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Such systems are being vigorously opposed by the National Vaccine Information Center, the vaccine-safety group. Barbara Fisher, the center's executive director, says tracking systems are not only a violation of patient privacy, but will inevitably lead to more vaccine mandates. It's not surprising, she says, that drug companies support vaccine registries, which have also been set up as pilot programs in several states with grants from the CDC.
"Congress needs to give emergency funding to independent scientists to take an unbiased look at these vaccines," Fisher says, "instead of putting the research in the hands of the CDC, who have already decided to force every child to take them."
Like everywhere else, the debate over Texas's hepatitis B policy grew louder and more contentious after the September 1, 1998, 20/20 report on the safety of the vaccine. Three days before the show aired, the Harris County Department of Health issued a "public-health alert" giving local health officials a heads-up to the upcoming broadcast on "the alleged adverse reactions that have been attributed to the vaccine."
Included in the packet was a "fact sheet" prepared by Blaine Hollinger that defended the vaccine's safety record while emphasizing the need for the routine immunization of children. Following the broadcast, the accuracy of the information in those fact sheets was publicly challenged by a scientist featured on the 20/20 broadcast, who, it turns out, is also employed by Baylor College of Medicine.
Bonnie Dunbar, a molecular biologist and immunology researcher at Baylor, has been an outspoken critic of the hepatitis B vaccine, which is manufactured by a technique that reproduces the DNA strand of the virus. It is the first of its kind to be so widely used. Dunbar began to question the safety of the vaccine after two scientists in her lab became seriously ill following immunization. One of those researchers was Dunbar's brother, Bohn, who is permanently disabled with a lupuslike disorder that several examining physicians say was triggered by the vaccine.
Dunbar suspects that some people are vulnerable to the synthetic proteins in the hepatitis B vaccine. She's trying to get funding to conduct research into a relatively new phenomenon called "molecular mimicry," which suggests that the body's immune system may mistake the foreign proteins in a vaccine with natural proteins. When that happens, the immune system launches an attack on the healthy cells and tissues it's supposed to protect.
Dunbar believes molecular mimicry may be one reason the hepatitis B vaccine seems to trigger autoimmune disorders such as Guillain-Barre syndrome, multiple sclerosis and chronic fatigue syndrome in some people. And she's worried that 36 states, including Texas, have mandated the use of the vaccine in children without a better understanding of molecular mimicry.
"I would challenge any colleague, clinician or research scientist to claim we have a basic understanding of the human newborn immune system," Dunbar argues. "It is remarkable to me that newborn infants, especially those not at risk for the hepatitis B disease itself, are being administered multiple injections of this vaccine and there have been few clinical trials to evaluate the potential long-term effects."
Blaine Hollinger adamantly disagrees with Dunbar on the vaccine's safety record and says her theory that molecular mimicry can trigger serious adverse reaction requires "a huge leap of faith." He suggests --without mentioning her by name --that Dunbar may be biased against the vaccine, not because it allegedly hurt her brother, but because Bohn Dunbar is seeking damages from the manufacturer, as well as through the government's vaccine-injury compensation program.
"All I can say is that the people who are making accusations about the safety of this vaccine should look at their own house," says Hollinger, who says he was one of the first people to receive the hepatitis B vaccine, which has also been administered to his wife, children and grandchildren with no negative effects. "The studies that look at this -- and there are continuing reviews of this issue -- have really not found anything that suggests there is an enhanced risk of connective tissue disorder, such as multiple sclerosis or Guillain-Barre syndrome, in patients who have received the vaccine versus those who have not. I think that's the bottom line."
Not everyone in the medical and scientific community sees it that way. In April Jane Orient, the Arizona physician, sent a letter to Texas legislators to criticize the state's hepatitis B mandate, citing the "very serious side effects" associated with the vaccine. In the opinion of the Association of American Physicians and Surgeons, she wrote, the vaccine posed more potential problems than the disease, and much-needed research on the safety of the vaccine "may be delayed if policy-making and research programs are tainted with conflicts of interest."
In a recent interview, Orient said that "corporate medicine" is destroying a fundamental medical ethic: the obligation of physicians to treat patients to the best of their knowledge and judgment. Orient says those who would make public-health policy are "trying to change the basic ethics of medicine from doing what's best for the individual patient to doing what they perceive is the best for society.
"They always compare it to polio. They say, 'Look what happened with polio,' " she says. "But polio was voluntary. No one made you take it. It's a whole different story when you're forcing them to take the vaccine for a disease that's not easily transmitted and does not have devastating consequences," Orient argues. "Hepatitis B in children is usually very mild."