South Africa to Use Blood Substitute to Reduce Risk of HIV Transmission Through Tainted Blood
To reduce the risk of HIV transmission through contaminated blood, South Africa will soon begin to use a manufactured blood substitute made from purified cow's blood, the New York Times reports. The substitute, called Hemopure, would be used in general surgical procedures and to treat acute anemia (Feder, New York Times, 4/10). South Africa's Medicines Control Council approved the product yesterday (Nessman, Associated Press, 4/10). Hemopure manufacturer Biopure Corp. plans to offer the product free "in limited quantities" to South African doctors, who will be conducting additional tests to examine the product's benefits (New York Times, 4/10). Like red blood cells, Hemopure carries oxygen to body tissues (Associated Press, 4/10). However, Hemopure and similar blood substitutes are considered "partial and temporary replacements" for human blood because oxygen delivery is the only blood function they can perform. Blood substitutes carry several benefits -- they can be stored at room temperature, can remain potent for years instead of weeks, are "less vulnerable" to contamination than donated blood and can be given to patients without the risk of the sometimes deadly reactions caused by mismatching the blood type of donors and recipients (New York Times, 4/10). However, the product may cause some side effects, including slightly increased risk of stomach pain, weakness, hypertension, jaundice and nausea (Associated Press, 4/10).
Cost and Trade
Carl Rausch, chair and CEO of Biopure, said that his company is not yet sure what it will charge South African doctors for Hemopure. Biopure said it does "not expect significant commercial sales in South Africa until next year," because the company currently only has a limited amount of the product available. Under the current deal, Hemopure will be distributed to doctors in hospitals run by Netcare Healthcare Holdings, one of the joint owners of Tshepo Pharmaceuticals, Hemopure's distributor in South Africa. However, Hemopure's distribution and sales in South Africa are not expected to have a "direct effec[t]" on the review of blood substitutes at the FDA and similar agencies in other countries, the Times reports (New York Times, 4/10). Hemopure is currently only approved for use in dogs in Europe and the United States. Biopure plans to file a marketing application for approval of human use of Hemopure in the United States and Europe later this year (Associated Press, 4/10).