The advocacy group Public Citizen supported by many bioethics specialists has lodged a complaint against investigators at the Hennepin County Medical Center in Minneapolis to the FDA and Office for Human Research Protections. Two studies conducted in that center involved the use of ketamine or other sedative drugs by paramedics for prehospital agitation.
Usually, the investigators must get the approval of an Institutional Review Board (IRB) to conduct any clinical study. What’s more one of the mandatory documents is the informed consent form which must be signed and dated by patients participating in trials with the exception of emergency cases. However, in this particular study IRB stated that there is no need for the consent and receiving these drugs associated with “minimal risk” both for study participants and for any patients who were prescribed with the same medication.
During the 1st study “profoundly agitated” patients were administered either haloperidol (antipsychotic drug) or ketamine which is also known as a “date rape” drug because after taking it people may experience memory blackouts. The choice of the medicine to be prescribed was not based on clinical considerations but only on the study protocol according to which all patients should take haloperidol during the first 3 months of the trial, ketamine in the next 6 months, then haloperidol in the last 3 months of the trial.
All in all, between October 2015 and September 2016, 146 patients were enrolled into the study and received the treatment according to the protocol. It was found out that severe side effects were observed much more frequently when patients were taking ketamine (49% compared to 5% for haloperidol treatment). What’s more, patients who were receiving ketamine required intubation due to breathing difficulty (39% versus 4% for haloperidol-treated patients).
Despite of the fact that it was evident that ketamine treatment was associated with much more safety concerns investigators in the Hennepin County Medical Center moved on to the second study, in the framework of which they compared the efficacy of ketamine treatment with the efficacy of midazolam treatment. They have included 146 subjects during the first year of the study and planned to include 420 patients during the second one. The second study along with the first one was open-label and not randomized. Therefore, during the second study subjects administered one of two doses of ketamine, depending on their agitation level in the first 6 months.
However, the study was stopped on June 25 after the Minneapolis Star Tribune has published an article denouncing the fact that even those patients who were not severely agitated or already restrained kept taking ketamine. Journalists suggested that it was done at the urging of police. They have also exposed one fact when a paramedic gave an injection of ketamine to a woman who had asked for an asthma pump. All these complaints were confirmed by the report from Office of Police Conduct Review, a division of the city’s Department of Civil Rights.