Antibiotics The Perfect Storm
Antibiotics are truly miracle drugs. As a class, they are one of the only ones that actually cure disease as opposed to most drugs that only help relieve symptoms or control disease. Because bacteria that cause serious disease in humans are becoming more
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David M. Shlaes
Antibiotics The Perfect Storm
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David M. Shlaes Anti-infectives Consulting, LLC Montauk Avenue 219 06378 Stonington CT, USA [email protected]
ISBN 978-90-481-9056-0 e-ISBN 978-90-481-9057-7 DOI 10.1007/978-90-481-9057-7 Springer Dordrecht Heidelberg London New York Library of Congress Control Number: 2010934450 © Springer Science+Business Media B.V. 2010 No part of this work may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording or otherwise, without written permission from the Publisher, with the exception of any material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
To Jan for years of hard work, patience, understanding, love and support.
David M. Shlaes MD, PhD has had a 30-year career in anti-infectives spanning academia and industry with a long-standing scientific interest in antimicrobial resistance. In 1991 he was appointed Professor of Medicine at Case Western Reserve University. In 1996, Dr. Shlaes became vice president for Infectious Diseases at Wyeth Research for 6 years, assuming responsibility for the strategic direction for infectious diseases within Wyeth. In 1998 Dr. Shlaes was the cover feature in the April issue of Business Week dedicated to antibiotics research. In 2002, Dr. Shlaes became executive vice president, Research and Development for Idenix, Pharmaceuticals, a company located in Cambridge, MA, focused on the discovery and development of antivirals. In 2005, he left Idenix to form a consulting company for the Pharmaceutical Industry (Anti-Infectives Consulting, LLC). He was recently an independent director for Novexel, S.A, an anti-infectives biotech in Paris that was just sold to Astra-Zeneca. He consults for a number of other anti-infective focused biotechs and frequently works with VC firms in the evaluation of anti-infective companies.
Contents
1 The Perfect Storm . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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2 The Miracle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3 Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antibiotics for Animals and Crops Lead to Resistance for People In Our Hospitals, Things Are Getting Critical . . . . . . . . . . Antibiotic Resistance Plus Toxin Production Equals Death . . . Our Communities are Not Spared . . . . . . . . . . . . . . . . . Resistance – Summing Up . . . . . . . . . . . . . . . . . . . .
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4 The FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . We Need Them, but They Have Become Part of the Problem . . The FDA Increases Clinical Trial Design Stringency and Costs. Companies Abandon Antibiotic Research . . . . . . . .
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