Thanks to a former Fairview Hospital patient with the courage to speak out about his mistreatment, the University of Minnesota is finally ending a controversial research practice. As of last month, the university will no longer test experimental drugs on mentally ill patients who have been involuntarily confined to a locked psychiatric unit under a 72-hour hold (“U halts recruiting of confined patients,” Sept. 26).
Yet instead of thanking the patient who spoke out, or apologizing for recruiting him under coercive conditions, the university has done its best to discredit him.
In July 2007, Robert Huber came to Fairview for help. He was hearing voices and feeling panicked. His treating psychiatrist, Dr. Stephen Olson, used a 72-hour emergency hold to confine Huber to a locked psychiatric unit. Then Olson asked Huber to sign up for a research study testing an experimental drug.
A pharmaceutical company was testing an unapproved antipsychotic drug called bifeprunox. Huber had never been prescribed any antipsychotic drug before, much less an experimental one, but he agreed to take part because he thought it was the only way to escape confinement. “I was so afraid they were going to lock me up,” Huber told the Star Tribune.
The study went very badly. The drug caused severe side-effects. Huber considered suicide. Only a few weeks after he was enrolled, the FDA rejected the drug for marketing approval, citing the death of a research subject in Europe. Yet nobody at the university told Huber — or for that matter, any of the other subjects enrolled in the U study — that the FDA had rejected the drug.
When Huber’s story was made public by KMSP-TV news in 2014, the university tried to smear him. A press statement prepared with the assistance of Brian Lucas, the senior communications director for the U’s Academic Health Center, read in part: “His medical record shows extreme anxiety and paranoia, a history of head injuries and lengthy battle with alcoholism. It is highly inappropriate for him to be put in the media spotlight as a spokesperson for clinical trial safety.”
In early 2013, Huber and I filed separate complaints to the university. It took over 14 months for the university to respond. The university hired an external consulting firm at a cost of $22,000, but neither the university nor the consulting firm ever bothered to interview Huber about what had happened to him. Finally, on May 6 of last year, the university sent Huber a letter informing him of its conclusion. The letter conceded minor problems but said, “You were not pressured or coerced to participate in this study.”
This is an astonishing response. Involuntarily committed psychiatric patients are an extraordinarily vulnerable group. They have been stripped of their liberty; their thinking is often clouded by illness, medication, or both; they are dependent on their psychiatrists for care, and those very same psychiatrists will determine when they can be released from a locked unit. The very first paragraph of the Nuremberg Code, instituted after the Nazi research atrocities, states that all research subjects “should be so situated as to be able to exercise free power of choice,” without duress, constraint or coercion.
Recruiting such subjects also comes very close to being illegal. In 2009, in response to the death of Dan Markingson, the Minnesota Legislature passed “Dan’s Law,” which prohibits the recruitment of patients under civil commitment orders into psychiatric drug studies.
But there was a loophole in the law. It made no mention of patients like Huber, who were not yet under a civil commitment order but who had been involuntarily confined on an emergency basis under a 72-hour hold.
Given the events of last spring — including two scathing investigations of psychiatric research practices and the temporary suspension of enrollment into psychiatric studies — one might think that university leaders would be chastened. Yet they have refused to admit that Huber was pressured into the study. My colleague, Leigh Turner, has written about the issue to Sen. Terri Bonoff, DFL-Minnetonka, chair of the Senate Higher Education and Workforce Development Committee. But Bonoff is unwilling to take action.
Huber deserves an apology from the university. He also deserves our gratitude, for having the courage to step forward and tell his story. There may well have been many other patients like him over the years. If the university is genuinely committed to research reform, it will find out how many other involuntarily committed patients have been recruited into research studies, and will apologize to them as well.
Carl Elliott is a professor at the Center for Bioethics at the University of Minnesota. The views expressed here are his own.