Tuesday, August 29, 2006

Katrina victims battle mental illness

Now the victims of Katrina are vulnerable to become victimized one more time - by the mental health system and big pharma looking to cash in on sales of anti-depressants.

Yahoo - Reuters reports that mental illness has been diagnosed in Katrina's victims.

The report states:

200,000 people from Alabama, Louisiana and Mississippi face serious
mental illness because of Katrina, with about a third suffering from
post-traumatic stress syndrome and the remainder depression


About 25 percent reported having nightmares about their experiences -- a
figure that rises to nearly 50 percent for people who lived in New

For those who subscribe to the theory of social constructionism, this is probably a good opportunity to apply the Katrina tragedy to human interactions and responsibility with each other seeing that this was a rather large example of the relationship between public and government, between cause and effect, between living and dying.

Monday, August 28, 2006

Cybertronics charged under SEC laws

The recent news about Dr. Nemeroff stepping down from his position as editor of the American College of Neuropsychopharmacology journal called Neuropsychopharmacology for not disclosing a conflict of interest with Cybertronics. Dr. Nemeroff is chairman of Cyberonics' Mechanism of Action Advisory Board.

This comes on the heals a complaint filed with the United States Securities Exchange ommission against Cybertronics on August 18, 2006, for violation of the United States securities laws under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 by:

making false and misleading statements regarding Cyberonics' Vagus
Nerve Stimulation Therapy System (the "VNS Device") as a therapy for
treatment-resistant depression ("TRD").

From the First Amended application with the United States District court in Texas Lead plaintiffs allege that the defendants failed to disclose that certain individuals associated with the U.S. Food and Drug Administration ("FDA") had safety and efficacy concerns about the use of the VNS Device for the treatment of depression and questioned the adequacy of evidence of safety and effectiveness presented to the FDA by the Company, that the defendants misrepresented the prospect for payer reimbursement for the VNS Device, that the defendants concealed executive compensation and governance issues, and that the defendants falsely stated that an analyst's statements about options granted in June 2004 were inaccurate and without merit.

Lead plaintiffs seek to represent a class of all persons and entities, except those named as defendants, who purchased or otherwise acquired Company securities during the period February 5, 2004 through August 1, 2006.

The amended complaint seeks unspecified monetary damages and equitable or injunctive relief, if available.

Cybertronics's annual report is pending a review of stock option grants and accounting issues so it's stocks have taken a hit. See Yahoo Biz and Yahoo Finance

The MediaScan of StockHouse USA, an internet exchange pitt stop to empower investors provided links to the above financial reports.

I wouldn't expect the Ontario Securities Commission to get on the band wagon with the SEC. Beside Cybertronics being hyped by the IEEE - the Institute of Electrical and Electronics Engineers in their Spectrum magazine with an article called 'Psychiatry's shocking new tools', the Centre for Addiction and Mental Health "Canada's leading addiction and mental health teaching hospital" and "is fully affiliated with the University of Toronto", has been funded by Cybertronics as it appears in this list from their website along with quite a few large pharmaceutical companies such as:

AstraZeneca Canada Inc.
Aventis Pharmaceuticals Inc.
Eli Lilly Canada Inc.
GlaxoSmithKline Inc.
Merck Frosst Canada Inc.
Pfizer Canada Inc.
Purdue Pharma

And Government Ministries:

Citizenship and Immigration Canada (Joe Volpe being a former Minister of and recipient of donations from Apotex - a generic pharmaceutical company in Toronto),

Ontario Ministry of Community and Social Services
Ontario Ministry of Correctional Services
Ontario Ministry of Health and Long-Term Care

And of course, the University of Toronto, who has been cited in this article on questionable research ethics.

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.


Promoting Openness, Full Disclosure, and Accountability


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"


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

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

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

Medical Journal Editor to Quit
In Wake of Disclosure Oversight
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


. Medical Reviews Face Criticism 07/19/06

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Wednesday, August 23, 2006

Blog of note

Here's a new blog that all concerned about misconduct in the pharmaceutical industry should endeavor to read - it's called Scientific Misconduct Blog - worth the internet reading time.

