Friday, October 28, 2016

Tag: University of Minnesota

Lancet Editorial Points to “Trouble with Psychiatry Trials”

While clinical trials make up the “bedrock of evidence-based medicine” in other specialties, psychiatry faces a number of both ethical and scientific problems related to its use of randomized control trials. According to a new editorial in The Lancet Psychiatry, the field of psychiatry research has particular problems with ethical issues in recruitment, inaccurate classification systems, and controversial placebo comparisons, and then, once the studies are finished, it often remains unclear what the “outcomes actually mean for people’s lives.”

Yet Another External Review Finds Shocking Flaws in Psychiatric Research at...

Last year, eleven years after the suicide of Dan Markingson in a University of Minnesota drug study, external investigations found evidence of coerced study recruitment, troubling conflicts of interest, shoddy scientific review, deep mistrust of U leaders, and a climate of fear and intimidation in the Psychiatry Department. U leaders solemnly promised the people of Minnesota that they were finally going to clean up the mess. Last week, yet another investigation found that nothing has changed.

University Owes Mistreated Psychiatric Subjects an Apology

The University of Minnesota recently announced that it is ending the controversial practice of recruiting study participants from patients involuntarily being held in their psychiatric unit. In a commentary for Minnesota’s Star Tribune, bioethicist and MIA contributor Carl Elliot reports that the university has still not apologized to the patient who spoke out against this practice. Instead, “the university has done its best to discredit him.”

Eight Unanswered Questions about Psychiatric Research in Minnesota

The wait has been exhausting, but it is possible that a flicker of light may finally shine on the dark recent history of psychiatric research at the University of Minnesota. Given these upcoming investigations of psychiatric research at the University of Minnesota, the time is right to look back at some of the disturbing, unanswered questions that have emerged over the past several years.

University of Minnesota Psychiatry: A Pattern of Research Abuse

KMSP News has aired a report of yet another mentally ill man pressured to enroll in a study of an unapproved antipsychotic drug, with near-disastrous results. His story bears a striking resemblance to the case of Dan Markingson, who committed suicide in a University of Minnesota study in 2004.

Are You Ready for Multiple Lawsuits By Victims of Psychiatric Misconduct?

Professor Leigh Turner of the University of Minnesota Center for Bioethics blasts the Board of Regents for ignoring psychiatric research abuse.

Markingson Case Supporters: Please Join Our Call-In Campaign

Patient advocates and bioethicists have launched a call-in campaign demanding action on psychiatric research abuse at the University of Minnesota.

Have You Ever Taken an Experimental Antipsychotic Called Bifeprunox?

In 2004, a patient was given an experimental antipsychotic called bifeprunox and died of hepatorenal failure nine days later. But the sponsor apparently did not investigate the death for three years. In late 2007 the sponsor issued a safety alert and suspended all bifeprunox studies. This is where things get interesting.

CAFÉ Study: Real Science or Marketing Exercise?

I received the following question from a reader regarding the controversial CAFÉ – Comparisons of Atypicals in First Episode of Psychosis - study. (This was the study in which Dan Markingson committed suicide.) "It appears that there was no head-to-head with a control group taking a placebo pill. Nor was there a control group featuring 'old' types of 'antipsychotic'. If that was the case then it is very poor study . . . what on earth can you hope to show from the data?" I started to write a response, but the subject is complex, and my response became the following article.

Investigate the Markingson Suicide? Not So Fast, Says University President

Responding to a letter signed by 175 scholars asking for an inquiry into the death of Dan Markingson at the University of Minnesota, the Faculty Senate voted to investigate clinical research at the university. But the university president says the Markingson case will not be part of the investigation. What is he trying to hide?

KMSP-TV Investigative Report on Psychiatric Research Abuse at the University of...

For a scathing, 11-minute overview of the death of Dan Markingson at the University of Minnesota, and new allegations of coercion into psychiatric clinical trials, you can't do much better than this excellent investigative report by Jeff Baillon.

