University of Minnesota

You Can Run, But You Can't Hide

From Pharmalot:

Nearly seven years ago, 26-year-old Dan Markingson killed himself while participating in a clinical trial at the University of Minnesota, where researchers were studying the Seroquel antipsychotic. And the circumstances surrounding his participation and subsequent death led to widely publicized allegations that the university put its own interests ahead of the patient.

How so? One reason - an academic researcher also consulted for AstraZeneca, which markets the pill and sponsored the study. And the researchers were allegedly under pressure to bolster enrollment. These details emerged following a lawsuit filed by Markingson’s mother, who objected to her son’s participation because he was already mentally ill and possibly incompetent, but was enrolled anyway (background here).

Her lawsuit went nowhere, as did a complaint to the state medical board about one researcher, Charles Schulz, who has denied any wrongdoing (more detail here). Yet a group of eight university bioethicists recently wrote the university’s Board of Regents to complain that the school failed to properly monitor the situation and to demand that an independent board should probe the episode.

Now, the school has exonerated itself. In a letter sent by the Regents to the bioethicists, the school determined there was no “improper or inappropriate” care provided to the patient and there was no evidence of misconduct or that any laws or regulations were violated (read the letter). And the Regents noted the FDA, the Minnesota Attorney General and the Minnesota Board of Medical Practice had previously conducted investigations and reached the same conclusion.

A central issue was the extent to which Markingson’s participation contributed to his suicide. The researchers and the university maintained he had actually begun to improve prior to his death. “Not withstanding (his mother’s) belief, there is simply no evidence that Mr. Markingon’s death was causally connected to his participation” in the study, wrote university general counsel Mark Rotenberg, in a separate letter to the same bioethicists. His office conducted the university probe.

Can you say: conflict of interest?

The circumstances in which Markingson wound up in the study were central to the controversy. Back in 2003, he suddenly exhibited troubling behavior and threatened his mother before he was briefly committed involuntarily to a mental institution. To avoid remaining there, he was placed in the university trial, although just before that occurred, this same physician reportedly indicated in a court petition that he was dangerous and mentally incapable of consenting to taking antipsychotics.

As his mother, Mary Weiss, wondered: How could her son suddenly be capable of consenting to a participation in a research study while he was in a state mental institution? A report written in Mother Jones by Carl Elliott, one of the university bioethicists, suggested the researchers were under pressure to bolster enrollment in the trial.

This same report also noted that patients experiencing their first psychotic episode are at higher risk of killing themselves or other people. “For this reason, most studies of antipsychotic drugs specifically bar researchers from recruiting patients at risk of violence or suicide, for fear that they might kill themselves or someone else during the study,” he wrote at the time.

And the angels wept.  I am ashamed of my university..