10 years in, study scandal lives on

A professor asked for an investigation into documents that the U says aren’t real.

by Cody Nelson

The University of Minnesota’s top lawyer and a prominent professor are going head-to-head as part of an ongoing dispute over a clinical drug trial that happened a decade ago.

Bioethics professor Carl Elliott requested an investigation Feb. 20 into potential research misconduct in the Comparison of Atypicals in First Episode of Psychosis, or CAFE, study. Now, Mark Rotenberg, the University’s general counsel, is saying the documents at the center of Elliott’s request aren’t authentic.

“Professor Elliott’s allegations are very serious allegations against our psychiatry faculty and department,” Rotenberg said. “The University is diligently looking at those allegations.”

Elliott’s request for an investigation — and the University’s response — are the latest development in the years-long back-and-forth between University administrators and critics of the study, one that’s often churned up more conflict than resolution.

Questions about consent

The CAFE study began internationally in May 2002, and 26-year-old Dan Markingson joined the study at its University of Minnesota site in 2003.

Funded by AstraZeneca to test its anti-psychotic drug Seroquel, the CAFE study included subjects who were experiencing their first psychotic episodes. Markingson was one of 17 participants at the University of Minnesota Medical Center, Fairview.

A week before he requested an investigation, Elliott posted a medical form on his blog that appeared to be a duplicate of a form from Markingson’s file.

Six months after joining the study, Markingson stabbed himself to death, prompting many calls for investigations into the study.

Investigations by the University’s Institutional Review Board, the U.S. Food and Drug Administration and the Minnesota Board of Medical Practice found no evidence of research misconduct.

Elliott posted an Evaluation to Sign Consent form, a series of questions for potential research subjects. Their answers show whether they are aware enough of study procedures to consent to participate in the study.

When Elliott posted the form on his blog and on a Facebook group for families of CAFE study participants, several people responded saying they had identical copies of the form, according to a letter Elliott sent to the University.

On Feb. 20, Elliott wrote to Frances Lawrenz, the University’s associate vice president for research, asking for an investigation.

Lawrenz denied Elliott’s investigation request in a Feb. 26 email response.

According to Elliott’s letter, only one family agreed to let him post their form on his blog under the condition of anonymity. The family told Elliott the form was given to them by the University’s psychiatry department.

The duplicate appeared to be a photocopy of Markingson’s form with the same answers and signatures from the evaluator and study coordinator, Jean Kenney, and witness, Elizabeth Lemke.

The Minnesota Board of Social Work in November 2012 was the only agency to officially allege any wrongdoing regarding the CAFE study or Markingson’s suicide. The report didn’t mention the duplication of forms but said Kenney made repeated documentation errors, performed tasks beyond her expertise and didn’t adequately address family concerns regarding Markingson’s treatment.

Form witness Lemke, now Elizabeth Smaby, had no comment on the forms, according to her husband, Paul Smaby.

“It seems possible that someone in the Department of Psychiatry may have been using a generic photocopied form with pre-determined answers as documentation that mentally ill research subjects were competent to consent to research studies,” Elliott said in the letter.

But Rotenberg told the Minnesota Daily in an interview that after compiling and evaluating all 17 consent forms, the University determined Elliott’s allegations to be unfounded.

Additional concerns

In his request for an investigation, Elliott also referred to Markingson’s HIPAA form from when he was admitted to the Fairview in November 2003.

HIPAA forms are agreements that allow medical information to be released for patient care purposes when they are admitted to a treatment facility.

Markingson’s mother, Mary Weiss, and her friend, Mike Howard, said they believe Markingson never signed a HIPAA form when he was admitted to Fairview.

After Markingson’s death and the subsequent wrongful death lawsuit that Weiss filed against the University, Weiss and Howard said they never saw a signed HIPAA form. Instead, they were only able to obtain the first, unsigned page when they requested it from Fairview, they said.

In April 2010, Howard filed a complaint with the Board of Regents against Stephen Olson, the CAFE study’s lead psychiatrist, alleging the study coordinators never obtained a signed HIPAA form from Markingson.

If the form wasn’t signed, Howard said, then study coordinators could not have accessed Markingson’s medical records and so he could not have consented to be in the study.

On March 16, 2011, Rotenberg responded to Howard’s complaint by providing a copy of the signed form, dated Nov. 24, 2003.

In Lawrenz’s response to Elliott’s request for an investigation, she said the issues raised around the HIPAA forms, as well the Evaluation to Sign Consent forms, were outside the scope of the University’s academic policy on research misconduct.

Conflicting accounts

To date, the University has not made its documents public, and the families who Elliott said claimed to have duplicate forms remain anonymous.

The time lapse between the events in question and the call for an investigation makes it hard to respond, Rotenberg said.

“It becomes more and more difficult for people who are responding to allegations like this to answer them promptly and adequately as time goes on,” he said.

But Leigh Turner, an associate bioethics professor at the University, said it would’ve been unlikely for someone to raise questions about consent forms several years ago.

“I don’t really see how anyone could’ve gone down that road until some new evidence came to light,” he said.

It’s still unclear what the evidence means.

Turner said he would like to see an outside investigation to determine whether there was any wrongdoing in obtaining consent from research subjects.

“It’s the documents themselves that turn the situation one way or the other,” he said. “Short of having access to them, it’s a little bit difficult to know what exactly took place.”