This doesn’t sound so good:
On the front page of its Business section, the New York Times (2/7, B1, Pollack) reported, “Opening the barn door to a new era in farming and pharmaceuticals, the Food and Drug Administration [FDA] on Friday approved the first drug produced by livestock that have been given a human gene.”
According to the Wall Street Journal (2/7, Dooren), “the drug, Atryn, developed by GTC Biotherapeutics Inc. from the milk of a genetically altered goat, will be used to treat patients with a rare blood-clotting disorder known as hereditary antithrombin deficiency.” Atryn “could be used by some pregnant women and patients undergoing surgery who cannot be given blood-thinners normally used to treat the condition.” Initially, “Atryn’s use would be…limited to about 100,000 patients.”
The medication combines “human DNA for antithrombin with goat DNA in such a way that goat’s milk glands would express human antithrombin,” the Washington Post (2/7, A5, Vedantam) explained. According to Thomas E. Newberry, a vice president at GTC, “the mammary gland is designed by nature to make proteins for offspring in a substance that we call milk, so all we have done is provide the extra bit of coding so it makes this particular protein.” Newberry said that “researchers are seeking to produce drugs in animals because they can be manufactured faster and more cheaply than by synthetic processes.” Antithrombin, for instance, “can be extracted from plasma in donated blood. But if all the blood donations in the country were used to extract antithrombin, scientists would have about 220 pounds of the protein a year.” Newberry claimed that “the same amount can be by made with 150 goats, and the company already has 200 animals producing the protein.”
The AP (2/6, Alonso-Zaldivar, Perrone) added that, “amid the growing questions about GE technology, the FDA last month issued guidelines on how it will regulate products made from the animals.” The agency “said it will not allow any such products to be sold without first submitting them to scrutiny by independent advisers at a public meeting.” However, “consumer groups said the FDA’s long-awaited policy will not require all genetically engineered foods to be labeled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment, particularly if some escape and begin to mate with animals in nature.”
The Boston Globe (2/7, Wallack), Bloomberg News (2/7, Larkin), the Wall Street Journal (2/6, Goldstein) Health Blog, the Chicago Tribune (2/7), MedPage Today (2/6, Fiore), WebMD (2/6, Hitti) and the Forbes (2/7, Herper) The Science Business blog also covered the story.
