… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Star-TribuneBy Carl ElliottOctober 7, 2015Thanks 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].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.”
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.