FDA Drug Approval Standards Challenged
CategoriesThe 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 western world? The New England Journal of Medicine, in a recent article, challenges the wisdom of such lax approval standards.
My proposal: Let's start by comparing drugs not with placebo but with the best known previous treatment - be it another drug, be it specific nutritional support, or a herbal or other intervention. We might actually learn something about the real efficacy or lack of it of new drugs that way. And let's also evaluate the side effects against the actual increase in efficacy over previous treatments. Now that would be an idea!
FDA Standards - Good Enough for Government Work?
posted by Sepp Hasslberger on Wednesday September 21 2005
updated on Tuesday September 27 2005URL of this article:
http://www.newmediaexplorer.org/sepp/2005/09/21/fda_drug_approval_standards_challenged.htm
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