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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 market (see Box 8.7). <strong>The</strong>se withdrawals were mainly due to inadequate evidence <strong>of</strong> efficacy in widespread clinical use, loss <strong>of</strong> therapeutic interest or poor market performance. To what extent the withdrawal <strong>of</strong> medicines can be attributed exclusively, or in part, to the use <strong>of</strong> <strong>animals</strong> in <strong>research</strong> would need to be assessed in individual cases (see paragraphs 10.27–10.43). 46 Box 8.6: Medicines withdrawn in the UK for safety reasons 1995–2005 Name <strong>of</strong> medicine (brand name ) Year action taken Primary safety concerns Naftidr<strong>of</strong>uryl oxalate injection 1995 Cardiotoxicity (Praxilene) Pemoline (Volital) 1997 Liver toxicity Troglitazone (Romazin) 1997 Liver toxicity Fenfluramine (Ponderax) 1997 Heart valve disease Dexfenfluramine (Adifax) 1997 Heart valve disease Sertindole (Serdolect)* 1998 Disorders <strong>of</strong> heart rhythm Tolcapone (Tasmar)† 1998 Liver toxicity Mibefradil (Posicor) 1998 Drug interactions Trovafloxacin (Trovan)‡ 1999 Liver toxicity Grepafloxacin (Raxar) 1999 Disorders <strong>of</strong> heart rhythm Pulmonary surfactant (Alec) 2000 Increased mortality Cisapride (Prepulsid) 2000 Disorders <strong>of</strong> heart rhythm Droperidol (Droleptan) 2001 Disorders <strong>of</strong> heart rhythm Cerivastatin (Lipobay) 2001 Muscle toxicity Levacetylmethadol (Orlaam) 2001 Cardiac arrhythmias Kava kava 2003 Liver toxicity R<strong>of</strong>ecoxib (Vioxx) 2004 Myocardial infarction/stroke Valdecoxib (Bextra) 2005 Serious skin reactions * Sertindole has since been reintroduced under very restricted conditions. ‡ Tasmar, Trovan and Orlaam were licensed through the centralised procedure with the European Commission as the Licensing Authority. ‡ Trovafloxacin was never marketed in the UK. Source: MHRA 46 See also Chapter 6, footnote 40. 148
T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s Box 8.7: Medicines withdrawn from the market* Between 1961 and 1992 a total <strong>of</strong> 131 medicines were withdrawn from France (63), Germany (58), UK (49) and USA (41) (note that some were withdrawn from more than one country). Only ten were withdrawn in all four countries. In the UK the 49 withdrawn medicines can be separated into four groups, as follows: 1) Medicines withdrawn after long-term use, which were marketed before detailed animal or clinical tests, or in use despite known toxicity, and later replaced by a medicine for the same indication with less toxicity Product Year <strong>of</strong> launch Year withdrawn Aspirin (paediatric form) 1899 1986 Aminopyrine 1900 1975 Clioquinol 1930 (1900) 1981 Dipyrone 1930 1977 Oxyphenisatine 1955 1978 Oxyphenbutazone 1962 1984 Phenacetin 1900 1980 Phenformin 1959 1982 2) Medicines withdrawn because <strong>of</strong> toxicity (generally carcinogenicity) revealed by animal tests that were continued after launch Product Year withdrawn Alcl<strong>of</strong>enac 1979 Chlormadinone 1970 Danthron 1987 Fencl<strong>of</strong>enac 1984 Indopr<strong>of</strong>en 1983 Megestrol 1970 Methapyrilene 1979 Polidexide 1975 3) Medicines withdrawn for reasons unrelated to standard investigation <strong>of</strong> toxicity (i.e. particular type <strong>of</strong> toxic effect apparent after launch) Product Alphaxalone Cromoglycate (eyedrops) Desensitising vaccines Doxylamine Factor VIII Growth hormone (natural) Guanethidine (eyedrops) Indomethacin-R Mebanazine Nialamide Phenoxypropazine Thalidomide Zomepirac Reason for withdrawal Allergy to excipient New formulation (untested) Allergy Alleged teratogenicity Risk <strong>of</strong> AIDS transmission Possibility <strong>of</strong> CJD transmission New formulation (untested) New formulation (untested) Toxic interaction with diet or other drugs Toxic interaction with diet or other drugs Toxic interaction with diet or other drugs Teratogenicity not tested for Allergy CHAPTER 8 THE USE OF ANIMALS FOR RESEARCH IN THE PHARMACEUTICAL INDUSTRY Continued 149
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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 2 Use of <
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Chapter 5 The use
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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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