Ketamine study at Hennepin Healthcare suspended after criticism from politicians

Hennepin Healthcare announced Monday it will halt a clinical trial on ketamine following criticism over the hospital enrolling patients before getting consent.

The use of the sedative, administered to agitated patients by paramedics during emergency calls, is already the subject of outside reviews commissioned by the hospital and the city of Minneapolis.

"Hennepin Healthcare would never conduct research without appropriate consent from patients involved," hospital spokeswoman Christine Hill said in a statement Monday evening.

"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."

Earlier Monday, state Sen. Jeff Hayden and Hennepin County Commissioner Peter McLaughlin called the county hospital's clinical trial "unconscionable and unethical."

"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 color and low-income Minnesotans must take extra care," said the statement from Hayden, DFL-Minneapolis, and McLaughlin.

"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."

The Hennepin County Board has asked Hennepin Healthcare to appear at a meeting Tuesday and provide a report on the study. The developments Monday came a day after a Star Tribune story about the hospital's ketamine research.

The story quoted from a draft police oversight report, obtained by the Star Tribune, which questioned the role of ketamine in some emergency situations. In one case, a paramedic gave an injection of ketamine to a woman who had asked for an asthma pump after she had been Maced by a police officer, the report said.

"It is troubling that the dictate of the 'study' mentioned by the paramedics appears to have played a significant role in the decision to administer ketamine," the report's authors wrote.

In an interview last week, doctors for the hospital defended the drug as a vital tool for dealing with agitated patients and said their consent procedures are legal and ethical.

"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," said Dr. Jon Cole, emergency physician and toxicologist at Hennepin Healthcare.

The study, which began last year, gives patients the option to ask that their information be removed retroactively.

Hayden and McLaughlin also responded to allegations made in the police oversight draft that officers appeared to be crossing a line by asking paramedics to inject people with ketamine. On Friday, those allegations prompted Mayor Jacob Frey to hire former acting U.S. Attorney General Sally Yates to lead an independent investigation of police actions.

"Ketamine is a serious drug, with side effects from amnesia to hallucinations," Hayden and McLaughlin said. "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."

Andy Mannix • 612-673-4036