In 2007, John Stossel interviewed Allen McDowell on an
ABC News
program titled “Scared Stiff: Worry in America.” During the program, Stossel showed a clip of news reporter Robin Roberts and Allen McDowell during the pertussis vaccine scare. “Sudden infant death,” said Roberts. “You put your baby into the crib, you wake up the next morning, and your baby is dead.” “It’s extremely dangerous,” said McDowell. “They had the ability to make a safer vaccine.” Twenty-five years had passed since Lea Thomspon’s program. During that time, epidemiological studies had clearly shown that pertussis vaccine didn’t cause brain damage or Sudden Infant Death Syndrome, and advances in neurology and genetics had better defined the real causes of the problems. But Allen McDowell was unbowed. “The vaccine just wasn’t as safe as it could have been?” asked Stossel. “There’s no dispute about that,” replied McDowell. “They were making so much money off the old vaccine that they didn’t really have any incentive to improve it.” Stossel, in voice-over, said, “McDowell made money, too. The lawyer who now works out of his house won lots of lawsuits—for how much money?” “I made a good chunk of money,” said McDowell. “One hundred million?” asked Stossel. “I really can’t say,” McDowell demurred. “It’s under protective order.”
During his interview with Stossel, McDowell never mentioned his law partner, Anthony Colantoni. Between July 1990 and October 1991, Colantoni received $1.53 million in compensation checks from the Vaccine Injury Compensation Program for families of children presumably damaged by pertussis vaccine. But Colantoni gave only $124,000 to his clients, putting the remaining $1.4 million into the account of McDowell & Colantoni. His method of concealing what he’d done was simple. “When the victims or family members of the estates [of plaintiffs] would call,” said U.S. Attorney James B. Burns, “he would deny he had received the checks.” In March 1993, by consent of the Illinois Supreme Court, Anthony Colantoni was disbarred. McDowell was never implicated in his partner’s scheme.
Vaccine Roulette
was arguably one of the most powerful programs ever to air on American television: thousands of parents stopped giving pertussis vaccine to their children; personal-injury lawyers pummeled pharmaceutical companies, causing many to stop making vaccines; and Congress passed a law to protect vaccine makers, while at the same time compensating those who were allegedly harmed by vaccines.
During the next fifteen years the tide turned. David Miller’s study lay in ruins at the hands of a British judge. And study after study showed that children immunized with DTP weren’t at greater risk of brain damage. As a consequence, public health agencies and medical societies throughout the world no longer considered pertussis vaccine to be a rare cause of permanent harm. Even the Vaccine Injury Compensation Program, a system designed to compensate those who felt wronged by vaccines, had removed epilepsy as a possible consequence of pertussis vaccine.
Despite this overwhelming evidence, and despite all of the harm that had been done by the false notion that pertussis vaccine was maiming America’s children, Lea Thompson was without remorse. In 1997, during a celebration in her honor held by the National Vaccine Information Center, the group once called Dissatisfied Parents Together, Thompson remembered
Vaccine Roulette
: “The reason it was important to me is not because it was great research, although we did a pretty good job, or that [it] was a beautifully produced piece of work.
DPT
[
Vaccine Roulette
] was important to me personally because it spawned a movement.” A movement that almost eliminated vaccines for American children, a movement that continues to cause many parents to reject vaccines in favor of the diseases they prevent, and a movement that was based on a notion that has been shown again and again to be incorrect.
In retrospect, it isn’t surprising that an anti-vaccine movement sprang up in the United States in the 1980s. The surprise is that it didn’t happen sooner.
In the early 1940s, a yellow fever vaccine was routinely given to American soldiers. Everyone got it. To make sure the vaccine virus was stable across a broad range of temperatures, manufacturers added human serum, a decision that proved disastrous. (Serum is blood without red blood cells or clotting factors.) Unbeknownst to the manufacturer, some of the blood donors had hepatitis. At the time, scientists didn’t know about the different types of hepatitis viruses or how they were spread. In March 1942, the Surgeon General’s Office noted a striking increase in the number of recruits with hepatitis; more than three hundred thousand soldiers were infected with what we now know as hepatitis B virus; sixty-two died from the disease.
