Lawmakers act to ensure safety of patients at U of M psych dept.

- Minnesota lawmakers took notice of the series of stories by the Fox 9 Investigators on the research troubles within the Department of Psychiatry at the University of Minnesota. The legislature recently passed two bills to protect mentally ill patients from potential research misconduct. One of those bills has already been signed into law by Governor Mark Dayton.

Bill signed into law

Sen. Terri Bonhoff (D-Minnetonka) said the Fox 9 Investigators' story prompted her to push for legislation that makes it illegal for researchers to recruit patients who are under a 72-hour hold which is now law.

The story was based on Robert who checked himself into the E.R. after thinking he had a brain tumor.

But, the ringing in his ears and the voices in his head were actually symptoms of schizophrenia.

"What happened to me was really horrible at the University," Robert told the Fox 9 Investigators.

He was placed on a 72-hour emergency hold, which meant he was locked up until doctors could figure out a treatment plan to stabilize his condition.

During that time a U of M researcher recruited him to enroll in a study for an experimental drug.

"When you're in there, they make it like they scare you, so you just want to do anything to get out of there," he said. "That was my way out, was this research study."

Robert said he wasn't competent enough to understand what he was getting into. He blamed the test drug for making him sicker.

The drug never did get FDA approval after it was linked to the death of another patient who suffered liver failure.

Second bill waiting for Governor's signature

The Fox 9 investigation into the death of Dan Markingson, who committed suicide while in a different U of M psychiatric drug trial, also got the attention of lawmakers this session.

Markingson's mother had wanted him removed from the study, but was unable to convince researchers to do so.

"People are going to have a voice and someone to go to if they need help and they're not being heard," said Rep. Connie Bernardy (D-Fridley).

Bernardy convinced her colleagues to pass a bill creating a mental health ombudsman who will watch over future psychiatric research trials.

"I think we do have some confidence that the mental health ombudsman will do a sufficient job of monitoring these cases in a way that the U has been consistently been unwilling to do," Carl Elliott, a bio-ethics professor and vocal critic of the practices at in the Department of Psychiatry, said. 

The university has put a number of research reforms in place since the Fox 9 stories aired and other outside reviews called for improvements in the program, but critics wanted another layer of protection.

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