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Authors: Paul A. Offit M.D.
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British health officials were in a tough spot. They couldn’t claim that the benefits of pertussis vaccine outweighed its risks when risk estimates were all over the map. So they decided to fund a study that would determine once and for all the risk of brain damage from pertussis vaccine. Then and only then could parents weigh the risk of getting the vaccine against the risk of not getting it.
To assess the risks, health officials turned to Dr. David Miller, a professor of community medicine at the Central Middlesex Hospital in London. Miller and his colleagues launched the most comprehensive, expensive, and time-consuming study to date. Between 1976 and 1979, Miller’s team asked consultant pediatricians, infectious disease specialists, and neurosurgeons to report any children who had serious neurological illnesses, then determined whether those children were more likely to have recently received DTP than normal children. Miller found “a statistically significant association with diphtheria, tetanus, and pertussis vaccine ... especially within 72 hours.” According to the Miller study, DTP caused permanent brain damage in one in one hundred thousand children given three doses of vaccine.
Miller’s study was the first to address the question of risk using appropriate controls. As a consequence, academic physicians around the world believed it. When vaccine expert Edward Mortimer stood in front of Paula Hawkins’s committee in 1982 and declared pertussis vaccine to be a rare cause of permanent harm, it was David Miller’s study he was thinking about.
In the United States, the dominoes fell: parents decried the vaccine, the media trumpeted their claims in dramatic headlines, and medical experts supported them with evidence from Miller’s study. It was a perfect storm. And it added up to one thing: lawsuits. Many, many lawsuits.
During
Vaccine Roulette
, Lea Thompson offered a preview of coming events. “More and more families of DPT victims are deciding to sue,” said Thompson. “Not only doctors, but manufacturers and the government.” Personal-injury lawyers advertised their services on television and radio commercials, in newspapers, in magazines, and on the backs of telephone books. They urged parents of vaccine-damaged children to come forward, to get the justice and compensation they deserved. In 1981, one year before
Vaccine Roulette
, 3 lawsuits were filed against vaccine makers. By the end of 1982, lawyers had filed 17 lawsuits; during each of the next four years, they filed 41, 73, 219, and 255.
Vaccine Roulette
, Lea Thompson offered a preview of coming events. “More and more families of DPT victims are deciding to sue,” said Thompson. “Not only doctors, but manufacturers and the government.” Personal-injury lawyers advertised their services on television and radio commercials, in newspapers, in magazines, and on the backs of telephone books. They urged parents of vaccine-damaged children to come forward, to get the justice and compensation they deserved. In 1981, one year before
Vaccine Roulette
, 3 lawsuits were filed against vaccine makers. By the end of 1982, lawyers had filed 17 lawsuits; during each of the next four years, they filed 41, 73, 219, and 255.
Jurors were sympathetic. On March 7, 1983, four-month-old Tyler White “suffered a seizure lasting several hours” after his second DTP vaccine. A few months later he had another, then another, and was diagnosed with epilepsy and severe developmental delays. Three years later, a jury awarded Tyler $2.1 million. On March 17, 1980, Michelle Graham “developed a severe and irreversible neurological condition known as encephalopathy [brain damage]” after her first DTP shot. The jury awarded Michelle $15 million. Melanie Tom received $7.5 million. Other lawsuits included awards for $5.5 million, $2.5 million, and $1.7 million, and many more were settled out of court “in the million-dollar range.”
The amount of money requested by plaintiffs increased exponentially from $25 million in 1981 (one year before
Vaccine Roulette
) to $414 million in 1982, $655 million in 1983, $1.3 billion in 1984, and $3.2 billion in 1985. In response, pharmaceutical companies increased the prices of their vaccines and scrambled to get liability insurance. In early 1982, DTP vaccine cost $0.12 per dose. In June 1983, the cost rose to $2.30; the next year, to $2.80. By 1985, the cost of one dose of DTP vaccine was $4.29—a thirty-five-fold increase in less than three years. Increased revenues didn’t offset the cost of awards. In 1984, the amount claimed in lawsuits exceeded DTP sales twentyfold. In 1985, despite a near doubling of the price, the damages claimed exceeded sales thirtyfold.
