For the Record: U's Kaler responds to critics over Markingson case (from MPR)

link to original MPR post


University of Minnesota President Eric Kaler responded Friday to an expanding group of critics calling for his resignation.

Kaler has found himself under fire as the university navigates the fallout from the 2004 suicide of a drug-trial patient — and allegations that it mishandled the case before and after the patient's death.

A legislative audit found the university ignored "serious ethical issues" in its treatment of Dan Markingson, a mentally ill man who committed suicide while participating in a clinical drug trial run by the university.

Former Gov. Arne Carlson called for the university to fire Kaler in an op-ed piece for the Minneapolis Star Tribune last week. Carlson talked to MPR News' Tom Weber on Monday.

• Carlson's Star Tribune commentary: University can't regain trust under current leadership

The trial and suicide occurred before Kaler took office, but Carlson said the president didn't handle the case appropriately, based on the information he received about it.The university declined to comment this week until Kaler joined Weber Friday to discuss the case and the criticism.

Investigation

A state legislative audit in March rebuked the university — and its psychiatry department in particular — for the way it treated Markingson, who had been participating in a university study of an anti-psychotic drug made by the pharmaceutical company AstraZeneca, which financed the research.

An external review in February also criticized the university for not doing enough now to protect vulnerable patients like Markingson.

• Legislative auditor's report | MPR News story

The audit was prompted in December 2013 by lingering faculty concerns over Markingson's death.

Critics say university researchers coerced Markingson into participating in their clinical drug trial, dismissed the concerns of his mother that he was getting worse and ignored her pleas to remove him from the study. University President Kaler has long defended the university's record, saying a previous federal investigation found no wrongdoing.

Legislative Auditor James Nobles wrote in his report 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" that 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," Nobles 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.

Fallout

Psychiatry head steps down | Dr. Charles Schulz, who led the university's psychiatry department for 16 years, announced in early April that he is stepping down. He will remain on the faculty and keep his position as executive medical director, according to a university announcement this morning. In a statement, university officials said the move "will allow him to focus his time more exclusively on patient care."

Schulz, coincidentally, faced more scrutiny on Friday after the New York Times raised questions about the recruitment of subjects for a 2010 drug trial.

• April 10: University of Minnesota bioethicist Leigh Turner, a critic of Kaler's, discusses Schulz's move

University says it will reform | Kaler told faculty members in early March that the University of Minnesota will change the way it treats human test subjects.

Kaler said when the review began that he expected the report would validate the school's practices. He told the university's Faculty Senate he had thought the school was doing better than it was.

"It is worrisome that we have such a distance to go to reach the very highest standards," he said.

In early April, the university announced it had gathered a team to lay out a plan for carrying out dozens of reforms recommended in the February review. Kaler says he expects the plan by May 15.

Concern in the Legislature | At the March hearing about the legislative audit, state Sen. Eric Pratt, R-Prior Lake, told Kaler, "You can't have an ethical program unless you have ethical people ... people willing to look at themselves critically and admit their mistakes." Kaler responded that he was open to personnel changes if they were necessary.

Alumni call for Kaler resignation | A group of alumni — who identify themselves as "teachers and scholars of medical ethics" — signed a letter to the Legislature demanding Kaler's resignation. Carlson and university bioethicists Carl Elliot and Leigh Turner sent a similar letter in February.

Kaler responds to Carlson, critics

Kaler said he's focusing his efforts on acknowledging the mistakes of the past and learning from them. Knowing what he knows now, would he have done things differently?"It's been a very harmful injustice. It's brought tremendous reputational harm to the University of Minnesota," Carlson said.

"I certainly would have," he said. "Hindsight is a wonderful thing that's 20/20, and when I arrived, I should have taken a deeper look at our human subjects around patients with diminished capacity. I should have called a group together to do that before we did it in 2013."

Carlson and other critics of the university's approach to the Markingson case have made a number of statements about how the case was handled and how it ought to be remedied. In his conversation with MPR News, Kaler offered a response.

Kaler should step down

Kaler, Carlson said, should no longer be at the helm.

