With considerable pressure building to criminalize GHB in many states, CERI Executive Director, Steven Wm. Fowkes recently testified before a California State Legislature committee considering such a law. Steve, who is one of the most knowledgeable and respected people in the country on the subject of GHB (among other health-related topics), presented a powerful and persuasive case for keeping GHB legal and available.
Unfortunately, posturing politicians who have jumped aboard the "drug war" bandwagon usually have little regard for actual facts when there is news to be made and votes to be won. Equally unfortunate is the fact that virtually the only voices being heard publicly on the subject of GHB these days are those of law enforcement officers, FDA officials, DEA agents, and physician "experts" who know absolutely nothing of the 30+ years of research and clinical experience with GHB that demonstrate its extraordinary safety and utility for a wide variety of purposes.
A key example of their ignorance is that they actually believe GHB is a newly synthesized "designer drug" rather than a naturally occurring nutrient. We take our hats off to Steve and commend him for his courage in publicly speaking the truth on this controversial subject. The following FAQ (Frequently Asked Questions) is adapted from his testimony. We encourage you to read it and use the facts it contains to lobby your state representatives and to help dispel the myths currently being spread by those who have no regard for the truth about GHB.
What is GHB?
GHB (gamma-hydroxybutyrate) is a natural product of human metabolism. It is a carbohydrate, found extensively throughout the human diet (all animal-flesh foods contain GHB). GHB is biologically synthesized from the inhibitory neurotransmitter 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. Henri Laborit, a world-famous French researcher and winner of the Lasker Award (the "American Nobel") in 1957. For more than 30 years, GHB has come to be used in Europe for many purposes, including:
- 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 drug abuse (it eases the withdrawal syndrome)
- an anti-anxiety, anti-stress, and anti-depressant agent
In the US, GHB is currently available only by prescription through compounding pharmacies. It has no formal drug status with the FDA, although 15 INDs (investigational new drug applications) are pending.
What effects does GHB cause?
In low doses (<1 gm), GHB is a mild relaxant. It causes a subtle drop in muscle tone and a mild relaxation of inhibitions (making people more sociable), very much like drinking a beer or a glass of wine. This effect lasts for 1 or 2 hours. In moderate doses (1-2 gm), GHB causes strong relaxation (mental and physical). This effect happens in 5 to 10 minutes on an empty stomach and 15 to 30 minutes on a full stomach. GHB slows and deepens respiration (causing no net effect on blood gasses) and it slows heart rate. There may be noticeable interference with articulation, motor coordination and balance. At this dose, the effects can last 2 to 3 hours. In larger doses (2-4 gm), interference with motor control and speech is more pronounced and the relaxation effect is quite strong, often causing sleepiness or sleep.
"Because it works to relieve anxiety and depression so rapidly and is so safe, GHB has been recommended by healthcare professionals as the anti-anxiety/antidepressant agent of choice for potentially suicidal patients."
The sleep induced by GHB is very deep, making it more difficult than usual to wake somebody. This state has been inappropriately labeled "coma" by some medical authorities who have minimal concern for the inflammatory nature of the term in the public's perception. Comas are technically defined as unarousability, 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. Deepening stage 3 and 4 sleep may also be the mechanism by which GHB increases growth hormone output (which normally takes place during the deepest stages of sleep). At the 2-4 gm dose range, GHB's effects last about 3 to 4 hours. At high doses (4-8 gm) and on an empty stomach, extremely deep sleep is usually induced within 5 to 15 minutes. The effect will sometimes last up to 4 hours. At extremely high doses (10-30 gm), the deep-sleep lasts for much longer periods. The highest reported GHB dose (termed a "poisoning" by the authors) involved a man who took an estimated 15 tablespoons (50-75 grams) of GHB! He woke up 24 hours later feeling groggy with a mild headache. He had no lasting effects.
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 (DSH&E) created a new category of "dietary supplement," comprising items 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, as well as extracts, concentrates and metabolites of all of the above.
"Few medicines have as many beneficial actions on the body as GHB for the prevention and treatment of debility and disease. Even fewer have such minimal side effects."
