November 16, 2018 09:52 AM
A consumer group wants the Food and Drug Administration to sanction Hennepin Healthcare.
The group accuses the hospital of approving studies that allowed people to be sedated without their consent.
Specifically, the group Public Citizen criticized Hennepin County Medical Center's review board, the Human Subjects Research Committee, which is in charge of protecting the people who were the subjects of the Ketamine studies. The Human Subjects Research Committee is the Institutional Review Board or IRB for HCMC.
Public Citizen is pointing to a recent FDA investigation into HCMC's Ketamine studies as proof sanctions are warranted and why research at the medical center should be suspended.
The FDA report found, in at least two instances, the review board fast-tracked studies involving Ketamine that weren't eligible to be expedited.
Two University of Minnesota professors joined Public Citizen's calls for the FDA to impose penalties at HCMC and require the medical center to make changes.
"You can't take for granted that [the patients administered Ketamine] lacked the capacity to make informed decisions," said Dr. Leigh Turner, Associate Professor in the Center for Bioethics at the University of Minnesota.
"The community needs to be informed about the study, there needs to be community consultation," added Dr. Turner. "There's a whole series of things that were not taking place here so the initial mistakes are taking place with the research team. Then you have an institutional review board that are supposed to catch mistakes like that."
According to the FDA investigation, not only did the IRB fail to ensure there were safeguards in place to protect multiple patients and subjects, federal investigators found some of HCMC's studies didn't meet the criteria for this research to be fast-tracked.
"It's disturbing and it's something that an IRB should be able to flag quickly that this is research that should not be expedited," said Dr. Turner. "It needs to be assessed in a very careful manner."
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In a statement released to KSTP, Hennepin Healthcare said, in part, "the decision to administer sedatives, as well as the choice of sedatives, at all times was in the sole discretion of EMS professionals and in full accordance with emergency treatment protocols."
"I think this is the kind of double speak that [HCMC] is using," said Dr. Turner. "If you look at the information about these Ketamine studies in the public domain and then you look at the statements Hennepin officials are making, I think these are dishonest inaccurate statements and they need to come clean."
Below is the full statement released to 5 EYEWITNESS NEWS by Hennepin Healthcare:
Hennepin Healthcare emergency medical services (EMS) have a number of FDA-approved sedatives available to them to use in circumstances where patients' high level of agitation make them a risk to themselves or others during the pre-hospital phase of care.
In order to improve patient care, Hennepin Healthcare conducted a study using stopwatches to measure time- to-sedation observations, while recording patient variables such as level of agitation. The decision to administer sedatives, as well as the choice of sedatives, at all times was in the sole discretion of EMS professionals and in full accordance with emergency treatment protocols- i.e. the stopwatch and observations was the research. The observations were recorded for approximately one year prior to a decision by the Hennepin Healthcare study investigator to voluntarily pause the study while reviewing our processes in response to local community inquiries.
In early August, 2018 the FDA conducted an inspection of Hennepin Healthcare's Institutional Review Board's (IRB) processes and procedures, which resulted in four FDA Form 483 observations. These preliminary observations are neither formal nor conclusory, and according to FDA, do "not constitute a final Agency determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its relevant regulations." Hennepin Healthcare has provided formal written responses to each of these observations which we expect will fully address them. We will continue to work with the FDA and understand the importance of protecting the integrity of FDA's review processes.
Hennepin Healthcare has undertaken several reviews by independent experts to evaluate its research and emergency medical practices with the intent to improve our processes. These reviews, as well as theFDA'sassessment are still ongoing. We understand our mission includes providing the highest standards of medical care, and also conducting studies that help to continuously improve the health and wellness of our patients. We will continue to engage with the community to create a better understanding of proposed and approved research activities that benefit all of us.
Updated: November 16, 2018 09:52 AM
Created: October 29, 2018 05:06 PM
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