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 d
iseases 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.”
Deadly Choices: How the Anti-Vaccine Movement Threatens Us All Page 9
