The Markingson Files: University of Minnesota under new scrutiny in drug trial death

The suicide death of one man a decade ago continues to reverberate throughout the University of Minnesota clinical research program.

Dan Markingson suffered from schizophrenia and killed himself in May 2004 while taking part in a clinical trial for an antipsychotic drug made by AstraZeneca. The trial was run by the University of Minnesota, and Markingson was a patient of a University of Minnesota professor.

I wrote several posts about Dan Markingson’s death and the quest to find out what really happened, and I thought that after multiple government and journalistic investigations into the death, nothing new would come to light. Recently, though, there have been a series of new developments. A brief timeline is below.

February 27, 2015 – The Association for the Accreditation of Human Research Protection Programs finds in a report that research subjects at the University of Minnesota were “susceptible to risks that otherwise would be avoidable.” It recommends better systems to prevent patients from being coerced into clinical trials. The association wrote:

Some research subjects, by virtue of impairment or incapacity, may be unable to fully protect their own interests at the point of study enrollment and during the course of research participation.

March 19, 2015 – A legislative auditor releases a report about Markingson’s death and how the university handled it. The auditor, James Noble, also testifies before the Minnesota Senate. Noble recommends that the University of Minnesota put a hold on psychiatric drug trials until the university can prove that it has fixed oversight problems and patient protection gaps. Jeremy Olson at the Star Tribune wrote:

While noting that there is no proven link between the drug trial and Markingson’s death, Nobles’ staff said: ‘We are especially troubled by the response of University leaders … they have made misleading statements about previous reviews and been consistently unwilling to discuss or even acknowledge that serious ethical issues and conflicts are involved.’

At the same hearing, university president Eric Kaler apologized to Markingson’s family and agreed to suspend enrollment in psychiatric drug trials.

March 27, 2015 - Carolyn Chalmers, a former director of the Office for Conflict Resolution at the University of Minnesota, writes in the Star Tribune that Kaler’s response to the legislative auditor report did not go deep enough. She wrote:

In the 10 years since Markingson’s death, the university has had two presidents, several medical school deans and several senior vice presidents of the Academic Health Center. When so many different leaders touch a problem, yet there is no change in the management of the problem, we likely have a systemic cultural pattern rather than an individual proclivity that needs correction.

April 1, 2015 – Jeff Baillon on Fox 9 in Minneapolis reports that the state Board of Medical Practice hired a consultant who found problems with Markingson’s recruitment into the clinical trial. The Board chose not to act on the findings, which raises additional questions about the lack of oversight and action at the state level.

Suddenly, Markingson’s death is a fast developing story again. So I will try to stay on top of it and provide updates along the way.

Photo by Bala Sivakumar via Flickr.