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Saturday November 21, 2009 |
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Review by FDA Committee of Potential Treatment for Lupus January 28, 2002 - 1:46 PM by Head News Manager | Category:
Genitourinary Conditions |
On April 19, 2001, the FDA's Arthritis Advisory Committee considered data for a synthetic DHEA (dehydroepiandrosterone) product
submitted by Genelabs Technologies' (Redwood City, CA) as a treatment of systemic lupus erythematosus, a serious autoimmune
condition for which there are few and limited treatments. The meeting largely pitted clinicians against an FDA statistical review
that repeatedly characterized Genelabs' data as "not statistically significant," especially for adverse events when compared with
placebo. The really odd (and fishy) thing about this meeting was that the FDA did not ask the Arthritis Advisory Committee to
vote, thus avoiding a formal recommendation. This is considered highly unusual. We fear that this indicates the FDA will use any
ploy to avoid approving DHEA for the treatment of any disease. The FDA well knows that DHEA is available as a dietary supplement
and that the courts support First Amendment protection of the communication of truthful information about the effects of dietary
supplements. Lost in the FDA's calculations is the suffering of lupus victims.<br><br>-- Nature Biotechnology 19:500 (2001)
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Source: Review by FDA Committee of Potential Treatment for Lupus
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