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U of M dispute over research ethics morphs into academic freedom flap

Carl Elliott
umn.edu
Carl Elliott

You wouldn’t know it from reading local media, but in recent weeks the University of Minnesota has become Ground Zero in a high-stakes controversy over academic freedom. A number of faculty members have accused the administration of trying to silence a professor who has repeatedly drawn national attention to research protocols he charges are unethical.

It would appear that the simmering dispute is about to become a full-on conflagration.

Last fall, the magazine Mother Jones published a lengthy investigative article penned by Carl Elliott, a U of M bioethics professor and highly respected author of two books. The most recent, “White Coat, Black Hat: Adventures on the Dark Side of Medicine,” expands on the controversy.

A terrific, if horrifying, read, the Mother Jones story documents the 2003 death of a mentally ill man who was enrolled under questionable circumstances in a clinical trial at the U of the psychiatric drug Seroquel. The gist: Under pressure to find more participants for the lucrative trial, researchers enrolled Dan Markingson despite the fact that he had repeatedly threatened to kill his mother. Within six months, while he was still in the program, Markingson stabbed himself to death with a box cutter.

'$15,648 for each subject'
A taste:

“As a patient on public assistance, Dan's treatment would have normally generated little income for the university. Under its arrangement with AstraZeneca, however, the psychiatry department earned $15,648 for each subject who completed the CAFE study. ...

"In fact, during the months before Dan was enrolled, the department was apparently feeling pressure from [the contractor] that managed the study to step up recruitment. According to emails written by Jean Kenney, the university's study coordinator, the site had been placed on probation for its recruitment problems, and they were still 'struggling to get patients.' ...

"That began to change in April 2003, when the psychiatry department established a specialized inpatient unit at Fairview hospital called Station 12, in which every patient could be evaluated for research.”

After the piece was published a group of faculty members asked the university Board of Regents to order an independent investigation. In February, the regents declined.

(Lawmakers were more easily moved. Last year they passed a law banning researchers from enrolling certain mentally ill people in clinical trials.)

Enter the U's general counsel
A couple of weeks afterward, General Counsel Mark Rotenberg addressed the university’s Academic Freedom and Tenure Committee, seemingly suggesting that Elliott had defamed his colleagues. “What is the faculty[’s] collective role in addressing factually incorrect attacks on particular university faculty research activities?” he asked.

After reviewing the minutes of the meeting, still other faculty, including the president of the Minnesota chapter of the American Association of University Professors, decried Rotenberg’s question as inappropriate.

The “committee’s last meeting seemed to be presuming that the claims made against the researchers were false,” philosophy professor Naomi Scheman wrote to Elliott, according to Corporate Counsel magazine. “The committee cannot work on that highly prejudicial presumption. It is precisely what is at issue in the case.”

Most recently, Rotenberg defended his remarks in an interview with the Chronicle of Higher Education. “The faculty, as a collective body, should take an interest in attacks on their members that serve to deter or chill controversial research,” he told the paper.

What Scheman and others heard, in essence: Silence Elliott in the name of academic liberty.

As reported by the Hastings Center on bioethics, which has followed the controversy, many attended the next meeting of the academic freedom committee on April 22.

'Trying to turn the tables'
“Philosopher and historian of science Ken Waters,” the magazine reported, “was just as concerned. ‘The university's general counsel planted a false question, the implicature of which [the committee] seemed to be uncritically accepting (that Carl was advancing factually incorrect claims),’ he wrote to me in an e-mail. ‘And in planting the question, the counsel was trying to turn the tables and squelch my colleagues' academic freedom by somehow suggesting that they were impinging upon the academic freedom of others.’ ”

More details can be found on a blog maintained by pharma critics and closer to home by university-watchers at The Periodic Table.

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Comments (6)

To be fair to local media-

The Star-Tribune has two posts related to this matter on their Community Voices site:

April 25th
University of Minnesota General Counsel: Is Defamation Protected By Academic Freedom?

April 29th
Chicago Philosopher Calls Out U of M General Counsel on "a quite brazen attack on academic freedom"

link: http://www.startribune.com/local/yourvoices/Bill_Gleason.html

Also, I am the sole proprietor of the blog The Periodic Table, however, Mr. Michael McNabb, another University of Minnesota alumnus has made some excellent and incisive guest posts.

Please keep up the good work.

My best.

Bill Gleason

Why keep this in house? Of COURSE let's discuss in the media. Because after all, since each of us contributes like 2 bucks a year to the University at this point - we should all have a say.

Elliott should have thought about the repercussions when he was dragging faculty through the mud. Now he pretends the world is against him. Serves him right.

And by the way, could the public care less about this? There are two audiences who care about the issue of "academic freedom." The media and faculty at the U who feel their "voices aren't being heard."

Who cares? A lot of patients should...

"attorneys deposed the director of the U's Institutional Review Board (IRB) or research subjects ethical review committee, Moira Keane. The attorney asked what she thought was a routine question--didn't the IRB have the responsibility to protect human research subjects?--before proceeding to the issues under dispute. But Ms. Keane refused to admit that the IRB had any such responsibility. The attorney thought she had misunderstood (after all, the U-MN website says the purpose of the IRB is to "protect the rights and welfare of human research subjects") but Ms. Keane stood firm. In the end, all she would admit was that it was the role of the IRB to make sure that research investigators at the U had a plan to protect human research subjects. As Dr. Elliott then notes, this is as good as saying that the IRB at U-MN doesn't do a thing--since it was precisely to protect human subjects from the dangers of an overzealous investigator that IRBs were first created."

Source: Hooked: Ethics, Medicine, and Pharma
Dr. Howard Brody: http://bit.ly/bz6Ss5

And if anyone thinks for a second that the public could care less about this matter, they are sadly mistaken. There has already been one piece of legislation passed at the state legislature because of it and there may be more if the U doesn't clean up its act.

Another step in the corporatization of higher ed; MN's profit center indeed.

Would this have happened if we funded higher education appropriately? If we actually believed in the value of higher ed?

Bill, thanks for your reply. I started reading it...but fell asleep. The good news though, was that I had a dream. In that dream the faculty at my state institution did more for their day jobs than blog and tweet. Unfortunately, when I woke up your reply was still on my computer screen and I knew reality had returned once again.

No wonder Republicans have no concerns cutting the U's budget. All they have to do is head over the Star Tribune or Twitter to see evidence of faculty who could be trimmed.