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GHB Report to the California Legislature
by Steven Wm. Fowkes ( Con't)


Page 2 of 2.


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 if 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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