The FDA will proceed with a closed-door hearing about a proposed non-consent trial for a blood substitute even though its developer, Biopure, has said that it has no objections to keeping it open to the public. The Navy wants to gain the agency's approval for the trial, which would test Hemopure among trauma patients unable to consent to their participation. Military officials evidently had not been able to agree on terms to make the hearing public, although some involved noted that the FDA also appeared reluctant to open up the hearing to reporters. The decision immediately sparked fresh controversy among critics.
- for more on the hearing, read this Wall Street Journal report (sub. req.)
PLUS: Biopure is seeking UK approval for Hemopure. Report