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Research Article

Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation

  • Kristin Rising,

    Affiliation: School of Medicine, University of California San Francisco, San Francisco, California, United States of America

    ยค Current address: Department of Internal Medicine, Boston Medical Center, Boston, Massachusetts, United States of America

    X
  • Peter Bacchetti,

    Affiliation: Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, United States of America

    X
  • Lisa Bero mail

    To whom correspondence should be addressed. E-mail: berol@pharmacy.ucsf.edu

    Affiliation: Clinical Pharmacy and Health Policy, University of California San Francisco, San Francisco, California, United States of America

    X
  • Published: November 25, 2008
  • DOI: 10.1371/journal.pmed.0050217

Reader Comments (4)

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The FDA silence is very loud

Posted by plosmedicine on 31 Mar 2009 at 00:32 GMT

Author: david egilman
Position: clinical associate prof
Institution: Brown University
E-mail: degilman@egilman.com
Submitted Date: November 26, 2008
Published Date: November 27, 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 FDA knows everything that Bero published is true. In fact as Rosenheck has shown, when the FDA concludes that sponsor studies are worthless they remain silent when sponsors publish these bogus results with false claims of efficacy. [Rosenheck, International Journal of Law and Psychiatry 28 (2005) 467–483] .

There is no excuse for this silence which has resulted in untold death disabilty and of course, profits.

No competing interests declared.