(KMSP) - A national watchdog group is demanding a federal investigation after allegations that Hennepin Healthcare enrolled patients in clinical trials involving the powerful sedative ketamine, without patient consent.
On Wednesday, a Washington D.C.-based organization filed at 14-page complaint to both the Food and Drug Administration and the Office for Human Research Protections. In the letter, “Public Citizen” asks for an immediate investigation into Hennepin County Medical Center for what they call “high-risk experiments.” Hennepin Healthcare is the umbrella organization that oversees HCMC.
The letter is signed by more than 60 doctors, bioethicists and academics, including several from Minnesota. The organization claims there were "serious regulatory and ethical lapses.”
“I would describe these failures by this institution as colossal. There is no doubt. There is no doubt that when you look at these trials that they were greater than minimal risk experiments involving some of the most vulnerable types of subjects that you could have participate in a trial,” said Dr. Michael Carome, Director of Public Citizen’s Health Research Group.
The group is calling out two clinical trials testing the safety and effectiveness of ketamine compared with other powerful sedatives. The first trial ended in 2016.
The second trial started last year but was suspended this summer after a report indicated that Minneapolis Police Officers were allegedly urging paramedics to administer the drug to sedate patients or criminal suspects before they arrived at the hospital.
“It’s not even a close call. These were serious failures by this institution, and we need regulators like the FDA or Office for Human Research Protections to immediately investigate,” Carome said.
Last month, Hennepin Healthcare's chief medical officer responded to criticism over the trials.
“To the best of our knowledge, no patient receives sedation medication who should not have received sedation medication because of the study,” Hennepin Healthcare Chief Medical Officer Dr. William Heegaard told the system’s board in June.
On Wednesday, the system released the following statement:
“We are aware of the letter requesting additional reviews of our medical studies. We are committed to transparency and retaining the public's trust and independent outside reviews help us to do that. To that end, we are participating in ongoing internal and independent external reviews. These include the Minnesota EMS Regulatory Board review, as well as two independent external reviews that are looking at our research and clinical protocols.
In addition, our IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been since 2011. AAHRPP accreditation verifies that an organization follows rigorous standards for ethics, quality, and protections for human research. Our IRB is currently undergoing the usual reaccreditation review process by AAHRPP and we look forward to the results of the evaluation of our standards by this respected external peer review accreditation agency.
To ensure that the external reviews are completed with integrity and independence, we will provide information requested by reviewers to help them complete their work. At the conclusion of these reviews, we expect that the Institutional Review Board data will be public and we also look forward to sharing conclusions of the independent outside reviews.
Hennepin Healthcare respects the important concerns regarding community awareness of medical studies and is committing to a higher level of transparency that goes beyond federal regulations to ensure greater community engagement in our work to improve patient care.”
Carome believes a federal review must come next.
“The breakdowns in the system for protecting human subjects at Hennepin County Medical Center - as seen in these two trials - were extreme. And it’s likely that they are failing for review and oversight for other research trials,” Carome said.
On Thursday, the Public Safety and Emergency Management Committee of the Minneapolis City Council is expected to review a research study on Minneapolis Police officer involvement in the use of sedatives during arrests.