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Gov. Arne Carlson on Kaler and U research ethics: ‘Where is the accountability? Where is the oversight?’

Carlson: “I think President Kaler owes it to the public to set in motion a whole independent review of his role, as well as [the role] of his vice president, the legal department and the Board of Regents.”

Former Gov. Arne Carlson
MinnPost file photo by James Nord
Former Gov. Arne Carlson

In an op-ed for the Star Tribune and on several recent radio and television programs, former Gov. Arne Carlson has been calling on the University of Minnesota to fire its president, Eric Kaler, for his continual “cover-up” of problems regarding research ethics in the university’s psychiatry department.

Last month, the Minnesota Office of the Legislative Auditor released a scathing report that rebuked Kaler and the U for misleading the public about serious ethical breaches in the tragic case of Dan Markingson, a young man from St. Paul who committed suicide in 2004 while enrolled in an industry-sponsored clinical trial at the U involving the anti-psychotic drug Seroquel. In the wake of the report, the U immediately suspended enrollment in any clinical drug trials being overseen by its psychiatry department until a team of independent reviewers could determine that all patients in those trials are protected.

Kaler, however, disagrees that there was any kind of cover-up going on at the U. “When I arrived in 2011, I was made aware of the [Markingson] case,” he said in an MPR interview on Friday. “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. … 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.”   

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But the issue is not quieting down. Last week, a group of 15 U alumni who are now teachers or scholars of medical ethics joined Carlson in calling for Kaler’s firing. And on Friday, the New York Times ran an article that detailed yet another questionably run clinical trial involving the U’s psychiatry department (and Seroquel). In this 2010 study, controls were so lax that one of the enrollees — a sex offender — crushed up the drug and surreptitiously fed it to other men at his residential treatment facility.  

On Friday — before Kaler spoke on MPR and before the Times published its article — MinnPost talked with Carlson about the university’s handling of the controversies surrounding its psychiatric department and why he thinks it’s time for Kaler to step down. An edited version of that interview follows. MinnPost has requested a followup interview with Kaler, but was told he is not immediately available. 

MinnPost: Why do you believe that President Kaler should be fired? 

Arne Carlson: When [Kaler became president of the University of Minnesota in September 2011] he had already been sent materials by Dr. Carl Elliott, who’s a professor of bioethics, relative to all the dilemmas and problems and legal faults that were occurring at the university. So he was informed when he came that this problem existed. This problem had also received considerable attention from both the national media and the local media, including, by the way, the Minnesota Daily. So when he came in, he had to make a decision, and that decision was, “Do I call up Professor Elliott and sit down and find out what this is all about? Do I do some independent research and find out what this is about? Or do I simply let the past continue to roll?” He chose the latter. He made that decision.

When he made that decision he chose to consciously not obey the rules of the University of Minnesota. He deliberately made the move that he would no longer pursue the mission of the University of Minnesota, which is a search for truth. [He] became part of subverting the truth and stonewalling … and ultimately deceiving by claiming [there had been] investigations that never occurred and claiming that these were exhaustive investigations. How can you have an exhaustive investigation that was never held?

MP: In President Kaler’s response to the legislative auditor’s report he wrote that if the earlier external reviews of the Markingson case had been flawed, then he and other officials at the U had not been aware of it.

U of M President Eric Kaler
MinnPost file photo by John Noltner
U of M President Eric Kaler

AC: Bear in mind that this is the highest paid administrator in public service in Minnesota. He makes significantly more than the president of the United States, so the public has a perfect right to expect a high level of performance. So [Kaler] now says, “Gee, I did not know.” That means he paid no attention whatsoever to the materials that were sent by Professor Elliot. It means he paid no attention whatsoever to all the media reports, and he paid no attention whatsoever to the history of the program, which by that time had included six suicide deaths, the incarceration and imprisonment of a professor and the barring of research by the [U.S. Food and Drug Administration] of several of his own personnel. 

So either it’s a case of profound ignorance or he’s simply being untruthful. 

MP: Why would he choose to ignore that information?

AC: I think that’s a question he has to answer. … I think President Kaler owes it to the public to set in motion a whole independent review of his role, as well as [the role] of his vice president, the [university’s] legal department and the Board of Regents. They’re all complicit in the cover-up, and it requires an independent review. But he is absolutely adamantly opposed to any such review.

MP: In the wake of the legislative auditor’s report, the university has created two new committees to develop and implement reforms to its human research programs. Leigh Turner [a bioethics professor at the U] and others have criticized the university for appointing to those committees people who either ignored or dismissed earlier calls to investigate the Markingson case. Do you share those concerns? 

AC: What’s interesting here is for 10 years you’ve had people waving the red flag and saying, “Gee, this is wrong, this is wrong, this is wrong.” Not one of those people has been put on any committee. Not one. But all the people who were either part or acquiesced in the cover-up, they’re all on the committee. … Then they bring in a doctor [to head one of the committees], and he’s packed with financial conflicts of interest. … We have 80,000 doctors in America, and we can’t find one without a conflict of interest?  [The U has appointed Dr. William Tremaine, a gastroenterologist who is director of the Mayo Foundation Office of Human Research Protection, to head one of the new committees. Tremaine has received funding from many pharmaceutical companies, including AstraZeneca, the company that funded the U study that Dan Markingson was in when he committed suicide.]

