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FDA backs first drug from 'modified' animal
Source: Agencies |
February 8, 2009, Sunday
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US health officials has approved the first drug made using genetically engineered animals, despite lingering concerns over health and environmental implications.
The drug, GTC Biotherapeutics' anti-clotting therapy Atryn, is an intravenous therapy made using a human protein gathered from female goats specially bred to produce it in their milk.
It aims to prevent excessive blood clots in patients with a disorder known as hereditary antithrombin deficiency. The company estimates the condition affects anywhere from 60,000 to 600,000 people in the United States.
"The approval of Atryn marks a significant milestone in the development of this innovative recombinant technology," GTC Chairman and CEO Geoffrey Cox said.
But some genetic safety and animal advocates have raised doubts about using so-called transgenic animals to make pharmaceuticals, saying the FDA needs to provide more information about genetically engineered animals.
The FDA last month, under the Bush administration, issued final guidelines on regulating animals with altered DNA. It has yet to approve such an animal for human consumption.
Agency officials have said they aimed to make the regulatory process more open, but critics argue they did not go far enough and are calling on President Obama's administration to review the policy.
"This is a backdoor way to approve genetically engineered animals," said Jaydee Hanson, a policy analyst for the nonprofit group Center for Food Safety.
The FDA said it had "determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply." It also said GTC must properly dispose of any dead goats by burying or burning.
Clotting
GTC's goats are bred using cells injected with human DNA in a process that it says is a cost-effective way to produce human antithrombin, a natural protein to prevent blood from clotting. The company has a herd of about 200 at its Massachusetts facility that it says is otherwise normal and healthy.
The FDA looked at the impact on goats as they aged. "We have looked carefully at seven generations of these (genetically engineered) goats; all are healthy and we haven't seen any adverse effects," said a spokeswoman.
The drug, GTC Biotherapeutics' anti-clotting therapy Atryn, is an intravenous therapy made using a human protein gathered from female goats specially bred to produce it in their milk.
It aims to prevent excessive blood clots in patients with a disorder known as hereditary antithrombin deficiency. The company estimates the condition affects anywhere from 60,000 to 600,000 people in the United States.
"The approval of Atryn marks a significant milestone in the development of this innovative recombinant technology," GTC Chairman and CEO Geoffrey Cox said.
But some genetic safety and animal advocates have raised doubts about using so-called transgenic animals to make pharmaceuticals, saying the FDA needs to provide more information about genetically engineered animals.
The FDA last month, under the Bush administration, issued final guidelines on regulating animals with altered DNA. It has yet to approve such an animal for human consumption.
Agency officials have said they aimed to make the regulatory process more open, but critics argue they did not go far enough and are calling on President Obama's administration to review the policy.
"This is a backdoor way to approve genetically engineered animals," said Jaydee Hanson, a policy analyst for the nonprofit group Center for Food Safety.
The FDA said it had "determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply." It also said GTC must properly dispose of any dead goats by burying or burning.
Clotting
GTC's goats are bred using cells injected with human DNA in a process that it says is a cost-effective way to produce human antithrombin, a natural protein to prevent blood from clotting. The company has a herd of about 200 at its Massachusetts facility that it says is otherwise normal and healthy.
The FDA looked at the impact on goats as they aged. "We have looked carefully at seven generations of these (genetically engineered) goats; all are healthy and we haven't seen any adverse effects," said a spokeswoman.
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