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Why the University of Minnesota psychiatric research scandal must be investigated

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CC/Flickr/Matthew Traucht
For three years the University of Minnesota has managed to bluster and stonewall its way through all the criticism, insisting that it has already been exonerated.
elliott portrait
Carl Elliott

Three former editors of the New England Journal of Medicine have called for an investigation. So has the scholar who uncovered the Guatemala syphilis studies. The former Health and Disability Commissioner of New Zealand has called the conduct of the researchers “unethical,” pointing out the need to “put in safeguards in place to prevent a similar tragedy from happening again.” A recent Medical Journal of Australia editorial compared it to the exploitation of poor black men with syphilis in Tuskegee, Ala. Yet the University of Minnesota, where the research scandal occurred, simply keeps repeating, “Nothing to see here, folks. Just move along.”

The research abuse in this case is so stunning that when I first learned about it I could scarcely imagine it happening anywhere, much less at the university where I work. In late 2003, psychiatric researchers at the University of Minnesota recruited a mentally ill young man named Dan Markingson into a profitable, industry-funded research study of antipsychotic drugs. The researchers signed him up over the objections of his mother, Mary Weiss, who did not want him in the study, and despite the fact that he could not give proper informed consent. Dan was acutely psychotic, plagued by delusions about demons, and he had repeatedly been judged incapable of making his own medical decisions. Even worse, he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of the psychiatrist who recruited him into the study.

For months, Mary tried desperately to get Dan out of the study, warning that he was getting worse and that he was in danger of committing suicide. But her warnings were ignored. On April 23, 2004, she left a voice message with the study coordinator, asking, “Do we have to wait for him to kill himself or someone else before anyone does anything?” Three weeks later, Dan committed suicide in the most violent way imaginable. His body was discovered in the shower of a halfway house, his throat slit so severely that he was nearly decapitated, along with a note that said, “I went through this experience smiling.”

Conflicts of interest, other issues

As outrageous as that sounds, there is more. The psychiatrists had financial conflicts of interest from their work with the pharmaceutical industry. The study sponsor also provided financial incentives for the researchers to keep subjects in the study as long as possible. Last fall, the state Board of Social Work found that the study coordinator had falsified the initials of doctors on study records, failed to warn Dan of new dangers of the study drugs, had been given medical responsibilities far beyond her training as a social worker, and had failed to respond to Mary’s warnings that Dan was in danger of killing himself.

After Dan’s suicide, it got even worse. When Mary’s lawsuit against the university was dismissed on technical grounds of “sovereign immunity,” the university lawyers filed a legal action against her called a “notice to assess costs,” demanding that she pay them $57,000 in legal fees. Yes, you read that correctly: The U tried to force the mother of a suicide victim to pay it $57,000.

None of this is a secret. The case has generated international outrage. Yet for three years the University of Minnesota has managed to bluster and stonewall its way through all the criticism, insisting that it has already been exonerated. Even when the state Legislature passed “Dan’s Law” in 2009, banning psychiatrists from recruiting mentally ill patients under an involuntary commitment order into drug studies, the university continued to insist it had done nothing wrong.

A petition to Gov. Dayton

Two weeks ago, as a last resort, Mary Weiss, the mother of Dan Markingson, and her friend Mike Howard started a petition to Gov. Mark Dayton. Their request is simple: Please appoint an external, impartial panel to investigate the scandal. More than 1,200 people have signed, including well over 150 academic experts. Many University of Minnesota alumni have joined as well. A typical but telling comment: “I am ashamed of my alma mater right now.”

This is not an issue from the distant past. We do not know if other research subjects have died, or if they have been injured or mistreated. We do not even know if mistreatment is still continuing today. That may well be the most compelling reason for Minnesotans to sign the petition. If a case of research abuse this brazen can be sanctioned and defended by the university, there is no way to feel confident that other research subjects are being protected. In 2004 it was Dan Markingson. But it could have been any of us.

Carl Elliott is a professor in the Center for Bioethics at the University of Minnesota

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Comments (5)

A pattern of behavior at the University of Minnesota?

"For almost four years, the University of Minnesota covered up findings that Dr. Barry Garfinkel knew about and participated in scientific misconduct, including fraud, in a drug study, according to a report obtained Wednesday.

As recently as last August the University said it had found no evidence of intentional wrongdoing by the psychiatrist. The University had claimed repeatedly that Garfinkel was merely negligent in supervising the research.

