… has kept after his employer, the University of Minnesota, in the matter of Dan Markingson and research ethics. Elliott and others have long argued that Markingson was too mentally fragile to have given informed consent to take part in a UM clinical drug trial, and that his suicide during the trial might not have happened had he not been “coerced …into participating … and then exploited…”
The university has been singularly and stupidly determined to deny that anything at all is amiss in any of its research protocols, and Carl has been subject to pressure and ridicule on that campus. Finally, however, something like victory might be in sight:
University of Minnesota President Eric Kaler told faculty leaders Friday that the university will change the way it treats human test subjects.
Last week, a review of the university’s human research practices criticized the school — and, in particular, its psychiatry department — for not doing enough to protect vulnerable adults in its research.
One doesn’t want to get too excited, though. As Carl points out:
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.
March 8th, 2015 at 8:56AM
Carl is a powerful example for all of the profs out there who say what can we poor weak us do about corruption on campuses (all while selling themselves as somehow in the business of forming future active/responsible citizens) but he is sadly all too right about the incentives/oversight. The pressures are now even greater on researchers than ever before with less federal funding, more pressure from state governments to be in partnerships with businesses, even in getting hired now as junior faculty one is expected to be bringing research dollars to the job/school.
March 8th, 2015 at 10:38AM
President Eisenhower presciently warned about this trend when he discussed the government-academic complex: “… research has become … more formalized, complex, and costly. A steadily increasing share is conducted for, by, or at the direction of, the Federal government.… the free university, historically the fountainhead of free ideas and scientific discovery, has experienced a revolution in the conduct of research. Partly because of the huge costs involved, a government contract becomes virtually a substitute for intellectual curiosity… The prospect of domination of the nation’s scholars by Federal employment, project allocations, and the power of money is ever present and is gravely to be regarded.”
Today we see another variant on Eisenhower’s theme – the entry of for-profit corporations into academic medicine – with much the same dangers. In the business research model patients are viewed as commodities and the clinical studies conducted are shaped by the marketing departments of pharmaceutical corporations. Some years ago I coined the term experimercial for such pretend clinical trials. It is bad enough when unforeseen harm occurs in a genuine clinical study – but it is insufferable when it occurs in an experimercial. The commercial pressure to enroll dubiously appropriate subjects is very real. Hitting the numbers can become the main objective because nowadays the investigators themselves don’t run the analyses in multi-center studies. Kudos to Carl Elliott.
March 8th, 2015 at 2:58PM
Having attended the senate faculty hearing and listened to Kaler attempt to answer questions that were directed at him, it now seems improbable to me that any human being could ever endure such pain again. No matter the subject matter of the question being asked, Kaler had a stock answer, and if that didn’t work he resorted to his backup line that everything happened before he arrived on campus…and therefore can’t be held accountable. The most compelling question still unanswered is …where is he getting his information from? Besides the department of psychiatry chair and the principal rogue study investigator the only common denominator is the Academic Health Center’s legal counsel, the same counsel that has claimed for all these years nothing was wrong at the U, and that they were Lilly white.
March 8th, 2015 at 5:47PM
well maybe Eli Lilly white…