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    The FDA requires only two studies show positive results to approve a drug


    Posted by .(JavaScript must be enabled to view this email address)
    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.

    Video

    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

    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
    617.384.8564 phone
    617.384.8555 fax
    http://connects.catalyst.harvard.edu/profiles/profile/person/96221
    .(JavaScript must be enabled to view this email address)

    Dr. Kirsch’s Book

    Dr. Kirsch’s Book about the antidepressant myth

    The Emperor’s New Drugs: Exploding the Antidepressant Myth

    Articles on the same subject can be found here:


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