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Bioethicists respond to U of M Regents’ refusal to appoint outside panel

The University of Minnesota’s Board of Regents has rebuffed a request by eight bioethicists to appoint an outside panel of experts to investigate the ethical issues raised by the case of Dan Markingson, a young man who committed suicide in 2004 while enrolled in a psychiatric research study at the U of M.

In a letter dated Feb. 7 and released Monday, the board noted that “extensive reviews” of the case had been conducted by “a number of independent experts and government units,” including the U.S. Food and Drug Administration, the Hennepin County District Court, and the Minnesota Board of Medical Practice.

“Each and every one of these reviews resulted in the same conclusion: there was no improper or inappropriate care provided to Mr. Markingson, nor is there evidence of misconduct or violation of applicable laws or regulations,” the letter said.

“[W]e do not believe further University resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies,” the board concluded.

Not surprised
“Once again, the university had a chance to do the right thing, and once again it failed,” said Dr. Carl Elliott, a professor of bioethics at the U of M and a signator to last November’s letter to the Board of Regents, in an e-mailed statement to MinnPost. “That’s not surprising, but it’s still disappointing.”

“I wasn’t all that surprised either,” said Leigh Turner, another signator and an associate professor in the center for Bioethics, the School of Public Health and the College of Pharmacy, in a phone interview. “It seems to be in keeping with previous strategies to manage this case.”

Turner noted that the board solicited input only from U of M general counsel Mark Rotenberg. “You’re getting a very circumscribed take on the issue,” he said. “[General counsels] generally play a risk-management role. What you’ve got here is a letter that’s an exercise in risk management.”

“The general counsel keeps repeating that this matter has already been investigated and the university has been cleared, but it is precisely those investigations that have been called into question,” said Elliott. “This is exactly the reason why we have been calling for an independent investigation.”

Financial conflicts
Markingson was 26 years old and experiencing psychotic episodes when he was recruited into a U of M clinical trial of the antipsychotic drug Seroquel (quetiapine). The study was funded by the drug’s manufacturer, AstraZeneca, and the U of M psychiatry department earned $15,648 for each patient it enrolled in the trial. In addition, the two U of M psychiatrists who led the study, Drs. Charles S. Schulz and Stephen C. Olson, had personally earned hundreds of thousands of dollars from various drug companies, including AstraZeneca.

“Given all the press about this case, it’s stunning that the university has not even addressed the fact that Dan Markingson was under an involuntary commitment order when he was recruited into the study, and had been ordered to follow the treatment recommendations of his psychiatrist,” said Elliott in his e-mail statement. “This practice is now illegal in Minnesota. The state legislature has banned it. Even so, the university apparently does not think the matter is important enough to investigate.”

Last year, AstraZeneca agreed to pay $520 million to settle a federal investigation into its illegal marketing of Seroquel. Part of that investigation had concerned AstraZeneca’s payments to physicians.

“The unsealed documents in that litigation implicated our Department of Psychiatry — in fact, they implicated Charles Schulz,” said Elliott. “… Yet again, the university apparently does not think this is worrying enough to look into.”

Corporate revenue streams
The U of M adopted a new conflict-of-interest policy in August, which covers all researchers in the Academic Health Center, including those in the Department of Psychiatry. But that policy doesn’t stop pharmaceutical and other companies from pouring money into the university, said Turner.

“Universities are feeling cash-crunched,” he said. “Many are getting less money from state budgets. They’re looking for other revenue streams.”

The U of M Board of Regents acknowledged the importance of these revenue streams in its letter.

“In an era when public funding of our University and its research is limited, we must recognize that critically important medical and health research requires substantial private investment, both from donors and from corporate sponsors,” the letter stated. “Those funding sources provide great opportunities — and pose significant challenges — for the University. We believe our faculty is ideally suited to engage in a rigorous, open, and honest exploration of these opportunities and challenges, and the impact they may have for the integrity of our research mission.”

Recent research has shown, however, that corporate-sponsored medical studies are frequently designed to place the drug being investigated in the best light.

“The results typically favor the company,” said Turner. Thus, even participating in such studies raises conflicts of interest for researchers and their institutions, he said.

Listing the conflicts of interest of U of M researchers and the university on a website is not enough, Turner added. “Simply acknowledging that you’re taking money from drug companies doesn’t eliminate the conflict of interest,” he said.

Industry-sponsored studies “create a financial architecture where the incentives are to recruit and retain” patients, he explained. “But what if it’s in the patient’s interest to be dropped from the study and receive standard care?”

