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'The system has failed'.

"Few studies have sustained as It much criticism as Study 329," wrote Peter Doshi, Ph.D. In fact, an officer of the Food and Drug Administration who reviewed the trial formally in 2002 said "on balance, this trial should be considered as a failed trial, in that neither active treatment group showed superiority over placebo by a statistically significant margin." But more than 2 million prescriptions were written for children and adolescents in the United States that same year.

"The first draft of the manuscript ultimately published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) was not written by any of the 22 named authors but by an outside medical writer hired by [GlaxoSmithKline]." In addition, Dr. Martin Keller, the lead author, "had been the focus of a front-page investigation in the Boston Globe in 1999 that documented his under-reporting of financial ties to drug companies.

"For those who have been calling for a retraction of the Keller paper for many years, the system has failed. None of the paper's 22 mostly academic university authors, nor the journal's editors, nor the academic and professional institutions they belong to, have intervened to correct the record. The paper remains without so much as an erratum, and none of its authors ... have been disciplined."

Dr. Doshi is an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and an associate editor at BMJ. He declared being first author of the reanalysis under the restoring invisible and abandoned trials (RIAT) declaration, which was coauthored by Dr. David Healy, a member of the group that reanalyzed Study 329. He was a reviewer for the reanalysis manuscript and provided unpaid advice on the RIAT process before and during the submission process. He also successfully requested data from clinical study reports of Study 329 and eight other GSK studies. These comments are taken from his accompanying feature (BMJ. 2015;351:h4629. doi: 10.1136/bmj.h4629).

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Title Annotation:VIEW ON THE NEWS; failures of clinical trials
Author:Doshi, Peter
Publication:Clinical Psychiatry News
Geographic Code:1USA
Date:Oct 1, 2015
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