Think we were talking about BPUR last week...
FDA Panel Votes Against Biopure Study
An FDA advisory panel recommended against a study of Biopure's blood substitute, despite heavy pressure from the Navy.
• Blood Substitute Needed, Navy Says
Opening paragraphs of article...
FDA Panel Votes Against Blood-Substitute Study
Despite Push From Navy,
Test of Biopure's Treatment
Fails to Win Endorsement
By ZACHARY M. SEWARD and THOMAS M. BURTON
December 15, 2006; Page B2
Bucking heavy pressure from the U.S. Navy, a federal advisory panel recommended against carrying out a controversial study of Biopure Corp.'s blood substitute. The treatment carries significant safety risks and often would have been administered to human trauma victims without their consent.
The Food and Drug Administration usually follows advisory panels' advice, but it doesn't have to. The decision on testing Hemopure is vital for its developer, Biopure Corp., of Cambridge, Mass. Hemopure currently is only approved for limited human use in South Africa.
The panel vote was 11 against, eight in favor and one abstention. Biopure's chairman and chief executive, Zafiris G. Zafirelis, declined to comment on the outcome immediately following the meeting. "I need to digest the comments," he said.
Hemopure is controversial because it has been consistently linked to serious complications in earlier studies, documents show. |
