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The Cutter Incident

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

Paul A. Offit
Copyright Date: 2005
Published by: Yale University Press
Pages: 256
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  • Book Info
    The Cutter Incident
    Book Description:

    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.

    eISBN: 978-0-300-13037-9
    Subjects: History

Table of Contents

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  1. Front Matter
    (pp. i-viii)
  2. Table of Contents
    (pp. ix-x)
  3. Prologue
    (pp. xi-xii)

    We live longer than we used to. During the twentieth century, the lifespan of Americans increased by thirty years. Much of the increase was caused by such advances as antibiotics, purified drinking water, sanitation, safer workplaces, better nutrition, safer foods, seatbelts, and a decline in smoking. But no single medical advance had a greater impact on human health than vaccines. Before vaccines, Americans could expect that every year measles would infect 4 million children and kill three thousand; diphtheria would kill fifteen thousand people, mostly teenagers; rubella (German measles) would cause twenty thousand babies to be born blind, deaf, or...

  4. Introduction
    (pp. 1-3)

    ON MONDAY AFTERNOON, APRIL 18, 1955, JOSEPHINE Gottsdanker drove her five-year-old daughter, Anne, and ten-year-old son, Jerry, to the pediatrician. Several days earlier Josephine, an intense, bespectacled, highly educated woman, had watched the television programSee It Now,in which Edward R. Murrow, a CBS News correspondent, had interviewed Jonas Salk, the scientist who had just developed a polio vaccine. Josephine wanted Salk’s new vaccine for her children. In the doctor’s office she watched the nurse take a vial of vaccine out of the refrigerator, draw the vaccine into a properly sterilized glass syringe, and inject it into the muscle...

  5. 1 Little White Coffins
    (pp. 4-18)

    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...

  6. 2 Back to the Drawing Board
    (pp. 19-43)

    THE 1916 EPIDEMIC IN NEW YORK CITY HAD MADE polio an American disease. Five years later an event that took place off the coast of New Brunswick, Canada, reinforced that notion.

    Franklin Delano Roosevelt, then thirty-nine years old, was visiting his family’s summer home on Campobello Island. FDR had been a nominee for vice president, secretary of the navy, and a New York legislator. Flamboyant and charismatic, he “loved to swim and to sail, play tennis, golf; to run in the woods and ride horseback in the fields.” Late in the afternoon on August 10, 1921, Roosevelt was sitting at...

  7. 3 The Grand Experiment
    (pp. 44-57)

    IN THE FALL OF 1953, THE NATIONAL FOUNDAtion for Infantile Paralysis wanted to perform a large trial of Jonas Salk’s vaccine. Unfortunately, Salk didn’t have a vaccine. But he was getting close.

    In 1952 the United States had suffered its worst polio epidemic; fifty-eight thousand people (or one of every three thousand Americans) had been affected. To determine whether Salk’s vaccine could prevent a disease that occurred in roughly 0.03 percent of the population, hundreds of thousands of children would need to be immunized. Only pharmaceutical companies had the facilities and resources to make that much vaccine, so that was...

  8. 4 How Does It Feel to Be a Killer of Children?
    (pp. 58-82)

    THE LABORATORY OF BIOLOGICS CONTROL, THE tiny federal agency within the National Institutes of Health responsible for licensing vaccines, was born of a strange event that occurred in the early 1900s. In 1901 a diphtheria epidemic swept across St. Louis, Missouri. Diphtheria was caused by a poison (toxin) released by the bacteriumCorynebacterium diphtheriae.Diphtheria toxin caused a thick, gray coating on the back of the throat that made it difficult for children to swallow and breathe. The toxin also traveled to the heart, causing heart failure, and to the nervous system, causing paralysis. Sometimes the swelling in the throat...

  9. 5 A Man-Made Polio Epidemic
    (pp. 83-104)

    ON SUNDAY, APRIL 24, 1955, J. E. WYATT, THE HEALTH officer in charge of Idaho’s southeast district, received a phone call from a local physician about a girl in Pocatello. “I’ve just seen a youngster who seems to have polio,” the doctor said. “Her mother says she noticed a little stiffness of the neck yesterday and she had fever. Today her left arm became paralyzed. Her name is Susan Pierce.”

    Wyatt was aware of the field trial of Salk’s vaccine. He knew that more than four hundred thousand children had received the vaccine the year before without incident. Reassured by...

  10. 6 What Went Wrong at Cutter Laboratories
    (pp. 105-131)

    A SERIES OF SEVEN EVENTS AT CUTTER LABORAtories resulted in a polio vaccine containing live polio virus. For children to be paralyzed and killed, all seven had to occur.

    First, Cutter used the Mahoney strain. Jonas Salk had injected thousands of monkeys to determine which strains of type 1 polio virus induced the greatest quantities of antibodies, and he found that the Mahoney strain worked best. When Salk made his choice, he knew that Mahoney was deadlier than any other type 1 strain, but he felt that if Mahoney was completely inactivated, it didn’t matter. Salk’s choice of the Mahoney...

  11. 7 Cutter in Court
    (pp. 132-153)

    IN 1996 A CARTOON IN THESAN DIEGO UNION Tribunedepicted St. Peter on the telephone. Standing before him, smiling like an angel, was a well-dressed man: “I’ve got a guy here claiming he was struck and injured by one of the Pearly Gates,” said St. Peter. Inscribed on the man’s briefcase was the name “M. Belli.”

    From the 1950s through the 1990s Melvin Belli was one of the most influential lawyers in the United States. A personal injury (or torts) lawyer, Belli represented people who were wrongly hurt by medicines, cars, airplanes, cigarettes, cement trucks, or exploding bottles of...

  12. 8 Cigars, Parasites, and Human Toes
    (pp. 154-177)

    THE JURY HAD FOUND THAT CUTTER LABORATORIES was not negligent in the production of polio vaccine, but Cutter was still financially responsible (liable) for harm caused by its product. Liability without negligence (fault) was born. The Gottsdanker verdict meant that if pharmaceutical companies made a product according to industry standards, using the best science that was available, and found months or years after its sale that it caused harm—a harm not predictable—they were liable for the damage. Melvin Belli understood that the Gottsdanker decision was a blueprint for a revolution. “It is going to change the face of...

  13. 9 Death for the Lambs
    (pp. 178-191)

    THE CUTTER INCIDENT HAS MANY LEGACIES. FOR one thing, the incident led to the effective federal regulation of vaccines. Because Cutter Laboratories made a vaccine that caused paralysis, the federal government launched an immediate investigation into the manufacture and testing procedures of all companies; it found that regulations and guidelines were inadequate. Better procedures for filtration, storage, and safety testing were developed, and within months safe polio vaccine was made. Within a few years, the number of children paralyzed or killed by natural polio decreased by a factor of ten. On July 15, 1955, only three months after the incident,...

  14. Epilogue
    (pp. 192-194)

    THE CUTTER INCIDENT CAUSED AN IMMEDIATE change in the way that vaccines were made and regulated in the United States. As a consequence, companies made a safer polio vaccine and children’s lives were saved. But the price paid for this knowledge was that many children were paralyzed for the rest of their lives. On the wall of the Vietnam Veterans Memorial in Washington, D.C., are inscribed the words of Major Michael O’Donnell, killed in action on February 7, 1978: “And in time when men reflect and feel safe to call that war insane, take one moment to embrace those gentle...

  15. Notes
    (pp. 195-224)
  16. Selected Bibliography
    (pp. 225-228)
  17. Acknowledgments
    (pp. 229-230)
  18. Index
    (pp. 231-238)