FDA Approves Drug Made from a Transgenic Animal

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FDA Approves Drug Made from a Transgenic Animal

By Dr. Ray Greek on National Anti-Vivisection Society

Animals cannot be used to predict human response and are not really needed for use in basic research. That being said, animals can be viably used in basic research, dissection, as a source of spare parts for humans and in other ways. One of these other ways is to manufacture drugs.

Drugs derived from transgenic animals are now appearing on the market. The first FDA approved drug from a transgenic animal, a goat, is called ATryn. ATryn is an anticoagulant, antithrombin-a that is excreted in the milk of these transgenic goats. The drug is meant for people with inherited antithrombin deficiency that are at risk for blood clots during surgery or childbirth.

There is already a human version of the drug on the market. Thrombate III (antithrombin III) has the same efficacy as ATryn. The makers of ATryn hope it will be less expensive than Thrombate III. The maker of ATryn also points out that human-derived drugs may risk infection from the donors. Of course, animal-derived drugs also have an infection risk.

In order to produce the drug, the goats, like Premarin horses, must be pregnant. And like monoclonal antibody production, producing drugs from animals risks immune-mediated reactions due to contamination with animal proteins.

Aside from the ethical and scientific issues surrounding the production of ATryn, it is another example of the failure of the Three Rs. Here we have an example of animals being used to produce a drug that is already available. If science and society took the Three Rs seriously we would not be seeing a human-derived drug being replaced with an animal-derived drug. And more such drugs are in the future.

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