Medicine In Milk

08 Jan 2009

It seems likely that the first genetically engineered animal approved for commercial use won’t be a fast-growing salmon, as had been expected, but a goat that produces an anti-clotting drug in its milk.

In a development which is concerning many consumer groups, an anti-clotting drug made from the milk of genetically engineered goats came closer to approval yesterday after experts at the US Food and Drug Administration (FDA) reported that the medication works and its safety is acceptable.

The drug, called ATryn, is intended to help people with a rare genetic disorder that makes them vulnerable to life-threatening blood clots. A US biotechnology company developed the drug by altering the genes of goats so they would produce milk rich in antithrombin, a protein that acts as a natural blood thinner in humans.

If the drug is approved, it will be the first application under new FDA regulations that allow animals to be genetically altered to produce drugs, model human disease, produce industrial or consumer products or enhance their use as 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,’ stated Greg Jaffe of the Center for Science in the Public Interest. ‘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.’

The FDA will receive further advice on the risks and benefits of ATryn from its scientific advisers at a meeting this Friday, prior to making their final decision. ‘It’s the first time we’ve held an advisory committee meeting on any product from a genetically engineered animal,’ said FDA spokeswoman Siobhan DeLancey.

USA Today
Associated Press

Bess Mucke
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