Indy hospitals tested blood substitute
You’re in a car crash, unconscious and bleeding profusely. Without your consent, you are injected with an experimental blood substitute. That’s what happened to dozens of trauma patients across the country in the past two years, most without advance knowledge that they were becoming part of a clinical trial. At least 47 of them died.At least 32 hospitals across the United States, including Wishard Memorial and Methodist hospitals in Indianapolis, were involved in the study of the blood substitute, Polyheme, to determine whether it would save more lives among victims of car crashes, shootings and other trauma.
There were 47 deaths nationwide among the 350 subjects who received Polyheme in the clinical trial, Northfield Laboratories, the company that makes the product, reported Wednesday. Thirty-five of the 363 patients given the standard treatment — real blood — died.
The company’s stock fell 55 percent to $1.90 per share after it reported the results.
Wishard, Methodist and Northfield would not release results from individual hospitals.
“We did have a positive experience here,” said Rick Lowry, one of the study coordinators for the project and trauma program manager for Clarian Health Partners, which operates Methodist. “Our patients all did well. We had very low mortality rates.”
In most clinical studies, patients must volunteer and sign elaborate, detailed consent forms in advance of the treatment to prove they know what they’re getting into.
Northfield said it had no other way to test the product. Trauma patients are generally unconscious and cannot give consent.
The Polyheme trial was one of 15 no-consent studies the FDA has permitted since 1996, when it began allowing researchers to enroll patients in clinical trials without their permission if the treatment showed enough potential to save lives.
The bioethics standard for participation in a trial is informed consent.
“Emergency research flies in the face of that,” said Eric Meslin, director of the Indiana University Center for Bioethics. “The justification for carrying out emergency research, like all research, is to find out the best way of treating patients in an emergency.”
The Polyheme trial has prompted debate among bioethicists for more than three years.
“This is completely unethical,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “They withheld blood — the gold standard — for a product that has proven in previous clinical circumstances to raise the death rate.”
Meslin said the Polyheme trial already has proved to be a case study in medical research and informed consent. His center has devoted a section of its Web site to a summary and timeline of the events surrounding the trial.
