Monday, July 23, 2012

Drug from Genetically Altered Goats Gets FDA Stamp of Approval

In early February 2009 the FDA officially approved the genetically engineered drug ATryn. Developed by GTC Biotherapeutics, ATryn contains the anti-clotting protein antithrombin, which is produced in the milk of genetically altered goats. The goats come from embryos which have been injected with a human gene and then placed in a surrogate female. When the altered goats are born and mature, the gene causes them to produce a large amount of antithrombin in their milk. This technique of growing genetically altered animals for pharmaceutical purposes is dubbed "pharming." Genetically crossing two species in this manner is cause for suspicion and even alarm. There is no possible way to predict the consequences of this kind of experimentation. Questions remain as to why such a controversial method is necessary for producing antithrombin. Based on sales in Europe of a similar drug, sales for ATryn are not expected to be sizable. The drug is not designed to replace conventional blood thinners, but instead is made for use only during risky periods of surgery or childbirth. Not to mention the fact that there are alternative methods that use human plasma and cell cultures to produce the protein. While these techniques are more expensive and produce less antithrombin, they are also far less disconcerting when compared to the alternative. It makes you wonder why we must to go to such extremes to produce the drug in this manner. It can be difficult to control what results from genetic mutation. In the past, there have been cases where animals altered with human genes suffered from unanticipated degeneration. Critics say the kind of suffering some of these animals may go through cannot be considered ethical. The Humane Society of the United States says these practices perpetuate the idea that animals are mere objects to use for our own devices as opposed to feeling creatures. There are many other concerns related to the way ATryn is produced. These include the possibility of germs from the goats contaminating the drugs or even the chance that products from these goats could enter the mass food supply. If breeding is not highly controlled, there is a chance these mutated genes could spread among wild or commercial animals. Some are concerned that the FDA`s new policy does not require genetically engineered products to be labeled accordingly. After all, if such products are allowed to enter the market, we should have the right to be able to identify and refuse them if we so choose. We have to ask ourselves if we are truly ready for an onslaught of genetically altered drugs in the market. That is exactly what we are inviting by approving this drug. Even if you are wondering if ATryn is really so bad, the fact remains that the approval of such a drug is really just the first step down a troubling road that may lead to dire consequences. Source -

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