WASHINGTON - December 15 - The Food and Drug Administration (FDA) should not approve a proposed experiment to be conducted by the U.S. Navy in which unconscious trauma victims would be given a potentially dangerous blood substitute, Public Citizen said today.
In testimony delivered to the FDA Blood Products Advisory Committee, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, warned that data show patients given HBOC-201, also known as Hemopure, a blood substitute manufactured by Biopure Corp., are at increased risk for cardiovascular events such as congestive heart failure and death than patients given blood.
The FDA’s own data show increased adverse events experienced by patients during earlier, now-abandoned attempts to approve HBOC-201 for elective surgery. In people younger than 70 who received either human blood or standard intravenous solutions, there were three deaths, 16 serious cardiovascular events and 28 serious adverse events out of 422 patients randomized to get these therapies. By contrast, in the groups randomized to receive HBOC-201, there were nine deaths, a total of 41 serious cardiovascular events and a total of 76 serious adverse events out of 476 patients.
“The absence of informed consent in light of the above would be unconscionable, but even with informed consent, this trial is unethical,” Wolfe said.
The advisory committee meeting to consider the blood product was originally scheduled for July, and the FDA announced it would be closed to the public. Public Citizen sued, saying that closing the meeting violated federal law. In response, the FDA cancelled the meeting. Today’s meeting was open to the public.
Biopure is seeking FDA approval for the U.S. Navy to conduct a clinic trial using the blood substitute.
Public Citizen’s testimony is available here.