Mistakes admitted in second University drug trial

An investigation of another University psychiatric drug study found errors. 

by Christopher Aadland

For the second time this year, the University of Minnesota has admitted to mistakes in the treatment of a Psychiatry Department drug trial patient.

The admission came a day before the Board of Regents held a public forum — the second forum held at the University last week — to allow the public to voice their opinions of the school’s human subjects protection programs and planned reforms. The forums were announced last March in the wake of two reports that scrutinized the school’s research practices.  

An investigation found that the patient, Robert Huber, wasn’t coerced to enroll in the study, or forced to remain in the program. But it found that he was inadequately informed about the study before he consented to enroll, and wasn’t told about the Food and Drug Administration’s decision to not approve the drug.

“We … are sorry that your rights and welfare in the bifeprunox study were compromised,” said Debra Dykhuis, executive director of the University’s Human Research Protection Program in a May 6 letter.

Huber filed a complaint with the University’s institutional review board last year alleging misconduct by a University psychiatrist in the drug study.

In March, the state’s legislative auditor released a report that examined the circumstances surrounding the 2004 suicide of Dan Markingson, a man who was enrolled in an antipsychotic drug study at the University when he died.

While that review found ethical concerns relating to Markingson’s participation in the study and the University’s response to concerns raised by his death, another review — managed by the Association for the Accreditation of Human Research Protection Programs — found that the institutional review board at the University was insufficient.

The first two reviews triggered a swath of proposed changes to how the University protects human research subjects, including suspension of all psychiatric drug trials at the institution until an independent board can review them and the formation of an “implementation team,” charged with presenting recommended changes to University President Eric Kaler by May 15.

Held on the eve of the 11th anniversary of Markingson’s suicide, regents heard from faculty members, members of the public and former Gov. Arne Carlson.

“The story needs to be told honesty, including by the Board of Regents,” said Naomi Scheman at the forum, a professor of philosophy at the University. “That story needs to be told honestly so that we can move forward and support the terrific, life-saving research that goes on the University.”

While some speakers voiced their support for the University’s research and how it’s benefited them or family members, others were critical of the regents’ oversight and how the University and handled the controversy.

“The Board of Regents has allowed itself to become an appendage of the office of the president,” Carlson said Thursday. “This scandal could not have occurred if the board of regents had done their job.”

But Regent Dean Johnson defended the board’s actions throughout the decade-long debate.

He said he trusts the University’s administration even though the board may not have been provided with all the facts regarding the Markingson case.

“We’re very serious about what has gone on,” he said. “Can we improve? Yes, and we’re going to.”