WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) on April 28 denied Public Citizen’s petition asking the agency to disqualify emergency department researchers at Hennepin County Medical Center (HCMC) in Minneapolis, Minn. who repeatedly tested the dangerous general anesthetic ketamine and other powerful sedatives on agitated patients without their consent. Public Citizen had urged the FDA to direct HCMC to contact the more than 1,700 patients who were unwittingly enrolled in unethical experiments to inform them that their rights were violated and health potentially endangered by the researchers. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:
“The FDA’s failure to seriously sanction HCMC researchers sends a clear signal to the research community and public that the agency is not serious about protecting the rights and welfare of human subjects. Over a four-year period, HCMC researchers engaged in a pattern of repetitive egregious violations of federal regulations intended to protect human research subjects. The FDA should have required the hospital to contact the more than 1,700 patients who were unwittingly enrolled in unethical experiments and inform them that their rights were violated and that their health was potentially endangered by the medical center’s researchers.
“The case for the FDA disqualifying the HCMC researchers is overwhelming. The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”