blog to follow soon
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Maria A. Oquendo, M.D.
President, American Psychiatric Association
Columbia University Medical Center
300 West 72nd Street
Suite 1F
New York, NY 10023
RE: CIT-MD-18, Wagner et al., ‘A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents.’ Am J Psych 2004; 161 (6): 1079-1083. Dear Dr. Oquendo, We write to you as President of the American Psychiatric Association, and as a staunch supporter of ethics in psychiatry, about our concerns regarding gross misrepresentations made in the above referenced journal article published in the American Journal of Psychiatry in 2004 and reiterated recently in comments that appeared in the American Psychiatric Association’s Psychiatric Newsiv discussing the same clinical trial in 2016. Specifically, between January 2000 and April 2001 Forest Laboratories, Inc., conducted a multi-site clinical trial of citalopram for depression in children and adolescents, Protocol CIT-MD-I8, IND Number 22,368, with the results published in 2004 by Wagner et al. in the American Journal of Psychiatry. The article was ghostwritten by agents of the manufacturer and seriously misrepresented both the effectiveness and the safety of citalopram in treating child and adolescent depression. While substantive problems with CIT-MD-18 and the Wagner et al. article have been exposed in legal actionsi and in the medical literature,ii,iii the article continues to be cited uncritically in the psychiatric literature as evidence of the efficacy of citalopram for treatment of adolescent depressioniv when, in fact, it was no better than placebo. Our main concern is that children and adolescents are continuing to be harmed because well-intentioned physicians have been misled. Moreover, the misrepresentation has been compounded by the following issues:
The putative research misconduct involved in the CIT-MD-18 study reveals the pervasive influence of Forest’s marketing objectives on the preparation and publication of a ‘scientific’ manuscript written primarily for marketing purposes and only secondarily as a peer-reviewed journal article. Forest’s own internal documents disclosed in litigation show that company staff were aware that there were serious problems with the conduct of this trial but concealed the problems in advancing their commercial objectives. Procedural deviations went unreported (failure to disclose that unblinded patients were included in the final outcome analyses contrary to the study protocol in order to impart statistical significance to a non-significant primary outcome measure). An implausibly large effect size was claimed. Positive post hoc measures were introduced while negative primary and secondary outcomes were not reported. Adverse events were misleadingly analyzed, hiding substantial agitation in the citalopram group. Many of the de-classified Forest documents have now been posted on the Drug Industry Document Archive (DIDA) at the University of California, San Francisco, and many more documents are in the process of being released into the public domain.
We believe that the unretracted Wagner et al. article represents a stain on the high standard of the American Journal of Psychiatry (AJP) and the American Psychiatric Association (APA). Neither the AJP nor the APA can claim to be a leader in scientific research and moral integrity while failing to redress this article that negligently misrepresents scientific findings. In bringing this matter to your attention, we also ask that you write to the current editor of the American Journal of Psychiatry, Dr. Robert Freedman, supporting our request for retraction of Wagner et al. journal article. We are making this letter available to interested parties and for possible posting in the public domain. Yours sincerely Jay D. Amsterdam, MD
Emeritus Professor of Psychiatry
Distinguished Life Fellow of the American Psychiatric Association
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania
Jon N. Jureidini, MB, PhD
Clinical Professor
University of Adelaide
Adelaide, Australia
Leemon B. McHenry, PhD
Lecturer, retired
Department of Philosophy
California State University, Northridge
Northridge, California
David Healy, MD, FRCPsych
Professor of Psychiatry
Department of Psychological Medicine
Bangor University
Bangor, Wales, UK
Bernard J. Carroll, MBBS, PhD, FRCPsych
Emeritus Professor and Chairman
Department of Psychiatry and Behavioral Sciences
Duke University Medical Center
Durham, North Carolina
John M. Nardo, MD
Assistant Professor, retired
Department of Psychiatry
Emory University
Atlanta, Georgia
Thomas A. Ban, MD, FRCP(C)
Emeritus Professor of Psychiatry
Distinguished Life Fellow of the American Psychiatry Association
Vanderbilt University
Nashville, Tennessee
Mark Kramer, MD, PhD
ENEKASUNO, LLC
Executive Vice President, C.O.O
