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

JAMA
“Well written and easily understood, yet balanced with enough technical detail for medical professionals to read informatively cover to cover.”
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
Publishers Weekly
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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Product Details

  • ISBN-13: 9780300108644
  • Publisher: Yale University Press
  • Publication date: 10/10/2005
  • Pages: 256
  • Product dimensions: 6.36 (w) x 9.60 (h) x 0.93 (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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Read an Excerpt

THE CUTTER INCIDENT

How America's First Polio Vaccine Led to the Growing Vaccine Crisis
By Paul A. Offit

Yale University Press

Copyright © 2005 Paul A. Offit
All right reserved.

ISBN: 978-0-300-10864-4


Chapter One

Little White Coffins

There were three little hearses before the door; all her children had been swept away. -New York City social worker, July 27, 1916

ON JUNE 6, 1916, THE NEW YORK CITY HEALTH Department received reports on two children, John Pamaris and Armanda Schuccjio; both had suddenly developed high fever and paralysis. Two days later, the health department heard about four more children with the same symptoms. All six children were less than eight years old, all lived in Brooklyn, all were born of immigrant Italian parents, and all had polio. By the end of that week, 6 cases had grown to 33; by the end of the following week, 33 had grown to 150. The disease had spread from Brooklyn to all five New York City boroughs.

The man in charge of controlling the outbreak was Haven Emerson. Appointed commissioner of health just one year earlier, Emerson was the son of a physician and the grandnephew of poet Ralph Waldo Emerson. A tall, angular man with thinning hair and a mustache, Emerson was a public health zealot. He was confident that his rigorous control measures would stop the spread of polio. Although sporadic casesof polio had occurred since the fifteenth century B.C., Emerson knew that large outbreaks had never occurred in the United States. In the late 1800s and early 1900s, small outbreaks had occurred in Otter Creek, Vermont; Philadelphia, Pennsylvania; West Feliciana, Louisiana; and Boston, Massachusetts. But America's experience with polio didn't prepare Emerson for what was about to happen in New York City that summer.

Emerson's strategy was two-pronged: promote better sanitation and quarantine suspected cases. He reasoned that polio was a contagious disease and that quarantining people would decrease the spread of infection. (Quarantine, derived from the Italian quarantina, meaning "forty," originally referred to the forty days that ships were held at port before passengers-who were feared to carry the plague-could disembark.) Emerson also reasoned that polio, like other infectious diseases, would spread more easily in communities with inadequate plumbing and poor sewage. He described his plan: "All premises housing a case of polio [were to be] placarded and the family quarantined; the windows were to be screened, the bed linen disinfected, nurses were to change their clothing immediately after tending any patient, and household pets were not allowed in any patient's room." Emerson quarantined thousands of children, but many parents imposed their own form of isolation. A social worker recalled, "In one house the window was not only shut, but the cracks were stuffed with rags so that the disease could not come in. The babies had no clothes on, and were so wet and hot that they looked as if they had been dipped in oil, and the flies were sticking all over them."

Few tenement dwellers met the requirements for home quarantine-a private toilet, separate dining facilities, and a private nurse. As a result, children from poorer families were taken to hospitals, often against their parents' will. On August 25, 1916, a story appeared in the New York Journal:

Mrs. Jennie Dasnoit of 365 64th St., Brooklyn, is under the care of a physician today as a result of a strange experience with the infantile paralysis quarantine. Three policemen forced their way into her home, broke down the door to the bedroom, and drew their revolvers in assisting the ambulance surgeon to obtain possession of her small nephew, a paralysis suspect. The child, Cornelius Wilson, two-year-old son of Mrs. Dasnoit's dead sister, is in the Kingston Avenue Hospital, Brooklyn, where the physicians have not yet decided that he is suffering from paralysis.

The policemen entered the house, Mrs. Dasnoit says, by cutting the screen covering a window on the first floor, breaking their way into the room where Mrs. Dasnoit stood with the baby in her arms. Their revolvers were drawn, she charges.

Mrs. Dasnoit's screams attracted neighbors to the house but before they could enter two of the policemen held her while the third pulled the child from her arms and passed him through the window to the surgeon.

Parents fought back. Anna Henry, a nurse employed by the clinic at Public School 91 in Flatbush (Brooklyn), reported to police that she received a letter written in blood: "If you report any more of our babies to the Board of Health we will kill you and nobody will know what happened to you. Keep off our street and don't report our homes and we will do you no harm." At the bottom of the letter, beneath a crude drawing of a skull and crossbones, was the statement: "We will kill you like a dog." Anna Henry was later escorted by the police to and from work.

Haven Emerson believed that the epidemic started because "90 immigrant Italians under the age of ten had [moved to] Brooklyn where the outbreak appeared" and that immigrants were the first to get polio because they were poorer and dirtier. He wanted residents to bathe their children and fix their toilets, yards, cellars, and plumbing. He wanted the city to provide fresh water, collect garbage more frequently, and protect people from flies. Every day janitors and homeowners, under penalty of fine or imprisonment, complied with Emerson's sanitary code; every day 4 million gallons of water washed the streets; every day city workers killed 300-450 cats and dogs because they believed them to harbor germ-carrying fleas; and every day children continued to be paralyzed. During the week of June 24, 1916, polio claimed another 233 children.

