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The World's Health Care Crisis

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The World's Health Care Crisis The World’s Health Care Crisis This page intentionally left blank The World’s Health Care Crisis From the Laboratory Bench to the Patient’s Bedside By Ibis Sánchez-Serrano AMSTERDAM • BOSTON • HEIDELBERG • LONDON • NEW YORK • OXFORD PARIS • SAN DIEGO • SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO Elsevier 32 Jamestown Road, London, NW1 7BY 225 Wyman Street, Waltham, MA 02451, USA First edition 2011 Copyright © 2011 Elsevier Inc. All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the Publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangement with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are changing constantly. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods, they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress ISBN: 978-0-12-391875-8 For information on all Elsevier publications visit our website at www.elsevierdirect.com This book has been manufactured using Print On Demand technology. Each copy is produced to order and is limited to black ink. The online version of this book will show color figures where appropriate. I dedicate this book to my family, with all my love. Like any Latin family, they have been there for me in the joyful moments and in the difficult times, feeling always very proud of whatever I did, even if they did not quite understand what I was doing. And to my friend Daniel Morand, who has been not only a friend, but also an older brother to me. He has done for me what few people nowadays are capable of doing for others. This page intentionally left blank When you set out on your journey to Ithaca, pray that the road is long, full of adventure, full of knowledge. The Lestrygonians and the Cyclops, the angry Poseidon—do not fear them: You will never find such as these on your path, if your thoughts remain lofty, if a fine emotion touches your spirit and your body. The Lestrygonians and the Cyclops, the fierce Poseidon you will never encounter, if you do not carry them within your soul, if your soul does not set them up before you. Pray that the road is long. That the summer mornings are many, when, with such pleasure, with such joy you will enter ports seen for the first time; stop at Phoenician markets, and purchase fine merchandise, mother-of-pearl and coral, amber and ebony, and sensual perfumes of all kinds, as many sensual perfumes as you can; visit many Egyptian cities, to learn and learn from their sages. Always keep Ithaca in your mind. To arrive there is your ultimate goal. But do not hurry the voyage at all. It is better to let it last for many years; and to anchor at the island when you are old, rich with all you have gained on the way, not expecting that Ithaca will offer you riches. Ithaca has given you the beautiful voyage. Without her you would have never set out on the road. She has nothing more to give you. And if you find her poor, Ithaca has not deceived you. Wise as you have become, with so much experience, you must already have understood what Ithacas mean. —Konstantinos P. Kavafis, Ithaca (1911) This page intentionally left blank Contents Preface xiii Acknowledgments xix Introduction xxi Part I The Global Health Care Crisis 1 1 The World’s Health Care Crisis: The United States’ Leadership 3 The US Health Care Crisis 6 The US Health Care System 9 2 The Health Care Crisis in Other Parts of the World 29 The French Health Care System 30 The UK Health Care System 32 Private Insurance Use in Europe 35 Other Industrialized Nations 38 The Developing World: In Search of Hope 38 The Pharmaceutical Industry 41 Part II Understanding the Biopharmaceutical Business 45 3 A Brief Commercial History of the Biopharmaceutical Industry up to the Year 2000 47 The Pharmaceutical Industry Begins 48 The Swiss Pharmaceutical Industry 51 The English Pharmaceutical Players 52 The United States Enters the Scene 53 Impact of World War I (1914–18) 55 Impact of World War II (1939–45) 57 The Biotechnology Era 60 Regulatory Pathways for Biotechnology 64 4 The Biopharmaceutical Industry in the Twenty-first Century: Titanic Challenges Ahead 71 The Biotechnology Business Crisis 87 The Biopharmaceutical Industry’s Short-Term Solutions to the Crisis 92 x Contents 5 Understanding Research and Development and Marketing in a Biopharmaceutical Company 101 Drug Discovery 103 Drug Development 106 Regulators 108 Intellectual Property 109 Conducting Clinical Trials 110 Types of Drugs 112 Generic Drugs 112 Pricing 114 Marketing 115 6 The Pharmaceutical Regulators 119 Causes of the Drug Approval Lag 120 FDA and EMEA Initiatives to Optimize Drug Approval 121 FDA Critical Path Initiative 123 EMEA’s Road Map to 2010 126 The FDA Amendment Act of 2007 127 Part III The Complexity of Innovation 133 7 The Academia–Industry Relationship 135 8 Translating Academic Innovation into Health Care Products 149 Translating Basic Discoveries into Commercial Products 163 Venture Capitalists 164 Challenges in Translating Innovation into Commercial Products 173 Intellectual Property Rights 176 Taxpayers’ Money for Innovation and Commercial Applications 178 Important Implications for the Developing World 179 9 The Biotechnology World and Its Challenges 183 10 Causes of the Pharmaceutical Crisis 203 Drug Discovery and Development Before Biotechnology 203 Impact of Biotechnology in Drug Discovery and Development 205 Part IV Morality and Duty on a Lonely Planet 215 11 Wealth versus Poverty 217 Medicines for the Developing World: Yes, This Is Our Problem 217 Bridging the Gap? 220 Going Beyond Business 223 Contents xi 12 Social Responsibility, Governmental Role, and Nongovernmental Organizations 229 Part V Reinventing Research and Development 237 13 Time for Reorganization 239 Reorganization of Research and Development at the Industrial Level 242 Translational Research 249 Suggestions for Improving the System 255 Conclusion: Future Trends 261 List of Terms 265 Bibliography 269 This page intentionally left blank Preface This is, precisely, the gravest thing … There are too many intelligent people all over the world who only talk about our problems, but who do not act. If our goal is to save the world, then we need to start a crusade. So, it is not only about publishing a summary of all our ills, but about finding remedies for them. It is about providing the layperson access to a more noble and dignified concept of humankind. —Georges Mathieu (French painter), interviewed by novelist Vintila Horia (Viaje a los centros de la tierra, 1971) Over the last couple of years, many people have asked me, “Ibis, what are you doing with your life?” To this question, I have always replied unequivocally (and not with- out a grain of self-defensiveness), “I am writing a book on the biopharmaceutical industry!” I found it very interesting that most people, many of them with advanced degrees (including physicians) and hailing from several different countries, would invariably bombard me with the following comments after hearing my response: You know, the pharmaceutical industry is a mafia … you are lucky to be alive if you are writing a book about it! Do you know that they spend more money lobbying in Washington, D.C., in mar- keting, and in lavish promotion than they do in R&D? Do you know how power- ful they are and how they work in combination with the government and insurance companies? I am sure you are aware of how they manipulate the scientific and clinical data so that they can pass their drugs through the regulatory systems. Of course, pharmaceutical companies do not like to talk about prevention; in fact, they don’t want to cure diseases, because for them it is more profitable to treat them as chronic ailments. Do you know all the big pharmaceutical companies do in Africa and how they experiment with people? Are you aware of the horrible nature of those experiments, especially in patients with HIV/AIDS? Haven’t you seen the movie [fill-in-the-blank]? Even the recent (and mysterious) outbreak of so-called swine flu, caused by the A(H1N1) virus, has led to speculation on the Internet as to all sorts of conspiracy theories, primarily the theory that this virus was prepared by the pharmaceutical industry to create a pandemic for which they would find the cure and, as such, make massive amounts of money and improve their ailing finances.1 Although these are some of the main (and at times, the only) ideas that many peo- ple all over the world have about the pharmaceutical industry, I need to say, right xiv Preface from the start, that this book is neither a corroboration nor a rejection of these ideas.
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