The DEMONIZATION of GHB

The DEMONIZATION of GHB by Ward Dean MD

As Alabama proposes life in prison for possession of two ounces (sic), the GHB demonization reaches new heights of absurdity.

One of my patients called recently to tell me that a bill was being introduced in the Alabama State Legislature this year that would make possession of 56 grams of GHB – about two ounces (and presumably also, GBL and 1,4 BD) punishable by life in prison without possibility of parole!

The bill, sponsored by Senators Hap Myers, Vivien Figures, and J.T. “Jabo “Waggoner. The legislators who introduced the bill admitted that they had little or no knowledge of the bill other than what they were told by its real sponsor, the Alabama Attorney General.

First Open Hearings on GHB

GHB proponents have rarely had an opportunity to present the medical/scientific side of the case. All previous hearings at the state and federal levels have been driven by the FDA/DEA. Hearings have always been quietly planned, with only witnesses supporting the governments position being invited. Even on the few occasions that proponents of GHB learned of the hearings, they were either not allowed to speak or were not given adequate time to present their views.

On Wednesday , March 8th, Don McGriff, Kelly Nelson and I testified before the Alabama Senate Judicial Committee. Don McGriff is a former Republican candidate for Lieutenant Governor and non-practicing attorney from Mobile, who suffers from narcolepsy. Kelly Nelson is a 72 year old grandmother and fitness instructor.

The vote was anticipated to be a slam-dunk for the Attorney General. After the testimony, however, many senators admitted that they were now confused. The bill was tabled until the following week to allow senators to gather more information

Despite this unexpected turn of events-the only newspaper in Alabama which covered the hearing somewhat accurately was the Mobile Register.

http://www.al.com/news/mobile/Mar2000/9-a355395a.html

All other Alabama papers which covered the hearings printed “take-out pieces” on GHB, with only incidental comments on the hearings.

http://www.al.com/news/huntsville/Mar2000/9-e7963.html

http://www.al.com/news/huntsville/Mar2000/9-e9371.html

The cursory treatment of our testimony was somewhat surprising. I would think the unexpected results might be newsworthy. These results would be even more surprising if GHB were really as bad as claimed by the Attorney General.

Distortions of the Truth

I believe the reason the bill was tabled was because members of the committee saw and heard documentary evidence for the first time which indicated that the Attorney General may not have accurately interpreted the facts about the numerous benefits and overwhelming safety of GHB.

The day following the open hearing, the Alabama Attorney General sent the following letter to the members of the Judicial Committee:

March 9, 2000

Dear Senate Judiciary Members:

Please allow me the opportunity to address concerns that arose during yesterday’s public hearing on Senate Bill 305 regarding the date-rape drugs GHB and flunitrazepam.

First, I want to emphasize that this bill is strictly about the trafficking of drugs that are already illegal to possess and are currently being used in Alabama to facilitate criminal activities. Exceptions are in this legislation to allow any government authorized legitimate use. As you will notice in the attached memo, however, neither of these is drugs is currently recognized by Alabama or the federal government to have a legitimate use, and neither can be legally bought or sold in the United States.

In 1998, my office proposed to the Alabama Department of Public Health to add GHB to Schedule I (the most dangerous and controlled substances) because of the growing trend in other parts of the nation to use this dangerous drug in sex offenses, and in August of that year it was added. Since that time, this drug has surfaced across Alabama in increasing fashion.

The Auburn University Student Counseling Center believes more than two-dozen girls were victims if date rape involving drugs during the past year. Using GHB as a “party drug”, students from Huntsville and Trussville have been hospitalized because of dangerous experimentation. Mobile and Baldwin county emergency rooms are reporting an average of one to two GHB-related cases a week. The Department of Forensics also performed an autopsy last year where the victim conclusively died from a GHB overdose, and reports indicate at least three other Alabama citizens have died from GHB.

I have attached a short memo that addresses the concerns from yesterday’s hearing. Please take a few minutes to read through this memo. I believe you will come to the same conclusion that these date-rape drugs must be added to the trafficking laws of Alabama.

