Hennepin County Commissioner Mike Opat voiced frustration Tuesday with Hennepin Healthcare’s top leadership for a lack of transparency about their handling of the hospital’s now-halted ketamine research.
At a County Board meeting, Opat said he found out that inspectors for the Food and Drug Administration had visited the hospital eight times in August when a county lawyer notified him the Star Tribune was preparing to publish a story about the reports this week.
“So where exactly is the transparency?” Opat said. “Where is it, for this public hospital that we own?”
On Monday, the Star Tribune reported on the FDA inspections of the board in charge of protecting human subjects for Hennepin Healthcare research. Those inspectors determined the Institutional Review Board expedited approval for sedative studies on vulnerable patients without following FDA criteria.
Dr. Jon Pryor, Hennepin Healthcare CEO, disagreed with Opat’s criticism in an interview Tuesday. He said the hospital has provided regular updates to county commissioners, especially the two members who also serve on Hennepin Healthcare’s board of directors, Peter McLaughlin and Jan Callison.
“I just don’t understand why he said that,” said Pryor. “I can’t get into his mind.”
Opat acknowledged the hospital followed up with answers to questions raised at the County Board meeting on June 26, when Chief Medical Officer Dr. William Heegaard spoke about the ketamine controversy. The hospital came under criticism from the public and elected officials after revelations that its EMS workers used the powerful sedative during emergency calls in the field and enrolled patients in studies without prior consent.
Heegaard told the commissioners that the ketamine research had been put on hold because of questions about whether patients’ safety had been adequately protected.
Opat said the hospital has not been responsive since that meeting, saying he hasn’t seen or heard from Pryor in months.
“If you’re going to be a transparent organization, then you would have shared the fact that the FDA came to your hospital eight times before I read it in the newspaper,” Opat said.
Pryor emphasized that the FDA inspection reports were not final, and said the hospital has provided detailed responses to the investigators. Pryor declined to share those responses or talk directly about the FDA’s findings.
“I do stand by the fact that we followed our processes to the best of our knowledge or the best of our ability,” Pryor said. “We didn’t flout patient safety rules. We tried to protect our patients who are our community. We care about them.”
He said there is likely room for improvement for any hospital doing the magnitude of research as Hennepin Healthcare. “Are there things that they are going to find? The FDA spent eight days here. ... Of course they’re going to find some things that we did wrong or we could do better,” he said. “And we’re looking forward to getting those down and learning from it. We want them to find things.”
Pryor said he will talk about the FDA’s and several other examinations into the hospital’s research process once they are completed. “We don’t think we’re going to get to the truth if this is played out publicly,” he said.
Pryor said the hospital is taking steps to improve its research process. Leadership has been getting feedback from minority community members and a mental health advocacy group, and the hospital will launch a community advisory board, based on one at the University of Minnesota, that will better communicate to the public about research.