Healthy volunteers in commercial clinical drug trials : when human beings become guinea pigs

163 Pages·2017·2.55 MB·English

by  Mwale

This book provides a richly detailed contribution to the understanding
of healthy volunteer experiences in clinical drug trials in the UK.
Contemporary society, especially the West, has seen a significant
increase in the production and use of pharmaceutical products,
particularly for disease treatment. However, despite the large numbers
of people involved, particularly in the UK, very little is known about
their experiences in commercial phase I clinical drug trials. Shadreck
Mwale critiques common conceptions of the terms ‘volunteer’ and
‘altruism’ as used in policy and practice of human involvement in
clinical trials and calls for an awareness of the complexity of the terms
and how the social contexts participants find themselves in shape acts
of voluntarism. Based on extensive empirical evidence and conceptual
analysis, the book presents new insights into the lives of healthy
volunteers, challenges bioethical conceptions and generates new H
frameworks for policy and practice of FIHCTs. It will be of particular e
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interest to scholars and practitioners in the wider social sciences, l
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medical Sociology and medical anthropology, pharmacology and
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bioethics. C
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Shadreck Mwale is a Senior Lecturer in Applied Social Sciences at nl
icu HEALTHY VOLUNTEERS
the University of Brighton, UK. His research interests are in health, n
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inequalities, use and regulation of medical technological innovations in l te IN COMMERCIAL
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health and human involvement in clinical trials. e
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Shadreck Mwale
ISBN 978-3-319-59213-8
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Healthy Volunteers in Commercial Clinical
Drug Trials
Shadreck Mwale
Healthy Volunteers
in Commercial
Clinical Drug Trials
When Human Beings Become Guinea Pigs
Shadreck Mwale
School of Applied Social Sciences
University of Brighton
Brighton, UK
ISBN 978-3-319-59213-8 ISBN 978-3-319-59214-5 (eBook)
DOI 10.1007/978-3-319-59214-5
Library of Congress Control Number: 2017943647
© The Editor(s) (if applicable) and The Author(s) 2017
This work is subject to copyright. All rights are solely and exclusively licensed by the
Publisher, whether the whole or part of the material is concerned, specifically the rights
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Moriah and Jesse
For always reminding what is really important in life
A
cknowledgements
First and foremost, I owe my biggest debt to writing this book to my
participants,- who took the time to share their experiences and stories
on their journeys as human guinea pigs. You challenged me and opened
my eyes to the hidden world of human involvement in clinical trials.
THANK YOU very much.
Thanks to my colleagues at University of Brighton, Ms. Marylynn
Fyvie-Gauld, Dr. Kepa Artaraz, Dr. Mark Erickson, Prof. Phil Haynes,
and my mentor Prof. Gillian Bendelow, for your unwavering support and
for giving me pause for thought at different stages of putting this book
together. I am also grateful to Dr. Sindi Gordon University of Sussex, for
her creative writing input, and to Dr. Simon Lewis, for always providing
critical feedback on clinical trial processes and practices.
Thanks also to my supervisors Dr. Catherine Will and Dr. Alex
Faulkner, both at University of Sussex, for your support.
I am grateful to all the reviewers, and to the editorial team at
Palgrave, Holly Tyler and Jo O’Neill, for the feedback and for taking me
to task on various oddities to help me tighten my argument throughout
the process of putting this book together.
Last, but not least, the research on which this book is based was
funded by the ESRC; thanks for what was a life-changing financial
support.
vii
viii ACKNOWLEDGEMENTS
Disclaimer: All names of research participants used in this publication
have been replaced with fictitious names to protect their identities. Any
resemblance to real persons, living or dead, is purely coincidental.
c
ontents
1 Healthy Volunteering and Phase I Clinical Drug Trials
in the UK 1
2 Risk, Rewards, and Rational Consent in Healthy
Volunteering 25
3 Risk, Motivation and Decision-making
in Everyday Life: A Phenomenological Approach 47
4 Who Takes Part in Clinical Drug Trials? 59
5 ‘Context Is Everything’: The Reality of Becoming
a Human Guinea Pig 71
6 Economic Exchanges? Healthy Volunteering as
a Form of Labour 87
7 Volunteering for Free Is Dead, Long Live Reciprocity?
Revisiting the Gift Relationship 105
8 When Human Beings Become Guinea Pigs 123
ix
x CONTENTS
References 141
Index 145
A
bbreviAtions
ABPI Association of British Pharmaceutical Industry
CCRU Common Cold Research Unit
CISCRP Centre for Information and Study on Clinical Research Participation
CRO Contract Research Organisation
FDA Food and Drug Administration
GP General Practitioners
HV Healthy Volunteer
ICH International Conference on Harmonisation
MHRA Medicines and Healthcare products Regulatory Agency
NHS National Health Service
ONS Office of National Statistics
REC Research Ethics Committee
TB Tuberculosis
TGN TeGeNero
TOPS The Over-Volunteering Prevention Strategy
WHO World Health Organisation
xi