Thank you for your time and consideration. If you have any questions, please contact me at 242-7401 or John Wible, General Counsel for Public Healthy at 206-5209.

Sincerely,
Bill Pryor
Attorney General

Memo from Attorney General Bill Pryor

Reference GHB

GHB is the common name for gamma hydroxybutyrate. It is a liquid drug that is colorless, odorless, and, when mixed in a drink, is virtually tasteless. GHB is mostly made in clandestine labs and GHB kits are easily available over the internet. These homemade concoctions are especially dangerous because the potency cannot be controlled. GHB can be snorted, smoked or mixed into drinks. It can cause loss of consciousness, liver failure, vomiting, tremors and potentially fatal respiratory problems (possibly death).

Dr. Dean‘s Reply to the Above Memo

It is clear from his description of GHB that the Mr. Pryor knows very little about it. First, GHB is not a liquid as he stated. It is a white crystalline powder, much like bicarbonate of soda. It can be dissolved in water or other beverages.

Mr. Pryor said that “when mixed in a drink [it] is virtually tasteless.” GHB is, in fact, quite salty. When mixed in a drink, it ruins the drink (like dumping bicarb in a drink).

Mr. Pryor said GHB could be “snorted, smoked or mixed into drinks.” The only way GHB is commonly used is by oral ingestion-by mixing in beverages. As a carbohydrate molecule, GHB would burn, and be totally inactivated by anyone trying to smoke it. Snorting would be equally ineffectual- (like “snorting” sodium bicarbonate). In Europe, GHB is available in a liquid for injection where it is used as a general anesthetic for children.

Mr. Pryor said that the kits are dangerous “because the potency cannot be controlled.” On the contrary, the kits are very safe because all ingredients are pre-measured, and dosages are clearly indicated.

Mr. Pryor said that GHB can cause liver failure. GHB actually improves liver function. I have used it on a number of patients with hepatitis C, who experienced complete normalization of their liver enzymes and restoration to good health. I know of several other physicians who have had similar experiences. Long term animal studies with daily high-dose feedings of GHB for two years resulted in a reduction of liver and mammary tumors, and no organ toxicity whatsoever.

Mr. Pryor said that GHB can cause “potentially fatal respiratory problems.” In even high doses, GHB does not suppress the reticular activating center of the brain which controls respiration (unlike drugs like alcohol and Rohypnol). In fact, although GHB slows the respiratory rate, it deepens the respirations, so there is little change in blood oxygen content.

I have requested documentation from the Attorney General upon which he allegedly based his statements. While awaiting receipt of this documentation, I’d like to review a number of potential distortions of the truth that have previously been made or implied by the Attorney General and others, that:

(1) “GHB is toxic.”

GHB is toxic only in doses 40-100 times the recommended sleep-inducing dose of 6gms each night (Three grams upon retiring and three grams, if needed because of early awakening). The early awakening is because of GHB’s extremely short half life. Another aspect of GHB’s non-toxicity is that it is rapidly broken down in the body into harmless carbon dioxide and water (unlike synthetic drugs which turn into other synthetic substances that can have other adverse effects).

(2) “GHB is frequently used as a ‘date rape drug.'”

This is a supreme example of “the big lie.” Tell a lie often enough and people soon believe it. GHB is not a date rape drug. If, in fact, it has been used for such violent purposes, this is a microscopic fraction of GHB’s total beneficial uses. Results of the most comprehensive study of the prevalence of various factors used to facilitate rape is illustrated in the figure below.

(Source: ElSohly, M.A., Salamone, S.J. Prevalence of drugs used in cases of alleged sexual assault, Journal of Analytical Toxicology, 1999, 23 (3), 141-146).

Note that the most common factor in rape is physical force. The most commonly used mind-altering substance used to facilitate rape is alcohol. Now, alcohol is not even scheduled by the Controlled Substances Act! Yet alcohol is involved in almost ten times as many date rapes as GHB! The next most common substance involved is marijuana, which is a Schedule I (Schedule I is for substances with a high potential for abuse and absolutely no medical or therapeutic uses).

