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U of M suspends enrollment in psychiatric drug trials in the wake of scathing report on Markingson case

U of M suspends enrollment in psychiatric drug trials
The new report is a stunning rebuke of the university’s handling of the tragic and troubling case of Dan Markingson.

In response to a scathing report released Thursday by the Minnesota Office of the Legislative Auditor, the University of Minnesota has announced that it is suspending enrollment into interventional drug studies being overseen by its psychiatry department until independent reviewers can determine that the studies fully protect all patients.

The university also said it intends to appoint a “community oversight board” of outside experts to make sure patients are protected in clinical trials going forward.

“We are now aware that some of our practices have not been above reproach,” wrote University President Eric Kaler in a letter that was submitted along with the auditor’s report to the Minnesota State Legislature. “We regret not identifying our own shortcoming ourselves, and are committed to being transparent and responsive as we move forward.”

‘Serious ethical issues’

The new report is a stunning rebuke of the university’s handling of the tragic and troubling case of Dan Markingson, a mentally ill young man from St. Paul who committed suicide in 2004 while enrolled in a U of M industry-sponsored clinical trial of the antipsychotic drug quetiapine (Seroquel).

According to legislative auditor James Nobles, the university’s repeated insistence in recent years that the Markingson case has been fully reviewed — and that the university and its personnel, including Dr. Stephen Olson, the psychiatrist who oversaw the Seroquel study, have been cleared of any and all wrongdoing — is misleading.

“We do not think it is possible to know whether Dan Markingon’s suicide was connected to his participation in the University clinical drug study; the suicide of a person with serious mental illness may involve many contributing factors,” Nobles writes. “However, the Markingson case raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge. They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration for the Markingson case by making misleading statements about past reviews. This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation.” 

"The Markingson case shows that one death can create not only a personal and family tragedy but also a public controversy that can seriously damage the University's reputation," he adds.

Nobles notes in the report that the U's unwillingness to address the questions of ethics and conflicts of interest that have arisen from the Markingson case was demonstrated as recently as late last month, when a separate external review of the institution's clinical research programs was released by the Association for the Accreditation of Human Research Protection Programs.

The findings of that independent review were "far-reaching," "substantive," and "damning," writes Nobles, yet Kaler and the university responded with a statement that was "disappointing because it again tried to diminish the importance of the problem."

‘Superficial’ and ‘compromised’ reviews

In his report, Nobles details the insufficiencies of earlier reviews of the U's handling of the Markingson case, including what he describes as the “superficial” investigation into Dan Markingon’s suicide by the U’s Institutional Review Board (IRB).

“The IRB did not review medical records, did not seek information from anyone other than Dr. Olson, and did not review information about Markingson’s suicide,” Nobles points out. 

Nobles’ report also cites a remarkable example of conflict of interest involving another review of the Markingson case — one that was conducted by the Minnesota Board of Medical Practice, which regulates physicians and other medical professionals in the state. This review was undertaken when Markingson’s mother, Mary Weiss, filed an ethical complaint against Olson — a complaint that was dismissed after an “independent expert consultant” hired by the board reviewed the case.

“We found that the consultant had numerous conflicts of interest, conflicts the consultant had alerted the Board to before it hired him to review the Markingson case,” writes Nobles. 

Those conflicts of interest included being a member of the U’s IRB at the time the IRB approved the study in which Markingson participated, being the director of the medical center where the Seroquel clinical trial took place and being a paid consultant to AstraZeneca, the drug company that manufactures Seroquel.

Indeed, the “independent” expert received more than $83,000 in payments from AstraZeneca in 2006 alone, according to Nobles.

‘Hope tempered with realism’

None of the information in the legislative auditor’s report surprised Dr. Carl Elliott, a professor of bioethics at the U, who has been pressing for many years to have independent investigators look into how the university recruited Dan Markingson for the Seroquel study and how it continues to enroll other vulnerable patients into psychiatric drug trials.

“It’s nice to have an independent confirmation of what we’ve been telling the university for five years, but which they have refused to listen to,” he told MinnPost on Thursday.

Elliott said he is not convinced, however, that Kaler and other university leaders are going to take responsibility for what happened in the Markingson case — or take the necessary steps to fix the problem going forward.

“One of the most worrying findings in the report was the widespread belief on campus that the university leadership doesn’t care about human study subjects,” he said. 

Leigh Turner, another U bioethicist who has also been outspoken about the issues raised by the Markingson case, expressed similar concerns. “Can we expect reform from the very people who have done nothing for the past several years?” he said in a phone interview.

“I hope there’s some change,” he added. “But the fact that [Markingson died in 2004] and it’s now 2015, I think hope has to be tempered with a dose of realism. There are some very powerful forces interested in minimizing the findings and suggesting that there are only minor things that need to be done.”

Turner believes the best chance for change at the university may come from the state legislature.

“I don’t expect the university to take particularly meaningful steps. They are invested in the status quo,” he said. “But I do think there is a moment here for state legislators to do something, and the question is whether or not they will do that.”

