Saturday, March 28, 2015

For the Record: Kaler acknowledges U misstatements on drug study




(emphasis added)
For the first time, President Eric Kaler acknowledged that the University of Minnesota made “misleading or inaccurate” statements in the aftermath of the suicide of Dan Markingson, a psychiatric patient who was in a U drug study at the time of his death.
Kaler made the admission Friday as the Board of Regents took steps to deal with the fallout from a scathing report about the case by Legislative Auditor James Nobles.
Nobles’ report, released last week, stopped short of linking Markingson’s 2004 death to the drug study. But it found that the U had turned a blind eye to conflicts of interest and made “misleading statements” about prior reviews that supposedly cleared the U of wrongdoing.
In response, the regents voted Friday to suspend enrollment in psychiatric drug studies and toughen scrutiny of research involving human subjects.
Kaler, meeting with reporters, acknowledged that the public may have been misled by the university’s repeated claims that it had been investigated, and cleared, by the state attorney general.
“That was not a full-fledged attorney general’s investigation,” Kaler said. He said the attorney general’s office had merely helped the state Board of Medical Practice review a complaint against two U psychiatrists.
“Was there an attorney general’s office investigation? The answer is no,” Kaler said. But he said the university’s assertions, which began before he became president, “would have led somebody to believe” that it was. “In that sense, it was misleading or inaccurate.” He later called it “imprecise,” adding, “I don’t think it was meant to mislead.”
Kaler said it’s impossible to know if Markingson’s death was linked to the study itself, but he issued an apology to Markingson’s mother, Mary Weiss, who had tried to get her son out of the study. “I’m deeply sorry that he passed away while under our care,” Kaler said. “In that sense, we failed his family.” He said he hopes to meet with Weiss “to convey that in person.”
He also vowed to ensure that future research is conducted in “safest and most ethical way possible.”
The resolution approved by the regents Friday calls for suspending enrollment in all psychiatric drug studies until they’re reviewed by an independent board of experts. It also calls for stepping up scrutiny of research involving “vulnerable populations.”
Nobles issued a statement saying he was pleased by the actions.
Mike Howard, a friend of Markingson’s mother, had a mixed reaction.
“This is certainly progress,” he said. But “it would have been nice,” he added, if the university had admitted it was at fault. “You know: ‘We made a mistake and now we want to fix it.’ ”

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