Medical Oncology Research
Madrid and Barcelona, Spain
Daniel Carlat, MD
Associate Clinical Professor of Psychiatry
Tufts University School of Medicine
Boston, Massachusetts
Publisher and Editor-in-Chief
The Carlat Psychiatry Report
daniel.carlat@gmail.com
Samuel Gershon, MD, FRCP
Emeritus Professor of Psychiatry
University of Pittsburgh
Pittsburgh, Pennsylvania
Robert T. Rubin, MD, PhD
Distinguished Professor Emeritus
Distinguished Life Fellow of the American Psychiatric Association
Department of Psychiatry and Biobehavioral Sciences
David Geffen School of Medicine
UCLA
Los Angeles, California
James G. Williams, PhD
Emeritus Professor of Religion
Syracuse University
Syracuse, New York
Barry Blackwell, MD
Emeritus Professor and Chairman
Department of Psychiatry
Milwaukee Clinical Campus
University of Wisconsin School of Medicine
Milwaukee, Wisconsin
Edmund C. Levin, MD
Distinguished Life Fellow and Diplomate of the American Psychiatric Association Senior Life Fellow and Diplomate of the American Academy of Child and Adolescent Psychiatry
Department of Psychiatry
Alta Bates Medical Center
Berkeley, California
Steven A. Ager, MD, MS, DLFAPA, FCPP
Adjunct Clinical Associate Professor of Psychiatry
School of Medicine
Temple University
Philadelphia, Pennsylvania
Julie M. Zito, PhD
Professor of Pharmacy and Psychiatry
University of Maryland, Baltimore
Baltimore, Maryland
i United States v. Forest Pharmaceuticals, Inc., Cr. No. 10-10294-NG (D. Mass.); Celexa and Lexapro Marketing and Sales Practices Litigation: Master Docket 09-MD-2067-(NMG)
ii Martin A, Gilliam WS, Bostic JQ, Rey JM. Letter to the editor. Child psychopharmacology, effect sizes, and the big bang. Am J Psych 2005; 162 (4): 817;
iii Jureidini J, Amsterdam J, McHenry L. The citalopram CIT-MD-18 pediatric depression trial: A deconstruction of medical ghostwriting, data manipulation and academic malfeasance,” International Journal of Risk & Safety in Medicine, 28, 2016: 33-43
iv Levin, A. Child psychiatrists look at specialty from both macro, micro perspectives. Psychiatric News, 51/12, June 17, 2016: 23.
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John Ioannidis isn’t the only one who deserves a special seat in Heaven for fighting the good fight. Outstanding work!
Someone might want to check into the surgeon general’s clinical trial work and developments. He has an MBA and is listed as wanting to decrease the stigma of mental illness
Always a red flag for me
Amen, Brothers & Sisters!!
I’m sure the APA will refer this to the genius archangels on the committee that “investigated” ethics of the DSM 5 financial COI.
As a betting man, my money would be on a James Comey whitewash full of pompous sophistry that fools no one.
Sounds like you’ve been heard. Are we turning a corner? (probably not but it’s nice to think about) https://www.statnews.com/pharmalot/2016/08/02/psychiatry-retraction-antidepressants/
Great effort : )
so, you are on vacation, release this letter while away, and now what?
Akin to a White House release on a Friday Holiday weekend???
Besides, where’s the hypocrisy of the APA members cosigned above?!
Bigger fish to fry, folks…
Congratulations Jon Juriedini for being the lone Australian voice in this matter
You have censored my last comment, so, I am out here, I would hazard to guess most other commenters are glad.
Preaching to choirs is fun for the author, but, do you want genuine debate and fair dissent, or just echoes?
Besides, this horse of pharmaceutical chicanery is so dead, even the vultures have left the building.
And, it is disingenuous to cite people who I assume are active in the APA challenging the APA who are part of this dynamic of lies, deceit, and putting the public at risk.
YOU KNOW THAT DR NARDO, yet, you wipe out my opinion.
Thank you for the opportunity to comment in the past, be safe, be well, and be of value as you can.
Sincerely,
Joel Hassman, MD
Philip Benjamin,
Amen. For a long time, Jon was almost the lone voice in the world!
Joel,
I hold your comments until I read them first to eliminate political comments. I do that for reasons I’ve mentioned to you before. I was out of town and didn’t review them until I returned this evening. And, by the way, pharmacologic chicanary is likely to be the ongoing topic here. As it says at the top of the page, “1boringoldman”…
Appreciate the clarification, but, I feel it discriminatory, so to be frank but respectful, I defer to no longer participate in a blog that others have posted comments which remain that have been as much if not more abrasive, as I accept I can be at times.
I call it as I see it, Dr N, sorry that is not acceptable to you. Again, wish you well with your blog, thanks for the memories.
Sincerely,
Joel H
I guarantee that the APA brass will handle it with “civility” since that is their most highly treasured value. That was not a compliment.