Please help Mary Weiss find the justice she seeks

He is a poor son whose sonship does not make him 

desire to serve all men's mothers. 

~ Harry Emerson Fosdick

Mothers are the necessity of invention.

~ Bill Watterson

Mary Weiss with her son, Dan Markingson

I have another petition up in the upper right hand corner, the same picture of Mary Weiss and her son Dan Markingson as above--the text of the petition is below... 

Carl Elliott, a bioethics professor at the University of Minnesota, has done a tremendous amount of work attempting to get regulatory authorites to perfom their ethical and legal duties, to investigate and hold accountable the unethical professionals who failed Dan Markingson.  read his post about the petition here

my comment: The ethical failures and medical negligence of doctors Schultz and Olsen are the proximate cause, i.e. an act or failure to act which  resulted in Dan Markingson's death. These two doctors were  unethical, careless and medically negligent.  Why has there been no homicide investigation for what is clearly criminally negligent manslaughter? Plainly, these psychiatrists were aware of the risks, yet they failed to perform essential duties they owed to Dan.  When a patient dies because an unethical doctor is willfully negligent and fails to provide adequate medical care to a vulnerable adult whom the doctor owes both an ethical and legal duty of care to; it is homicide. In my opinion, Dan Markingson is the victim of iatrogenic homicide. 

via Change.org:

Petition by Mike Howard

In November 2003, psychiatrists at the University of Minnesota used the threat of involuntary commitment to force a mentally ill young man named Dan Markingson into a very profitable, industry-funded study of antipsychotic drugs. Dan was enrolled in the study over the objections of his mother, Mary Weiss. For months Mary tried desperately to get him out of the study, warning the psychiatrists that Dan’s condition was deteriorating and that he was in danger of killing himself. The psychiatrists refused to listen to her. On May 8, 2004, Dan committed suicide, and Mary lost her only child.

I feel privileged and humbled to have called Dan my friend. Because of a very unique situation I had a front row seat watching Dan’s resilience as he attempted to overcome not only his original mental and emotional crisis, but also the trauma that occurred when he was betrayed by those who were charged and licensed to provide care, healing and protection. For the past nine years Mary and I have tried unsuccessfully to have the University of Minnesota and its psychiatrists held accountable for Dan’s death. But Mary’s lawsuit against the university was dismissed on a technicality in 2009, and the university used legal threats to force her to give up her right of appeal.

Even so, Mary has refused to back down. In 2009, the Minnesota state legislature passed “Dan’s Law,” which prohibits researchers from recruiting a patient under an involuntary commitment order into a psychiatric drug study. Media outlets such as Mother Jones, the St. Paul Pioneer Press, City Pages and Scientific American have published accounts of Dan’s story. His story was also featured in the documentary film, Off Label. In 2010, AstraZeneca, the sponsor of the study in which Dan died, settled federal fraud charges for $520 million, and a University of Minnesota psychiatrist was implicated. Last year, the Minnesota Board of Social Work found serious wrongdoing by the study coordinator for the research study in which Dan died.

More recently, evidence of fraud and serious privacy violations in psychiatric studies at the university have emerged. It is possible that other research subjects have died or suffered serious injuries, or that they have been mistreated in other ways. Bioethicists at the University of Minnesota itself have called for an external investigation, yet the university still refuses.

I cannot tell anyone else what way of speaking out is most aligned with his or her own personal principles. However, I believe those of us who are personally affected by these issues must break the silence about the human rights violations inherent in coerced participation in psychiatric research. While University of Minnesota researchers used many unethical methods to force Dan to participate in this research study, the most egregious of them was fear. Dan was afraid that there was no alternative to taking part in the study, and that he would face a complete loss of liberty if he did not participate.

Given the repeated failure of university officials to act in good faith, I believe that the Governor of Minnesota, Mark Dayton, should appoint an external panel of experts to investigate ethical wrongdoing in psychiatric research at the University of Minnesota, including the circumstances surrounding Dan’s death. The panel should be given latitude to investigate the University of Minnesota human subject protection program, the Department of Psychiatry, the Office of the General Counsel, and any other university officials involved in the oversight of human research.

