FDA says HCMC doctors kept ketamine study going after pledging to stop, enrolled patients without consent
Medical staff at HCMC continued to sedate people with ketamine and collect data for a study for months after the hospital’s leadership told elected officials they had voluntarily halted the research in response to questions over ethics and patient safety.
New inspection reports from federal regulators also say that doctors involved in the research failed to disclose incidents of patients suffering serious medical complications — such as trouble breathing or high blood pressure — to the committee in charge of keeping study subjects safe.
HCMC officials have already responded to the reports, vigorously rebutting many of the findings.
Two inspectors from the Food and Drug Administration (FDA) visited the Twin Cities hospital 17 times, collectively, in April as part of an investigation into HCMC’s sedative research. The records from those inspections, obtained by the Star Tribune through a public records request, raise a fresh set of questions over the hospital’s research practices.
According to the documents:
• In dozens of cases, researchers failed to inform patients of their enrollment in hospital studies, even after the subjects were sedated.
• Hospital staff did not always properly monitor patients’ vital signs after they’d been sedated.
• In one case, doctors did not report that a patient enrolled in a study died, despite a requirement to do so even if the death “is not thought to be related to the study treatment.”
• The researchers did not obtain permission from the FDA for a drug study deemed “investigational,” and did not appear to meet exemption from this approval.
In a separate visit to the hospital last August, the same inspectors examined records related to HCMC’s Institutional Review Board (IRB), which is charged with approving research and keeping patients safe. Those inspection reports found the IRB appeared to fall short of federal guidelines in several areas, including by enrolling patients without their prior consent.
The inspection reports are not final determinations, and HCMC is aggressively defending its research. In a response to the FDA, the hospital acknowledges some mistakes, such as failing to notify a small number of subjects they’d been enrolled in studies. Leadership has also suspended one doctor from serving in the prestigious role of sole principal investigator for three years, and assigned that doctor a mentor, according to HCMC’s letter to the FDA. The hospital redacted the doctor’s name from the letter, saying releasing the identity could threaten the doctor’s safety.
In interviews and prepared statements, HCMC leadership denies the most damning claims in the reports, arguing that the FDA inspectors fundamentally overstate the added risks the study methods pose….
http://www.startribune.com/fda-hcmc-doctors-kept-ketamine-study-going-after-pledging-to-stop/511269232/
https://www.documentcloud.org/documents/6152335-Redacted-Response-to-FEI-3015212514-R.html#document/p2/a506943
https://www.documentcloud.org/documents/6152332-Redacted-483-FEI-3015213291.html#document/p4/a507033
https://www.forbes.com/sites/judystone/2018/07/26/hennepin-ketamine-study-raises-questions-about-ethics-and-consent/#1be7ec4c5be7
Lots of studies being done with Ketamine. Anon has read articles or seen headlines over the past decade or so mostly in studies/trials/treatment for Major Depressive Disorder. This article barely mentions that the people being involutarily dosed with Ketamine and involutarily "studied" are the most vulnerable and therefore expendable.
Its pretty fucked up that docs can just volunteer a person without consent. Something tells me FF shooters don't volunteer to join the circus. Clowns don't care if you want to go to the circus or not, your ticket (waiver consent) is free of charge (free from choice)
Doctors act like Clowns>>>Lie, Deny, Counter-accuse
i should add
#NotAllClowns
Bill Baer is a former , I read all of his books a few years ago. If you remember, he had been a CNN contributor for a long time. He made a few remarks that fit with CNNs narative early on, but this guy knows "disinformation is real, disionformation is necessary." He had already made himself scarce before CNN went "proud shitholer."
If anybody understands POTUS, FLYNN and others it's Baer. He was arrested and interogated by the FBI during CLinton years for ….fuck it. I will do another post