After ketamine concerns, Hennepin Healthcare will suspend more research studies

A day after suspending its study of the use of ketamine on agitated people by paramedics, Hennepin Healthcare said it would halt similar clinical trials that seek consent from patients only after treatment.

Dr. William Heegaard, chief medical officer for the hospital system, appeared before the Hennepin County Board Tuesday to respond to ethical concerns over a ketamine study in which patients are enrolled without their consent.

Heegaard defended Hennepin Healthcare's practices as complying with rules and regulations, but said the hospital wants to pause its research and address complaints from the public.

"The community is hurting. I see it," Heegaard said. "We don't want to add to the pain and distrust. … We can do more."

Heegaard did not say the number of studies that will be halted, but said it would be every one with a similar consent policy, called a "waiver of consent," unless stopping the study would put patients at risk.

After County Commissioner Peter McLaughlin and state Sen. Jeff Hayden, DFL-Minneapolis, released a statement denouncing the study as "unconscionable and unethical," the hospital announced Monday it would suspend the ketamine study.

Hennepin Healthcare's decision to halt clinical studies is the latest response to concern and outrage over the findings of a city of Minneapolis draft report into the use of ketamine during EMS calls. The city of Minneapolis has hired former Acting U.S. Attorney General Sally Yates to investigate whether its police officers improperly influenced paramedics' decision to use the drug.

Heegaard's appearance before commissioners comes two days after a Star Tribune story describing how the draft report questioned whether the hospital's study played a role in some people being injected with ketamine.

On Tuesday, Heegaard said Hennepin Healthcare has requested that a state regulatory board conduct a review of cases of ketamine use described in the draft report. It will also consult with a national expert on the hospital's research protocols and look to practices from other health care systems.

Heegaard acknowledged the conversations between police and paramedics detailed in the police oversight report "could be interpreted in many ways, some of them negative," but warned against rushing to judgment before all the facts are in.

Heegaard said the use of sedatives overall has declined in recent years among Hennepin Healthcare paramedics, but ketamine has been used more frequently. He attributed this to a rise in encounters with people experiencing "profound agitation," a condition he said can be fatal without medical intervention.

Heegaard emphasized several times that paramedics did not use ketamine more frequently to serve the study. "We only use it in life-threatening situations," he said.

McLaughlin pressed Heegaard on what changes the hospital would make to its practices in order to win back public trust. McLaughlin made several references to the Tuskegee experiment, in which doctors studied untreated syphilis in black men without their consent, from 1932 to 1972.

"There is a high level of sensitivity, and rightly so, in the African-American community," said McLaughlin.

Heegaard said the first step will be to examine if there is a better research procedure the hospital could implement. He said the hospital will also look at ways to better engage with community, including people of color, about their research.

"We are trying to improve the care," he said. "We're working hard to try to do things better, to save people's lives, to reduce all these bad things that are happening. But I would agree, I think we could do a better job at being transparent and getting feedback."

As Heegaard left the meeting, he was swarmed by news cameras and several activists filming with their phones and yelling at him on the way to the elevator.

"I find that morally wrong for you to administer drugs to patients without their consent," one woman shouted. "How do you sleep at night?"

Andy Mannix • 612-673-4036