According to MedPage Today, Public Citizen is calling for the immediate suspension of a large National Institutes of Health (NIH) sponsored trial comparing blood transfusion strategies after heart attacks. The consumer advocacy group said that the Myocardial Ischemia and Transfusion (MINT) trial should be halted due to “serious ethical violations.”1
The MINT trial begun in April and was expected to be completed in 2021. Public Citizen claims that the trial is unethical and fails to adequately protect patients enrolled in the trial. They argue that the consent form does not fairly describe the trial. Furthermore, the trial protocol does not supply adequate information that would enable an IRB to assess the trial.
“One of the most troubling ethical lapses in the MINT trial is the failure of the consent form to fully disclose to potential subjects the possible risks of using a restrictive blood transfusion strategy,” said the director of Public Citizen’s health group, Michael Carome, MD, in a press release. “A reasonable person who is considering enrolling in this trial certainly would want to know about prior research results that strongly suggest that use of a restrictive strategy in heart attack patients increases the chances of dying or having another heart attack, and yet the consent form makes no mention of these risks.”
MINT principal investigator Jeffrey Carson provided the following statement:
“The Myocardial Ischemia and Transfusion Trial seeks to answer an important question about the optimal amount of blood transfusion that we give to patients with low red blood cell counts who have had a heart attack. Previous small trials do not provide adequate data for accurate predictions, which is why the NIH funded this high-quality large trial. The health and safety of our participants is our top concern. Our protocols and processes have been reviewed by more than 35 institutional review boards across the country, as well as the Data Safety Monitoring Board, which is an independent organization comprised of physicians and ethicists. Each board, independently, has approved it.”1
Carson was also apart of the 2013 pilot trial with 110 patients which suggested that more restrictive transfusion might be beneficial. Bob Harrington from Stanford is not involved in the trial but says that he has “been interested in the topic for many years.”1 Harrington noted that the wide variation in clinical practice for this area makes it very hard to find a clear answer. He clarified saying, “the possible benefit of the restrictive strategy is a hypothesis and the reason that we do randomized controlled trials. Certainly, a careful interim monitoring plan is important and I assume that the NHLBI, as the sponsor, has established one, as they typically do.”1
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1 https://www.medpagetoday.com/cardiology/cardiobrief/67098