Pandemics, Pills, and Politics Stefan Elbe Published by Johns Hopkins University Press Elbe, Stefan. Pandemics, Pills, and Politics: Governing Global Health Security. Johns Hopkins University Press, 2018. Project MUSE. doi:10.1353/book.59674. https://muse.jhu.edu/. For additional information about this book https://muse.jhu.edu/book/59674 [ Access provided at 2 Oct 2021 15:24 GMT with no institutional affiliation ] This work is licensed under a Creative Commons Attribution 4.0 International License. Pandemics, Pills, and Politics This page intentionally left blank Pandemics, Pills, and Politics Governing Global Health Security Stefan Elbe JOHNS HOPKINS UNIVERSITY PRESS BALTIMORE To the Reader: Nothing in, or referenced in, this book should be construed as offering medical advice. Although every effort has been made to ensure the factual accuracy of the contents, no liability can be accepted for any use of the information in the book. This book was brought to publication with the generous assistance of the Euro pean Research Council. © 2018 Johns Hopkins University Press This work is also available in an OA edition, which is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License: https://creativecommons.org/licenses/by-nc-nd/4.0/. All rights reserved. Published 2018. Printed in the United States of Amer i ca on acid- free paper 9 ​8 ​7 ​6 ​5 ​4 ​3 ​2 ​1 Johns Hopkins University Press 2715 North Charles Street Baltimore, Mary land 21218 - 4363 www . press . jhu . edu Library of Congress Cataloging- in- Publication Data Names: Elbe, Stefan, 1975– author. Title: Pandemics, pills, and politics : governing global health security / Stefan Elbe. Description: Baltimore, Mary land : Johns Hopkins University Press, [2018] | Includes bibliographical references and index. Identifiers: LCCN 2017043199 | ISBN 9781421425580 (pbk. : alk. paper) | ISBN 9781421425597 (electronic) | ISBN 1421425580 (pbk. : alk. paper) | ISBN 1421425599 (electronic) Subjects: | MESH: Global Health | Health Policy | Security Measures— trends | Influenza, Human— drug therapy | Phar ma ceu ti cal Research Classification: LCC RA418 | NLM WA 530.1 | DDC 362.1— dc23 LC rec ord available at https:// lccn . loc . gov / 2017043199 A cata log rec ord for this book is available from the British Library. Special discounts are available for bulk purchases of this book. For more information, please contact Special Sales at 410-516-6936 or specialsales@press . jhu . edu. Johns Hopkins University Press uses environmentally friendly book materials, includ- ing recycled text paper that is composed of at least 30 percent post- consumer waste, whenever pos si ble. To Alexander This page intentionally left blank And we must come together to prevent, and detect, and fight every kind of biological danger— whether it’s a pandemic like H1N1, or a terrorist threat, or a treatable disease. — President Barack Obama We will seek to advance access to and effective use of technologies to mitigate the impact from outbreaks of infectious disease, regardless of their cause. — US National Security Council Our nation must have a system that is nimble and flexible enough to produce medical countermea sures quickly in the face of an attack or threat, whether it’s one we know about today or a new one. — US Secretary of Health and Human Ser vices This page intentionally left blank Contents Preface xi Acknowl edgments xiii List of Abbreviations xv 1 Encapsulating Security: Phar ma ceu ti cal Defenses against Biological Danger 1 Part One: The Development Challenges 2 Discovering a Virus’s Achilles Heel: Flu Fighting at the Molecular Scale 31 3 The Pill Always Wins: Gilead Sciences, Roche, and the Birth of Tamiflu 54 Part Two: The Acquisition Challenges 4 What a Difference a Day Makes: The Margin Call for Regulatory Agencies 79 5 Virtual Blockbuster: Bird Flu and the Pandemic of Preparedness Planning 106 Part Three: The Deployment Challenges 6 In the Eye of the Storm: Global Access, Generics, and Intellectual Property 137 7 “Ode to Tamiflu”: Side Effects, Teenage “Suicides,” and Corporate Liabilities 163 8 Data Backlash: Roche and Cochrane Square Up over Clinical Trial Data 184 9 “To Boldly Go . .”: Phar ma ceu ti cal Enterprises and Global Health Security 211 x Contents Epilogue: Phar ma ceu ti cals, Security, and Molecular Life 233 References 237 Index 255 Preface Can a pill strengthen national security? The suggestion may seem odd, but many governments around the world have come to believe pre- cisely that. Several states now consider the ability to rapidly develop new medicines and vaccines critical to their national security. In an intercon- nected world, security is no longer about armed force alone; it also entails protecting populations against a broad spectrum of biological dangers. The spread of a new pandemic, a bioterrorist attack, or even an accidental laboratory release could all cause mass deaths, crippling economic shocks, and widespread societal disruption. Governments are therefore working more closely with companies to develop a new range of phar ma ceu ti cal de- fenses, or “medical