Tied for third is a class of drugs that includes Rohypnol. Rohypnol is a drug like Valium, with many similar effects. Rohypnol also causes amnesia. Surgeons like to use Rohypnol as a sedative/anti-anxiety agent prior to surgery, because the patient doesn’t recall any pain (s)he may have experienced. However, Rohypnol is not even legal in the U.S. At the behest of a $40,000 lobbyist, Rohypnol was downgraded to Schedule 4-a much less restrictive classification. Yet Rohypnol (and drugs of its class) are involved in almost twice as many date rapes as GHB.

Tied with Rohypnol for third (and/ or fourth) place is crack cocaine-another substance that is also already a Schedule I. Why is GHB called the date rape drug when it is used in less than 4% of the alleged rapes. In the 48 cases in which GHB was detected, it was combined with one or more of the other drugs in 37 instances.

(3) “GHB has no [approved] medical uses.”

A number of extensively researched therapeutic uses for GHB are enumerated on page 18 of my book, GHB, The Natural Mood Enhancer, and are explained in detail with appropriate documentation in other parts of the book. Numerous other beneficial effects are constantly being reported, including delaying the rate of aging.

Orphan Medical is a pharmaceutical firm that is preparing to market a “medically prepared” version of GHB-sodium GHB. Orphan’s version of GHB is actually chemically identical to the over- the-counter dietary supplement as well as most of the “illicitly manufactured” GHB. However, the Attorney General, the DEA, and the FDA rarely notify anyone about the impending release of Orphan Medical’s product. I believe that most of the senators were unaware of this fact, and appeared surprised when I informed them of Orphan’s plans.

Thus, this appears to be similar to a previous episode of DEA/FDA collusion with the pharmaceutical companies. Tryptophan, an amino acid that is still used in baby formulas and intravenous feedings, was banned in the 1980’s, just prior to the introduction of Paxil ®, Prozac ® and Zoloft. These powerful antidepressants all owe their effectiveness to action on the same neurotransmitter system modified by tryptophan.

In one of Orphan Medical’s recent press releases (available on their website [www.orphan.com]) , the company hints that physicians will be able to use the product for its numerous other uses, in addition to that of narcolepsy–for which its approval is anticipated to be imminent.

(4) “There is no antidote to GHB ‘poisoning.'”

Physostigmine, a drug used to treat myesthenia gravis, rapidly awakens patients who have taken sleep-inducing doses of GHB. This has been known since 1976, and is published in the scientific literature.

(5) “GHB is a synthetic, designer drug.”

GHB is a naturally occurring molecule that appears to be essential for mammalian (including human) physiology. Consequently, everyone in Alabama is guilty of “possession of a controlled substance,” making us all unindicted felons.

Furthermore, since GHB has been identified in beef and many plants, the food supply is also contaminated with a controlled substance (according to current law). Under the proposed law, consuming a Big Mac quarter pounder could potentially subject one to life in prison without parole.

What are we supposed to eat?

These are not frivolous comments. Certainly the legislators could contrive a bill that would exempt McDonald’s, Wendy’s, Burger King, etc, as well as all grocery stores and meat markets which sell products with low-dose contaminations of GHB. However, consider that no other controlled substance occurs naturally in all animals and most plants-and no other controlled substance is essential for life! No other controlled substance requires such a carefully contrived list of exceptions in order to be lawful.

Something appears to be wrong here. If all the other controlled substance statutes can be written in a cookie-cutter fashion, why would so many exceptions have to be made for a law which regulates naturally occurring GHB?

(6) “GHB is made from lye and engine degreaser.”

This is partly true. GBL is a precursor chemical which is used to manufacture GHB (Actually, all one has to do is mix sodium hydroxide [lye/drano] and GBL. GBL is an industrial solvent. But so is water-and water is even more commonly used as a solvent than GBL. Lye (sodium hydroxide)-when ingested, is extremely toxic. However, when mixed with GBL and completely reacted, it becomes nontoxic GHB. GBL, when mixed with water, is likewise nontoxic (it can be mildly caustic if taken full-strength).

