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Why Animal Studies Are Still Being Used in Drug Development

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Why Animal Studies Are Still Being Used in Drug Development WHY ANIMAL STUDIES ARE STILL BEING USED IN DRUG DEVELOPMENT AN INNOVATION SYSTEM PERSPECTIVE Examination committee: Prof. dr. I. Kimber, University of Manchester Dr. J. Mittra, University of Edinburgh Prof. dr. A.H.L.M. Pieters, Utrecht University Prof. dr. B. Silva-Lima, University of Lisbon Prof. dr. C.N. van der Weele, Wageningen University ISBN 978-90-6464-735-2 Copyrigtht © 2013 M. Kooijman c/o Faculty of Geosciences, Utrecht University Lay-out: Irma Chaigneau DWARSE produkties Cover: Irma Chaigneau DWARSE produkties Printing: GVO drukkers & vormgevers B.V. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission by the author. WHY ANIMAL STUDIES ARE STILL BEING USED IN DRUG DEVELOPMENT AN INNOVATION SYSTEM PERSPECTIVE Waarom dierproeven nog steeds worden gebruikt in medicijnontwikkeling Een innovatiesysteem perspectief (met een samenvatting in het Nederlands) PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit Utrecht op gezag van de rector magnificus, prof. dr. G.J. van der Zwaan, ingevolge het besluit van het college voor promoties in het openbaar te verdedigen op vrijdag 20 december 2013 des middags te 12.45 uur door Marlous Kooijman geboren op 10 mei 1984 te Culemborg Promotoren: Prof. dr. M. P. Hekkert Prof. dr. H. Schellekens Prof. dr. E. H. M. Moors The studies presented in this thesis were performed in the context of the predictive value of animal testing project (T6-301), a project of the Dutch Top Institute Pharma. Printing of this thesis was kindly supported by Nefarma and Stichting Proefdiervrij. TABLE OF CONteNTS 1. INTRODUCTION 9 1.1 Background 9 1.2 Objectives and research question 15 1.3 Thesis outline 16 2. THEORETICAL BACKGROUND 17 2.1 Insights from innovation theory 17 2.2 Lock-in, institutional theory and innovation 19 3. RESEARCH DESIGN 23 3.1 Substituting animal studies in established drug development processes 23 3.2 Adopting innovative methods in novel drug development processes of new drug classes 25 4. CONCLUSION & DISCUSSION 28 4.1 Understanding the lock-in of animal studies in drug development 28 4.2 Escaping the lock-in of animal studies in drug development 37 4.3 Theoretical contribution 40 4.4 Final considerations 42 5. REFERENCES 43 ANNEXES 53 ANNEX I How institutional logics hamper innovation: the case of animal testing 55 ANNEX II How institutional logics influence innovation: the case of animal testing 83 ANNEX III The value of nonhuman primates in the development of monoclonal antibodies 115 ANNEX IV Immunogenicity of mAbs in non-human primates during nonclinical safety assessment 133 ANNEX V Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance? 151 ANNEX VI The risk-based approach to ATMP development – Generally accepted by regulators but infrequently used by companies 163 SUMMARY 183 SAMENVATTING 191 DANKWOORD 201 ABOUT THE AUTHOR 205 ABBREVIATIONS 206 LiST OF PUBLICATIONS 207 WHY ANIMAL STUDIES ARE STILL BEING USED IN DRUG DEVELOPMENT 1 1. INTRODUCTION INTRODUCTION 1.1 BACKGROUND Animal studies have played a leading part in drug development1 ever since modern medicine regulation started in the first half of the 20th century. At that time, governments experienced that more regulation was necessary to guard citizens from possible adverse effects of drugs as a consequence of the increasing role of drugs in everyday life and the Elixir Sulfanilamide2 tragedy in 1937 (Rägo & Santoso, 2008; Hartung & Daston, 2009). As a result of this tragedy and the increasing role of drugs in society, the Federal Food, Drug and Cosmetic Act was implemented in the United States in 1938. This act required a premarket proof-of-safety for new drugs (Food and Drug Administration, 2012). The Thalidomide3 disaster in the late 1950s influenced the development of medicines far more, as it totally reshaped regulatory systems for drugs. With the introduction of the Kefauver-Harris amendment in the United States in 1962, it became required that all new drugs had to be approved by the Food and Drug Administration (FDA) to gain market authorization. Approval could be gained based on proven efficacy and safety. Other countries followed and introduced similar acts such as Directive 65/65/EEC in the European Economic Community in 1965. In that way animal models became the gold standard to demonstrate safety and efficacy of drug for humans. As pharmaceutical markets became more globalized in the 1980s, animal studies became entrenched in international test guidelines of the Organisation for Economic Co-operation and Development (OECD) and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Nuffield Council on Bioethics estimated that new drugs have to be tested in between 1500-3000 animals just for the safety assessment to gain market authorization (Nuffield Council on Bioethics, 2005). Many of the animal studies required by the legislation today were developed under crisis conditions such as the Elixir Sulfanilamide and Thalidomide tragedies (Abbott, 2008). As a result, the value of these animal studies to predict human risk has never undergone rigorous validation (Abbott, 2008). Most animal studies in the drug development process have relied on face validity (empirical evidence based on 1 Drug development includes the safety, efficacy and quality assessment of drugs. 