicity.

I was present in the San Francisco courtroom when the oral arguments for appeal were presented. Charges of prosecutorial misconduct were openly discussed by the three-member panel of judges relating to several actions of the prosecutor. Falsifying the impartial analysis of the INDs was only one charge. There were also charges of repeated prejudicial comments to the jury about the defendant’s failure to testify indicating his guilt, and several unprofessional personal attacks on the defense counsel in front of the jury. The judges suggested referring the matter for disbarment proceedings.

The government’s cases against the GHB defendants are unraveling at the seams. In hindsight, we can now see that the convictions were obtained by sacrificing justice in the interest of the FDA’s politically motivated policy towards GHB. They couldn’t convict on the real evidence, so they falsified evidence through expert witnesses and withheld evidence by blocking the INDs.

What’s in the INDs?

There are 15 INDs filed with the FDA for 1) improving sleep patterns and maintaining daytime alertness in narcolepsy, 2) reducing schizophrenic symptoms, 3) stabilizing Parkinson’s disease, 4) reducing nocturnal myoclonus (painful leg cramps at night), 5) improving memory problems, 6) stimulating natural growth hormone release, 7) decreasing pain and improving sleep in fibromyalgia, 8) relieving symptoms in Huntington’s chorea, 9) regulating muscle tone in dystonia musculorum deformans, 10) controlling tardive dyskinesia symptoms, 11) decreasing drug withdrawal symptoms (alcohol and opiates), 12) decreasing hyperactivity and learning disabilities in children, 13) inducing sedation and tranquilization, 14) relieving anxiety, and 15) lowering cholesterol.

GHB has been recommended as the anti-anxiety agent of choice for potentially suicidal patients.

The incredible dichotomy between GHB as a safe miracle nutrient (with extensive applications to a host of human maladies) and GHB as a lethal designer drug (used for date rape and other nefarious purposes) can hardly be more striking. This can hardly be an accident. It must be by design. But who’s design?

Medical Uses

The proliferation of GHB INDs establishes clearly that the potential medical uses of GHB are extensive. The exact medical applications to which GHB is presently being applied should be provided in direct testimony from practicing physicians using GHB. That some US physicians do not use GHB is fundamentally irrelevant. That GHB-ignorant physicians are willing to testify that GHB has no medical uses is also irrelevant (and inaccurate). That police spokespersons are testifying that GHB has no medical uses and is “100% abused” (Los Angeles Police Detective Trinka Porrata testifying before the Assembly Committee on Public Safety, February 25th, 1997) is also irrelevant (not to mention medically incompetent).

GHB is being used in other countries for many medical purposes. One of the purposes that deserves special mention is its use in France and Italy as an aid to childbirth. It’s ability to calm maternal anxiety, protect against hypoxic injury to the baby, and accelerate dilation of the cervix (termed “spectacular” in one report) provide a graphic contraposition to allegations of toxicity, addiction and lethality.

It is rare to find a substance with as many applications to such a host of human maladies. Few medicines have as many beneficial actions upon the body as GHB for the prevention and treatment of debility and disease. Even fewer medicines have less side effects. The scientific and medical consensus on GHB established by conscientious laboratory and clinical investigation of the applications of GHB to enhance health and decrease suffering can only be sensationalized to a limited degree before all pretense at accuracy and honesty must be abandoned. It is unfortunate, but absolutely necessary, that we assess the rationale for SB3, SB54, and AB6 in light of this research.

Media Reports

Extensive contradictory information on GHB has been presented to the public via the media. The experts upon which media stories are based are associated with 1) the FDA, 2) the DEA, 3) local police agencies, 4) coroners. 5) doctors and scientists.

Some stories on GHB, for example NBC Nightly News with Peter Jennings, have reported glowingly on the current and potential medical uses and benefits of GHB. These positive reports are based on medical and scientific experts who have researched and tested GHB in clinical settings.

Other reports have referred to GHB as a lethal, brain-damaging, “date rape,” designer drug. These reports rely upon police and regulatory agencies for their expert witnesses. The scientific experts (coroners) that are potentially qualified to judge GHB are quoted only in a limited context, and autopsy reports listing GHB as the cause of death have been suborned (in a scientific sense) by the “helpful” advice of DEA and FDA agents who have “generously” informed local coroners of the dangerous, lethal and insidious nature of GHB. According to the investigation of Ward Dean, M.D., every instance in which GHB has been listed as a cause of death involved some other cause of death. Expert witnesses are available to testify about the details of these cases.

The much-publicized case of Texas teenager Hillory Farias is a tragic case where DEA and FDA objectives brutally exploited the girl’s family to promote a negative media image of GHB. Very little evidence was found to suggested that Miss Farias ever ingested any GHB. Having been told that their daughter was poisoned by GHB, the family was encouraged to speak out against it with the press. When the family later realized that Hillory’s death was not due to GHB, they were devastated by the FDA’s and DEA’s indifference to human feeling, horrified and shocked that the loss of their daughter was used to promote subversive propaganda.

The medical examiner did not report that Hillory’s death was caused by GHB until a “helpful voice” influenced his determination some 6 weeks after the death occurred. This case may reveal the urgency with which certain government officials feel compelled to frighten the public about GHB. If this was the plan, as it appears to have been, it was poorly planned and incompetently executed. Miss Farias’ symptoms and etiology were inconsistent with the effects of GHB. Crucial health history factors were overlooked. Instead, the medical examiner focused on “traces” of GHB in the body as evidence. Since GHB is a natural metabolite of the human body, traces are always present. Traces of GHB only serve to establish that one is an animal and not a plant.

Given the extreme nature of the anti-GHB disinformation campaign, it is vital that we examine, in depth, the irreconcilable differences between GHB as a deadly, designer, date-rape drug and GHB as a safe and effective miracle nutrient. This examination is necessary to ensure that public policy does not subvert public health and welfare.

