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From the February 18th, 1996 issue of Smart Drug News [v5n7]. Copyright (c) 1997. All rights reserved.
Gamma-hydroxybutyric acid (GHB) is a natural substance found in many foods, and is both a precursor and metabolite of the amino acid GABA (see SDN v4n7p4). One might think, given its nutrient derivation, that GHB would be accepted as just another food supplement in the over-the-counter health food market. While that may once have been the case, it certainly isnt the way GHB is currently perceived by the FDA.
Prior to 1994, the FDA had the power to arbitrarily classify almost anything as a drug. The FDAs definition of a drug included 1) non-food items intended to affect the structure or function of the body of man or other animals, and 2) items intended to treat, cure, mitigate or prevent disease. The category of food supplements did not then exist. In the eyes of the FDA, food supplements could be classified in many different ways: as drugs, food additives, or even adulterants. By their ridiculously broad definition, almost anything and everything could be considered a drug, including water, exercise, sports equipment, classical music, or sunlight all of which can either affect the structure or function of the body, or treat or prevent disease.
Although these arbitrary and capricious powers of the FDA to label nutritional supplements as food preservatives and adulterants were repeatedly ruled improper and illegal in a number of court decisions, the agency failed to restrain its actions. Finally, attempts to rein in this rogue Federal agency culminated in the passage of the Dietary Supplement Health & Education Act of 1994 (DSH&EA), wherein those powers were severely restricted. With the passage of DSH&EA, the FDA was absolutely prohibited from classifying nutrients as food preservatives or adulterants. Furthermore, they were permitted to remove food supplements from the market only if there was a threat to public health involved. Any such removals would require convening a set of public hearings to review the decision, at which public input would be accepted, all testimony would be open, and the proceedings would be published in the Federal Register. Never before had the internal decision-making process of the FDA been exposed to public scrutiny. Significantly, the FDA has so far avoided any decisions that would require such exposure.
In November, 1990, 4 years prior to the DSH&EA, the FDA issued a national press release announcing that GHB was a drug. Instead of following formal regulatory procedures for assigning a status to GHB, the FDA took the unusual (and legally unsanctioned) step of announcing their decision in a press release! Thats all a press release! Based on this press release, agents of the FDA started investigating, arresting and prosecuting many health food store owners and distributors for selling an unapproved new drug (i.e., GHB). Some people were promised lenient treatment if they would testify against others (the big fish). Some of these people went to prison, and are now branded as convicted felons unable to vote, own firearms, or enjoy many of the other rights of free citizens. We will probably never know what process was followed in this decision. However, the FDAs disdain for following even their own rules and regulations had become routine operating procedure.
At a recent court case at which I [WD] testified as an expert witness regarding the safety of GHB, it became evident that the government representatives in this case (prosecutors, FDA agents and FDA expert witnesses) either didnt know what they were talking about regarding GHB (which I have a hard time believing) or were deliberately lying (the only reasonable alternative).
In previous, similar GHB cases, the prosecution (the Justice Department) attempted to portray GHB as a Schedule I controlled substance (a drug that has no medical uses, with a strong potential for addiction and abuse like heroin). Federal prosecutors withheld knowledge from the defense of the existence of a number of Investigational New Drug Applications (INDs) for GHB on the rationale that they contained no relevant information. Years later, after a number of people had spent considerable time in prison, higher courts ruled against the withholding of these INDs, overturned many of the GHB convictions, and forced the FDA to submit copies of all INDs to the courts for inclusion in still-pending trials, or re-trial of overturned cases.
The GHB INDs were telling. Instead of corroborating the FDAs views and the testimony of government expert witnesses, the INDs flatly contradicted them. GHB was repeatedly described, in IND after IND, as a safe, non-toxic, non-addictive substance, with an extremely wide margin of safety. With the INDs in evidence, the prosecution is having a hard time convincing either judge or jury of the dangers of GHB. With the growing realization that GHB was never properly classified as a drug, and that it now fits the Federal legal definition of a food supplement, the judicial system is recognizing that it has been had by the FDA. One of the FDAs expert witnesses who recently testified as to the dangers of GHB was forced to admit that she had never seen a single patient who had taken GHB.