More findings

Here are other key findings from the legislative auditor’s report: 

  • Dan Markingson was extraordinarily vulnerable when Dr. Olson recruited him into a drug study; Markingson was mentally ill and faced commitment to a state psychiatric hospital if he did not cooperate with the Fairview University Medical Center treatment plan and his treatment team’s aftercare recommendations following discharge.
  • AstraZeneca, the financial sponsor of the CAFÉ drug study, prorated its payments to the University based on the number of subjects Dr. Olson enrolled in the study and the number of follow-up meetings the subjects completed. Dr. Olson’s goal was to enroll 30 people, and he had difficulty meeting that goal. This created an incentive to enroll and keep Dan Markingson in the CAFÉ drug study in November 2003.
  • Markingson’s mother, Mary Weiss, expressed strong concerns about her son’s participation in the drug study and continually warned that he was not improving. There is a little evidence that the study team adequately followed up with her about her concerns.
  • Dr. Olson told the University’s Institutional Review Board (IRB) that drug study participants would each have an advocate, but Markingson did not have an advocate with him at the time he signed the informed consent to participate in the CAFÉ drug study.
  • The Minnesota Board of Social Work investigated CAFÉ study coordinator Jean Kenney, a licensed independent clinical social worker. The Board found that she performed tasks beyond her competency and made significant errors. As result, the Board entered into an Agreement for Corrective Action with Kenney. Although the Board only had jurisdiction over Kenney, we believe its findings suggest that Dr. Olson inappropriately delegated tasks to Kenney and failed to provide her with adequate supervision.
  • University leaders — both administrators and regents — have responded to the Markingson case by dismissing the need for further review and ignoring serious ethical issues.

You can read the legislative auditor's full report at the agency's website.

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Comments (8)

An important story for patient advocates, too.

Thanks Susan for bringing attention to this long-delayed reckoning. I also appreciated your recent piece on the overprescribing of antipsychotics. I look forward to the Mental Health & Addiction column and the patient advocates that populate its pages addressing these topics too. It is, after all, good news for patients when lapses in patient care are discovered and addressed, even when they call into question the providers we so often turn to for guidance and treatment practices. Too often the media gets in a good news/bad news dichotomy with mental illness -- either you are telling the hopeful stories of treatment success or you are part of the problem. That allows stories like this one to take a decade to become taken seriously.

I am pleased by the release

I am pleased by the release of this report, and wish that my alma matter had not been in cover-up mode for nearly a decade, including the worthless whitewash of a report conducted by former U of MN General Counsel Mark Rotenberg before he skipped town.

How many more patients were harmed by the U of MN while top administrators were dragging their feet?

I want to see top administrators at the Medical School lose their jobs over this.

Never gonna' happen...

More likely a new title and a raise-you know, for being responsive to this crisis.

Don't hold your breath

First have a look a this:

Conflict of Interest at the U of M medical school: http://bit.ly/1ExJrfQ

And then be aware that Dr. Leo Furcht is still chairman of the Department of Laboratory Medicine and Pathology, the department where the current Dean and VP of Health Sciences did his residency.

Problems are endemic.

William B. Gleason, PhD
University of Minnesota alum and retired faculty
Department of Laboratory Medicine and Pathology
U of M Med School

Bill?

Isn't funding part of the issue here? I know NIH and other research grants are disappearing almost across the board and that means researchers cut corners and get their money from private industry. This is the sequester coming to haunt us because none of that NIH budget is being restored.

Yes, Paul

NIH funding is a big problem. And it is going to get worse at the U. The med school will probably get more money from the governor to get more faculty who will supposedly get more NIH funding. So-called set-up funds for these faculty members is approximately one million dollars [sic] per hire. This is yet another example of pounding sand down a rat hole.

This is what I had to say in 2008:

"I [W. Gleason] am certainly not against the University obtaining funding from the State in support of its legitimate mission as a land grant institution. In fact we need every penny we can get to stabilize tuition and support the core of the university, including non-science areas that are also critical for our remaining a great university. This is a matter of priorities and also a matter of the soul of a university. It is not a Driven to Discover marketing campaign."

These proposed blank check biomedical science buildings have financial implications for the U that are not being examined carefully and honestly. Where is the money going to come from to pay for the new faculty? Set up funds are, crudely speaking, a million dollars per new faculty member. And the NIH funding situation right now is terrible. What is the basis for the estimates of NIH funding that will be gained from these buildings?"

link: http://bit.ly/1boAUVw
THURSDAY, MARCH 11, 2010
The Craziness Continues at
the University of Minnesota

So we've heard this song and dance before when funds were extracted from the legislature for the so-called biomedical discovery district. The claim is now being made that if we hire more faculty they will get more NIH funding and everything will be hunky-dory.

Don't bet on it.

Bill Gleason
U of M grad and retired faculty member
Department of Lab Medicine and Pathology
Med School

ps: For evidence that the NIH problem is of long standing, please see

FRIDAY, SEPTEMBER 14, 2007
Another Indication That More NIH Funding Is Not Necessarily Going to Solve BigU Medical School's Problems... link http://bit.ly/1GLVFEo

and related posts

So glad this is finally

So glad this is finally getting some attention, but given the AAHRPP report from February which revealed systemic oversight issues and problems with the U's IRB, I'm not sure that the narrow focus on the Dept of Psychiatry as 'the' problem is the most helpful approach. Obviously, major changes are needed in the Dept of Psychiatry, but I am concerned that U of MN administration might try to use these changes--essentially sacrifice one dept--to deflect attention from the larger institutional issues that must be also be addressed. It does little good to deal with a single bad apple if the barrel itself is rotten.

So glad this is finally getting some attention

Thank you for bringing the focus to the bigger picture. The many faults noted here can be seen threaded throughout most of the medical health system industry. All one has to do is serf the net to see the harm being done on all levels. That's what our main health care system used by the majority is about, making money at the cost of consumer's quality of life. Unfortunately, this is happening worldwide. The only respectable element I have found during my quest to understand how such horrible things can happen to people are all the practitioners who start out with sincere intentions, and those who wake up to the harm being done. The more we can educate the consumers, the quicker this may come to an end. Supply & demand. Obviously, there are also health providers who are ethical healers.