Sunday, November 15, 2009

FDA Approves Drug from Gene-Altered Goats

http://www.nytimes.com/2009/02/07/business/07goatdrug.html

I found this article while browsing the NY Times online for relatively recent stories about cloning and cloning technologies. Just earlier this year, the FDA approved "the first drug produced by livestock that have been given a human gene." A herd of 200 bioengineered/transgenic/"pharm" animals--in this case goats--all have a human gene that codes for the production of a certain human protein that can help prevent the formation of some fatal blood clots. Whenever the goats lactate, the gene is turned on, and the protein is produced. It may then be harvested in large quantities, purified, and given as drug therapy to patients with a rare disorder.

This article reports on a huge turning point in the technology of cloning. The US government stated in 2008 that meat, milk, and other food products from cloned animals were safe. But for the first time, the FDA is now supporting a therapy that is a direct product of cloning technologies. Cloning has been accepted as a valid form of producing medical treatments. The article recognizes that drugs have been derived from animals before (as we know, bovine insulin used to be used widely for diabetics). But "this is the first drug from a herd of genetically engineered animals created specifically to serve as living pharmaceutical factories."

Of course, the cloning of goats and their use as "factories" has brought on great controversy. Animal rights activists, as one could predict, are not too pleased with the prospect of animals being treated as "tools." But there are other issues with this technology as well. As the NY Times mentions, we have no idea what might happen if a goat ran away, or got loose somehow, and came into contact with other goats. What if one bioengineered goat somehow bred with a normal goat--what would happen to the human gene?
What kind of consequences might there be if this human gene started spreading throughout a wider and wider goat population? Yes, this is a legitimate fear, but the article does not dwell on it, or try to instill fear in its readers. It goes on to acknowledge other, similar drugs that show great promise, such as one new "drug, produced in the milk of transgenic rabbits, to treat hereditary angioedema, a protein deficiency that can lead to dangerous swelling of tissues." The article treats cloning not as a threat or danger, but as a valid and scientifically sound technology that deserves respect. And in doing so, it encourages its readers to do the same.

Much of the rest of the article, which enumerates the benefits of using animals to produce proteins, fits in with what we already know. Many biopharmaceutical companies tried to produce vast quantities of human proteins in big tanks. But they faced problems of building the facilities, and keeping everything entirely sterile. The use of transgenic animals eliminates these practical issues, but of course raises other ethical ones. There is also the risk of a disease killing all the goats.
One question to consider: Where do we go from here? The FDA has given a nod of approval to cloning technologies. If we accept the idea of using goats to produce proteins, how much of a leap is it to accepting the notion of using pigs to produce transplantable organs? Where do we draw the line, and why? What is the line? Does it depend on our view of animal rights, or on what we are willing to place in our own bodies? With this recent approval come a number of questions that we will soon have to answer for ourselves.

C. Heard

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