Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts PDF
Preview Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts
MEDICAL PROOFS, SOCIAL EXPERIMENTS This page has been left blank intentionally Medical Proofs, Social Experiments Clinical Trials in Shifting Contexts Edited by CATHERINE WILL University of Sussex, UK TIAGO MOREIRA Durham University, UK First published 2010 by Ashgate Publishing Published 2016 by Routledge 2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN 711 Third Avenue, New York, NY 10017, USA Routledge is an imprint of the Taylor & Francis Group, an informa business Copyright © Catherine Will and Tiago Moreira 2010 Catherine Will and Tiago Moreira have asserted their right under the Copyright, Designs and Patents Act, 1988, to be identified as the editors of this work. All rights reserved. No part of this book may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers. Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. British Library Cataloguing in Publication Data Medical proofs, social experiments : clinical trials in shifting contexts. 1.Clinical trials--Social aspects. I. Will, Catherine. II. Moreira, Tiago. 615.5'0724-dc22 Library of Congress Cataloging-in-Publication Data Medical proofs, social experiments : clinical trials in shifting contexts / [edited] by Catherine Will and Tiago Moreira. p.cm. Includes bibliographical references and index. ISBN 978-0-7546-7928-8 (hardback) -- ISBN 978-0-7546-9832-6 (ebook) 1. Clinical trials. 2. Drug approval. I. Will, Catherine. II. Moreira, Tiago. [DNLM: 1. Clinical Trials as Topic. 2. Drug Approval--methods. QV 771] R853.C55M42 2010 615.5072'4--dc22 2010030306 ISBN 9780754679288 (hbk) ISBN 9781315594675 (ebk) Contents List of Contributors vii Introduction: Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts 1 Catherine Will and Tiago Moreira PART I: THE PRACTICES OF RESEARCH 1 Reconciling Research with Medical Care in RCTs 17 Stefan Timmermans 2 Bridging the Ontological Divide: Different Social Worlds in the Conduct of a Pilot Study 33 Ben Heaven 3 From Dirty Data to Credible Scientific Evidence: Some Practices Used to Clean Data in Large Randomised Clinical Trials 49 Claes-Fredrik Helgesson PART II: FRAMING COLLECTIVE INTERPRETATION 4 Addressing the Commercial Context: The Collective Critique of Clinical Trials 67 Catherine Will 5 When are Trials Not Enough? Clinical Versus Cost-effectiveness in the Controversy Over Access to Dementia Drugs in the NHS 85 Tiago Moreira vi Medical Proofs, Social Experiments PART III TESTING THE LIMITS FOR POLICY 6 Comparing Artificial Groups: On the History and Assumptions of the Randomised Controlled Trial 103 Trudy Dehue 7 Pragmatic Fact-making: Contracts and Contexts in the UK and the Gambia 121 Ann Kelly 8 Trial, Trial, Trial Again: Reconstructing the Gold Standard in the Science of Prostate Cancer Detection 137 Alex Faulkner Conclusion: So What? 153 Tiago Moreira and Catherine Will Bibliography 161 Index 183 List of Contributors Trudy Dehue: Department of Psychology esp. Principles and History, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, The Netherlands. Email: [email protected]. Alex Faulkner: Centre for Biomedicine & Society, School of Social Science & Public Policy, King’s College London, Strand Building (6th Floor), Strand, London, WC2R 2LS. Email: [email protected]. Ben Heaven: Institute of Health & Society, Newcastle University, Medical Sciences New Build, Richardson Road, Newcastle upon Tyne, NE2 4AX. Email: [email protected]. Claes-Fredrik Helgesson: Department of Thematic Studies – Technology and Social Change, Linköping University, SE-581 83 Linköping, Sweden. Email clae- [email protected]. Ann Kelly: Anthropologies of African Biosciences Research Group, Health Policy Unit, London School of Hygiene and Tropical Medicine, 15–17 Tavistock Place, London, WC1H 9SH. Email: [email protected]. Tiago Moreira: School of Applied Social Sciences, Durham University, 32 Old Elvet, Durham, DH1 3HN. Email: [email protected]. Stefan Timmermans: UCLA Department of Sociology, 266 Haines Hall, Los Angeles, CA90095-155, United States. Email: [email protected]. Catherine Will: Department of Sociology, University of Sussex, Friston Building, Falmer, Brighton, BN1 9SP. Email: [email protected]. This page has been left blank intentionally Introduction Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts Catherine Will and Tiago Moreira What kinds of ‘work’ must be done, and in what locations, to make credible medical proofs? Who and what is involved in the production and articulation of evidence to inform decisions about the organisation and distribution of healthcare in contemporary societies? In this collection we explore the importance and continued evolution of the controlled clinical trial as a key technique for producing evidence in medicine, and for mediating between pharmaceutical companies, clinicians, governments and the public. In the first half of the 20th century a number of different methodological factors came together to inform new experimental approaches to estimating the effects of treatments, through comparisons between different groups of patients. The use of randomisation to create these comparison groups, and the emphasis on further techniques such as blinding to manage clinical optimism, became increasingly important as trial methodology became standardised as part of efforts to manage the claims made by the pharmaceutical industry (Marks, 1997). Since the institutionalisation, in the 1960s, of the requirement to demonstrate clinical efficacy as well as safety in order to obtain therapeutic marketing licences in the United States and Europe, randomised controlled trials (RCTs) have been an integral part of drug research and development. Indeed the organisation of trials is now a sizeable industry in its own right, consuming many billions of dollars from global pharmaceutical spending on research and development every year.1 Increasingly such trials have not only been used to adjudicate on safety or efficacy, but also to help understand the everyday value of treatments and set priorities for spending across health care organisations. In this context, there has been an increase in trials designed to assess ‘effectiveness’, defined as the benefit of an intervention under usual conditions (rather than the ‘ideal’ conditions produced in a highly controlled efficacy trial). Meanwhile governments have supported a wide range of trials directly, filling in the gaps left by commercial R&D. In the UK since the 1990s these aims have been furthered by the Health 1 Global pharmaceutical spending was approximately $55 billion in 2000, 40% of which was dedicated to clinical trials of new drugs (http./ec.europa.eu/internal_market/ indprop/docs/invent/patentingdna_en.pdf).
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