Bonnie S. Dunbar is not your typical anti-vaccine activist. A professor of molecular and cell biology at Baylor College of Medicine in Houston, she has been honored by the National Institutes of Health for her pioneering vaccine work.
But she began challenging federal vaccine policy six years ago, after her brother and a medical student who worked for her developed severe complications following a series of hepatitis B shots.
Her brother developed severe joint and muscle pain, fatigue, vision impairment and multiple sclerosis-like symptoms. “He hasn't been out of bed since,” she says.
The lab worker lost vision in one eye three weeks after her second injection and ended up in the hospital for two months after her third booster.
Alarmed, Dunbar scoured the medical literature on adverse reactions to the shot, the nation's first genetically engineered vaccine made with recombinant DNA. She found 121 articles in medical journals from around the world listing a variety of adverse reactions, including multiple sclerosis, rheumatoid arthritis, optic neuritis, Bell's Palsy, Guillain-Barr Syndrome and diabetes. In addition, Dunbar insists, a dozen specialists confirmed that her brother had suffered a classic adverse reaction to the vaccine.
Eventually, Dunbar filed a Freedom of Information (FOI) request for all reports from the Food and Drug Administration's (FDA) Vaccine Adverse Event Reporting System (VAERS). “I was overwhelmed by the thousands of reports I received, hundreds of which were identical to the reports I had filed,” she told the House Government Reform Subcommittee on May 18, 1999.
Dunbar is now in the vanguard of an increasingly vocal group of parents, health workers and scientists who claim that, for a small segment of the Caucasian population, the hepatitis B vaccine may be worse than the disease. They want the government to study whether some people may be genetically predisposed to react negatively to the shot. And they want it to be voluntary, especially for newborns, which are at minimal risk of contracting the disease.
Public health officials and representatives of health-provider organizations insist that any connection between the vaccine and chronic or autoimmune diseases is purely coincidental.
“Hepatitis B vaccines are among the safest vaccines we have,” Harold S. Margolis, chief of the Hepatitis Branch at the Centers for Disease Control and Prevention's (CDC) National Center for Infectious Diseases, told the congressional panel. “Several reviews have not shown a scientific association between hepatitis B vaccination and severe neurological adverse events such as optic neuritis and Guillain-Barr Syndrome. In addition, preliminary data from French and British studies have shown no significant association between hepatitis B vaccination and multiple sclerosis.”
Dunbar and other critics say they have repeatedly asked the CDC for copies of those studies, but so far have not received them. “We are still waiting for the data they keep quoting,” says Dunbar.
Susan S. Ellenberg, director of biostatistics and epidemiology at the FDA's Center for Biologics Evaluation and Research, echoed Margolis' comments. “At present, we have . . . little in the way of verified serious risks” from the hepatitis B vaccine, she said.
Benjamin Schwartz, acting director of epidemiology and surveillance for the CDC's National Immunization Program, points out that while more than 24,000 adverse reactions have been reported to VAERS, more than 30 million people have been vaccinated safely since the early 1990s.
Necessity of Hepatitis B Questioned
Observers say the fate of the hepatitis B vaccine is being closely watched because it is the first genetically engineered vaccine. Hundreds more are in the pipeline. The so-called Hep B vaccine has been controversial ever since 1991, when the CDC recommended that all newborns receive it before leaving the hospital. States officials then added the vaccine to their mandatory-immunization schedules for public school entrance eligibility, and immunizing newborns became standard pediatric practice.
Hepatitis B is rampant in some Asian and African countries, but in the United States it is primarily spread through infected blood or sex, and those at greatest risk of the disease are intravenous drug addicts, gay men and prostitutes, or babies of infected mothers. Why not just immunize babies whose mothers were carriers of the disease, critics ask.
“The idea of giving this vaccine to a 1-day-old baby, a newborn, is preposterous,” Mayer Eisenstein, chairman of the Department of Medicine at St. Mary of Nazareth Hospital in Chicago, told a 1997 Illinois Board of Health hearing.
“There is no raging hepatitis B epidemic among babies in this country,” says Michael Belkin, whose 5-week-old daughter Lyla Rose died in 1998 with a swollen brain 15 hours after receiving her second hepatitis B booster shot.
Critics say a baby is more likely to have an adverse reaction than it is to contract the disease. Subcommittee Chairman John L. Mica, R-Fla., cited a recent New Hampshire study he “found shocking,” showing that serious reactions to the vaccine -- including 11 deaths -- “were 16 times greater” than incidents of the disease.
