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Scott H. Podolsky - The Antibiotic Era: Reform, Resistance, and the Pursuit of a Rational Therapeutics

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In The Antibiotic Era, physician-historian Scott H. Podolsky narrates the far-reaching history of antibiotics, focusing particularly on reform efforts that attempted to fundamentally change how antibiotics are developed and prescribed. This sweeping chronicle reveals the struggles faced by crusading reformers from the 1940s onward as they advocated for a rational therapeutics at the crowded intersection of bugs and drugs, patients and doctors, industry and medical academia, and government and the media.

During the postWorld War II wonder drug revolution, antibiotics were viewed as a panacea for mastering infectious disease. But from the beginning, critics raised concerns about irrational usage and overprescription. The first generation of antibiotic reformers focused on regulating the drug industry. The reforms they set in motion included the adoption of controlled clinical trials as the ultimate arbiters of therapeutic efficacy, the passage of the Kefauver-Harris amendments mandating proof of drug efficacy via well-controlled studies, and the empowering of the Food and Drug Administration to remove inefficacious drugs from the market. Despite such victories, no entity was empowered to rein in physicians who inappropriately prescribed, or overly prescribed, approved drugs.

Now, in an era of emerging bugs and receding drugs, discussions of antibiotic resistance focus on the need to develop novel antibiotics and the need for more appropriate prescription practices in the face of pharmaceutical marketing, pressure from patients, and the structural constraints that impede rational delivery of antibiotics worldwide. Concerns about the enduring utility of antibioticsindeed, about a post-antibiotic eraare widespread, as evidenced by reports from the Centers for Disease Control and Prevention, academia, and popular media alike. Only by understanding the historical forces that have shaped our current situation, Podolsky argues, can we properly understand and frame our choices moving forward.

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The Antibiotic Era

The Antibiotic Era

Reform, Resistance, and the Pursuit of a Rational Therapeutics

SCOTT H. PODOLSKY

This book was brought to publication with the generous assistance of the - photo 1

This book was brought to publication with the generous assistance of the Department of Global Health and Social Medicine, Harvard Medical School.

2015 Johns Hopkins University Press

All rights reserved. Published 2015

Printed in the United States of America on acid-free paper

9 8 7 6 5 4 3 2 1

Johns Hopkins University Press

2715 North Charles Street

Baltimore, Maryland 21218-4363

www.press.jhu.edu

Library of Congress Cataloging-in-Publication Data

Podolsky, Scott H., author.

The antibiotic era : reform, resistance, and the pursuit of a rational therapeutics / Scott H. Podolsky.

p. ; cm.

Includes bibliographical references and index.

ISBN 978-1-4214-1593-2 (hardcover : alk. paper) ISBN 1-4214-1593-3 (hardcover : alk. paper) ISBN 978-1-4214-1594-9 (electronic) ISBN 1-4214-1594-1 (electronic)

I. Title.

[DNLM: 1. Anti-Bacterial AgentshistoryUnited States. 2. Drug IndustryhistoryUnited States. 3. Drug ResistanceUnited States. 4. History, 20th CenturyUnited States. 5. Legislation, DrughistoryUnited States. QV 11 AA1]

RM267

615.7922dc23 2014014551

A catalog record 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, including recycled text paper that is composed of at least 30 percent post-consumer waste, whenever possible.

For Roz and Leon Fink,

and in memory of

Lorna and Jack Podolsky

CONTENTS
ACKNOWLEDGMENTS

In many ways, this book grew out of my prior book project, Pneumonia Before Antibiotics, as Ive continued to engage in the clinic and as a historian with issues of therapeutic autonomy, education, regulation, and innovation. Indeed, Jeremy Greene has quipped that I should have titled this book Pneumonia After Antibiotics. Since the publication of Pneumonia, Ive had the great fortune to become director of the Center for the History of Medicine at the Francis A. Countway Library of Medicine, to teach with and learn from fellow members of Harvard Medical Schools Department of Global Health and Social Medicine, to continue to provide primary care to my patients at Massachusetts General Hospital, and to engage with colleagues worldwide attempting to define and promote the rational production and delivery of antibiotics. Ive learned a great deal in the process, and its a privilege to be able to give thanks in this space.

