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The FDA requires only two studies show positive results to approve a drug
Sunday, August 14, 2016 9:50 am Email this article
The US Food and Drug Administration (FDA) will approve an antidepressant or any other drug if only two trials show positive results, regardless of whether there are numerous other studies showing that the drugs are no more effective than a placebo. This fact was noted on the television show "60 MInutes" on Sunday, February 19, 2012 (8.5-minutes into the video).
"To approve any drug, the [US] Food and Drug Administration merely requires that companies show their pill is more effective than a placebo in two clinical trials even if many other drug trials failed," 60-Minutes correspondent, Lesley Stahl noted.
"The FDA for antidepressants has a fairly low bar. A new drug can be no better than placebo in ten trials, but if two trials show its better, it gets approved," noted Walter Brown, MD, Clinical Professor of Psychiatry at Brown University’s School of Medicine.
"That's not the way I would do it if I were King," Dr. Brown noted.
The video can be viewed here
The 14-minute video is posted here.
This article was originally published on Feb 23, 2012.
About Irving Kirsch, PhD
Irving Kirsch, PhD: Associate Director of the Harvard-wide Program in Placebo Studies
Here is description of Irving Kirsch from the Harvard-wide Program in Placebo Studies
“Irving Kirsch, PhD, is a faculty member at Harvard Medical School and Professor Emeritus of Psychology at the University of Hull, United Kingdom, and the University of Connecticut. Irving is noted for his research on placebo effects, antidepressants, expectancy and hypnosis. He is the originator of response expectancy theory and his analyses of clinical trials of antidepressants have influenced official treatment guidelines in the United Kingdom.
“Irving received his PhD in psychology from the University of Southern California in 1975. In 1975, he joined the psychology department at the University of Connecticut, where he worked until 2004, when he became Professor of Psychology at the University of Plymouth. He moved to the University of Hull in 2007 and joined the faculty of the Harvard Medical School in 2011.”
Contact Info for Irving Kirsch, PhD
Irving Kirsch, PhD
Harvard Medical School
Educ & Glob Prog Admin c/o Sally Andrews
641 Huntington Ave
Boston, MA 02115
Dr. Kirsch’s Book
Dr. Kirsch’s Book about the antidepressant myth
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