Rat in'a Hat - Hamilton's new film

Like the hype around Snakes on a Plane, Hamilton has been hyping its rat infestation - except Samuel L. Jackson hasn't called me yet to intimidate me into seeing the flick.

But I did get a call from my mum - all the way from the bush. And she asked me how our rat problem was fairing! How did she know that Hamilton had a rat infestation? Did the name of the blog give it away?

Let's be clear - the rats are on the 'Mountain' (tongue in cheek at mountain) - not us in the lower city - we just have bed bugs and neither one can the City's health department seem to resolve.

I guess the concept of letting some cats run loose on the mountain to eat up the rather large rats has been bantered about. Well, thaaat's great, not. Once the rat's fleas start biting the cats and then households take them in "because the cats are so cute" (or the rats are soooo cute), we can all expect to have an outbreak of bubonic plague.

But that's ok, you know, it's only the Mountain. There's a few individuals on the Mountain that I admit I'd have schadefreude if they got a ring around the rosie or two, or three or four...

Hey, wait a minute....damn!

Something just bit me....

what the?....

HEY!... Noooooo!

Wednesday, August 16, 2006

U.S. psychiatrist gets away with bad behaviour

The Los Angeles Times
Probes Targeted UCI Researcher
Alleged ethical and financial breaches by Dr. Steven G. Potkin drew scrutiny
but no sanctions. The professor defends his activities.
By Christian Berthelsen
August 13, 2006

TV news personality Jane Pauley had a message to deliver in April when she
spoke at a fundraiser for UC Irvine's Brain Imaging Center. She told the 140
guests at the Island Hotel in Newport Beach about her battle with mental
illness and spoke in support of the research being done by the center's
director - and Pauley's brother-in-law - UCI psychiatry professor Steven G.

Potkin is one of UCI's biggest stars. The 60-year-old psychiatrist is among
the university's most prolific researchers. He brings in lucrative contracts
from some of the world's biggest drug companies and has presided over as
many as a dozen clinical trials at a time.

Recently, his investigation into nicotine's effects on the brain received
national attention. And in March, the university proudly trumpeted his role
in heading a $24-million National Institutes of Health project that will be
headquartered at UCI.

But at the same time Potkin has attracted funding and recognition for UCI,
he has also been investigated three times by the university for alleged
ethical or financial breaches, according to more than 300 pages of documents
obtained by The Times. And although Potkin says he was not disciplined as a
result the investigations, each raised serious questions about his practices
and how UCI dealt with the issues.

Most recently, administrators found in 2004 that the professor had skirted
the school's patient safety review board to test a drug for a pharmaceutical
company without the required university approval. When UCI learned of the
research, it ordered Potkin to immediately halt the study.

Seven years earlier, administrators looked into why Potkin had directed drug
companies to pay more than $2 million in research funds to a firm his family
owned. The payments were related to studies he was performing at UCI. The
university concluded that the company may have been set up to avoid UCI
overhead fees, and it prohibited Potkin from using the company in future
research projects.

UCI launched its first investigation of Potkin's work in 1989, four years
after the psychiatrist arrived at the university from the National
Institutes of Mental Health, where he specialized in schizophrenia research.
Fellow UCI doctors accused Potkin of wrongfully billing Medi-Cal for his
research. Although Medi-Cal rejected some billings for the clinical trial,
the state and UCI concluded that Medi-Cal was not defrauded.

Despite the repeated investigations, Potkin's star has continued to rise,
and this summer he was given a raise and a promotion.

The grants that researchers such as Potkin bring are an important source of
funds for universities. The publicity brings prestige that attracts
students, professors and donors, which is especially important for a school
such as UCI, which is still trying to build its reputation.

