More studies on Hennepin Healthcare to suspend in the sedation debate



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One day after suspending her study of the use of ketamine on people agitated by paramedics, Hennepin Healthcare said it would halt similar clinical trials that require patient consent only after treatment.

Dr. William Heegaard, Chief Medical Officer of the Hospital System, appeared before the Hennepin County Council Tuesday to address ethical concerns regarding a study on ketamine in which patients are enrolled without their consent.

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

"The community is suffering, I see it," Heegaard said. "We do not want to add to pain and mistrust … we can do more."

Mr. Heegaard did not specify the number of studies that will be interrupted, but he asserted that all people with a similar consent policy, called "waiver of consent," would not put patients at risk. they put an end to the study.

After the county commissioner, Peter McLaughlin, and state senator Jeff Hayden issued a statement denouncing the study as "inconceivable and immoral", the hospital announced Monday night the suspension of the Study on ketamine.

Hennepin Healthcare's decision to discontinue clinical studies is the latest response to the concern and indignation sparked by the findings of a Minneapolis City report draft on the ## 147 ## ###################################################################################### Use of ketamine during EMS calls. The city of Minneapolis hired former US Attorney General Sally Yates to determine whether its police officers had unduly influenced the decision of paramedics to use the drug.

The appearance of Heegaard in front of the commissioners comes two days after a Star Tribune story describing how the preliminary report asked if the hospital study played a role in some people who were given a ketamine injection .

On Tuesday, Heegaard said Hennepin Healthcare had asked a state regulatory agency to conduct a review of the use cases of ketamine described in the draft report. He will also consult with a national expert on hospital research protocols and will look at the practices of other health care systems.

Heegaard acknowledged that police-paramedic conversations detailed in the police surveillance report "could be interpreted in many ways, some of which are negative," but cautioned against rushed judgment before all the facts were known.

Heegaard said that 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 an increase in encounters with people experiencing "deep agitation," a condition that he says can be fatal without medical intervention.

Heegaard repeatedly pointed out that paramedics do not use ketamine more frequently to serve the study. "We only use it in life-threatening situations," he said.

McLaughlin pressed Heegaard about the changes the hospital would make to his practices in order to regain public confidence. 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," McLaughlin said.

Heegaard said the first step will be to consider whether there is a better search procedure that the hospital could implement. He added that the hospital would also look for ways to better communicate with the community, including people of color, about their research.

"We are trying to improve care," he said. "We are working hard to try to do things better, to save people's lives, to reduce all these bad things, but I agree, I think we could do a better job of being transparent and getting more comments. "

While Heegaard was leaving the meeting, he was invaded by cameras and several activists filming with their phones and screaming at him on the way to the elevator.

"I find it morally unacceptable for you to administer medication to patients without their consent," a woman shouted. "How do you sleep at night?"

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