Hepatitis B Vaccine Comes under Fire

Ever since the hepatitis B vaccine was approved by the FDA more than a decade ago, concerned parents have been questioning its use. Now it appears that the debate over the safety of the vaccine is raising questions at the state and national level.

In a statement released on July 8, the Association of American Physicians and Surgeons (AAPS), an independent organization representing more than 4,000 doctors, recommended an immediate moratorium on mandatory hepatitis B vaccinations for schoolchildren pending further research about possible dangerous side effects.

"It's one thing to bar a student from school if he is carrying an infectious disease posing a threat to other children," said Dr. Jane Orient, the executive director of AAPS. "But to require a questionable medical treatment as a condition of attendance crosses over the line to practicing medicine."

The statement follows recent concerns raised by lawmakers, parents and safety groups in New Jersey who believe the vaccine is unsafe and may be harmful to their children. And although the position of the AAPS may not be in line with that of "conventional" medicine, it could signal the start of a trend in which consumers and the physicians who treat them begin questioning state and national vaccination policies.

Hepatitis B Facts and Figures

Each year, approximately 200,000 people in the United States catch hepatitis B and approximately 5,000 people die from it, according to the Centers for Disease Controls (CDC). People can contract hepatitis B by direct contact with the blood or bodily fluids of an infected person; for example, by having unprotected sex or sharing needles with an infected person.

Hemophiliacs, intravenous drug users, people who have unprotected sex with more than one partner, and people whose jobs involve contact with human blood are considered to be at a much higher risk of catching the disease than the normal population. Babies can also catch the disease from an infected mother through childbirth. Hepatitis B is not spread through food, water or by casual contact. According to raw data from the nation's Vaccine Adverse Event Reporting System (VAERS) and other government publications, the incidence of hepatitis B in the United States is approximately 1 in 25,000. Since the occurrence of hepatitis B is concentrated in groups at high risk of exposure due to occupation, sexual promiscuity or drug abuse, the incidence of the disease occurring in children is believed to be considerably less.

Despite the inordinately low number of pediatric hepatitis B cases in the U.S., a vaccine for the disease was first made available in 1982 and has been in general use since. In 1991, the CDC's Advisory Committee on Immunization Practices issued a recommendation for universal use of the vaccine in children and newborns.

The vaccine is now mandatory in 42 states, including New York, Connecticut, Pennsylvania and Delaware. As long as the vaccine has been in production, however, parents in the U.S. and elsewhere have opposed its use.

In 1998, according to a New York Times article, the French government suspended hepatitis B vaccinations of schoolchildren, citing fears that the vaccine was causing multiple sclerosis and other neurological disorders. A follow-up report published by the World Health Organization in March stated that the vaccination program had been discontinued, and that there was no current plan to reinstate the vaccination campaign in schools.

More recently, the National Vaccine Information Center (NVIC), a parent group based in Washington, issued a report which stated that of the millions of children born in the U.S. between July 1, 1990 and October 31, 1998, a total of 24,775 adverse events, including 439 deaths, allegedly linked to the vaccine were reported to the federal drug agency. Barbara Loe Fisher, a co-founder of the NVIC, said that the raw numbers linked the vaccine to long-term "multiple sclerosis-like symptoms, including joint pain and cognitive problems."

A spokesperson for the FDA downplayed the findings, however, stating: "There are a lot of things that happen to children that could account for the damage in the claims filed."

Proposed Mandate Raises Concerns in New Jersey

The controversy regarding the vaccine's efficacy has touched off a wave of nervous feelings in many states, including New Jersey. In June, a measure that would make the hepatitis B vaccine mandatory for all school age children passed the state Assembly and was headed for a Senate vote. State Senator C. Louis Bassano then added an amendment which would have allowed parents to decide whether or not to allow their children to be inoculated for the vaccine. When Senator Bassano introduced the amendment, the measure was left off the legislative agenda, with the belief that the law would be reintroduced at the next legislative session. Instead, the state Health Department took it off the agenda and began writing a rule requiring the vaccination - without allowing parents the option of refusing inoculation for their children.