Nor is Turner impressed with the Board of Regent’s suggestion in its letter that the U of M community “engage in further discussion about these wider issues.”

“They’re saying, ‘Let’s just create a little space where those of you who are concerned can talk about it,’” he said. “That’s not going to resolve these issues, for there’s no attempt to deal with any of the structural problems.”

Comments (5)

  1. Submitted by William Gleason on 02/08/2011 - 12:25 pm.

    Sooner or later, the University of Minnesota is going to have to face up to this situation.

    I am deeply disappointed in this head in the sand behavior. It is not going to do our reputation any good. Major changes are needed in the Department of Psychiatry – and elsewhere in the med school – to restore our good name.

    A tiny fraction of people are involved in this unethical behavior. The great majority of U of M docs are wonderful people – it is sad to see them pilloried for the gutless behavior of a few, now the Regents.

    William B. Gleason
    University of Minnesota
    Medical School Faculty
    U of M alum

  2. Submitted by Justin Paquette on 02/08/2011 - 01:23 pm.

    For those curious to learn more about past federal, state, and independent reviews referenced in this article (all of which found that Dan’s death was not the result of improper or inappropriate care, and none of which found any evidence of misconduct by the physicians overseeing his care) we’ve put the letter from the Board of Regents on the Academic Health Center website. We’ve also posted the full letter from the University’s General Counsel, which addresses each of the concerns pointed out by these eight faculty and why they were dismissed.


    -Justin Paquette, PR Manager for the Academic Health Center

  3. Submitted by Sheila Ehrich on 02/08/2011 - 02:38 pm.

    This is not surprise to me either. Over his tenure, Mark Rotenberg’s style of “risk management” has cost the University of Minnesota and Minnesota’s taxpayers millions in payouts and legal costs (with Mark making out like a bandit, I’m sure). This head-in-the sand approach has failed so many times you’d think he and the Univerity would learn from their experiences. But, no, they just keep on keepin’ on.

    And one might think that the Legislature would look at what is happening as a result of the continuous cutting to University funding brings in more and more corporate money with strings.

    I know this subject is a sidetrack from the article, but …

    The U’s former College of Agriculture made the University one of the great landgrant research institutions in agriculture FOR MINNESOTA’S FARMERS. But not any more, the U’s research now only seems to serve corporate interests with the results of its research being used to justify more corporate farming and questionable land and water conservation practices. Those at the Minnesota Institute for Sustainable Agriculture have to beg for crumbs and yet localized small farming and organinc farming are the fastest growing sectors of agriculture and have been for the past decade.

    It’s time for the Regents to wake up to their responsibilities, get out of bed with the pharmaceutical and agricultural corporations, etc., and start figuring out how to return the University to being a publically supported institution, not one that is bought and paid for by companies who want to not only set the agenda, but determine the outcomes before the research has even started.

    Cutting Mark Rotenberg’s salary everytime his actions result in a multi-million dollar payout may be small potatoes, but it might just be a good place to start.

  4. Submitted by David Plyler on 02/08/2011 - 03:27 pm.

    I’ve been following this case for awhile and I’m always blown away by the commentary.

    Sheila – your logic doesn’t make much sense. You’re attacking a University lawyer, chastising him for high “payouts and legal fees” yet you also attack him and the U of M for NOT looking at this case again. Which is it? You cite taxpayer dollars. Do you want your tax dollars going to look at a case for the 100th time or do you want them to conserve your money and, I don’t know, look for new solutions to problems?

    What if they did look at this case again. And again they find the University didn’t do anything wrong. Are you going to attack them again for wasting more resources?

    You need to pick a side. And just “attacking any and all things University” isn’t a side. Unless you’re a tenured faculty evidently.

  5. Submitted by William Gleason on 02/08/2011 - 04:09 pm.

    Actually, Rotenberg doesn’t have a monetary stake here, since he is paid a salary by the U.

    But David’s argument is still very weak. The U’s position seems to be that as long as they don’t break any laws, everything is hunky-dory. For an example of this inane attitude, please see the performance of our last Dean, F

    Not exactly. There is this thing called the Hippocratic Oath. And the public is becoming more and more aware of what goes on in Academic Health Centers and Hospitals. What’s happened here is far from anything to brag bout. People = patients will vote with their feet.

    The U of M medical school and the homeopathy espousing Academic Health Center is going to have to clean up their act or pay the consequences.

    The problem in arguing with stupid people is that they don’t even realize what is in their own best interest.

    Bill Gleason

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