Let me finish by allowing Mary Weiss, Dan’s mother, to speak for herself.

Dan and I were very close. I have experienced more anguish than I thought humanly possible since Dan’s death. He had dreams, like everyone. He had a talent for creative writing, and he had hoped one day to write for The New Yorker magazine. Unfortunately, his unfinished life robbed him of this dream. In fact, his short time on earth took many dreams from him, and also from me. The things he wished for, I wanted him to realize. Please demand an investigation into the circumstances surrounding Dan’s death, and help ensure no other family ever suffers such a loss from unregulated and improperly supervised clinical trials. Please sign the petition below. Help us find justice, not vengeance.

Text of the Letter to

To:
Mark Dayton, Governor of Minnesota 

Dear Governor Dayton,

I just signed a petition asking you to investigate possible research misconduct in the Department of Psychiatry at the University of Minnesota.

I am disturbed by the refusal of university officials to investigate the suicide of Dan Markingson in an industry-sponsored research study in 2004. I am also concerned by the university’s refusal to look into the possibility of misconduct in other psychiatric research studies. As a public institution, the University of Minnesota has a responsibility to answer legitimate questions about its research activities and to protect the rights and welfare of research subjects.

I urge you to appoint an impartial, external panel of experts in research ethics and regulation to investigate.

Thank you for your consideration.

Sincerely,
[Your name]

What can be done about medical research and pharmaceutical fraud?

Carl Elliot in Attention trial lawyers: Your Ez guide to Suing a pharma thought leader, reports the untenable situation in academic medicine stating, "Medical school professors routinely lend their names to ghostwritten, pharma-sponsored articles which they did not actually write. This is fraud. Yet just as routinely, medical school administrators look the other way. The same goes for journal editors, research oversight bodies, and virtually everyone else in a position to stop the practice." (This has been going on for decades now) Elliott then asks, "What's left to be done?" He further reports how a couple of law professors, have determined that class action lawsuits could be brought under the RICO statutes against the academic researchers perpetrating fraud. Pharma recruits those who are willing to sell their "academic integrity" and "professional reputation" to market drugs based on unethically conducted research, that is unethically reported;  essentially, a corrupt marketing strategy. This type of fraud has resulted in the very real deaths of countless thousands of patients. 

It's not "First thing we do, let's kill all the lawyers:" (1).

"Legal Remedies for medical Ghostwriting: Imposing Liability on Guest Authors of Ghostwritten Articles" is basically a step by step guide on how to, "Sue the bastards," which is desperately needed since it is obvious that academia's medical researchers and the pharmaceutical industry do not police themselves. It is equally plain that a lack of ethical integrity is ignored by virtually every entity with a duty to hold these "professionals" accountable. There is little to no investigation of questionable and even baltantly unethical conduct; no effort to protect the public, and apparently, no duty owed to the potential victims who will be harmed or killed.

Here are the Summary points from the PLoS article:

• "Ghostwriting of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal disputes.
• 
  
• Medical journals, academic institutions, and professional disciplinary bodies have thus far failed to enforce effective sanctions.
• The practice of ghostwriting could be deterred more effectively through the imposition of legal liability on the “guest authors” who lend their names to ghostwritten articles.
• 
  
• We argue that a guest author's claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).
• 
  
• The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This claim also appropriately reflects the negative impact of ghostwriting on the legal system." Read the rest here. 

Citation: Stern S, Lemmens T (2011) Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles. PLoS Med 8(8): e1001070. doi:10.1371/journal.pmed.1001070

Published: August 2, 2011

Copyright: © 2011 Stern, Lemmens. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: The research is supported by a grant from the Social Sciences and Humanities Research Council on The Promotion of Integrity in Biomedical Research. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Abbreviations: RICO, Racketeer Influenced and Corrupt Organizations Act

* E-mail: simon.stern@utoronto.ca

Provenance: Invited; externally peer reviewed.

