"Synthetic Blood Clotter for Hemophilia Licensed"

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

"Synthetic Blood Clotter for Hemophilia Licensed"

Washington Post (Health) (12/22/92), P. 5
Herman, Robin

Abstract: A genetically-engineered substitute for the human blood-clotting protein called factor 8 has been licensed by the Food and Drug Administration for the treatment of people with hemophilia. Last week, Baxter Healthcare Corp. began shipping Recombinate to distributors for control of excessive bleeding by people with hemophilia A, which only occurs in males. People with hemophilia currently receive injections of natural factor 8, extracted from the pooled blood of thousands of blood donors. This practice resulted in the transmission of HIV to least 80 percent of people with severe hemophilia in the early 1980s, and hepatitis to more than 90 percent. The laboratory-produced form of factor 8 does not carry human viruses. However, its introduction will not have the effect it might have had years ago, before donated factor 8 was made safer by more sensitive blood-screening tests for HIV and hepatitis, and new purification and viral inactivation techniques. Nevertheless, the National Hemophilia Foundation and others back the product because of its guaranteed safety, which might make people more willing to use it not just to stop bleeding but also as a preventive measure. FDA Commissioner David A. Kessler, said, "The production of factor 8 by recombinant DNA technology eliminates even the theoretical possibility of the transmission of viruses from plasma." Yet Alan Brownstein, executive director of the hemophilia foundation, is worried about the exorbitant price of the substitute. A person with severe hemophilia would have to pay more than $82,000 a year for the new product, based on pricing figures provided by Baxter, he said.

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