Public Citizen, a consumer advocacy nonprofit founded by former third-party presidential candidate Ralph Nader, is calling for a halt to a national heart attack study that St. Luke’s Hospital is participating in.
The group says the study is unethical because it puts one group of patients at greater risk without fully informing them of it.
“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,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group.
The trial in question is called Myocardial Ischemia and Transfusion, or MINT. It seeks to determine when a blood transfusion should be given to heart attack patients with low red blood cell counts by studying 3,500 patients at more than 50 sites nationwide.
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A previous pilot study found that patients treated with a “restrictive transfusion strategy” were slightly more likely to suffer congestive heart failure or another heart attack within 30 days and slightly more likely to die within six months than patients treated with a “liberal transfusion strategy.”
But the pilot study only enrolled 55 patients in each group and Dr. Jeffrey Carson, the Rutgers Robert Wood Johnson Medical School professor who led it, said it was too small to be conclusive.
Carson said that’s why the National Institutes of Health is funding the current “high-quality, large trial,” which he is also leading.
“The health and safety of our participants is our top concern,” Carson said 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.”
Dr. Adam Salisbury, the cardiologist leading the study at St. Luke’s, said he echoed everything Carson said, and added that previous studies he reviewed in other patient populations showed a restrictive transfusion strategy working as well or better than a liberal one.
“Do we know that one of these approaches is the right approach?” Salisbury said. “If we knew that already we certainly wouldn’t participate in the trial, and in this case I don’t think we do know that.”
Salisbury said the MINT study is the first large-scale, randomized trial of its kind and will provide valuable insights into what the ideal threshold is to deliver a blood transfusion to heart attack patients.
Salisbury said there’s probably not a medical industry sponsor that would be interested in continuing MINT if NIH pulls the federal funding.
“I think it would be quite difficult to carry a trial like this on (without federal funding),” Salisbury said.
A spreadsheet from Public Citizen said that North Kansas City Hospital was also part of the trial, with Dr. Zafir Hawa as lead investigator. But a spokeswoman for the hospital said that was not accurate.
“There was an opportunity to do so, but no, he’s not participating in the study,” KC Hall said.
Carome said the list of 67 participating hospitals was compiled based on letters of support for the study from the hospitals that Carson sent to NIH, and provided a letter signed by Hawa.
“It certainly is possible that some institutions decided not to proceed with the study,” Carome said.