Furthermore, in any issue of public policy, the rights of individuals to “life, liberty and the pursuit of happiness” must not be sacrificed without clear cause. I think most health-conscious Americans would consider good nutrition to be an essential and unalienable aspect of life, liberty and the pursuit of happiness. These Americans made this sentiment well known to Congress when the FDA tried, twice, to classify nutrients as drugs (i.e.>, to restrict nutritional freedom of choice). Even during the height of the Gulf War, the volume of mail sent to Congress protesting FDA policy towards nutrients exceeded the volume of mail on all other issues combined. There is no way to do justice to the deep and abiding suspicion that nutrition-savvy Americans have for the FDA. The FDA’s campaign against over-the-counter supplements has been so protracted that many consumers decide to take a dietary supplement because the FDA says they shouldn’t! The adversarial nature of the FDA’s relationship to non-drug interests (unpatentable health technologies in general) is not in the public’s interest or for their welfare. First of all, Americans want access to therapies that are the safest and most effective available, regardless of whether or not there are economic interests that can afford the tens to hundreds of millions of dollars required for drug approval. Secondarily, if there actually were to be a public-health emergency regarding supplements, the FDA’s advice would be most likely to be ignored by those consumers most affected (just as the proverbial shepherd was ignored after crying “wolf” one to many times). The FDA has effectively destroyed their credibility within a major portion of the supplement-consuming public. This is not a trivial problem, nor will it be easily repaired.

Is GHB a Designer Drug?

No.

The term “designer drug” refers to a synthetic chemical analog of some other drug which is created in a laboratory for illicit purposes (as distinguished from chemical analogs designed in laboratory by drug-company chemists for testing for the drug-approval process). Since GHB is a naturally occurring nutrient and human metabolite, it is not a synthetic compound. It has been “designed” by nature, or God, not by a chemist. Furthermore, it is not illicit. Until such time as a law is passed changing GHB’s legal status, GHB is as legal as any other nutrient, food, or dietary supplement.

Date Rape

Centuries of experience have confirmed that alcohol is the date-rape drug of choice. Current statistics state that 70% of “acquaintance rape” or “date rape” involve the use of alcohol [U.S. Justice Department]. Although some researchers have suggested that the incidence of date rape was not high, people are now coming to realize the magnitude of the under-reporting of this form of violent assault. Criminal penalties are becoming increasingly severe.

Although GHB has been available for years, only recently have there been reports of its use in date rape. There has been one well publicized case in Los Angeles associating GHB with date rape. From the time of that report, the media have labeled GHB as a “date rape drug” attributing qualities to GHB that are fictitious. Specifically, the media has reported that not only can a victim be rendered unconscious for the purposes of rape, but that the victim can suffer amnesia leaving no trace of memory of their attacker or the circumstances leading up to the attack. This is an extensive distortion of the facts. These reports may have been designed specifically to further a campaign of misinformation about GHB, sparked by the success of sensational stories about Rohypnol’s use as a date-rape drug. Every story associating GHB with date rape cites law enforcement agencies as the source of information.

I have no intent to conceal or distort facts related to the subject of date rape, nor to downplay the seriousness of such an assault. I think that everybody can agree that there appears to be no shortage of unscrupulous individuals with a deficit of respect for the rights of others. I do believe that it is possible that GHB could be used for purposes of date rape. GHB and alcohol have similar pharmacological properties regarding 1) induction of relaxation, 2) increasing feelings of physical well-being, and 3) lowering of psychological inhibitions. Beyond that, there are major differences. While alcohol frequently produces irritability, hostility and aggressiveness, GHB universally makes people passive, sociable and gregarious. The passivity quality of GHB intoxication is not conducive to deliberate interpersonal violence.

The lack of aggressiveness with GHB results from a key difference between the way GHB is metabolized compared to the way that alcohol is metabolized. Alcohol is metabolized into acetaldehyde, a nerve irritant which is chemically related to embalming fluid and which is 30 times more toxic than alcohol. GHB’s metabolites are completely non-toxic.

Despite GHB’s biochemical inadequacies as a date-rape drug, there may be some potential risk in this regard that should be considered. The problem is that we have no reliable information about it. We have only inflammatory accusations associated with an overtly biased policy of misinformation. I fear that misinformation is a bad foundation on which to construct public policy.

What should be done about GHB now? Without any specific facts, I can only suggest that GHB be compared to 1) alcohol (which is currently unrestricted to adults) and 2) Rohypnol (a drug with serious date-rape abuse potential which has recently been classified as schedule IV within California). The choice would appear to be between 1) preemptive intervention (schedule V, or IV at most) and 2) leaving GHB as an over-the-counter substance until good information is available. AB6 specifies schedule II, and SB3 and SB54 specify schedule I.

Regardless of GHB’s status, consumer education about date-rape is needed. It is unreasonable to assume that scheduling will eliminate GHB use by criminally inclined individuals any more than Prohibition during the 20s eliminated alcohol’s use for such purposes. It has been argued that exactly the opposite occurs. The largest single advantage of an open market offers may be the extremely low cost and high educational efficacy of product labeling. There are companies that are willing and ready to market high-purity GHB as a dietary supplement with full-disclosure labeling. However, due to fears of FDA retaliation, these companies will not bring GHB back into the over-the-counter market without some explicit political or judicial support at the state or federal level.

Does GHB Interfere with Driving?

In high doses, yes. Like alcohol, GHB lowers muscle tone and slows reaction time. This interferes with coordination and the ability to operate mechanical equipment. Driving under the influence of GHB should be considered of similar risk to driving under the influence of alcohol. It should be (and I believe is) equally criminal within existing law. Dangerous mechanical equipment should not be operated by people under the influence of GHB. The window of this effect is 2-4 hours.

Unlike alcohol, GHB does not leave lingering adverse effects on the brain. While alcohol use causes lingering nervous system impairments (of which hangover is just one), GHB wears off completely. The post-GHB state is characterized by quicker mental abilities, enhanced memory function, faster reaction time, and a lingering feeling of wellbeing.

Low-dose GHB (approximately 100-250 mg) are unlikely to impair driving and may well improve coordination and reaction time. Driving ability, or any physical or mental challenge for that matter, involves a balance between mental alertness and physical relaxation. In other words, tenseness and nervousness can slow reaction time, impair decision making, and decrease performance.

Standard coordination sobriety tests would measure impaired driving skills resulting from GHB intoxication equally well as they measure alcohol intoxication. The alcohol breath test will not work at all with GHB. There may well be a need to make existing methods of assessing GHB levels more accessible to law enforcement personnel who may need to establish forensic standards to quantify GHB intoxication in persons suspected of driving under the influence of GHB. I would predict that a urine test would suffice.

Toxicity

GHB is fundamentally non-toxic.