Since GHB is both a nutrient and a metabolite of the amino acid GABA, it meets two separate legal qualifications for status as a dietary supplement. According to the DSH&E, 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 rule-making 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 rule-making procedure. The loss of the FDA's power to declare nutrients to be drugs may be one of the reasons that the agency is trying to influence the courts, the DEA, local coroners, media reporters, and state legislatures to demonize and criminalize GHB.
The FDA's national press release of November 8, 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, charging 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 knowledge that GHB was being studied under FDA-sanctioned INDs. When the existence of these INDs became known to the defendants, the government blocked access to the INDs on the premise that they "contained no relevant information." Many 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 nontoxic and nonaddictive, 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 disbarring Sharon Kerns, the US attorney in charge of GHB investigations and prosecutions.
The government's cases against the GHB defendants are now unraveling at the seams. In hindsight, we can 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 by using government-employee expert witnesses and they withheld evidence by blocking access to the INDs.
What's in the GHB INDs?
There are 15 INDs filed with the FDA for GHB for:
- Improving sleep patterns and maintaining daytime alertness in narcolepsy
- Reducing schizophrenic symptoms
- Stabilizing Parkinson's disease
- Reducing nocturnal myoclonus (painful leg cramps at night)
- Improving memory problems
- Stimulating natural growth hormone release
- Decreasing pain and improving sleep in fibromyalgia patients
- Relieving symptoms associated with Huntington's chorea
- Regulating muscle tone in dystonia musculorum deformans
- Controlling tardive dyskinesia symptoms
- Decreasing drug withdrawal symptoms (alcohol and opiates)
- Decreasing hyperactivity and learning disabilities in children
- Inducing sedation and tranquilization
- Relieving anxiety
- Lowering cholesterol
Because it works to relieve anxiety and depression so rapidly and is so safe, GHB has been recommended by healthcare professionals as the anti-anxiety/antidepressant agent of choice for potentially suicidal patients. The proliferation of GHB INDs establishes clearly that the potential health-enhancing uses of GHB are extensive.
"According to an investigation by Ward Dean, MD., every instance in which GHB has been listed as the cause of death involved some other more likely cause of death."
GHB is being used in other countries for many medical purposes. One use that deserves special mention is as an aid to childbirth in France and Italy. GHB's ability to calm maternal anxiety, protect against hypoxic injury to the baby, and accelerate dilation of the cervix (termed "spectacular" in one report) provides 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 on the body as GHB for the prevention and treatment of debility and disease. Even fewer have such minimal side effects.
The scientific and medical consensus on GHB, established by conscientious laboratory and clinical investigation to be effective in enhancing health and decreasing suffering, can be sensationalized only to a limited degree before all pretense at accuracy and honesty must be abandoned.
What has the news media been reporting about GHB?
Extensive contradictory information on GHB has been presented to the public via the media. A few stories on GHB have actually reported glowingly on the current and potential medical uses and benefits of GHB. These positive reports are based on the work of medical and scientific experts who have researched and tested GHB in clinical settings. Most press reports, however, have treated 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 presumably 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 supposed dangerous, lethal and insidious nature of GHB.
According to an investigation by Ward Dean, MD, who has also testified as an expert witness for the defense in several GHB cases, every instance in which GHB has been listed as the cause of death involved some other more likely cause of death. 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. The evidence that Ms. Farias ever ingested any GHB at all was highly suspect.
After being told that their daughter was poisoned by GHB (based on questionable much-delayed autopsy findings), the family was encouraged to speak out against GHB. When the family later realized that Hillory's death was not due to GHB, but probably to a congenital and hereditary heart condition, 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. Ms. Farias' symptoms and etiology were inconsistent with the effects of GHB. Crucial health history factors were overlooked. The medical examiner did not report that Hillory's death was caused by GHB until a "helpful voice" from the federal government influenced this determination some 6 weeks after the death occurred. This case serves to reveal the urgent need certain government officials seem to have to frighten the public about GHB.
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 a laboratory by drug-company chemists 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.