UCI's medical programs have been racked by problems in the last decade,
including the theft of eggs and embryos from patients, cancer research
violations, illicit sales of body parts and shortcomings in its liver,
kidney and bone marrow transplant programs. In each case, critics say,
warnings were ignored and serious problems downplayed.

Dr. Mike Samoszuk, a former pathology professor who left UCI late last year
to work as the chief medical officer for a medical device division of a drug
company, said that although he had no knowledge of the Potkin case, the
university's thirst for research funding may have caused it to look the
other way when ethical lapses were discovered.

"Even though clinical research is a noble and worthy activity, it's very
easy to lose your moral compass if your primary goal is the dollar amount of
grant funding that you generate,"Samoszuk said.

UCI said it couldn't discuss specifics of personnel matters. Potkin, in an
hourlong interview, defended his activities, saying that UCI administrators
approved his business dealings and that his work helped patients and the

But documents provided by the university suggest that some of Potkin's
activities had not been approved by UCI.

In 2004, Potkin and psychiatry department co-chairman William E. "Biff"
Bunney applied to the university board that monitors human research for
permission to test an Alzheimer's drug for Praecis Pharmaceuticals, a small
company in Waltham, Mass. The request was not immediately approved.

The professors went ahead anyway, using a private company they had
previously formed to conduct the research at an assisted-living facility for
Alzheimer's patients in San Juan Capistrano.

The professors had previously signed an agreement with the university
allowing them to consult on clinical trials through their company but not to
work as principal investigators on a study through the firm. The agreement
was later modified to allow the professors to supervise principal
investigators through their company.

On learning that the men had gone ahead without university approval of a
study that listed them as principal researchers, Thomas Cesario, the dean of
UC Irvine's medical school, took swift action. In a Dec. 8, 2004, memo,
Cesario told the psychiatrists that he had learned of their outside trial
and that they were violating UCI policies. "We require this study be halted
immediately until further notice," he wrote.

In a letter to Cesario the next day, the doctors acknowledged that they were
listed as the principal researchers but said they were only providing
"management and consulting" services for another company. The company the
doctors said was running the trial, Pharmacologic Development Physicians
Inc., had been established two months earlier by Steven Mee, a former
medical school student under Potkin and Bunney who had completed his
residency the year before. Mee did not return a telephone call seeking

Potkin said he was not trying to avoid university scrutiny but, rather, had
moved the study out from under UCI's auspices because of a shortage of
psychiatry beds available for research. "What this issue has all been about
is the loss of research facility beds in a place that was supposed to do
research," Potkin said. "That was really the point. When we don't have beds
and don't have resources to do that, we have to come up with other solutions
to do that."

He also maintained that the amended permission form gave him approval to
conduct the trial and that UCI's policy for monitoring research did not
apply to "outside activities."
"I would agree that things could have been written more precisely," he said.
"There's no question in my mind that when we did this we had full approval
to do this."

Cesario thought differently.
"When you first conceived of the company with Biff, my clear understanding
was that this was a consulting business," Cesario wrote Potkin and Bunney on
Dec. 18, 2004. "It was not a business to run clinical trials outside of the

In April 2005 someone complained anonymously about the Praecis trial to the
National Institutes of Health. The agency asked UCI whether a Potkin-owned
company had used NIH-funded school staff and resources for the research and
whether the doctors had performed a clinical trial without review board
approval. As a condition of receiving federal funding, research institutions
such as UCI must guarantee that its review boards will safeguard human

"I'm surprised they didn't suffer a direct, immediate and tough penalty,"
said Dr. Arthur Caplan, chairman of the medical ethics department at the
University of Pennsylvania.

Cesario acknowledged in a letter to the NIH that the doctors had conducted
their research through a private company and that they had used UCI's
brain-imaging facilities. The letter also said the company paid for the
service, which was allowable under the NIH grant.

