--eight of my colleagues in bioethics at the U of Minnesota have signed a letter calling on the Board of Regents to launch an independent investigation into the case of Dan Markingson:
The letter acknowledges that an FDA investigation in 2005 cleared the University and the drug firm sponsoring the research study that led to Markingson's death by suicide, AstraZeneca, of any blame. Still, say the bioethicists, there are many unresolved issues that demand further inquiry, which they proceed to list:
- "recruiting a mentally ill, possibly incompetent subject into a research study while he was under an involuntary commitment order;
- large financial conflicts of interest on the part of the university researchers conducting the study;
- a payment structure for the study which included financial incentives to recruit and retain subjects rather than provide them with standard therapy;
- an allegedly biased study design aimed at generating positive results for AstraZeneca rather than investigating a genuine scientific question;
- the failure of university researchers to address the legitimate concerns of Mr. Markingson’s mother, Mary Weiss, who warned that her son was suicidal and who attempted for months to have him removed from the study as his mental condition deteriorated;
- the apparent development of a specialized unit in Fairview Hospital designed to identify severely mentally ill subjects for recruitment into research studies;
- and finally, a failure of the institutional oversight system for protecting human subjects of research.”
Perhaps the most egregious, from an ethical standpoint, is the last. Carl Elliott of U-Minn, in the Mother Jones article profiled in my most recent post on this topic (link above), quoted the erstwhile chair of the University's IRB as denying that the institutional review board had a responsibility to protect human subjects of research, when most of us assumed that that was precisely the mission of an IRB.
I would like to be able to say that it's standard procedure for those of us in bioethics to be the first to protest loudly and publicly when our own institutions cross the line into questionable behavior. Sadly, it's often not the case; few see the bioethics program as a base of true power within an academic medical center, and most of us, consciously or not, end up adopting a don't-rock-the-boat mentality. Nevertheless, one of the signatories to the Minnesota letter has been there and done that. Mary Faith Marshall, PhD was once the bioethicist for the Medical University of South Carolina, and lost her job there as a result of critizing the institution's policies of secretly screening and then arresting newly delivered mothers for cocaine use (policies that were later found unconstitutional in a major U.S. Supreme Court decision).
Institutional conflict of interest was a problem at U-Minn even before the Markingson case arose. It's understandable, but ultimately indefensible, that precisely at the time in an institution's history when a thorough airing out of the problem followed by serious reform is the right thing to do, the natural instinct is instead to hunker down and circle the wagons.
I'm outraged that the UMN is still trialing SEROQUEL XR right now. Dr Schulz is running the trial and AstraZeneca is sponsoring it. Trialing the drug against placebo for Borderline Personality Disorder. Simply put: it's another patent extension for Seroquel.
It's a crime that Schulz is allowed, with his COI and the fate of Dan Markingson in the CAFE trial, that the UMN is STILL carrying on business as usual: unethical, corrupt and conflicted!
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