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Where's the Evidence?Debates in Modern Medicine$
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William A. Silverman

Print publication date: 1999

Print ISBN-13: 9780192630889

Published to Oxford Scholarship Online: September 2009

DOI: 10.1093/acprof:oso/9780192630889.001.0001

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Unbridled enthusiasm

Unbridled enthusiasm

Chapter:
(p.66) 17 Unbridled enthusiasm
Source:
Where's the Evidence?
Author(s):

William A. Silverman

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780192630889.003.0017

This chapter presents a 1991 commentary on restrictions on new treatments. The Kefauver-Harris Amendments to the US, Food and Drug Cosmetics Act in 1962 spelled out unprecedented requirements for proof of safety and efficacy in well-controlled clinical trials before a new drug is released for general use. AIDS patients have expressed strong opposition to these restrictions. The demand for regulation has raised concerns about a possible return to the past — a time of uninhibited therapeutic exuberance.

Keywords:   clinical trials, AIDS, new treatments, Kefauver-Harris Amendments, regulation

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