countermea sures,” to better protect their populations against such threats. Yet the quest to secure populations pharmaceutically is proving fiendishly difficult to implement in practice. It is also generating a maelstrom of pol- icy dilemmas and controversies along the way: ■ What are the major challenges in developing new medical countermea sures against deadly— but also highly unpredictable— diseases? ■ How do the power dynamics between phar ma ceu ti cal companies, governments, and other actors play out in this quest to develop new phar ma ceu ti cal defenses? ■ ­Will authorities ever get to a point where they can rapidly make lifesaving new medicines available to their populations in response to future outbreaks? In this volume, I explore the growing entanglement of phar ma ceu ti cals and security through an in- depth study of the world’s most prominent medical countermea sure: Tamiflu. Billions of Tamiflu capsules were stockpiled by governments around the world in the fight against pandemic flu. Tens of millions of people have taken the antiviral drug. Yet Tamiflu also attracted scientific controversy xii Preface about its effectiveness for pandemic preparedness. It provoked suspicions about undue commercial influence in government decision making about stockpiles. It even found itself at the center of a prolonged po liti cal battle over who should have access to the data about the safety and effectiveness of medicines. Through the prism of Tamiflu’s previously untold story, this volume reveals the major challenges involved in securing populations pharmaceutically and explores how governments are designing extensive new medical countermea sure regimes to overcome those challenges. At the heart of this phar ma ceu ti cal turn in security policy, I argue, lies something deeper: the rise of a new molecular vision of life that is reshaping the world we live in— including the way we now imagine and practice security. Acknowl edgments This book would never have come to fruition without the support of my family, for which I am deeply grateful. Louiza Odysseos has been a loving, constant, and inspiring intellectual companion to this proj ect over many years. Our three children too showed great patience in the fin- ishing stages of the book, while I inevitably juggled (and often fumbled) the competing demands of authorship and fatherhood. Both my mother and my mother- in- law eased the journey im mensely by frequently volun- teering to help with childcare so that I could undertake the travel required for carry ing out the research proj ect on which the book is based. The book has also benefited greatly from extensive discussions and ex- changes with Anne Roemer- Mahler and Christopher Long, as we worked together on a larger research proj ect exploring the role of phar ma ceu ti cals in security policy over the past couple of years. Along the way, many other friends and colleagues similarly provided intellectual inspiration and helpful feedback, in par tic u lar the members of the Global Health Section at the International Studies Association, the Global Health Working Group of the British International Studies Association, and the Eu ro pean Inter- national Studies Association. Here at the University of Sussex, the work has also benefited from generous feedback and engagement by members of the Department of International Relations, the Centre for Global Health Policy, and the university’s wider Global Health Group. The book is much richer for all of their helpful engagement. Any errors of fact or interpretation remain, of course, entirely my own. I would also like to thank, in par tic u lar, the many people who agreed to participate in the research pro cess. A number of leading prac ti tion ers in in- ternational organ izations, industry, governments, and nongovernmental organ izations provided valuable insights into many of the key themes that form the focus of this book. Some did so through their participation in a stakeholder workshop held at the Royal Institution in February 2014. Many others did so by agreeing to be interviewed for this proj ect. They are too numerous to be listed here (and several wished to remain anonymous), but xiv Acknowl edgments they have my gratitude for being so generous in time and spirit, often agree- ing to quite long and detailed interviews about their involvement with Tamiflu, and sharing their fascinating stories about their encounters with the medicine. Fi nally, I would also like to thank Karis Petty of the Centre for Global Health Policy, who provided valuable help in the final stages of compiling the manuscript. The analy sis presented in this book is shaped extensively by my disci- plinary background in international relations. Themes like security, power, po liti cal economy, globalization, governance, and biopolitics thus reverber- ate throughout the pages to follow. Yet the material also touches upon other debates in the social sciences around global health, the politics of knowl- edge, the study of businesses and management, the wider role of phar- ma ceu ti cals in society, and so forth.