Monoclonal antibodies (MABs) are used in essentially every field of human and
veterinary biomedical research and in diagnosing and treating many cancers,
bacterial and viral infections, and other ailments. They are especially
useful because they "attack" specific antigens within the body. Some
laboratories manufacture large quantities of MABs in bioreactors.
Unfortu-nately, many others still use the outdated and painful ascites
method of producing MABs in animals.
Animals Suffer Needlessly
When animals are used, MABs develop in their abdominal fluid in response to
tumor cells placed there by laboratory staff. This causes ascites--a painful
swelling of the abdomen's peritoneal cavity. In addition, the animals suffer
when staff inject a chemical to "prime" their bodies to make antibodies and
when they withdraw the MAB-containing fluid by piercing the animals' severely
swollen bodies with large syringes. Many animals die of dehydration from the
sudden loss of so much fluid.
It is estimated that up to 1 million animals undergo this torment each year
in the U.S.
Alternatives Readily Available
Since 1975, scientists have known MABs could be produced without the use of
animals, but animal use proliferated in small-scale production. In the
1990s, the American Anti-Vivisection Society's (AAVS') Alternatives Research
& Development Foundation (ARDF) provided funds for experienced scientists to
develop a humane, efficient, economical laboratory method of MAB production:
gas-permeable tissue culture bags. These specially designed plastic bags
grow a desired antibody when the correct cells and culture medium are placed
inside them. The bags make more MABs in less time for less money and
eliminate the contamination which results from the use of ascites. Many
other alternatives are also available.
Europe Leads the Switch to Alternatives
The alternatives are so simple, reliable, and economical that The
Netherlands, Germany, and Switzerland have banned use of the ascites method.
In April 1997, ECVAM, the European Centre for the Validation of Alternative
Methods, published its recommendation that the entire European Union (EU)
prohibit animal MAB production. The EU is expected to follow ECVAM's
recommendation.
Animal Welfare Act Falls Short
The U.S. Animal Welfare Act (AWA) requires all animal laboratories'
Institutional Animal Care and Use Committees (IACUCs) to ask experimenters
whether they considered alternatives before proposing to experiment on
animals. Unfortunately, experimenters in the U.S. are not required to use
alternatives whenever possible--in contrast with European law. To end
ascites MAB production and use in all U.S. laboratories, the U.S. Department
of Agriculture (USDA), which administers the AWA, must announce a ban.
NIH Fails To Comply with Law
The National Institutes of Health (NIH) can end ascites MAB production and
use for all experiments receiving NIH grants, The National Institutes of
Health Revitalization Act of 1993 (NIHRA) mandates that the Director of NIH
prepare a plan for the use of alternatives to animals in NIH-funded
experiments. It requires NIH to conduct or support research into
alternatives, encourage experimenters to use those found to be valid and
reliable, and train experimenters to use such alternatives. The plan
submitted in October 1993 fails to meet those requirements: It talks about
developing alternatives, but provides no staff or system to accomplish the
task.
The AAVS Takes Action
In March 1997, the ARDF surveyed and offered information on alternative MAB
production techniques to about 1,000 directors of IACUCs at registered
laboratories. Many requested information on alternatives. The survey
results indicate (1) animals continue to suffer needlessly from ascites under
the U.S. Animal Welfare Act; (2) alternatives are underutilized; and (3)
NIH-funded experimenters are not being educated and trained in the
alternatives as mandated by the NIHRA.
In April 1997, the AAVS petitioned the USDA to prohibit ascites MAB
production and use in all U.S. laboratories, and petitioned NIH to end
ascites production and use in all NIH-funded experiments. Please write to
your Congressional Representative and U.S. Senators and ask them to urge NIH
Director Harold Varmus and Agriculture Secretary Dan Glickman to decide in
favor of the AAVS monoclonal antibodies petitions. Thank you!
For more information, please call, fax, write, or e-mail the AAVS at
aavsdc@aol.com.
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American Anti-Vivisection Society, 801 Old York Road #204, Jenkintown, PA
19046; 215-887-0816; fax 215-887-2088