First Drug Made from Genetically Engineered Animals Approved by FDA
Photo via Arbroath
A blood thinning drug called ATryn, which is made from the milk of genetically altered goats, was approved by the Food and Drug Administration last Friday—making it the first drug made from genetically engineered animals ever to be approved for use in the US, according to the Associated Press.
The approval of the drug clears the way for a whole new class of medications—those that are created from genetically altered animals instead of chemicals.
A Blood Thinning Drug from Goat's Milk
The drug, made by GTC Biotherapeutics, is an injection that will be used to treat patients who suffer from a rare hereditary disorder that puts them at a high risk for deadly blood clots. From the AP:
About 1 in 5,000 people don't produce enough antithrombin protein, according to Framingham, Mass.-based based GTC. As a result, their blood 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.
Pregnant women with the ailment are at higher risk of miscarriage or stillbirth, because of blood clots in the placenta.
ATryn will not replace the conventional blood thinning treatments already prescribed, but will be used only during times of heightened risk, like when patients are to undergo surgery or give birth.
How to Make Blood Thinner from Genetically Engineered Goats
To make the drug, scientists from GTC put modified DNA, or rDNA, for the human antithrombin protein into single-cell embryos of goats. Goat embryos with the gene were then inserted into the wombs of surrogate mothers who gave birth to baby goats that produce the protein-charged milk.
Drugs from Genetically Engineered Animals
The approval of drugs from genetically engineered animals opens up a vast gray area, however. The FDA said it reviewed seven generations of the GE goats, and found them to be "healthy." But there still s slew of unanswered questions, like what would happen if some of the GE goats were to escape or were rereleased into the wild? What could happen if the engineered gene was introduced to a wild population of goats?
Also, some consumer groups claim that the FDA's "long-awaited policy will not require all genetically engineered foods to be labeled as such."
So it's difficult to predict how exactly this new frontier in medication will be handled, even though the FDA issued their final guidelines on regulating drugs made from genetically engineered animals (PDF). How will the public take to the prospect of using materials from genetically engineered animals' for drugs? Especially since other forms of genetic engineering like cloning remain steeped in controversy--ethical questions regarding scientists playing God will no doubt remain.
And if the GTC stock shares are any indicator of public opinion, it's not good—they fell 14.6 percent on the day of the controversial medication's approval.