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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.
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.
"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
"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
"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
"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 immunization as our most effective public health
tool."—Jonathan R. Carapetis, British Medical Journal
"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
After a wave of books celebrating the 50th anniversary of Jonas Salk's polio vaccine, Offit's troubling account is the first to focus on a largely forgotten aspect-one with negative repercussions 50 years later. In a nuanced examination of a complex story, Offit, a professor of pediatrics and expert in infectious diseases, relates how Cutter Laboratories, one of several pharmaceutical companies licensed to produce Salk's killed-virus vaccine, shipped many lots of vaccine containing live virus, creating a mini polio epidemic: 40,000 children became ill, 200 were permanently paralyzed, 10 died. Offit carefully examines how Cutter was and was not responsible: tests for detecting live virus at the time were simply not sensitive enough, but Cutter departed from Salk's safe production protocols. And while the company knew there was a problem, it failed to notify the government's oversight agency. Cutter faced costly lawsuits that have resulted, according to Offit, in today's vaccine crisis: shortages (think of last year's flu vaccine) due to pharmaceutical companies' unwillingness to risk testing and producing vaccines and face possible litigation. In another example of the law of unintended consequences, Offit shows how "the Cutter Incident" led Salk's vaccine to be replaced by a less safe one: Sabin's live-virus vaccine. (Oct.) Copyright 2005 Reed Business Information.
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