Blood substitute too risky to test - More Health News - MSNBC.com

Blood substitute too risky to test, panel says
But Navy says product is urgently needed for soldiers on the battlefield

Updated: 9:10 p.m. ET Dec 14, 2006
WASHINGTON - A Navy plan to test a blood substitute on civilian trauma victims should remain on hold, federal health advisers recommended Thursday, saying the experiment’s risks outweigh its benefits.

The nonbinding vote appears to be the latest blow to the Navy, which has repeatedly sought Food and Drug Administration approval to test the product, derived from cow blood, on roughly 1,100 trauma victims in emergency situations. It proposes doing so without obtaining the customary informed consent of patients.

Dr. Jay Epstein, director of FDA’s office of blood research and review, told panelists that trials done without consent must clear a higher hurdle. The trials can’t just minimize the harm that might befall participants but should promise them some benefit as well, he said.