Double Standards in Medical Research in Developing Countries

This book explores the ethical controversies that have surrounded the design and conduct of international medical research sponsored by industrialized countries or industry, and carried out in developing countries. The chief concern is that research subjects in developing countries may be exploited because sponsors of research employ double standards. One debate focuses on whether the standard of care provided to subjects of medical research in developing countries should be the same as that which research subjects receive in North America and Europe. Another controversy addresses the obligations of sponsors of medical research to provide the successful products of research to the population in developing countries where the research is conducted. Other concerns examined are whether the process of obtaining informed consent in developing countries is adequate, and whether prior ethical review of research meets standards that are well established in the industrialized world. Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable.

RUTH MACKLIN is Professor of Bioethics at Albert Einstein College of Medicine in New York and is one of the founders of bioethics in the United States. Her books include Against Relativism, Enemies of Patients, and Surrogates and Other Mothers. She has also published numerous articles in scholarly and professional journals. Professor Macklin is a past president of the International Association of Bioethics, current vice-president of the Council for International Organizations of Medical Sciences, serves on the editorial board of several journals in bioethics, and is an adviser to the World Health Organization. She was appointed by President Clinton to the Advisory Committee on Human Radiation Experiments, and has served as a member of numerous scientific committees at the National Institutes of Health.

Cambridge Law, Medicine and Ethics

This is a series of books focusing on medical law, but including titles in which both legal and ethical policy issues are discussed. The series is intended to respond to the growing importance of medical law not only in universities and in legal and medical practice, but in public and political affairs. It aims to reflect the fact that many major policy issues over the last few years have had a strong medical law dimension (organ retention, embryonic stem cell research, safety issues etc.). The emphasis is therefore on issues of public concern or practical significance rather than merely on the theoretical dimensions of the subject.

General Editor
Professor Alexander McCall Smith

Editorial Advisory Board
Dr Alexander Morgan Capron, Director, Ethics and Health, World Health Organization
Professor Jim Childress, University of Virginia
Professor Margot Brazier, University of Manchester
Dr Ruth Chadwick, University of Lancaster
Dame Ruth Deech, University of Oxford
Professor Martin Bobrow, University of Cambridge

Books in the series
Marcus Radetzki, Marian Radetzki, Niklas Juth
Genes and Insurance: Ethical, Legal and Economic Issues
0 521 83090 7

Ruth Macklin, Double Standards in Medical Research in Developing Countries
0 521 83388 4 hardback
0 521 54170 0 paperback

Double Standards in Medical Research in Developing Countries

Ruth Macklin

PUBLISHED BY THE PRESS SYNDICATE OF THE UNIVERSITY OF CAMBRIDGE
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CAMBRIDGE UNIVERSITY PRESS
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© Ruth Macklin 2004

This book is in copyright. Subject to statutory exception
and to the provisions of relevant collective licensing agreements,
no reproduction of any part may take place without
the written permission of Cambridge University Press.

First published 2004

Printed in the United Kingdom at the University Press, Cambridge

Typeface Plantin 10/12 pt.   System LATEX 2_e   [TB]

A catalogue record for this book is available from the British Library

Library of Congress Cataloging in Publication data
Macklin, Ruth, 1938–
Double standards in medical research in developing countries / Ruth Macklin.
   p.   cm. – (Cambridge law, medicine, and ethics; 2)
Includes bibliographical references and index.
ISBN 0 521 83388 4 – ISBN 0 521 54170 0 (pbk.)
1. Medical care – Research – Developing countries.   2. Medical ethics – Developing countries.   3. Public health – Research – Developing countries.   I. Title.   II. Series.
RA441.M33   2004   174.2′8 – dc22   2003065532

ISBN 0 521 83388 4 hardback
ISBN 0 521 54170 0 paperback

The publisher has used its best endeavours to ensure that the URLs for external websites referred to in this book are correct and active at the time of going to press. However, the publisher has no responsibility for the websites and can make no guarantee that a site will remain live or that the content is or will remain appropriate.

Contents

Acknowledgments

The author is grateful to the many people – some identified in endnotes, others unnamed – whose words and ideas were invaluable resources for this book. Special thanks go to the individuals and organizations who granted permission to quote their comments on drafts of the 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. I profited greatly from numerous conversations with Reidar Lie, who corrected some errors and provided much food for thought. I benefited from my collaborative work with Alice Page while serving as Senior Consultant to the National Bioethics Advisory Commission on its international project and after the project’s completion. Colleagues on the professional staff of the World Health Organization, the Joint United Nations Program on HIV/AIDS (UNAIDS), and CIOMS made possible my participation in meetings, workshops, and review of research that provided essential information for this book. I am especially indebted in this regard to David Griffin, José Esparza, Peter Piot, and Juhana Idänpään-Heikkilä. I also benefited from and am grateful to the anonymous reviewers of the proposal I submitted for this book to Cambridge University Press.

   Work on the book was begun during a month’s residency at the Rockefeller Foundation’s Bellagio Study and Conference Center in Italy. There can be no better setting for reflection and productive work, and I am most grateful for the opportunity my residency there provided for organizing the book and completing the initial chapters. Several colleagues who were at Bellagio during my stay helped to shape my thinking on critical issues.

   Last but not least, I thank the following people at CUP with whom I worked from beginning to end: Finola O’Sullivan, Nikki Burton, Alison Powell, and Diane Ilott. I am grateful to the General Editor, Alexander McCall Smith, for including this book in the new Cambridge University Press Series.