The controversy over Biopure's attempt to gain approval for a non-consent trial of its blood substitute Hemopure took another twist yesterday when the FDA canceled a closed-door hearing on the treatment. The move to cancel today's closed-door hearing came soon after Public Citizen filed suit against the FDA's decision to bar the public from the proceeding. A spokesperson for the agency said that they were planning to schedule a public hearing on Hemopure.
The Navy has been anxious to push ahead with a non-consent trial to see how Hemopure works in trauma situations. Another blood substitute program mounted by Northfield Laboratories has also been hammered by critics who claim that patients taking part in studies of Polyheme were never warned of earlier safety issues linked to the treatment. Anyone who delivers an approved blood substitute would have a number of eager clients to work with. Blood donations have a short shelf life and can be hard to obtain for a number of blood types.
- here's the Seattle Post-Intelligencer article