It is argued that the time has come to face up to the truth about the relevance and reliability of animal procedures and alternative methods, fully taking into account the difference between risk (randomness with known probabilities) and uncertainty (randomness with unknowable probabilities). Then, combined with recognition of the dangers of ignorance and ideology, and of special interest versus the common good, an approach based on an intelligent combination of idealism and realism could accelerate progress toward the much-needed reform of biomedical research and testing, by fully gaining the benefits promised by the Three Rs.
In the field of higher education in Gujarat, India, there has been an increasing degree of replacement of dissection and animal experiments, reflecting efforts to modernise and make humane the education and training of students. Nominees from the Indian government agency that controls animal experimentation, the CPCSEA, some of whom are also involved in animal protection organisations, are increasingly rejecting applications for animal-based practical classes in universities. Examples of replacement at two universities are given, along with details of the regulations, outreach, training, provision of alternatives, and cultural and economic realities that have helped create a context for successful curricular transformation.
A sensitive cell transformation assay for tumor initiators as well as promoters has been developed using a v-Ha-ras-transfected BALB/c 3T3 cell line, Bhas 42. In order to establish the method as a routine procedure, we have conducted a NEDO Project for the confirmation of its usefulness. Six laboratories joined in this project and examined nine chemicals, so as to be tested for a chemical by three laboratories. Judgments on carcinogenic compounds, N-methyl-N'-nitro-N-nitrosoguanidine and benzo[a]pyrene, were positive in the initiation assay and negative in the promotion assay. Although benz[a]anthracene is a carcinogen and pyrene is reported to be non-carcinogenic to animals, they gave positive results in both initiation and promotion assays. Anthracene, a non-carcinogen, was negative in both initiation and promotion assays. Mezerein, lithocholic acid and methapyrilene hydrochloride, known to act as tumor promoters, were judged positive in the promotion assay and negative in the initiation assay. Phorbol, a negative control for tumor-promoting phorbol esters, was shown negative in both initiation and promotion assays. In conclusion, this inter-laboratory collaborative study demonstrated that the Bhas 42 cell transformation assay is reproducible and applicable to the detection of both initiators and promoters, leaving the possibility of more improvement by the modification of the protocol and guidance for the procedure.