Very scary. Going to put an untested substance from a modified goat into a person. I wonder how long it will take for some crazy corporation executive to think of the idea of sending these animals to slaughter for food after they can no longer serve their medical purpose? 100% organic, I bet.


http://seattletimes.nwsource.com/html/health/2008717509_gene07.html
FDA approves for sale drug made in DNA-modified goats' milk
By Shankar Vedantam



WASHINGTON — Federal officials Friday approved for the first time the sale of a drug made in animals genetically modified to secrete the compound in their milk.

The drug comes from goats whose DNA was altered to produce a drug for patients with a rare blood disorder.

Using animals as factories to produce medications needed by humans has been a long-standing goal. Federal officials emphasized that the technique has vast potential for patients and can be carried out without harm to the animals.

The drug approved Friday by the Food and Drug Administration (FDA), ATryn, is used to untangle blood clots in patients who lack sufficient quantities of antithrombin, a protein that acts as a natural blood thinner. Patients with hereditary antithrombin deficiency are at high risk during surgeries and childbirth, and the drug would be given in hospital settings. About one in 5,000 Americans has the disorder.

The blood in such people is more likely to stick together, occasionally causing clots that can travel to the lungs or brain, causing death. Half of patients with the disorder experience their first life-threatening clot before age 25.

Patients with hereditary antithrombin deficiency are prescribed conventional blood thinners, such as Plavix. That will not change with the new approval. ATryn is only approved for use when patients are undergoing surgery or having a baby, when the risk of dangerous clots is particularly high.

"This is very exciting, it is novel and has great potential for where we can go with this new technology," said Bernadette Dunham, who directs the FDA's Center for Veterinary Medicine.

The drug is made by GTC Biotherapeutics of Framingham, Mass. Company scientists combined human DNA for antithrombin with goat DNA in such a way that the goats' milk glands would express human antithrombin.

"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," said Thomas Newberry, a vice president at GTC Biotherapeutics. Researchers are seeking to produce drugs in animals because they can be manufactured faster and more cheaply than by synthetic processes, he said.

Antithrombin, for example, 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. The same amount can be by made with 150 goats, and the company already has 200 animals producing the protein, Newberry said.

Other animals could have been used, but the company chose goats because it takes only 18 months to raise a goat altered to produce milk laced with antithrombin, Newberry said. Rabbits would breed faster and cows would produce more milk, but goats offered the largest supply at the quickest pace.

FDA officials said that although their primary responsibility was to make sure the drug was safe, the agency had also taken care to ensure that the goats were not harmed.

Material from The Associated Press is included in this report.

Copyright © 2009 The Seattle Times Company