"The post-GHB state is characterized by keener mental abilities, enhanced memory function, faster reaction time, and a lingering feeling of well-being."
Is GHB a date-rape drug?
Centuries of experience have confirmed that the date-rape drug of choice is alcohol ("candy is dandy, but liquor is quicker"). Current statistics from the U.S. Justice Department confirm that 70% of "acquaintance rape" or "date rape" involves the use of alcohol. Although GHB has been available for decades, 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 her attacker or the circumstances leading up to the attack. This is an extensive distortion of the facts. Every media-hyped story associating GHB with date rape cites law enforcement agencies as the source of information. I do believe that it is possible to use GHB for purposes of date rape. GHB and alcohol have similar pharmacological properties: inducing relaxation, increasing feelings of physical well-being, and lowering psychological inhibitions.
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 alcohol prohibition during the 1920s eliminated alcohol's use for such purposes.
It has been argued that exactly the opposite occurs. The largest single advantage that 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. Driving (or operating any dangerous equipment) under the influence of GHB or any other sleep-inducing substance, including Nyquil® or Benadryl,® should be considered the same risk as driving under the influence of alcohol.
Is GHB toxic?
No. 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 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. 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 keener mental abilities, enhanced memory function, faster reaction time, and a lingering feeling of well-being. 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 cannot be said for other sleep-aid drugs which are presently widely prescribed in the US.
"In my opinion, a large percentage of adverse reactions attributed to GHB by the media are due to contaminants or other substances, not to GHB."
Can GHB be lethal?
Not likely. Everybody reported to have been "poisoned" with GHB has "fully recovered," even a man who took 15 tablespoons (50-75 gm). There have been no long-term consequences identified in any of these cases despite close observation by attending physicians. It is exceedingly difficult to ingest the 50 to 150 gm that might threaten life. In high doses, for example, GHB causes nausea and vomiting, which strongly limits the maximum amount that a person can consume.
Can GHB contribute to death by other causes?
We don't know. It is possible. But there are no supporting data that allow us to answer this question definitively. GHB should not be taken with any substance that acts as a CNS depressant. In other words, it should not be taken with alcohol, tranquilizers (benzodiazepines), sedatives (barbiturates), 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 respiratory suppression when combined with these drugs. Ironically, GHB is being used clinically to treat drug addiction and drug withdrawal symptoms associated with the use of CNS depressants and opiates. It is reported to be outstandingly effective for this use.
What is the cost of prohibition?
If there is any lesson here for US legislators, it is that prohibition (criminalization) is a dysfunctional method of dealing with self-inflicted harm caused by the behavioral problems of the public. This remedy was attempted with the prohibition of alcohol in the 1920s and other recreational drugs later, with less than satisfactory results. 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. Faced with prohibition, distillers turned to poisonous wood alcohol in an effort to circumvent the law. This practice 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-brewed 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 "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 reported by the media are reactions to contaminants or other substances, not to 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.
Another social cost of prohibition is ignorance. 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, as already mentioned, has known synergistic effects when used with other CNS depressants. Although this information can be effectively communicated by labeling or prescription, labeling is not available with "street" GHB. 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 teenaged 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 their lack of familiarity with GHB, they panic when they come across passed-out teenagers where there are no signs of alcohol having been consumed. For many, the reaction, unnecessary and potentially dangerous, is to take the youngsters on a quick, scary, expensive trip to the emergency room.
Are alcohol- and GHB-induced sleep the same thing?
No, they 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 brain functions that take place during sleep. With GHB, the natural sleep processes are strongly enhanced. So a person who is GHB-intoxicated really is sleeping when passed out; however, this sleep can be so deep as to render the person difficult to wake up. With heavy doses, even repeated sharp slaps to the face may not arouse someone in GHB-induced sleep. Naturally, this can be terribly unnerving to parents who do not know that their kids have taken GHB, or to emergency medical personnel who are unfamiliar with GHB.
Despite the unfamiliar nature of GHB intoxication, people invariably recover fully and generally feel quite wonderful afterwards. The post-GHB state, as indicated previously, is typically characterized as one of enhanced alertness, energy, motivation and mood.