A consumer advocacy group is calling for immediate suspension of a clinical trial involving heart attack patients. Geisinger Medical Center is among 67 medical institutions across the United States and Canada listed as taking part in the study.
Public Citizen said the new clinical trial “should be halted because it fails to adequately protect human subjects and doesn’t satisfy basic ethical requirements.”
The nonprofit consumer advocacy organization based in Washington, D.C., detailed its concerns in a letter it sent Tuesday to the U.S. Department of Health and Human Services’ Office for Human Research Protections and the U.S. Department of Veterans Affairs’ Office of Research Oversight. Four VA hospitals are involved in the study, but none are in Pennsylvania. Other Pennsylvania medical institutions in the trial are in Philadelphia and Pittsburgh.
The trial is funded by the National Institutes of Health, which is part of Health and Human Services.
The Myocardial Ischemia and Transfusion Trial, or MINT, is enrolling 3,500 hospitalized adult patients who have had heart attacks and anemia, said Dr. Michael A. Carome, director of Public Citizen’s Health Research Group. Some patients will receive a transfusion sooner at a higher red blood cell, or RBC, level, under a “liberal” treatment strategy, and others, under a “restrictive” strategy, will be transfused when they hit a significantly lower red blood cell level.
“The trial’s purpose is to determine whether patients who have been hospitalized for a heart attack are at greater risk of dying or suffering another acute heart attack in the short term if they are managed with a restrictive RBC transfusion strategy instead of a liberal RBC transfusion strategy,” the group stated. “Importantly, results from prior trials already strongly suggest that in patients with heart disease, a restrictive transfusion strategy is more likely to lead to further heart attacks and death than a liberal strategy.
“The study is riddled with flaws, and the consent form fails to warn patients of the true risks of participating in the trial.”
Repeated attempts to obtain a comment from Geisinger officials were unsuccessful on Monday and Tuesday.
Carome said in a telephone interview the institutions recently began enrolling patients.
“It involves randomly assigning patients who come into the hospital,” he said. “If they’re coming in with a heart attack or hospitalized for something else and develop a heart attack, these patients also have low red blood cell count, or anemia.”
He said the study randomly assigns the patients to be transfused under the liberal or restrictive strategy.
“There is a consent process with a consent form we have obtained under the Freedom of Information Act,” Carome said.
According to the consent form, which Carome obtained from the trial’s lead institution, Rutgers-Robert Wood Johnson Medical School, New Brunswick, N.J., “There is no local standard of care for when to give the blood, and doctors use different red blood cell counts to guide their decision. … The purpose of this study is to determine at what blood count patients should be given a transfusion.”
But, Carome said, “We are concerned the trial involves inadequate protection for patients.”
He said those concerns are driven by two key factors.
“Our number one concern is that in the consent form, it does not adequately describe the risk of the research and what we already know of the risk of transfusion,” he said.
“It’s not definitive evidence, but it strongly suggests a risk of death,” Carome said.
He said that in a previous similar study of 110 patients, divided between treatment under restrictive and liberal strategies, seven, or 13 percent, of those treated under the restrictive strategy died within 30 days, compared to one patient, or 2 percent, treated under the liberal strategy.
The group’s second major concern is researchers did not adequately state what’s usually done in terms of transfusions, he said.
Carome said the group wants the clinical trial suspended until researchers could adequately study what the usual care is so they could understand the risk better.
Public Citizen also said it wants the agencies to require the researchers to revise the protocol to describe all prior evidence from randomized clinical trials that compared liberal and restrictive blood transfusion strategies, and how the MINT trial will affect the care of the patients at the institutions that are to enroll subjects.
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