As Lawyers and Bureaucrats Delay, The Body Count Rises

It took over twenty years for the state medical board to sanction a Minnesota psychiatrist who was responsible for the deaths and injuries of 46 patients. Today, in the Markingson case, it looks as if history is repeating itself. How many patients die while bureaucrats delay?

The Slow Torture of Mary Weiss

Dan Markingson was floridly psychotic and unable to give informed consent when University of Minnesota researchers coerced him into an industry-funded drug study. His mother, Mary Weiss, warned the researchers that Dan was in danger of killing himself, but she was ignored. Dan committed a violent suicide in 2004. Last week, after fighting the university and research regulators for nine years, Mary suffered a severe stroke. Her struggle for justice is in serious danger.

How Much can a Psychiatrist Charge to Visit With a Dead...

At the University of Minnesota, the answer is apparently $1,446. If harmless clerical errors were to blame for oddities like this, that fact should be easy to clarify simply by looking at the relevant documents.  But if there are systematic issues with the administration of clinical trials that makes it possible to bill for a visit with a dead subject, those issues would be important for other universities and private trial sites as well. 

And That’s the News from the Department of Psychiatry

In the business of clinical trials, the most valuable commodities are the research subjects. Filling clinical trials is hard, and filling them quickly is even harder. That’s why in 2000 a clinical investigator told the HHS Office of the Inspector General that research sponsors were looking for three things from research sites: “No. 1—rapid enrollment. No. 2 — rapid enrollment. No. 3 — rapid enrollment.”

How to Get Away with Academic Misconduct at the University of...

In early 2009, antipsychotic fraud was making headlines.  Eli Lilly had announced in January that it would plead guilty to charges that it had...

The Road to Perdition

The recent research scandals out of the University of Minnesota’s Department of Psychiatry may be alarming, but they are not new. Back in the 1990s, when the university was working its way towards a crippling probation by the National Institutes of Health (for yet another episode of misconduct (this time in the Department of Surgery), the Department of Psychiatry hosted two spectacular cases of research wrongdoing, both of which resulted in faculty members being disqualified from conducting research by the FDA.

Were Research Subjects Mistreated in the CATIE Study?

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.

Fact-Checking the General Counsel in the Markingson Case

Ever since critics began asking questions about the death of Dan Markinson in a clinical trial at the University of Minnesota, the General Counsel for the university, Mark Rotenberg, has responded with a uniform message: the case has already been investigated many times, and no wrongdoing has ever been found. That's how Rotenberg responded to my article about the case in Mother Jones, and that's how he responded last week to the news that the Board of Social Work had issued a “corrective action” to the study coordinator for the clinical trial in which Markingson died.

The University of Minnesota was not Involved? Some Further Thoughts...

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.

“Do We Have to Wait Until He Kills Himself or Someone...

In the "agreement for corrective action" against CAFE study coordinator Jean Kenney last week, the Board of Social Work cited Kenney's failure to respond to "alarming voicemail messages" from family members of Dan Markingson. Presumably, the Board is referring to a message left by his mother, Mary Weiss, which warned, "Do we have to wait until he kills himself or someone else before anyone else does anything?" The failure of Kenney and Stephen Olson to take the warnings of Mary Weiss seriously has been one of the most disturbing aspects of this case. In a deposition for the lawsuit filed by Weiss, Kenney was questioned about her response. Here is an excerpt. (The initial questions come from Gale Pearson, an attorney for Mary Weiss.)

“I Was Just Following Orders”: a Seroquel Suicide, a Study Coordinator,...

Out here in Minnesota, where the snow is gently falling, many of us are hunched over our computers, puzzling over a document just posted by the state Board of Social Work. It concerns the death of Dan Markingson (or as the document calls him, “Client #1”). Markingson, of course, was a young man under a commitment order who was coerced into a profitable Seroquel marketing study at the University of Minnesota over the objections of his mother, and whose condition spiraled downward until he committed suicide.

“Unfortunate experiments” in New Zealand and Minnesota

Carl Elliott writes on the discrepancy between New Zealand's response to a research scandal - which lead to a national debate and dramatic reforms - and the silence following clinical trial scandals in the U.S.

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