An FDA panel comprised of independent experts has voted 11 to 8 against allowing the U.S. Navy to test emergency transfusions of an experimental blood substitute on civilian trauma patients because most of those patients would be unable to give consent. The panel concluded that the Navy lacked sufficient evidence to support its proposal to test Biopure Corp.'s Hemopure, which is made from cow blood.
"I do think there is a potential benefit. We just don't have the data," said panelist Dr. Thomas Quinn of Johns Hopkins University in Baltimore, according to a Yahoo News report.
The FDA is not bound by the vote but usually follows the recommendations of its advisory panels.
Navy officials stated that the product could save lives in combat zones when victims cannot quickly reach a hospital. Hemopure, also known as HBOC-201, can help deliver oxygen to vital organs until real blood is available. It can be stored for long periods without refrigeration.
"This is especially important in close-quarter urban combat and in other special situations where evacuation may be dangerous or delayed or both," said Navy Deputy Surgeon General Dr. John Mateczun.