Disavow A Paxil Study Once And For All?
By Ed Silverman
August 7th, 2012
A decade ago, the Journal of the American Academy of Child and Adolescent Psychiatry published a paper concluding that the Paxil antidepressant, which is sold by GlaxoSmithKline, was “generally well tolerated and effective for major depression in adolescents” [here it is]. But the study has since been discredited amid charges that primary and secondary outcomes were conflated, selective results were reported and ghostwriting was involved. Nonetheless, the paper has never been retracted and the universities whose academics were listed as co-authors failed to rebuke the authors. One example: Brown University, which declined to take action concerning lead author and psychiatrist Martin Keller. Dalhousie University similarly declined to take any action regarding psychiatry professor Stan Kutcher, who was another of the 22 listed co-authors on what was known as Study 329.
What might it take for any of the universities to change their insitutitional minds? Apparently, not a guilty plea by Glaxo as part of a $3 billion settlement for illegal marketing and misbranding offenses. As part of the deal, the feds charged the drugmaker prepared, published and distributing a misleading medical journal article that misreported that a Paxil clinical trial demonstrated efficacy in treating depression in patients under age 18, when the study failed to demonstrate efficacy. This was Study 329, which has been plagued by ghostwriting charges. Yet, as The Chronicle of Higher Education writes, the universities, the medical journal, and the federal government have so far avoided questions about whether they should finally take or force corrective or punitive action. “At this moment I don’t have any comment,” Andres Martin, a professor of psychiatry at Yale University and editor in chief of the journal, tells the paper. While he says the journal is still considering its options, he declined to say when a decision would be made. Meanwhile, Brown University remains indifferent to the guilty plea. Christina Paxson, who became Brown president on the same day the deal was announced, does not see any reason for further action, a spokeswoman tells the Chronicle. “The recent announcement by the US Department of Justice did not suggest that any further reviews of the paper by the university are immediately warranted,” the spokeswoman says…
The Journal’s purpose is to advance research, clinical practice, and theory in child and adolescent psychiatry. It is interested in manuscripts from diverse viewpoints, including genetic, epidemiological, neurobiological, cognitive, behavioral, psychodynamic, social, cultural, and economic. Studies of diagnostic reliability and validity, psychotherapeutic and psychopharmacological treatment efficacy, and mental health services effectiveness are encouraged. The Journal also seeks to promote the well-being of children and families by publishing scholarly papers on such subjects as health policy, legislation, advocacy, culture and society, and service provision as they pertain to the mental health of children and families.
Martin J. Drell M.D.Head, Section of Infant, Child and Adolescent PsychiatryLSU-Health, New Orleans, LA.
Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial
by MARTIN B. KELLER, M.D., NEAL D. RYAN, M.D., MICHAEL STROBER, PH.D., RACHEL G. KLEIN, PH.D., STAN P. KUTCHER, M.D., BORIS BIRMAHER, M.D., OWEN R. HAGINO, M.D., HAROLD KOPLEWICZ, M.D., GABRIELLE A. CARLSON, M.D., GREGORY N. CLARKE, PH.D., GRAHAM J. EMSLIE, M.D., DAVID FEINBERG, M.D., BARBARA GELLER, M.D., VIVEK KUSUMAKAR, M.D., GEORGE PAPATHEODOROU, M.D., WILLIAM H. SACK, M.D., MICHAEL SWEENEY, PH.D., KAREN DINEEN WAGNER, M.D., PH.D., ELIZABETH B. WELLER, M.D., NANCY C. WINTERS, M.D., ROSEMARY OAKES, M.S., AND JAMES P. MCCAFFERTY, B.S.
Journal of the American Academy of Child and Adolescent Psychiatry, 2001, 40(7):762–772.