Wall Street Journal - Medical Journal Editor to Quit In Wake of Disclosure Overs

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[sSRI-Research] Wall Street Journal - Medical Journal Editor

to Quit In Wake of Disclosure Oversight [comments - Vera Sharav]

 

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure,

and Accountability

www.ahrp.org

 

FYI

 

A notice from The American College of Neuropsychopharmacology, the

inner sanctum of biological--predominantly drug-centered

psychiatry--informs the membership of the resignation of Dr. Charles

Nemeroff, the Editor-in-Chief of its journal, Neuropsychopharmacology.

 

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] http://www.ahrp.org/cms/content/view/295/55/

 

Furthermore, the article appears to have been Vera Sharav

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. " http://www.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]

http://www.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? "

http://www.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 member 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]

http://www.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 &

Psychometrics, 2006, 75:154-160.

see AHRP comments: http://www.ahrp.org/cms/content/view/143/55/

 

3. 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

http://www.ahrp.org/cms/content/view/26/55/

 

4. 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.

http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

 

5. 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.

 

6. 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

212-595-8974

veracare <veracare

 

 

 

Sarah Timm [stimm]

Friday, August 25, 2006 1:01 PM

Memo from ACNP Council

 

 

August 25, 2006

Membership

ACNP Council

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

 

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

 

RELATED ARTICLE

.. Medical Reviews Face Criticism 07/19/06

 

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