Adverse Reactions: The Fenoterol Story

230 Pages·2007·1.534 MB·English

by  Neil Pearce

Adverse reActions
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Adverse reActions
the Fenoterol story
neil PeArce
AucklAnd university Press
First published 2007
Auckland University Press
University of Auckland
Private Bag 92019
Auckland
New Zealand
www.auckland.ac.nz/aup
© Neil Pearce
isbn 978 1 86940 374 4
National Library of New Zealand Cataloguing-in-Publication Data
Pearce, Neil.
Adverse reactions : the Fenoterol story / Neil Pearce.
isbn 978-1-86940-374-4
1. Fenoterol. 2. Asthma—Research. 3. Asthma—Research—New
Zealand. 4. Asthma—Mortality. 5. Asthma—New Zealand—
Mortality.
I. Title.
616.238061—dc 22
This book is copyright. Apart from fair dealing for the purpose of private study,
research, criticism or review, as permitted under the Copyright Act, no part
may be reproduced by any process without prior permission of the publisher.
Cover design: Spencer Levine, Base Two
Printed by Printlink Ltd, Wellington
This book is dedicated to my parents
(Arthur and Peggy Pearce)
and my family (Lynette, Anna, Lucy)
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contents
List of Figures viii
List of Tables ix
Abbreviations x
Beta agonists (and brand-names) x
Foreword xi
Acknowledgements xiii
Introduction 1
Chapter 1 Some history 3
Chapter 2 History is rewritten 23
Chapter 3 History repeats itself 31
Chapter 4 ‘Maybe these drugs are not all the same’ 45
Chapter 5 The first study 61
Chapter 6 Getting the paper published 83
Chapter 7 Adverse reactions 114
Chapter 8 The second study 134
Chapter 9 Mixed reactions 144
Chapter 10 Positive reactions 164
Conclusion Parting shots 176
Notes 194
Bibliography 206
Index 212
list of Figures
Figure 1: Asthma deaths per 100,000 per year in the
5- to 34-year age-group in New Zealand,
Australia, England and Wales, and the
USA during 1910–1960 6
Figure 2: Asthma deaths per 100,000 per year in
the 5- to 34-year age-group in New
Zealand, England and Wales, Australia,
West Germany, Canada and the United
States during the 1960s and 1970s 8
Figure 3: Sales and prescriptions of beta agonist
inhalers (thousands) and asthma deaths
per 100,000 per year in the 5- to 34-year
age-group in England and Wales during
the 1960s 11
Figure 4: New Zealand isoprenaline forte sales per
capita and asthma deaths per 100,000 in the 5-
to 34-year age-group between 1962 and 1988 34
Figure 5: New Zealand beta agonist sales (millions of
doses and asthma mortality per 100,000 in
the 5-to 34-year age-group 40
Figure 6: New Zealand inhaled corticosteroid sales
and asthma mortality per 100,000 in the
5–to 34-year age-group 43
Figure 7: New Zealand asthma mortality per 100,000
and fenoterol market share (%) 47
Figure 8: Cardiac side-effects of fenoterol, isoprenaline,
salbutamol and placebo – as indicated by the
effects on the QS2 Index (QS2I) 53
Figure 9: Design of the first case-control study 135
Figure 10: Design of the second case-control study 136
Figure 11: New Zealand asthma mortality and fenoterol
sales 175
viii
list of tables
Table 1: Hypothetical data from a study of deaths in
asthmatics followed during 1981–83 78
Table 2: Hypothetical data from a study of deaths in
asthmatics followed during 1981–83, and a
sample of those who did not die 78
Table 3: Numbers of cases and controls prescribed
fenoterol 79
Table 4: Numbers of cases and controls prescribed
fenoterol, stratified by asthma severity (based
on an asthma hospital admission during the
previous 12 months) 81
Table 5: Numbers of cases and controls prescribed
fenoterol in various subgroups of asthma
severity 81
Table 6: Numbers of cases and controls prescribed
fenoterol and salbutamol in the second case-
control study 137
Table 7: Numbers of cases and controls prescribed
fenoterol in various subgroups of asthma
severity 138
ix