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  Vol. 295 No. 17, May 3, 2006 TABLE OF CONTENTS
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How the US Drug Safety System Should Be Changed

Brian L. Strom, MD, MPH

JAMA. 2006;295:2072-2075.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

If the whole materia medica, as now used, could be sunk to the bottom of the sea, it would be all the better for mankind, and all the worse for the fishes.—Oliver Wendell Holmes, Sr1

Reading a recent newspaper might remind one of the above quote. One of the questions the nation is currently confronted with is what should be done to address the safety of drugs. In this Commentary, the current system of drug safety monitoring will be described and the limitations of the current system will be highlighted. A potential solution will then be proposed that will require legislation to implement.

Current System of Drug Safety Monitoring

The current system of drug safety monitoring includes preclinical testing followed by 3 phases of clinical studies (Figure). Drug approval is sometimes followed by postmarketing studies. Usually, only 500 to 3000 patients are studied before marketing. Therefore, by definition, . . . [Full Text of this Article]

Author Affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia.



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