However, it is not even necessary to make GHB to obtain its benefits. BD and GBL both convert into (turn into) GHB in the body, using natural enzymes that are already in the body.

(7) “GHB is difficult to identify on laboratory tests.”

Actually, the test is technically very simple. However, the test requires a long collimeter tube, and few labs are so equipped. But if the problem with GHB abuse is as large as the authorities claim, then more GHB testing facilities could be profitably established. Samples can now be prepared at remote sites and sent for testing. The molecule is very stable. If a test for GHB is needed and not done, it is not because GHB is difficult to test for.

(8) “GHB has caused many deaths.”

I have reviewed as many autopsies as I have been able to obtain, (despite a frequent reluctance on the part of the FDA and DEA to provide details of the alleged deaths [and “Adverse Events”]). In addition, many medical examiners are sometimes reluctant to provide me with requested public documents. However, of the autopsies I have reviewed, I have yet to find an autopsy that unequivocally proved that the death was caused by any toxicity of GHB. Alcohol and/or illicit drugs were involved in many (if not most) of the cases.

In several cases, there was no GHB involvement at all (confirmed by laboratory examination). In other cases, the death was more likely due to have been due to a preexisting condition-in some cases, the condition for which GHB was being taken-usually with a beneficial and most likely life-prolonging effect.

I’ve often said that anything can be abused. I’ve even pointed out that deaths have occurred due to water intoxication. Extremely relevant at this time is the recent death of a 53 year old male which was attributed by the Medical Examiner to “hypoxic encephalopathy due to acute GHB toxicity.”

The autopsy report showed that the individual was brought in to the ER unconscious, with a sodium of 107 (which the admitting physician reported as incompatible with life-normal levels are 130-145). The history was that this long-time alcoholic and drug abuser had gone clean. However, within several months of discontinuing his other drugs, he began to feel badly, and occasionally became disoriented. His sleep was very poor, and he began to drink lots of water. He then began to take GBL to help himself sleep. It would help for a while, and it made him feel better. However, he became progressively worse, ultimately lapsing into a coma, and was taken to the hospital. Based on this history, the County Medical Examiner (Placer County, California) made the above diagnosis–“Due to Acute GHB Toxicity.” However, there were no laboratory reports with the autopsy (lab was “pending” at the time of determination). I finally received the “missing” lab report which revealed a blood GHB level of 12.5 mg/L. There was no GHB in the urine. This amount of GHB is well within the range that is normally produced by the body after death. The fact that there was no GHB in the urine proves conclusively that the decedent had not taken any GHB prior to lapsing into the coma. The coma was due to low sodium, and had nothing to do with GHB. It is clear that the cause of death was a previously undiagnosed case of a disease known as diabetes insipidus, which causes excessive urination. This resulted in thirst and subsequent “water intoxication” which caused him to excrete excessive sodium, resulting in the profound hyponatremia (low blood sodium). The consumption of GBL in no way contributed to this death. The clinical presentation is certainly not consistent with a GHB overdose, and there is absolutely nothing in the scientific literature that would indicate that chronic use of GHB or its precursors would cause diabetes insipidus or hyponatremia.

This was a case where the death really was due to water – and got blamed on GHB!

Potential Problems that are Likely to Result from Passage of the Proposed Bill

GBL and BD are valuable industrial chemicals, available by the tank car load. Four hundred million pounds of GBL, and at least twice as much BD are manufactured each year. Because of the shear volume of these products produced annually, increasing the accountability and security of GBL and BD to the level of other “List 1 Chemicals” would probably bankrupt industry and eliminate many valuable consumer products (floor cleaners, paint strippers, acetone free nail polish removers, beer, pineapple ice cream, plastics, auto bodies, and many others).