In the early 1990s, federal immunization officials decided to immunize newborns because they felt that not enough adults in the high-risk groups were being immunized. Even though incidence of the disease had been declining for five years, “it wasn't declining fast enough for some of us,” says Louis Cooper, vice president-elect of the American Academy of Pediatrics (AAP). “It appeared we had the potential to wipe this disease out, because we had a vaccine that was safe and effective.”
But some critics see a more sinister motive for vaccinating hours-old newborns. “It's a perfect way to disguise any adverse reaction,” says Clifford Shoemaker, a Vienna, Va.-based attorney who has represented vaccine-injured children for 30 years. “Then the parent can't say, 'Before the vaccination, my child was like this.' ”
Vaccinating infants is the most effective way to combat the disease, which is a serious public health threat, health officials say. “Hepatitis B kills 4,000 to 5,000 Americans each year,” Margolis told the House panel. He said national studies carried out by the CDC have shown that 5 percent of Americans -- 12.5 million people -- have been infected with hepatitis B, and that about 300,000 were infected with the disease every year between 1970 and 1990, including 25,000 children.
Critics say such estimates are way overblown in an effort to frighten parents. They cite the CDC's own annual report on communicable diseases, which says only about 1,000 Americans die each year from hepatitis B, and only 10,416 new cases were reported in 1997. Only 26,611 cases were reported in 1985, when the disease reached its peak, and cases have been declining ever since, according to the report.
Health officials say the estimates seem high because only about one-tenth of actual cases get reported to the CDC, and three times as many people are asymptomatic carriers of the disease as those who actually get it.
In 1998 a group representing 15,000 French parents and others sued SmithKline Beecham, alleging, among other things, that vaccine companies and health officials had exaggerated the risks associated with hepatitis B. The manufacturer was fined about $20,000 for causing at least one case of multiple sclerosis, and French health authorities later discontinued their mandatory hepatitis B vaccination program for adolescents.
Safety Studies Described as Inadequate
Critics contend that safety studies conducted for the vaccine were too small, too short and too limited to detect long-term adverse reactions. For instance, when he asked a manufacturer's representative to show him the evidence that the vaccine is safe for 1-day-old infants, Eisenstein said the representative told him, “We have none. Our studies were done on 5- and 10-year-olds.”
The drug companies' own product inserts state that the vaccines were tested on fewer than 2,000 persons, who were monitored for only five days after receiving them. And critics told the House panel that several often-cited long-term safety studies for the vaccine were conducted on Alaskan natives or Asians -- not Caucasians, who have been reporting the most adverse reactions.
In fact, the long-term studies in Asia and Alaska were done for an earlier plasma-derived conventional hepatitis B vaccine, not for the genetically engineered version. The FDA allowed the manufacturers to do “abbreviated studies” on the genetically engineered version of the vaccine “to assure they were comparably effective,” says William Shaffner, chairman of the Department of Preventive Medicine at Vanderbilt University and an expert on the hepatitis B vaccine. Most mainstream scientists believe genetically engineered vaccines are safer than older versions, but others say more study is needed on their long-term impact.
“The manufacturers and public health officials keep saying there's no study proving that the vaccine is causing these adverse reactions,” Belkin says. “I say back to them: 'Show us the proof that these vaccines are safe for all genetic populations.' They don't have any.”
A 1994 Institute of Medicine (IOM) study also complained that no large, controlled, observational studies or clinical trials investigated the kinds of long-term adverse reactions described in the medical journals. “The lack of adequate data regarding many of the adverse events was of major concern to the committee [which] . . . encountered many gaps and limitations in knowledge bearing directly or indirectly on the safety of vaccines,” the report said.
Marcel Kinsbourne, a pediatric neurologist who often testifies in vaccine-injury cases, suggests that there are no long-term studies because “the best defense in a product-liability case is no research. Then the plaintiffs cannot prevail.”
Margolis said several ongoing studies are investigating whether adverse events are associated with the vaccine. But he warned that case reports rarely provide a convincing link between the adverse event and vaccination.
Dunbar says she and other critics will withhold judgment on the studies until they are allowed to see actual data and all of the scientific controls used, with long-term follow-up information. But, she says, “If the studies only concentrate on ethnic, inner-city populations, they still will not prove that the vaccine is safe for all populations, especially Caucasians.”