The Cutter Incident


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How America’s First Polio Vaccine Led to the Growing Vaccine Crisis

Paul A. Offit

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Vaccines have saved more lives than any other single medical advance. Yet today only four companies make vaccines, and there is a growing crisis in vaccine availability. Why has this happened? This remarkable book recounts for the first time a devastating episode in 1955 at Cutter Laboratories in Berkeley, California, thathas led many pharmaceutical companies to abandon vaccine manufacture.

Drawing on interviews with public health officials, pharmaceutical company executives, attorneys, Cutter employees, and victims of the vaccine, as well as on previously unavailable archives, Dr. Paul Offit offers a full account of the Cutter disaster. He describes the nation’s relief when the polio vaccine was developed by Jonas Salk in 1955, the production of the vaccine at industrial facilities such as the one operated by Cutter, and the tragedy that occurred when 200,000 people were inadvertently injected with live virulent polio virus: 70,000 became ill, 200 were permanently paralyzed, and 10 died. Dr. Offit also explores how, as a consequence of the tragedy, one jury’s verdict set in motion events that eventually suppressed the production of vaccines already licensed and deterred the development of new vaccines that hold the promise of preventing other fatal diseases.

Paul Offit, M.D., is Chief of Infectious Diseases at the Children's Hospital of Philadelphia and a professor of pediatrics and Maurice R. Hilleman Professor of Vaccinology at the University of Pennsylvania School of Medicine.

"What is causing the shortage of desperately needed vaccines to combat pneumonia, tetanus, chicken pox, measles, mumps and influenza? Why is an effective vaccine for Lyme disease no longer on the market? And what are the consequences for our children? Dr. Paul Offit confronts these vital questions in The Cutter Incident, a brilliant piece of writing about a medical tragedy, exactly fifty years ago, that revolutionized the development and testing of vaccines in the United States, while forever changing the legal culture that had once kept punitive lawsuits under control. Offit’s remarkable book is certain to become a fixture in the increasingly angry battle over the impact of medical liability on the effective treatment of disease."—David M. Oshinsky, author of Polio: An American Story

“Dr. Offit brings us into the entangled world of medicine and law. Readers will have a better understanding of the impact that legal suits have on the vaccine industry, investment, and decisions not to pursue lifesaving vaccines because of liability issues.”—Dean Mason, President and CEO, Sabine Vaccine Institute

"One of the best overviews of vaccines from the vantage of events associated with vaccine safety during an earlier era that I have ever read."—Maurice Hilleman, Merck Institute for Vaccinology

“This book not only brings to life the main actors involved, it also demonstrates how this incident created legal precedents that forever changed product liability laws.”—Roland Sutter, World Health Organization

“Well written and easily understood, yet balanced with enough technical detail for medical professionals to read informatively cover to cover.”—Journal of the American Medical Association

"Infectious diseases remain a primary cause of human suffering and death around the world. As Offit so clearly outlines in The Cutter Incident, solutions must be found to the predicaments that contribute to the lack of vaccines against many of these diseases."—David L. Heymann, New England Journal of Medicine

"Dr. Offit is a gifted writer with a knack for boiling down the historic, technical, medical mystery and legal strands of his story into a clear, concise narrative with the pacing and tension more typical of a thriller than one would expect of a work of scholar. . . . The author builds a plausible case that the no-fault liability verdict has let us forget that medical advance is a matter of trial and error, and that few new life-saving medicines can ever by both totally effective and completely harmless."—New York Law Journal

"A comprehensive and readily comprehensible account that seamlessly moves from historical narrative through technical exposition, mystery thriller, courtroom drama, and legal review to social commentary. . . . The Cutter Incident offers a concise and thoroughly documented account (well illustrated with rare period photos) of a medical tragedy and its continuing consequences. Offit presents a powerful case for a far more enlightened approach to the development and use of lifesaving vaccines."—Olen Kew, Science

"[A] fascinating and deeply troubling account."—Shannon Hendrickson, SciTech Book News

"Paul Offit, a physician, achieves an almost thrillerlike intensity with a fast-paced account of the many tribulations and errors that preceded the Salk vaccine's momentous triumph."—Wilson Quarterly

"Enthralling. . . . The Cutter Incident is an absolute model of its genre. It is so tautly written that it reads like a good thriller, such that one is eager to find out what happened next. Offfit conveys the science with admirable clarity, and he presents the philosophical and legal issues simply but without simplifications. It is the best kind of medical history."—Theodore Dalrymple, City Journal

"Offit . . . has written a fascinating and highly readable account of the development of the polio vaccine. He also offers a compelling plea for a strengthened law to provide relief to companies that produce vaccines so that our nation may be afforded the most cost-effective and long-lasting form of prevention against many infectious diseases—an effective vaccine."—Stanley Goldfarb, New York Post

"The best account you will ever read about the interplay between big drug companies and bigger government."—Peter Huber, Forbes

"Written at a level the layperson will understand, but still engaging for readers with a health care background, the book is a quick and interesting read. . . . The book is a worthwhile read that will expand the reader's understanding of the history and context of early vaccination efforts in the United States. It skillfully recounts the story of the first polio vaccine and clearly shows how liability concerns keep pharmaceutical companies from releasing new vaccines, particularly those vaccines that are intended for children and pregnant women."—Christina Cameli, Journal of Midwifery and Women's Health

"Wonderful."—Scott Barrett, Health Affairs

"This is an extraordinary book. . . . What makes this book extraordinary is the author's ability to weave the well-known and less well-known historical events into a compelling and thought-provoking essay on the challenging vaccine issues of the day. . . . I recommend this thoughtful book to everyone."—Walter R. Dowdle, Microbe

"The book is very well written and reads almost like a detective story, with a nice balance between personal anecdotes and new materials not discussed in other accounts of the Cutter incident. It draws on meticulous archival documentation and on interviews with public health officers, pharmaceutical company executives, Cutter employees, and victims of the partially inactivated vaccine. . . . An important and valuable contribution."—Nadav Davidovitch, Isis
ISBN: 9780300126051
Publication Date: September 28, 2007
256 pages, 6 1/8 x 9 1/4
25 b/w illus.