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 Unfortu-nately, many others still use the outdated and painful ascites method of producing MABs in animals.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 email@example.com.
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American Anti-Vivisection Society, 801 Old York Road #204, Jenkintown, PA 19046; 215-887-0816; fax 215-887-2088
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