Inquiry Into Troubled Drug Study Urged At University of Minnesota

Dec. 10--A dozen faculty members and a student group at the University of Minnesota are calling for an investigation into the 2004 suicide of Dan Markingson, a West St. Paul man who participated in a medication study at the U that critics say might have featured a series of ethical violations.

The appeals are coming from bioethicists, a faculty group and graduate students at the U who in the past two weeks have directed letters and a resolution raising concerns to the university's Board of Regents, which today will conclude its two-day meeting on campus.

A university spokesman said Thursday that Mark Rotenberg -- the U's top lawyer -- likely will be informing board leaders today about the letters, which amplify concerns first raised in a 2008 series of articles in the Pioneer Press.

"It's fair to say this is a ‘routine' review, based on the concerns that were raised," said Daniel Wolter, the university spokesman. "At this point, it's premature to say what, if any, further review the board would pursue."

In one of the letters to the board, eight bioethicists argue that the Pioneer Press stories and a subsequent article published in the magazine Mother Jones raise questions that should be addressed by a panel of outside experts convened by the U. The experts would review the conduct of researchers in a study financed by drug maker AstraZeneca that sought to compare the effectiveness of three commonly used antipsychotic drugs.

"Over the past two years,

(the) articles ... have suggested an alarming series of ethical violations and lapses with that study which, if true, suggest serious problems in the way that clinical research is conducted and overseen at the U," the bioethicists wrote in their Nov. 29 letter. "Patients participating in research studies at the University of Minnesota need to be confident that the University is doing everything it can to protect them from harm."

One of the bioethicists who signed the letter is Dr. Carl Elliott, a pediatrician and philosopher who also wrote the magazine article. Elliott said the article, which was published in the September/October edition, added to the debate by suggesting the study in which Markingson participated was designed primarily to help a drug company market its product -- not to answer a genuine scientific question.

"It's one thing to ask subjects to enroll in a research study that is aimed at generating useful scientific knowledge and will advance patient care," Elliott said. "It's another thing entirely to enroll in a clinical trial that's being conducted to advance the marketing aims of a pharmaceutical company."

A second letter to the board was signed by four faculty members who are part of a group called the Faculty for the Renewal of Public Education. The Dec. 5 letter also called for an independent investigation -- a call that was seconded Wednesday with a resolution passed by the U's Graduate and Professional Student Assembly.

The Pioneer Press articles detailed how Markingson's mother, Mary Weiss, couldn't get her son removed from the study even as she came to believe Dan Markingson's schizophrenia was worsening. Weiss filed a lawsuit accusing Markingson's psychiatrist and the study's director, Dr. Stephen Olson, of coercing him to sign up.

The lawsuit claimed the university kept Markingson enrolled to preserve its research and to keep payments coming from his participation. The U received about $15,000 for Markingson's participation, and the study offered the university a total of $327,000 and a chance to raise the profile of the U's schizophrenia program.

The death prompted reviews by the state mental health ombudsman and the U.S. Food and Drug Administration about the conduct of the university and Olson, who was Markingson's only psychiatrist at the time he recruited him into the study. But neither Olson nor the U has been blamed by any oversight agency for the death or cited for research violations.

The U was dismissed from Weiss' lawsuit in February 2008, and Olson settled in April of that year.

Justin Paquette, a spokesman for the U's Academic Health Center, said Thursday that he would not make Olson available to respond to the letters and student resolution. But he pointed to a statement the U posted on the health center's website that enumerates the various outside groups that have investigated the case.

"None found fault with the University," the statement reads, "none found fault with the involved faculty."

Christopher Snowbeck can be reached at 651-228-5479.

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