U of M: Researchers did not properly prepare subject in drug trial

The University of Minnesota has apologized to a former research participant for failing to follow several safety procedures while he was in a 2007 university drug trial.

In a May 6 letter, Debra Dykhuis, executive director of the university's human research protection program, told Robert Huber that researchers did not adequately prepare him for the drug trial involving bifeprunox, an antipsychotic drug developed to treat schizophrenia.

A university oversight panel and a team hired by U of M also found that researchers had failed to disclose important information about the drug, Dykhuis wrote. They also improperly prepped him for the study before he gave his consent.

However, she rejected Huber's complaint that researchers coerced him into participating in the experiment, writing that university personnel had properly enrolled him.

"We appreciate your coming forward with your complaint and are sorry that your rights and welfare in the bifeprunox study were compromised," Dykhuis wrote.

Huber, a 44-year-old from Rosemount, disagreed with the university's findings, saying investigators never interviewed him. He said he answered a handful of basic questions during a phone call from a university representative, but that was the extent of his input.

"I think [the letter] is insufficient, and it lacks integrity," he said.

As to his complaint that he had been coerced into participating, Huber said researchers told him he was potentially dangerous, and that the U might keep him in the hospital if he did not participate in the drug trial. He said researchers also said he had a large medical bill — one they would pay off if he participated.

Huber said the effects of schizophrenia meant he was "out of it" when researchers pressured him to enroll.

"You can't think clearly," he said. "You can't make decisions correctly. And you're hearing things that aren't really there."

Huber said he also made at least two trips to the hospital emergency room during the study, and said researchers dismissed his complaints of complaints such as blurred vision, insomnia and severe abdominal pain — signs that his body was reacting badly to the drug.

University of Minnesota Medical School spokesperson Brian Lucas said he could not comment much about the case, but said U of M leaders are fixing the problems Dykhuis mentioned in the letter.

The letter follows three inquiries this year that indicate the university is not adequately protecting its human research subjects. The reports have prompted harsh criticism over an apparent lack of commitment by university leaders and some researchers to protect their research patients.

The latest inquiriy, noted that some U of M psychiatrists and Fairview Health Services caregivers have a "profound" lack of trust in some university psychiatry researchers. The report said they do not trust the researchers to protect their subjects.

That report added context to an external review finding in February that the psychiatry department suffered from a "culture of fear" that hindered some people from pushing for better protection of patients.

Many of the concerns reported so far appear to be over problems that existed in 2004, when a mentally ill man named Dan Markingson killed himself while participating in a university drug trial.

A March legislative audit found multiple problems with the way researchers treated Markingson. It said his enrollment conditions were potentially coercive, and said university leaders had ignored concerns about it for years.

In her May 6 letter, Dykhuis told Huber that he had been mentally fit to consent to the experiment, had done so without any coercion and had been allowed to withdraw from the study at any time.

But she said the university had made three errors:

Overly aggressive preparation. Researchers should not have told Huber to avoid consuming anything the night before they wanted to take a blood sample.

Not warning him of a risk. The U's consent forms should have informed Huber of the risks involved in stopping his current medications so he could take the new drug.

Lack of U.S. Food and Drug Administration information. Researchers should have told Huber of a prior FDA decision not to approve the drug he was about to take.

At the time, the FDA was also investigating whether the death of another bifeprunox test subject was related to the drug.

In a May 8 letter to U of M bioethicist Carl Elliott, Dykhuis wrote that the university would not seek disciplinary action against one of its researchers, Dr. Stephen Olson, over his conduct in bifeprunox studies. In 2004, Olson had been Markingson's psychiatrist and the lead researcher in the drug trial that Markingson participated in.

Elliott called the university's investigation into Olson and Huber's cases a "whitewash."

Lucas, the medical school spokesperson, said in a written statement that the university is working to solve the problems listed in the letter to Huber — including revising consent forms so they warn of the risks of stopping medications. He said U of M also wants to ensure researchers promptly inform the university of any FDA notifications.

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