Deadly Choices: How the Anti-Vaccine Movement Threatens Us All - Paul A. Offit (2010)
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
By 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.)
All of these problems were worthy targets for a consumer advocate. But Barbara Loe Fisher chose to take vaccine safety activism in a dramatically different direction.
Beginning in the early 1980s, and for the next three decades, every time a new vaccine was recommended, the media sought out Barbara Loe Fisher for her opinion. The first vaccine licensed under Fisher’s watch prevented Hib.
Older American pediatricians have witnessed the horror of Hib disease. Before the vaccine, Hib was the most common cause of meningitis, often leaving children deaf, blind, or severely mentally disabled. And it was a common cause of bloodstream infections (sepsis) and pneumonia. But one disease caused by Hib is even more frightening—a disease that most parents have never heard of and most young doctors have never seen: epiglottitis.
The epiglottis is a thumb-like wedge of tissue at the back of the throat; when people swallow, it flops down over the windpipe, preventing food and water from entering the lungs. Hib is unique among bacteria in its capacity to infect the epiglottis. Once infected, the epiglottis can block the windpipe—no different, in a sense, than being smothered by a pillow. Before 1990, every big city hospital had an “epiglottitis team,” designed to usher children quickly and quietly into the operating room for a lifesaving tracheostomy (a surgical hole in the windpipe). The quietly part was particularly important. Once agitated, children with epiglottitis were much more likely to suffocate on the spot. No disease was more nerve-wracking.
In 1987, the Food and Drug Administration licensed the first Hib vaccine. To doctors across the country, the vaccine was a godsend. At last, they could prevent the severe, permanently disabling, and fatal cases of Hib that occurred every year. Barbara Loe Fisher didn’t share their enthusiasm. On World News Tonight with Peter Jennings, she cautioned, “We have to do more independent vaccine risk studies to find out whether or not vaccinations are causing chronic diseases, like diabetes.” Fisher’s response was predictable. Years before, in her book A Shot in the Dark, she had written, “With the increasing number of vaccinations American babies have been required to use has come increasing numbers of reports of chronic immune and neurological disorders being suffered by older children and young adults including asthma, chronic ear infections, autism, learning disabilities, attention deficit disorder, diabetes, rheumatoid arthritis, multiple sclerosis, chronic fatigue syndrome, lupus, and cancer. The unanswered question is whether multiple vaccinations, which are suppressing many diseases, especially in childhood, are playing a leading role in the rise of chronic illnesses later in life.” By simply replacing infectious diseases with chronic diseases, vaccines, according to Fisher, were responsible for many of mankind’s ills. For every new vaccine, Fisher would find at least one doctor to support her view. In the case of the Hib vaccine, it was Bart Classen.
Classen was the president and chief executive officer of Classen Immunotherapies, a company that held patents on alternative vaccine schedules and alternative methods to identify vaccine side effects. To establish that Hib vaccine caused diabetes, Classen showed that children in Finland who had received three doses of vaccine in infancy were more likely to have diabetes than those who had received only one dose in the second year of life. Appearing with Barbara Loe Fisher on World News Tonight, he said, “In fact, the scheduling has a major impact on the development of diabetes. We’re saying that when you look at the big picture, looking at five, ten years down the road, that this isn’t the ideal schedule.”
This was big news. The Hib vaccine, thought to be one of medicine’s greatest lifesavers, was, according to Classen, actually causing children to suffer a lifelong, debilitating, often fatal disease. Other researchers rushed to confirm Classen’s findings. One group examined the risk of diabetes in twenty-one thousand American children who had received the Hib vaccine and compared it with twenty-one thousand children who hadn’t. The risk of diabetes was the same in both groups. Other investigators examined two hundred and fifty American children with diabetes to see if they were more likely to have been vaccinated than other children. Again, Hib vaccine didn’t increase the risk of diabetes. Indeed, no vaccine has ever been shown to increase the risk of diabetes. The inability of researchers to reproduce Classen’s findings caused them to take a closer look at his original study. They found severe flaws in his analytical methods, further substantiated when, ten years after vaccination, Finnish children who had received Hib vaccine in infancy weren’t more likely to have diabetes—exactly the opposite of what Classen had said on World News Tonight.
Barbara Loe Fisher’s appearance on national television with Bart Classen wasn’t her only public comment on the Hib vaccine. One ironic twist remained.
Heather Whitestone was born in 1973 in the tiny town of Dothan, Alabama. After high school Whitestone attended Jacksonville State University and started competing in beauty pageants. On September 17, 1994, at the age of twenty-one, she was crowned Miss America—the first with a severe disability. “I lost my hearing when I was eighteen months old,” she said. After Whitestone accepted her crown, her mother told a local news reporter what she thought had caused her daughter’s deafness: DTP vaccine. Whitestone’s prominence, combined with her mother’s revelation, was chilling for any parent deciding whether to vaccinate their child. Barbara Loe Fisher quickly weighed in: “It’s so often that the parent who is with the child and witnesses the high fever, witnesses the convulsions, the shock or whatever; it comes down to whether the doctor agrees it was due to the vaccination just given. [The medical community] continues to try to sweep these children under the rug.”
