NOTE: Another very useful roundup from Pete Shanks of the Center for Genetics and Society. See his original article on the Biopolitical Times site for multiple embedded links.
---
---
Tragedy on the Pharm
Pete Shanks
Biopolitical Times, May 24 2010
http://www.biopoliticaltimes.rsvp1.com/article.php?id=5221

Last year, in New Zealand, a state-owned company called AgResearch produced four genetically modified calves. The modification was intended to generate human follicle stimulating hormone (FSH) that could be used in treating infertility. Three of them developed huge ovaries -- "the size of tennis balls rather than the usual thumbnail-size." Two died unexpectedly at the age of six months; the third "was put down for scientists to study." The one survivor is still producing human proteins in its milk.

There are many possible responses to this debacle, but we should start by noting the callous response of the scientists involved, who did not see the deaths as a "big deal" and called them "part of the learning process." Moreover, AgResearch, which is "owned by the people of New Zealand, working for the benefit of New Zealand," kept it quiet until compelled to release veterinary reports through the local equivalent of a Freedom of Information Act request.

AgResearch is supposed to improve agricultural productivity. It does this in many ways, including the development of innovations in wool (until it recently cut back that division) and accessorized four-wheel bikes that enable farmers to assess the nitrogen and other content of their pasture by riding over it. But it sees its prime directive as "to develop and source biotechnologies to help keep New Zealand at the forefront of agriculture."

The revelation of the dead cows has sparked renewed efforts to have public debate in New Zealand about the development of these technologies. Indeed, there is a lawsuit to change the regulatory process: GE Free New Zealand won in the lower court, lost on appeal, and is trying to take the issue to the country's Supreme Court. And another suit is specifically challenging the decision to allow research on modifying the three species currently under study.

There seems to be no particular shortage of FSH, which is regularly used though sometimes associated with ovarian hyper-stimulation syndrome. Still, producing it in the milk of modified cows might theoretically be cost-effective. The concept of "pharming" (as this method of generating pharmaceutical products is often called) has been around for a long time -- it's what was behind the original cloning of Dolly the sheep, who was rapidly followed in 1997 by Polly and Molly, sheep who were not only cloned but genetically modified with the intention of producing a human blood clotting factor.

However, pharming has had very limited success. One product, ATryn (which reduces blood clotting) is produced from goats, and was approved in Europe in 2006, and in the U.S. in 2009. Others are under development, using both animals and plants, but progress has certainly been slower than anticipated. Indeed, AgResearch itself has shelved plans to modify "buffalo, pigs, llamas, alpacas, horses and deer" and is restricting its efforts to cattle, sheep and goats. And, if the lawsuit succeeds, maybe not even them.