The University of Minnesota has received severe criticism for its treatment of test subjects in recent months. The psychiatry department's human research program has been temporarily suspended, hundreds of medical scholars from around the world are calling on the Minnesota legislature to hold hearings on misconduct, and former Gov. Arne Carlson wants U president Eric Kaler sacked.
It's all because of the 2004 death of schizophrenia patient Dan Markingson. External investigations of his case revealed that Dr. Stephen Olson recruited Markingson for an AstraZeneca drug trial under threat of commitment. Though Markingson killed himself several months into the study (11 years ago today), the U repeatedly denied any wrongdoing until forced by the state to acknowledge its ethical breaches.
The U has since apologized for its treatment of Markingson, but another former test subject, Robert Huber, is still waiting for his due.
Dr. Olson was Huber's psychiatrist. They met in 2007 when Huber went to Fairview Health Services looking for medication to treat symptoms of what would later be diagnosed as schizophrenia. Instead, he was locked up for two weeks and threatened with a longer commitment if he didn't agree to participate in Olson's research on the antipsychotic drug Bifeprunox, Huber says.
"I didn't want to sign up," he says. "I was not aware of the disability because I was basically incompetent."
As part of Olson's drug trial, Huber took Bifeprunox for about two weeks before the Food and Drug administration rejected it for patient consumption. Olson kept him on the regimen for about 10 weeks afterward.
Huber started experiencing sharp stabbing pains in his stomach, with blurred vision and severe headaches. He went to the emergency room begging to be taken off the drug, he says. He wanted to kill himself just to stop the pain.
The trial came to an end with the death of another Bifeprunox test subject involved in a different test. Huber never sought treatment from Olson again, and in 2014 filed a complaint with the state Board of Medical Practice accusing the researcher of malpractice. That complaint was dismissed. He received a form letter from the board declining to discipline Olson.
In February 2014, Huber filed a complaint with the university's office of human research protections, which promised to investigate potential ethical breaches in his case. While he waited for the results, Huber told his story to Fox 9's investigative team, which found that Olson had dismissed Huber's symptoms as "psychosomatic" in his reports to Solvay Pharmaceuticals, the maker of Bifeprunox.
On Wednesday, Huber finally received the results of the U of M's investigation: a two-page letter denying, without additional explanation, that he was coerced. The university would not be taking any disciplinary action against the research team.
Yet Debra Dykhuis of the U's Human Research Protection Program did concede that Huber "should have been informed in August 2007 of the FDA decision not to approve bifeprunox." She did not answer why Huber was asked to continue using it. In conclusion, she wrote: "We appreciate your coming forward with your complaint and are sorry that your rights and welfare in the bifeprunox study were compromised."
Requests for clarification from the U about Huber's continued prescription of this FDA-rejected drug and Olson's recruiting practices have not been answered by Thursday afternoon. We will update as soon as we hear back.
So far, the Office of the Legislative Auditor has no plans to investigate Huber's case with the same depth as Markingson's. After all, Markingson died and Huber was only injured.
"One thing that we are doing is we have obtained records from the university about adverse events, things that happen during clinical trials that could put a research subject at risk," says Joel Alter of the Office of the Legislative Auditor. "We're looking at a number of additional clinical trials and we're hoping to put something out on that, but we're not sure of the timeline."
Huber can't get anyone at the Board of Medical Practice to give his case any more thought. Even though the Legislative Auditor found that the Board of Medical Practice hired a consultant with numerous conflicts of interest to investigate Olson in the Markingson case, a seven-year statute of limitations would prevent Huber from reopening his own complaint.
"These days I still go to my doctor. I've done therapy. I get all kinds of help," Huber says. "I'm still the same old, and I am considered a vulnerable adult. It's a struggle like anything."
Yet he hasn't been contemplating suicide since forsaking Bifeprunox.
"The problem with people with mental illness is we can be tricked very easily," he says. "I've been talking about these studies for years now. Since 2007 I have been complaining and complaining. I don't know that much about universities at all. I'm just some poor sap that they suckered into it."
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