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Non-Human Primates in Biomedical Research

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Non-Human Primates in Biomedical Research Science Shop for Biology Non-human primates in biomedical research Frouke Pieters P-UB-2006-06 Non-human primates in biomedical research Reasons and alternatives for their use Frouke Pieters Science shop for Biology Netherlands Centre Alternatives to Animal Use, Utrecht University, The Netherlands April 2007 P-UB-2006-06 Colofon Report number P-UB-2006-06 ISBN 978-90-5209-158-7 Price € 5,- Publication date April 2007 Edition First Title Non-human primates in biomedical research Reasons and alternatives for their use Author Frouke Pieters Supervisor Prof. Dr. C. Hendriksen, Netherlands Centre Alternatives to animal use, Utrecht University, The Netherlands Project coordinator Ir. M. A. Vaal, Science Shop for Biology, Utrecht University Commissioned by Working party 'Primate Research in the Netherlands' under the auspices of the Dutch Association for Laboratory Animal Science, Amsterdam Reproduction Document Diensten Centrum Uithof Publisher Science shop for Biology, Utrecht University Padualaan 8, 3584 CH Utrecht, The Netherlands. .. 31 30 253 7363 www.bio.uu.nl/scienceshop Copyright This document (or parts thereof) may not be multiplied in any form. Parts of the document may be used for other publications, if a reference is included. Contents Preface 5 Summary 7 Samenvatting 8 1 Introduction 9 1.1 Motivation 9 1.2 Definition of the problem 10 1.3 Scope and definitions 10 1.4 Approach 11 1.5 Structure 12 2 Use of primates 13 2.1 Figures 13 2.2 Goals of primate studies 18 2.3 Regulations on animal experimentation 21 2.4 Ethics 22 2.5 Problems and arguments 27 3 Alternatives to animal use 29 3.1 Introduction 29 3.2 Alternatives 29 3.3 Problems and arguments 35 3.4 Introduction case studies 36 4 Primate research for human diseases 38 4.1 Subjects of primate studies on disease 38 4.2 Case study: HIV 43 4.3 Discussion on all studies using primates 52 5 Preclinical studies 55 5.1 Introduction 55 5.2 Regulatory influence 57 5.3 Use of primates 60 5.4 Case study 1 61 5.5 Case study 2 66 5.6 Alternatives 70 5.7 Discussion 73 6 Routine safety evaluations 82 6.1 Introduction 82 6.2 Case study: OPV 82 6.3 Other routine safety tests on primates 97 6.4 Conclusion 98 7 Conclusion 100 7.1 Use of primates 100 7.2 Reasons 101 7.3 Alternatives 102 7.4 Problems concerning alternatives 105 7.5 Recommendations 107 References 109 Appendices 124 Appendix 1: List of respondents 124 Appendix 2: Overview of EU categories on animal use 125 Appendix 3: Explanation on EU categories of animal use 126 Appendix 4: Use of primates in the Netherlands in 2004 (EU statistics) 127 Appendix 5: Use of primates in the Netherlands in 2004 (NL statistics) 128 Appendix 6: Use of primates in the EU in 2002 129 Appendix 7: Calculations on use of primates for OPV 130 Non-human primates in biomedical research Preface This report is the final thesis for my Masters in Biology at Utrecht University, the Netherlands. The study was conducted over a nine month period as a project at the Netherlands Centre Alternatives to animal use (NCA). Professor Coenraad Hendriksen was responsible for daily supervision of my research. Additional supervision was also given by Janne Kuil on behalf of the initiating working party 'Primate research in the Netherlands'. Furthermore, Manon Vaal of the Science Shop for Biology, Utrecht University acted as the intermediary supervisor between this working party and the student-researcher. Naturally, it goes without saying that the study has been conducted from a scientific perspective; views and personal opinions have been separated from factual information. However, the researcher's background may be useful to the reader, certainly given that this is a delicate subject where so many interests and opinions come together. My own attitude towards animal experiments is generally a pragmatic but critical one. Animal experiments may be useful in order to proceed with biomedical science and medicine, but I tend to question the necessity of all these experiments. During the course of this research, I addressed many sides of the story in an open-minded but critical fashion, taking the views of both the proponents and opponents of animal experimentation into account. This has consequently increased my understanding of the need for a primate model in some cases. Nonetheless, my personal view is that the use of animals should be reduced to only the absolutely necessary experiments. I therefore hope that this study will contribute to the reduction and replacement of the use of primates in biomedical research. I would like to thank all those who helped me during this study: first of all the respondents, without whom there would be nothing to say on the subject. It is regretful that some of these respondents have chosen to remain anonymous due to personal or commercial concerns. The British NC3R's allowed me to attend a workshop on the use of primates for biologicals, which was incredibly helpful. I would also like to extend my gratitude to Coenraad Hendriksen, Janne Kuil and Manon Vaal