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.