Sunday, August 22, 2010

Chickens, Coming Home to Roost

At the University of Minnesota

The first of what is sure to be a lengthy and drawn out examination of what has gone wrong with the University of Minnesota in general and the medical school in particular has been kicked off by U of M bioethicist Carl Elliot in an article that will appear in print in September in Mother Jones.

There has already been significant commentary on the piece, for example the recent piece in MinnPost by Susan Perry: "Disturbing suicide tale: U of M professor reexamines ethics questions of drug trial."

It’s a disturbing tale (the unsuccessful efforts of Markingson's mother to get her son released from the trial and into other treatment are particularly heartbreaking) and one that, as Elliott acknowledges, was first told in the Pioneer Press by Jeremy Olson and Paul Tosto.

“[T]he more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported,” he [Carl Elliot] writes. “The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs."

Those hazards include questionable informed consent (is a young man who’s experiencing psychotic episodes competent to give his consent?) and financial conflicts of interest. According to Elliott, the U of M psychiatry department earned $15,648 for each person it enrolled in the Seroquel study. In addition, the study’s two U of M investigators, Drs. Charles S. Schulz and Stephen C. Olson, personally earned a combined $811,045 between 2002 and 2008 from Big Pharma, including $261,364 from AstraZeneca, the maker of Seroquel.

“Even by the standards of a fairly ugly history [of clinical drug trials with ethical breaches] in medical history — even by those standards, this [case] jumps up,” Elliott told me in an interview last week. “There were so many things that went wrong — the consent process, the under which [Markingson] was recruited into the trial, commitment order the financial incentives of the university, the financial incentives of the investigators, and the sheer worthlessness of the trial. Anyone who looked into this and knew anything about clinical research would say this is terrible.”

Elliott sees the trial's worthlessness as a particularly abhorrent part of the story. The Seroquel study was designed as a marketing tool, he suggests, not as a true scientific inquiry.

Elliott said he’s been astonished by how few people at the U of M have bothered to examine too closely the university’s role in the Markingson case. “What’s amazing is that everybody who has looked at it has just concluded that we did everything right here,” he said. “It’s true that the university has had one conflict of interest scandal after another," he added, "but with all of those, you’re just talking about money. You’re not talking about a death in a clinical trial. Usually, when someone dies, people pay attention.”

Markingson’s mother, Mary Weiss, sued the U of M, AstraZeneca, Olson and Schulz, but, as Elliott points out, her case never went to trial. It was dismissed in 2008 with a partial summary judgment. The judge ruled that Weiss' lawyer had not shown any evidence linking Seroquel to Dan’s suicide. Furthermore, he said, her lawyers (and the judge’s own independent research efforts) had failed to point to any case or statute that would support the contention that AstraZeneca — or any pharmaceutical company — had a duty to put the interests of its research subjects above those of the company. The malpractice suit against Schulz was also dismissed, and that against Olson was eventually settled for $75,000, which was insufficient to even cover Weiss' legal costs, says Elliott.

But the legal matters didn’t end there. The U of M has sued Weiss to recover its own costs. “After it’s all done," said Elliott, "after this poor woman has had her son die in a research study, to turn around and sue her....” He paused. "I would like to know who made that decision — and why,” he said.


You can get free instant access to the full article right now on the Mother Jones website if you agree to receive the magazine's e-mail updates. Go here.


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