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Project GHB News
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Project GHB News is an Internet newsletter delivering the latest information about GHB and its precursors, and various other recreational drug news. We rely on your input and welcome articles written by subscribers, doctors, nurses, emergency medical personnel, and other individuals affected by the use of GHB. Send news items or full length articles to the editor. Features
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Don't forget trendydrugs.org - not just GHB info, but lots of stuff on MDMA (exstasy) and more. Thank you for subscribing. Please forward this to anyone who may have interest. Automatically recommend the website and newsletter by clicking here: recommend There are 930 subscribers [ top ]
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Viewer CommentsTo Whom It May Concern: I am writing this in attempt to give insight over the
course of the past I continued to use GHB for 4 years until it was made
illegal, soon after a After I graduated in Dec of 1999, I attempted to apply for
various jobs at During that period I sought to find detox facilities and
doctors that were In July I came across a message
board on the Internet that dealt with GHB By September I reentered Computer School, I continued on
through November I felt I needed to make up for all the time I spent at
home and to forget I realize now that it would have to come to an end some
how whether I Name Withheld [ top ] See other comments submitted since 1998 Videos: ArticlesFDA, Orphan Medical, and Xyrem(R): Ok, so you've heard the talk. Orphan Medical finally had their hearing with the FDA panel. Orphan Medical, a small company that develops drugs for uncommon diseases, is seeking approval to sell the drug, Xyrem, as a therapy for narcolepsy's sleepiness and cataplexy. Orphan Medical's press release (at the bottom of this newsletter) states the FDA Advisory Committee found Xyrem(R) effective for treating cataplexy associated with narcolepsy. While this is true, the panel was split on whether the product was a safe therapy for the condition. The committee agreed that there is efficacy shown at a dose range of 6-9 grams (in split doses during the night) in reducing the incidence of cataplexy (in people with narcolepsy who are also being treated with stimulants). They found that there was 1) no evidence that it helps narcolepsy without cataplexy (thus no evidence of value as a sleep aid alone), 2) inadequate demonstration of safety, and 3) it should be excluded from off label use. [ top ] Orphan Medical was quite short of the agreed upon number of patient years needed (there is a precise amount needed for regular drugs, and while there is no specific number needed for orphan drugs, they had been given a figure and weren't even close). The recommendations go to FDA who COULD ignore them and approve it anyway. More likely, they will be required to do additional studies. Many people agree that approving a drug as a prescription drug at a time when the rest of the world is moving away from it is not a wise thing to do (New Zealand approved it a year ago and now regret it; other countries are starting to restrict it and are only beginning to realize the depth of it). NIDA is releasing $2 million in GHB research grants.....the evidence isn't all in. It is interesting that the literature package Orphan Medical (OM) was proposing for patients and doctors NEVER uses the phrase "gamma hydroxy butyrate." It only mentions "sodium oxybate" (old name for GHB) plus the trade name Xyrem. Would doctors and patients realize what drug they were being given?? Most would agree that patients have a right, a need, to know exactly what drug they are being given. Doctors have a right, and need, to know what they are prescribing. Presenting before the National Association of State Controlled Substance Authorities two years ago, OM stated that if GHB was placed in Schedule I, there could be no research. This is not true. Schedule I drugs can and are researched with proper protocols in place. Today, Orphan Medical's representative (Dr. Balster speaking for them) provided inaccurate info regarding the legal status of GHB, claiming that GBL and BD aren't covered in the federal legislation (they are in fact covered, as analogs of GHB) and presented misleading graphs showing the production level of Xyrem versus BD and GBL. The graphs were misleading because they included the tonnage of industrial-use product. They asserted that it isn't GHB that causes the problems............only GBL and BD. They admit that it is converted to GHB in the body, but blame the conversion process. One top issue isn't so much actual diversion of the product, but that it could (most likely will) be a shield to protect those in possession from arrest. Even if truly restricted to those diagnosed with narcolepsy/cataplexy, it would indeed be a problem. As an example, there is one reported instance of someone being diagnosed as having narcolepsy (even after extensive testing by one of the highly regarded LA area sleep disorder clinics). The patient actually had Epstein Barre virus!! [top] Once in possession of a prescription and a bottle (which is easily counterfeited), there will be no recourse. Of course, in states with adequate DUI laws, it won't protect them in a DUI situation, but for possession it will provide a solid shield. There is no field test kit for GHB now (not a real one) and there would be NO way whatsoever to determine in the field if the bottle they present contains Xyrem or street GHB. No way at all. Who will expend the money for sophisticated testing to try to figure it out? And, unless it proved to contain only an analog, there'd be no way to differentiate anyway. It's just plain old GHB. Split scheduling of this drug is totally unenforceable (never done before with any other drug and not feasible with a drug that can't be identified anyway). No one can deny that narcolepsy and cataplexy are debilitating illnesses. Improved treatment IS desperately needed for the sufferers. But will the treatment be Xyrem? Will more studies be required before a suitable treatment is released to the public? We all have yet to find out. Please keep tuning in to the Project GHB newsletter for updated information. What do you think? Vote here: News Items on the Xyrem(R) story: [newest items first]
We would like to
feature your article here Questions AnsweredTara from Colorado writes: While I recognize that people may have been injured in the use of GHB and its analogs and I am sorry for your loss, I take issue with your assertions that withdrawal from this drug is tantamount to that of heroin. I used "Zen" (active ingredient: Sucol-B) nearly everyday for a period of about 4 months about two years ago. I bought it from a site online that advertised it with all the buzz words you mentioned: relaxation, weight-loss, etc. I liked the effects (buzz), although the dose was difficult to measure, as you state. I usually took it close to bed time but there were times where I would nod off on the couch. It never made me throw up. My point is this: I used this stuff in a quantity that amounted to "regular" bordering on "heavy". Every day, sometimes twice. However, when I stopped, there was no withdrawal whatsoever. Absolutely, positively NONE. I guess I just kind of feel that your information isn't that close to accurate... Editor: Hi. Glad to know you're not addicted! From an individual standpoint, I can see how you would feel GHB is not addictive. Many people have felt the same as you. It is not uncommon. However, it is important to realize that while some people do not become addicted, others DO, and in a very bad way! Those who become addicted to GHB suffer incredible withdrawals, sometimes worse than heroin. This is a comparison made by actual users of GHB who have experienced heroin withdrawal in the past. Your lack of severe withdrawal symptoms doesn't mean GHB is not addictive - just like any drug. For example, some people drink alcohol daily (though not recommended) and then stop with no problem, others cannot. Just pop on over to the GHB addiction and withdrawal message board to see how GHB addiction has affected many people. GHB affects people differently - different strengths and mixtures add to the lack of stability with GHB - this is one of the main reasons why GHB has never been approved as a medicine - its lack of safety across the board. Thanks for your input. Sincerely, Anya Shortridge, Director Project GHB, Inc. How to HelpWe need your help to continue. If you would like to contribute financially, here's where to send it! Donations to Project GHB, Inc. are tax deductible! You will receive a receipt for your tax records. WHERE TO SEND YOUR TAX-DEDUCTIBLE DONATIONS: Checks, money orders: Project GHB, Inc. Please note whether or not you care to be mentioned as a contributor in this newsletter or on the website.