Heather Whitestone, the first Miss America with a disability, was a controversial figure in the anti-vaccine movement. (Courtesy of Donna Connor/Sygma/Corbis.)
Heather’s mother had omitted one critical part of the story. Ted Williams, the Dothan, Alabama, pediatrician who had taken care of Heather, had followed her rise to fame with pride. But when Heather’s mother claimed that DTP had caused her daughter’s illness, Williams stepped forward. He knew that Heather wasn’t deaf because of DTP; she was deaf because of a near-fatal case of Hib meningitis. Fisher responded to Williams’s revelations angrily, seeing conspiracy. “Within hours after the Miss America pageant, a horrified medical establishment moved quickly to publicly dispute any connection between Heather’s deafness and the DPT vaccine and instead blame her deafness on a bacterial infection,” said Fisher. “The American medical establishment went to extraordinary lengths to publicly challenge Heather and her mother in order to avoid having to acknowledge DPT vaccine risks.”
American children have used Hib vaccine for more than twenty years. During that time the number with Hib meningitis, bloodstream infections, pneumonia, and epiglottitis has decreased from twenty thousand every year to fewer than fifty. Sadly, some parents watching World News Tonight, frightened by Barbara Loe Fisher’s and Bart Classen’s warning that Hib vaccine could cause diabetes, might have chosen not to vaccinate their children: a choice that would have put them at unnecessary risk of a highly disabling, often fatal infection.
The next vaccine recommended for infants protected against hepatitis B virus. It was immediately controversial. Although most parents had probably never heard of Hib, they had all heard of and feared meningitis. So the Hib vaccine was an easy sell. But while most parents know what hepatitis is, they had never considered it a disease of children. Actually, it’s more common than people realize.
Before the vaccine, hepatitis B virus infected about two hundred thousand people in the United States every year, mostly teenagers and young adults. The infection isn’t trivial, causing fever, vomiting, nausea, food intolerance, abdominal pain, headache, muscle pain, joint pain, rash, and dark urine followed a few days later by jaundice (yellowing of the skin and eyes) and an enlargement and tenderness of the liver. Some patients become disoriented, extremely sleepy, semi-conscious, or comatose: all symptoms of severe liver damage. Four of ten people in the United States with symptomatic hepatitis B infection will be hospitalized and five thousand killed by the virus every year. For those who survive, the virus may cause a long-lived infection, resulting in permanent scarring of the liver (cirrhosis) or liver cancer. Worse: people chronically infected with hepatitis B virus often don’t know it—problematic, given that many are highly contagious to others. For this reason, hepatitis B infections are known as the “silent epidemic.” Prior to the development of hepatitis B vaccine, about a million people in the United States were chronically infected.
In 1981, the year before Barbara Loe Fisher watched Vaccine Roulette, the first hepatitis B vaccine was licensed. It wasn’t recommended for routine use in children. Public health officials reasoned that the best way to eliminate the disease was to recommend the vaccine for those most likely to become infected—specifically, people who have sex with an infected person, especially men who have sex with men; healthcare providers unknowingly exposed to contagious patients; intravenous drug users; prisoners; and people who get tattoos from places that don’t adequately sterilize equipment between customers. Between 1981 and 1991, the vaccine was recommended only for those at highest risk. Unfortunately, the strategy failed, miserably; and the incidence of hepatitis B virus infections remained unchanged. So, government officials embarked on the second stage of their plan, recommending three doses of the hepatitis B vaccine for all babies, the first to be given soon after birth.
The new hepatitis B vaccine policy was a public relations nightmare. Because the vaccine had initially been recommended for prisoners, intravenous drug users, and men who had sex with men, it was viewed as “dirty”: a vaccine that had no place in the infant vaccine schedule. Fisher leveraged this perception to promote her premise that vaccines caused chronic diseases. The doctor who supported her this time was Bonnie Dunbar.
On January 22, 1999, ABC’s 20/20 aired a program that deeply scared the American public. (Fisher, who provided information to the show’s producer, can be seen briefly pointing to a computer screen.) Sylvia Chase was the correspondent. The program began with a teaser: “Next, an important medical controversy. Serious new questions about a vaccine most school children are forced to get: one given to millions of babies every year.” “We just thought it was like all the immunization shots,” said one mother. “We were doing it to protect our child.” “It’s the hepatitis B vaccine,” warned the announcer. “These parents thought it would protect their child. No one told them that there might be risks.” “Within three weeks of the third shot, I lost my vision,” said one woman. The announcer then revealed the show’s premise: “Is it smart preventive medicine, or an unnecessary risk? Sylvia Chase asks: When it comes to hepatitis B, who’s calling the shots?”
The 20/20 program told the stories of several healthcare providers who had developed multiple sclerosis after getting the hepatitis B vaccine.
CHASE: These medical workers say they were healthy. Then they were vaccinated.
WORKER #1: Within two months I was very ill. I was ill in bed.
WORKER #2: I can’t even feed myself.
DUNBAR: These people were completely healthy.
CHASE: Dr. Bonnie Dunbar, a cellular biologist at Baylor College of Medicine, believes that in certain people a genetic component sets off an explosive chain of events.