Unlike alcohol, GHB has no general toxicity or organ toxicity. It is cleanly and quickly metabolized by the liver to carbon dioxide and water. Unlike alcohol, it does not kill brain cells and it does not cause cross-linking damage (an aging effect) to either tissues or skin (i.e., wrinkling). It does not cause cirrhosis of the liver. In 30 years of research, no long-term adverse effect has yet been identified.

These properties make GHB an excellent relaxation and sleep aid for pilots, truck drivers, factory workers and military personnel because of the rapidity at which it is cleared from the system and the complete lack of any lasting pharmacological effects. This can not be said for other sleep-aid drugs which are presently widely prescribed in the US.

What Effects Does GHB Cause?

In low doses (less than a gram), GHB is a mild relaxant. It causes a subtle drop in muscle tone and a a mild relaxation of inhibitions (making people more sociable), very much like drinking a beer or glass of wine. This effect lasts for 1 or 2 hours.

In moderate doses (1-2 grams), GHB causes strong relaxation (mental and physical). This effect happens in 5-10 minutes on an empty stomach and 15-30 minutes on a full stomach (like with alcohol, food dramatically decreases the strength of the effect). GHB slows and deepens respiration (causing no net effect on blood gasses) and it slows heart rate, makes people passive, calm and possibly sleepy). There may be noticeable interference with articulation, motor coordination and balance. At this dose, the effects can last 2-3 hours.

In stronger doses (2-4 grams), interference with motor control and speech is more pronounced. The relaxation effect is quite strong, often causing sleepiness or sleep. The sleep induced by GHB is very deep, making it more difficult than would usually be expected to wake somebody. This state has been inappropriately labeled “coma” by some medical authorities with minimal concern for the popular perception of such an inflammatory term. Comas are technically defined as unarrousability, but the dangerous aspects of coma have to do with hypometabolism (inadequate production of biological energy) that interferes with normal mental function. During GHB-induced sleep, all the normal physiological sleep functions of the brain (stages 1, 2, 3 and 4, and REM) take place in a normal sequence.

The sleep-enhancing properties of GHB are potentially of immense value to society. GHB selectively deepens stage 3 and 4 sleep, which are most frequently impaired in the elderly. This is probably the mechanism by which GHB treats narcolepsy. This may also be the mechanism by which GHB increases growth hormone output (which normally takes place during the deepest stages of sleep).

Not all people fall asleep on GHB. At the 2-4 gram dose range, GHB’s effects last about 3-4 hours.

At high doses (4-8 grams), powerful deep sleep is usually induced within 5-15 minutes on an empty stomach. The effect will sometimes last up to 4 hours.

At extremely high doses (10-30 grams), the deep-sleep effects last for much longer periods. The highest reported GHB dose (termed a “poisoning” by the authors) involved a man who took an estimated 15 tablespoons of GHB! He woke up 24 hours later feeling groggy with a mild headache. He had no lasting effects.

GHB: Is it Lethal?

No. Everybody reported to have been “poisoned” with GHB has “fully recovered,” even the man who took 15 tablespoons (50-75 grams?). There have been no long-term consequences identified in any of these cases despite close observation by attending physicians.

Although it is possible that somebody could ingest the 50-150 grams (2-5 ounces, 5 heaping tablespoons?) that might be expected to be life threatening, it is exceedingly difficult to do so. In high doses, GHB causes nausea and vomiting, which strongly limits the maximum amount that a person can consume. It is possible that a dedicated person wishing to commit suicide might be able to take a sleep-inducing dose of GHB and then, just before falling asleep, gulp down a huge amount of GHB, but this is not something which can be done accidentally. The sodium content alone (NaGHB is 17% sodium by weight) is enough to make somebody gag. It is the equivalent of trying to swallow 2 heaping tablespoons of pure table salt.

Can GHB Contribute to Death by Other Causes?

We don’t know. It is possible. But there is no supporting data with which to answer this question definitively.

Like alcohol, GHB is contraindicated with CNS depressants. GHB should not be taken with alcohol, tranquilizers (benzodiazepines), sedatives (barbituates), or opiates (morphine, heroin, etc.). While GHB does not seriously suppress respiration by itself, CNS depressants do. Although it has not been measured, it is possible that GHB increases that respiratory suppression when combined with these drugs.

Interestingly, GHB is being used clinically to treat drug addiction and drug withdrawal symptoms for CNS depressants and opiates. It is reported to be outstandingly effective for this use.

Patent Status

GHB cannot be patented. It is a generic substance, naturally occurring in both plant and animal species, and is therefore ineligible for chemical patent. Novel uses for GHB can be patented with use patents, however, these are difficult to defend, they do not protect against other, competing uses, and they have minimal market value. Use patents are considered fundamentally worthless by venture capitalists.

The lack of patentability means that no one owns marketing rights to GHB. There is no one who has a vested interest in defending the “good name” of GHB against prejudicial comments by budget-mongering governmental agents or unscrupulous media reporters. This accounts for a large part of the significant discrepancy between the scientific facts and media “factoids” about GHB.

The pervasive consequences of GHB’s lack of ownership is best illustrated by comparison to a product that is patented, trademarked or owned. If false or misleading information is presented to the public about Tylenol, for example, McNeil Pharmaceuticals must be reckoned with. Allegations of death from Tylenol in the cyanide-tampering incident would directly damage the good reputation of the McNeil name and the market value of the Tylenol brand name. Any media or government representative would be directly liable for such comments. At the very least, a demand for public apology would be necessary. No such damage, liability or apology is at issue with a generic substance like GHB. There is no owner to be damaged. There is no legal consequence to the person providing false information in a public forum.

Media Misrepresentations About GHB

There was a widespread media report in the fall of 1993, which was unsupported by the subsequent coroner’s report, that GHB played a role in the death of actor River Phoenix. At that time, Newsweek reported that GHB was “an obscure and dangerous steroid substitute”. In fact, GHB is not a steroid, it does not act like a steroid, nor can it in any way be considered steroid like. GHB is a carbohydrate, an entirely different category of chemical than steroids. The Newsweek report remains uncorrected. There was no “owner” to complain to Newsweek, there were no liabilities to consider, and letters to the Editor went unanswered.

