Public Citizen, a nonprofit consumer advocacy group founded by the political activist and former third-party presidential candidate Ralph Nader, is calling for a national heart attack study backed by the National Institutes of Health to be halted due to ethical concerns.
In a letter sent Monday to HHS' Office for Human Research Protections and the Veterans Health Administration's Office of Research Oversight, the consumer advocacy group said the study does not provide adequate protections to enrollees and fails to satisfy basic ethical principles.
Here are four things to know.
1. The Myocardial Ischemia and Transfusion (MINT) trial plans to enroll 3,500 across more than 50 sites nationwide — including several VA hospitals — to determine when providers should administer blood transfusions to heart attack patients with low red blood cell counts. For the trial, some patients will receive transfusions sooner at higher red blood cell levels and others will receive transfusions later when their red blood cell count reaches a lower level.
2. A previous pilot study involving 55 patients found those administered transfusions later were more likely to experience congestive heart failure or another heart attack within 30 days. These patients were also more likely to die within six months than their study counterparts who were administered transfusions sooner, according to The Kansas City Star.
3. Lead of the pilot study and MINT trial Jeffrey Carson, MD, a professor at the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J., said the pilot study was too small to be conclusive.
"The health and safety of our participants is our top concern," Dr. Carson told The Kansas City Star via email. "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."
4. In the letter, Public Citizen argued the later transfusion strategy may put the health of participants at an unacceptable risk and the sample consent forms do not adequately describe the purposes of the research, among other alleged ethical shortfalls.
"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 Michael Carome, MD, 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."
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