this article is a classic... The Emperor's New Drugs

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http://journals.apa.org/prevention/volume5/pre0050023a.html

 

Prevention & Treatment, Volume 5, Article 23, posted July 15, 2002

Copyright 2002 by the American Psychological Association

 

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The Emperor's New Drugs: An Analysis of Antidepressant Medication

Data Submitted to the U.S. Food and Drug Administration

Irving Kirsch

University of Connecticut

 

Thomas J. Moore

The George Washington University School of Public Health and Health

Services

 

Alan Scoboria and Sarah S. Nicholls

University of Connecticut

 

 

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ABSTRACT

 

This article reports an analysis of the efficacy data submitted to

the U.S. Food and Drug Administration for approval of the 6 most

widely prescribed antidepressants approved between 1987 and 1999.

Approximately 80% of the response to medication was duplicated in

placebo control groups, and the mean difference between drug and

placebo was approximately 2 points on the 17-item (50-point) and 21-

item (62-point) Hamilton Depression Scale. Improvement at the highest

doses of medication was not different from improvement at the lowest

doses. The proportion of the drug response duplicated by placebo was

significantly greater with observed cases (OC) data than with last

observation carried forward (LOCF) data. If drug and placebo effects

are additive, the pharmacological effects of antidepressants are

clinically negligible. If they are not additive, alternative

experimental designs are needed for the evaluation of antidepressants.

 

Keywords: drug efficacy, placebo, meta-analysis, depression