Thereafter, media references to GHB became increasingly laced with sensationalism and relied less and less on fact. In the last year, the terminology applied to GHB has become malignant. It is at best misleading, but more often completely erroneous. Peter Jenning’s of NBC Nightly News ended a recent and very positive report on some of GHB’s medical uses with the statement, “It is important to understand that GHB may cause brain damage.” There is no basis for this statement whatsoever. In more than 30 years of research, there are no reports of GHB-caused brain damage. None.

Sadly, this incident is not an isolated occurrence. There are many more examples. News programs and articles have labeled GHB as: 1) a “party drug,” 2) a “new synthetic weight loss drug,” 3) a “night club sex drug,” 4) a “new designer drug,” 5) a “lethal drug,” 6) a “dangerous synthetic steroid drug,” 6) a “Killer aphrodisiac”, and the list goes on.

The exaggeration of danger by media and governmental agencies has become endemic to our society. If we compare the media on GHB with that of acetaminophen (generic Tylenol), we see severe contrasts. According to data from poison control centers around the country, there were 102,619 adverse effects reported from use of acetaminophen in 1994. The September 1995 issue of American Journal of Emergency Medicine reported 309 deaths attributed to acetaminophen from just 42 US metropolitan areas.

The reason there are no headlines about Tylenol-induced deaths is that Tylenol is a major advertiser. Media has a direct vested interest in seeing that this information is maintained in proper context and is therefore minimally reported. Whatever we might think about the need for more widespread consumer education about the liver toxicity of acetaminophen, the number of deaths is quite small compared to the use. The standard of liability””can a reasonable person use the drug safely as labeled””is a sound basis for public policy. One cannot ignore the costs and focus solely on the benefits, just as one cannot ignore the benefits and focus only on the costs.

The bias towards GHB is obvious. Have there been any headlines: “Tylenol””Unsuspected Killer” or “Pain Killer Kills More than Just Pain.” Media hype about Tylenol is expensive in more than one way. Media hype about GHB is free.

Professional Misrepresentations About GHB

Is the media the source of all this hype? No. Governmental agents are.

The reports on GHB and River Phoenix were supposedly started by a club-goer “friend” of River Phoenix. But the media sources were informed of this “fact” by DEA agent(s). These agents also informed the Los Angeles media that GHB stood for a LA designer street drug called “Great Bodily Harm” or “Grievous Bodily Harm.” Without confirmation, the media lapped it up and ran stories about River Phoenix, Great Bodily Harm, and countless other DEA-fabricated factoids. Apparently, the reporters did not realize they were being had. The acronym GHB does not match Great Bodily Harm (GBH).

In his investigations of the reported GHB-induced deaths of teenagers across the country, Dr. Ward Dean has discovered that “helpful” DEA and FDA agents have been working behind the scenes to bring local police and coroners up to speed on the dangers and lethality of GHB. This assistance is the basis of the autopsy reports declaring GHB to be the cause of death. Review of these cases reveals that GHB was not the cause of death, and, at most, it might have played a contributory role to other causes which, instead of being cited as the real primary cause of death, were not even mentioned as contributing causes. Instead of being impartial, scientifically based findings, these autopsy findings have become scientifically suborned by DEA and FDA misinformation. These coroners have also been had by the DEA and FDA.

GHB is known to have a high level of safety. Information is available from research studies, reference texts, scientists and clinicians to establish these facts. The fact that DEA and FDA agents are stating otherwise does not require that we re-examine the validity of scientific methodology. It demands that we examine the political motivations of the DEA and FDA. There are a growing number of experts who can set the record straight on GHB. Legislators are encouraged to review the primary literature and invite these experts to testify.

The same DEA and FDA personnel who are so helpful to local coroners are also equally helpful to local police, paramedics, and health practitioners who may be exposed to GHB for the first time. Often, these personnel are so busy that they do not question the information they are given. They act on the the information, and perpetuate it without question.

Fortunately, in our modern age, information is becoming increasingly more accessible through enhancements in telecommunications and computer technology. Many police departments have begun reaching out through the Internet to access alternative sources of information which are less “provincial” than traditional “in house” channels. Not all law enforcement personnel have bought into the DEA/FDA story on GHB. I have been asked to provide information about GHB by several police departments. In my opinion, these departments are primarily concerned about delivering quality community services to the young adults of their community who are misusing GHB as a party drug””an admirable goal which I fully support. Unfortunately, there does not appear to be equal concern for other members of the community who are behaving responsibly towards GHB. In fact, only two police department personnel who talked to me were even aware that GHB was being used by more than just teenagers, that it is being used non-party (medical and health) purposes, and that it has been used for years before there was a “GHB problem” that needed addressing.

Alternatives to Prohibition

If there is any lesson of which US legislators should be aware, it is that prohibition (criminalization) is a dysfunctional method of dealing with self-inflicted harm caused by the behavioral problems of its citizens. This has been attempted with the prohibition of alcohol in the 20s and other recreational drugs later, with less than satisfactory results. One can argue that such prohibition experiments have weakened the effectiveness of law for the victims of violent crimes, and provided a powerful source of corruption to undermine law enforcement agencies from within. The secondary social costs of prohibition are far from trivial, and they should be carefully considered.

A major social cost of prohibition is product quality. With alcohol prohibition in the 20s, consumers got wood-alcohol contaminated liquor. This problem completely disappeared when prohibition of alcohol was repealed.

In the case of GHB, the FDA’s campaign to imprison GHB manufacturers and distributors has resulted in the emergence of home-brew GHB which, depending on the starting materials and recipe, may be contaminated with butyrolactone, toxic solvents, heavy metals, and polyester derivatives. This contamination is not a natural product of the GHB marketplace, it is an artifact of prohibition. Nobody knows for sure to what extent these contaminants are causing problems in GHB consumers, however, I have received reports from people who have been using pure GHB for years without incident who have had serious reactions from home-brew “street” GHB. It is my opinion that this is a much more serious problem than anybody is acknowledging, and that a large percentage of adverse reactions to GHB that have appeared in the media are reactions to contaminants, not GHB.

I am convinced that the contamination problems would immediately disappear if the legal status of GHB as an over-the-counter nutrient were reaffirmed. Despite the Dietary Supplement Health & Education Act’s removal of arbitrary FDA powers to reclassify nutrients as drugs whenever they felt like it, the campaign to discredit and illegalize GHB has not stopped. Far from it. It has shifted into an alliance with the DEA and local police to vilify and criminalize GHB on a state-by-state and community-by-community basis.

