FDA to Discuss Using Cow-Human Blood Substitute On Trauma Victims Without Their Consent

The Navy's latest proposal to test a blood substitute on 1,100 trauma victims appears more likely to earn a go-ahead from regulators who had blocked the experiment over safety concerns. The Navy wants to test the product, derived from cow blood, on civilian trauma victims in emergency situations. It proposes doing so without obtaining their consent in advance, as is customary in clinical trials. The substitute blood, called Hemopure, would be given on the way to the hospital to patients ages 18 to 69 who have lost dangerous amounts of blood. It would substitute the saline fluids typically given in ambulances when donated blood is unavailable for transfusion. Three times since June 2005, the Food and Drug Administration has blocked Hemopure trials from starting. Each time, it has cited safety concerns. Its manufacturer, Biopure Corp., based in Cambridge, Mass., contends that the benefits of Hemopure outweigh its risks. The Navy, which is overseeing the government-funded study, has since revised its design. It now says the product won't be given to patients 70 or older, and it's limiting the amount of Hemopure that would be given to trauma victims. Those changes may persuade the FDA to allow the experiment to proceed.