By David Gutierrez | The FDA allowed tests to proceed on new varieties of artificial blood even though it should have been aware that the products drastically increased patients’ risk of heart attacks and death, according to a review conducted by the National Institutes of Health and Public Citizen, and published in the Journal of the American Medical Association.
“It’s hard to understand,” lead researcher Charles Natanson said. “They already had data that these products could cause heart attacks and evidence that they could kill.”
At question are new kinds of artificial blood that do not require refrigeration. No such products are approved for use in the United States, although at least one variety has been approved in South Africa.
Using FDA data acquired as part of a Public Citizen lawsuit, the researchers conducted a meta-analysis of 16 studies involving a total of 3,711 patients and five kinds of artificial blood. They found that the blood substitutes raised patients’ risk of death by 30 percent. While the FDA should have known of this risk as early as 2000, it has approved five studies since then and is considering another. In one of those trials alone, 11 of the 714 patients receiving the experimental blood substitute had heart attacks, and 47 died.
“It didn’t matter what type of patient you studied,” Natanson said. “There was no one product that was responsible for this. It was similar regardless of the patient population studied, the company that manufactured the product, whether the study was published or unpublished, or the chemical characteristics of the individual products. The effect was robust.”
But the FDA did not reveal this risk to doctors and hospitals that were considering participation in future studies, the researchers found.
“The risk appears to be a class risk. It appears to be present for all products,” said William D. Hoffman, former chief medical officer for Biopure, one of the makers of the new artificial blood. “They should all be on hold until they figure out what is causing the toxicity.”
Sources for this story include: www.washingtonpost.com.