In the early 1950s, Jonas Salk made a vaccine to prevent polio. Horrified that children could be fine one minute and wheelchair-bound the next, Americans gave their money to the March of Dimes, which gave it to Jonas Salk. Salk reasoned that killed poliovirus would induce a protective immune response without causing disease. Working with mice and then monkeys, Salk figured out how to make a vaccine by growing poliovirus in laboratory cells, purifying it away from the cells, and killing it with formaldehyde. In 1954, the March of Dimes tested Salk’s vaccine in a trial of almost two million children. (It was then and remains today the largest vaccine trial ever performed.) When the results of the study were announced, church bells rang across the country, factories observed moments of silence, synagogues held special prayer meetings, and parents, teachers, and students wept. “It was as if a war had ended,” one observer recalled. The euphoria didn’t last long. Two weeks later, public health officials recalled every lot of polio vaccine.
When the March of Dimes had tested Salk’s vaccine, it relied on two veteran vaccine makers: Eli Lilly and Parke-Davis. But when the vaccine was licensed for sale, three other companies joined in: Wyeth, Pitman-Moore, and Cutter Laboratories. It soon became clear that Cutter, a small pharmaceutical company in Berkeley, California, had made it badly, failing to fully inactivate the virus. As a consequence, one hundred and twenty thousand children were inadvertently injected with a vaccine that contained live, potentially deadly poliovirus: seventy thousand suffered mild polio, two hundred were severely and permanently paralyzed, and ten died. It was one of the worst biological disasters in American history. Cutter Laboratories never made another dose of polio vaccine again.
Perhaps the worst vaccine disaster in history didn’t occur in America; it occurred in Germany. In 1921, two French researchers, Albert Calmette, a physician, and Camille Guérin, a veterinarian, reasoned that a bacterium (
Mycobacterium bovis
) that caused tuberculosis in cows could protect people against human tuberculosis. They developed a vaccine later called BCG (Bacillus of Calmette and Guérin), a modified form of which is still used today. In 1929, however, 250 ten-day-old children in Lubeck were given a BCG vaccine that wasn’t made of BCG. It was made of pure, highly lethal human tuberculosis bacteria. Seventy-two babies died from the mistake.
The yellow fever, Cutter, and BCG vaccine disasters didn’t spur significant anti-vaccine activity. (However, the Cutter incident led to the creation of a vaccine regulatory system that prevented these kinds of tragedies from happening again.) In America, people still trusted vaccines; and they trusted those who made and recommended them. It would take fear of pertussis vaccine to turn the tide; ironic, given that the pertussis vaccine tragedy was imagined.
CHAPTER 5
Make the Angels Weep
If they can get you asking the wrong questions, they don’t have to worry about the answers.
—THOMAS PYNCHON,
GRAVITY’S RAINBOW
B
y the late 1980s, Barbara Loe Fisher was riding high. She had written
A Shot in the Dark: Why the P in the DPT Vaccination May Be Hazardous to Your Child’s Health
, praised by the
San Francisco Chronicle
as “cautious, credible, horrifying, and outrageous all at once.” She had spurred an enormous effort by academic researchers, pharmaceutical companies, and public health officials to make a purer pertussis vaccine. She had helped craft legislation that included a monitoring system for licensed vaccines—a system that would, ten years later, detect a rare but serious side effect. And although the reason for Fisher’s activism—her belief that pertussis vaccine had caused her son’s learning disabilities—wasn’t supported by the science, she had been a catalyst to changes that clearly benefited children. She was, in short, America’s premier vaccine safety activist. The media believed her, politicians relied on her, and parents turned to her. Barbara Loe Fisher was poised to do a tremendous amount of good.
Unfortunately, during the next three decades, the opportunity was squandered—an opportunity that had been so hard won.
