An outside review commissioned by the University of Minnesota has found a university psychiatry researcher made three safety procedure violations during a 2007 study — two of them serious.
The report by FTI Consulting, released Friday, says Dr. Stephen Olson failed to give a research subject important information about a drug he was taking. Olson and his team also inappropriately prepped the patient for the study before he agreed to participate.
But the FTI Consulting review also found that Olson had not coerced his patient into participating. It said the patient had given his informed consent, and had always been free to drop out of the study.
In an interview, Olson acknowledged some of the errors pointed out in the FTI report, but said he was pleased that the report and another by a U of M oversight panel also released on Friday, cleared him of the coercion-related allegations, ones he considers the most serious.
"I don't coerce patients," he said.
The two reports center on the case of 44-year-old Robert Huber of Rosemount, who enrolled in Olson's study of bifeprunox, an antipsychotic 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 FTI and the university's oversight panel cleared Olson of Huber's allegations.
But the two reports diverge in other ways. The U's panel saw no major procedural violations in its report, but FTI disagreed.
First, 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.
Second, it said the U's consent forms should have informed Huber of the potential consequences of stopping his medications so he could take the new drug.
Third, FTI found Olson should have told Huber of a prior FDA decision not to approve the drug he was about to take.
Olson said he accepted the findings. He said he got Huber's consent for the study, and thought he'd save his patient some time by starting him quickly on the experiment.
The university psychiatrist said he usually left it to drug companies to make him aware of new information — such as the FDA decision — or necessary procedural changes.
And Olson said the consent forms did warn of risks, but perhaps weren't as thorough as authorities wanted.
He said FTI's contradiction of the U's oversight panel shows that "research is complex. There are differences of opinion even among experts about how studies are ideally conducted."
Olson has been under heavy scrutiny over his role in the case of Dan Markingson, a mentally ill man who killed himself during a commercially-sponsored drug trial run by Olson at the university.
Critics have long accused Olson of forcing Markingson into the trial against his mother's warnings. In March, a state legislative audit said the circumstances under which Markingson enrolled in the study were potentially coercive.
The legislative audit also noted a Minnesota Board of Social Work investigation of the Markingson case. The board concluded that the coordinator of Markingson's study was incompetent in some tasks and made major errors. The audit said the board's findings suggested that Olson failed to supervise her and gave her work beyond her abilities.
A Food and Drug Administration inquiry into the board's findings, also released Friday, rejected them.
"The allegations," it said, "were unfounded and were not corroborated based upon our inspection findings."
In a written statement, University of Minnesota Medical School Dean Brooks Jackson said, "We have made it clear that we have an obligation to examine our practices and take steps to do a better job at protecting patients, particularly those with diminished mental capacity. While these reports provide evidence of our commitment to human subject protection, they do not reduce the urgency of our mission."
In a March 8 letter, a university official wrote that the U will not discipline Olson for the errors.
U of M bioethicist Leigh Turner asked in an email, "Are we to therefore conclude that University of Minnesota researchers can engage in serious noncompliance ... with no disciplinary consequences?"