The long, troubled push to develop artificial blood suffered another blow as a company that has led the charge announced it was shutting down. Northfield Laboratories in Evanston, Illinois, said on Friday that it has "terminated the employment" of virtually everyone working there, after the U.S. Food and Drug Administration (FDA) refused to allow its product on the market. A receptionist still taking calls said the company couldn't answer any questions.
Northfield Labs has been in business since 1985 and working to develop its blood substitute PolyHeme. Like the handful of other artificial blood products in development (and the only one on the market, Hemopure, available in South Africa), PolyHeme has its benefits: It has a much longer shelf life than real blood (at least a year versus just over a month), it can't transmit disease, and, in theory, there's an unlimited supply.
But the effort to develop fake blood has been riddled with roadblocks and questions.
Most importantly, is artificial blood safe, and does it work as well as real blood? On 30 April, FDA said no, turning down the company's application to get PolyHeme on the market. The agency's concerns mirror those described last year in a meta-analysis of blood substitute trials. In it, critical care specialist Charles Natanson of the Clinical Center at the U.S. National Institutes of Health in Bethesda, Maryland, argued that blood substitutes, no matter how they're designed, raise the risk of death by almost 30% and nearly triple the rate of heart attacks in the people who receive them in clinical trials, mainly surgery and trauma patients.
Northfield and Biopure in Cambridge, Massachusetts—the company that makes Hemopure, the other blood substitute that's in large clinical trials—vigorously attacked Natanson's article, saying its scientific design was flawed and its conclusions unreliable . But faced with FDA's decision, Northfield, it seems, realized quickly that without its flagship product, it would have to close its doors.
It's unclear what this latest twist means for Biopure, Northfield's biggest competitor. The company has clinical trials running in Europe and South Africa but has been struggling, too, financially and otherwise. In January, it reported that it was running out of money and needed a cash infusion to keep going; in December, Biopure said that FDA refused to allow a trial at the U.S. Naval Medical Research Center to go forward, in part because of safety concerns.