Better Science V. ALTERNATIVES AND BIOLOGICALS Although often overlooked, the production and testing of biologicals consumes 15% or more of all animals used in United States laboratories specifically and the world in general. For example, a complete batch test for a therapeutic protein can involve 12,000 mice and cost $2.4 million without producing any useful information. Potency tests of such products as vaccines are still routinely based on the principle of protection, i.e., survival or death after exposure, which was first introduced in the 1890s. Many of these tests are exceptionally cruel, involving high levels of pain and distress for a variety of species of rodents, dogs, cats and non-human primates (including chimpanzees). According to 1998 USDA statistics, more than 60% of the animals experiencing unrelieved pain and distress were used for vaccine testing. Essentially all of this work was conducted in industry laboratories. As a category, biologicals include antibodies, blood products, bioactive compounds (e.g., cytokines), hormones, immunosera products, recombinant-DNA proteins and vaccines. Nearly all of these are produced under mandated quality, potency and efficacy controls. Abandonment of the erroneous concept that functional tests in animals corresponds to the same function in a human, production of biological products in a form which allows easy quantification of characteristics and elimination of excessive duplication of national testing requirements will rapidly advance the development and use of alternative replacements for safety testing of biologicals. For example, introduction of a new vaccine presently might require 32 different in vivo testing protocols instead of a few in vitro alternatives. The field of biologicals production and testing includes several glaring anachronisms. Target animal safety tests with sample sizes of two are statistically meaningless and could be eliminated immediately. Similarly, the general or abnormal toxicity tests was one of the first animal-based tests developed; is used for a variety of materials; duplicates data produced by more familiar tests; is widely acknowledged to be useless; and was deleted from the European Pharmacopoeia in 1997 with no negative consequences. It could be eliminated worldwide immediately with a similar harmless outcome. Because some vaccines utilize live pathogens (e.g., oral polio (OPV), MMR, varicella, yellow fever, or are well defined (e.g., influenza), they have always been tested using in vitro methods. Cholera and typhoid vaccines are not tested for potency due to a lack of valid animal models. Neurovirulence tests for OPV, recombinant FSH hormones, tetanus and diptheria vaccines all now have alternative replacements for the previous more traditional animal-based tests. Vaccines and some biologically active compounds are routinely produced using in vitro methods. Perhaps the most successful example of this is the production of monoclonal antibodies (MAbs), which began as a new in vitro technique; was usurped by a very painful and distressful in vivo method; and can now be done entirely via alternative replacement methods. In fact, there are so many in vitro MAb methods currently available, all producing high quality antibodies at lower costs, that the old in vivo approach is prohibited or severely restricted in many countries including the United States. Production of polyclonal antibodies continues to rely on injections of test substances (antigens) into various species of animals and subsequent bleeding to retrieve the antibodies. As an interim step, which will also be replaced, such antibodies can be produced in chicken eggs (eliminating the use and bleeding of mammals). Although somewhat technically difficult and in the early stages of development, within a few years it will be possible to use recombinant DNA techniques to produce all antibodies - mono- and polyclonal. This final evolution of technological methods will completely eliminate an entire area of traditional animal usage (millions of animals per year) and at the same time provide a higher quality, less expensive product. This is the promise and reality of the alternatives approach. << Back To Contents | Next Section >>

Other NEAVS Fact Sheets: Benefits of Non-Animal Tests | Xenotransplants | Animal Welfare Act | Limitations of Animal Tests | Non-Animal Product Safety Test Alternatives << Back to Better Science  | Home