Hepatitis B Vaccine Effort Draws Fire - Critics Cite Reports of Adverse Effects in Opposing Mandatory Inoculations of Children

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Hepatitis B Vaccine Effort Draws Fire
Critics Cite Reports of Adverse Effects in Opposing Mandatory Inoculations of Children

By Marc Kaufman
Washington Post Staff Writer

Public health campaigns to control hepatitis B through mandatory childhood vaccination programs have created an increasingly vocal and determined backlash from groups claiming the vaccine is harming more people than health officials will acknowledge.

Armed with federal statistics they say show the vaccine has resulted in thousands of "adverse reactions"--including conditions similar to rheumatoid arthritis and multiple sclerosis--these critics are demanding that parents be allowed more easily to choose not to give their children the hepatitis B vaccine. Health authorities in France, responding to similar concerns, ended their mandatory hepatitis B vaccination program for 11- and 12-year-olds in October.

American public health officials, however, have made clear that they see no reason to scale back their hepatitis B campaigns, saying the vaccine is one of the safest and most useful ever devised. Research, they say, has not found any correlation between the hepatitis B vaccine and any significant or unexpected reactions.

"We take it very seriously when people use inappropriate information to undermine vaccine programs," said Barbara Reynolds, a spokeswoman for the U.S. Centers for Disease Control and Prevention (CDC). "There is a real chance they can push us back to a pre-vaccine, developing-country level of health care in the U.S.," she said. "Something similar is already happening in countries like Sweden, Japan and the United Kingdom."

The CDC reports that the hepatitis B virus, which attacks the liver, infects about 200,000 Americans annually and sends 11,000 people to the hospital with deep fatigue, muscle pain and jaundice. Chronically infected people can develop liver cancer and other potentially fatal diseases. There is no cure.

Hepatitis B virus is spread through blood and other bodily fluids. It is widespread in some tropical nations, but in the United States is found most frequently in intravenous drug users and people who participate in high-risk sexual activities. Health care workers are also considered at high risk. While critics of the vaccine program say most young children don't need it because they are not at risk, public health officials say the best way to attack the disease is through vaccinations at birth or before school. Since the early 1990s, hepatitis B inoculations have been given routinely to infants in the United States. At least 36 states--including Virginia and Maryland--and the District of Columbia require the full series of three shots before a child can register for school.

While the stakes are always high in disputes about vaccinations, the hepatitis B controversy has an added importance: The vaccine is the first to use recombinant DNA technology. With other genetically engineered vaccines in the pipeline, the fate of the hepatitis B vaccine is being closely watched.

Bonnie Loe Fisher, president of the National Vaccine Information Center in Vienna, has been at the center of calls to reassess the safety of the hepatitis B vaccine. "This whole issue has become very, very polarized," she said. "Top authorities have committed themselves to a policy on the vaccine and insist there is no problem here. On the other side, people are suffering."

While Fisher has been a critic of government policies on vaccines since she co-founded her group in 1982--although she insists she is not "anti-vaccine" and has given vaccines to her own children--others concerned about the hepatitis B vaccine have not been skeptics before. Baylor College of Medicine molecular biologist Bonnie S. Dunbar, who has worked on vaccine development and autoimmune responses for two decades, has been raising some of the most pointed questions with researchers, at conferences and in the media.

She came to her skepticism through experience. As she explains it, her brother Bohn Dunbar, then a healthy, active man of 46, got the hepatitis B vaccine five years ago. Soon after, she said, he developed rashes on his face and became deeply fatigued. "Basically, he never gets out of bed now," Bonnie Dunbar said. "He has gone to more than a dozen doctors, and they have told him they believe he had a reaction to the vaccine." After a medical student in her lab also had a severe reaction, Dunbar began research on the vaccine.

What she found, she said, was that many people were complaining of apparently adverse reactions to the vaccine and that people of European descent seemed to be most likely to respond poorly to the vaccine. She said she grew increasingly concerned after learning that the vaccine's manufacturer, Merck & Co., had not tested for adverse reactions beyond five days. Merck spokeswoman Isabelle Claxton disagreed sharply with Dunbar's conclusion and said Merck was constantly studying the safety and efficacy of its vaccines. She said Merck is sponsoring a "significant," long-term Harvard University study of nurses who have been required to take the hepatitis B vaccine. She said results of the study are expected this summer.

According to Gina Mootrey, a medical epidemiologist with the CDC's National Immunization Program, there are several additional studies either planned or underway into reactions to the hepatitis B vaccine. Some of those studies, she said, will be looking at its long-term effects. "I don't think there is the evidence out there now that would make us change any of our policies," said Mootry. "At this point in time, we still believe the vaccine to be extremely safe."

Critics of the vaccine point to the "adverse event" reports that have come in to the Vaccine Adverse Event Reporting System (VAERS) operated by the Food and Drug Administration. The reporting system was established in 1986 as part of the Vaccine Injury Act, which redirected all vaccine claims from the civil courts to the U.S. Court of Claims.

According to the National Vaccine Information Center, between 1990 and 1998 the system received 24,775 reports of adverse reactions to inoculations that included the hepatitis B vaccine. More than two-thirds of the reports, the center said, were from patients who had received only the hepatitis B vaccine.

Mootrey agreed that the number of VAERS reports "is fairly sizable," but said the large volume was predictable because more than 40 million people (an estimate based on the number of doses distributed) have been vaccinated since the campaign began in the early 1990s.

CDC officials say that because the reporting system takes in unconfirmed information and often takes in many reports about the same person, it provides little more than a first alert that something may be wrong with a vaccine. But CDC officials say a follow-up survey of VAERS reports regarding infants who received the vaccine from 1991 to 1994 concluded that there were "no unexpected events."

In a recent press release, the CDC wrote that "VAERS data can easily be misinterpreted or mis-analyzed. Because the VAERS data is available to the general public, this unfortunately is not uncommon."

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