The letter, obtained as part of a public records request, was never sent.
UCI spokesman Tom Vasich said that before it was to be mailed, NIH said it
only wanted a financial audit. The three-page audit contained none of the
admissions in Cesario's unsent letter. The report said the auditors "found
no evidence" that NIH funds were used for Potkin's and Bunney's private
company. NIH accepted the university's findings and did not conduct its own
investigation. A spokesman for the agency would not comment on the case.

Potkin's research had earlier come under scrutiny in 1997, when
administrators asked questions about another outside company involved in his

Research funds typically are paid to the university. But in 20 of Potkin's
studies, he arranged for drug companies to channel some funding directly to
the firm Pacific Clinical Studies, according to university documents.
Pacific Clinical Studies was owned jointly, by Potkin's brother Ralph, a
pulmonary care doctor, and a trust in their parents' names. Potkin told
university auditors that the money was used to pay staff used in recruiting
patients for studies and for patient costs such as pet boarding.

One Potkin client, Janssen, a drug firm in Titusville, N.J., became
"increasingly uncomfortable" with the payments it was making to PCS and
stopped making them, according to a June 1998 internal UCI memo. Janssen,
according to the memo, was worried because of the arrangement's similarity
to a case in which the chairman of the psychiatry department at the Medical
College of Georgia pleaded guilty to diverting research funding from the
school to a company he controlled. A spokesman for Janssen parent Johnson &
Johnson declined to comment.

The UCI audit, completed in September 1998, concluded that Potkin's actions
did not technically violate the university's nepotism policy, since PCS got
its money from the drug companies rather than from UCI. However, the audit
suggested that PCS "may have been established" to avoid paying university
overhead that is attached to research projects. The report said all of the
company's money came from Potkin's clinical trials, with the exception of
one his brother ran. The drug companies paid PCS $2.4 million.

Seven months after the audit was completed, Cesario and Frederic Wan, then
the vice chancellor for research, told Potkin that PCS could no longer work
on clinical trials at the university.

Potkin said in the interview that UCI knew about PCS' involvement, since it
was mentioned in the school's contracts with the drug companies. He said the
money PCS received was in addition to any research grant to UCI.

"Patients benefited," he said, "and more research was completed at the

Vasich, the university spokesman, said that although UCI knew of the
company's involvement, Potkin did not reveal its ties to his family.

UCI investigated Potkin for the first time in 1989. Doctors there told
administrators that Potkin was inappropriately billing Medi-Cal for patients
in his research trials. Bills submitted for patients in Potkin's studies had
been turned down three times by Medi-Cal, documents show.

In response, Potkin called a meeting to present what UCI psychiatrist Dan
Bates described in an affidavit as a plan to "fool Medi-Cal into reimbursing
the department for unauthorized expenditures."

The sworn statement was one of four that UCI doctors and a psychologist
submitted in support of another physician who filed a complaint with UCI
alleging that he was retaliated against for making the Medi-Cal allegations.

In the affidavits, Bates and psychiatrist Chris Heh said Potkin directed
staff to keep two sets of records, disguising the names of the drugs that
patients were receiving on the version made available to Medi-Cal.

According to the affidavits, although patients were receiving the
experimental drugs Raclopride and Zacopride, one set of charts indicated
that patients had been given drugs labeled Haldol-R and Haldol-Z. Haldol is
an FDA-approved drug that is eligible for Medi-Cal reimbursement, while the
other drugs are not.

Several doctors and nurses complained to administrators, and documents show
the whistle-blowers thought that their warnings were ignored.

Larry Drake, a business manager for the psychiatry department, wrote to
department chairman Bunney, "If you recall several months ago, after hearing
of these issues, I suggested that you form a committee to review the ethics
of the research unit. This was not done!"

UCI eventually launched an audit. The results, issued in September 1990,
said there were no improprieties. It said Medi-Cal had approved payments for
the hospital stays of some patients in the research trials and that the
state had not been billed for experimental drugs.

The state attorney general's office did not file charges after conducting
its own inquiry.

In his interview with The Times, Potkin denied that billings were
inappropriate. He said Medi-Cal was billed only for the hospital stays of
patients before they were enrolled in the study.

