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ARCHIVE - Franken-Goats? Animals As Drug Machines

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Dr. Andrew C. von Eschenbach, Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane; Rockville, Maryland 20857
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Dear Commissioner von Eschenbach,

Please consider my comments about the FDA's evaluation of ATryn, an antithrombin from GTC Biotherapeutics developed to prevent blood clots. There are too many animal welfare and human safety issues to allow Atryn and other transgenic drugs on the market.

To manufacture Atryn, GTC inserts a human gene into the DNA of goat embryos. For every 100 attempts at pronuclear injection, only one to 10 animals effectively become transgenic offspring. The 90 to 99 percent of animals who fail to assimilate the key gene are killed.

While GTC's nuclear-transfer process prompts a higher rate of viable transgenic goats, offspring may have severe birth defects. Scientists have no solid explanation for why a transgene misses its targeted section of the genome and results in a malformed baby goat.

Using goats as "drug factories" raises significant concerns about reliability. If scientists cannot explain birth defects in goats, they cannot accurately predict allergic effects in humans who ingest ATryn. U.S. deaths or injuries linked to drug therapies more than doubled from 1998 to 2005, according to recent findings in the Archives of Internal Medicine. The American Medical Association has cited adverse drug reactions (ADRs) as a leading cause of death in U.S.

Drugs derived from transgenic animals have the potential to pass harmful pathogens to humans and should not earn FDA approval. Moreover, with ongoing advances in animal-free technology, it is unethical to introduce any drug rooted in animal suffering and exploitation.

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UPDATE: 2/6/09, FDA Okays Goats As Drug Machines
SOURCE: 2/6/09 F.D.A. Approves Drug From Gene-Altered Goats

The Food and Drug Administration approved the first drug produced by livestock given a human gene. The drug, meant to prevent fatal blood clots in people with a rare condition, is a human protein extracted from the milk of genetically engineered goats. The FDA also approved the goats used to make the drug, the first such animals cleared under guidelines to regulate the use of transgenic animals in the nation's drug and food supply. Made by a company called GTC Biotherapeutics, the human anticlotting protein is produced by a herd of 200 bioengineered goats living under carefully controlled conditions on a farm in central Massachusetts...

Don't Put Human Genes Into Goats for Drug Development!
Medicine From Milk: Gene Therapy Could Transform Goats Into Pharmaceutical Factories
Old McDonald had a pharm

"The headquarters of GTC Biotherapeutics looks like any other New England farmstead. But behind barn doors...a herd of pygmy goats are working round the clock, their milk glands churning out hundreds of gallons of high-grade pharmaceutical compounds... Some animal biologists say biotech companies are overselling the safety of drugs from transgenic animals. Meanwhile, ethicists question whether we should be restyling animals as drug producers at all..."

Old McDonald had a pharm And genetically modified his goats and chickens to produce drugs for humans. But hold on. Should we be doing this to animals? c_goats/print.html
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