Saturday, May 10, 2014

"Are you ready for the possibility of multiple lawsuits brought by victims of psychiatric research misconduct?"

Here are the comments that Leigh Turner delivered to the Board of Regents in the public session yesterday. (Like me, Leigh is a professor in the Center for Bioethics at the U.) The final section of Leigh's speech was difficult to hear, because he was being shouted down by the board Chairman, Richard Beeson.

I wish to address a subject that has great significance for next year’s budget, the University of Minnesota’s reputation, and, most importantly, the health and safety of the citizens our university was established to serve.

Yesterday was the tenth anniversary of Dan Markingson’s death. Dan committed suicide while he was a research subject in a psychiatric clinical study conducted at the University of Minnesota Medical Center. Today, a vigil was held to commemorate Dan’s death.

Despite repeated pleas, university officials have never investigated whether Dan was a victim of research misconduct. President Kaler recently ordered a review of current research practices and policies. This review will not address whether the care Dan received met ethical, legal, and clinical standards.

It appears that senior administrators have no intention of ever investigating Dan’s death. Are you prepared for the possibility that if a legitimate independent investigation occurs the University of Minnesota could be exposed as an institution where research misconduct occurred and you dismissed all requests to investigate possible wrongdoing?

Before Dan entered the CAFÉ trial he was repeatedly deemed psychotic and incapable of making health-related decisions. The study coordinator who evaluated Dan’s ability to provide consent and enrolled him in the trial not only had a financial conflict of interest as a member of the AstraZeneca-funded research team but also was not qualified to assess Dan’s decision-making capacity. Why has no one investigated whether Dan was capable of providing informed consent?

When Dan entered the study he was under a court-ordered stay of commitment. He had to follow his doctor’s treatment plan. Why have you not investigated whether the threat of involuntary commitment was used to coerce Dan into the CAFÉ study?

As Dan’s health deteriorated, his mother, Mary Weiss, pleaded with his psychiatrists to remove Dan from the trial. She frantically warned them that Dan was at risk of killing himself or someone else. Shortly after, Dan cut his throat with a box cutter, plunged the knife and his fist into his abdomen, and bled to death in the bathtub of a halfway house. Had Dan been removed from the CAFÉ study and provided more personalized care after his mother’s warnings perhaps he would be alive today.

There are many indications that other research subjects have been harmed. Three individuals contacted me and pointed to the Markingson case as indicative of what their loved ones endured. Additional individuals reporting research abuse contacted Professor Carl Elliott. There are other signs of research misconduct but you have ignored all of them.

As you review next year’s budget I urge you to consider the possibility that the University of Minnesota is one investigation away from being exposed as the site of a major research scandal.

Are you prepared for what a thorough investigation of psychiatric trials here might find? Do you know how many psychiatric research subjects have died or been seriously injured here? Why are open records requests to obtain such data routinely stonewalled? Are you aware of the loss of federal funding, mass faculty departures, and public outrage that occurs when research scandals are exposed? Are you ready for the possibility of multiple lawsuits brought by victims of psychiatric research misconduct? Will you remove President Kaler and other university officials from their positions if it emerges that research misconduct occurred and yet they resisted repeated calls for an investigation? Have you considered the economic and reputational harm this university will suffer if it emerges that faculty members mistreated vulnerable patients and no one in a position of authority acted to stop the abuse or investigate reports of wrongdoing?

We have a responsibility to put the safety and health of this state’s most vulnerable citizens above all other considerations. Has this institution budgeted for the consequences of failing to fulfill this moral obligation?

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