Prohibition vs Education

One of the social costs of prohibition is ignorance. When commercial sales of a product are shut down by prohibition, legitimate avenues of consumer (citizen) education through labeling and advertisement are closed. Home-brew GHB rarely comes with adequate labeling. In fact, the most common form of street GHB is a liquid solution, which it is often inaccurate as to potency. It would seem that kitchen chemists are rather more careless about such matters than dietary supplement manufacturers.

There is a pressing need for truthful, non-misleading, and comprehensive information about GHB. Unlike many nutrients, subtle variations in GHB dosage can have a large impact on the effect obtained””depending on the specific GHB application. Also, GHB has known synergy with other CNS depressants. While this information can be effectively communicated by labeling or prescription, the combination of GHB and alcohol is especially difficult to put into practice. GHB and alcohol serve many similar social functions””to put inhibited people at ease, to lower interpersonal barriers to communication, to relax tension, etc. When GHB and alcohol are both present, people have an added burden of having to think about what they are drinking, where they would normally not bother.

In the club scene, alcohol is the drug of choice. In fact, it is part of the economic structure of the club as a business. Most clubs express this economic relationship by imposing drink minimums for their clientele. While non-alcoholic beverages are available, there is a certain social stigma against ordering a virgin drink or non-alcoholic beer which may be sufficient to influence those persons with a lack of self confidence or assertiveness to order alcohol after consuming GHB. Many experienced GHB users can do this with little difficulty, because they know their individual tolerance from experience. To somebody without GHB experience and/or alcohol experience, the simultaneous use of GHB and alcohol may seem much too easy and they get into trouble, especially when the experienced GHB user incorrectly assumes that their experience with GHB will apply to others, or is deliberately playing control games with the initiate.

These same problems exist for alcohol. Teenagers taking on alcohol for the first time have to learn limits. Some teenagers blow it, seriously. If they are lucky, they may just spend time hunched over a toilet throwing up. Since most adults have been through this process, nobody gets alarmed at the sight of a teenage relative throwing up after drinking too much. With GHB, however, the situation is different. Most adults are not familiar with the effects of GHB. While adults are willing to let passed-out teenagers “sleep it off” where alcohol is concerned, they are not where GHB is concerned. Due to unfamiliarity with the process, adults panic when they come across passed-out teenagers where there are no signs of alcohol having been consumed. This often results in an quick trip to the emergency room””a highly expensive trip in most situations.

Alcohol-induced sleep and GHB-induced sleep are quite different. While one might think that alcohol-intoxicated people are sleeping when passed out, they really are not. Unlike GHB, alcohol strongly interferes with the brain functions that take place during sleep. With GHB, the natural sleep process are strongly enhanced. So GHB-intoxicated people really are sleeping when they are passed out. However, this sleep can be so deep as to render the person difficult to awake. With heavy doses, even repeated sharp slaps to the face may not arouse them. This can be terribly unnerving to parents who do not know that their kids are experimenting with GHB, or to emergency medical personnel who are unfamiliar with GHB.

Despite the unfamiliar nature of GHB intoxication, people invariably recover fully. Unlike with alcohol, with GHB there is no hangover, CNS irritation, blood-shot eyes, burst capillaries, or sensitivity to light or sounds. When the GHB wears off, people generally feel quite wonderful. This is not too unexpected. Sleep is a remarkable restorative even when normal. When sleep is enhanced, it can be positively energizing. The post-GHB state is typically characterized as above average in alertness, energy, motivation and mood.

Regardless of the moral and ethical judgments we may make about the private behaviors of other citizens, we must recognize that prohibition has not been successful””rather the opposite. Even in the case of suicide, where one must acknowledge the irrevocable and self-destructive nature of the act, prohibition is at best a marginally effective preventive strategy.

The Ethical Compulsion to Protect

In most people 2-4 grams is sufficient to induce a deep GHB sleep. Narcoleptics regularly use 4-8 grams to enhance their sleep, but doses exceeding 8-16 grams can be used on a regular basis without adverse effects. Of the many reported cases of extremely high GHB intake, all have recovered fully. In one case, a man consumed an estimated 15 tablespoons of GHB! He slept for 24 hours and woke up with a mild headache and grogginess, which wore off completely.

All of these documented cases of GHB “poisonings” (as some scientists call them) have resulted in full and complete recovery of the “victims.” How do we then justify prohibition based on harm to the user?

We must also take into account the undocumented reports of GHB-related deaths that are being sensationalized in the media. Are they really due to GHB? Dr. Ward Dean and I have attempted to critically investigate these cases with some degree of scientific methodology. To the extent that we have not been blocked, we have found that none of them can be attributed to any purported toxic effect of GHB.

If there is no physical damage to justify prohibition, is there any moral or spiritual damage of consequence?

Does it Matter that GHB is not FDA Approved as a Drug?

Although the FDA has yet to approve GHB for any medical use (IND applications are pending), this does not indicate that GHB lacks medical value or will not enhance public health. Every substance which is now FDA approved was once not approved, yet the its medical value was the same before as after. The difference between pre-approval and post-approval is in the knowledge in our minds, not in the substance.

There is a strong provincial attitude in the United States to discount the uses that other countries and cultures put to a substance. This is not rational or scientifically valid, but it is a common prejudice. US authorities pander to this prejudice when they declare that, “There are no legitimate uses for GHB” [Keith Kamita, Narcotics Enforcement Administrator, as quoted in West Hawaii Today, February 11, 1997]. This is absurd. Similar statements have been made before the California Legislature [the Assembly Committee on Public Safety].

The situation is much worse than provincialism. It is also elitist. The authorities also base their groundless opinion about GHB’s illegitimacy on ignorance of the clinical uses to which GHB is being applied by alternative and complementary medical doctors (who just happen to be unconnected to the major (i.e., federally funded) research institutions that also know nothing about the medical applications of GHB).

Fortunately, such provincial and elitist attitudes are changing under the onslaught of informed consumer demand. There is no reason that consumers cannot become as educated about GHB as they are about alcohol, vitamins, diet or exercise.

A growing number of physicians in the US and around the world are now prescribing GHB to patients for a number of purposes. These include therapy for alcoholism and drug addiction, treatment of depression and anxiety, stress management, sleep enhancement, growth hormone enhancement, sexual dysfunctions, autoimmune diseases, trauma medicine, and much more. These are not rare conditions. They are serious issues that affect a major portion of our population. Why would we prohibit something of such positive potential without a clear and present danger?

