Tuesday, December 7, 2010

University of Minnesota ethics professors

seek inquiry into drug study, subject's death

Six years after Dan Markingson's suicide, questions linger about the study in which he was enrolled.

In a letter to the board Monday, the professors questioned whether U psychiatrists lacked ethical judgment in enrolling the victim, Dan Markingson, a schizophrenic who may have lacked the wherewithal to consent to research. They also questioned whether financial incentives from AstraZeneca, the drugmaker funding the study, presented conflicts for the researchers, Dr. Stephen Olson and Dr. S. Charles Schulz.
"While it is understandable that some of our colleagues will have little interest in revisiting this case and the ethical issues it raises, we are persuaded that there is a disturbing and unjustifiable gap between how the University has responded to this death and the careful, critical investigation it warrants," the professors wrote.

U leaders will take the letter seriously and take the protection of human research subjects seriously, said the U's general counsel, Mark Rotenberg. He stressed that other government entities have found no causal link between the study and the death.

"The fact that this is tragic doesn't mean the treating physicians did anything wrong," he said.

Among the new critics is Mary Faith Marshall, a bioethics professor who served on federal panels regarding the protection of human research subjects. She also served on an advisory panel that investigated conflicts of interest after the 1999 death of Jesse Geslinger, a participant in a gene transfer study at the University of Pennsylvania.

Whether or not the U was at fault, Marshall said the institution owes Markingson's mother, Mary Weiss of Cottage Grove, an apology and an investigation. She called Markingson's death "an example of a failure" to protect research subjects.

The patient, Dan Markingson, was committed to the psychiatric wing of University of Minnesota Medical Center, Fairview in 2003 and entered into a clinical trial for an anti-psychotic drug. He committed suicide a year later. The incident was largely exposed by the St. Paul Pioneer Press and, some believe, implicates University researchers in ethical lapses.

Markingson was still enrolled when he died by suicide at a group home. Weiss had implored researchers to release her son because she felt the drug under study wasn't treating his delusional behavior.
The lead author of the letter is Carl Elliott, a U of M bioethicist who wrote an article in Mother Jones magazine recently about Markingson's death and researchers' financial ties to the drug industry. Elliott also testified with Weiss for the passage of "Dan's law," which prohibits mentally ill patients under civil commitments in Minnesota from consenting to research.

Other bioethicists who signed the letter: Dianne Bartels, Joan Liaschenko, Dr. John Song, Leigh Turner, Susan Craddock and Joan Tronto.

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