- The Washington Times - Thursday, December 14, 2006


A blood substitute the military wants to test on civilian trauma victims is urgently needed to save lives on the battlefield in places such as Iraq, a Navy official told federal advisers yesterday.

The Navy wants 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.

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 for the saline fluids typically given in ambulances when donated blood is unavailable for transfusion.

In Iraq, 68 percent of the U.S. troops who die of trauma before reaching a hospital experience severe bleeding as part of their injuries, the Navy’s deputy surgeon general, Rear Adm. John Mateczun, told a panel of federal health advisers. An available blood substitute could save many of those lives, he said.

“We urgently need an oxygen-carrying capability that does not require refrigeration, is universally compatible and can be readily administered in a field setting,” Adm. Mateczun said in remarks to a Food and Drug Administration (FDA) panel convened to consider whether the agency should lift a hold on the experiment. The FDA isn’t required to follow the recommendations of its advisory committees but usually does.

Three times since June 2005, the FDA has blocked Hemopure trials from starting. Each time, it has cited safety concerns. Hemopure’s manufacturer, Biopure Corp., based in Cambridge, Mass., says the product’s benefits outweigh its risks. The Navy agrees.

The Naval Medical Research Center, which is overseeing the government-funded study, has since revised its design for the experiment. It now says the product won’t be given to patients 70 or older, and it is limiting the amount of Hemopure that would be given to trauma victims. Many of them are expected to be young men under the influence of alcohol. The battlefield is too uncontrolled to do the research, an FDA spokeswoman said.

The proposed changes have moved the FDA closer to giving its go-ahead to the experiment, which is required for the product to eventually win approval, according to agency review documents. Still, the proposed experiment came under sharp questioning yesterday by agency staffers, who said it was hard to determine whether the trial’s benefits outweighed its risks, the agency spokeswoman said.

One critic said the proposed trial is unethical and the FDA’s previous reasons for blocking the trial remain valid.

“Human subjects would be exposed to an unreasonable and significant risk,” said Dr. Sidney Wolfe of the watchdog group Public Citizen. Yesterday’s meeting originally was to have been held in secret in July, but the FDA postponed it at the last minute after Public Citizen sued.

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