There is no clear and present danger. GHB’s safety is universally acknowledged by scientists. In a 1992 report, Ming-Yan Chin and Richard A. Kreutzer, MD., (both staff members of the California Department of Health Services) wrote, “there are no documented reports of long term [detrimental] effects. Nor is there any evidence of physiologic addiction.” Despite Chin and Kreutzer’s observations, physiological addiction to GHB is possible. There are some unusual circumstances that put some individuals at risk when high doses of GHB are consumed quite frequently (8-12 times a day). But this is a highly unusual circumstance that involves only a tiny portion of the population. It is infinitely rarer than addiction to alcohol.

The long-term safety of GHB has been verified in narcolepsy studies. Very high doses of GHB have been used for very long periods of time in multiple studies, and “No investigator reported any long-term adverse effects, addictive or dependent qualities associated with the drug.” Chin and Kreutzer add, “Researchers working with narcoleptics consider GHB a relatively harmless and effective drug.”

When evaluating a drug for approval for medical use, the FDA is supposed to employ a risk/benefit ratio to determine whether a drug is safe enough for consumption by the general public. Most drugs, even the majority of over-the-counter (OTC) drugs have significant side effects. The task of the FDA is to determine whether the benefits offered by a substance are sufficient to offset the risks that may be involved with its use. For example, it is a fairly well known fact that aspirin, ibuprofen and Tylenol pose some health risks for a number of people. Consider the following statistics: According to the 1994 data collected from poison control centers around the country the number of adverse effects per year for Ibuprofen: 35,703, Aspirin: 19,796, Acetaminophen (Tylenol): 102,619. Government data reports of deaths per year from 42 metropolitan areas for aspirin: 80 deaths, and acetaminophen (Tylenol): 309 deaths. Nationwide numbers are higher. As of 1990, “only 46 adverse reactions to GHB had been reported to the CDC””surely constituting only a infinitesimal fraction of actual usage””all followed by rapid and complete recovery.” [Chin, 1992]. In addition, we need to note that most of these adverse reactions were merely deep sleep, which prompted concerned relatives to admit victims to emergency room facilities. The deep sleep is misleadingly termed “coma” by scientists due to some superficial similarities between these conditions. Likewise, the muscle relaxation induced by GHB can cause muscle twitching, which is called “seizures.”

The high numbers of problems and deaths from common medications sheds light upon the facts that are important to consider when evaluating the value or danger of a substance for human consumption. The benefits from aspirin, ibuprofen, and acetaminophen are high enough that the number of complications and deaths from their use have been considered too insignificant to remove them from the marketplace. When GHB is measured up against some very basic OTC medications in terms of a risk/benefit ratio, GHB is far safer and of greater benefit than many common medicines.

More than thirty years of scientific research into the effects of GHB clearly contraindicates GHB’s media image as a menacing poison. Prior to the cases of high dose levels taken in 1989 without proper knowledge, GHB’s safety was largely taken for granted in scientific literature and was available for sale to the public. A 1964 report lists “very low toxicity” as one of the “principle elements” of GHB’s pharmacology [Laborit, 1964]. A 1969 summary of its anesthetic uses called GHB “a truly non toxic hypnotic,” repeatedly emphasized its “lack of toxicity,” and cited evidence that it demonstrates “no toxic effects on the liver and kidney” [Vickers 1969]. In describing the way GHB is metabolized, a 1972 paper mentions “the absence of any need of detoxification by the organism” [Laborit, 1972].

The LD50 (lethal dose for 50% mortality) is a way of quantifying the toxicity of a substance. The LD50 for GHB in rats has been calculated at 1.7 grams per kilogram of body weight [Laborit, 1964]. Some have questioned whether the animal deaths that occur at these dosage levels are due to the activity of GHB or to the sodium toxicity that accompanies the use of salt form of GHB [Vickers, 1969]. Extrapolating from these data, the LD50 for humans would be around 115 grams (over a quarter-pound of dry GHB). While there are severe inaccuracies in extrapolating from rats to humans, one can appreciate the magnitude of GHB’s relative safety. Few vitamins can match this level of safety.

The benefits of GHB are significant enough that Dr. Martin Scharf, head of the Tri-State Sleep Disorder Center of Cincinnati, Ohio recently reported on NBC Nightly News that millions of people may potentially benefit from use of GHB. Dr. Scharf’s experience with GHB is extensive. He is a valuable source of solid information, especially regarding GHB’s treatment of sleep disorders.

As far as side effects from GHB’s use, some research programs have reported “no side effects at all”. This statement, however, needs to be understood in context. It is important to understand that if a physician prescribes GHB as a sleep aid, then drowsiness is not considered a side effect, but rather the desired effect. For clarity, we can list the “possibly undesirable effects” of GHB as: drowsiness (common), slurred speech (common, dose related), uncoordination (common, dose related), dizziness (common at high doses), nausea (at high doses, it can lead to vomiting), headache (somewhat uncommon), sleepwalking (uncommon), bed wetting (uncommon), and diarrhea (uncommon). Although some of these symptoms are disturbing, they pose little danger or risk.

Much of the inflammatory nature of descriptions of GHB may stem from the relative unfamiliarity that most physicians have with its properties. Perhaps a short information video tape provided to emergency rooms around the country would reduce this problem.

In 1991, the two scientists from the California Department of Health Services, Chin and Kreutzer, wrote a report on ten “poisonings” associated with GHB. Of the ten “poisonings” reported, four involved “unknown doses, ” four featured the “co-ingestion” of other drugs, (usually alcohol), one involved unmedicated epilepsy, and another a history of grand mal seizures. Chin and Kreutzer stated that the “more severe reactions…generally occurred when patients took an unmeasured dose, a particularly large dose, or several doses within a short period of time.” Such problems are easily avoided by following proper directions for GHB’s use.

