Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation
Public Citizen wrote to the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to bring to their attention the July 26, 2018, report, MPD Involvement in Pre-Hospital Sedation, which was issued by the Office of Police Conduct Review in Minneapolis. The report contains new information pertinent to two prospective clinical trials that involved testing the dangerous general anesthetic ketamine and powerful sedatives on agitated patients without their consent.
July 30, 2018, OHRP acknowledgment email.
August 3, 2018, FDA acknowledgment letter.
See Public Citizen’s other work on ethics and clinical trials.