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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 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 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.



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