Monday, December 9, 2013

The Daily weighs in on the #Markingson "investigation"

My question: Will the University of Minnesota Face Up To Ethical Responsibilities or Continue In Denial and Evasion?

The Faculty Senate wants an outside panel to examine clinical trials.
By Kia Farhang Marion Renault December 09, 2013

The University of Minnesota Faculty Senate is calling for an independent, external panel to examine how the University does clinical research on human subjects.

The measure passed in a 67-23 vote Thursday after renewed calls from scholars and bioethicists to re-examine the 2004 suicide of Dan Markingson, a 26-year-old who participated in a clinical drug trial 10 years ago at the University of Minnesota Medical Center, Fairview.

Since Markingson’s suicide, many within and outside the University have raised questions about the CAFE study, the psychiatric drug trial he participated in and the University’s standards for ethical research.

An international group of bioethicists wrote to University President Eric Kaler and the Faculty Senate in October asking for an independent investigation of issues arising from the CAFE study.

The measure calls for a look at current human research practices at the University, not an investigation of the Markingson case.

The resolution that passed Thursday isn’t binding, said Eva von Dassow, Faculty Senate vice chair and associate classical and near Eastern studies professor.

But Kaler, who chairs the Faculty Senate, told reporters after the meeting that he’s moving forward with the recommendation.

University officials will begin scouting nationwide early next year for experts to conduct the review, Kaler said, but no timeline is set for when the evaluation would be completed.

Kaler said he thinks the investigation will show that the University’s current research policies are “in very good shape.”

The Faculty Senate made three amendments to the original proposal, including one that requires the results of the inquiry to be reported back to the Senate for discussion.

The other two amendments added more details about Markingson to the resolution and struck the word “investigative” from the panel’s definition.

Markingson case lingers

While Thursday’s resolution doesn’t call for an investigation into the Markingson case, several faculty members said lingering questions from the incident have clouded the University’s reputation as a premier research institution.

Multiple reviews of the Markingson case at the University, state and national levels found no wrongdoing in the CAFE study. The only official finding of wrongdoing was a corrective action agreement for a study coordinator from a Minnesota Board of Social Work investigation last fall.

But several prominent scholars don’t believe past inquiries into the case were credible, said philosophy professor Naomi Scheman.

“We do have a good reputation, and we’ve worked hard to earn that reputation,” she said, “but it’s crumbling before our eyes.”

Others, like public health professor Dr. Russell Luepker, said at the meeting that the investigations into the Markingson case have been sufficient. He said documents questioning those past investigations contain a “number of half-truths and distortions.”

But Luepker said he supports a review of the University’s ethics procedures and practices despite his qualms about the proposal’s origins.

“The issue here, I think, is not a 10-year-old case of a tragedy that occurred, which has been investigated thoroughly, and nothing has been found,” he said, “but we should never stop from asking questions and review such a critical area.”

Cultural studies and comparative literature professor Cesare Casarino said the full truth of the Markingson case still needs to come out.

When it comes to determining whether there was any wrongdoing in the case, the burden of proof is on the University, Casarino said.

Dr. Stephen Olson, the CAFE study’s lead psychiatrist, told reporters after the meeting that he welcomes any investigation into the Markingson case.

“I’ve got nothing to hide,” he said. “We didn’t do anything wrong.”

He said at the meeting that Markingson’s suicide was tragic but unsurprising.

“Cancer patients die in cancer studies all the time,” he said, “and it’s not a surprise that people with mental illness will die in a trial of mental illness.”

Olson said he and his colleagues involved with the study haven’t been able to fully defend themselves because they don’t have the legal right to release Markingson’s medical records.

For Mike Howard, a representative for Markingson’s mother, Mary Weiss, the Faculty Senate’s action Thursday was “a huge vindication.”

‘This cloud hangs over us’

The University already has channels set in place, like the Institutional Review Board, that hold it to “rigorous standards of ethics,” pediatrics professor Dr. Sue Berry said at the meeting.

But William Durfee, a mechanical engineering professor and Faculty Consultative Committee chair, said while the University passes those voluntary accreditation processes with “flying colors,” it might not be enough.

“There’s a sense … as faculty that we almost want to hold the University to a higher standard than that,” he said.

Sociology professor David Pellow said he’s been through the IRB process at five different research universities and found the University of Minnesota’s to be the most “rigorous,” “comprehensive” and “impressive.”

But Pellow said his confidence has faltered and he feels the University should respond to “a growing and global call” for an external review.

Not conducting the review, he said, could be dangerous for the University as a whole.

“As scholars around the nation, and indeed the world, look askance and wearily at our perceived troublesome practices … [they will] likely discourage their students and colleagues from studying here, working here and collaborating with faculty here,” Pellow said.

Anthropology professor Karen-Sue Taussig said the University needs to show its commitment to research ethics, especially to the 175 international bioethicists and scholars who signed the October letter to the Faculty Senate, many of whom are renowned in their fields.

“The fact that this cloud hangs over us in the way that it does shows that we are not being successful in demonstrating that to the public and our colleagues elsewhere,” she said.

=============End of Daily Article

To try to evade looking into what happened in the Markingson case is a very bad strategy for the university, painful as it may be after many years of denial that anything was wrong.

I've written about this on the Star-Tribune Community Blogs website:

A short excerpt:

The Gordian Knot of the Markingson matter can be solved, crudely speaking, in two ways. One is the "Alexandrine solution." [cutting the knot in half with a sword]
 But simply "give them an investigation of things as they are now" may solve the problem at one level, but will it will simply intensify questioning and even outrage at another. The time for stonewalling is over.
 The alternative is to take the knot apart. Follow the unravelled rope from one end - the Markingson case - to the other end: clincal practices in the present.  What was wrong - if anything - in the Markingson case?  What has changed as a result of it - for example Dan's Law? And where do we stand now, has anything actually changed? Is there a difference between what is ethical and what is legal?  Are we now following clinical practices in accord with  the highest ethical standards not just the law? 
 "Profiles in courage" should not only be an exemplar for politicians. It is time for the University of Minnesota administration to step up to the plate and demonstrate some courage.
I'll write again as things develop. We all love our university. Some day I'd like to be #umnproud again. 

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