In Section 3 of AB6, we read “There have been reports that gamma-hydroxybutyrate has caused ailments ranging from nausea and respiratory problems, to seizures and comas, and according to health care practitioners, the drug is very easy to overdose on and has a potential for causing death.” The “nausea” problems are minor and dose related. The “respiratory problems” are undocumented. GHB does decrease the rate of respiration, but it also deepens respiration at the same time. There is no net effect on blood gasses as measured by scientists. “Seizures” is another name for myoclonus or muscle twitching. It is seriously misleading and highly prejudicial to call these muscle twitches seizures. There is none of the potential brain damage that can be caused by epilepsy. “Comas” refers to really deep sleep. It is highly misleading to call GHB-induced sleep a coma. One might just as well state that narcoleptics benefit from nightly drug-induced comas, but that would also be misleading. The comas that follow serious accidents and head traumas are not characterized by normal sleep patterns and EEGs. GHB-induced sleep is characterized by normal (but deeper) sleep patterns and EEGs. The use of “coma” is deliberately inflammatory and decidedly misleading.

The statement that GHB “is very easy to overdose on” and has the “potential for causing death” is also inflammatory. Salt is very easy to overdose and has the potential to cause death. But is this of any significance to protecting the public health and welfare? It is true that GHB has a steeper dose-response curve than alcohol. Therefore,if one is looking for a specific effect at a specific dose, then overdosage is easy. But the consequences of overdosage is merely deep sleep. There is no long-term harm done, other than the loss of a few hours of time. The pejorative connotations of “overdosage,” namely toxicity and long-term damage, does not easily happen with GHB. It is possible that a dedicated and motivated person can consume 50-75 grams of GHB in one sitting, but it is not easy to do. It is like trying to put down 25-50 grams of salt. It is not possible that somebody could do this by accident.

The death issue is also inflammatory. The stories of GHB-induced deaths are anecdotal, unconfirmed and problematic. Controlled attempts to produce such effects in animals have failed. There is no evidence to establish any “reasonable basis” for GHB having contributed to the alleged deaths. There is only speculation. And speculation, in the absence of data, is worth what we pay for it.

The attribution to “health care professionals” must be examined. To whom is it referring? According to the health care professionals who use GHB, it is quite difficult to overdose on GHB and there is no potential for causing death in their patients. These health care professionals provide detailed instructions to their patients as to what to expect from GHB, how to explore their individual sensitivity to GHB with a series of escalating doses, and which activities should be avoided and which drugs should not be taken at the same time as GHB.

While these health-care experts are not at all concerned about GHB toxicity within their practices, they are concerned about 1) how the current politicization of the GHB issue might adversely affect their practice and medical license, and 2) the potential health problems that their patients might suffer with the use of street GHB of unknown quality. It is important to recognize that these concerns are not inherent in GHB. These concerns have arisen from the politically motivated actions of Federal regulatory agencies towards GHB.

Companies which have a strong interest in marketing high-quality GHB as an over-the-counter nutrient are fearful of FDA retaliation were they to market GHB. Despite the legality of marketing GHB, they realize that the FDA has a vast vested interest in keeping GHB out of the over-the-counter market. While some of these companies are willing to take on the challenge of the media misrepresentations about GHB, none are willing to put their businesses (and clients) at risk with the FDA. Although the FDA repeatedly denies that retaliation is part of their modus operandi, instances of egregious retaliation have been exposed by Congressional investigations. However, most representatives of companies under FDA regulatory jurisdiction will only discuss the matter off the record.

Social Implications for an Aging Population

In the recent NBC Nightly News report on GHB, Eve Van Cauter, Ph.D., of the Department of Medicine of the University of Chicago reported that at the age of 25, the average amount of deep slow wave sleep a person receives each night is 90 minutes. When a person reaches age 40, this time decreases to 30 minutes; and by the age of 60, the slow wave sleep each night may only be 5 minutes. It is the slow wave or deep sleep which provides the body with profound rest and it is during this period the body produces many of its hormones (i.e., growth hormone). Ms. Van Cauter stated that use of GHB as a sleep aid significantly increases the amount of slow wave sleep each night which provides the beneficial result of allowing the body more time to restore itself. This aspect of GHB’s function implies possible anti-aging and immune system stimulation and calls for further research to determine whether this is the case. Many physicians are already calling GHB a potent “youthifier.”

On a recent Hard Copy, young men falling asleep on the sidewalk outside a nightclub were presented. The nodding heads and strain to keep the eyes open were quite typical of GHB’s sleep inducing action when taken in larger amounts. For someone unfamiliar with GHB, these pictures might be a source of serious concern. But for someone familiar with GHB and the plight of millions of people who suffer from insomnia or other insidious sleep disturbances, this could be a blessing. The fact that a few people are testing their GHB limits in a public setting, however inappropriate, should not be used to replicate their carelessness by passing a law that will adversely affect thousands more people than will hopefully be protected. Increasing numbers of physicians are coming to consider GHB as the best aid for sleep available. Let’s not throw the baby out with the bath water.

Anti-Hypoxia

At very high doses of GHB, some cardiac and respiratory depression can occur. This leaves the question as to why people have not died who were found with such low rates of respiration that some rescue workers have referred to the patient as “clinically dead” (although they may have been unqualified to make this determination). The answer may be the quick, efficient and effective work of paramedics. However, given the widespread recreational use of combining alcohol with GHB, the answer is more likely because GHB may protect the brain and heart during conditions which depress vital functions and oxygen availability. In animal studies, GHB has extended survival time under conditions of low oxygen supply (hypoxia) up to eighty-five percent [Artru, 1980], and has increased the survival time of the mouse heart when completely deprived of oxygen (anoxia) [Vickers, 1969]. Unlike all other known anesthetics, GHB does not result in an overall decrease in oxygen consumption by the body [Laborit, 1964]. GHB also protects against various kinds of arrhythmia (irregularity of heartbeat) that can be induced in animals [Vickers, 1969; Laborit, 1964]. It is also suspected that GHB possesses a protective function which involves a reduced oxygen and glucose requirement for the brain cells. [Chin and Kreutzer, 1992; Artru, 1980] This is one of the reasons GHB is considered quite safe and may perhaps be ideal as an anesthetic for childbirth. GHB is considered protective not only for the birthing mother, but also for the newborn infant.

GHB has gained some popularity as an obstetric anesthetic in Italy and France [Vickers, 1969]. It has been attributed with “spectacular action on the dilation of the cervix” [Laborit, 1964]. Other attributes of GHB that can be valuable in childbirth include decreased anxiety, greater intensity and frequency of uterine contractions, increased sensitivity to oxytocic drugs (used to induce contractions), preservation of reflexes, a lack of respiratory depression in the fetus, and protection against cardiac anoxia (which could be especially important when the fetus’s oxygen supply is threatened by wrapping of the umbilical cord around the neck) [Vickers, 1969; Laborit, 1964].