At the Countway, Kathryn Hammond Baker has been a brilliant collaborator, continually positioning our center to support scholarship, while our remarkable staff members always make us look good through their dedication and consistent excellence. Special thanks go to Jack Eckert and Jess Murphy for facilitating (and tolerating) my extensive research on Max Finland in particular; I appreciate them all the more, knowing they work as diligently for all of our centers users. Zak Kohane and Alexa McCray, the Countways director and deputy director, have been supportive of both our center and my own scholarship, as have Jay Jayasankar and Roz Vogel, president and administrative head of the Boston Medical Library. Its an embarrassment of riches to work not only amid the books and journals of the Countway but also amid its remarkable librarians and staff, and Im especially grateful to Elizabeth Bueso, Betsy Eggleston, David Osterbur, and Julia Whalen for their ongoing wisdom and availability.

At Harvard Medical Schools Department of Global Health and Social Medicine, its impossible not to be inspired and influenced by the examples of our leaders, Paul Farmer and Anne Becker. Im personally grateful for their support, as well as that of Jennifer Puccetti and Rebecca Grow, in particular. My esteemed colleagues Allan Brandt and David Jones continue to shape my thinking and support my efforts in many ways, as they have for many years. I am truly fortunate and grateful. Leon Eisenberg provided wise counsel at the start of this book, and hes greatly missed by all who were lucky enough to know him and learn from him. At HMS itself, Dean Jeffrey Flier has created an environment where history is a means not only of celebration but also of critical inquiry. Across the river, Im proud to be affiliated with Harvards History of Science Department and exposed from the one side to such role models as Charles Rosenberg and to fantastic students from the other side. Again, this is an embarrassment of riches.

At the Massachusetts General Medical Group, I continue to learn from both my colleagues and my patients. Im grateful to everyone in the practice, while special thanks go to our groups directors during this project, Steve Levisohn, David Finn, and Amy Schoenbaum, to my office roommate Patty Gibbons, and to my team of Anne Drake, Angela McCaul, Tina Rosado, and Fred Rose, who take such wonderful care of our patients. MGH and its Division of General Internal Medicine provided critical funding at an early stage of the project and have been consistently supportive of my work.

My thinking about the issues examined in this book has evolved considerably over the past decade, and Im honored to thank colleagues who have provided both encouragement and critique. Im especially indebted to my frequent collaborator Jeremy Greene, who generously read through several versions of the manuscript, by which time he had already provided countless leads and shaped my understanding of the history of therapeutics more broadly. Ed Dwyer and Fred Tauber, both long-term mentors, read through the entire manuscript, as did Robert Guidos, Calvin Kunin, John Powers, and Dominique Tobbell, who have been engaged with the issues described here for many years. At Harvard, Ive benefited from discussions with Jerry Avorn, Daniel Carpenter, Yonatan Grad, Ted Kaptchuk, Aaron Kesselheim, and Peter Tishler, while beyond Harvard Ive received valuable input and insights from Robert Bud, Iain Chalmers, Arthur Daemmrich, David Herzberg, Greg Higby, Suzanne Junod, Claas Kirchelle, Jerry Klein, John Lesch, Stuart Levy, Nick Rasmussen, John Swann, Ulrike Thoms, Jo Tricker, Elizabeth Watkins, and the late Mark Finlay. The enduring influence of Harry Marks will be apparent throughout.

I extend particular thanks to the European Science Foundations Drugs Networking Programme and to the hosts of a series of conferences concerning the history (and future) of antibiotics and pharmaceuticals more generally. Christoph Gradmann, Flurin Condreau, Anne Kveim Lie, and Mara Jess Santesmases not only individually influenced my thinking, but they also provided environments where scholars could converse across national and disciplinary boundaries. If the intention of such conferences was to broaden the thinking of participants, then they were wildly successful in my case. Im also grateful to the hosts and audiences at the American Association for the History of Medicine, Beth Israel Deaconess Medical Centers Division of Pulmonary Medicine, the Boston Colloquium on the History of Psychiatry and Medicine, Brigham and Womens Hospitals Division of Pharmacoepidemiology, Clark Universitys Department of Biology, Dartmouth Medical Schools Pathology Research and Review Seminar Series, the Food and Drug Administration, the Massachusetts Infectious Disease Society, multiple venues at Massachusetts General Hospital, the New England Tuberculosis Symposium, and Yale Universitys Program in the History of Science and Medicine for close attention and feedback.

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