Re-analysis of controversial Paxil study shows drug 'ineffective and unsafe' for teens
You can subscribe to Retraction Watch blog and get several reports a week about research plagiarism, obfuscation, deception. . . and more. The blog was launched in August 2010 and is produced by science writers Ivan Oransky, Editorial Director of MedPage Today and Adam Marcus, editor of Gastroenterology & Endoscopy News. I, for one, have been astounded by the number of retractions, not to mention the amount of fraud. Retraction Watch is well documented and often high drama. In the case of this Paxil study, it is also important.
We can hope that someday the Times will show a similar concern for individuals who commit education fraud. But for that to happen,first, they need to recognize the fraud--instead of applauding it in their editorial pages.
by Retraction Watch Staff
The antidepressant Paxil isn't safe or effective for teens after all, says a re-analysis of a 2001 study published today in The BMJ.
The original 2001 paper in Journal of the American Academy of Child and Adolescent Psychiatry -- study 329, as it's known -- helped greenlight use of the drug (generically known as paroxetine) in young people. But it's faced accusations of ghostwriting, undisclosed conflicts of interest, and issues with data analysis since publication.
According to BMJ feature, also published today:
And over the years, many researchers have called for the retraction of the 2001 paper, a stance bolstered by the new paper.
The new analysis in BMJ includes documents that were previously confidential, such as "about 77,000 pages of de-identified individual case report forms" posted by GSK "after negotiation." It concludes:
The new paper found a discrepancy between instances of harm listed in the appendix of the original paper, and those reported on case report forms:
The original paper also downplayed the harm that they did report, according to the BMJ authors. The first author of the original paper, and the accompanying clinical study report:
The original paper, Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial, was cited 334 times, according to Thomson Scientific's Web of Knowledge. It found:
In a two-page statement [ PDF] sent to us by Martin Keller, first author on the original paper and a Professor Emeritus of Psychiatry and Human Behavior at Brown University, nine of the 22 authors voice "strong disagreement" with the reanalysis. They take issue with critiques of sponsor involvement, the analysis of side effects, and the charge that it was ghostwritten (the "report was authored mainly by the academic investigators with industry collaboration," they write.) Ultimately, they conclude
The BMJ feature authored by the journal's associate editor, Peter Doshi, highlights the swift disconnect in the early '00s between the skepticism of the trial, and the glowing version of Paxil presented to the public:
On study329.org, the authors of the new paper detail attempts to have the original paper retracted. Those have been unsuccessful, The BMJ feature explains:
The current editor of JAACAP, Andres Martin, has stood by the paper, notably in an assembly of the American Academy of Child and Adolescent Psychiatry, which publishes the journal, last October. The BMJ feature reports:
However, there's no public information about that investigation:
The BMJ even interviewed our own Ivan Oransky (under embargo):
We contacted Martin for this piece ourselves, and will update if we hear back.
In response to a call for retraction addressed to Brown University, The BMJ feature reports that Edward Wing, former dean of medicine and biological sciences, wrote in 2011:
That does not shock the leadership here at Retraction Watch, as The BMJ reports:
We contacted the Brown communications office, and will update this post if we hear back.
The paper is the first publication of a BMJ initiative called Restoring invisible and abandoned trials (RIAT), designed to open up conversations with old data. But its success will depend on who else is willing to talk -- BMJ co-author Joanna Le Noury told us that, in this and future RIAT cases, reanalysis:
An editorial in BMJ entitled Liberating the data from clinical trials, also published today, notes that reanalysis is rare, and often revealing:
As for the status of the original Study 329, BMJ co-author John Nardo told us:
Staff with Ohanian Comment
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