The proposed mandate will go through the state's Public Health Council and should be released by year's end. Once the mandate is written, the public will have a 30-day period to offer their comments, but Senator Bassano thinks that time isn't nearly enough. "Some parents in my constituency have concerns over the safety record of this vaccine," the senator said. "They say giving this vaccine to children is more risk than benefit. These questions were asked of me by parents, and I think they should be considered publicly.

"They are trying to treat the wrong set of people with this vaccine. They can't reach the adults through education, so this is their solution. I think it is a poor one."

Michael Belkin, a financial and economic forecaster from Manhattan, agrees with Senator Bassano. In September 1998, Belkin's five-week-old daughter Lyla Rose is believed to have died from complications of the hepatitis B vaccine. An autopsy of the baby ruled out choking as a cause of death, but revealed swelling of the brain.

"Look in any neurology textbook and it will tell you about post-vaccinal encephalomyelitis, brain swelling following vaccination," said Belkin. He called the hepatitis B vaccine "the Ford Pinto of the vaccine world with the exploding gas tank. It should not be given to newborns or small children."

Physician Group Issues Strong Warning

While politicians and parents are fighting the vaccine mandate in New Jersey, the Association of American Physicians and Surgeons (AAPS) has picked up the anti-vaccine banner at the national level. In June, Dr. Jane Orient, executive director of AAPS, testified before Congress and called for an immediate halt to the vaccine.

"It is apparent that critical medical decisions for an entire generation of American children are being made by small committees whose members have incestuous ties with agencies that stand to gain power, or manufacturers that stand to gain enormous profits, from the policy that is made," said Dr. Orient. "With hepatitis B vaccine, the case for mandatory immunization with few exceptions is far less persuasive than with smallpox or polio vaccines, which protected against highly lethal or disabling, relatively common, and easily transmissible diseases. An intelligent and conscientious physician might well recommend against hepatitis B vaccine, especially in newborns, unless a baby is at unusual risk because of an infected mother or household contact, or membership in a population in which disease is common."

"Public policy regarding vaccines is fundamentally flawed," Dr. Orient concluded. "It is permeated by conflicts of interest. It is based on poor scientific methodology (including studies that are too small, too short, and too limited in populations represented), which is, moreover, insulated from independent criticism. The evidence is far too poor to warrant overriding the independent judgments of patients, parents and attending physicians, even if this were ethically or legally acceptable."

A month after testifying before Congress, AAPS issued a press release once again calling for a moratorium on the vaccine pending further research about possible side effects. The association also accused school districts that do require vaccination of practicing medicine without a license.

"Children younger than 14 are three times more likely to die or suffer adverse reactions after receiving hepatitis B vaccines than to catch the disease," said Dr. Orient, citing data taken from the Vaccine Adverse Event Reporting System. "We find it shocking that government health officials cavalierly dismiss reports of serious adverse vaccine effects as coincidental and that school officials ignore them altogether."

For its part, the CDC's website states that "case reports of unusual illnesses following vaccines are most often related to other causes" and have no relation to the vaccine. The site also states that "whenever large numbers of vaccines are given, some adverse events will occur coincidentally after vaccination and be falsely attributed to the vaccine."

Issue Leaves an Opening for Chiropractic

The statements presented by Senator Bassano and Dr. Orient raise some interesting scenarios. Their actions could signal the start of a trend toward greater awareness of the potential dangers of vaccinations.

Doctors and lawmakers, for instance, may finally begin questioning the efficacy of administering vaccines that may be as dangerous as the disease they are supposed to protect patients from. Parents may break free of the traditional "herd mentality" that their MD knows best and take a greater interest toward the well-being of their children.

The situation also creates possibilities for the chiropractic profession. As long-time advocates of informed choice for patients and parents, the national and state chiropractic associations have an opportunity to voice their opinion on the matter. Will they take a stand, or will they watch from the sidelines while other groups champion causes that were once voiced solely by chiropractic?

While the outcome of the vaccination debate remains to be seen, the fact that the issue is being discussed at all represents a step in the right direction. Parents have a right to know that what their children receive will not cause more harm than good. Doctors have a duty to discuss the possible side-effects of the hepatitis B vaccine with their patients. And the chiropractic profession has a responsibility to speak out on the subject and promote the free flow of information between patients and doctors.