Posted on 12/22/2006 8:57:45 PM PST by neverdem
Just when Northfield Laboratories Inc. is on the verge of finding out whether its experimental blood substitute works well enough to submit to the Food and Drug Administration for possible approval, the regulatory climate appears to have become much tougher.
Last week Northfield's primary rival in the race to get a blood substitute to market was rebuffed by advisers to the FDA, who decided against endorsing a controversial clinical trial of Biopure Corp.'s Hemopure blood substitute.
The two companies are racing to develop a potentially lucrative product that can save lives in trauma situations by carrying oxygen through the body--an improvement on the saline used during emergencies now. A blood substitute would also be easier to transport, especially to battlefields and accident scenes, and does not require the sometimes complicated matching process real blood does.
The FDA panel's vote came despite pressure from the U.S. Navy, which had agreed to run the test for Biopure, testing it on civilian trauma patients without their consent, a rare and disputed method of testing that has already been conducted by Northfield for its product, Polyheme.
While Northfield's test of Polyheme got a green light by the FDA and was completed earlier this year, there has been an outpouring of criticism of the Evanston biotech company's trial. Critics say the testing was unethical and that not enough people were notified of the test, while others say they believe Northfield's product is dangerous.
Even though Northfield's trial is finished and the company is on the verge of announcing whether it has met its endpoint before submitting the product to the FDA for possible approval, enough negative feedback on blood substitutes could doom Polyheme, industry analysts say. Northfield said it would announce results before the end of this year.
If the FDA does not order more...
(Excerpt) Read more at chicagotribune.com ...
Prions removed from animal blood
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