Consequently, accountability and security requirements for these substances were waived in the recently-passed Federal Law (which I believe goes into effect on April 16th. Presumably, penalties for diversion would be those for other Class I chemicals which do have the statutory security and accountability requirements.

Because of the voluminous production of the two chemicals from which GHB can be manufactured/produced (12 million pounds), it will be difficult if not impossible to eliminate the production of GHB and/or its precursors (chemicals from which GHB is derived). Some GBL/BD will certainly be available through “illicit” channels. Stopping GHB production is going to be much more difficult than wiping out some poppy fields in Colombia, or spraying paraquat on marijuana plants in Mexico.

A lot of GBL and BD will probably be labelled “for industrial use only,” and sold with a “wink.” While in responsible hands, such a product can be diluted appropriately and be safely and beneficially consumed. Such users who could benefit include most adults of all ages, and even many children (GHB has been used successfully for autism and attention deficit disorder). Most “Industrial Grade” GBL actually is well within pharmaceutical standards of purity for contaminants and heavy metals (usually, the most common contaminant is water). “Pharmaceutical Grade” purity is often exactly the same product, but with a higher price.

However, because of the restrictions against dietary supplement use of GHB, there will be no instructions as to the proper dilution, and recommended dosage of the “bootleg” versions. Warnings against combining with alcohol and other central nervous system depressants will also obviously not be included.

Unfortunately, the consumers of this “bootleg GHB” will most likely be those most inclined to abuse it. Those who use GHB responsibly and benefit the most are generally law abiding adults-especially senior citizens. As we get older, sleep disturbances become more common. GHB normalizes sleep, resulting in deeper, more restful sleep, with consequent greater daytime alertness, improvement in memory, alleviation of depression, loss of body fat and increased musculature and bone density (due to release of growth hormone at night), reduction in cholesterol and reduction in oxygen requirements of the heart and brain (thereby actually protecting one against heart attacks and strokes). These are just a few of the well-documented benefits of GHB for “normal” people.

What Should be Done

First, since GHB meets the definition of dietary supplement in accordance with the Dietary Supplement Health and Education Act of 1994, I recommend that GHB be removed immediately from the list of controlled substances in Alabama.

Second, standards of purity and good manufacturing techniques should be established for the manufacture of GHB.

Third, appropriate warnings and dosage recommendations should be drafted to be incorporated on the label (just as on cigarette packs, [talk about dangerous drugs!])

Fourth, prohibit sales to minors. For example, in Florida, my children (11 and 13) cannot go into a K-Mart and buy a box of BBs. Florida law restricts sales of BBs to adults. I have to buy them.

Other considerations include possibly limiting sales in Alabama State Liquor stores (where ages are closely monitored)- although I really recommend separating these products from alcohol altogether. Taxes are another consideration.

Conclusion – Legal and Constitutional Considerations

Rape is a crime. Rape facilitated by a substance intended to incapacitate an individual is also a crime, with even more severe penalties. Adulterating someone’s food or beverage is also already covered by the criminal code.

Although the Attorney General claims that criminal use of GHB has increased in Alabama, he has yet to provide us with any evidence of completed or pending prosecutions for a crime. Why increase the penalties for a crime for which no one has yet been punished.

The Eighth Amendment to the Constitution for the United States protects citizens from cruel and unusual punishment. Life in prison without parole for possession of a dose of GHB that will safely induce natural sleep for one night appears to me to be “cruel and unusual punishment.” Especially when the same substance is about to be approved by the FDA for narcolepsy, yet which will admittedly (by Orphan Medical) be prescribed for a wide variety of legitimate uses. I doubt whether any rapists are imprisoned for life without parole.

The statements cited in this brief article can all be confirmed by scientific and public documents. One of the best sources of accurate information about GHB is the voluminous Investigational New Drug studies (INDs) on file with the FDA, which document over 25 years of research on the safety and clinical benefits of GHB. These documents have previously been placed into evidence in many court cases, and should now be considered public documents. I encourage investigative reporters and legislators to request these documents from the FDA.

 

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