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 Nonetheless, the paper has never been retracted and the universities whose academics were listed as co-authors failed to rebuke the authors.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.
The damage continues to be perpetuated by one of the largest parent support groups for parents of kids w mental health issues–and are very pro-med—look at their scientific advisory board: http://www.thebalancedmind.org/about/staff/cabf-scientific-advisory-council you will find many of the names listed in the article referenced in this article by Mickey.
Alongside Joseph Biederman the king pin of bipolar drugging fame….
(the parent site used to be CABF).
You ask the question: Who hasn’t heard of study 329? Even after the recent judgement against Glaxo, I don’t think the real implications of ghost writing and inflated efficacy are widely known. Those of us who have been personally affected by SSRI are very aware of the problem. The people who could make substantive changes to the approval and scientific process still support these drugs wholeheartedly.
I felt the same way about Paxil before I tried to stop taking it. I absolved it of all responsibility for the problems I was having. The regular drumbeat of depression that I experienced every 4-6 weeks for 10 years, the weight gain, the loss of cognition, lowered self awareness, my insular attitude, lack of empathy. The list is too long for a blog comment. All of those things are slowly tapering away as I taper off Paxil.
My pipe dream is that regulators and doctors would take SSRI for a year, then try to wean off of them using their own schedule. Not because I wish them that kind of pain, but I think it would do more to change minds than any settlement or testimony.
Maybe Glaxo CEO, Andrew Witty, should call for its retraction…it is, after all, part of an “era” that he wants to bury, which is kind of ironic considering the suicide data was buried from 329.
Fid,
That’s actually not a bad idea!
I already drew up a template for him Mickey, all he [Witty] has to do is sign it. – http://fiddaman.blogspot.co.nz/2012/08/glaxos-andrew-witty-and-paxil-329.html
Fid also has one for the American Academy of Child and Adolescent Psychiatrists:
http://fiddaman.blogspot.co.nz/2012/08/email-to-editor-of-jaacap-re-paxil-329.html
Yup, they never answered.
Excellent work, Fid.
Another shining example of how academic psychiatry is exemplary in its passionate efforts at failing at its primary task: teaching its students what is right versus wrong.
Residency for anyone with a soul must be like walking through a minefield in hell.
Except you don’t blow up, just get embraced by the minions of the lair!
I don’t think that academic psychiatry’s primary task is teaching its students what is right versus wrong. In 1946, the psychiatrist, and Canada’s first Deputy Minister of Health, Brock Chisholm, laid the founding belief of psychiatry….”The reinterpretation and eventual eradication of the concept of right and wrong….are the belated objectives of practically all effective psychotherapy…The fact is that most psychiatrists and psychologists and many other respectable people have escaped from these moral chains and are able to observe and think freely…if the race is to be freed from its crippling burden of good and evil, it must be psychiatrists who take the original responsibility. This is a challenge which must be met”. (quoted from “Law, Liberty and Psychiatry” by Thomas Szasz)
Hello, I understand your interest in keeping kids safe. I have devoted my life to this cause. However, the people writing comments on this post, and the links listed above, are clearly written by people who have NEVER dealt with suicidal and severely depressed kids.
Until you do, and you really understand and have REAL facts (not just your clueless interpretation of “right and wrong”), please don’t make posts on these sites.
You say this is article is discredited – Who are you to decide this? Who stated this was “written by a ghost writer”? I feel confident in stating that a “ghost writer” could contribute, but they could never write this. It takes decades to become a scientist and write at this level.
This whole post, and the associated links, are written by people with opinions, but not with experience in working with depressed kids, and certainly not by people who understand this field.
Clueless,
You say this article is discredited – Who are you to decide this? Who stated this was “written by a ghost writer”? I feel confident in stating that a “ghost writer” could contribute, but they could never write this. It takes decades to become a scientist and write at this level.
You are either naive or sadly uninformed. The ghost-writer was Sally Laden, Pharm-D [Scientific Therapeutics Information]. The decider in the most recent suit was the DOJ and the cost was high [Biggest Deal Ever: Glaxo Pays $3B For Bad Behavior]. And as for me, the author of this blog, I am a 70 y/o Internist, Psychiatrist, Psychoanalyst currently seeing adolescents at a C&A Clinic. You might try doing a little more research before your next sermon…