"When President Kaler came on board, he was sent materials on the seriousness of the Markingson case, the fact that there was a cover-up in existence, and all he had to do was meet with members of his own department of bioethics at the university to discover what the truth was. He refused to do that. And instead he participated in the cover-up," Carlson said.

Kaler said he has no plans to leave his position.

"I don't have any plans to resign," he said. "I think I have strong support in the faculty leadership; I know I have board support. I have made, literally, thousands of decisions in the four years I've been here, and some have been criticized, rightly and wrongly. But I think any decision like that should be based on the body of my work, not on one particular issue."

The university covered up its own mishandling

The former governor said the university administration's response to the Markingson case constitutes a cover-up.

"When I use the word cover-up, what I'm saying is, every time anybody ... asks for information from the university, they are told: 'This has been investigated' time and time and time again," he said. "It turns out that, of the five investigations, four never really existed. So, you decide for yourself what this constitutes. Is that the kind of behavior you want from the head of an institution whose reputation rests on its ability to reflect integrity?"

Kaler said he disagrees.

"I don't think this in any way ... is a cover up. When I arrived in 2011, I was made aware of the case. It was then six years, seven years old. I reviewed the documents. I reviewed a report from the FDA, I reviewed legal findings, I reviewed a report from the Board of Medical Practice of Minnesota. And I relied on those highly credible organizations in their findings," he said.

"Significantly, the legislative auditor pointed out that the FDA findings unequivocally state that there was no evidence of misconduct or significant violation of research protocol," he added. "The Board of Medical Practice [report] was presented as a thorough investigation, according to the auditor. It's clear, in hindsight, that those reports were not as reliable or thorough as they were represented to be. But I would argue that, presented with [that] kind of evidence from those kinds of sources, it was hard for me to believe that there was ever misconduct."

There should be legislative hearings

Schulz's resignation as head of the university's psychiatry department isn't enough, Carlson said. He called the move, in which Schulz will remain on faculty and keep his position as executive medical director for the school, inadequate.

"First of all, there has not been one single hearing on the cover-up," Carlson said. "There has not been one single hearing where President Kaler, his team, his lawyers, and members of the Board of Regents were subject to questions. ... How come?"

Kaler said the audit itself is accountability enough.

"I don't think such hearings are necessary. I think all of the documents are in the public domain," he said. "And what's really important is that we've made very important steps forward to improve our human subject studies: We commissioned in 2013 with leadership from the faculty senate an external review that was incredibly thorough, and we are working hard to implement the findings from that group."

He added: "In fact, the principal findings from the legislative auditor was to implement those plans. I called that group in and asked them to define what we needed to do to be above reproach, and they generated 63 recommendations. Frankly, when I read that report, the distance between where we are now, which is at the level of the rules and law, to get from there to beyond reproach is a pretty good distance. We have much work to do, but we're going to do it."

Jim Nobles, Minnesota's legislative auditor and author of the Markingson report, recommended that changes be codified into law in order to provide additional accountability. But Kaler said there is enough momentum on the part of the university's administration to put the recommended changes into place.

"I don't think a law is necessary to have that happen. We're going to be incredibly transparent," he said. "One of the reasons I'm doing this conversation with you [MPR News' Tom Weber] now is to help the people of Minnesota understand that we're being open and that we're moving forward to implement the plans. People will be able to see that. And if you don't see that and you don't believe that's being done, then you ought to call for my resignation. "

The university administration has been misleading in its public responses to the case

The legislative auditor's report said university leaders have repeatedly made misleading statements about the thoroughness of past reviews as they rejected calls to look into it further. Carlson contends that university administrators participated in a cover-up to hide the school's shortcomings in the Markingson case, a claim Kaler rejects. But the university has stumbled in its recent public response, and has had to correct itself on a number of occasions.

"As the legislative auditor reported and as I reported," Carlson said, "that cover-up was essentially a series of false statements, clearly designed to mislead the public, the legislature and the faculty."

Carlson said the university had been purposely evasive, in order to perpetuate a cover-up. Kaler admitted the school had made mistakes, but said none of them had been intentional.

