UMN president agrees to outside review of clinical research practices

University of Minnesota President Eric Kaler says he will form an outside panel to review how the U treats human subjects in clinical trials.

His announcement followed a faculty resolution today requesting a review of the U’s practices. (See Item No. 10 on the second-to-last page above.)

The panel is a response to the 2004 death of patient Dan Markingson, who killed himself while enrolled in a clinical drug study at the U.

Faculty leader Naomi Scheman says lingering questions over his death have put the U’s reputation under a cloud.

“It’s not going away because — despite the university’s insistence that it has been adequately investigated — very credible, serious, thoughtful, fair-minded people do not find those investigations genuinely to be credible.”

Kaler says he welcomes the review, saying it would put to rest any doubts over how the U handles people in clinical research.

“Let’s look at what we’re doing now, currently. I have a great deal of confidence in what we’re doing, and I think an external validation of that — which is what I expect it to be — will close the chapters.”

Kaler said he will form the panel early next year.

Carl Elliott, who has been one of the main scholars raising questions — and who has called for an outside investigation into Markingson’s death — says he’s trying to stay optimistic:

“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.”

This morning, a friend of the Markingson family, Mike Howard, delivered a petition with almost 3,500 signatures to Gov. Mark Dayton’s office asking for “an external panel of experts to investigate ethical wrongdoing in psychiatric research at the University of Minnesota, including the circumstances surrounding Dan’s death.”

He later Kaler’s announcement of the panel “a tremendous first step.”

He added:

“The records will speak for themselves. … It does restore some faith that there is some honesty and integrity at the University. Because for a long time, it has been held in a closet. And today is the first day it came out.”

  • InFlamitory

    And what drug(s) were they using on their human test subjects? Are these the same schools that get state and federal funding to run these programs to turn out information to make drug companies a huge profit? Doesn’t seem the most biased way to test the efficacy of any drug, much less psychotropics which have a historically poor performance record overall. They have yet to turn out drugs that actually work far better than placebos (in any real numbers aside from a handful for things such a schizophrenia) yet billions of prescriptions are written yearly and our population isn’t getting “better”. Time to do some real research. Find some real answers. But that wouldn’t make as much money in the end, would it?

  • Cindy Carlson

    I just believe the University of Minnesota to be incapable of regulating itself or holding itself accountable when it comes to research involving human subjects and psychiatry. I have followed this case for years with keen interest and all the main characters at the University exhibit the same quality – they’re totally unable to ever tell the truth- Dr. Olson appeared at this hearing and did his best to endear the audience with his ” I did nothing wrong, and I’m the victim here” routine. It didn’t work.