INVESTIGATORS: Side-effects of drug study? - My29 WFTC Minneapolis-St. Paul

INVESTIGATORS: Side-effects of drug study?

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A petition drive is under way, calling on Gov. Mark Dayton to order an investigation of the University of Minnesota. More than 3,000 people -- including some prominent medical professionals -- have signed it.

The issue? Possible research misconduct by the U's Department of Psychiatry, and Fox 9 Investigator Jeff Baillon looked into the tragic death that set the effort in motion.

Dan Markingson was Mary Weiss' only child, and she still holds onto the recording he left on her voicemail to feel his company -- the message he left a few days before his life came to a horrific end.

"Mary literally collapsed on the floor and just screamed, 'Oh no! Oh no!,'" family friend Mike Howard recalled.

Weiss believed her son had a rage burning within, and her instincts proved to be true. Just before Mother's Day in 2004, Markingson grabbed a box cutter and violently slashed into his chest and neck, nearly decapitating himself.

"He didn't pass away; he was killed," Weiss said in a documentary film. "They let him die, and they need to be held accountable."

Weiss recently suffered a stroke and didn't feel up to an on-camera interview with the Fox 9 Investigators, but she shared her story with filmmakers of "Off Label," who dedicated the film to her.

"Dan became ill, and I got him into Fairview Riverside Hospital," she said in the film.

In the documentary, she described her son's struggle with the onset of a mental illness.

"It was obvious he was deteriorating," she said.

She also explained that he was under a court order to follow the recommendations of his psychiatrist.

"It is an obvious conflict of interest," Weiss contends in the film.

Weiss detailed how that psychiatrist was the same University of Minnesota doctor who was conducting a drug study for a pharmaceutical company that paid part of his salary.

"Dan had the choice of either going into the study or going into a mental hospital," she said. "He chose the study."

Markingson signed a consent form, but Weiss believes her son was not in a condition to understand what he was signing up for -- and his condition, she says, only got worse once he started taking the study drug he was assigned.

"We had tried for everyone to help us, but because Dan was of legal age, I had no way of getting him out of the study other than pleading with the doctors to let him out, which they would not," she said.

For months, Weiss sent letters -- one by certified mail -- and made phone calls to the university. Notes taken by the drug study coordinator show Weiss even left a message saying, "Do we have to wait until he kills himself or someone else before anyone does anything?"

"He was psychotic," Weiss said.

Three weeks later, Markingson's mutilated body was found in the bathroom of a group home.

"I think, at some point in time, the university needs to man-up and say, 'We are going to hold ourselves accountable," Howard said.

Howard has stood with Weiss during her nearly decade-long battle with the U of M. They found an ally in Carl Elliot, a bioethics professor at the U with doctorate degrees in both medicine and philosophy.

"I have never come across a case this egregious," Elliott said.

Elliott has written books on the drug industry.

"When the mother of a research study subject is calling you repeatedly, warning you that she thinks her son is going to commit suicide, you don't simply ignore her," Elliott said.

The University of Minnesota maintains its care of Markingson was appropriate -- that there's no causal link between the drug study and his suicide, and in fact, an investigation by the FDA found "no evidence of misconduct" on the U's part.

"It is a deeply flawed and incompetent inspection report," Elliott assessed.

Elliott is critical of the FDA report, in part, because the inspector never interviewed Weiss.

"So, the only side she got were those from the U of M," Elliott explained.

Weiss did file a lawsuit, but a judge dismissed the case on the grounds that, under state statute, the University was immune from being sued. The U turned around and filed a claim for Weiss to pay its $57,000 legal tab, but it dropped the claim after Weiss agreed not to appeal the judge's ruling.

Weiss did proceed with a malpractice suit against Markingson's psychiatrist, Steven Olson -- also the lead investigator of the drug trial. It was settled out of court, and the University would not allow the Fox 9 Investigators to interview Olson.

"I think they're hiding things that were done fraudulently, things that were done sloppily, and they're trying to cover up," Howard said.

Howard points to a report that came out last November as ammunition. The state board of social work issued an "agreement for corrective action" with Jean Kenney, a social worker who was the coordinator of the drug study Markingson was in after the board found Kenney had dispensed medications without a license, signed off on medical charts using the initials of Markingson's psychiatrist and failed to adequately address family concerns that Markingson was in danger of killing himself.