"To the degree that there were misleading statements made, I've apologized for those," he said. "The one that I know of was the statement in one of our communications that, in fact, the attorney general had conducted an investigation. And that is not precisely correct. What happened is that the attorney general took some depositions in assistance to the Board of Medical Practice. That's not an attorney general investigation, and that was an incorrect statement."

He went on: "At some point also, we talked... — I believe back in the 2000s — about an [Institutional Review Board] investigation. In fact, it was an IRB look at this, but it didn't qualify as an IRB investigation. Again, I relied on things from the FDA and the [Minnesota Board of Medical Practice]. These are the national and statewide organizations that are meant to guarantee the outcome in these kinds of siutations."

The university's research suffers from rampant conflict of interest

Nobles' audit found that the university's research oversight panel conducted a "superficial review" of the case, which he said suffered from conflicts of interest.

Markingson's mother, Mary Weiss, said Dr. Stephen Olson held a clear conflict of interest — he was her son's treating physician but also the director of the clinical trial, where there were financial and other pressures to keep Markingson enrolled in the study over her objections.

In addition, Nobles' legislative audit found that a Minnesota Board of Medical Practice review of Olson was "compromised" because the consultant analyzing the case had "numerous" conflicts of interest.

Kaler said the university is working on it.

"I think that the appearance of conflict of interest is certainly there," he said. "We have a conflict of interest management plan. As part of the recommendations from the external panel, we will look at our conflict of interest statments and be sure that we have the right language, that we do trust but we also verify to a greater degree than we probably do now.

"As part of our going forward," he added, "we're going to engage in these conversations, and we're going to decide openly where conflicts of interest exist; where they exist and can be managed; and where they exist and cannot be managed and must be avoided."

The mistakes of the past must be accounted for in the present

"Let me put it this way: If this episode had occurred in the Obama administration, we would have hearings 24 hours a day, nonstop," Carlson said. "If this were in the Dayton administration, I suspect we would have the same.

"We ought not to treat management systems differently. We should hold the management system at the University of Minnesota just as accountable as we would a governor's management system, a president's management system or a business managment system. And we're not doing it here."

Kaler said he sees this as an issue of addressing the mistakes of the past — and learning from them. Throughout his tenure, he has repeatedly stated that one of his top-level goals is to make the University of Minnesota one of the nation's best public research universities.

MPR News' Tom Weber asked Kaler if reaching that goal is still possible, given the blow to the university's reputation that came with the audit.

"We've got to move forward. We're talking about trials that took place in 2004, 2005, 2008," Kaler said. "Your question highlights the need for us, with great intensity, to move forward with the recommendations of the external panel and to develop a research ethics environment that is above reproach.

"Those efforts will not happen instantaneously. They will take time. But it is absolutely a personal priority of mine to restore confidence in the ethics of our human subject resarch, particularly for people with diminished capacity. I take this personally. I love the University of Minnesota, and I'm enormously unhappy that this situation happened in the 2000s, and we're going to fix it."

The people who created the problem are now being asked to fix it

Given all the causes a former governor might choose to champion after his term is up, why this one? Carlson said it's because he saw in this case a group of people without a voice. "One of the things I remember the most is that sometimes the best causes are the ones that are lost causes," he said. When a group of people associated with the case approached him, he couldn't ignore it.

"These were people who, for 10 years, including the mother of Dan Markingson, were simply looking for justice. They were looking for some answers. Doors had been slammed in their face. They had been told one whopper after another. They had been mistreated. They had been sued. One of the professors has been placed on probation.

"So, a lot of people have been hurt. ... Not one single person has been held accountable. Nobody. And now we're asking the same people who created this scandal to give us the remedy."

Kaler, though, disagrees. A lot has changed since 2004, he said.

"We have a new general counsel, a new vice president for research, a new dean of the school of medicine, a new vice president for health sciences, and a new president in place since those trials occurred," he said.

"Now, could we be faulted, each and every one of us individually as we came into office and looked at this, [for not all reaching] the same conclusion? Is that a fault? Perhaps it's a human failing, but I don't think it limits our ability to move the conversation forward."

Kaler's statement on the Markingson case

MPR News' Tom Weber, Cathy Wurzer, Alex Friedrich, Britta Greene and Paul Tosto contributed to this report.