New Study Blasts FDA for Allowing Human Testing of Risky Artificial Blood

April 28, 2008— -- A new report criticizes the Food and Drug Administration (FDA) for allowing experimental blood substitutes to be tested in humans despite knowing the products significantly increased the risks of heart attacks and death.

The FDA was aware of the increased health risks as early as 2000 but did not make the data available to the public, according the study.

The study, published online today by the Journal of the American Medical Association (JAMA), reviewed clinical trial data of five different artificial blood products. Researchers found that overall patients given blood substitutes faced a 30 percent greater risk of death and a 171 percent increased risk of heart attack compared to those who received conventional treatment.

The authors, from the National Institutes of Health and the consumer group Public Citizen, criticized the FDA for not putting a stop to further experiments.

"Had the agency placed a moratorium on trials at that point, product-related deaths and (heart attacks) in subsequent trials mostly likely would have been prevented," the authors wrote.

The FDA contends that rules meant to protect company trade secrets prevented it from releasing the data to the public.

One of the blood substitutes reviewed was Polyheme, which was the subject of a highly controversial clinical trial. As reported by ABC News, the experimental product was given to seriously injured accident victims in 27 cities across the U.S. without their knowledge or consent. To the alarm of medical ethicists, patients given Polyheme were denied real blood even after it became available at the emergency room.

Results from the trial released last year showed patients given Polyheme had higher rates of mortality and side effects compared to control patients who received standard treatment. According to Northfield Labs, the maker of Polyheme, 11.1 percent of patients given Polyheme died, compared to 9.1 percent of control patients. Forty percent of Polyheme patients suffered serious adverse effects, versus 35 percent in the control group.