He also said it was standard practice to keep two sets of charts in research
trials and that the notations were "absolutely not" done to justify Medi-Cal
billings. The drug labelings, he said, were a shorthand way of showing the
drugs were being tested againstHaldol.

In their affidavits, Drs. Heh and Nora Johnson said the drugs were being
tested against a placebo.

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available for educational purposes, to advance
understanding of human rights, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this constitutes a 'fair
use' of any such copyrighted material as provided for in Title 17 U.S.C.
section 107 of the US Copyright Law. This material is distributed without

Monday, August 14, 2006

Squealer alert #2

It's amazing how when anything is mentioned about lawyers that those speaking about them or writing about access to them just pussy foot around this issue.

Take this article Chief justice warns of "epidemic'' of self representation in courts in the National Post that quotes Chief Justice Beverley McLachlin as trying to find an explanation of why Canadians are representing themselves in court.

What she has failed to say because she doesn't want to let the cat out of the bag is that Canada - more likely Ontario - is failing to administer justice or live up to its Charter obligations because if there is 40% of Canadians that represent themselves legally in a court of law, then it's about 45% percent who have no representation at all - including themselves - thus rendering the guaranteed right of equal protection and equal benefit under the law a cruel joke.

Here's an excerpt of what Chief Justice McLachlin had to say:

"Does the typical law firm's fee structure have anything to do with this?" she asked. "Can more creative ways be found to bill clients proportionate to the complexity and the value of the proceedings?"

Are lawyers fees a deterrent to getting access to legal services? YES

She elaborated at a news conference, cautioning that she is not calling on lawyers to change their billing methods, but simply pointing out that it is a prospect they may want to review.

Can you get any more wishy-washy than this?

"I think it's for the bar to answer than question," she said. "It would be presumptuous of me to say law firms should do this or that or the other thing but I raised it as a question for the bar to ask themselves."

Well, let me be presumptuous then. There is no access to justice or guaranteed rights for certain individuals in Canada. The legal community has thumbed their noses at the Constitution Act, 1982 and the Charter.

Check out how the Ministry of the Attorney General of Ontario champions access rights on their website.

Legal Aid Ontario (LAO), an independent agency funded largely by the Province of Ontario, is responsible for the delivery of high quality legal aid services to low-income individuals throughout Ontario.

This is one of the most ridiculous things I've ever read. The first was on the Federal Minister of Justice's website stating that the Convention on the Elimination of Discrimination Against Women (C.E.D.A.W.) was not legally binding only morally. It's also an indication of how out of touch the Ministry of the Attorney General of Ontario is out of touch because it doesn't fit with the reality of what is happening in Ontario.

"Legal aid certificates are issued to eligible individuals, who can then retain a private lawyer of their choice. "

Of our choice? This is the most ridiculous thing that may have ever been written. What choice is there if the choice to choose from is 0?

If there is an epidemic for persons representing themselves - then it's beyond outrageous epidemic proportions for individuals not able to represent themselves nor have someone represent them.

A Scenario to Consider

What if we lived in a culture where, if a person has cancer, nothing is done about it? Or any other disease? What if we lived in a country that only offers limited services for those not able to afford a doctor? What would you do if you have cancer and called a clinic looking for medical services that provides for clients that can't give $3000 up front to private surgeons prior to surgery because the government told you that clinic covers cancer services?

When you call you find out that the clinic only serves indigent persons with hemorrhoids, reflux disease or athletes foot because only those diseases affect the poor.

You've been sent a document in mail that came from the government. That document told you as a Canadian your guaranteed medical services for cancer even if your poor, but you find out the hard way - by calling all the clinics and private doctors but they tell you they don't serve persons with cancer unless you have $3000 up front.

The private doctors to tell you to go to Wal-Mart to get the latest do-it-yourself surgery kit so you can operate on yourself but you find out it will take you 6 months to read the manual and you only have one month to live.

