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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
(Related)
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announcing their decision in a press release! That's all-a press release! Based an this <br /> press release, agents of the FDA started investigating, arresting and prosecuting many <br /> health food store owners and distributors for selling an"unapproved new drug" (i.e., GHB). <br /> Some people wire promised lenient treatment if they would testify against others (the "big <br /> fish"). Some of these people went to prison, and are now branded as "convicted felons"- <br /> unable to vote, own firearms, or enjoy many of the other rights of free citizens. We will <br /> probably never know what process was followed in this decision. However, the FDA's <br /> disdain for following even their own rules and regulations had become routine operating <br /> procedure. <br /> At a recent court case at which I [WD) testified as an expert witness regarding the safety of <br /> GHB, it became evident that the government representatives in this case (prosecutors, FDA <br /> agents and FDA expert witnesses) either didn't know what they were talking about <br /> regarding GHB (which I have a hard time believing) or were deliberately lying (the only <br /> reasonable alternative). <br /> In previous, similar GHB cases, the prosecution (the Justice Department) attempted to <br /> portray GHB as a Schedule I controlled substance (a drug that has no medical uses, with a <br /> strong potential for addiction and abuse-like heroin). Federal prosecutors withheld <br /> knowledge from the defense of the existence of a number of Investigational New Drug <br /> Applications (INDs) for GHB on the rationale that they "contained no relevant <br /> information." Years later, after a number of people had spent considerable time in prison, <br /> higher courts ruled against the withholding of these INDs, overturned many of the GHB <br /> convictions, and forced the FDA to submit copies of all INDs to the courts for inclusion in <br /> still-pending trials, or re-trial of overturned cases. <br /> The GHB INDs were telling. Instead of corroborating the FDA's views and the testimony <br /> of government expert witnesses, the INDs flatly contradicted them. GHB was repeatedly <br /> described, in IND after IND, as a safe, non-toxic, non-addictive substance, with an <br /> extremely wide margin of safety. With the INDs in evidence, the prosecution is having a <br /> hard time convincing either judge or jury of the dangers of GHB. With the growing <br /> realization that GHB was never properly classified as a drug, and that it now fits the <br /> Federal legal def?nition of a food supplement, the judicial system is recognizing that it bas <br /> been "had" by the FDA. One of the FDA's expert witnesses who recently testified as to the <br /> dangers of GHB was forced to admit that she had never seen a single patient who had taken <br /> GHB. <br /> As the FDA's GHB convictions are unraveling at the seams-with at least one US <br /> government attorney in jeopardy of being disbarred because of prosecutorial misconduct in <br /> these GHB cases-the FDA has adopted several, new, "end-run" tactics. They have shifted <br /> emphasis in the anti-GIiB crusade from the courts to the media. FDA, DEA and police <br /> <br /> agents are telling reporters that GHB is a dangerous, lethal and addictive drug; that it is an <br /> illegal "designer" drug; and that it is a "date rape" drug. Such "expert" opinions have <br /> <br /> propagated a plethora of hysterical articles in the popular (and even medical) press to <br /> <br />
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