for their supervision, useful nuances and help with respondents, and Nina Cohen for her advice on how to conduct qualitative research. Finally, I would like to thank Jo Swabe for her correction of my English. Frouke Pieters, Utrecht, October 2006 5 Science shop for Biology Non-human primates in biomedical research Summary More than one hundred thousand non-human primates are used for biomedical research annually worldwide. The United States, Europe and Japan are the main countries that use these primates. In the European Union, some ten thousand primates are used every year. These are mainly Old World species, which are primarily used for toxicological and safety purposes. While the use of these animals leads to ethical objections, the scientific quality of primate studies is also the subject of discussion. This study investigates the extent to which the use of primates could be reduced or replaced through an analysis of the existing literature and interviews with stakeholders. In fundamental studies on disease, different (animal) models are often used alongside each other; arguments regarding why primates are used are only seldom given. Primates mainly seem to be used for immunologic reasons, which exclude the use of any in vitro alternative. In preclinical research, it appears that primates are mainly used for conventional medicines, which is contradictory to expectations. Next to scientific arguments for the use of primates, non-scientific reasons also play a major role. Financial and regulatory issues appear to be the most important factors, which hamper the replacement or reduction of primate use. The necessity of using primates for routine safety tests has not been established. The use of primates for both fundamental and preclinical studies is likely to increase in the near future, consequently increasing the need to replace or reduce the use of primates as much as possible. The most promising alternatives seem to be the use of other animal species, human tissue or volunteers and a tiered approach to reduce the number of primates. Although the use of other animal models is certainly not a 3R-alternative, this is generally regarded as some improvement and a first step towards complete replacement. However, there are a number of factors that hamper the development and implementation of alternatives. These include problems with the selection of the relevant animal model, regulatory requirements, information, motivation and funding for alternatives, as well as personal and commercial interests. Furthermore, there are no criteria that a model has to fulfil, which makes it hard to judge the traditional model or an alternative method on its merits. This, together with safety issues and fear of liability, makes regulators slow to implement alternatives. In view of this, the most relevant model for both fundamental and applied studies should be subject to discussion. For primate studies, advice on the relevance of the model could even be mandatory. Furthermore, the criteria that any model should fulfil must be decided and research into alternatives should be intensified. However, any stricter regulations on the use of primates should only be decided on in discussion with stakeholders, to prevent the outsourcing of primate studies to countries where animal welfare may be poorer. 7 Non-human primates in biomedical research Samenvatting Wereldwijd worden jaarlijks meer dan honderdduizend niet-humane primaten gebruikt in biomedisch onderzoek, vooral in de Verenigde Staten, Europa en Japan. In de Europese Unie gaat het om zo'n tienduizend per jaar, voornamelijk Oude Wereld apen, en met name voor toxicologische en andere veiligheidstesten. Het gebruik van apen in biomedisch onderzoek levert ethische problemen op, terwijl er ook discussie is over de wetenschappelijke kwaliteit van het primatenmodel. Daarom is door middel van literatuurstudie en interviews met betrokkenen geïnventariseerd in hoeverre het gebruik van primaten verminderd of vervangen zou kunnen worden. In fundamenteel wetenschappelijk onderzoek worden regelmatig verschillende (dier)modellen naast elkaar gebruikt en zelden worden argumenten gegeven waarom het primatenmodel gekozen is. Het immuunsysteem lijkt de voornaamste reden te zijn, wat het gebruik van in vitro alternatieven uitsluit. In preklinisch onderzoek blijken, in tegenstelling tot verwachtingen, primaten voornamelijk voor conventionele geneesmiddelen gebruikt te worden. Naast wetenschappelijke argumenten lijken niet-wetenschappelijke een grote rol te spelen in het gebruik van primaten: financiële redenen en eisen van regelgevers belemmeren het gebruik van alternatieven. Voor routinematig veiligheidsonderzoek is de noodzaak van het gebruik van primaten niet aangetoond. Waarschijnlijk neemt voor zowel fundamentele als preklinische doeleinden het gebruik van primaten toe in de nabije toekomst, wat het belang van vervangings- of verminderingsalternatieven onderstreept. De meest veelbelovende alternatieven zijn het gebruik van andere diersoorten, menselijke vrijwilligers of menselijk weefsel en een stapsgewijze aanpak om het gebruik van primaten te doen verminderen.
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