Alcoholism and Withdrawal

GHB shows great promise in the treatment of alcoholism. In Europe, one of its primary uses is to relieve withdrawal symptoms, cravings, and anxiety among alcoholics. A 1989 study was conducted with alcoholics according to a methodologically rigorous, double-blind, placebo-controlled format. The treatment was considered very successful. After the first administration of GHB, “nearly all withdrawal symptoms disappeared within two to seven hours….” The subjects in this study were given steadily decreasing doses of GHB for seven days. During this period, the intensity of withdrawal syndrome, measured on a scale of 0 to 3, remained below 2, the rating designated for “moderate.” Minimal side effects were observed. The researchers concluded, “the results clearly indicated that GHB is effective for the suppression of withdrawal symptoms in alcoholics” [Gallimberti, 1989].

Depression

Regarding the effect of increased levels of happiness, some US psychiatrists now prescribe GHB as an anti-depressant agent used during the day in several small doses. The reports have been noteworthy. Several report increased levels of happiness are sustained even when the person no longer has GHB in their system. Claude Rifat, a French biologist, reported, “GHB may be the first authentic anti-depressant. GHB suppresses depressed ideation with amazing rapidity….. (GHB) strongly stimulates the desire to be and remain alive despite unfavorable circumstances. Despair disappears, replaced by a feeling that life is worth living. GHB can suppress depression within hours. No conventional so called anti-depressant does that. Conventional antidepressants can takes weeks or months to alleviate suffering. GHB treatment is also very short; less than a month of treatment is usually effective, as opposed to months or years with other treatments.” Increased levels of happiness may also be the result of the extended periods of deeper sleep and a more rested body.

Mental Enhancement

Mental clarity, perception and judgment all appear to improve with low dose use. Rapid eye movement sleep and protein synthesis ”” processes which may be linked, and both of which are facilitated by GHB””have been correlated with periods of intensive learning [Laborit, 1972]. GHB has also been shown to stimulate the release of acetylcholine, one of the brain’s own intelligence and alertness boosting chemicals [Gallimberti, 1989]. Preliminary testing suggest improved reaction times and perceptual and cognitive reflexes with low dose use of GHB. These findings of increased alertness are surprising to those accustomed to expecting GHB to act solely as a sedative. Perhaps the answer lies in the fact that nature designed this molecule.

GHB Availability

GHB is now available through any local pharmacy in the United States. It has been sold in the United States for decades. Some time during the 80s, GHB entered the over-the-counter supplement market. In 1990, the FDA issued a press release which declared GHB to be an “unapproved new drug.” Retail sales ended and non-prescription GHB was driven into the underground. Medical demand was met by compounding pharmacies. Recently, it has become available by prescription through regular pharmacies as well. The FDA is aware of GHB’s distribution through pharmacies and has not interfered in any way.

After the FDA’s precipitous actions against GHB in 1990, GHB consumers began to look for other sources of GHB. While a significant number of people chose to import European GHB through the FDA’s 1988 personal-use importation policy, high costs have driven many consumers to buy GHB on the street or make their own GHB at home. The chemical process for making GHB is quite simple (using only butyrolactone, hydroxide and water) and uses a minimum of equipment (I can do it with a Pyrex bowl, pH papers, a hot plate and a microwave oven).

Butyrolactone is a bulk chemical used as a solvent and chemical intermediate. Hydroxide exists in many forms: sodium hydroxide (used in drain cleaners), potassium hydroxide (a chemical reagent and hydroponics pH balancer), magnesium hydroxide (milk of magnesia) or calcium hydroxide (slaked lime). [Actually, carbonates (laundry detergent and baking soda) are sufficiently alkaline to hydrolyze butyrolactone into GHB]. Needless to say, control of these chemicals would be problematic.

While this synthesis is exceedingly simple, even by the standards of first-year organic chemistry students, there may be problems when it is attempted by inexperienced consumers. If directions are ignored, low-quality ingredients are substituted for pure starting materials, the reaction is not evaporated to dryness, or flammable solvents are used, there may be problems. There could be fire risks, or there could be various impurities that might pose significant toxicity to consumers. Many consumers purchase home-brew GHB from their friends or from strangers. Much of this GHB is sold in a liquid form that may or may not have been evaporated to dryness before being sold. Consumers do not know how it was made, nor do they have any real assurances of the quality of the product. It is even possible that careless individuals are using industrial-grade engine degreasing solvents to make GHB. I fear for the spectrum of contaminants that might be present in such material.

Consumer Protection and Public Welfare

Detective Trinka Porrata testified before the Assembly Committee on Public Health that street GHB samples had been widely tested by the Los Angeles Police Department. Perhaps the results of these tests should be made available to committee members to assess the public health dangers of continued de facto prohibition of this legal nutrient by policymakers and agents of the FDA. I have no doubt that were there to be conspicuous official acknowledgment of GHB’s legal status as a dietary supplement, that reputable manufacturers would quickly enter the market and eliminate the demand for GHB of unknown quality””and provide much needed educational outreach to interested consumers.

Conclusion

Consumer protection and public health would be better served by formally acknowledging the legal status of GHB and encouraging it to be manufactured and distributed by reputable vendors who can compete on the basis of product quality and extensive labeling. The poor quality of street GHB and the paucity of accurate consumer information about GHB are the biggest long-term contributors to public health risk.

The GHB “crisis” has been manufactured by the FDA, aided and abetted by the DEA, compounded by local police, inflamed by the media, and perpetuated by ignorance. We do not need to have this become a permanent part of our culture as law. We do not need to disenfranchise patients, impair the practice of medicine, and drive citizens to obtain their food supplements in the drug underground. The public welfare will be best served by treating the public as responsible citizens with the capacity to guide their own nutrition decisions””in consultation with their chosen health-care professionals.

 

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GHB Report to the California Legislature by Steven Wm. Fowkes What is GHB? GHB (gamma-hydroxybutyric acid) is a natural metabolite of human metabolism. It is a carbohydrate, found extensively throughout the human diet (all animal-flesh foods contain GHB). GHB is biologically synthesized from gamma-aminobutyric acid (GABA), a structurally similar amino acid that is also widespread…
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