Faculty take on clinical drug trials

The Markingson case prompted a proposed Faculty Senate resolution.

by Cody Nelson

The University of Minnesota Faculty Senate will discuss a resolution Thursday to create an independent, external panel to investigate how the institution conducts clinical research on human subjects.

The Faculty Consultative Committee is recommending that the full Senate approve the resolution in order to ensure the University is meeting ethical standards.

The proposed resolution stems from the years-old controversy surrounding University drug trial participant Dan Markingson, who committed suicide six months after joining the study in 2003.

Markingson participated in the CAFE study, a psychiatric drug trial sponsored by AstraZeneca and run by University professors.

In October, a group of bioethicists from around the world wrote a letter to the Faculty Senate asking for an outside investigation of the case. The group raised concerns about previous action on the case, including a Minnesota Board of Social Work investigation and a lawsuit filed against the University by Markingson’s mother, Mary Weiss.

“We are aware that officials within your university have suggested that various investigations have already taken place,” the letter said. “However, such claims hold only at the most superficial level.”

Some researchers say an investigation will find more cases like Markingson’s.

Trudo Lemmens, a University of Toronto professor and one of the letter’s key authors, said part of its intent was to show that concerns about the Markingson case aren’t unique to researchers in Minnesota.

“The external academic community is really worried about what is happening at the University of Minnesota,” he said.

The proposed investigation wouldn’t consider past research like the CAFE study. But the resolution says it would examine “current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities.”

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

The board’s investigation found that study coordinator Jean Kenney made repeated errors in documentation, performed tasks beyond her expertise and didn’t adequately address family concerns over how Markingson was treated.

Associate professor in bioethics and public health Leigh Turner, who arrived at the University in 2008, said his colleagues have been concerned about the CAFE study as long as he’s been on campus.

“It’s just something that needs to be addressed, and it needs to be addressed in a definitive way,” he said.

Mechanical engineering professor William Durfee, chairman for the University’s Faculty Consultative Committee, said psychiatric clinical trials involving human test subjects are a highly sensitive area of research.

The panel’s investigation could provide reassurance that University research practices meet ethical standards, he said.

“You need to do the research to get ahead,” he said, “but you need to be exceptionally careful that you’re following best practices in terms of enrollment and managing subjects all the way.”

But Mike Howard, a close friend to Weiss who has been involved with the Markingson case, said he thinks it’s unlikely an investigation would find no wrongdoing, and he thinks there are other “victims” like Markingson.

“I find it hard to believe that they would not find anything wrong,” Howard said.

Issues with the University’s research practices in the Markingson case have lingered for years, Turner said.

Though much discussion of research misconduct focuses on the CAFE study, Turner said, one important question remains:

“Is Dan Markingson part of a larger community of research subjects that’ve been harmed by research studies here?”