August 27

ACNP Journal Editor Quits Amid Exposure of Conflicts of Interest

The resignation comes after the Wall Street Journal reported that the authors of research review article in the ACNP journal had concealed conflicts of interest. [1] https://ahrp.org/cms/content/view/295/55/ 

Furthermore, the article appears to have been ghostwritten by a writer paid by Cyberonics’ communication management company. The lead author was the journal’s editor in chief. The New York Times described the relationship in an editorial as, "incestuous." https://ahrp.org/cms/content/view/301/55/

Dr. Nemeroff, chairman of Psychiatry at Emory, a past president of the ACNP, is not an outlier in the profession. Indeed, Dr. Nemeroff and the ACNP are
the key opinion leaders in psychiatry whose influence on research and treatment paradigms in psychiatry are the bedrock of this primarily commercial enterprise.

The case represents a microcosm of Biological psychiatry and its failure to rise to the level of a science-based medical discipline. Neither its diagnostic guide (DSM-IV), nor treatment guidelines (TMAP) are based on any validated scientific standards of professional judgment–they are based on the financial interests of those who write the standards. [2] https://ahrp.org/cms/content/view/143/55/

Most importantly, when this case is considered alongside the tainted antidepressant drug literature, only then does the magnitude of the disconnect between psychiatry’s academic literature and the data that that literature is supposed to reflect.

For example, The Executive Summary of ACNP’s Task Force on SSRIs and Suicidal Behavior in Youth, was issued by GYMR, a public relations firm in
Washington (in January 2004) 10 days prior to an FDA advisory committee hearing about this issue. Just as the VNS article bye Nemeroff et al,
acknowledged "editorial support in developing early drafts of this manuscript," the ACNP Report acknowledged "medical writing input." 

Indeed, Dr. David Healy has noted: "There is probably no other area of medicine in which the academic literature is so at odds with the raw data. A
possible explanation is that this literature has had a significant ghostwriting input, a possibility that the ACNP Task Force Report, published 10 days before the FDA hearing and widely seen as a pre-emptive strike at FDA, does nothing to dispel."

For a long time foollowing its dissemination to the press, the ACNP SSRI Task Force Executive Summary report was unavailable from ACNP offices. Those who wished to obtain a copy  were referred to GYMR, whose medical writers, its website promised, "know how to take the language of science and medicine and transform it into the more understandable language of health". http://www.gymr.com/docs/capabilities/index.jsp
Further underscoring its public relations value:  "GYMR knows how to grab the attention of DC and national reporters–reporters who set the agenda for
media in communities nationwide."

The message that GYMR disseminated with the ACNP logo was meant to deflect from the evidence by reassuring the public: "taking Selective Serotonin
Reuptake Inhibitors (SSRIs) or other new generation antidepressant drugs does not increase the risk of suicidal thinking or suicide attempts."  [3]

But, as Dr. Healy points out, the authors’s diclaimer that "they might be mistaken in that they had not seen the raw data," is incomprehensible: "The authors of the Task Force Report [ ] include [Graham] Emslie, [Karen] Wagner and [Neil] Ryan who are authors on almost all of the randomized trials on
SSRIs, in addition to study 329."
"On what basis," he asks, "can they claim not to have seen the raw data?" https://ahrp.org/risks/healy/FDA0204.php

The answer is provided by a GlaxoSmithKline internal memo, which makes clear, that the antidepressant drug reports authored by members the ACNP
Task Force were based on selective partial clinical trial data: "positive data from study 329 will be published…there are no plans to publish data from Study 377." [4] https://ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html
NY State Attorney General, Elliott Spitzer, characterized such partial concealment of data as FRAUD. 

But what about the integrity of medicine and science?

Even after those reports of partial data have been discredited, they continue to be cited as authoritative. Indeed, the Final report of the ACNP Task Force continues to cite those studies as authoritative. [5] http://www.nature.com/npp/journal/vaop/ncurrent/full/1300958a.html

Concealment of financial conflicts of interest is only one symptom of the disease.
Financial conflicts of interest permeate the entire fabric of medicine–but as the case example demonstrates, psychiatry is fartherst afield from
acceptable conduct. Fraudulent practices–such as, concealment of negative data, and clinical trials designed NOT to detect severe, though rare, adverse effects, have resulted in the approval of tainted drugs that injur and kill. The proliferation of expensive but worthless treatments is also bankrupting the public healthcare budget.

See also, comments by ACNP member, Dr. Bernard Carroll, retired chairman of psychiatry at Duke University, on his blog, Health Care Renewal (Tuesday,
August 08, 2006) "Money and Medical Journals" http://hcrenewal.blogspot.com/

References:

  1. Charles B Nemeroff, Helen S Mayberg, Scott E Krahl, James McNamara, Alan Frazer, Thomas R Henry, Mark S George, Dennis S Charney and Stephen K Brannan.  VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms  Neuropsychopharmacology (July, 2006) 31, 1345-1355. published online 19 April 2006. http://www.nature.com/npp/journal/v31/n7/full/1301082a.html
     
    2.  Lisa Cosgrove and Sheldon Krimsky, Financial Ties between DSM-IV Panel Members and the Pharmaceutical Industry, in Psychotherapy &  sychometrics, 2006, 75:154-160. see AHRP comments: https://ahrp.org/cms/content/view/143/55/

  2. ACNP Task Force on SSRIs and Suicidal Behavior in Youth. Executive Summary was issued by GYMR Communications without any accompanying data analysis. Whether the document was ghostwritten is anyone’s guess.   The Task Force known ties to the pharmaceutical industry https://ahrp.org/cms/content/view/26/55/

  3. See,  GlaxoSmithKline internal 1998 memo indicating that publication of Paxil pediatric study 329 will be based on only partial (positive) data. And the memo indicates that study 377 will not be published at all because it failed. https://ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

  4. Among the published reports about Paxil study 329: Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B et al (2001). Efficacy of
    paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 40: 762-772.;
    Montgomery SA, Dunner DL, Dunbar GC (1995). Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo. Eur Neuropsychopharmacol 5: 5-13.