DUNBAR: The only thing that happened is they took this vaccine and within a month most of these people had completely debilitating life-style changes.
The implication was clear; hepatitis B vaccine caused multiple sclerosis. Chase then described the same problem that Lea Thompson had described for DTP:
CHASE: Three-day-old Ben Converse’s seizures began less than twenty-four hours after his first shot. Now Ben is developmentally disabled. Thirty-three hours after his vaccination, thirteen-day-old Nicky Sexton’s heart stopped. The coroner said it was Sudden Infant Death Syndrome, or SIDS. Lyla Belkin’s death was also attributed to SIDS. She had received her first shot at six days old: the second one, a month later.
MR. BELKIN: How is a baby possibly going to get hepatitis B? It’s ridiculous to give this vaccine to a child. I wish we’d known that before receiving this vaccine.
CHASE: You did what the doctor told you to do.
MRS. BELKIN: I did what the doctor told me to do. Yes, of course.
CHASE: And they didn’t say that there were any cases of deaths or serious reactions?
MRS. BELKIN: No, nothing.
CHASE: On September 16, 1998, Mrs. Belkin nursed Lyla at 5:30 a.m., not long after, she found her pale and cold.
MRS. BELKIN: (fighting back tears) She died early in the morning about sixteen hours after vaccination.
The scene shifted back to the show’s hosts, Hugh Downs and Barbara Walters. Walters looked into the camera, incredulous. “What a choice for parents to have to make,” she declared. “There is so much conflicting information!” Unfortunately, the problem with the program wasn’t that there was so much conflicting information; it was that there was so much wrong information, such as the false notion that babies aren’t at risk of getting infected. “How’s a baby possibly going to catch hepatitis B virus?” Michael Belkin had asked. Fisher echoed Belkin’s disbelief. “There are only four hundred cases a year of hepatitis B in children under fourteen [years of age],” she said. “It’s not a disease your average, healthy child is likely to contract.” Although it is true that most disease and death caused by hepatitis B virus occur in adults, every year before the hepatitis B vaccine about sixteen thousand children less than ten years of age were infected by nonsexual, person-to-person contact. (Hepatitis B virus can spread fairly casually, such as by sharing toothbrushes.) Worst of all, infants infected with hepatitis B virus are at the highest risk of long-term problems; many develop cirrhosis or liver cancer later in life. Although childhood infections accounted for fewer than 10 percent of all infections in the United States, they accounted for 20 percent of all cases of chronic liver disease. This is the reason public health officials had recommended the vaccine for newborns.
Another misleading message from the 20/20 broadcast was that hepatitis B vaccine caused SIDS. The most compelling story was that of Lyla Belkin, who died of SIDS following her second dose. Fisher asked Michael Belkin to head the Hepatitis B Vaccine Project at her National Vaccine Information Center. Soon Belkin, a Wall Street financial advisor, was everywhere. In February 1999, at a meeting of a federal vaccine advisory group at the CDC, he said, “I hold each one of you who participated in the promulgation or perpetuation of that mandated newborn vaccination policy personally responsible for the death of my daughter.” Several months later, Belkin told a congressional committee, “Almost every newborn U.S. baby is now greeted on its entry into the world by a vaccine injection against a sexually transmitted disease for which the baby is not at risk—because they [health officials] couldn’t get the junkies, prostitutes, homosexuals, and promiscuous heterosexuals to take the vaccine. Parents need to understand that the system providing the vaccines injected into their children’s veins is corrupt and scientifically flawed.”
Despite Belkin’s certainty that hepatitis B vaccine had caused his daughter’s SIDS, study after study failed to support him. Indeed, during the 1990s, when the vaccine was given to more and more babies, fewer and fewer died of SIDS. This wasn’t because of the vaccine; it was because of an aggressive program called “Back to Sleep.” Investigators had found that children who died of SIDS were more likely to have been lying on their faces than on their backs at the time of death. Encouraging parents to lay their children on their backs dramatically reduced the incidence of SIDS.
Sylvia Chase’s 20/20 segment also trumpeted the notion that hepatitis B vaccine caused multiple sclerosis—an accusation that didn’t hold up. Two years after the program, investigators published two large studies that assessed whether the vaccine caused multiple sclerosis (it didn’t) or worsened symptoms in people who already had the disease (again, it didn’t).
At the time of the 20/20 broadcast, the hepatitis B vaccine had been given to fifty million infants and children and seventy million teenagers and adults in the United States. Since 1991, when it was first recommended for all infants, the vaccine has virtually eliminated the disease in children. Barbara Loe Fisher used her considerable platform in the 1990s to warn American parents that the hepatitis B vaccine was unnecessary, that it caused SIDS, and that it caused multiple sclerosis—positions that could have misled parents into avoiding a vaccine that has prevented a great deal of suffering and death.
Fisher’s assault on newly recommended vaccines didn’t end with hepatitis B. Next up was a vaccine to prevent pneumococcus, the most common cause of pneumonia and, like Hib, an important cause of meningitis and bloodstream infections.
