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Research Article

Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration

  • Irving Kirsch mail,

    To whom correspondence should be addressed. E-mail: i.kirsch@hull.ac.uk

    Affiliation: Department of Psychology, University of Hull, Hull, United Kingdom

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  • Brett J Deacon,

    Affiliation: University of Wyoming, Laramie, Wyoming, United States of America

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  • Tania B Huedo-Medina,

    Affiliation: Center for Health, Intervention, and Prevention, University of Connecticut, Storrs, Connecticut, United States of America

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  • Alan Scoboria,

    Affiliation: Department of Psychology, University of Windsor, Windsor, Ontario, Canada

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  • Thomas J Moore,

    Affiliation: Institute for Safe Medication Practices, Huntingdon Valley, Pennsylvania, United States of America

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  • Blair T Johnson

    Affiliation: Center for Health, Intervention, and Prevention, University of Connecticut, Storrs, Connecticut, United States of America

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  • Published: February 26, 2008
  • DOI: 10.1371/journal.pmed.0050045

Reader Comments (47)

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A spoonful of sugar

Posted by plosmedicine on 31 Mar 2009 at 00:22 GMT

Author: Philip Cowen
Position: Professor of Psychopharmacology
Institution: University of Oxford
E-mail: phil.cowen@psych.ox.ac.uk
Submitted Date: March 01, 2008
Published Date: March 3, 2008
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

The most remarkable aspect of the paper of Kirsch et al has been its stellar media reception. The message of the paper was hardly news; the high frequency of failed clinical trials of antidepressants in the FDA database has been known for many years and widely commented on. Clinically it is important to recognise that such trials are carried out for regulatory purposes and bear only a passing resemblance to the real world. To measure how well antidepressants work in clinical practice requires pragmatic effectiveness studies, which were not, of course, the subject of the article. One would have hoped that this caveat would have encouraged the authors and editors, in the usual way of good scientific practice, to recommend caution in extrapolating their findings; presumably, however, they thought this unnecessary.

What cultural factors could have led the media to accord this somewhat limited paper the status of a divine revelation? An important issue must be the present standing of drug companies who now compete (largely through their own making) with Osama Bin Laden and clearing banks in public affection. What could be easier (or more gratifying) than to accept this account as yet another example of snake oil salesmanship to the unwary.

Unfortunately the paper also plays to a more insidious and egregious phenomenon, discrimination against the mentally ill. What Kirsch et al really show from this database is not that antidepressants don’t work in the FDA trials (most patients seem to do well) but rather that patients with depression, even of a severe nature, respond well to a sugar pill. What could trivialise severe depression more, or show less respect to its sufferers? Patients who have the courage to speak out and explain how they have been helped by antidepressants can now be patronised and stigmatised to an even greater extent.

Promoting the efficacy of sugar pills in the treatment of moderate to severe depression has another implication. Generally for this range of disorders, cognitive therapy and antidepressants are about equally effective. Therefore if Kirsch et al are correct there seems little point in spending large sums of money funding psychological treatments when all that is needed for the management of severe depression is the prescription of sugar pills. This startling and economically important conclusion seems to have eluded both authors and editors in their haste to discredit the real experts, depressed people themselves.

Competing interests declared: I am a Professor of Psychopharmacology and have advised Pharmaceutical companies on the psychopharmacology of new antidepressants.