Update -In the September issue of Mother Jones magazine, Dr. Carl Elliott, a professor of bioethics at the University of Minnesota, writes about the suicide in 2004 of 26-year-old Dan Markingson, who was enrolled at the time in a U of M industry-funded clinical trial of the antipsychotic drug Seroquel (quetiapine).
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.
But Elliott’s purpose in writing the article wasn’t only to revisit the tragic details of Markingson's story. “[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 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. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.”
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.
At the time Markingson entered the Seroquel study, reports Elliott, the investigators were having serious problems recruiting subjects. Did that factor lead them to enroll someone into the study who shouldn’t have been?
“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 commitment order under which [Markingson] was recruited into the trial, 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. Such studies, he writes, present a huge ethical problem that isn't being properly addressed by the oversight systems currently in place:What is simply assumed [when bioethicists and regulators debate the risks of a clinical trial], without much consideration at all, is that the research is being conducted to produce scientific knowledge. This assumption is codified in a number of foundational ethics documents, such as the Nuremberg Code, which was instituted following Nazi experiments on concentration camp victims. … But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation [involving various prescription drugs] suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to “generative commercially attractive messages”?Or, as Elliott told me: “I don’t think anybody who enrolls in a clinical trial thinks, “I know this study is risky, but I think it’s worth it to help Pfizer or AstraZeneca market their drug.”
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.
The Mother Jones article reaches subscribers’ mailboxes today. Everybody else will have to wait until it hits the newsstands on Aug. 31.
Here it is
via minnpost.com
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