FDA Standards -� Good Enough for Government Work?

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21 Sep 2005 20:54:22 -0000

Health Supreme Update: FDA Drug Approval Standards Challenged

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((((( Health Supreme Update: FDA Drug Approval Standards Challenged

)))))

 

September 21, 2005

 

 

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The FDA, in evaluating new drugs for approval, does not require

that these drugs be any better than existing drugs, even if

their costs are several times higher than those of currently

available medicines. Typically, trials compare the new drug

against a placebo. Keep in mind that placebos are specifically

formulated for each trial by the same company that does the

drug trial and that the composition of a placebo is neither

standard nor is it usually disclosed. (See: Prescribing a

placebo) Incredibly, the FDA neither performs a formal

risk-benefit analysis on drugs it approves. Is it any wonder

that medicines have become a major cause of death in the in the

western world? The New England Journal of Medicine, in a recent

article, challenges the wisdom of such lax approval standards.

 

FDA Standards - Good Enough for Government Work?

http://content.nejm.org/cgi/content/full/353/10/969

 

 

 

 

 

 

 

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http://www.newmediaexplorer.org/sepp/2005/09/21/fda_drug_approval_standards_chal\

lenged.htm

 

 

 

 

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