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Subscribe to the Project GHB newsletter
Copyright © 2001 Project GHB, Inc.
Project GHB
"Creating public awareness
of the dangers of GHB"
Project GHB exists to educate the public about the dangers of the substance GHB
which has become an increasingly popular drug of choice, causing addiction,
injuries and death. Our goal is to save lives.
Project GHB is a 501c3 non-profit corporation
Project GHB, Inc.
P.O. Box 710693
San Diego, CA 92171
www.projectGHB.org
Orphan Medical Announces FDA Advisory Committee Finds Xyrem(R) Effective for Treating Cataplexy Associated with NarcolepsyMINNEAPOLIS, June 7 /PRNewswire/ -- ORPHAN MEDICAL, INC. (Nasdaq: ORPH - news) announced today that the Peripheral and Central Nervous System Advisory Committee of the U.S. Food and Drug Administration (FDA) voted today that Xyrem® (sodium oxybate) oral solution is an effective treatment for cataplexy (sudden loss of muscle tone) associated with narcolepsy. The Advisory Committee voted 6 to 3 that Xyrem, whose active ingredient is gamma hydroxybutyric acid or GHB, is effective in treating cataplexy at a dose of 9 grams per day. It voted 5 to 4 that it is also effective at a dose of 6 grams per day. The committee voted 4 to 4, with one abstention, on the issue of safety, and 8 to 1 that a risk management plan is necessary for the safe use of Xyrem, as Orphan Medical had recommended. ``We are encouraged by the outcome of the committee's deliberations, even though the voting was not unanimous, and we're pleased by the committee's general view that new therapies are needed for cataplexy associated with narcolepsy. We will meet promptly with the FDA and feel confident we can address the clinical issues discussed by the committee,'' said John Bullion, CEO of Orphan Medical. ``Xyrem is now one step closer to approval and helping physicians better manage narcoleptic patients with cataplexy. We remain committed to the value of this drug in an under-served population.'' Narcolepsy is a chronic neurological sleep disorder affecting 100,000 to 125,000 individuals in the U.S. Its primary symptoms are excessive daytime sleepiness, often accompanied by cataplexy. Cataplexy is a sudden loss of muscle tone in response to strong emotional reactions, often causing the patient to collapse unexpectedly during waking hours. If approved, Xyrem would be the only treatment approved by FDA as effective in managing cataplexy in those afflicted with narcolepsy. Xyrem was designated by the FDA for a priority review in October 2000. In addition to the clinical issues raised by the committee, the Company also will address with FDA issues regarding product labeling, the distribution system proposed by the Company to assure safe use, and manufacturing controls to assure compliance with FDA's Good Manufacturing Practice regulations. Orphan will host a conference call on Thursday, June 7th, at 9:30am EDT, for the financial community. Senior management will be available to discuss the recommendations of the FDA advisory committee and the company's outlook for the remainder of the year. The telephone number is 877-278-2458 or you may access the audio webcast at http://acc.activate.net/teleconferenceregister/Intercall/. Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases. The Company serves three strategic therapeutic market segments that are characterized by well-defined patient populations and served by physician specialists: oncology support, antidotes and sleep disorders. Orphan Medical's Internet Web site address is http://www.orphan.com The information in this press release may contain forward-looking
statements within the meaning of the Private Securities Litigation reform
Act of 1995. A number of factors could cause actual results to differ
materially from the Company's assumptions and expectations. These are set
forth in the cautionary statements included in Exhibit 99 to Orphan
Medical's most recent Form 10-Q or Form 10-K filed with the Securities and
Exchange Commission. (These documents can be accessed through the Orphan
Medical Web site at http://www.orphan.com). All forward-looking statements
are qualified by, and should be considered in conjunction with, such
cautionary statements. Orphan Medical Noonan/Russo Communications
John Howell Bullion (CEO) Glenn Silver (media), ext. 271
Tim McGrath (CFO) David Walsey (investors), ext. 230
(952) 513-6900 (212) 696-4455
SOURCE: Orphan Medical, Inc.[ top ] |