Ethical lapse at University of Minnesota?

The University of Minnesota's Center of Bioethics requested on Monday that the Board of Regents investigate the suicide of a former clinical trial patient.

According to The Minnesota Daily, the patient, Dan Markingson, took part in a clinical trial for an anti-psychotic drug and one year later committed suicide. Eight professors from the university's Center for Bioethics would like the incident to be formally investigated by a more impartial panel of experts.

In 2003, Markingson was committed to the psychiatric wing of the university's Fairview Medical Center and subsequently entered into the clinical trial. According to Pioneer Press the study, which was funded by AstraZeneca, a drug maker, compared the effectiveness of three different anti-psychotic drugs. The research group was comprised of schizophrenic patients experiencing the first sign of symptoms.

The Pioneer Press also said that Markingson was not actually diagnosed with schizophrenia until after he was enrolled in the study. His mother told Pioneer Press that she did not see any marked improvement in her son's condition while he was enrolled in the study and that she actually wrote to Dr. Stephen Olson, Markingson's psychiatrist and the study's director, asking him to consider different courses of treatment which would have effectively disqualified him from the trial.

A question of bias could be raised at this point. According to Pioneer Press, Markingson's disqualification from the program would have resulted in a cut in funding for the study. Olson, as Markinson consulting physiatrist and the one who had originally committed him also had a financial incentive to enroll suitable patients for the study. Olson dismissed the conflict of interest claiming that Markingon would have been receiving one or more of the drugs anyway, even if he had not been enrolled in the trial.

The Minnesota Daily said that the incident has already been investigated and cleared by an internal review board as well as by the FDA. Bioethics professor Carl Elliot does not believe the university's response was adequate however, and would like to see further investigation done.

"It looks as if some very serious ethical problems occurred in this trial and we'd like the university to look into that," Elliot told the Daily.

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This page contains a single entry by published on December 7, 2010 4:18 PM.

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