If the private doctors don't tell you to go to Wal-Mart, they tell you they are too busy to take you on as a patient so why don't you try the bigger medical firms in Toronto? Sometimes they tell you to go to the government subsidized medical clinics but when you tell them they only serves persons with athletes foot, they tell you contact another that you know only serve persons with ingrown toenails.

You then find out that there are other people with cancer, which isn't strange in itself because people get cancer. It's how they got it that is alarming. It's because the cancer is contagious and it spread from phone calls made to the Society of Clinics - a self-governing body that tries to lobby the government to prevent the sale of do-it-yourself-cancer-surgery kits from Wal-Mart and any other books or services that may make it easier for people to perform self-surgery.

When faced with the daunting task of self-surgery you call the local M.P.P's office and they tell you to go to Wal-Mart or call the Society of Clinics after all, it's not brain surgery.

Sunday, August 13, 2006

U.S. Congress probes researchers & big pharma

Congress to Probe Policies at NIH
A bipartisan group asks the health agency for details of a researcher's ties to drug companies to assess its conflict-of-interest guidelines.

By David Willman, Times Staff Writer
August 10, 2006

WASHINGTON — A bipartisan group of congressional leaders has asked the director of the National Institutes of Health to provide details of a senior researcher's ties to several pharmaceutical companies.

The congressional leaders, including the Republican chairman and the ranking Democrat of the House Energy and Commerce Committee, said in their letter that they wanted the details in order to evaluate conflict-of-interest policies at the NIH. They requested a response by week's end.

"We have received the letter, and NIH will be responding to the committee," NIH spokesman Donald Ralbovsky said Wednesday.

The senior researcher, Dr. Thomas J. Walsh of the National Cancer Institute, helped lead clinical trials that used the companies' drugs to treat suspected fungal infections in patients with compromised immune systems. Walsh also appeared alongside company representatives at various U.S. Food and Drug Administration meetings regarding antifungal products made by the companies.

Two of the companies, Pfizer Inc. and Merck & Co., have acknowledged paying Walsh fees in recent years.

According to the congressional letter, the Energy and Commerce Committee "is seeking to determine if there is a sufficient factual basis to formally investigate questions about National Institutes of Health policy, the adequacy of NIH oversight or other issues that may be raised by the conduct of this NIH scientist."

The July 28 letter was signed by Rep. Joe L. Barton, R-Texas, the committee's chairman; Rep. John D. Dingell, D-Mich., the ranking Democrat; Rep. Edward Whitfield, R-Ky., the chairman of the panel's Oversight and Investigations Subcommittee; and Rep. Bart Stupak, D-Mich.

The letter was prompted by articles published July 16 by the Los Angeles Times, which reported Walsh's appearances with the companies at the FDA meetings, his acceptance of fees from Merck and Pfizer, and his leadership role with the clinical trials.

Walsh's fees were not among the industry payments reported by the NIH to the congressional committee two years ago, when the panel first examined potential conflicts of interest among agency scientists.

The Times also reported that, when results of two of the clinical trials were published in 1999 and in 2004, controversy flared as other scientists questioned whether dosages of "control" drugs used in the studies were adequate. The dosages were set by the scientists who designed and carried out the research in collaboration with the sponsoring companies.

U.S. conflict-of-interest law generally prohibits a federal employee from representing an outside party before a government agency. Walsh, in earlier comments to the newspaper, said that he appeared before the FDA not as a company representative but "as a government scientist providing information and/or evaluation" regarding clinical trials.

As for the dosages, Walsh and researchers with whom he collaborated had said that the studies were properly conducted and followed accepted standards of care. Both studies' designs were reviewed and approved by the FDA and by boards at the medical sites where patients were treated.

In their letter to the NIH director, the four congressional leaders requested a wide range of documents, including all internal financial-disclosure reports filed by Walsh from 1995 to 2005.

The letter also requested copies of any related policy that "permits [NIH] scientists as part of their official duties to assist drug companies with presentations to FDA advisory committees or FDA staff."