In 1998, researchers in Northern California performed a landmark study. They tested the pneumococcal vaccine in thirty-eight thousand infants: half received it and half didn’t. The results were dramatic. Pneumococcus caused bloodstream infections in seventeen children who didn’t get the vaccine and in not a single child who did: seventeen versus zero. Excited, researchers made their findings public.
On the evening of September 25, 1998, John McKenzie, a correspondent for World News Tonight with Peter Jennings, told the story of the pneumococcal vaccine. The program included Barbara Loe Fisher, Bart Classen, and Neal Halsey, a vaccine expert from the AAP.
JENNINGS: In California today, researchers have announced a new vaccine which they say will protect children from several diseases. They are very encouraged about the clinical trials. But the news raises a question—do children need another vaccine? Here’s ABC’s John McKenzie.
MCKENZIE: Most children in this country are injected with at least ten different vaccines. Now, some doctors seem eager to add yet another—this new pneumococcal vaccine.
NEAL HALSEY: It’s one of the most important, if not the most important, vaccines that has been developed in the last ten years.
MCKENZIE: The vaccine appears to prevent the most dangerous form of pneumococcal disease called bacterial meningitis. It also might help prevent pneumonia and middle ear infection. While few people doubt that this new vaccine is effective, a controversy is erupting about whether every child in the country actually needs it, whether we really know enough to say the benefits outweigh the risks. Young children are the most vulnerable to serious pneumococcal disease, with ten thousand cases reported each year. But relatively few, only about two hundred, are actually deadly. The vast majority are treated effectively with antibiotics.
FISHER: If we’re going to require a vaccine, it should be for a disease that’s highly contagious, is extremely deadly, and is in epidemic form. This disease does not qualify.
MCKENZIE: The reason that some are urging caution is that nobody knows the long-term side effects of any vaccine. And the few cases where people have started to look, the results have been disturbing.
CLASSEN: Published studies showed that when one follows these kids, and looks for diseases like diabetes and asthma ... the immunized kids seem to be at an increased risk.
FISHER: The vaccine should definitely be made available for children who are in poor health, having a compromised immune system, but it should not be required for all children.
MCKENZIE: While vaccines have saved the lives of millions, some researchers warn that before we add another, we have a better understanding of the risks involved.
At the time that the World News Tonight piece aired, parents didn’t have a choice about whether or not to get the pneumococcal vaccine. That’s because it hadn’t been licensed yet. But for parents who would soon face that choice, World News Tonight had done much to mislead them.
As she had done with the Hib vaccine, Fisher allied herself with Bart Classen, who, without any supportive evidence, claimed that the pneumococcal vaccine caused diabetes. Also, Fisher had claimed that diseases caused by pneumococcus were not particularly common, affecting only those in poor health. This wasn’t true. Before the vaccine, every year pneumococcus caused four million ear infections, one hundred and twenty thousand cases of pneumonia requiring hospitalization, thirty thousand bloodstream infections, and twenty-five hundred cases of meningitis. Most of these diseases occurred in previously healthy children. And, although the bacterium didn’t kill as many children as measles or polio, John McKenzie’s comment that it killed “relatively few, only about two hundred” was rather callous to those parents whose children had suffered and died from pneumococcus.
Within a year of the World News Tonight program, federal health officials asked Barbara Loe Fisher to serve on one of the most powerful vaccine advisory committees in the United States—a committee that advised the FDA. No vaccines have been licensed without approval from this committee. Fisher was asked to serve because health officials believed that once she saw how carefully vaccines were tested—once she got a look behind the curtain—she would feel more confident about the safety of vaccines. It didn’t happen.
The first vaccine on which Fisher was asked to vote was the pneumococcal vaccine. In 1999, after reviewing all of the safety and efficacy data, committee members cast their vote: 11 to 1 in favor of licensing the vaccine. The lone dissenting vote was that of Barbara Loe Fisher. Because the FDA didn’t require unanimous approval for licensure, in January 2000 it licensed the vaccine. Robert Daum, a professor of pediatrics at the University of Chicago Children’s Hospital, said, “I think this is a giant step for the health of children.” Fisher disagreed. “There’s not enough evidence about the safety of this vaccine,” she said. “What we basically have here is a post-marketing experiment.”
By 2009, almost a hundred million doses of the pneumococcal vaccine had been given to American children. As a consequence, the incidence of pneumococcal disease has decreased dramatically.37 Far fewer children now get meningitis, pneumonia, and bloodstream infections caused by pneumococcus. And, although we’ll never know their names, hundreds of children are still alive because they got the pneumococcal vaccine. That’s not all. Because the vaccine has reduced the number of children who carry pneumococcus in the nose and throat, older people, such as their grandparents, have also benefited. Finally, the chronic diseases predicted by Barbara Loe Fisher and Bart Classen in front of millions and millions of television viewers never materialized.
In 1998, another vaccine was licensed and recommended for young children. After the vaccine had been used for about a year, something happened that should have put Barbara Loe Fisher’s concerns about the government’s interest in vaccine safety to rest.
