U of M invites debate on human research after silencing critics

The U's human research program hasn't bounced back from a year of damning ethics reviews, but it will host a convention on human experimentation in December.

The U's human research program hasn't bounced back from a year of damning ethics reviews, but it will host a convention on human experimentation in December.

This week, the University of Minnesota announced that it will host a brave new conference in early December centered on cutting edge best practices in human experimentation. Invited are the country’s top researchers, bioethicists, and patient advocates.

Things could get awkward fast. The U’s human research program has gotten a lot of attention over the past year, but not for a job well done.

“This whole thing is just a pure PR exercise,” says U bioethicist Carl Elliott, who was invited to speak for 10 minutes on one of the panels. In that 10 minutes, he’s going to try to be blunt about some of the shenanigans that the U’s human research program got up to in the past decade, but he’s not too excited about it.

In March, a long-delayed external review of the program found that back in 2003, U researcher Dr. Stephen Olson recruited Dan Markingson, one of his schizophrenia patients, for a drug experiment under threat of involuntary commitment. Despite protestations from Markingson’s mother that her son was rapidly deteriorating, Olson wouldn’t pull the plug on the study. Six months later, Markingson stabbed himself to death with a box cutter.

In May, another patient came forward. Robert Huber claimed that in 2007, he was in the throes of a schizophrenic episode when Olson approached him in the hospital. Like Markingson, he was given the choice of commitment or participation in a drug study, Huber said. He took the drug for 10 weeks, unable to quit in spite of stabbing pains in his stomach. He later found out that the FDA rejected the drug two weeks into his study, but the U had kept him in the dark.

Then, like a scandal machine that won't stop giving, psychologist Ken Winters was caught forging federal patient protection documents. He said he wanted to get a move on studying teen drug users, and simply got tired of waiting for the right certificates.

By the time the U hosts this convention, “Research with Human Participants: The National Debates,” it won’t have reclaimed full accreditation from the Association for the Accreditation of Human Research Protection Programs. Many of the reforms required won’t be fully implemented until June 2016.

Meanwhile, Markingson’s mother is now disabled after suffering multiple strokes throughout 11 years of petitioning the U to look into her son’s case. Huber has never received a formal apology.

“The entire thing is organized by the bioethics people who said nothing about this case for 11 years,” Elliott says, referring to U bioethicists Steve Miles and Susan Wolf. The two were notably silent while the U tousled with Markingson’s family and Huber, yet are the only bioethicists on the convention’s planning committee.

Likewise, none of the 181 scholars and ethicists who signed on to a 2013 letter calling for an independent investigation into the Markingson case were invited.

“The University is taking various kinds of steps at reform, monthly reports to state legislature, task forces and committees and all these checkboxes,” says Leigh Turner, another U bioethicist who has been dogging the administration since 2008 to review its human research program. “It’s a lot of waving their hands and suggesting that they’re doing something. This is their big coming out party, suggesting we’re still the national model.”