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Legislative auditor blasts U over ethics, conflicts in drug trial patient's suicide

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U officials face Senate questioning
University of Minnesota officials faced Senate questioning over a legislative audit of the 2004 suicide of a patient during a U clinical drug trial, March 19, 2015. Left to right: Medical school Dean Brooks Jackson, Trustee Patricia Simmons, President Eric Kaler, Vice President for Research Brian Herman.
Alex Friedrich | MPR News

Updated 5 p.m. | Posted 2:12 p.m.

A state legislative audit has found that the University of Minnesota ignored "serious ethical issues" in its handling of a mentally ill drug trial patient a decade ago.

The report, released Thursday, said the university failed to adequately protect Dan Markingson, who committed suicide in 2004 while participating in the trial. 

Legislative auditor James Nobles wrote that it's impossible to know whether Markingson's suicide was linked to the U's drug study. But he found that researchers ignored repeated warnings that Markingson's condition was not improving.

Nobles' audit also found that the university's research oversight panel conducted a "superficial review" of the case, which he said suffered from conflicts of interest. And he said university leaders have repeatedly made misleading statements about the thoroughness of past reviews as they rejected calls to look into it further.

"The insular and inaccurate response has seriously harmed the University of Minnesota's credibility and reputation," he wrote.

The auditor recommended lawmakers prohibit the U from approving more psychiatry department drug studies until the university fully implements suggestions from an outside review panel.

Markingson was participating in a university study of an anti-psychotic drug made by the pharmaceutical company AstraZeneca, which financed the research. 

In a written response to the audit, university President Eric Kaler said the U would immediately suspend enrollment in active and pending interventional drug trials. He also said a special team will put forth a plan of action within 60 days.

"While we believed that our current research program reflected this commitment, recent findings from a review by an external independent panel and an Office of the Legislative Auditor report demonstrate that we can and must do better," he wrote.

In testimony Thursday afternoon before a state Senate panel, Kaler apologized to Markingson's family "for his death under our care." 

He also apologized for the university's prior misleading statements on the matter and said that the university expected to have a set of recommendations by May 15 to improve the clinical trial system and its oversight. 

Critics say researchers coerced Markingson into taking part. His mother, Mary Weiss, says she warned them repeatedly he was not mentally competent to give his consent — and might kill himself — and asked that they take him out of the study.

Weiss says the university exploited her son by keeping him in the study so it could continue making money by participating in it. 

She said the study's director, Dr. Stephen Olson,  held a conflict of interest because as Markingson's psychiatrist, he was the one who decided whether Markingson should participate in the trial or be committed to a hospital — and yet had a financial incentive to enroll Markingson in the study.

The audit's main findings appear to back up many of Weiss' claims. Among them:

• Markingson "faced commitment to a state psychiatric hospital" if he didn't participate properly in the drug trial.

• Markingson's psychiatrist, Olson, had a financial incentive to enroll Markingson in the study and keep him there.

• Auditors found little proof that the U's drug study team adequately followed up on "strong concerns" that Markingson's mother expressed about his participation.

• Markingson did not have anyone to advocate for him when he signed a consent form to participate in the drug trial.

• The Institutional Review Board, the internal group charged with oversight of the U's research, failed to review medical records, and got its information solely from Olson, the psychiatrist who worked with Markingson.

• Olson "inappropriately" delegated work to the coordinator of Markingson's study, and gave her inadequate supervision. The coordinator "performed tasks beyond her competency and made significant errors."

• A Minnesota Board of Medical Practice review of Olson was "compromised" because the consultant analyzing the case had "numerous" conflicts of interest.

Nobles also referred to a university-financed external review released three weeks ago. It found the U suffered from "many weaknesses" in its efforts to protect its research subjects, and had not been aggressive enough in protecting them.

The strongly-worded report found "weak and often inadequate" oversight of research, which could put patients at risk. 

It said ethics training for researchers met "minimal standards," and said researchers didn't pay enough attention to getting the proper consent of patients with impaired decision-making ability.

What reviewers found most striking was a "commonly conveyed sense of doubt in leadership's commitment to human subject protection" on the U of M campus.

Another major concern of reviewers was a "culture of fear" in the department of psychiatry when it came to efforts to improve the protection of test subjects.

Early last month, Senate higher education committee Chair Terri Bonoff, DFL-Minnetonka, tried unsuccessfully to delay the Legislature's March 4 appointment of University of Minnesota regents until the release of the legislative audit. She said she wanted to use the information to inform lawmakers' decisions.

University critics, including former Gov. Arne Carlson, have criticized the U's Board of Regents of ignoring requests that the Markingson case be reinvestigated and the U's drug-trial history be examined.

Nobles said he also is considering a follow-up investigation of the university psychiatric drug studies since the Markingson case.

During the hearing's public comment period, Olson told senators he was very sorry for Markingson's family over the death, "but I don't think there was anything about his participation in the trial, my conduct" that led to Markingson's suicide.

However, University of Minnesota bioethicist Leigh Turner criticized Kaler and others at the university for "crocodile tears" and said that the U president and others have known for years that there were problems but did nothing to fix them until the auditor's report forced them to respond.

He questioned why Olson, the psychiatry department or its chairman Dr. Charles Schulz have not faced consequences. 

"The U PR strategy, which is what you're getting today, is still the same," Turner said. "They could have done these things years ago and chose to do nothing," he added.

"We're here 11 years later because we didn't have a good investigation up front, because we didn't do the right steps early on in the process," state Sen. Eric Pratt, R- Prior Lake, told Kaler at the hearing.

"You can't have an ethical program unless you have ethical people ... people willing to look at themselves critically and admit their mistakes."