University of Minnesota Admits Manipulation of Patient in Schizophrenia Drug Study

Raising serious questions about patient safeguards, the University of Minnesota has acknowledged missteps and even manipulation in the care of a patient in a schizophrenia drug study. Robert Huber claimed he was coerced during inpatient hospital confinement into enrolling in a schizophrenia drug trial.

Although the investigation concluded that a university psychiatrist did not coerce Huber, or force him to remain in the study against his will, it found that caregivers prematurely prepped him for the study before he gave consent. They also failed to pass along key safety information that could have influenced his decision to participate. Such patient manipulation in a drug study violates U.S. Food and Drug Administration protocols.

While the university official apologized to Huber, admitting that his “rights and welfare were compromised,” Huber said he remains upset that FTI Consulting, the agency hired by the university to conduct the investigation, never talked to him about his side of the case.

Huber, 44, was taken to the University of Minnesota Medical Center in July 2007 with schizophrenia symptoms and confined for two weeks. During that time, he claims to have received daily requests from Dr. Stephen Olson to volunteer for a drug trial involving an experimental medication called bifeprunox.

Huber was repeatedly assured that the drug was safe, despite the fact that one of the main goals of the study was determining the drug’s safety. Huber felt coerced when the doctors showed him the cost of his hospital care if he failed to sign up and have the study pick up the tab. Huber said he decided to enroll because, “I was so afraid they were going to lock me up.”

Bifeprunox was being studied by Solvay Pharmaceuticals as the next advance in the treatment of schizophrenia. A month after Huber enrolled in the drug trial, however, the FDA announced it would not be approving the medication. Despite the FDA's rejection, the national trial was not halted.

Huber continued taking the medication through October 2007. In that three-month period, he experienced abdominal pains so severe that he required at least two visits to hospital emergency rooms. He claims he even contemplated suicide to make the pain stop. Records indicate that Olson believed Huber’s pains were “unlikely” to be related to the study medication, and might be psychosomatic.

The investigation concluded Huber was not told about the FDA decision not to approve bifeprunox. The university addressed their mistakes by taking the following steps; revising patient consent forms, making it mandatory for researchers to notify Internal Review Boards when they receive letters from the FDA, and informing patients if a drug being tested in a clinical trial has been rejected by the FDA.