FDA Complaint on MN Ketamine Research Conducted Without Patient Consent

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Wednesday, July 25, 2018

The advocacy group Public Citizen has filed a complaint with the FDA and Office for Human Research Protections about trials conducted at Hennepin Healthcare (formerly Hennepin County Medical Center), in which paramedics used the sedative ketamine to treat "prehospital agitation." The letter is signed by dozens of bioethicists and medical experts, including Carl Elliott and Leigh Turner of the University of Minnesota Center for Bioethics, a Consortium member. According to reporting in the Washington Post, during the 4-year study "paramedics used either the anesthetic ketamine or a different powerful drug to sedate patients. . . . Patients or caregivers were not asked for permission to participate, and they were informed only later that they had become part of a medical experiment." Previous research, also conducted by Hennepin Healthcare, demonstrated that ketamine frequently causes complications that require patients by intubated. Regarding the recently halted study that was the catalyst for the complaint, Leigh Turner notes, “Even if there’s a case for using these drugs, there’s a case for being very judicious about when to use it.” He also expressed concern about the danger of the study influencing decisions by paramedics: “That’s going to lead to a reduction in the scope of clinical judgment, where EMS doesn’t have the full array of medications. The study is playing a role in which medication people get,” Turner said.