Ethics of Research involving animals
Summary
8.42 Pharmaceutical research and development has been transformed over the past 50 years because of the availability of advanced information and diagnostic technologies, and an increased understanding of genetics. At present a wide range of advanced methods that do not involve animals is used together with animal research. Although there has been a substantial decline in the total use of animals, pharmaceutical research remains responsible for a significant proportion of the animal experiments conducted in the UK each year. A very wide range of basic and applied medical and veterinary research projects is supported or conducted by pharmaceutical companies as part of the search for new medicines and vaccines for use in humans and animals. We described eight different stages in the development process. The majority of animals (60-80%) are used in the characterisation of promising candidate medicines; less (5-15%) are used in the preceding discovery and selection process. GM mice are most commonly used in the early stages of development of new medicines to assess the importance of a drug target, although they are also used increasingly in later stages (target validation) or as animal models of a disease (see Chapter 7).
8.43 The welfare implications for animals involved in research are as varied as the research itself. Non-experimental factors, such as housing, husbandry and the training of those handling the animals, especially in relation to the implementation of Refinements, all influence welfare. Some techniques, such as methods for administering a medicine and measuring the level in blood, are generic for all types of research. In the case of specific animal models of disease, welfare implications depend on the symptoms of the disease. A special case is the production of vaccines. Since the exact quality of biological products is often very difficult to control, tests to assess potency and toxicity are carried out on each batch, which may lead to symptoms ranging from lack of appetite to paralysis for animals such as monkeys, mice and guinea pigs.
8.44 The use of animals in pharmaceutical research and development in the future is difficult to predict. The following are among the many possible outcomes:47
- the use of animals may continue to fall as the use of advanced methods increases;
- the use of animals may remain static, but advanced imaging, sensing and biomarkers willallow extraction of even more information in an increasingly refined way;
- the use of animals may rise because the increasing volume of information from the early stages of drug discovery presents the possibility of more and more new medicines.
47 See ABPI (2001) Statistics, Animal Research and Development of Medicines, available at:
http://www.abpi.org.uk/publications/briefings/40301-ABPI-Brief-Statistics.pdf Accessed on: 2 May 2005. Various sources
suggest that the use of animals is falling when compared with research and development activity undertaken by the largest pharmaceutical companies (see Samuels G (2003) Medicines: Tried And Tested - In Animals?, available at:
http://www.abpi.org.uk/publications/publication_details/mttur/mttur_ani.asp; GlaxoSmithKline (2002) The Impact of Medicines: Corporate and Social Responsibility, available at: http://www.gsk.com/financial/reps02/CSR02/GSKcsr-10.htm#ref),
or that the numbers of animals used may vary from year to year (AstraZeneca (2003) Animal research, available at:
http://www.astrazeneca.com/Article/11174.aspx). All accessed on: 2 May 2005.