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By Andy Mannix
Star Tribune
MINNEAPOLIS – Hennepin Healthcare announced Monday that it would terminate a clinical trial on ketamine following criticism of patient registration at the hospital prior to obtaining their consent.
The use of sedative, administered to patients agitated by paramedics during emergency calls, is already the subject of external reviews commissioned by the hospital and the city of Minneapolis.
"Hennepin Healthcare will never conduct research without the proper consent of patients," hospital spokeswoman Christine Hill said in a statement Monday night.
"However, because of the concerns expressed, we decided to suspend the study and committed ourselves to a much higher level of transparency and community dialogue, well beyond federal regulation.
Earlier Monday, state Sen. Jeff Hayden and Hennepin County Commissioner, Peter McLaughlin, called the county hospital's clinical trial "unconstitutional and contrary to the law." ;ethics".
"While we understand that Hennepin Healthcare has followed federal research procedures, we believe that an urban hospital that treats a large number of low-income people of color and Minnesota must take extra precautions," Hayden said. , DFL-Minneapolis, and McLaughlin.
"Anything less is neglecting the history of abuse for these communities as test subjects for new drugs and medical procedures, which is unacceptable, we can – and must – do better."
The Hennepin County Council asked Hennepin Healthcare to appear at a meeting on Tuesday and provide a report on the study. The developments took place Monday after a Star Tribune article on the hospital's research on ketamine.
The story quoted from an interim police surveillance report, obtained by the Star Tribune, which questioned the role of ketamine in certain emergency situations. In one case, an ambulance attendant administered a ketamine injection to a woman who had asked for a pump for asthma after being macerated by a police officer, according to the report.
"It is disturbing that the dictate of" study "mentioned by paramedics seems to have played an important role in the decision to administer ketamine," the report authors wrote.
In an interview last week, hospital doctors defended the drug as an essential tool for treating agitated patients and said their consent procedures are legal and ethical.
"Whenever we interact with EMS about it, we stress to them, limpid: Under no circumstances will the study ever 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 opportunity to request that their information be removed retroactively.
Hayden and McLaughlin also responded to allegations in the police surveillance project that officers appeared to cross a line by asking paramedics to inject ketamine to patients. On Friday, these charges prompted Mayor Jacob Frey to hire former Acting Attorney General Sally Yates to conduct an independent investigation into police actions.
"Ketamine is a serious drug, with side effects from amnesia to hallucinations," said Hayden and McLaughlin. "Health care decisions, including medications to be taken or to participate in research studies, should be made between a patient and his or her health care provider – not at the request of the police.
Copyright 2018 Star Tribune
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