As the FDAs GHB convictions are unraveling at the seams with at least one US government attorney in jeopardy of being disbarred because of prosecutorial misconduct in these GHB cases the FDA has adopted several, new, end-run tactics. They have shifted emphasis in the anti-GHB crusade from the courts to the media. FDA, DEA and police agents are telling reporters that GHB is a dangerous, lethal and addictive drug; that it is an illegal designer drug; and that it is a date rape drug. Such expert opinions have propagated a plethora of hysterical articles in the popular (and even medical) press to demonize GHB. Frenzied media reports about River Phoenix, dead teenagers, and near-death experiences of GHB-using club-goers are sweeping the nation.
We have found, however, in the process of investigating every alleged GHB-related death, that none can be legitimately attributed to any purported toxic effect of GHB. Furthermore, in almost every case in which GHB was declared as a cause of death, I [WD] found that the medical examiner had been influenced in his decision by a helpful agent from the FDA or DEA, who had kindly explained the dangerous toxicity of GHB. In many cases, allegations of GHB use were simply not true (e.g., River Phoenixs death). In all others, in which GHB use was confirmed, the cause of death was due to other factors or other diseases. The Chief Medical Examiner of San Francisco County who developed the most widely used technique for identifying and quantifying GHB levels in body fluids and tissues, and whose laboratory is frequently used by the FDA and DEA to test samples told me [WD] that he had never seen a death due to GHB toxicity. He explained what he believed to be the true cause of death in every case.
The strategy begind the anti-GHB media campaign is tough new laws to criminalize GHB sales and posession. Attempts are now underway in several state capitols to ram new anti-GHB bills through state legislatures before any more kids will die from the evil GHB. Georgia, Rhode Island, Florida and California are states that have already introduced such bills. Who knows which other states will follow suit shortly.
In California, Assembly Bill 6 (AB6) specifies that GHB will become classified as a Schedule I drug (that would only be lawfully available for research and would have no approved medical use). No medical uses? Thats right, no medical uses! Although GHB is currently recommended and/or prescribed by doctors for a host of applications (lowering muscle tension, enhancing relaxation, relieving anxiety, inducing natural sleep, aleviating depression, assisting marital sex problems, etc.), no medical uses will be allowed.
Apparently, California doesnt care that 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 Parkinsons 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 Huntingtons chorea, 9) regulating muscle tone in dystonia musculorum deformans, 10) controling 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 [in fact, it has been recommended as the anti-anxiety agent of choice for potentially suicidal patients], and 15) lowering cholesterol. No medical applications, indeed.
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. What or who is behind this reefer madness of the 90s? Whatever or whomever it is, they are pushing this issue hard. Californias AB6 states, In order to protect the health and well-being of the public as soon as possible, it is necessary that this act go into immediate effect.
The lack of danger and minimal addictive risks of GHB are graphically illustrated by the FDA-approved protocols for dispensing GHB in narcolepsy studies. After preliminary laboratory-monitored sleep studies (one or two nights to obtain a baseline), the test subjects are given large containers of GHB, told what dose range to take (6-8 grams per night), and instructed to come back for more when they need it.
The protocol also instructs the subjects go to bed immediately after taking the GHB, and remain in bed for 6-8 hours until morning. However, considering the number of elderly subjects in the studies, with their known propensity to visit the bathroom several times each night, it is doubtful that these instructions are rigidly followed. Were there any adverse effects? In one of the multi-year studies, which employed nearly 75 people, it appeared that there was about a 20% incidence of bed-wetting the most disturbing side effect. However, when the data were analyzed, it was found that all the bed-wetting was experienced by one 84-year-old patient, who said that hed rather continue to wet the bed and get a good nights sleep than stop taking GHB! Other side effects that were occasionally reported included sleep-walking and various minor incidences of nausea and vomiting (which were dose-related, and usually resolved with continued use). Included in these INDs were reports of many people taking as much as 30 grams of GHB per day for several months without ill effects.
This is hardly a picture of danger and addiction. This is hardly irrelevant to court cases in which government expert witnesses are testifying about GHBs toxicities, dangers and addictive properties. And this is hardly a situation requiring criminalization. This is a crisis 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 GHB madness 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.