Wednesday, September 16, 2015

BMJ: "No correction, no retraction, no apology, no comment." A new reanalysis of the notorious Study 329 shows GSK fraud, with the complicity of Brown University and the AACAP

From Peter Doshi of the BMJ:

A major reanalysis just published in The BMJ of tens of thousands of pages of original trial documents from GlaxoSmithKline’s infamous Study 329, has concluded that the antidepressant paroxetine (Paxil) is neither safe nor effective in adolescents with depression. This conclusion, drawn by independent researchers, is in direct contrast to that of the trial’s original journal publication in 2001, which had proclaimed paroxetine “generally well tolerated and effective.” The new paper, published under the restoring invisible and abandoned trials (RIAT) initiative, has reignited calls for retraction of the original study, putting additional pressure on academic and professional institutions to publicly address the many allegations of wrongdoing.

The rest of Doshi's excellent, comprehensive editorial is here.

And the RIAT reanalysis is here.

UPDATE: The press has started to pick up the story: The Guardian, Time, and The Washington Post.

UPDATE 2: The best resource of all is the newly launched Study 329 website.

UPDATE 3.  And now the New York Times, which says:

That study — featured prominently by the journal BMJ — is a clear break from scientific custom and reflects a new era in scientific publishing, some experts said, opening the way for journals to post multiple interpretations of the same experiment. It comes at a time of self-examination across science — retractions are at an all-time high; recent cases of fraud have shaken fields as diverse as anesthesia and political science; and earlier this month researchers reported that less than half of a sample of psychology papers held up.

“This paper is alarming, but its existence is a good thing,” said Brian Nosek, a professor of psychology at the University of Virginia, who was not involved in either the original study or the reanalysis. “It signals that the community is waking up, checking its work and doing what science is supposed to do — self-correct.”

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