Friday, October 22, 2021

On the Hennepin Healthcare forced ketamine trials: "They endangered human subjects enrolled in these trials and violated those subjects' rights," said Carome. "Those are just egregious violations — they're the most serious violations I've seen in a warning letter issued to researchers like this."

An alarming update on the forced ketamine studies on non-consenting subjects at Hennepin Healthcare, in  the Star Tribune:

Hennepin Healthcare doctors failed to comply with federal safety laws in experimental drug research on members of the public comparing ketamine and other powerful sedatives, the FDA informed the hospital in two warning letters the agency made public this week.

An FDA investigator who visited the hospital in 2019 discovered "objectionable conditions" on studies led by Dr. Jon Cole and Dr. Lauren Klein, both of whom ignored FDA regulations and used practices that subjected patients to "significantly increased risk," according to the letters. The hospital has since used "factually incorrect" statements to defend its research to the FDA, the letters say.

"It's quite clear that the agency's view is that there were significant violations here," said Patti Zettler, former associate chief counsel for the FDA, who now teaches at the Ohio State University Moritz College of Law. "The facts here are quite troubling."

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