GHB�??Finally Gets Respect�??Now Available by Prescription
Ward Dean, M.D.
Gamma-hydroxybutyric acid (GHB) is known to most of the general public as the FDA- and media-demonized and much-maligned �??synthetic, designer, date rape drug�?? (sic).
However, for the overwhelming majority of people who have actually used GHB, it is recognized as the most non-toxic, non-habit-forming, sleep-inducing substance known.
In addition to being the only known substance that induces, and actually improves, natural sleep, GHB is a highly effective treatment for a variety of hard-to-treat disorders (see Box). GHB is a naturally occurring endogenous substance (i.e., it exists in virtually every mammalian cell in small amounts).
Thus, it qualified as a dietary supplement under the 1994 Dietary Supplement Health & Education Act (DSHEA). In fact, VRP previously carried products (RenewTrient and SomatoPro) containing natural, endogenous precursors of GHB.
They were among our most popular supplements ever, before GHB was made a Schedule I Controlled Substance and the FDA/DEA went on the warpath against its precursors.
�??If the FDA doesn�??t like it, it�??s got to be good.�??
Before March 13, 2000, GHB and its precursors, e.g., gamma-butyrolactone (GBL) and 1,4-butanediol (BD), were available over the counter. Several were marketed as dietary supplements.
GHB gained popularity as a �??sociabilizer,�?? with disinhibiting and euphoric effects similar to alcohol (but without the liver- and brain-pickling side effects of alcohol). However, it was also a highly effective anti-depressant, pain reliever, and sleep inducer.
Thus, it was �??stepping on�?? some large pharmaceutical toes (i.e., reducing their profits). This would certainly seem to be a factor in the FDA�??s interest in restricting GHB�??s use. Almost from the inception of its popularity, the FDA began exerting its muscle to remove GHB and its precursors from the market.
To do this, FDA had to convince the public that GHB was an extremely toxic, highly addictive substance, with a primary use as a �??date rape drug.�??
(For the background of this devious campaign, read a number of my articles from back issues of Vitamin Research News, or on VRP�??s website, where you can also find a summary by attorney Paul Anacker).
The FDA�??s decade-long campaign of disinformation and intimidation finally worked. On February 18, 2000, Congress enacted Public Law 106-172 (titled the �??Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000�??), directing the Attorney General to place GHB in Schedule I of the Controlled Substances Act.
That law also made GBL a �??List I Chemical�?? and mentioned BD as a possible Controlled Substance Analogue.
Orphan Medical and Xyrem
However, while the FDA and DEA were busy demonizing GHB, a small but enterprising pharmaceutical company was tortuously working its way through the complex new drug application process to get GHB approved as a prescription drug.
Orphan Medical specializes in developing pharmaceuticals for �??orphan diseases�?? (illnesses which are quite rare, and thus generally not considered worthy, from a profit perspective, to spend the time or energy trying to find cures).
Orphan Medical set out to develop GHB as a treatment for narcolepsy with cataplexy�??a rare sleeping disorder that causes inability to sleep at night resulting in sudden and unpredictable loss of muscle control during the day.
This condition can obviously be hazardous, and certainly limits one�??s employment opportunities and ability to carry out a normal life. Orthodox treatment for narcolepsy with cataplexy had consisted of mind-numbing hypnotic drugs to induce sleep, and chronic use of amphetamines during the day to maintain alertness.
After years of jumping through the administrative and medical hoops required by the FDA�??s complex new drug application process�??and with new hurdles to overcome because of the years of disinformation propagated by the government and major media, GHB was finally approved as a Schedule III drug for the treatment of narcolepsy with cataplexy on August 17, 2002.
Now trade-named Xyrem, and described by the euphemistic scientific name of �??sodium oxybate�?? (the sodium salt of GHB), GHB is now a drug available by prescription.
As with all prescription drugs, once approved by the FDA, physicians can prescribe it for patients for any of use, even for patients who don�??t suffer from the disease for which it was �??approved.�??
