Sunday, June 16, 2019

Is it time to shut down emergency research at Hennepin Healthcare?

It's hard to imagine how HCMC leaders could have made their forced ketamine study worse, but somehow they have managed to do it. A year ago, they calmly assured the public and county officials that, although concern about the study was overblown, they were voluntarily stopping the controversial study.

According to the FDA, they were lying.

Here is how the Star Tribune puts it:

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.

And that's not all. According to the Star Tribune, the FDA found other serious problems:

• 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.

You might understandably wonder why HCMC officials would simply defy the FDA and lie to county officials. To get some sense of what at least one ER physician at HCMC was thinking, check out this presentation by Dr. Nick Simpson in Austin last January, "Political Pitfalls: Enduring a Media Crisis Surrounding Ketamine Sedation and Research." (HT @LeighGTurner)