The Cutter Incident: How America's First Polio Vaccine Led to the Growing Vaccine Crisis

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Overview

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.

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Editorial Reviews

David M. Oshinsky
"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
Dean Mason
“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
Maurice Hilleman
"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
Roland Sutter
“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
JAMA
“Well written and easily understood, yet balanced with enough technical detail for medical professionals to read informatively cover to cover.”
New England Journal of Medicine - David L. Heymann
"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
New York Law Journal
"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
Science - Olen Kew
"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
SciTech Book News - Shannon Hendrickson
"[A] fascinating and deeply troubling account."—Shannon Hendrickson, SciTech Book News
The British Medical Journal - Jonathan R Carapetis
'The Cutter Incident is an enjoyable read, at times like a detective thriller, at others like a courtroom drama.' - Jonathan R. Carapetis, The British Medical Journal
Wilson Quarterly
"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
City Journal - Theodore Dalrymple
"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 simplications. It is the best kind of medical history."—Theodore Dalrymple, City Journal
New York Post - Stanley Goldfarb
"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
British Medical Journal - Jonathan R. Carapetis
"Offit describes the development of polio vaccine, from trials of early vaccines through to the appearance on the scene of Jonas Salk. . . . The Cutter Incident is an enjoyable read, at times like a detective thriller; at other times like a courtroom drama. . . . [The book] reminds us how close we have been and indeed still are—to losing immunisation as our most effective public health tool."—Jonathan R. Carapetis, British Medical Journal
Forbes - Peter Huber
"The best account you will ever read about the interplay between big drug companies and bigger government."—Peter Huber, Forbes
Journal of Midwifery and Women's Health - Christina Cameli
"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
Health Affairs - Scott Barrett
"Wonderful."—Scott Barrett, Health Affairs
Microbe - Walter R. Dowdle
"This is an extraordinary book. . . . What makes this book extraordinary is the author's ability to weave the well-known and less-weel-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
Isis - Nadav Davidovitch
"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
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Product Details

  • ISBN-13: 9780300126051
  • Publisher: Yale University Press
  • Publication date: 9/28/2007
  • Pages: 256
  • Sales rank: 1,451,679
  • Product dimensions: 6.00 (w) x 9.10 (h) x 0.60 (d)

Meet the Author

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.

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Sort by: Showing all of 2 Customer Reviews
  • Anonymous

    Posted September 26, 2007

    An excellent historical review of early polio vaccine development

    This is an excellent book. The Cutter Incident chronicles the development of the first successful polio vaccine, and the tragic problems associated with the 1955 vaccine supply. Fortunately, many important safeguards were instituted so that we would not experience a second 'Cutter Incident.'... Offit is correct that current liability trends discourage vaccine development just as misleading media reports and inflammatory books and Internet sites have called into question the obvious benefits of vaccination... Kuddos for Dr. Offit.

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  • Anonymous

    Posted December 30, 2005

    Author Proves His Opponents' Case

    This is a truly bizarre book. Somehow the author Paul Offit, MD, believes that telling a gripping story about the massive scientific, regulatory and industrial failures that lead to hundreds of thousands of people in 1955 being injected with a vaccine containing live polio viruses which resulted in thousands of people paralyzed for life and hundreds of deaths, would persuade people now that vaccine manufacturers should be shielded from any legal liability for their products. That in a nutshell is the purpose of this book. The first 130 pages tells the compelling story of the development of the polio vaccine and how a batch of polio vaccine made by Cutter Laboratories actually gave people the disease it was designed to prevent. This section is followed by a forty-page analysis of the legal consequences of the Cutter incident that verges on incoherence. Here Offit seems to make the classic mistake of physicians who assume they are the leading authority in the room on all subjects. Somehow Offit believes that a fundamental injustice to the vaccine industry occurred when juries found that Cutter Laboratories was liable for the damage created by their product. In Offit¿s analysis, as long as the pharmaceutical company thought the vaccine was safe, injured people should have no legal recourse. It would seem obvious that shielding firms from liability creates exactly the kind of environment where Cutter-type incidents would breed. This section is followed by a brief polemic, more of a rant, filled with factual errors, demanding the laundry list of political favors lusted after by the pharmaceutical industry. These demands go far beyond ¿tort reform,¿ the pharmaceutical industry is calling for the repeal of basic constitutional rights and the undermining of basic principles of American law to suit the short-term profit needs of a generously campaign-donating industry. While stating his academic and hospital associations, the book fails to disclose significant and relevant details of Offit's own financial and business dealings. In addition to being the leading vaccine promoter in the US, just google him, he is also a vaccine developer and business partner with Merck, GlaxoSmithKline and the Children¿s Hospital of Philadelphia, who collectively own a rotavirus vaccine that was recently overcame a major milestone to licensure. In the late 90s a rotavirus vaccine, not Offit's, was approved by the Advisory Committee on Immunization Practices (ACIP), the federal board that decides which vaccines are added to the federal 'recommended schedule.' Offit already had his vaccine under development and he also happened to sit on the ACIP when the rotavirus vaccine was approved. This type of conflict of interest, which would probably be a felony in the securities industry is standard operating procedure in the vaccine industry. Approval by the ACIP usually guarantees that a vaccine will become mandatory to attend school in most states and provides an immense guaranteed market for any vaccine. It also assures that the vaccine will be extended full liability protection. Shortly after the rotavirus was introduced it was quickly discovered that it destroyed the intestines and killed a number of people. It was quickly withdrawn, yet another vaccine created epidemic. The rotavirus incident, just like, Cutter, pointed out a basic fact of vaccine development, a sufficiently large sample to detect adverse reactions that may happen is small subset of people is almost never used, so the general public is used as guinea pigs on unproven vaccines. Interestingly, Offit mentions not a word about rotavirus in this book. Offit would have all vaccine injuries relegated to the current vaccine courts. These courts were created in the late eighties to adjudicate injuries related to vaccines in the ¿recommended schedule¿ of shots. Offit ignores the complete breakdown of the federal vaccine courts. According to the federal government¿s own data there

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