The maker of the synthetic blood substitute Polyheme says it did nothing wrong in a clinical trial involving tests of the product at emergency rooms across the nation. Northfield Laboratories is defending itself after a Wall Street Journal article reported that the company "quietly shut down' an earlier clinical trial when 10 of 80 patients suffered heart attacks. Company documents viewed by the newspaper reveal that researchers wrote the results off to inexperience on the part of the physicians administering the substitute.
Polyheme, which is Northfield's sole product, has been promoted as a potentially revolutionary advance in trauma care that would allow ambulance crews and emergency departments teams to save hundreds of lives a year. Facilities participating in the current trial include UC San Diego Medical Center, Scripps Mercy in San Diego, Loyola University Medical Center, Duke University Medical Center, the Mayo Clinic and Memorial Hermann in Houston.
- see the report in the Chicago Tribune