Vaccine Roulette
) to $414 million in 1982, $655 million in 1983, $1.3 billion in 1984, and $3.2 billion in 1985. In response, pharmaceutical companies increased the prices of their vaccines and scrambled to get liability insurance. In early 1982, DTP vaccine cost $0.12 per dose. In June 1983, the cost rose to $2.30; the next year, to $2.80. By 1985, the cost of one dose of DTP vaccine was $4.29—a thirty-five-fold increase in less than three years. Increased revenues didn’t offset the cost of awards. In 1984, the amount claimed in lawsuits exceeded DTP sales twentyfold. In 1985, despite a near doubling of the price, the damages claimed exceeded sales thirtyfold.
The result was predictable. Pharmaceutical companies abandoned vaccines. In 1960, seven companies made DTP. By 1982 only three remained: Connaught Laboratories of Swiftwater, Pennsylvania; Lederle Laboratories of Pearl River, New York; and Wyeth Laboratories of Philadelphia. On June 13, 1984, Wyeth announced it would no longer be distributing DTP. Later that summer, Connaught announced it was unable to get liability insurance and would stop making DTP vaccine for American children. Following Connaught’s announcement, Lederle was the only company left standing.
On December 19, 1984, James O. Mason, director of the Centers for Disease Control and Prevention, appeared before the House Subcommittee on Health and the Environment. The committee wanted to know how much DTP vaccine was available. The situation, as Mason described it, was desperate. “On November 27, [1984,] Lederle informed us that they were having some production difficulties and that two production lots scheduled for release in January and February 1985 would not be available. Contacts with state health departments were immediately undertaken and it was determined that there were approximately 1.5 million doses on hand in the states.” Mason then resorted to understatement: “Comparing this amount to an average national monthly use ... indicates that vaccine supplies would be essentially exhausted before the end of February 1985.” In three months, the United States would run out of pertussis vaccine. Mason knew what was at stake; he had to do something to extend the supply. So he recommended a suboptimal vaccine schedule, figuring that some immunity was better than no immunity: “[We have] developed recommendations to try to ensure maximum prevention during the period of likely shortage. These involved delaying administration of the fourth dose of DTP, usually given at eighteen months of age, and the fifth dose, usually given at four to six years of age.”
On February 12, 1985, a few months after the CDC had recommended withholding the fourth and fifth doses of DTP vaccine, the American Academy of Pediatrics held an emergency meeting to discuss vaccine shortages. Representatives from the American Medical Association, the American Academy of Family Physicians, the Department of Defense, the Department of Health and Human Services, pharmaceutical companies, and state, county, and city health departments attended. The news wasn’t good. A survey of hundreds of physicians found that although most had followed the CDC recommendation, one in three still couldn’t find enough vaccine.
It got worse.
In 1979, three-month-old Kevin Toner became permanently paralyzed from the waist down after receiving DTP. Kevin suffered an uncommon disorder called transverse myelitis, in which one segment of the spinal cord becomes inflamed. There was then and remains now no evidence that either pertussis or pertussis vaccine causes transverse myelitis. But in a courtroom, that didn’t matter. The jury awarded Kevin $1.13 million. The company that was sued was Lederle Laboratories—the only American company still distributing pertussis vaccine. To Lederle, the message was clear. It wasn’t only children with epilepsy and mental retardation who could be compensated. Everything was on the table. Lederle knew that its vaccine prevented only whooping cough, tetanus, and diphtheria, not every other illness that occurred in the first year of life. The Toner case was the last straw. On April 1, 1986, Lederle Laboratories announced to the AAP and the Department of Health and Human Services that it would no longer produce and distribute DTP vaccine.
Other vaccines suffered. The number of companies making measles vaccine dropped from six to one and those making polio vaccine from three to one. Vaccine makers were getting out of the business. The United States was on the verge of returning to the pre-vaccine era.
Realizing that American children might soon be denied lifesaving vaccines, the federal government stepped in. On October 18, 1986, the last day of the Ninety-Ninth Congress, legislators passed a bill that protected vaccine makers: the National Childhood Vaccine Injury Act. One month later, President Ronald Reagan signed it into law. The act contained the Vaccine Injury Compensation Program (VICP), which included a list of compensable injuries possibly caused by vaccines. Designed to make things easier for parents, the act specified awards for loss of earnings, lawyers’ fees, and up to $250,000 for pain and suffering. At the center of the program stood the injury that had led to the act’s passage: seizures and brain damage allegedly caused by pertussis vaccine.
The purpose of the National Childhood Vaccine Injury Act was to allow children to be compensated for vaccine damages without having to go through the expensive process of suing in state courts; to protect pharmaceutical companies from litigation; and to encourage vaccine makers to continue to research and produce new vaccines. The government had taken the burden of litigation off the backs of vaccine makers and put it on its own.