2 Nearly 100 people died after ingesting a drug called Elixir Sulfanilamide in 1937. 3 In the late 1950s, the sedative drug, Thalidomide, was used to cure morning sickness for pregnant women, among others. The drug was withdrawn from the market in 1961 because it caused severe birth defects. 9 observations that the experiment ‘looks like’ it is measuring what it is supposed to measure), but construct validity (whether it actually measures what we think it measures) has often not been determined (Della Pasqua, 2013). It is remarkable that the construct validity of animal studies is rarely rigorous assessed. Animals are in many respects different from humans (McMaster, 1993; Kola & Landis, 2004; Hartung, 2009; Khanna, 2012; Gori, 2013a), especially considering that the results of animal studies in apparently closely related species, as for example rats and mice, often not correspond (Rowan, 2007; Gori, 2010; Hartung, 2009, 2010). Modeling the effect of drugs on humans in animals is usually a trial-and-error process. A priori it is unknown if a given model will faithfully reproduce the effect of drugs on humans (Editorial, 2008). The predictive value of animal studies for human risks becomes even more uncertain when conducted to assess drugs for human specific diseases or to assess drugs based on human specific targets and structures. Around the start of the 21st century, the value of animal studies has gained increasing attention of researchers. Scientists at pharmaceutical companies and universities explored and criticized the value of animal studies in drug development (Igarashi et al., 1995; Olsen et al., 2000; Robinson et al., 2008; Hartung, 2008, 2009, 2011; Francia & Kerbel, 2010; Hunter et al., 2011; Begley & Ellis, 2012; Gori, 2013, 2013a; Van Meer et al., 2012, 2013; Rice, 2012; Laurijssens et al., 2013; Seok et al., 2013). The results of these studies support the presumption that animal experiments frequently have limited value in assessing the safety, efficacy and quality of drugs for humans. However, these studies to determine the value of animal experiments have limitations usually due to limited and/or biased datasets. More research is necessary to get a clear picture of the value of animal studies in drug development. The limited value of animal studies to predict human outcomes is an incentive for pharmaceutical companies to search for methods with a higher predictive value. The limited predictive value of animal studies results in the loss of valuable drugs and makes animal studies a slippery slope to clinical trials as it provides a false sense of safety. The attrition rate during clinical trials, the most expensive and time consuming phases of drug development, is high. Almost nine out of ten new drugs that enter clinical trials fail despite often encouraging results in animals studies (DiMasi et al., 2003; Kola & Landis, 2004; Rang, 2006; Paul et al., 2010). The research and development (R&D) efficiency of the pharmaceutical industry would benefit from innovative methods that 10 1 INTRODUCTION are more predictive for the effect of the use of drugs in humans than animal studies (Kola & Landis, 2004; Lindner, 2007; Paul et al., 2010; Mittra et al., 2011; Pammolli et al., 2011; Elebring, 2012; Khanna, 2012; Moggs et al., 2012; Ekins et al., 2013; Moreno & Pearson, 2013; Muthas et al., 2013). Furthermore, the opposition towards animal studies is as old as its use. Scientists and animal welfare organizations have attempted to create awareness about the limited value of animal studies to predict hazards for humans and about the ethical and economic issues related to the use of animal studies. The campaigns of animal welfare organizations that targeted at the use of animal studies in especially the development of cosmetics started to pay off in the European Union at the end of the 1970s (Salem & Rowan, 2001). Since then animal studies gained more public attention and were put on political agendas. In 1986, the European Union implemented Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes. This Directive intended to protect laboratory animals and to reduce the number of animal studies. On the one hand, the Directive required that animal studies should not be performed when alternative methods exist and on the other hand, it encouraged the development of innovative animal-free methods and testing strategies to substitute animal studies (referred to as ‘innovative methods’ in the remainder of this thesis) (European Economic Community, 1986).
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