After scathing report, U halts drug trials

The drug trial during which a man killed himself had ‘serious’ ethical issues, a report found.

by Christopher Aadland

More than a decade of scrutiny over the University of Minnesota’s handling of a drug trial participant’s death and the institution’s research ethics has prompted a swath of proposed changes.

The state legislative auditor’s office released a report last week that revealed “serious ethical issues and numerous conflicts of interest” surrounding the 2004 suicide of Dan Markingson, who was enrolled in an antipsychotic drug study at the University when he died. The report also says the school should halt enrollment in all psychiatric drug studies and allow state officials to oversee trials, among other recommendations.

The report said the University used misleading statements about the thoroughness of past reviews of the case, and it also faulted administrators and the Board of Regents for dismissing calls for further reviews.

“This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation,” the report read.

The Association for the Accreditation of Human Research Protection Programs, Inc. oversaw the study, which was released last month, examining the school’s research practices from 2011 to 2014. That report cited flaws in how the University protects human research subjects.

The legislative auditor’s review and the AAHRPP report were both presented at a Senate Higher Education and Workforce Development Committee meeting Thursday, where school leaders and officials fielded questions from lawmakers.

“We’re here 11 years later because we didn’t have a good investigation up front,” said Sen. Eric Pratt, R-Prior Lake. “You can’t have an ethical program unless you have ethical people.”

The legislative auditor’s report recommended drafting measures requiring the University to fully implement an external review panel’s recommendations before psychiatric drug trials could continue at the school.

The legislative auditor also wants the state’s Office of Ombudsman for Mental Health and Developmental Disabilities to oversee future psychiatric drug studies.

“We will, before the session ends, reconvene this group,” said Sen. Terri Bonoff, DFL-Minnetonka. “I’m sure you’ll see some legislative proposal come forward as a result.”

Bonoff said the legislation will incorporate both the auditor’s proposals and the AAHRPP’s recommendations.

Some state officials and advocates aren’t convinced that the University will respond to these changes internally.

“We don’t think trust is enough. We believe in trust, but verified, and we think that verification at this stage needs to come from outside the University,” Minnesota Legislative Auditor Jim Nobles said on Thursday.

Associate bioethics professor Leigh Turner, a longtime skeptic of the University’s research ethics, said he’s concerned the school won’t take meaningful action to address the issues highlighted in the auditor’s report.

Eliminating conflicts of interest

In 2003, Markingson agreed to participate in a schizophrenia drug study known as the CAFÃâ study, which was funded by the pharmaceutical company AstraZeneca.

Dr. Stephen Olson, an associate psychiatry professor at the University, was the principal investigator of the study responsible for Markingson.

The auditor’s review said Markingson should’ve never been recruited into the study in the first place because of conflicts of interest and incentive to enroll participants in the study.

“I am struck by the number of conflicts on the parts of so many of the participants all along in the process,” Sen. Julianne Ortman, R-Chanhassen said on Thursday. “Everybody seemed to have a conflict here.”

Medical School dean Dr. Brooks Jackson said Thursday that any new legislation that would require the school to completely eliminate reimbursement from pharmaceutical companies could cripple research at the University.

“What we need to do, despite that, is minimize that conflict of interest as much as possible,” he said at the meeting.

After the release of Thursday’s report, the University announced it would suspend enrollment in psychiatric trials until they are reviewed independently. It will also form a community oversight board and develop a “plan of action” by May 15.

“We are going to make these changes,” University President Eric Kaler said Thursday. “They’ll be very visible and very public.”

Regents will act on a resolution supporting Kaler’s actions and requiring additional oversight on Friday.

“We hold ourselves responsible and accountable to improve and will work tirelessly to restore confidence in our work,” Kaler said in a press release.

Mike Howard, a friend of Markingson’s mother, Mary Weiss, said at the meeting that Weiss was pleased with the thoroughness of the auditor’s report and hopes the changes will save future lives.

“Nothing is going to change anything for Dan Markingson, but  hopefully what Mr. Nobles’ report will do will change things in the future,” Howard said Thursday.