The ethics of research involving animals - Nuffield Council on ...

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T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s 8.4 From the late 1980s these developments continued to transform pharmaceutical <strong>research</strong> and development. Information technology became more efficient, allowing the integration <strong>of</strong> rapidly expanding amounts <strong>of</strong> data generated by advances in basic biological knowledge. This information was integrated with data from new technologies such as high-throughput chemistry and biology, genomics, pharmacogenetics, advanced diagnostic imaging and the application <strong>of</strong> bioinformatics. Since the 1980s, the continued expansion <strong>of</strong> pharmaceutical <strong>research</strong> in the UK has also been accompanied by the increasing use <strong>of</strong> a wide range <strong>of</strong> modern methods, which we describe below (see Figure 8.1). 4 <strong>The</strong> use <strong>of</strong> these methods was one factor that contributed to the decrease in <strong>animals</strong> involved in commercial <strong>research</strong> during the same period, from 60 percent (or 2.1 million) <strong>of</strong> the total number <strong>of</strong> procedures in 1987, to 36 percent (or 1 million) <strong>of</strong> the total in 2003. 5 Capture the potential <strong>of</strong> the human genome industrialisation <strong>of</strong> drug discovery Huge array <strong>of</strong> molecular targets + Vast, diverse chemical libraries Rapid identification <strong>of</strong> leads Extensive survey <strong>of</strong> biological function Genetics Genomics Proteomics High - throughput chemistry Ultra-high - Throughput screening High - throughput biology Novel technologies, including through partnerships Figure 8.1: <strong>The</strong> industrialisation <strong>of</strong> drug discovery to capture the potential <strong>of</strong> knowledge <strong>of</strong> the human genome Source: GlaxoSmithKline Use <strong>of</strong> <strong>animals</strong> in current pharmaceutical <strong>research</strong> and development 8.5 <strong>The</strong> discovery and development <strong>of</strong> new medicines 6 entails a very complex range <strong>of</strong> different methodologies (Figures 8.1 and 8.2). <strong>The</strong> process, undertaken primarily by the pharmaceutical industry, takes an average <strong>of</strong> 10–15 years. 7 In this section, we describe it in terms <strong>of</strong> eight stages, 4 <strong>The</strong> Association <strong>of</strong> the British Pharmaceutical Industry (ABPI) <strong>The</strong> Development <strong>of</strong> Medicines, available at: http://www.abpi.org.uk//publications/briefings/Dev_Medicines.pdf. Accessed on: 26 Apr 2005. 5 This figure includes the use <strong>of</strong> <strong>animals</strong> by companies outside <strong>of</strong> the pharmaceutical sector, for example in toxicity testing and ecotoxocity testing <strong>of</strong> products that might have an impact on the environment. See Home Office (2004) Statistics <strong>of</strong> Scientific Procedures on Living Animals Great Britain 2003 (London: HMSO), p22. In financial terms, the use <strong>of</strong> <strong>animals</strong> is only a small part <strong>of</strong> the total required to produce a licensed new medicine. Estimates <strong>of</strong> animal cost do not usually exceed five percent. See 71st Stephen Paget Memorial Lecture, available at: http://www.rds-online.org.uk/pages/news.asp?i_ToolbarID=6&i_PageID=176. Accessed on: 26 Apr 2005; AstraZeneca (2003) Take a Walk Along the Path to a New Medicine, available at: http://www.astrazeneca.com/sites/7/imagebank/typeArticleparam502178/seeking_new_medicines_v15.html. Accessed on: 26 Apr 2005. 6 We use the term discovery to refer to <strong>research</strong> that aims to find novel connections between diseases, molecular targets and wellcharacterised therapeutic interventions. We use the term development to refer to laboratory and animal studies designed to test the mechanisms, safety and efficacy <strong>of</strong> an intervention prior to its applications to humans (pre-clinical development) and to trials <strong>involving</strong> human participants to determine further the safety and efficacy <strong>of</strong> potential drug candidates (clinical development). 7 Network Science (2004) <strong>The</strong> Process <strong>of</strong> Drug Development, available at: http://www.netsci.org/scgi-bin/Courseware/projector.pl?Course_num=course1&Filename=top.html. Accessed on: 26 Apr 2005. 134
T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s beginning with target identification and ending with the launch <strong>of</strong> the new product (see Table 8.1). 8 Data from animal <strong>research</strong> are crucially important to <strong>research</strong>ers in the pharmaceutical industry when deciding whether a potential medicine will be effective and safe for use in humans. 9 Figure 8.2: Overview <strong>of</strong> the activities involved in modern drug discovery and development Source: GlaxoSmithKline Table 8.1: Overview <strong>of</strong> the process <strong>of</strong> discovery and development <strong>of</strong> medicines Objective Discovery and selection <strong>of</strong> potential new medicines <strong>The</strong> characterisation <strong>of</strong> promising candidate medicines Ensuring the safety <strong>of</strong> selected candidates Clinical studies on humans Stage no. 1 2 3 4 5 6 7 8 Description Target identification Identification <strong>of</strong> possible medicines Lead identification Lead optimisation Selecting candidate medicines Concept testing Development for launch Launch phase Average number <strong>of</strong> compounds entering each stage – 1,000,000 1,000 200 17 12 9 2.2 Average use <strong>of</strong> <strong>animals</strong> 5–15% 60–80% 10–20% Generally none Generally none Generally none CHAPTER 8 THE USE OF ANIMALS FOR RESEARCH IN THE PHARMACEUTICAL INDUSTRY 8 See AstraZeneca (2003) Take a Walk Along the Path to a New Medicine, available at: http://www.astrazeneca.com/sites/7/imagebank/typeArticleparam502178/seeking_new_medicines_v15.html. Accessed on: 26 Apr 2005. 9 Samuels G (2003) Medicines: Tried And Tested - In Animals?, available at: http://www.abpi.org.uk/publications/publication_details/mttur/mttur_ani.asp. Accessed on: 26 Apr 2005. 135
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The ethics
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The ethics
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Foreword The issue
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Table of contents
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Stages 1-2: discovery and selection
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Conclusions and recommendations ...
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Terms of reference
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T h e e t h i c s o f r e s e a r c
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Chapter 1 Introduction
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Chapter 2 The cont
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Chapter 3 Ethical issues raised by
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Chapter 4 The capa
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Section 3 Alternatives
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Section 4 Legal, ethical and policy
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Chapter 14 Discussion of</s
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Appendices
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Genetic screening: ethical issues P
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