On August 31, 1998, the FDA licensed a vaccine that protected against a common intestinal virus called rotavirus. Rotaviruses, which cause fever, vomiting, and diarrhea in infants and young children, are responsible for nine hundred thousand office visits, seventy thousand hospitalizations, and sixty deaths every year in the United States, mostly from dehydration. In the developing world, rotavirus is a more prodigious killer, causing the deaths of two thousand children every day. Because the disease is common and occasionally fatal, the CDC recommended the vaccine for all infants.
In July 1999—ten months after licensure—the CDC discovered something it hadn’t anticipated. Reports of fifteen children who had received rotavirus vaccine appeared in the Vaccine Adverse Events Reporting System (VAERS). These children shared several features: all had developed an uncommon form of intestinal blockage called intussusception (which occurs when one segment of the small intestine telescopes into another and gets stuck), all had recently received the rotavirus vaccine, and most were about two months old (intussusception is unusual in two-month-old children). Intussusception is a medical emergency. Children with the disorder can develop severe bleeding from the intestine or a bloodstream infection; both can be fatal.
The CDC knew that it had a problem. So, on July 16, 1999, it temporarily suspended the use of the new rotavirus vaccine until investigators could figure out what was going on. Finding an answer wasn’t going to be easy. Every year before the rotavirus vaccine had become available, one in two thousand infants in the United States developed intussusception, most between five and nine months of age. Jeff Koplan, head of the CDC, pulled people off other projects, spent millions of dollars, and made it clear that an explanation for the intussusception found in two-month-olds must come quickly. By October, only months after the possible association between rotavirus vaccine and intussusception was reported to VAERS, Koplan and his CDC team figured it out. Children who received the new rotavirus vaccine were twenty-five times more likely to get intussusception than those who hadn’t. Although the rotavirus vaccine clearly caused intussusception, the risk of getting the disease was quite low: one case per ten thousand vaccine recipients. That same month, the CDC withdrew its recommendation of the vaccine—and the company that produced it took it off the market. Seven years would pass before a safer rotavirus vaccine was made.
The serious side effect caused by the first rotavirus vaccine offered several insights into how the CDC monitors vaccines. Reports to VAERS quickly signaled a problem; CDC officials acted immediately, withholding the vaccine until they determined whether the problem was real and, once they found it, withdrew their recommendation. This is what happens when a vaccine actually causes a problem. Barbara Loe Fisher should have been reassured by all of this. But she wasn’t.
Another vaccine licensed on Fisher’s watch, and one that incurred her greatest wrath, prevented human papillomavirus (HPV), a known cause of cancer of the cervix. Cervical cancer isn’t rare, causing ten thousand American women to suffer and four thousand to die every year. The bad news is that about thirty different strains of HPV cause cancer. The good news is that two of the strains contained in the vaccine prevent 70 percent of cases. And HPV isn’t one of many viruses that cause cervical cancer; it’s the only virus that causes it. So, the HPV vaccine was a lifesaving breakthrough.
Although HPV vaccine was new, the strategy used to make it wasn’t. It was made with the same technology used to make the hepatitis B vaccine twenty years earlier. By 2006—when the CDC recommended it for teenage and adult women—HPV vaccine had been tested for seven years in more than thirty thousand women. Other than pain and tenderness at the site of injection, and occasional episodes of fainting, the vaccine didn’t appear to have any serious side effects. But Barbara Loe Fisher was determined to defeat the HPV vaccine, again claiming that it wasn’t necessary and that pharmaceutical companies had misrepresented data. “Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said Fisher. “Merck’s pre- and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get licensure.”
Two months later, Fisher turned up the volume: “In what is perhaps the most brilliant public relations and marketing strategy ever employed by a pharmaceutical company promoting the universal use of a vaccine most Americans do not need to prevent cervical cancer, Merck and Co. is in the process of pulling off one of the biggest money-making schemes in the history of medicine. The Big Pharma giant that brought us death by Vioxx has convinced the FDA, CDC, public-school officials, and gynecology professors as well as the entire European Union that every man and woman in the world must purchase and be injected with the HPV vaccine in order to survive.” Later, on her blog, she called it “the slut shot” and “the ‘cheaters’ vaccine.” (Because HPV infects 70 percent of women within five years of their first sexual encounter, one could infer that Barbara Loe Fisher doesn’t have a very high opinion of American women.)
As she had with the Hib, pneumococcal, and hepatitis B vaccines, Fisher claimed that HPV vaccine caused chronic, serious disabilities. She reported that young girls had been paralyzed and were dying from the vaccine: dying from blood clots that caused strokes and heart attacks. On CBS’s Sunday Morning, Fisher told Charles Osgood and millions of television viewers, “This is an intervention that carries the risk of injury or death.” CDC officials responded to the public’s growing concern, studying more than ten thousand reports to VAERS to determine if there was a pattern (as had been seen with the ill-fated first rotavirus vaccine) that suggested HPV vaccine might be causing a problem. They examined reports of paralysis and found “there has been no indication that [HPV vaccine] increases the rate of Guillain-Barré Syndrome [GBS, a rare cause of paralysis] in girls and women above the rate expected in the general population.” They also examined the medical records of twenty-seven people who had died soon after getting the vaccine, finding nothing to suggest that the vaccine had been the cause. People who had recently received HPV vaccine had died from complications of diabetes or heart failure or viral illnesses or bacterial meningitis or drug overdose or blood clots caused by birth-control pills or seizures in those already known to have epilepsy. Reports of death following HPV vaccine were consistent with deaths that were occurring in the general population before the vaccine was used. Fisher didn’t believe it. “The ‘coincidence’ defense mounted by doctors and drug-company officials every time a vaccination is followed by injury and death is as old as it is unscientific,” she blogged. “It’s amazing that they have been able to get away with it for so long.”
