Faculty members challenge panel reviewing U's human research

This week, three national experts will arrive at the University of Minnesota to examine how well it protects patients in research studies.

But some critics say the panel is so rife with conflicts of interest that the review will be a sham.

The university is paying about $142,000 for the outside review, which was prompted by lingering concerns about the death of a patient, Dan Markingson, in a U drug study 10 years ago.

In June, the university hired a national organization, the Association for the Accreditation of Human Research Protection Programs, to manage the inquiry, which is supposed to focus on "current policies, practices and oversight" of human research. The group named three outside experts, including scientists from Harvard and Johns Hopkins universities, to conduct the review.

But on Sunday, Leigh Turner, a U medical ethicist who has been critical of the administration, denounced the pending review as a "whitewash" and said he would refuse to meet with the panelists.

Among other things, he said one panel member was a consultant for the company that ran the drug study in which Markingson died. "I fear that you are being paid $141,900 for the service of whitewashing the University of Minnesota's reputation," Turner wrote in a Sept. 7 letter to the association. "I will have nothing to do with your sham review."

A dozen other professors sent a letter Sunday to Brian Herman, the vice president for research at the U, expressing concern about the panel's objectivity.

"The university is wasting money if the review is not credible," said Karen-Sue Taussig, an associate professor of anthropology and one of the co-signers of the letter. She said conflicts of interest could taint the review's integrity.

In a statement, Herman defended the review, saying it's being conducted "by a group of independent, internationally recognized experts in the field." He added that "potential conflicts of interest will be managed appropriately."

Elyse Summers, president of the association, acknowledged that one panel member was a consultant to the company that ran the drug study in the Markingson case. But she said that was disclosed to the university, and that if a conflict surfaces, he "will recuse himself from that portion of the review."

Turner, though, argued that's not enough. "This conflict of interest cannot simply be 'managed' and 'disclosed,' " he wrote. He also said the accrediting association has its own conflicts of interest, including close financial ties to both the university and to drug companies that sponsor research. He noted it was paid to accredit the University of Minnesota's research programs three times since 2004. "You cannot investigate yourself," he wrote.

The association, however, says it will have no direct role in the panel's findings or recommendations.

Will Durfee, an engineering professor and faculty liaison for the review, said anyone is free to bring up concerns directly with the panel. But he said the university "does not wish to insert itself into the process of managing conflicts … as that would compromise the independence of the panel."

Turner is one of two professors in the university's Center for Bioethics, along with Carl Elliott, who have repeatedly criticized the U's handling of the Markingson case. Markingson, who had schizophrenia, committed suicide at age 27 in May 2004 while part of a clinical trial testing antipsychotic drugs.

The university said it was cleared of wrongdoing, but critics say it has never been adequately investigated. The university agreed to the latest inquiry after the Faculty Senate passed a resolution in December calling for a review of how the university recruits and protects human subjects.

The resolution did not call for a new investigation of the Markingson case specifically.

"One of the problems with the Markingson case, and one of the reasons it won't go away, [is] because the reviews that have been done haven't been credible," Taussig said. "My big concern is wasting money on another investigation that may not be credible. And that's just discouraging."

Maura Lerner • 612-673-7384