"If you see these things going wrong with the study coordinator, wouldn't you want to step back and say, 'Who was watching her?'" Elliott asked. "'Who was telling her to do these things?'"

Kenney told the Fox 9 Investigators she didn't do anything that was wrong or against the law, and said Weiss was "very controlling" of Markingson's situation.

"You don't just kick someone out of a study because the mother wants it to happen," Kenney said.

Kenney said Markingson "was doing well," but added "the guy had pretty many stressors going on. Mom was very much interfering with things."

Additionally, Kenney said the fact that Markingson committed suicide near Mother's Day "was a really strong message."

"I went to the hospital -- the emergency room -- with symptoms of a mental illness," another study subject who asked that his face and voice be disguised told the Fox 9 Investigators.

This man was recruited for another study the U of M was paid to run for a pharmaceutical company.

"I don't think I was competent to be making that decision," he said. "I wasn't on any medication at all and I was experiencing really bad symptoms of mental illness."

The study subject explained that he signed up because he felt if he didn't, he wouldn't get out of Riverside Hospital.

"You know, when you're locked up in a place, you're very scared and you're willing to do whatever anyone basically suggests," he said.

So, he was put on an experimental drug for schizophrenia that was seeking FDA approval. He said the medication gave him severe headaches, blurred vision and abdominal pain -- so much pain that he admits he thought of committing suicide.

Three months into the study, he called an ambulance to take him back to Riverside Hospital.

"Instead of telling me to immediately stop taking the medication, they told me to cut the pills in half with a butter knife and continue taking them," he recalled.

The principal investigator of that drug trial was Dr. Stephen Olson. Via e-mail, he told the Fox 9 Investigators that the patient did not report severe headaches or blurred vision to him. Olson also said he did not tell the man to cut the study medication in half.

Eventually, the man dropped out of the study and went elsewhere to get help.

"I'm doing a lot better since then," he said.

The development of the test drug he was on was later terminated. It never did get FDA approval. This is the kind of case that troubles Elliott.

"Are there other subjects that are being put in danger?" he asked.

Elliott writes a blog about the Markingson suicide and research ethics. He's been very critical of the university and wants an outside investigation. He's angered many -- including his boss, the medical school Dean, who wrote a scathing op-ed in the newspaper.

"You've been knowingly putting out inaccurate information," the op-ed reads in part. "You're selective and distorted in your narrative about the case. This is a tragedy, not a scandal."

Yet, Elliott disagrees.

"It's a tragedy and a scandal," he said.

Tensions on campus are high. Elliott has moved out of his office in the Academic Health Center, saying "it's gotten uncomfortable."

"It's unpleasant," said Leigh Turner, PhD and professor of bioethics. "There's not much conversation. People are not getting along very well in here."

Turner supports Elliott's call for an investigation.

"I'm in full agreement with his critique," Turner said. "I think this is a major scandal for the University of Minnesota."

Internal university e-mails obtained by the Fox 9 Investigators through the state's open records law show how contentious things are. In March, a writer from "Scientific American" contacted the school for a piece she was doing about the Markingson case

"I became more and more appalled at errors and breaches in normal research conduct," writer Dr. Judy Stone, MD, said.

The university's senior director of communications sent out an internal message that read in part, "I looked her up and can't tell if she's a wacko or not…. I get nervous about anyone who would pay any attention to Carl."

"I was shocked that the university response to my inquiry was that I'm a wacko," Stone said.

Stone spent 24 years conducting clinical trials and even wrote a book about it. She said she started her reporting on Markingson with no interest on one side or the other, and she has never met Elliott.

"They won't talk to me and have told other faculty also not to talk to me," she said.

In October, a group of nearly 200 scholars from outside Minnesota sent a letter to the U of M Faculty Senate, urging them to request a public inquiry of the Markingson case.

"This is really a case that appears troubling to many specialists in the field," said Trudo Lemmens, with the University of Toronto.

The Fox 9 Investigators also asked the university for an interview. This was the response:

"We're not going to go on the record talking about this. To reiterate, this story is a decade old. We've told this story over and over again in the media, and there is nothing new."

Weiss is now fighting to regain her health after suffering two strokes, but there's a small pouch she wears around her neck which carries some of her son's ashes. Howard says the last 9 years have taken a tremendous toll on his good friend, but she's still determined to see someone be held accountable for her son's death -- and so is Elliott.

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