a time for change…

Posted on Tuesday 2 August 2016

blog to follow soon

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:

  1. In a letter of May 9, 2016, the Journal’s editor, Dr. Robert Freeman, was asked by three of the undersigned, Drs. Jureidini, Amsterdam and McHenry, to retract the article, but he has curtly refused to do so.
  2. In an email of July 11, 2016, Drs. Jureidini, Amsterdam and McHenry wrote to the former editor of the American Journal of Psychiatry who accepted the Wagner et al manuscript for publication, Dr. Nancy Andreasen, and asked her to support retraction of the article, but she did not respond.
  3. Drs. Jureidini, Amsterdam and McHenry submitted for publication a letter to the editor of the Psychiatric News, Catherine F. Brown, on July 7, 2016 regarding the misrepresentations of Dr. Wagner on CIT-MD-18 and received no response.
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.
  1.  
    Brett Deacon
    August 3, 2016 | 6:13 PM
     

    John Ioannidis isn’t the only one who deserves a special seat in Heaven for fighting the good fight. Outstanding work!

  2.  
    Cate Mullen
    August 3, 2016 | 7:52 PM
     

    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

  3.  
    Woody Harriman
    August 3, 2016 | 9:40 PM
     

    Amen, Brothers & Sisters!!

  4.  
    James OBrien, M.D.
    August 4, 2016 | 1:03 AM
     

    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.

  5.  
    Susan Molchan
    August 4, 2016 | 9:59 AM
     

    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 : )

  6.  
    August 4, 2016 | 2:59 PM
     

    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…

  7.  
    Philip Benjamin
    August 6, 2016 | 6:45 AM
     

    Congratulations Jon Juriedini for being the lone Australian voice in this matter

  8.  
    August 7, 2016 | 2:23 PM
     

    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

  9.  
    August 7, 2016 | 3:54 PM
     

    Philip Benjamin,

    Amen. For a long time, Jon was almost the lone voice in the world!

  10.  
    August 7, 2016 | 11:28 PM
     

    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”…

  11.  
    August 8, 2016 | 12:52 PM
     

    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

  12.  
    James OBrien, M.D.
    August 12, 2016 | 4:38 PM
     

    I guarantee that the APA brass will handle it with “civility” since that is their most highly treasured value. That was not a compliment.

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