University Admits Missteps In Second Drug Study
MINNEAPOLIS (AP) — The University of Minnesota is apologizing to a Rosemount man who claimed he was coerced into enrolling in a schizophrenia drug trial, a second local case to raise questions about patient safeguards during research.
While a yearlong investigation concluded Robert Huber wasn't coerced, it found caregivers prepped him for the study before he consented, according to the Star Tribune. It also found they failed to provide safety information.
In March, a legislative auditor raised ethics issues in the recruitment and treatment of a different patient in a schizophrenia drug study. Dan Markingson killed himself six months after starting the 2004 study.
In a May 6 letter to Huber, Debra Dykhuis, executive director of the university's Human Research Protections Program, said the university was sorry his "rights and welfare were compromised."
Huber, 44, told the newspaper he appreciated the admissions, but he remains upset that an agency hired by the university to conduct the investigation, FTI Consulting, never talked to him before concluding that he wasn't coerced.
He was taken to the University of Minnesota Medical Center in July 2007 with schizophrenia symptoms and confined for two weeks. During that time, he says, he received daily requests from Dr. Stephen Olson and others in the psychiatry department to volunteer for a drug trial involving an experimental medication called bifeprunox.
Huber said they repeatedly assured him the drug was safe — even though determining its safety was one of the very goals of the study. They even showed him the cost of his hospital care if he didn't sign up and have the study pick up the tab.
Huber said he decided to enroll because he thought Olson would keep him in the hospital until he did.
"I was so afraid they were going to lock me up," he said.
The consultant report on the case disagreed, concluding that Huber had the wherewithal to consent to the study.
The May 6 letter from Dykhuis listed three problems with his care, including that he was asked not to eat anything one evening in preparation for a study-related blood test the next morning, even though he hadn't yet consented in writing. The letter also noted he was not informed in August 2007 that the FDA had decided not to approve bifeprunox and he was not informed in his consent form of the risks taking him off all other medications before starting a new one.
The university has addressed all three problems, revising consent forms and asking all researchers to notify their Internal Review Boards when they receive letters from the FDA, said Brian Lucas, a spokesman for the university's Academic Health Center.
Months of medication adjustments following the study helped manage schizophrenia symptoms for Huber, who is unemployed due to his disability and living with relatives.
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