Somebody tell me that that is what we teach our students at the University of Minnesota school of business. Everything that’s being taught there is practiced in the opposite fashion at Morrill Hall. It’s stunning. Where is the transparency? Where is the accountability? Where is the oversight? …

Fundamentally, colleges and universities are in the business of integrity. They are in the mission of searching for the truth. And in the process of searching for the truth, you have tremendous respect for dissent. That’s what you expect on a college campus. Here we have the practice of the exact opposite. Submerge the truth at all costs. Deceive the public. Deceive the faculty. Deceive the legislature. Deceive the media. But the operative word is deceive. That doesn’t represent a very healthy search for the truth.

The second thing is the governance at the University of Minnesota. The president basically runs everything. I met with a member of the Board of Regents, and she told me in no uncertain terms that it was her feeling that the board feels that they are subservient to the president, and everything I’ve seen verifies that. I think the board feels they work for the president. The faculty Senate has very, very little power. Everything is concentrated in the office of the president, so he is completely and totally responsible for this whole scandal. His defense is ignorance. That’s a stunning defense. Somebody tell me the virtue of ignorance. 

MP: What is your reaction to the announcement that Dr. Charles Schulz is stepping down as head of the university’s Department of Psychiatry? [Schulz was co-investigator, along with U psychiatrist Dr. Stephen Olson, of the drug trial in which Markingson died.]

AC: First of all, when you lose your moral authority, which President Kaler has, and when you’re complicit in the cover-up, as President Kaler is — and as the Board of Regents is — then how can you punish anybody? You can’t because you’re not willing to punish yourself. So they arrange the softest of soft landings they possibly could. He still retains his position as medical director, and he retains his tenure in his professorship and his pension and everything else.

What you basically have at the University of Minnesota now is two different sets of laws. You have the people on top, the Board of Regents, the president and his top officers — they made the rules and the regulations, but they don’t have to obey them. They’re exempt from that. It’s only the faculty and the students and the employees who have to obey the rules and regulations. I don’t know how you can have a bifurcated system of justice and have it operating. 

MP: The CAFE drug study that Dan Markingson was enrolled in when he killed himself was not a study designed to come up with a new breakthrough drug to help people experiencing psychotic episodes. It was designed to compare three competing drugs that were already on the market. Should the U or any other university be involved in drug-company studies like that — ones that are primarily about building market share?

AC: You’re raising a very valid question. … When a company contracts with a university for a drug test, that test is more likely to be favorable than if it were conducted neutrally. So there’s a built-in bias. … There’s also a financial incentive [for the university]: For if you flavor, if you will, the results towards one company, they’re going to come back and give you more contracts. That means that if you’re a hard nose, you’re going to have a tough time getting those contracts. 

The very integrity of the FDA process is really at issue here. … I think that all these contracts should go through the National Institutes of Health, and they should disperse them out. There should be a neutral governing body that decides who gets what. Right now what you have is an endless array of conflicts of interest. You [the university researchers] get paid whatever it is — $15,000 — for every person you enroll. [For the CAFE study, AstraZeneca paid the U’s Department of Psychiatry $15,648 per enrollee.] You know as well as I do that there will be a temptation to go kind of easy on the [enrollment] restrictions.

MP: Particularly if you’re having trouble enrolling people.

AC: Of course. And your pool tends to be mentally impaired, so it’s a dreadful situation — it truly is — for universities. Nevertheless, [if you’re going to do the research] you want to make it as loaded with integrity and protection for the enrollee as is humanly possible.  

MP: Has the U’s reputation been tarnished by this?

AC: Very much so, and it continues to be tarnished. 

MP: Have you heard from people outside the university on that? 

AC: I’ve gotten a lot of emails. … I’ve got a good friend who’s on the review board at Massachusetts General [Hospital]. He’s stunned by this because just from an institutional perspective you want to do everything you possibly can to protect the integrity of your brand.  That’s what’s so stunning. All these news articles come out, and it doesn’t move President Kaler. When I showed him all these headlines [last June], he didn’t have any reaction whatsoever. And then, when I got into a debate with [Richard Beeson, chair of the Board of Regents,] about the brand — because Beeson sits on a bank board — I repeatedly asked him, “Do you mean to tell me if all these negative stories appeared about your bank, your bank board would have absolutely no concern?” His answer was, “You’re comparing apples and oranges.” I said, “No, I’m not. I have sat on corporate boards, and I know something about brand protection. Are you telling me that your bank board would ignore all this bad publicity and do nothing about it?” 

MP: What would you like to see done?

AC: The Legislature has been amazingly passive. That’s been a huge disappointment. There isn’t a single legislator who has stepped forth and said, “You know what? This scandal is serious. It imperils the virtues of a very fine university, and we’re the ones who appoint the Board of Regents. We have to assume responsibility. Let’s drill down and find out exactly what happened.”

There should be an investigation into the cover-up. It should be public. President Kaler, his vice president, his legal staff, [and] the Board of Regents should all be called in to testify and to be held accountable for the very rules and regulations that they themselves promulgate.  That has not happened — and apparently is not going to happen. … I think that’s appalling. I’m stunned, absolutely stunned. …

The issue here is not only the reputation of the University of Minnesota, but also the reputation of Minnesota as a state. I think this state celebrates people who have integrity, who are willing to be open, who are willing to care, who are willing to acknowledge when they make mistakes  — and who are willing to be held accountable. But I don’t believe the Board of Regents, President Kaler or his management staff reflect any of those virtues.