Prescribing Xyrem is a Little Different
However, it�??s not quite as easy to obtain Xyrem as other medications. One can�??t just obtain a prescription from any physician, and go down to the local drugstore to get the prescription filled.
In order to prescribe GHB, physicians must first sign up with the Xyrem Success Program, by calling toll free 866-997 3688 (866-XYREM88). The pharmacy will then send the physician product information which he must read, check off that he/she has read and understands the materials and fax it back to 866-470-1744.
This declares that the physician has read the materials, understands the indication, the dosing, and has educated the patient.
The physician also receives a special prescription pad that is to be used only for Xyrem. When a physician desires to prescribe Xyrem for a patient, the prescription is faxed to Xyrem Success Program, a department of Express Scripts, a specialty pharmacy in Missouri. Express Scripts has been given the sole franchise for disseminating GHB in the U.S.
Upon receipt of the prescription, educational material and a video are shipped overnight to the patient. The patient is asked to read the material and watch the video. A few days later a representative from the Success Program calls the patient, and goes through a series of questions to ensure the patient understands the information about the drug, how to use it and the penalties for diversion.
The patient is then sent a form that allows the Success Program to attempt to file this drug claim on the patient�??s insurance. The patient�??s insurance company (if the patient is insured) is called, to determine if insurance will pay for the Xyrem.
This becomes significant when one finds out that a month�??s supply of Xyrem is in the range of $250! (Although this is not especially high when compared to the cost of many prescription drugs, many users remember when a month�??s supply of pharmaceutical-grade GHB was in the range of $40-50 at health food stores.
Of course, the supplement companies did not have to incur the new drug application costs which Orphan Medical had to underwrite).
Although the relatively steep price deters many uninsured from continuing with the product, many without insurance don�??t mind paying it. For those who haven�??t been able to sleep, or who suffer from intractable illnesses not amenable to other treatments, $250 per month may be a small price to pay.
Despite the hassles of getting on the �??list�?? (Xyrem Success Program) and the time lapse from prescribing Xyrem until the first delivery (usually about 2-3 weeks), once all these administrative roadblocks have been successfully negotiated, Xyrem (GHB) arrives promptly by delivery service.
This is the �??closed loop�?? system developed by the FDA, DEA, and Orphan Medical to prevent diversion. (Xyrem has been made a Schedule III �??drug.�?? However, when used by an individual for whom it has not been legitimately prescribed, the FDA and DEA allege it is a Schedule I Controlled Substance.[1]
Schedule I means there is no medically useful purpose for a substance. It is the class in which crack cocaine and heroin are included).
From here on, a Xyrem prescription is relatively hassle-free. The prescription can only be filled for a maximum of three months at a time (I usually prescribe it for only one month, initially, titrating up until the patient arrives at the minimum effective dose).
Express Scripts efficiently keeps patients and physicians advised of the progress of the admini-strative process and when shipments have been made and received.
Although I have seen only one patient with narcolepsy (with cataplexy), I prescribe Xyrem on a regular basis for many other conditions for which Xyrem is appropriate.
Other indications for which I have prescribed Xyrem include chronic insomnia with daytime sleepiness (most common), chronic fatigue, fibromyalgia, reflex sympathetic dystrophy nocturnal myoclonus (leg cramps at night), shingles, intractable migraine headaches, and neuralgias and neuropathies of various types.
For those who were able to obtain relief from pain, suffering, and inability to sleep soundly at night only with GHB, I�??m glad this miracle substance has once again become available, despite the current restrictions.
[1] Attorney Paul Anacker alleges otherwise. Paul Anacker is a retired attorney who is extremely knowledgeable about dietary supplements and other health topics, and was the lead editor of my book Biological Aging Measurement.
Paul has recently come out of retirement to consult on more than four dozen GHB-related cases, state and federal, and is currently co-counsel for five federal cases across the nation involving GHB or its precursors. Mr. Anacker knows more about GHB, its precursors and DSHEA then any attorney I know.
I would strongly advise anyone who has a GHB-related case to contact Paul, before hiring a local attorney (anacker@hotmail.com).
History of Dr. Dean and GHB