When Barbara Loe Fisher burst onto the scene, several vaccines had serious side effects, every year causing allergic reactions, paralysis, or death. Public health officials and doctors didn’t hide these problems. But they didn’t do anything to correct them, either. And most parents had no idea they existed.
Beginning in the early 1960s, American children were given a polio vaccine that was ingested, not injected. Albert Sabin, a well-respected virologist and Jonas Salk’s fiercest rival, invented it. Sabin’s approach was dramatically different from Salk’s; instead of killing poliovirus with a chemical, as Salk had done, he weakened it. Sabin reasoned that by taking poliovirus and growing it over and over again in nonhuman cells, the virus would become less and less capable of reproducing itself in humans. And he was right. Sabin’s vaccine, dropped onto sugar cubes and given to millions of American children, worked. By 1979, polio, a disease that had caused hundreds of thousands of children to suffer and die, was eliminated from the United States. By 1991, it was eliminated from the Western Hemisphere—a remarkable accomplishment.
But there was one problem.
When Albert Sabin weakened poliovirus in his laboratory, he found that it could no longer grow in the brains and spinal cords of experimental monkeys; so he reasoned that the vaccine virus wouldn’t grow in children, either. But Sabin hadn’t anticipated a rare occurrence: polio caused by his polio vaccine. Although this problem was extremely rare—occurring in 1 of 2.5 million doses—it was real. Every year for the next twenty years, six to eight children in the United States got polio from the oral polio vaccine. And some of these children died from the disease. The problem caused by Sabin’s vaccine was avoidable; several countries never used it, relying on Salk’s to successfully eliminate the disease.
When Barbara Loe Fisher became a vaccine safety activist, she could have taken on Albert Sabin’s polio vaccine. Pharmaceutical companies had little incentive to make an inactivated polio vaccine—one that didn’t occasionally cause paralysis—and public health officials were unwilling to spend more money on a polio vaccine in the absence of public demand. (Because it required a syringe and needle, as well as a medical professional to give the shot, Salk’s vaccine was much more expensive than Sabin’s, which could just be squirted into the mouth.) It was a perfect situation for a consumer advocate. Years later, one advocate would force the government to acknowledge the rare but invariant paralysis that came with Sabin’s polio vaccine and to change public policy. It could have been Barbara Loe Fisher. But it wasn’t.
Sabin’s polio vaccine wasn’t the only problem.
Ten years before Jonas Salk made his polio vaccine, his former mentor, Thomas Francis, made an influenza vaccine. Francis took influenza virus, injected it into eggs, grew the virus, purified it, and inactivated it with formaldehyde. (Salk’s idea of inactivating poliovirus with formaldehyde came from working in Francis’s laboratory.) The influenza vaccine is made the same way today. Unfortunately, some people can’t get it because they’re severely allergic to eggs. (In the United States about a million are.) Reactions can be frightening, and can include hives, low blood pressure, difficulty breathing, and shock—all of which could be avoided; companies could grow influenza viruses in mammalian cells rather than avian ones. Although this procedure wouldn’t be easy, it’s doable. But, absent a public outcry, pharmaceutical companies have had little incentive to make the change and public health agencies haven’t insisted they do it. Again, it’s a perfect situation for an advocate.
Egg proteins aren’t the only vaccine component that causes severe allergic reactions, or even the most common cause of them; gelatin is. Made by extracting collagen from the bones and hides of pigs, gelatin is used as a stabilizing agent, allowing small quantities of live viral vaccines to be evenly distributed throughout a vial. (For decades, the MMR vaccine contained gelatin as a stabilizer; today only the chickenpox and nasal-spray influenza vaccines have it.) Most people don’t have a problem with gelatin, but some develop severe allergic reactions. Also, certain religious groups are hesitant to receive a vaccine made with pig products. Again, for those wanting to make vaccines safer, gelatin would be a great place to start. Other stabilizing agents are available.
Barbara Loe Fisher founded America’s modern-day anti-vaccine movement. (Courtesy of Dayna Smith.)