For the Record: U's handling of drug study suicide earns an 'F' among peers

Dan Markingson and his mother, Mary Weiss. Weiss was concerned that her son wasn't getting better during his six months in the U of M study. Courtesy Markingson family

Link to original on MPR News

As University of Minnesota leaders try to control the damage caused by their handling of a decade-old drug-trial suicide, some academics around the world are ensuring the case will live on in the classroom.

The story of Dan Markingson has become a case study in some college courses, and appears to bolster faculty and alumni concerns that the scandal has stained the university's reputation.

"I don't share my experience at the University of Minnesota with the kind of pride that I'd like to be able to," said Matt Lamkin, a U of M alumnus and University of Tulsa law professor who teaches the case in his classes.

The university has received scorching criticism in recent weeks after two recent reports blasted it for the way it has treated vulnerable human research subjects, including Markingson.

Markingson killed himself while participating in a corporate-sponsored clinical drug trial at the university in 2004. Last month, a legislative audit said the conditions under which Markingson participated were potentially coercive.

The legislative auditor found multiple conflicts of interest in the case, and said university leaders had blown off the concerns of Markingson's mother that he might hurt himself.

• April 17: U's Kaler responds to critics over Markingson case
• March 19: Legislative auditor blasts U over ethics, conflicts in drug trial patient's suicide

The audit also criticized the university for thwarting attempts to look into the case further. It said university leaders misled the public about the thoroughness of past inquiries, dismissed calls for a full investigation, and otherwise "ignored serious ethical issues."

Especially concerning to the investigators was that some of the very problems that plagued the Markingson case still haunt the university today, as shown in an external review released in February. "A primary problem ... is past and current university leadership that is defensive, insular, and unwilling to accept criticism," Legislative Auditor James Nobles wrote.

That's not exactly news to at least 175 scholars around the world who've had the Markingson case on their radar since at least since 2013. That's when University of Toronto health law professor Trudo Lemmens sent a letter to President Eric Kaler expressing concern over the U's handling of the situation.

Those 175 scholars who signed it — many of whom specialize in medicine, bioethics and law — come from U.S. colleges and universities such as Harvard, Stanford, Northwestern, and the universities of California, Pennsylvania, Virginia and Michigan. The letter also contained signatures from academics in 18 foreign countries, including 10 in Europe.

Some of those academics have either discussed the case or assigned it as reading material in at least 18 universities in the United States and other parts of the world, according to interviews, emails and copies of course syllabi.

"There's a lot of uproar, and there's certainly a lot of attention in the academic community about what's happening at the University of Minnesota," Lemmens said.

Scholars who spoke to MPR News said the case stands out for a few reasons.

First is its comprehensiveness.

Kenneth DeVille, chief institutional integrity officer in East Carolina University's division of health sciences, says the case contains many ethical concerns — such as patient coercion, safety of the study's design, and the U's response to concerns over Markingson's safety — that his students could easily understand.

The issues "really run the gamut," he said.

The case is also quite uncommon. Professors said only a handful of publicized contemporary cases rose to the level of Markingson's.

Chief among them are the 1999 death of 18-year-old Jesse Gelsinger during a University of Pennsylvania gene therapy experiment, and the 2001 death of 24-year-old Ellen Roche during a Johns Hopkins University asthma drug study. In both cases, federal investigators discovered multiple problems in the ways the universities handled the experiments.

Scholars say the Markingson case is also one of the few to have a wealth of information behind it, including original documentation online, and in scholarly journals, and major national publications.

The publicity has only increased with the university's refusal to come clean in the case, they said.

"Had the U not behaved the way it behaved, we might not be talking about this at all," said Misha Angrist, a Duke University professor who has taught the case to students of public policy. "You can't ignore the institutional response to what happened, and a large part of what makes this case so outrageous was the U's stonewalling."

Lecturers say their students react to the case with disbelief.

"The impact is profound," University of Sydney (Australia) bioethics professor Ian Kerridge wrote in an email. "They are stunned."

Law professor Lamkin said some of his students are outraged, and don't understand how such a case could happen.

"I've had multiple people ask why there have been no criminal charges," he said.

Students aren't the only ones who shake their heads.

Harvard psychiatry professor Alexander Tsai said when he talks to colleagues about the Markingson case, remarks about the university's handling of it are often "derisive in tone."

Tsai noted Kaler's recent statement that the U's declarations about previous investigations weren't false but "imprecise."

"You can't help but snicker when you hear something like that," Tsai said.

Yet Tsai and other scholars said that barring further revelations, the overall stain on the university's reputation will probably be short-lived. Most doubted the case would have much of an effect on the U of M's ability to recruit faculty and students or win grants.

U of M philosophy professor Naomi Scheman, who warned two years ago that the U had a cloud over its reputation, said she suspects there might be some problems in the Markingson case that aren't unique to the University of Minnesota.

"I would hope that ... [the case] is being used to point out problems that are endemic to most pharmaceutical company funded research at universities," she said. "I would be somewhat dismayed if it was being used in a way that allowed other institutions to pat themselves on the back and say, 'Look how horrible things are at the University of Minnesota. Aren't we by comparison wonderful?"