For the Record: Leadership and transparency were lacking in research subject’s suicide.- Star-Tribune - #Markingson

Link to original.

(Emphasis added)

Trust but verify' to rebuild trust in the U

• Article by: EDITORIAL BOARD , Star Tribune 
• Updated: March 27, 2015 - 7:19 PM

Leadership and transparency were lacking in research subject’s suicide.

Generations of Minnesotans have entrusted their health care to physicians and researchers trained at the state’s flagship educational institution — the University of Minnesota. But two new reports rooted in the 2004 suicide of a patient in a Department of Psychiatry medical study have raised disturbing questions about the U’s transparency and leadership on the case over the past decade.

One report, by the state’s Office of the Legislative Auditor, focused on the death of the patient, Dan Markingson, who suffered from schizophrenia when he was enrolled in a study funded by the drugmaker AstraZeneca. The other report, an external review of clinical trial practices, was set in motion by the Faculty Senate because of its concerns about handling of the case.

In November 2003, Markingson, a recent college graduate, was put under the care of Dr. Stephen Olson, who is still a professor in the U’s Psychiatry Department. Markingson initially responded to a drug called Risperdal. But within days, he agreed to be enrolled in a drug study overseen by Olson. Whether he was competent to provide consent or felt pressured to do so has been at issue.

The study compared the effectiveness of three drugs. Neither Olson nor Markingson and his family knew which drug he would be on. But there was a two-out-of-three chance that it would not be Risperdal — a risk that raises serious questions about the care he received. Markingson did end up on another drug, and the alarms his mother raised about his deterioration went unheeded. He killed himself in May 2004, although it is not possible to say his enrollment in the study caused his death.

It took 11 years for all of the details to come out about Markingson’s suicide and the bungled institutional handling of it. The auditor’s report revealed an institutional failure to adequately investigate the case and concluded that U officials had made “misleading” statements about the rigor of reviews of the case, including one by the U.S. Food and Drug Administration.

Lawmakers have already made a key reform with the 2009 “Dan’s Law,” which prohibits patients facing institutional commitment, as Markingson did, from being enrolled in research studies. But further changes are needed, and the external review launched by the Faculty Senate has offered guidance for implementing these reforms. Among them: ensuring that the U’s Institutional Review Board performs rigorous reviews of research safeguards and adverse outcomes.

It is not enough to finally say that the university is committed to reforms, as U President Eric Kaler, Board of Regents representatives and the medical school’s leadership have done. The Legislative Auditor has also offered pragmatic “trust-but-verify” solutions. Lawmakers should require the U to fully implement reforms outlined by the external review. In addition, lawmakers should authorize the state’s own mental health ombudsman’s office to monitor the U’s psychiatric studies.

Other needed steps include authorizing the legislative auditor to investigate the state Board of Medical Practice, which failed to objectively investigate Markingson’s death. It’s also critical that the U have adequate whistleblower protections in place. University bioethicist Carl Elliott has been marginalized professionally after challenging handling of Markingson’s death.

On Friday, U officials said they had asked Dr. William Tremaine, head of the Mayo Clinic’s Institutional Review Board, to provide independent guidance on its reforms, and he agreed to chair a key reform committee. That’s a sign the U is taking criticism to heart. But more work is needed.

Minnesotans have been ill-served by their flagship university in this tragic affair. Yet the state owes a debt of gratitude to Elliott and others who unrelentingly pushed for truth. Among them: Markingson’s mother, Mary Weiss; his friend Mike Howard; former Gov. Arne Carlson; and state Sen. Terri Bonoff. Their persistence shouldn’t have been necessary, but if lawmakers and Kaler follow through, it will help rebuild the institutional integrity that Minnesotans expect and deserve.