Perhaps Fisher’s most disingenuous comment about HPV vaccine was that it might cause cancer: “And how many [girls] will go on to develop fertility problems, cancer, or damage to their genes, all of which Merck admits in its product insert it hasn’t studied.” Fisher knew that infection with HPV could lead to cancer; so she raised the specter that the vaccine could do the same thing. But HPV causes cancer by incorporating two of its genes into cells that line the cervix. Because the HPV vaccine contains no HPV genes, only HPV proteins, it’s not possible for the vaccine to do this.
By 2009, more than thirty million doses of HPV vaccine had been given without serious consequences. Women who choose to believe Barbara Loe Fisher’s warnings and refuse the HPV vaccine are at increased risk of cervical cancer: an event that occurs twenty to twenty-five years after this very common infection.
Fisher’s ill-conceived notion that vaccines cause chronic diseases isn’t the only example of how she has squandered an opportunity to alert the media and parents about the real issues of vaccine safety. There were, unfortunately, many others:
• In 1995, when the chickenpox vaccine was recommended for all children, Fisher objected. “Certainly if your child has leukemia or a compromised immune system, you should have them vaccinated. But for your average kid, chickenpox is not a serious disease.” Before the vaccine, about ten thousand children were hospitalized and seventy killed by chickenpox every year. Most were previously healthy. Fisher also warned, “the chickenpox vaccine is just going to drive chickenpox into the adult population, where it can be deadly.” The chickenpox vaccine, which by 2009 had been used for fifteen years, has led to a 90 percent decrease in the disease, in both children and adults.
• Fisher also decried the concept of herd immunity. “If vaccines are as effective as they are touted to be,” she said, “then those who are vaccinated will not face any risk from those who are not.” This is clearly untrue, as illustrated by a particularly instructive measles outbreak in the Netherlands between 1999 and 2000. Researchers found that children were actually at greater risk if they were fully vaccinated and living in a relatively unvaccinated community than if they were unvaccinated and living in a highly vaccinated community. That’s because no vaccine is 100 percent effective and the greater the likelihood of exposure to a disease, the greater the risk.
• Fisher argued that diseases prevented by vaccines aren’t really that bad. “We have gotten into a mind-set where there is an abject fear of disease,” she said. “In the ‘50s, everyone had measles and mumps, and there wasn’t this drama attached.” Before the vaccine, measles caused more than a hundred thousand hospitalizations and five hundred deaths in the United States every year. Unlike Barbara Loe Fisher, who survived her encounter with measles, those who succumbed aren’t around to tell their stories.
• Fisher also argued that natural infection is better than immunization. “Experiencing infectious disease, including influenza, has been part of the human condition since man has walked the earth,” she blogged. “Why do vaccinologists insist on assuming that the human immune system is incapable of dealing with that experience? Or benefiting from it? Where is the evidence that it is good to never, ever get the flu?” Before the influenza vaccine was routinely given to children, two hundred thousand were hospitalized and a hundred killed by the virus every year. In 2009, during the H1N1 (swine flu) pandemic, more than a thousand American children died from the flu.
Perhaps Barbara Loe Fisher’s most enduring legacy can be found in the comments of Samuel Berkovic, the Melbourne neurologist who had found the real cause of seizures and mental retardation in children claimed to have been damaged by pertussis vaccine. Berkovic remembered the reaction of parents after his discovery: “Most of them were incredibly grateful because they had carried the guilt. They had taken the child to the doctor or maternal/child-health nurse and handed the kid over, and the infant got the vaccine. It was their fault. [They thought] ‘if only I’d listened to the lady down the street who said “Don’t give your kid a vaccine,” I’d have a healthy child.’ And when we tell them that that’s not right, that sadly your child had this change in the sodium channel that happened at conception and there was nothing you could do about it—that your child was destined to get this—there was an enormous sense of relief. For most, it’s relieved decades of guilt.”
By telling parents that diabetes, multiple sclerosis, asthma, allergies, seizures, mental retardation, paralysis, and autism are all caused by vaccines, Barbara Loe Fisher—whether intentionally or not—puts the burden of their children’s illnesses squarely on the shoulders of those parents. If only they hadn’t gotten their children vaccinated, none of these horrors would have happened. But now it’s too late; the only thing left is to be angry—angry at a government lost in bureaucracy, pharmaceutical companies in it for the money, and doctors who don’t care. By claiming that vaccines cause chronic diseases, Fisher contributes to this cycle of guilt, anger, and blame.
