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COM 0078.008 1996-1998
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COM 0078.008 1996-1998
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5/12/2008 3:45:24 PM
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Communications
Communications - Type
COM
Communications - Council Term
1996-1998
Communication
0078
Point
008
Author
Ward Dean, M.D., and Steven W.M. Fowkes
Communications - Referred To
COUNCIL
Comments
Distributed & filed - 3/19/97
Communications - File Code
HCC
Document Relationships
COM 0078.000 1996-1998
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<br /> f ~ <br /> The lack of danger and minimal addictive risks of GHB are graphically illustrated by the <br /> FDA-approved protocols for dispensing GHB in narcolepsy studies. After preliminary <br /> laboratory-monitored sleep studies (one or two nights to obtain a baseline), the test subjects <br /> are given large containers of GHB, told what dose range to take (6-8 grams per night), and <br /> instructed to come back for more GHB when they need it. <br /> The protocol also instructs the subjects go to bed immediately after taking the GHB, and <br /> remain in bed for 6-8 hours until morning. However, considering the number of elderly <br /> subjects in the studies, with their known propensity to visit the bathroom several times each <br /> night, it is doubtful that these instructions are rigidly followed. Were there any adverse <br /> effects? Iu oue of the multi-year studies, which employed nearly 75 people, it appeared that <br /> there was about a 20% incidence of bed-wetting-the most disturbing side effect. However, <br /> when the data were analyzed, it was found that all the bed-wetting was experienced by one <br /> 84year-old patient, who said that he'd rather continue to wet the bed and get a good night's <br /> sleep than stop taking GHB! Other side effects that were occasionally reported included <br /> sleep-walking and various minor incidences of nausea and vomiting (which were dose- <br /> related, and usually resolved with continued use). Included in these INDs were reports of <br /> many people taking as much as 30 grams of GHB per day for several months without ill <br /> effects. <br /> This is hardly a picture of danger and addiction. This is hardly "irrelevant" to court cases <br /> in which government expert witnesses are testifying about GHB's toxicities, dangers and <br /> addictive properties. And this is hardly a situation requiring criminalization. This is a <br /> crisis manufactured by the FDA, aided and abetted by the DEA, compounded by local <br /> police, inflamed by the media, and perpetuated by ignorance. We do not need to have <br /> "GAB madness" become a permanent part of our culture as law. We do not need to <br /> disenfranchise patients, impair the practice of medicine, and drive citizens to obtain their <br /> food supplements in the drug underground. <br /> Bins: <br /> Dr. Ward Dean is a graduate of the U.S. Military Academy at West Point, a recently <br /> retired Navy Commander, and the former flight surgeon for the anti-terrorist Delta Force. <br /> He is currently the Medical Director of the Center for Bio-Gerontology in Pensacola, <br /> Florida. <br /> Steven Fowkes is currently the Executive Director of the Cognitive Enhancement Research <br /> Institute in Menlo Park, California. He is an organic chemist. <br /> <br />
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