  5. J John Mann, Graham Emslie, Ross J Baldessarini, William Beardslee, Jan A Fawcett, Frederick K Goodwin, Andrew C Leon, Herbert Y Meltzer, Neal D Ryan, David Shaffer and Karen D Wagner. ACNP Task Force Report on SSRIs and Suicidal Behavior in Youth, Neuropsychopharmacology advance online
    publication 23 November 2005; http://www.nature.com/npp/journal/vaop/ncurrent/full/1300958a.html

Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org
 
 

From: Sarah Timm [mailto:stimm@ACNP.ORG]
Sent: Friday, August 25, 2006 1:01 PM
Subject: Memo from ACNP Council
Date:                August 25, 2006
To:                   Membership
From:               ACNP Council
Subject:            Neuropsychopharmacology Editor

Charles B. Nemeroff, MD, PhD has notified the ACNP Council that he will not
accept their May, 2006 offer of reappointment to a second term as
Editor-in-Chief of Neuropsychopharmacology.  Council has asked the
Publications Committee to begin an immediate search for a new editor. 

Dr. Nemeroff indicated that his decision was, in part, based on the recent
adverse publicity to the journal and the ACNP.

Council appreciates the work that Dr. Nemeroff has done. During his tenure,
a number of major innovations were instituted including the recruitment of 9
Field Editors in different subspecialty areas to handle the growing number
of submissions, the introduction of the Point-Counterpoint Series, and the
Complicated Case Series. The number of manuscript submissions per year
increased from 489 to approximately 800, the number of published pages
increased from 1836 to 2400, and the impact factor has risen from 4.497 to
5.369. Neuropsychopharmacology is currently ranked 5th of 90 psychiatry
journals, 17th of 187 neuroscience journals and 22 of 198 pharmacology
journals.

Dr. Nemeroff has served as second longest Editor-in-Chief.  Dr. Nemeroff has
served the ACNP as a Council member, past president and Editor-in-Chief.
Council is grateful to him for his efforts on behalf of the ACNP and wish
him much success in his future endeavors.

Sarah S. Timm, CMP
American College of Neuropsychopharmacology
545 Mainstream Drive, Suite 110
Nashville,  TN  37228
Phone:  615.324.2374
Fax:  615.324.2361
stimm@acnp.org

THE WALL STREET JOURNAL
Medical Journal Editor to Quit
In Wake of Disclosure Oversight
By DAVID ARMSTRONG
August 25, 2006 6:14 p.m.

The editor of the journal Neuropsychopharmacology is stepping down following
a flap over the medical journal’s failure to disclose that the authors of a
paper reviewing a new treatment for depression had financial ties to the
treatment’s developer.
 
One of the authors of the article was the editor himself, Charles B.
Nemeroff, who is the chairman of the Department of Psychiatry and Behavioral
Sciences at Emory University in Atlanta. In an email Friday, the owner of
the medical journal said Dr. Nemeroff had decided to step down as editor.
They said his decision was "in part, based on the recent adverse publicity
to the journal."

Attempts to contact Dr. Nemeroff for comment were unsuccessful.

The medical journal is published by the American College of
Neuropsychopharmacology, a medical society comprised of scientists and
physicians who study the brain and behavior. In an email to its members, the
college said Dr. Nemeroff had been reappointed as editor in May.

Last month, the journal published a review of a new treatment for depression
in which a small device is implanted in the chest to deliver mild electrical
pulses to the vagus nerve in the neck. The Food and Drug Administration
approved the device, made by Cyberonics Inc. of Houston, for use in treating
depression last year. The authors conclude that vagus nerve stimulation is
"a promising and well-tolerated intervention that is effective in a subset
of patients with treatment-resistant depression."

Of the nine authors of the review, eight are academic researchers who serve
as consultants to the company. None of those relationships were disclosed.
The ninth author is an employee of Cyberonics, which was reported in the
review article. On July 31, the journal published an online correction
disclosing the consulting relationships.

Approval of the device was controversial and a U.S. Senate investigation
found that FDA reviewers opposed use of the device for depression because
Cyberonics didn’t demonstrate reasonable assurances of safety and
effectiveness.

Dr. Nemeroff, in a previous interview, said there was "no intent whatsoever
on my part or any of my co-authors to hide the fact we were working in
collaboration with Cyberonics."

He also says the identification of one author as a Cyberonics employee as
well as a notation that the report was supported by a Cyberonics grant made
clear the review was connected to the company. Dr. Nemeroff says he serves
on two Cyberonics advisory boards but declined to say how much he was paid.

Write to David Armstrong at david.armstrong@wsj.com

 RELATED ARTICLE:  . Medical Reviews Face Criticism 07/19/06

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