On June 30 Emerson said, "We believe that application of well-organized sanitary measures will limit this outbreak." As July 4 approached, he urged parents to keep their children away from others. On July 5 all movie theaters banned children under the age of sixteen. Three days later, carnivals, parades, public picnics, and excursions ceased, leaving the streets deserted. In the following week there were another 700 cases and 170 deaths from polio. The epidemic continued unchecked.

On July 8 an editorial in the New York Medical Journal stated, "The plague seems to have reached its height and to be already abating." But the disease wasn't abating. In the week of August 5 there were another 1,200 cases and 370 deaths. Dr. Robert Guilfoy had announced in July that one child died from polio every two and one-half hours; by early August it was every twenty-six minutes. By mid-August, polio had paralyzed 5,500 people and killed 1,500.

Federal authorities, desperate to contain the epidemic, issued a regulation that no child could leave New York City without a certificate for interstate travel. Residents living outside the city panicked. A self-appointed citizens' committee of five hundred in Huntington, Long Island, entered every home in town looking for suspected cases of polio. Residents of Glen Cove, Long Island, threatened to kill the health officer and burn down the hospital after the arrival of several polio patients. Policemen in Hoboken, New Jersey, guarded every entrance to the city with instructions that no one could seek safe haven. At gunpoint, two policemen forced a family of seven to turn back; the family had given up their home in Brooklyn to move to Hoboken.

Isolated and desperate for a cure, New York City residents tried everything. They ingested catnip, skullcap, lady's slipper, earthworm oil, blackberry brandy, and the blood of frogs, snakes, and horses. Following a rumor about the wondrous powers of ox blood, parents showed up at East Side slaughterhouses with buckets. They hung charms around their necks made of pepper, garlic, camphor, and onions. A former state legislator sold cedar wood shavings to be worn around the neck "to protect the child from death and ... prevent germs [and] insects from attacking the victim," and one man sold "Sol," containing sassafras and alcohol, to "cure infantile paralysis." Both men spent thirty days in jail for making false claims.

Doctors, similarly desperate, injected adrenaline or fresh human saliva into the spinal fluid or took spinal fluid from infected people and injected it back under the skin. One physician, George Retan, claimed dramatic success with a technique that involved inserting a large hollow needle into a child's back, draining spinal fluid, and at the same time infusing large quantities of salt solution into a vein. Retan reasoned that his technique washed poisons out of the nervous system. With wider use-when the treatment killed more people than it saved-physicians abandoned the procedure.

During the last three weeks of August, polio paralyzed 3,500 people and killed 900. Typically, polio killed 5 percent of its victims, but in New York City in the summer of 1916, for reasons that remain unclear, 27 percent of those infected died.

Two years after the New York City polio epidemic, influenza killed 675,000 Americans-more than the combined number of American deaths in World War I, World War II, and the Vietnam War. Although the influenza deaths far outnumbered the polio deaths, polio was in many ways more devastating. People infected with influenza either died from pneumonia or recovered, but children paralyzed by polio rarely recovered. The sight of small children trying to use withered arms or struggling to walk with crutches or lying helplessly in breathing machines (called iron lungs) was a constant, crushing reminder of the infection.

By late September 1916 the number of new cases of polio finally declined, and New York City schools reopened. When the epidemic was over, polio had paralyzed more than 9,000 people and killed 2,400; most were children less than ten years old. It was the largest epidemic of polio ever recorded. One year later, the New York City Health Department reported that the world's knowledge of polio "was based on a smaller number of autopsies recorded in the whole medical literature than were performed at one of the department's hospitals during the past summer."

Months later, Haven Emerson admitted defeat: "There is no positive proof that a demonstrable amount of protection or prevention resulted from the general measures enforced." Emerson had assumed incorrectly that by quarantining infected children and promoting better sanitation he could stop the spread of polio. But polio was different from other infections.

New York City residents didn't know what caused polio. They blamed fish, milk, fleas, rats, cats, horses, mosquitoes, chickens, shark vapors, pasteurized milk, wireless electricity, radio waves, tobacco smoke, automobile exhaust, doctors' beards, organ grinders' monkeys, and poisonous gases from Europe. They blamed parents for tickling their children. They blamed tarantulas for injecting poisons into bananas. Although unknown to most New York City residents, the cause of polio had already been discovered.

