In 2004, Dan Markingson killed himself after participating in an antipsychotic drug study conducted by two University physicians, Dr. Stephen Olson, former head of the University’s psychiatry department, and Dr. Charles Schulz, former Department Chair and psychiatry professor. The suicide prompted more than a decade of scrutiny into the psychiatry department’s research practices.
Markingson was 26 years old when he was forced to make a decision: comply with his physician’s treatment plan, a clinical trial testing FDA-approved drugs, or face commitment to a psychiatric institution. Though he was later deemed a “vulnerable adult,” he agreed to the former.
In the months following his enrollment in the treatment plan, his mother, Mary Weiss, grew increasingly concerned about the state of his mental health. Though she repeatedly reached out to his care team, her concerns were not acted on. She asked the study coordinator, “Do we have to wait until he kills himself or anyone else before anyone does anything?” Within a month, he would take his own life.
While he was under the care of Dr. Olson, Markingson was enrolled in a psychiatric clinical trial headed by Olson. Olson’s role as Markingson’s physician presented a conflict of interest when recruiting him for the study, a state report said. Markingson did not have a patient advocate present at the time of his decision to enroll in the study, though Olson told the University all patients would. According to the same state report, the University received more than $15,000 for every subject who completed the study, which was sponsored by AstraZeneca.
Dr. Olson is still employed by the University, while Dr. Schulz retired in 2015 amid investigations into the Psychiatry Department. In his final State of the University address last spring, University President Eric Kaler said the University’s handling of the Markingson incident was one of the biggest regrets of his presidency.
Well aware of the scandal and attention brought onto the psychiatry department from the Markingson case, Dr. Sophia Vinogradov assumed the department head role in 2016 with the goal of creating a healing and prosperous department.
Altogether, the University has implemented 63 policies that aimed to improve its practices. Some of the changes implemented by the University include:
- The University’s Institutional Review Board, which reviews research involving human subjects consists of scientists, faculty and community members, now with about 80 members regularly review research proposals.
- Implementation of sophisticated methods to ensure that vulnerable populations, like those with diminished cognitive capacity, are properly protected in research
- Vinogradov convened a community advisory board for the department, which includes family members of those with mental illnesses, and is in the process of creating a committee consisting of those who have had personal experience with mental illness to advise her on the best practices for research opportunities and clinical work.
In 2009, “Dan’s Law” was passed, which prohibits people under state civil (involuntary) commitment from participating in psychiatric clinical drug trials.
A law passed in 2015 authorizes the state’s ombudsman to monitor individuals enrolled in clinical drug trials in the University’s Department of Psychiatry. Under the statute’s provisions, the ombudsman will gather records related to clinical drug trials and ensure that the psychiatry department is complying with federal law and Institutional Review Board mandates. Ombudsman Roberta Opheim said the ombudsman’s office will distribute information to each research participant to make sure they know they can contact the office with a complaint.
Even with dozens of policy changes, multiple investigations and a change in departmental leadership, a sense of distrust still persists among some in the University community.
“It’s impossible to know if things are truly better, or if they are just really good at not letting things get out,” said Dr. Carl Elliott, a professor in the University’s Center for Bioethics. “I think that the record hasn’t been good, so I wouldn’t be inclined to be terribly optimistic that things have changed.”Source: Minnesota Daily