Medical experts are calling for an investigation after two clinical trials in Minnesota reportedly gave agitated patients ketamine as part of a study they did not know they were part of.
The trials took place at Hennepin County Medical Center (HCMC) in Minneapolis between 2014 and June 2018. Paramedics injected people with ketamine or other sedatives, to see what worked best, but only told them later.
“This is clearly a prospective, high-risk experiment,” said Michael Carome, director of advocacy group Public Citizen in Washington DC, reported Nature. “This is really just a colossal failure of their programme to protect human subjects.”
Patients who had received the sedatives were told via a letter afterwards that they had unwittingly become part of a research study, using sedatives to experimentally treat their agitation. This was despite some concerns that using ketamine as a sedative can be dangerous.
“You are receiving this form because you or someone you care for was included in a research study examining patients with agitation,” one of the letters stated, reported The Washington Post.
“This is all I got," Brittany Buckley, one of the study's unwitting participants, told the Star Tribune, who first broke the story. “Just this form saying that I’m part of their little test.”
HCMC themselves have published research previously on ketamine being used for agitated patients, noting that respiratory problems are common. About 57 percent of study patients given ketamine needed a tube put in their throat to deliver oxygen, called intubation.
Federal rules state that patients must be asked if they want to take part in a research study before doing so, except in some circumstances like emergency situations where that can be waived by a review board.
Public Citizen, however, says the process should not have been waived in this instance. Their complaint has been co-signed by 64 doctors, bioethicists, and academic researchers, citing the previous research showing that ketamine can be harmful.
HCMC defended its actions to the Star Tribune. “We’ve all seen agitated and confused people just die, and we’re certain we can prevent that,” said Dr James Miner, chief of emergency medicine at Hennepin Healthcare. “We want to do it the best way possible.”
But the situation is certain to raise questions about ethics and consent. The study has now been suspended, but state senator Jeff Hayden and Hennepin County Commissioner Peter McLaughlin called it “unconscionable and unethical”.
Forbes noted that ketamine constituted a more than “minimal risk”, and raised concerns about the impact this may have on other clinical trials that struggle for participants. Former Acting US Attorney General Sally Yates will now lead an independent investigation into the events at HCMC.