Ethics of consent-less study of prehospital agitation treatment questioned.
Following revelations last month about two controlled trials of ketamine for treating severe agitation -- with drugs injected by first responders without the patients' individual consent -- the consumer group Public Citizen and dozens of independent physicians are calling for a federal investigation.
The Minneapolis Star Tribune newspaper published a series of stories in June detailing the trials, which were the first quasi-randomized studies comparing ketamine with traditional medications (i.e., haloperidol and midazolam) used to sedate agitated patients in emergency settings. The trials had been approved under a "waiver of consent" process, under which the investigators said risks were minimal; they also consulted beforehand with community groups, including patients in a homeless shelter under treatment for substance abuse.
Public Citizen is now hoping to make a federal case out of it. Their letter, dispatched just after midnight Wednesday, called on the FDA and the Department of Health and Human Services' Office for Human Research Protections to "immediately launch formal compliance oversight investigations."
The letter cited the adverse-event rates from the initial trial as indicating that the risks associated with ketamine were far from minimal, and questioned the method used to determine whether patients were severely agitated (scores of 2 or 3 on the Altered Mental Status Scale). It also said the institutional review board (IRB) that approved the trials, as well as the sponsors and investigators, should be scrutinized.