… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Friday, February 19, 2016
For the Record: Signatories to “University of Minnesota research lapses show self-reform is failing," Minneapolis Star Tribune, February 18, 2016
Professor Carl Elliott has kindly provided me a copy of his article (with professor Matt Lamkin, U Tulsa Law School) which appeared in the Star-Tribune recently.
Another year, another day, another damning indictment of the University of Minnesota’s Department of Psychiatry. If anyone was surprised by last week’s blistering assessment of psychiatric research at the university (“New lapses in U psych studies,” Feb. 12), they probably weren’t paying attention to the previous five. Those reviews found evidence of coerced study recruitment, troubling conflicts of interest, shoddy scientific review, deep mistrust of U leaders, and a climate of fear and intimidation in the Psychiatry Department. The difference with this latest review is that it comes nearly a year after U leaders solemnly promised the people of Minnesota that they were finally going to clean up the mess.
For more than a decade, U leaders brushed aside revelations that their Psychiatry Department was mistreating vulnerable patients, including Dan Markingson, a mentally ill young man under a civil commitment order who killed himself while in a U drug study. Last year, the state’s legislative auditor released a scathing report that not only confirmed these research abuses, but laid bare the U’s strategy for avoiding responsibility for its misdeeds. U leaders “have made misleading statements about previous reviews and been consistently unwilling to discuss or even acknowledge that serious ethical issues and conflicts are involved,” the legislative auditor wrote. “This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation.”
This latest debacle shows the administration falling back on the same old playbook. When Jan Dugas, the external consultant hired by the U, reported alarming problems in Psychiatry Department studies, the acting department chair responded, “This is nothing new; it happens all over the university.” On two occasions, Dugas said, she was intimidated and “verbally abused” by department faculty members. The director of the Human Research Protection Program refused to let Dugas see study records.
When Dugas uncovered more than 40 “critical or major” safety problems, legal violations and incidents of unethical conduct in just three weeks, officials abruptly pulled the plug on her investigation, saying it was no longer necessary. Leaders of the Clinical and Translational Science Institute told her “not to write a report” of her findings. When she was finally allowed to produce a report, she was told that no one else would be allowed to see it. U officials kept the report on ice for more than a month, stonewalling open-records requests while they prepared to spin its findings (now conveniently relabeled “allegations”). It is not clear when the report would have been released had it not been leaked to the news media last week. At that point, U President Eric Kaler explained: “We wanted to clarify the record before we released the report.”
It is understandable why U leaders did not want anyone to see the report. Research in the Psychiatry Department is portrayed as a dangerous, disorganized mess: unlicensed study personnel operating MRI and TMS machines; children approached for research studies without the permission of their parents; urine specimens collected from patients in fast-food restaurants and coffee shops.
Last summer, only two months after U leaders announced a reform plan they called “Markingson’s legacy,” a faculty member in the Psychiatry Department was found to have forged federal research documents. Now we learn that research personnel admitted to altering study documents when they prepared for audits. “We go behind the scenes and fix things up,” one interviewee said. “What people don’t know won’t hurt them.”
The response of U leaders has been utterly predictable. Just as before, they have disputed the consultant’s findings, minimized the significance of the report, and cloaked their response in a bureaucratic fog of euphemism and circumlocution. But no amount of double talk can hide the report’s main conclusion: “Practices in the Department of Psychiatry demonstrate a profound lack of knowledge about how to conduct clinical research and an intentional lack of adherence to requirements.”
This latest fiasco makes clear that the pathology at the University of Minnesota lies not just in the Department of Psychiatry, but in an administration whose overriding goal is to avoid accountability. The Board of Regents has responded to this latest scandal exactly as it has responded to all of the others — with a shrug. The U’s dysfunctional culture can’t be reformed by the same people who created and sustained it over so many years. The question now is: when will the Legislature bring the U’s leadership to heel?
Matt Lamkin is a professor at the University of Tulsa College of Law. Carl Elliott is a professor at the Center for Bioethics at the University of Minnesota. The views expressed here are their own. This article was submitted on behalf of a group of 83 University of Minnesota alumni and scholars in health law, bioethics, psychiatry and medicine.
Signatories to “University of Minnesota research lapses show self-reform is failing,” Minneapolis Star Trib... by MarkingsonCase
at 12:12 PM