(1) Henry The Sixth, Part 2 Act 4, scene 2

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first posted as "I Love the Logic! "Sue the bastards" August 2, 2011

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Bioethics of Research with Human Subjects

I have come to realize in the last week or so in particular that what I had thought and believed to be true seem to have little basis in how things are done.  It is knowledge that grieves me.  What is, is.  I don't wish to escape from reality; but I am not  happy when I validate dark suspicions about the nature and the breadth of man's inhumanity to man.   It's better to know than not; but it sure doesn't make me feel any safer.  It further erodes what small bit of confidence in my fellow man I do have.  Some aspects of what is real and what's really going on, seems surreal; truly strange and weird.  Real life has become like the horror and  sci-fi flicks that used to be on TV on Saturday afternoons when I was a kid, I didn't like them either...I always figured real life and real people are scary enough. I still feel that way...

via The Hastings Center:

Rethinking Informed Consent in Research 

"While voluntary informed consent to participate in research has long been an "axiom of bioethics," in reality there has been a "process of erosion and retreat" from this principle, said Alexander Capron in the Beecher Award Lecture on December 2, 2010 in New York. Capron noted the relevance of this trend in light of President Obama's request last month that his bioethics commission examine the ethics of human subjects research."
               

via The New Yorker
DEPT. OF MEDICAL ETHICS

GUINEA-PIGGING by Carl Elliott

 JANUARY 7, 2008  

a couple excerpts:

"As it turned out, the disciplinary action was a response to the injuries or deaths of forty-six patients  under Abuzzahab’s supervision. Seventeen of them had been research subjects in studies that he was conducting. These were not healthy-volunteer studies. According to the board, Abuzzahab had “enrolled psychiatrically disturbed and vulnerable patients into investigational drug studies without ensuring that they met eligibility criteria to be in the study and then kept them in the study after their conditions deteriorated.” The board had judged Abuzzahab a danger to the public and suspended his license, citing “a reckless, if not willful, disregard of the patients’ welfare.”

One case, which was reported in the Boston Globe, concerned a forty-one-year-old woman named Susan Endersbe, who had struggled for years with schizophrenia and suicidal thoughts. She had been doing well on her medication, however, until Abuzzahab enrolled her in a trial of an experimental anti-psychotic drug. In the trial, she was taken off her regular medication and became suicidal. When Abuzzahab gave her a day pass to leave the hospital unsupervised, she threw herself into the Mississippi River and drowned. In another case cited by the board, Abuzzahab had prescribed a “large supply of potentially lethal medications” to a woman with a history of substance abuse, “shortly after a serious suicide attempt.” She committed suicide by taking an overdose.

The public portion of Abuzzahab’s disciplinary file is freely available from the Minnesota licensing board, and has been posted on the Web site of Circare, a watchdog group that documents research abuse. When I ran a Google search on “Faruk Abuzzahab,” the first hit I got was a 1998 article in the Globe on his trial disasters. Yet none of this seems to have derailed Abuzzahab’s research career. Even after his suspension, the Times has reported, he continued to supervise drug trials, and to receive payments from at least a dozen drug companies. In 2003, the American Psychiatric Association awarded him a Distinguished Life Fellowship." (emphasis mine) Read more here

via Mother Jones:

The Deadly Corruption of Clinical Trials

When you risk life and limb to help test a drug, are you helping science—or Big Pharma? One patient's tragic, and telling, story.

—By Carl Elliott

| September/October 2010 Issue

an excerpt:
"IT'S NOT EASY TO WORK UP a good feeling about the institution that destroyed your life, which may be why Mary Weiss initially seemed a little reluctant to meet me. "You can understand my hesitation to look other than with suspicion at anyone associated with the University of Minnesota," Mary wrote to me in an email. In 2003, Mary's 26-year-old son, Dan, was enrolled against her wishes in a psychiatric drug study at the University of Minnesota, where I teach medical ethics. Less than six months later, Dan was dead. I'd learned about his death from a deeply unsettling newspaper series by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto that suggested he was coerced into a pharmaceutical-industry study from which the university stood to profit, but which provided him with inadequate care. Over the next few months, I talked to several university colleagues and administrators, trying to learn what had happened. Many of them dismissed the story as slanted and incomplete. Yet the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan's death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them."  (emphasis mine) read the rest here

 Guinea Pig Picture source: CavyMadness © 1999-2003 Nhan and Tammy Rao