Barbara Loe Fisher is a lightning rod for the media. She is a powerful voice during congressional hearings. And she is the one-stop shop for parents concerned that vaccines are hurting their children. But for all the attention she garners—for all the magazine stories and radio and television interviews—studies have consistently failed to support her concern that vaccines are causing chronic diseases. At the same time that Fisher diverts the media away from real problems with vaccines, one vaccine-safety advocate, working quietly and behind the scenes, has accomplished a great deal. His name is John Salamone.
Salamone was born in upstate New York, in the town of New City. When he was nineteen years old, while studying journalism and government at the University of Maryland, he became the youngest legislative director in Congress. Later, he handled congressional affairs for the Immigration and Naturalization Service. After fifteen years with the government, Salamone moved to the private sector, heading the nonprofit National Italian-American Foundation.
In 1990, Kathy and John Salamone brought their son David to their pediatrician’s office in suburban Washington, D.C., to get his vaccines—one of which was Albert Sabin’s oral polio vaccine. Two weeks after the visit, the Salamones noticed something wrong with their son. “He couldn’t turn over,” John said. “He could only move his head back and forth.” David Salamone was completely paralyzed below the waist. Eventually he regained the use of his left leg, but his right leg withered. Doctors fitted David with a leg brace and he learned to walk with a gait that, according to John, resembled “a drunken sailor.” David’s diagnosis was elusive. “The doctors were quite perplexed,” recalled Salamone. “They couldn’t figure it out because, let’s face it, not too many doctors these days are experts in polio. They just simply diagnosed him with a neuropathy of unknown etiology.”
David wore the heavy leg brace and started physical therapy. “They noticed that he was in pain,” said Salamone, “which was unusual for his condition. And so they sent us to a rheumatologist at Georgetown [who] said, ‘Let me just try some tests here.’ For the first time, at age three, after being sick quite a bit and always on antibiotics, he was diagnosed with [a congenital immune deficiency]. [Children with severe immune deficiencies are more likely to be paralyzed by the oral polio vaccine.] So now they had figured out why he was sick all of the time with these flu-like symptoms. Then they started to put it all together, to connect the dots and figure out that he got polio from the vaccine.”
Salamone learned that a safer vaccine (Salk’s), unavailable in the United States, had been used in countries such as Sweden, Norway, and Finland and some provinces in Canada with success, completely eliminating polio. He wanted to know why health officials in the United States used Sabin’s vaccine instead of Salk’s when the former caused a rare but dangerous side effect and the latter didn’t. So, John Salamone became a vaccine-safety advocate, founding an organization called Informed Parents Against Vaccine-Associated Polio (IPAV). “At first you feel guilt,” recalled Salamone. “Because you say to yourself, ‘we brought our child to the doctor and gave him polio.’ Then we got mad, upset, when we found out that there were other options of polio vaccine out there. So we said to ourselves, ‘Why wouldn’t they be giving that to everyone? Why would you even take a chance?’ Then we found out that there were a number of kids every year who were getting polio from the vaccine and I started to identify them little by little and communicate with those families. And in the meantime I wrote to my congressman and I wrote to the White House and I wrote to anyone I could write to and really it was falling on deaf ears. It seemed that if the price was a dozen kids or so a year that got polio from the vaccine well then that was just the price of having a universal vaccine program.”
John Salamone changed polio-vaccine policy in the United States after his son, David, suffered a crippling side effect. (Courtesy of Joseph M. Valenzano, Jr.)
The turning point came in 1993, when Salamone was asked to speak before the Institute of Medicine. He remembered what happened: “The next thing you know an [Associated Press] article picked up on my story and before you knew it I was getting calls from all these newspapers. At one point I was in Italy and somebody called me up and said there’s a full page in the Washington Post on the front page of the health section with a picture of you and David and the whole polio story.”
Salamone knew that if he were to change policy, he was going to have to convince the Advisory Committee on Immunization Practices (ACIP), which advises the CDC. “From there I decided that the only way we were going to make a change was to convince the ACIP and people down at the CDC that there was a need to make this change,” recalled Salamone. Every time the ACIP discussed the polio vaccine, John Salamone was there. And every time the AAP held its annual meetings, Salamone was sitting behind a booth manned by several children paralyzed by the vaccine. Salamone converted statistics into real people. Always respectful, clear spoken, and passionate, he was very persuasive. By 1998, the ACIP had switched to the inactivated polio vaccine, eliminating paralysis caused by the live, weakened vaccine. John Salamone’s advocacy had everything to do with that change.
In 2008, after twenty-five years with the National Italian-American Foundation, John Salamone retired. He and Kathy now live in Mount Holly, Virginia. “I was lucky,” recalls Salamone. “My degree is in journalism and my background is the Congress. If you believe in a God, He picked the right family to have a son who got polio from the vaccine. Because I had the combination of the ability to write and I had good contacts in Washington.” Salamone argues that successful vaccine advocacy depends on two things: “I think what worked was organizing families [and] getting the media involved. If the media hadn’t picked up on this, I would never have had my opportunity to go before the committee.”
In many ways, John Salamone and Barbara Loe Fisher are similar. Both are passionate advocates, both are superb writers and powerful speakers, both have had ready access to the media, and both have had the opportunity to make their case in front of congressional committees. But whereas Salamone’s concerns have been supported by science, Fisher’s haven’t. “[Fisher’s group] sends me material and I put it in the circular file,” says Salamone. “It seems to me that we can’t be guided by bad science. It would be reckless to go out there and attribute certain side effects to a vaccine when they’re not documented by science. Attacking vaccines with bad science and bad information is nothing short of reckless and irresponsible.”
