US hospital’s ketamine study forced to a halt over consent concerns

pharmafile | June 27, 2018 | News story | Research and Development Hennepin Healthcare, Ketamine, pharma 

Minneapolis-based hospital Hennepin County Medical Center has put the brakes on a clinical trial investigating the efficacy of ketamine in emergency situations after pressure from state officials.

Critics of the trial have called it “unconscionable and unethical” for allegedly failing to acquire consent from participants before enrolling them, and the study is already the target of external reviews commissioned by the city of Minneapolis and the hospital itself. According to an investigation by the Minneapolis Office of Police Conduct, documented ketamine injections during police calls increased in frequency from three in 2012 to 62 last year.

Owner of the hospital, Hennepin Healthcare, has denied the accusations. Spokesperson Christine Hill said: “Hennepin Healthcare would never conduct research without appropriate consent from patients involved. However, due to the concerns that have been expressed we have decided to put the study on hold at this time. In addition, we are committed to a much higher level of transparency and community dialogue, well beyond the federal regulations.”

Physicians at the hospital have defended the use of the drug, arguing it is key in managing agitated or aggressive patients. They also argue that all enrolment process is ethical, and participants are able to request that their information is removed retroactively. Dr Jon Cole, Emergency Physician and Toxicologist at Hennepin Healthcare, remarked: “Anytime that we interact with EMS about this, we emphasize to them, crystal clear: In no way is the study ever to increase the number of sedations.”

State Senator Jeff Hayden and Hennepin County Commissioner Peter McLaughlin issued a statement decrying the trial: “While we understand Hennepin Healthcare claims it has followed federal research procedures, we believe an urban hospital that treats a large number of people of colour and low-income Minnesotans must take extra care. Anything less disregards the history of maltreatment for these communities as test subjects for new drugs and medical procedures. This is unacceptable. We can – and must – do better.”

Furthermore, allegations have arisen in a police oversight draft that officers had been requesting that paramedics inject patients with ketamine, an issue which Hayden and McLaughlin also addressed: “Ketamine is a serious drug, with side effects from amnesia to hallucinations. Health care decisions, including which drugs to take or whether to be involved in research studies, should be made between a patient and their health care providers – not at the direction of police.”

Matt Fellows

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