Jan 9, 2009 01:55 PM | 1
Some consumer groups are bleating over the prospect of a new anti-clotting drug made from genetically modified goats.
An advisory committee to the Food and Drug Administration (FDA) is meeting today to discuss whether to recommend approval of ATryn, a med made from the milk of goats engineered to produce copious amounts of the blood-thinning protein antithrombin. This is the first time an FDA panel is considering a commercial food or drug product produced from a genetically altered animal.
(See a story from our September 2006 issue for more on ATryn.)
ATryn, manufactured by Massachusetts-based biotech GTC Biotherapeutics, is not being mulled as a sub for traditional blood thinners, but rather for use during surgery or childbirth for the one in 5,000 Americans with antithrombin deficiencies at increased risk of developing potentially fatal blood clots in their lungs or brains, the Associated Press says.
The European Commission approved ATryn for use in the 27 European Union countries in 2006.
But consumer advocates say more testing is needed to prove the safety of genetically engineered animals in drugs and food. "The regulatory process seems to have put the cart before the horse, analyzing the safety of the product before it has opined on the safety of the manufacturing process," Greg Jaffe of the Center for Science in the Public Interest told USA Today. "The FDA clearly needs to impose cradle-to-grave conditions to prevent the goats from leaving the farm or their products from entering the food supply."
Proponents of the drug, however, say that making antithrombin from goats may be cheaper and ensure a steadier supply than producing it from human blood components. "It's a new mechanism by which drugs could be produced in pretty large volume in the future," hematologist Stephan Moll, a consultant for the company, told the AP. Moll practices at the University of North Carolina, Chapel Hill.
Other companies have experimented with altering animals to produce medicines, such as antibodies made from cows. But ATryn would be the first FDA-product approved for commercial use, agency spokesperson Siobhan DeLancey says.
Image by iStockphoto/Sebastian Knight
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