Healthy Skepticism Library item: 7043

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Blood Substitute Is Needed On Battlefield, Navy Official Says
The Wall Street Journal 2006 Dec 14

Abstract:

A blood substitute the U.S. military wants to test on civilian trauma victims is urgently needed to save lives on the battlefield in places like Iraq, a U.S. Navy official told federal advisers Thursday.
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 in advance.
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% of the U.S. troops who die of trauma before reaching a hospital suffer 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 added.
“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 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., contends its benefits outweigh its risks, as does the Navy.
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 chaotic 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 Thursday by agency staff, 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 Sidney Wolfe of the watchdog group Public Citizen. Thursday’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.
Researchers say blood substitutes can both counter a dangerous drop in blood pressure in bleeding victims and carry oxygen from the lungs to the body. Saline fluids can do the former but not the latter. While blood can do both, it has its own limitations. Unlike blood, blood substitutes theoretically could be stored for years and then used without concern for infection or blood type.
The development and testing of experimental blood substitutes has been fraught with controversy: Baxter International Inc. stopped research on one such product in 1998 when more than 20 patients given the substitute died.
A second company, Northfield Laboratories Inc., began clinical trials in 2004 of another product, called Polyheme, giving it to trauma patients without their consent on the way to — and later, at — the hospital. Hemopure would be given only en route to the hospital.