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Friday, August 11, 2006

Squealer alert

Jeepers, I'm going to write something about this when I've got more time.

I've just come across the Board of Directors list for St. Joseph's Hospital in Hamilton. I appears that Tony Valeri is on the board as well as Dr. John Kelton the Dean of Medicine at McMaster. Kevin Smith the CEO of St. Joseph's hospital is also a professor at McMaster.

Talk about conflicts. This is the City of Conflicts. I think the Municipal Conflict of Interest Act was written with Hamilton in mind.

McMaster and St. Joe's, I've been told by a very respected doctor of medical research ethics that worked for St. Joe's, that what the doctor did by disclosing my name without my consent was illegal. He also told me that McMaster was worse at disclosing patient's names for clinical studies without consent than St. Joe's was. The problem is that both of these "professional" institutions would do it at all.

It is illegal but Marg Doma the Risk Manager at St. Joseph's in Hamilton says "they don't do anything illegal".

Riiiggght. Were's Squealer? Did he fall off his ladder?

As for Valeri, I don't see anything conflicting, yet. The only issue for me is that a guy who lied to the Federal Ethics Commissioner about his property and then to the Spectator could certainly influence the thinking of the other board members and their policies about "illegal" disclosure practices.

But still I wonder how much his influence had on St. Joe's or McMaster getting federal funding, if any?

You know, if it wasn't for bloggers then these stories wouldn't hit the front pages. HR was the first to contact a City Planner about Valeri's building permit explanation and posted it here before the Hamilton Spectator came up with the idea.

But I've heard Hyde nor Hare from The Spec - most likely because they read this blog!

Wednesday, August 09, 2006

Big Pharma charged with fraud

This is an alert from the Taxpayer's Against Fraud based out of the United States with a link from the PharmLive website:

The Attorney General of South Carolina, Henry McMaster announced today that the State of South Carolina has filed a lawsuit to recover over $40 million in taxpayer funds. McMaster believes several pharmaceutical companies fraudulently manipulated the prices of Medicaid and State Health Plan prescription drug claims.


The Attorney General’s office began reviewing this matter approximately one year ago. The defendants named in the State’s lawsuit are:

Abbott Laboratories, Inc.;
Baxter International, Inc. and its subsidiary Baxter Healthcare Corporation;
Dey, L.P., formerly known as Dey Laboratories;
Boehringer Ingelheim Roxane, Inc. and its subsidiaries Roxane Laboratories, Inc. and Ben Venue Laboratories, Inc.;
Schering-Plough Corporation and its subsidiaries Warrick Pharmaceuticals Corporation and Schering Corporation.

Since 1995, South Carolina Medicaid has spent over $300 million on prescription drugs from these companies and the State Health Plan of South Carolina has spent over $100 million.

The State will allege that the pharmaceutical companies intentionally misreported the average wholesale price (AWP) of selected drugs which increased the reimbursements paid by Medicaid and the State Health Plans, thereby overcharging South Carolina taxpayers over $40 million dollars.

Boy, wouldn't it be nice if Ontario's Attorney General made such announcements?

Monday, August 07, 2006

Waiting for Gadot...

I probably should (or shouldn't) comment on the Israeli-Hezbollah conflict. I spoke to my sis about it and she was worried that it would evolve into something very serious - like an all out third world war. I told her I wasn't worried. She asked me why?

While it does bother me that Israel invaded Lebanon, Hezbollah is an antagonist and I think the whole of the Middle East has to just get over the fact that Israel is not going anywhere. They are staying exactly where they are so the whole Islamo-fascist movement has to be dissolved.

But lets face it. Most of us are pretty sick and tired of listening about this issue that we have decided to ignore the Palestinians and the Israelis altogether.

Unless America wants to just swing over to the area and add a few of their soldiers to make everything hunky dory. Hopefully that would mean until those in the Middle East mature enough to stop pointing the finger at each other and work out their problems no one is going to listen to accusations of who has moral authority. Having the Americans there will make sure they play nice.

