The University of Minnesota is replacing its Psychiatry Department chairman following two scathing reviews of its safety protocols in research involving human subjects and its recruitment of a troubled man who later died by suicide in a schizophrenia drug trial.
Dr. Charles Schulz will continue clinical care and research in the department he has led since 1999, but Thursday's announcement that he is stepping down reflects a metamorphosis for a university that even a month ago adamantly defended his department against claims of coercive recruiting of vulnerable patients into research.
"Changing one person — it's not like switching a light switch" and problems will be fixed, said Leigh Turner, a U bioethicist who has demanded changes in top university administration due to the episode. "But there is a symbolic dimension to it. A chair is a symbolic face of a department. And this is a department that has been through a long period of controversy and questions about the conduct of its clinical trials."
Much of the criticism has centered on the recruitment of Dan Markingson, who died by suicide in 2004 while enrolled in the university's arm of a national study of three antipsychotic drugs. Markingson was recruited at the time by Dr. Stephen Olson, a psychiatrist who was treating him as well as running the study and advising a judge on whether Markingson should be committed to a locked inpatient facility. Legislation following news coverage of the case in 2008 prohibited this type of potentially coercive recruiting.
Perceptions that the U had put the problem behind it were shattered in February when an external review, ordered by the university's Faculty Senate, found that the school's efforts to safeguard patients in psychiatric research remain inadequate and do not "reflect the best efforts of a University of this caliber."
A month later, Legislative Auditor James Nobles issued a report criticizing the way Markingson was enrolled in his study and retained even after his mother expressed concerns over his condition.
University President Eric Kaler responded by publicly apologizing to Markingson's family and suspending recruitment to new psychiatric studies until completion of a review of patient safety protocols.
The controversy was not mentioned in a statement Thursday by Dr. Brooks Jackson, dean of the U's Medical School, who commended Schulz and said the decision to step down was solely made by the psychiatrist to "clear the way for new leadership, and to allow him to focus more on clinical care."
Dr. Mark Paller, an associate Medical School dean who is not a psychiatrist, will serve as interim department chairman during a search for Schulz's replacement.
Schulz will retain a chief medical officer position for behavioral health services provided in partnership with Fairview Health Services to patients at the U's hospital and clinics, which upset some faculty members hoping for a fresh start. Frustrated by the criticisms, members of the psychiatry faculty wrote a joint statement last week indicating that they are committed to learning from the episode.
"When the outcome is adverse for any patient under our care (including research), … we in the field can only use such tragic experiences to revisit our procedures, striving in all ways possible to improve and further minimize risk."
Schulz brought prestige and a track record in schizophrenia research and grant-writing when he took over the department 15 years ago. "It has been a privilege to lead a team of talented care providers who are committed to making a difference in the lives of patients and families dealing with mental illness," Schulz said in a statement Thursday. "There is still a great deal of work still to be done."
Like other doctors in recent years, Schulz has been scrutinized for the thousands of dollars in grants, speaking fees and other compensation he has received from drug companies such as AstraZeneca, the sponsor of the study in which Markingson was enrolled.
Schulz's name surfaced in documents submitted in a lawsuit against AstraZeneca, indicating that in 2000 he made statements about the company's new antipsychotic drug, Seroquel, that were more favorable than research indicated.
In a related development Wednesday, the U named a panel of experts to study the review commissioned by the Faculty Senate and propose improvements to research oversight.