Tag: Carl Elliot
While clinical trials make up the “bedrock of evidence-based medicine” in other specialties, psychiatry faces a number of both ethical and scientific problems related to its use of randomized control trials. According to a new editorial in The Lancet Psychiatry, the field of psychiatry research has particular problems with ethical issues in recruitment, inaccurate classification systems, and controversial placebo comparisons, and then, once the studies are finished, it often remains unclear what the “outcomes actually mean for people’s lives.”
Six men were hospitalized and one was pronounced brain dead after participating in a phase 1 clinical drug for a mood, anxiety, and motor dysfunction drug manufactured by Bial and administered by Biotrial. Carl Elliott, a bioethicist at the University of Minnesota, said investigators should look into questions like how much the men were paid and whether they properly consented to the trial. “Many Phase 1 trial volunteers are poor and unemployed, and they volunteer for trials like this because they are desperate for money,” he said. “This means they are easily exploited.”
The University of Minnesota recently announced that it is ending the controversial practice of recruiting study participants from patients involuntarily being held in their psychiatric unit. In a commentary for Minnesota’s Star Tribune, bioethicist and MIA contributor Carl Elliot reports that the university has still not apologized to the patient who spoke out against this practice. Instead, “the university has done its best to discredit him.”
In the Atlantic, Cari Romm describes “what it is like to earn a living as a research subject in clinical trials.” “Phase 1 trials are almost always where the money is,” she writes, but they are “also the least regulated” and “companies aren’t legally required to register a trial with Clinicaltrials.gov.” “It seems to me like if you were considering signing up for one of these things, you would at least want to know the data that’s out there about [safety],” said Carl Elliott, an author for MIA and expert on the ethics of human subject research.