But a November 1989 report by the university's official investigating committee flatly stated that Garfinkel, a nationally recognized expert in teen suicide, had taken part in fabricating records about one patient, either knew or should have known about other falsification of data and failed to correct widespread misconduct in the study.

The 65-page report, which was kept secret, was released to the Star Tribune yesterday by court order after the newspaper sued the university for access to the Garfinkel file."

Source: Garfinkel Case at the University of Minnesota
link: http://ow.ly/juVfF

And who was the General Counsel at the University of Minnesota when it took a lawsuit to make the internal university report public?

University general counsel Mark Rotenberg said yesterday that "the university categorically rejects any insinuation that we covered up any of the serious problems with the Anafranil study."

Source: Garfinkel Case at the University of Minnesota

Which leads to the obvious question: With this track record, why should we trust the office of the General Counsel to conduct a fair and impartial investigation in the Markingson case?

The General Counsel is the lawyer for the university and has an obvious conflict of interest in this matter.

Thus it is imperative that an investigation be done that is independent of his office.

If you are reading this and have not yet signed the petition to Governor Dayton asking for an independent investigation of the Markingson case, please consider doing so. More information and an opportunity to sign the petition may be found here.

link:
http://ow.ly/juWua

For further information on past evasiveness, please see:

Openness and Transparency at the University of Minnesota

link: http://ow.ly/juVXS

William B. Gleason, U of M faculty and alum

Please sign the petition to investigate the University

Following up on Bill Gleason's comment regarding General Counsel Mark Rotenberg and the U's handling and cover-up of the Garfinkel episode is this cut from the UMN February 1993 inner campus newsletter. It's obvious why an independent investigation is way beyond warranted regarding the University's handling of the death of Dan Markingson. The U.S. Federal Court found Dr. Garfinkel guilty of misconduct and barred him for life from doing any further research on human subjects and sends him to federal prison.....the University of Minnesota dock's him a month's pay.

Child psychiatrist Barry Garfinkel was indicted last week by a federal grand jury on 25 counts of research
fraud. He resigned as director of the Division of Child and Adolescent Psychiatry in the Department of
Psychiatry. "I believe I will need the extra time to devote to preparing the most vigorous and aggressive
defense to these scurrilous and unfounded charges," he said in a letter to department chair Paula Clayton.
Federal charges are linked to Garfinkel's study of Anafranil, a drug used to treat obsessive-compulsive disorder
in adolescents. Indictment charges Garfinkel with falsifying research data. A 1989 U investigation found the
research had "very substantial irregularities" but found no apparent harm to patients, and Dean David Brown
of the Medical School found no evidence of intentional wrongdoing by Garfinkel.
Following its investigation, the U required Garfinkel to forfeit one month's salary ($5,250), refrain from any
new clinical drug studies for one year, submit all research to a panel of 3 Medical School professors for 18
months, and prepare a research paper suitable for publication on the duties and responsibilities of a principal
investigator. In deciding on these actions rather than dismissal, the U weighed the severity of the research
misconduct against Garfinkel's outstanding prior record of excellence in medicine, teaching, and research.

Why the University of Minnesota psychiatric research scandal mus

That will be just the tip of the iceburg.

Drug Addiction
"So before any government strikes too heavily at spreading drug use, it should recognize
that it is a symptom of failed psychotherapy. The social scientist, the psychologist and
psychiatrist and health ministers have failed to handle spreading psychosomatic illness."
http://www.psychosomatic-healing.co.nz/drug.addiction.html

The Age of Fear:
Psychiatry's Reign of Terror Documentary
Filmed in Germany and Austria, The Age of Fear: Psychiatry's Reign of Terror, draws from over 80 interviews of psychiatric experts, historians and survivors. Containing shocking personal testimonies and stark inside footage, the documentary tells the true story of psychiatry's sordid history and current practices, revealing how its reliance on brutality and coercion has not changed since the moment it was born.
http://www.cchr.org/videos/age-of-fear.html

The Marketing of Madness: [Video]
Are We All Insane?
"The definitive documentary on psychotropic drugging—this is the story of the high-income partnership between drug companies and psychiatry which has created an $80 billion profit from the peddling of psychotropic drugs to an unsuspecting public."
http://www.cchr.org/videos/marketing-of-madness.html