Ironically, Salamone found that Barbara Loe Fisher’s group hurt his efforts to change policy. When Salamone manned a booth at AAP meetings he was often confronted by angry physicians: “Their response, candidly, was not great. My biggest problem was that when you talked about vaccine injury, you were immediately labeled as anti-vaccine. They wanted to put me in the same category as the Fishers of the world, the organizations that had a broader agenda of reducing if not eliminating many of the vaccines. To the contrary, I was pro-vaccine. But I was pro-vaccine safety. I was knowledgeable enough to know the history that many more people’s children and adults have been saved by vaccines than have ever died from them.”
Although John Salamone and Barbara Loe Fisher are both vaccine-safety activists, they have different core beliefs. First: Barbara Loe Fisher doesn’t trust doctors. This distrust was born of a time when she felt that they had lied about—or at least neglected to mention—harmful effects of pertussis vaccine. And she never forgot it. She portrays doctors as elitists and frauds. In A Shot in the Dark, referring to doctors, she quoted Shakespeare’s Measure for Measure:
But man, proud man,
Drest in a little brief authority,
Most ignorant of what he’s most assured,
His glassy essence, like an angry ape,
Plays such fantastic tricks before high heaven
As make the angels weep.
As the years passed, Fisher’s anger toward doctors, scientists, and public health officials only intensified. She accused them of deception: “Do public health authorities and pediatricians really think that mothers and fathers are going to passively accept the brain-damaging and killing of their children with unsafe vaccines? Do they really believe that the letters written after their names will protect them when the public knows the whole truth about what they have done to so many innocent children around the world?”
She accused them of not caring: “The medical ‘experts’ are not infallible and they are not immune from the desire for power, money, and fame. The failure to value the life of each individual child by writing off some children as expendable in service to the rest is at the root of much of the distrust educated parents have for the mass vaccination system and those who operate it.”
And she likened them to doctors in Nazi Germany: “We would do well to remember what happened in pre-World War II Germany, when doctors were legally allowed to kill anyone in society considered to be a threat to the public health and welfare. Are we preparing for the day when doctors can not only kill handicapped newborns but also handicapped older children and adults, including the vaccine-injured who face a lifetime of long-term care?”
John Salamone had every reason to question doctors. When his son got the oral polio vaccine, he was never told that there was a chance he could suffer permanent paralysis. But Salamone didn’t see doctors as evil. Rather, he believed he could convince them that choosing Sabin’s vaccine over Salk’s was illogical and dangerous. He believed that he could appeal to their ability to reason—that they were human and would respond humanely. And he was right. Salamone’s rational advocacy earned the respect of doctors and policy makers. The secretary of health and human services asked him to serve on the Advisory Commission on Childhood Vaccines and, later, the ACIP—the very committee he had implored to switch to a safer polio vaccine.
In contrast, Barbara Loe Fisher, rather than appreciating the researchers who spent millions of dollars on studies to answer her questions, had disdain for them. She believed that studies that failed to support her beliefs were useless—or, worse, fabricated. “Those determined to deny an association between vaccine-induced inflammatory conditions in the body usually like to use retrospective, case-controlled ‘studies’ that look at old medical records,” she blogged. “Using pencils and calculators to dismiss causal associations between vaccines and chronic diseases is easier than having to look at real live patients.... The pathetic attempts by the pencil pushers to write off onset of brain and immune dysfunction after vaccination in previously healthy people as just a ‘coincidence’ will not wash. The people, whose lives have been ruined by doctors too proud to admit harm being done, will not let them get away with it.” Fisher’s anger wasn’t limited to blog postings. In July 2002, at a meeting of parents, public health officials, doctors, and representatives from pharmaceutical companies, she berated the group. One attendee recalled, “On the last day of the meeting, Roger Bernier, the chief architect of the event, was [telling] everyone how important it was that we were all there participating in developing a plan for how we could all work together on vaccine safety issues. He spoke about the importance of the meeting, praised everyone for being there, and said that we were all being pro-active in moving ahead with this plan, before we had a crisis. Fisher was the next to speak. She was fiery. She retorted, ‘We are in a crisis. And if we don’t move forward with this plan, there will be a bloodbath! More government hearings—you bet! More media stories—absolutely!’”
In the early 1980s, Barbara Loe Fisher watched personal-injury lawyers win hundreds of millions of dollars in settlements and awards for alleged victims of pertussis vaccine. It was in a courtroom, not a scientific venue, that Fisher found a sympathetic ear. But with the birth of the National Childhood Vaccine Injury Act in 1986, parents now had to go through a special court. In 2009, this court would be put to the test. Again, vaccine activists and lawyers would seek hundreds of millions of dollars in compensation. It would be their next big bet. This time the complaint wasn’t epilepsy or mental retardation or learning disabilities; it was autism. And there was every reason to believe that the success of the pertussis litigation was about to be repeated.