On November 18, 1908, eight years before the polio epidemic in New York City, Karl Landsteiner, a doctor in Vienna, Austria, found the cause of polio. An intense, solitary man who kept a death mask of his mother on the wall above his bed, Landsteiner performed an autopsy on a nine-year-old Viennese boy who had died of polio. He removed the boy's spinal cord, ground it up, and injected it into two monkeys; soon both monkeys were paralyzed. When Landsteiner removed the spinal cords from the monkeys, sliced them into thin sections, and looked at them under a microscope, he found that they looked just like the spinal cords from children who had been killed by polio. Landsteiner reasoned that polio was caused by a virus that was present in the boy's spinal cord.

Three years after Landsteiner's discovery, Carl Kling, a twenty-four-year-old Swede working at the State Bacteriological Institute, figured out how polio virus was spread. During an outbreak in Sweden that paralyzed four thousand people, Kling examined the hearts, lungs, spinal cords, throats, and intestines of fourteen children who had died of polio. He duplicated Landsteiner's findings by showing that ground-up spinal cords from these children paralyzed monkeys. That wasn't a surprising discovery, but Kling also found that fluids taken from the throats, windpipes, and intestines of these children also paralyzed monkeys. He reasoned that polio might be spread from one person to another by a virus present in the saliva or intestines of people who were infected. At the time Kling performed his studies, polio had a range of symptoms that included sore throat and fever (mild polio); stiff neck, mild paralysis, and headache (abortive polio); permanent paralysis of the arms and legs (paralytic polio); and paralysis of the muscles necessary for breathing (bulbar polio). But Kling also found that in some instances polio was present in the throats and intestines of people who didn't have any symptoms (asymptomatic polio). Kling's observations explained why Haven Emerson couldn't stop the spread of polio in New York City by quarantining only people who were paralyzed by the disease: most people who were spreading polio weren't sick.

The next important discovery-and one that offered a ray of hope that polio could be prevented-was made by Simon Flexner, director of the Rockefeller Institute for Medical Research in New York City. Working at the same time as Carl Kling, Flexner took blood from monkeys who were recovering from polio and let it clot; the fraction of blood not contained in the clot was called serum. He then inoculated monkeys with a mixture of serum and polio-infected spinal cords. Typically monkeys inoculated with polio-infected spinal cords got polio. But to Flexner's surprise, with the addition of serum to the spinal cords before inoculation, polio virus didn't paralyze the monkeys. He called what he found in the serum from previously infected animals "germicidal substances." Today we call these "substances" antibodies.

Thirty years after Flexner had identified polio antibodies, a team of researchers at Johns Hopkins Hospital in Baltimore revealed more of polio's secrets. They determined that polio virus entered the body through the mouth and traveled to the intestines and then to the blood. They found, as had Carl Kling, that most people with polio virus in their intestines and blood never developed symptoms of polio. But in some people (and this could be as rare as 1 in 150 infected people), polio virus traveled from the blood to the spinal cord, entered the cells of the spinal cord, and made more polio virus particles. (A cell is the smallest structural unit that is capable of independent function. Organs such as the liver, spleen, brain, and spinal cord are composed of billions of cells.) In the process of reproducing itself in the cells of the spinal cord, polio virus destroyed the spinal cord and caused paralysis. The Hopkins researchers showed that polio virus had to enter the blood to get to the spinal cord. Thus if researchers could find a way to induce polio antibodies in blood, the antibodies could neutralize polio virus before it got to the spinal cord.

To understand what polio was and how it was spread, Landsteiner, Kling, Flexner, and the Hopkins researchers relied on monkeys. Working with monkeys was expensive, dangerous, and slow. But monkeys paved the way to the first ill-fated polio vaccines.

By the early 1900s it was apparent that people who were infected with polio were usually immune to a second infection. The task for polio researchers was clear: find a way to induce immunity without causing disease. The first researchers who tried to make a polio vaccine were John Kolmer of Philadelphia and Maurice Brodie of New York. Between 1934 and 1935, Kolmer and Brodie inoculated seventeen thousand children with their vaccines. At the time that Kolmer and Brodie made their vaccines, three viral vaccines had already been made. Each used a different strategy, but all used the same concept: separate a virus's capacity to cause disease from its capacity to induce antibodies that protected against disease.

(Continues...)



Excerpted from THE CUTTER INCIDENT by Paul A. Offit Copyright © 2005 by Paul A. Offit. Excerpted by permission.
All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
Excerpts are provided by Dial-A-Book Inc. solely for the personal use of visitors to this web site.

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Table of Contents

Contents

Prologue....................xi
Introduction....................1
CHAPTER 1 Little White Coffins....................4
CHAPTER 2 Back to the Drawing Board....................19
CHAPTER 3 The Grand Experiment....................44
CHAPTER 4 How Does It Feel to Be a Killer of Children?....................58
CHAPTER 5 A Man-Made Polio Epidemic....................83
CHAPTER 6 What Went Wrong at Cutter Laboratories....................105
CHAPTER 7 Cutter in Court....................132
CHAPTER 8 Cigars, Parasites, and Human Toes....................154
CHAPTER 9 Death for the Lambs....................178
Epilogue....................192
Notes....................195
Selected Bibliography....................225
Acknowledgments....................229
Index....................231
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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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