Although legislators had designed the program to satisfy everyone, no one was satisfied. Edward Brandt, from the Department of Health and Human Services, said, “The bill establishes a strong presumption that vaccine is responsible for essentially any adverse condition that happens after immunization unless there is incontrovertible evidence of other causation. This presumption of guilt would undermine public confidence in immunizations.” The American Medical Association wanted a panel of scientific experts to determine which vaccine side effects would be compensated, concerned that the task would otherwise fall to members of Congress. And parents were worried that vaccine makers, now largely protected from litigation, would have little interest in making vaccines safer. Henry Waxman, the California Democrat who had sponsored the legislation in the House of Representatives, said, “I recognize the bill I have introduced is probably not the first choice of most parties to this controversy. Manufacturers would undoubtedly prefer greater insulation from liability. Parents of injured children would certainly prefer larger compensation and fewer restrictions on court activity. The Reagan administration would, I am sure, prefer legislation that spends no money.”
Henry Waxman proposed legislation that saved vaccines for American children. (Courtesy of Bloomberg via Getty Images.)
Despite everyone’s misgivings, the National Childhood Vaccine Injury Act saved vaccines. In 1986, the year of the bill’s passage, lawyers filed 255 lawsuits against DTP-vaccine makers; by 1996, ten years after the act was passed, they filed only six. Also, the act provided a mechanism to inform parents about vaccine safety, a system to independently review vaccines, and the means to report suspected side effects through the Vaccine Adverse Events Reporting System, or VAERS.
In May 1982, Kathi Williams and Dissatisfied Parents Together had stood before Paula Hawkins’s congressional committee and read a list of demands. Only four years later, they’d gotten much of what they’d wanted.
Like their counterparts in the United States, British health officials would also be forced to confront lawsuits, angry parent groups, and distrustful media. But unlike what had happened in the United States, where vaccines were almost eliminated, the outcome in England would be different. The controversy would lead to one of the most unusual and dramatic product liability cases in modern history, and end with a surprising answer to the question of whether pertussis vaccine had caused permanent harm at all.
CHAPTER 3
A Crude Brew
Nothing in life is to be feared—only to be understood.
—MARIE CURIE
A
t the beginning of
DPT: Vaccine Roulette
, Lea Thompson asked Gordon Stewart to describe the pertussis vaccine. Stewart said it was “a crude brew of those bacteria and all their growth products.” Stewart’s description was an understatement.
t the beginning of
DPT: Vaccine Roulette
, Lea Thompson asked Gordon Stewart to describe the pertussis vaccine. Stewart said it was “a crude brew of those bacteria and all their growth products.” Stewart’s description was an understatement.
Bordetella pertussis
was first grown in a nutrient-rich broth in 1906. In the 1930s, Pearl Kendrick and Grace Eldering made a vaccine by simply killing pertussis bacteria with carbolic acid, an antiseptic. In 1939, they tested it. Kendrick and Eldering studied more than 4,000 children, giving their vaccine to half; during the next four years, they watched to see who got sick and who didn’t. The results were clear: whereas 348 unvaccinated children got whooping cough, only 52 vaccinated children suffered the disease. Ten years later, in 1948, the pertussis vaccine was combined with diphtheria and tetanus vaccines to make DTP. Although diphtheria, tetanus, and pertussis vaccines were given in the same syringe, the vaccines were quite different. That’s because scientists had a much better understanding of how diphtheria and tetanus caused disease.
was first grown in a nutrient-rich broth in 1906. In the 1930s, Pearl Kendrick and Grace Eldering made a vaccine by simply killing pertussis bacteria with carbolic acid, an antiseptic. In 1939, they tested it. Kendrick and Eldering studied more than 4,000 children, giving their vaccine to half; during the next four years, they watched to see who got sick and who didn’t. The results were clear: whereas 348 unvaccinated children got whooping cough, only 52 vaccinated children suffered the disease. Ten years later, in 1948, the pertussis vaccine was combined with diphtheria and tetanus vaccines to make DTP. Although diphtheria, tetanus, and pertussis vaccines were given in the same syringe, the vaccines were quite different. That’s because scientists had a much better understanding of how diphtheria and tetanus caused disease.
BOOK: Deadly Choices: How the Anti-Vaccine Movement Threatens Us All
12.35Mb size Format: txt, pdf, ePub
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