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UMN agrees to outside review of clinical research practices—but what parts and by whom?


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Delivering petition to Gov. Dayton's office Photo by Jeff Baillon, Fox 9 News

This research ethics series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues of “good clinical practices” and ethics: consent, investigator responsibilities and conflicts of interest. Then I examined the university’s response and then turned to the importance of careful documentation of consent. Next, I explained how I was transformed by Dan’s story from looking at it simply as an objective case lesson in clinical trial ethics, to an advocate for an independent investigation of the University of Minnesota. In a more recent post, I shared reactions to the announcement that Mark Rotenberg, the UMN’s General Counsel, was leaving Minnesota to assume a similar post, now as Counsel and Vice-President at Johns Hopkins University.  I have also asked Dr. Jeffrey Lieberman, who was Principal Investigator on the CAFE and CATIE trials, to address concerns that have been raised about the ethics and conduct of that trial. More recently, focus was on problems with IRBs. Denial of responsibility for any research misconduct was examined most recently.

After years of staunch denial of any research misconduct at the University of Minnesota (UMN), which I focused on last week, a breakthrough has been reached.

The UMN Faculty Senate held a discussion about the death of Dan Markingson, a participant in a psychiatry clinical trial. The Faculty Senate then voted 67-23 to ask for an independent review of the conduct of clinical trials.

The vote came after increased evidence suggestive of research misconduct has appeared (see previous posts in this series). In response to that, Fox 9 News featured the ongoing controversy. A petition on Change.org garnered almost 3500 signatories. Most recently, ~175 academics from all over the world sent a letter to the Faculty Senate. Signatories included Susan Reverby (the historian who brought unethical syphilis experiments in Guatemala to light), members of the President’s Council on Bioethics, and former editors of the New England Journal of Medicine. The UMN’s General Counsel, William Donohue arrogantly responded, “It is not clear from your letter whether you are completely familiar with the details of these previous reviews conducted by a number of experts and governmental units independent of the University.”

While President Kaler has taken a significant first step, agreeing to form a review panel, he stated. “Let’s look at what we’re doing now, currently” and that this “will close the chapters. Unfortunately, unless he goes further and specifically looks into evidence of alleged past abuses as well, Kaler’s action will not satisfy critics nor restore the UMN’s reputation.

As Professor Carl Elliott observed, “It all depends on who picks the panel, what they’re allowed to look at, and what kind of access and power they have to get at records, to get at court documents, to get at finances, to interview people who have been involved in clinical care as patients and research subjects that were in the department of psychiatry. All that stuff is going to be important .. for whoever sets up this panel to make sure they’re given the tools and expertise to do their job.”

President Kaler has the opportunity to demonstrate true leadership, looking seriously at where the UMN has failed its citizens, and doing a thorough analysis of where systems broke down and improving them.

In my opinion, an excellent approach would be the STAMP (systems- theoretic accident model and processes) analysis taken by MIT Professor Nancy Leveson in her book Engineering a Safer World and in the MIT program Partnership for a Systems Approach to Safety.

I hope President Kaler will demonstrate leadership, as the UMN would emerge stronger, with new found respect.

For further reading, previously in this series:

A Clinical Trial and Suicide Leave Many Questions: Part 1: Consent?

Part 2: Investigator Responsibilities

Part 3: Conflict of Interest

Part 4: The University of Minnesota’s Response

Part 5: The Case of the Mysteriously Appearing Documents

Part 6: The Run-Around, or Why I Now Call for an Independent Investigation of University of Minnesota

A New University of Minnesota Mystery-The Curious Departure of Mark Rotenberg

Yahrzeit – Reflections on Dan Markingson’s Legacy

Covering Clinical Trials: a message for journalists and critical readers

How Not to Run an Op-Ed Page

Anti-Psychiatry Prejudice? A response to Dr. Lieberman

Minnesota Attorney General Confirms They Did Not Exonerate UMN in Markingson Death

A Clinical Trial and Suicide: What do the UMN and Disney Have in Common?

 

Credits:

Photo of Mike Howard delivering Change.org petition to Gov. Dayton’s office, courtesy Jeff Baillon and Fox 9 News

“Molecules to Medicine” banner © Michele Banks

Judy Stone About the Author: Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

The views expressed are those of the author and are not necessarily those of Scientific American.





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