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Dr. Andrew C. von Eschenbach, Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane; Rockville, Maryland 20857
email:
andrew.voneschenbach@fda.hhs.gov
web mail:
www.fda.gov/comments/webform.html
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This Letter
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.
Sincerely,