Making A Killing: [Video]
THE UNTOLD STORY OF PSYCHOTROPIC DRUGGING
"Psychotropic drugs. It’s the story of big money—drugs that fuel a $330 billion psychiatric industry, without a single cure."
http://www.cchr.org/videos/making-a-killing.html

Diagnostic & Statistical Manual: Psychiatry's Deadliest Scam [Video]
An elaborate pseudoscientific sham...
It’s 943 pages long and lists out 374 mental “disorders.”
http://www.cchr.org/videos/diagnostic-statistical-manual.html

Dead Wrong: How Psychiatric Drugs Can Kill Your Child [Video]
Psychiatrists claim their drugs are safe for children?
Once you hear what eight brave mothers, their families, health experts, drug counselors and doctors have to say instead, you will come away convinced of one thing…
Psychiatrists are DEAD WRONG."
http://www.cchr.org/videos/dead-wrong.html

What's Wrong with Psychiatry? A Psychiatrist Explains [2 min video]
"Dr. Niall McLaren, a practicing psychiatrist for 22 years, explains what is wrong
with the psychiatric profession: That this is an industry which cannot take criticism,
for fear the entire model of biological psychiatry will unravel.
That there is no science to psychiatric diagnoses, no brain based diseases. And that
psychiatry only pushes mental disorders as biological disease/illness in order to
convince people to take psychiatric drugs, causing a host of dangerous side effects."
http://www.cchrint.org/videos/experts/whats-wrong-with-psychiatry-a-psyc...

Psychiatry: No Cures No Science [4 min video]
Psychiatrists openly admitting at the 2006 APA convention that they have
no scientific tests to prove mental illness and have no cures for these unproven mental illnesses.
http://www.cchrint.org/videos/mostviewed/nsnc/

A few things

Let me be clear this is an outrage! These people acted outside of Scientific guidelines and ethics in almost every way possible. They should be prosecuted to the full extent of the law for this, stripped of credentials and kicked firmly out of the scientific community.

Now that I've made my position clear let me also be clear that CCHR is a front group for Scientology. This group claims that Psychiatrists are responsible for the holocaust. Which is CRAZY! Like many other Scientology claims it is not based in reality or evidence of any kind (well other than the fabricated kind they love so much). There are lots of noncrazy groups that you can support that work to deal with unethical practices. Please do research before donating or participating with this group.

Also, since they claim to be the experts on Drugs, I though I should also mention the Scientology run drug rehab centers across North America are being shut down because of the startling number of deaths that happen there due to lack of proper care, and other legal violations.

Here is documentation from a Scientist about why NarCONon is not science, and doesn't work
http://www.cs.cmu.edu/~dst/Narconon/index.html

Here is an article about what Scientology did in Albuquerque
http://www.dailykos.com/story/2009/02/05/693628/-Scientology-Second-Chan...

Here is Scientology's NarCONon in trouble in Oklahoma
http://mcalesternews.com/breakingnews/x1752031894/A-decision-on-criminal...

The NarCONon in Three Rivers Canada was closed by the Canadian government for "The safety of recovering addicts" and will not be allowed to reopen
http://www.cbc.ca/news/canada/montreal/story/2012/04/17/narconon-trois-r...

Also NBC's Rock Center has done an investigative journalism series on NarCONon
http://www.cbc.ca/news/canada/montreal/story/2012/04/17/narconon-trois-r...

Scientology, or any group affiliated with them or run by them are things you want to avoid. They claim all kinds of things, without real evidence to back it up.

CCHR...

It is so typical to see mentions and promotions of CCHR in a situation like this.

CCHR (Citizen's Commission on Human Rights) is a front for $cientology, along with Narconon, Criminon, the Volunteer Ministers and Applied Scholastics.

Each of these is a Trojan Horse project, intended to poison the minds of the young and the gullible that L. Ron Hubbard was a great humanitarian.

Those who are paying attention will understand that this lie is 180 degrees away from the truth.

The truth is that the cult of $cientology and all of its Trojan Horses are vehicles for recruitment into the cult.

Your posted comment is an example of how low the cult will stoop to insinuate itself into tragic situations such as the OP.

Yes, the OP is a about a tragic failure of ethics in a medical community, but there is no way that the cult of scientology has the credentials or the credibility to assert its "guidance" into the midst of this fracas.

Protip: this is how "i c e b e r g" is spelled.