Saturday, August 26, 2006

Another med journal editor resigns

The Alliance for Human Research Protection has provided more insight into the world of psychiatry and medical research below. But before you read on, I'm adding my own twenty-five cents as usual.

Mental illness is not something you can easily predict or take stats on. The expectations of persons diagnosed with a mental illness or disorder to speak for themselves is so prevalent in this field of medicine it's very easy to manipulate "disease" symptoms as a sculptor manipulates clay because the perceptive discrimination patient's face with the "mental illness" label are the bigoted attitudes of doctors and others within this system of medicine that inherently undermines the rights of patient's - including being believed when a patient presents their symptoms or medical history. It's probably the one area of medicine whose ethics and scientific data are not put under the microscope.

What motivates most of us is money, and doctors or researchers are no different.

There are many reports of dubious individuals or organizations involved in mental health care that would do anything to influence the sale of drugs even if it means fabricating medical symptoms or fabricating medical records.

Perhaps manipulating medical records is the ulterior motive of researchers/doctors to provide clients for their clinical drug studies.

Perhaps it's necessary for a pharmaeceutical company to forecast sales in psychotropic drugs and means they would have to have reasonable knowledge that the need for these drugs are necessary. It's only necessary if there was a set number of persons who have a particular "disease" and this is where manipulating clinical data or research data can be lucrative as the inherant and perpeturated attitudes towards the newly diagnosed or past diagnosed would be an undermining of a patient's claim regarding their feelings on how the drug is making them feel.

If mental illness can be "created" by using particular unstandardized tests provided by a pharmaceutical company, those predictable numbers become less arbitrary and easier to define.

One way of predicting mental illness is to create it or "look for" symptoms as those described in a semantic listing test (questions and answers based on the DSM-IV) as opposed to verified scientific data for proven illnesses. The meaning of a word could mean something different from one person to the next when describing feelings or emotions or physical symptoms. I've noticed doctors in Hamilton take normal human reactions to unjust social conditions and turn it into a pathology that they believe justifies a symptom of a mental illness.

Dr. Christine Adam - an unsupervised 6th year psychiatric med student from McMaster and emergency physician at St. Joseph's hospital in Hamilton, Ontario, took a human right under clause 8 of the Ontario Human Rights Code to prove her ignorance of the law and subjected the patient to her own judgemental "political" opinion thus turning the diagnostical symptomatic criteria into a subjective medical term called "entitlement".

Not very scientific.

Such fabrication was duly compounded, either to maintain the fraud or due to incompetance by St. Joseph's Outpatient Psychiatry's clinician Debbie Fournier a registered nurse. This clinician chose to fabricate bogus illnesses attributed to the patient's sister and father on the patient's clinical records without there even being the slightest diagnosis of any illness in the past nor appropriate symptoms of it at the time of the medical examination. This clinician, instead of listening to the patient, interjected what she wanted to hear the patient say, that the disease runs in the family when it was clearly not what the patient had described.

This wasn't a mere misunderstanding, no medical practitioner should attribute any diagnosis to any person unless it was a medical fact not if a person indicates they can "relate to a symptom". Qualifying one symptom doesn't justify a diagnosis of a particular disease that may have symptoms that are indicative of other mental disorders or physiological disorders.

Since St. Joseph's hospital has a systemic tendancy to not to document accurate medical facts for persons that come in with a percieved mental illness, its not in the hospitals interest to document accurate medical facts when it presents an opportunity to manipulate them, thus underscoring the equivalency of a patient has a percieved mental illness therefore can't be believed to give accurate facts regarding their own health.


Mental health medicine does not provide physical blood test to prove a chemical imbalance actually exists or as a result of a PET scan that proves, for example, this area of the brain is affected and therefore it's indicative of schitzophrenia.

Most less serious "mental illnesses" aren't verified by physical tests. It's mostly subjective and depending on what "expertise" the doctor practices, that doctor can filter and diagnose any one mental illness with some semantic qualification if they are given the chance.

Guarantee of a mental illness "diagnosis" can also guarantee a demand for the supply of drugs and therefore giving a better forecast of sales thus increasing stock dividends and returns. Thus turning the science of medicine into a making money venture by taking advantage of vulnerable individuals. Such ventures can also guarantee research funding for a hospital from government sources and increase the profits that some politicians gain either in increasing stock value or political donations from individuals close to the pharmaceutical industry.

The Ontario Health Insurance Plan will not deny that St. Joseph's hospital in Hamilton is being investigated for research fraud.

*************************************************************************************

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability


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]

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."

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. [3]

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". See GYMR website

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."

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?" [5]

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. [6]

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"


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.
see AHRP comments

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. That study 377 will not be published at all because it failed. See this link

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;



Contact: Vera Hassner Sharav
212-595-8974
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

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