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Unethical NIH-Sponsored Clinical Trial – Involving Heart Attack Patients Throughout the U.S. and Canada – Must Be Halted

August 1, 2017

Unethical NIH-Sponsored Clinical Trial – Involving Heart Attack Patients Throughout the U.S. and Canada – Must Be Halted

Public Citizen Calls on Office for Human Research Protections and Department of Veterans Affairs to Halt Enrollment in MINT Trial

WASHINGTON, D.C. – Public Citizen today called for immediate suspension of a clinical trial that is expected to involve thousands of heart attack patients throughout the U.S. and Canada because of potentially serious ethical violations. Public Citizen’s concerns were detailed in a letter sent today to the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) and the U.S. Department of Veterans Affairs’ (VA) Office of Research Oversight (ORO).

The Myocardial Ischemia and Transfusion (MINT) trial will randomly assign hospital patients suffering acute heart attacks and significant anemia to one of two blood transfusion strategies based upon their red blood cell (RBC) levels. Some will be assigned to a “liberal” strategy in which they are transfused sooner at a higher RBC level, and others will be assigned to a “restrictive” strategy in which they are transfused when they hit a significantly lower RBC level.

Researchers then will measure how many subjects die or have another heart attack within 30 days. Prior studies already strongly suggest that a restrictive transfusion strategy is more likely to lead to further heart attacks and death than a liberal strategy.

The planned number of subjects is 3,500, to be enrolled at several dozen institutions throughout the U.S. and Canada. In March and April 2016, researchers at 67 institutions provided letters of support to the MINT trial’s principal investigator, expressing their commitment to, or interest in, participating in the trial. In some cases, researchers may have withdrawn support, or an institution may not give approval. Public Citizen’s list of institutions that expressed interest includes four VA hospitals.

The study is being funded by the National Institutes for Health, making it subject to the jurisdiction of the OHRP. Any participation by VA medical centers also would make the trial subject to oversight by the VA’s ORO.

Based on a review of the MINT trial’s protocol, sample consent forms and background information, Public Citizen is concerned that the trial lacks adequate protections for its human subjects and violates basic ethical principles:

• The restrictive transfusion strategy may be putting the subjects’ health and lives at unacceptable risk;
• The trial protocol fails to provide key information — including a description of current usual care blood transfusion practices for patients with heart attacks who are hospitalized at the institutions that are to enroll subjects — that an Institutional Review Board (IRB) would need to determine whether the study meets approval criteria; and
• The sample consent form fails to adequately describe the purpose of the research, the risks of the trial and whether the transfusion strategies being tested are experimental.

“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 Dr. Michael Carome, director of Public Citizen’s Health Research Group. “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.”

Public Citizen is calling on OHRP and ORO to suspend enrollment in the trial immediately, and require the researchers to conduct detailed surveys and/or studies of current blood transfusion practices for heart attack patients hospitalized at the participating institutions.

The agencies also should 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, Public Citizen said.

The researchers also must revise the consent forms and submit them, along with the revised protocol, to the OHRP, ORO and the IRBs responsible for reviewing the trial, Public Citizen said.

View Public Citizen’s letter.