A scathing state report on the 2004 suicide of Dan Markingson, a mentally ill man enrolled in a clinical trial by a University of Minnesota psychiatrist, left Minnesotans deeply disturbed about the callousness with which his family was treated and the dubious institutional values that allowed a decade to pass before the U addressed the ethical concerns the tragedy raised.
On Monday, the university took a crucial beginning step in rebuilding public trust in the practice of medicine at its flagship Medical Center. It released a 67-page “draft implementation plan” overhauling the institutional safeguards in place for patients in medical research trials.
At issue in the Markingson case: Whether the man, who had schizophrenia, was competent to consent to enrollment in a trial. And whether Markingson’s doctor put his financial and professional incentives above his patient’s medical interests to enroll him in the research, which a drug company was paying the U to conduct. Enrolling in the trial meant Markingson, who had responded well to one medication, was put on another.
While the new draft plan is thoughtful, thorough and unquestionably a positive development, it’s hard to read it without regret. Why did it take so long for the university to acknowledge and act on the need for change? It took extraordinary pressure for it to do so. Among those who weighed in were the Markingson family, state Sen. Terri Bonoff, the Faculty Senate, former Gov. Arne Carlson and the state’s Office of the Legislative Auditor, which prepared the damning report on the case released this spring. Yet once the U decided reforms were needed, it took just a month to put together new research safeguards that, if adopted as expected, will put this world-class medical center where it should have been all along: at the forefront of human-research protections.
The team of U faculty, staff and an outside expert from Mayo Clinic clearly worked hard on the draft plan. Their suggestions for improvement are solid. Great care obviously was taken to put in new safeguards for patients with illnesses that may affect their judgment when enrolling in a medical trial. Particularly pioneering are new processes focusing on “continuing consent” to ensure that patients with diminished capacity are protected as trials proceed over months or years.
New guidelines to minimize staff financial conflicts of interest are far-reaching and robust. New policies that will provide protected time for staff serving on an expanded number of institutional review board panels will also result in more serious scrutiny of research practices. A new community oversight board will provide additional scrutiny and provide another avenue for families, such as Markingson’s, to report concerns. Another sensible change: preventing department staff from reviewing research practices of their colleagues or allowing supervisors to ask staff reporting to them to review their work.
University President Eric Kaler’s absence at the news conference announcing the plan was regrettable. The best policies in the world are meaningless if the report containing them simply gathers dust. Dr. Steve Miles, who served on the plan development team, deserves credit for stating forcefully last week that “this is not a white paper, OK? This is a road map.’’ Strongly worded statements are also needed from Kaler and Board of Regents leadership.
It’s ultimately their responsibility to see that lasting reform occurs within an institutional culture that reacted self-servingly rather than compassionately after Markingson’s death. Assurance is needed from both that every possible step is being taken to heal this ethical wound.