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MINNEAPOLIS (AP) — An outside review says a University of Minnesota psychiatrist made three safety violations during a 2007 study, and two were serious.
The report released Friday says Dr. Stephen Olson failed to give a patient important information about a drug he took. It says Olson and his team also inappropriately prepped the patient for the study before he agreed to participate. But the review also found that Olson did not coerce his patient into participating. It said the patient gave informed consent and had always been free to drop out.
Olson told Minnesota Public Radio (http://bit.ly/1H9mNvB ) he accepted the findings and was pleased that the report, and another by a university oversight panel that was also released Friday, cleared him of the coercion allegation, which he considered the most serious.
"I don't coerce patients," he said.
Olson has been under scrutiny over the case of a different patient, Dan Markingson, a mentally ill man who killed himself in 2004 during a commercially sponsored drug trial run by Olson at the university. Critics have accused Olson of forcing Markingson into the trial against his mother's warnings.
In March, a scathing report from the Office of the Legislative Auditor said the circumstances under which Markingson enrolled in the study were potentially coercive, though there was no proven link between the drug trial and his death. Last month Dr. Charles Schulz stepped down as chairman of the psychiatry department. The university suspended enrollment in psychiatric drug studies until a review of patient protections is completed.
The two new reports center on Robert Huber, 44, of Rosemount, who enrolled in Olson's study of bifeprunox, a drug developed to treat schizophrenia. Huber claims Olson and his staff coerced him into participating, that his schizophrenia left him incapable of consenting, and that he felt he was not free to leave.
Both reports cleared Olson of Huber's allegations. But while the university's panel saw no major procedural violations, the report by FTI Consulting disagreed.
FTI said Olson and his team failed to get Huber's written consent before telling him to avoid consuming anything the night before they wanted to take a blood sample. It also said the university's consent forms should have informed Huber of the potential consequences of stopping his medications so he could take the new drug. And it said Olson should have told Huber of a prior Food and Drug Administration decision not to approve the drug he was about to take.
The university sent an apology to Huber earlier this month.
Information from: Minnesota Public Radio News, http://www.mprnews.org
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