FDA reconsiders non-consent trial of Hemopure

The FDA plans a closed-door hearing next week to determine if it will allow a non-consent study for the blood substitute Hemopure. The Navy has repeatedly asked for permission to launch a study that would give Biopure's fake blood to trauma patients who were unable to approve the switch. The agency has turned down other requests but is now reconsidering its decision.

Non-consent studies are occasionally approved if the FDA is satisfied that there is no practical way to gain a patient's approval while testing a therapy. And the military has taken an avid interest in a new blood substitute for use in war. Artificial blood offers a substitute that would not require matching blood types and would be far easier to stockpile. Northfield Laboratories' research of PolyHeme has been the subject of considerable controversy centered on heart attacks that afflicted several patients in an early trial. Congress has been investigating whether Northfield properly disclosed safety concerns while advancing the blood substitute.

- here's the article on Hemopure from The Wall Street Journal (sub. req.)