I'm all for Israeli aggression until Hezbollah is unarmed because the rest of us can't stand the idea of having anyone's religion dictate to us what we can and can't do, what we should or shouldn't do nor do we want to feel bullied or threatened by theocracies that have as part of its ideology hatred of Israel that's bred into its young children.

But the rhetoric is nothing different from what I've been listening to in Southern Ontario for the past 12 years from my friends from this area.

Windsor has probably one of the largest Shiite populations and Hezbollah supporters in Canada. Local politicians are benefiting from this male dominated community that they are no doubt influenced by political attitudes as are the rest of us.

I was influenced by the propaganda until it started getting ridiculous.

My buddy who's a Kurd, loves George Bush and grew up in the Middle East told me about a Canadian guy that came into his shoppe. He was spewing propaganda about Bush, was supportive of al Qaeda and the deaths of the innocent people from the World Trade Centres collapse and the death of our troops in Afghanistan. This guy was supportive of the Hezbollah but liked to patronize his Oakville neighbours by smoking Pot in his front yard. (He's probably just pissed off that the Canadian troops are interfering with the opium production in Afganistan).

The guy, you would assume, was from the Middle East or somewhere sympathetic. He wasn't, he was very Canadian, meaning - he had no background or family ties to the Middle East. He was bent on dogma and ideology alone - the same stuff I heard from unions - like CUPE.

When the 17 Canadian guys from Mississauga were arrested and arraigned on terrorism charges months ago, a guy I was "dating" told me he agreed with the accusation by the ring leader of these 17 that Canadian soldiers were raping Afghani women. As usual this was just indicative of the propaganda he was gleaning from his Sudanese community in Mississauga.

All this from a guy that hates that women get housing because they come from women's shelters. Yes, I agree that women getting housing from the shelter system has grown into a scam here in Hamilton but this guy should talk while he is working for cash and collecting his unemployment insurance benefits and has found some guy from Pakistan to forge a fake emissions certificate and has tried to hide from his grown children that he had a girlfriend, drank alcohol and has friends who traffik in Kat - a narcotic from Yemen or in Pot.

The hypocrysy and propaganda I'm seeing on a macro level with this conflict, I've seen from a micro level for the last 12 years. The stuff above is just a drop in the hypocrysy bucket but eventually it does become tiring. I've corrected my errors in judgement about the men I date, but it has left me quite indifferent to the propaganda wars and the conflicts of the Middle East. It's also given me reason to believe that Middle Eastern men are full of a lot of hot air when they belch their propaganda.

But if I have to lean, I'm leaning with Israel because I want to see if the Hezbollah will get a warhead with nuclear material from Iran, or from another entity. Not that I wish this fate on Israel - they are taking a chance when they invade a country that puts them in danger. But it will prove that Iran was lying all along, wouldn't it?

Even then, I'm not worried that it's the end of days and the coming of the Messiah, the Mahdi or Gadot.

So, if you'll excuse me, I'm going to finish my Oracles of Notradamus...

LGF busts Hezbollah propagandist

Wowzer...been so distracted by other writing that I forgot I had a blog.

But what spurred me to write was seeing Charles Johnson from Little Green Footballs on CNN about 20 minutes ago.

I've kinda been oblivious to the war between Israel and the Hezbollah - not because I don't care but because it's just more of the same stuff that's been going on since I had converted and left Islam.

Why did LGF catch my attention? Well it seems that bloggers have a clever eye and exposed a Lebanese photographers doctored photos for Reuters to make it look like the bombing from Israel was worse that it was. With some help from photo-shop there was added smoke and buildings from a copy tool. LGF has a whole series on his blog which will probably be a dedicated section in time but for now it's on the main page. You can access it here but it is a little slow - for obvious reasons

I guess all that bombing dust got in the way of the photo-shop mouse and the pic had to be enhanced...