1. WILLIAM BEARDSLEE - quite a lot available about him...

[Guest guest]

" ...6. J Mann, Graham Emslie, Ross J Baldessarini,

Beardslee, Jan A Fawcett, Frederick K Goodwin, C Leon, Herbert

Y Meltzer, Neal D , Shaffer and D Wagner. ACNP Task

Force Report on SSRIs and Suicidal Behavior in Youth,

Neuropsychopharmacology advance online

publication 23 November 2005... "

http://www.ahrp.org/cms/content/view/327/27/

ACNP Journal Editor Quits Amid Exposure of Conflicts of

Interest

Sunday, 27 August 2006

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. 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 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. 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, [] Wagner and [Neil] 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 GlaxoKline 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]

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. B Nemeroff, Helen S Mayberg, E Krahl,

McNamara, Alan Frazer, R Henry, Mark S , Dennis S

Charney and 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. 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:

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, GlaxoKline 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,

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 Mann, Graham Emslie, Ross J Baldessarini,

Beardslee, Jan A Fawcett, Frederick K Goodwin, C Leon, Herbert

Y Meltzer, Neal D , Shaffer and 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@... veracare@... ...

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