Safety of Controversial Hepatitis B Vaccine at Center of Debate

WASHINGTON – One of the newer vaccines, the shot to protect against Hepatitis B, is coming under heavy criticism from parent groups, lawyers and some scientists who claim it causes dangerous reactions and symptoms of chronic illness.

At particular issue is whether the shot should be given to babies.

State and federal public health officials are pushing for mandatory childhood vaccinations with the increasingly controversial HepB shots.

So far, 38 states and the District of Columbia have laws requiring the childhood inoculation – often mandatory for entrance into day care or kindergarten. Both the American Academy of Pediatrics and the federal Centers for Disease Control and Prevention recommend that all infants be injected with the first dose of HepB at birth before going home from the hospital. It is often the very first vaccination American newborns receive. They get two more shots, at an average $40 apiece, in their first year.

Critics claim this is too young, that the baby’s fragile immune system is still developing, is often harmed by the HepB shot – in very rare instances resulting in death.

They argue those most at risk from the disease are in older populations and people at risk through the exchange of infected blood, especially needle-using drug addicts, the sexually promiscuous, people who need repeated drug transfusions, health care workers exposed to infected blood and prison staffers.

The critics of federal policy contend the infants at high risk for contracting the disease are those born to infected mothers. So why, they ask, subject babies to a possibly reactive vaccine when they technology already exists to screen HepB in pregnant women?

Only 15 states, in contrast to the 38 mandating childhood shots, require expecting mothers to be screened for the disease.

"We are giving this vaccine to little-bitty babies before we have any reading on the health of the children," said northern Virginia lawyer Clifford Shoemaker, who has about 30 clients engaged in or preparing federal compensation claims for death and damage to their children after HepB shots.

The controversy is started to draw in governments.

Last month, the French health minister touched off an international row when he stopped mass inoculation of French 11 and 12-year olds in schools because of concern the shot might trigger neurological disorders. The French took notice of a court ruling that found evidence the shots might be connected to symptoms resembling multiple sclerosis. The French government is still inoculating infants and high risk adults.

The World Health Organization, which administers the vaccine in about 100 nations, reacted with condemnation of the move, claiming a "lack of scientific evidence" for it, and contending the French health ministry’s data "do not demonstrate a causal association between HepB immunization and central nervous system disease, including MS,"

World Health Organization officials in Switzerland said they were "concerned the decision may lead to a loss of public confidence in this vaccine," and prompt other countries to suspend usage.

In New Jersey earlier this year, Gov. Christie Whitman declined to sign into law – a move known as "pocket veto" – a bill that would have ordered HepB vaccination as a condition of entering grade school. She noted two reasons: a lack of clinical tests to prove that early shots confer lasting protection, and figures that show teens and adults are at much higher risk than children.

In asking for further study, Whitman said it would be "inappropriate" to mandate early age shots "without some assurance the immunization will protect them when they are at the highest risk of contracting hepatitis B." The governor’s Public Health Council had hearings on the matter in October and is expected to make a recommendation soon.

In Illinois, the state public health department last month stuck by its requirement that fifth and sixth graders be vaccinated with HepB or kept out of school, despite contentious hearings on the matter.

Parent groups in New Hampshire and Wyoming raised public protests in October against mandatory HepB shots before school entrance, with little effect.

Displays of a lack of confidence in the vaccine have spurred the CDC and World Health Organization to crank out publicity. The CDC routinely claims between 4,000 and 5,000 deaths a year in the United States from the disease, and that about 200,000 Americans are infected annually, including 36,000 "children" under the age of 20.

Yet, when the CDC’s own "Morbidity and Mortality Weekly Report" published HepB figures for 1996, the last statistically complete year, they showed 10,637 cases of the disease reported, with fewer than 300 of them in children under 14.

The CDC, other than noting a difference between estimated infections and reported cases, would not address the discrepancy. Instead, the CDC and World Health Organization answer most inquiries about the vaccine’s safety with barrages of "fact sheets" claiming HepB "is the first anti-cancer vaccine."

This is because HepB complications can sometimes evolve into liver cancer and cirrhosis.

The HepB shot, the World Health Organization claims in its releases "is the first vaccine against a major human cancer, as it is the chronic carriers of HepB who are at high risk of death from cirrhosis of the liver and liver cancer."

About 90 percent of adults, federal figures show, are able to fend off the typical month-long HepB symptoms that used to be called yellow jaundice (for the victim’s skin color); nausea, vomiting, fatigue, low fevers, joint pain, headache, cough, a tender liver.

When they do, lifelong immunity is thought to result. The other 10 percent are a problem, becoming chronic carriers at greater risk of liver damage and death.

The CDC claim is that when children or infants get it, they keep it, with 90 percent becoming chronic carriers who sometimes see the disease surface when they grow up.

Hepatitis B, notes CDC expert Dr. Eric Mast, is "a silent disease until people die as adults from the complications." That is one reason federal public health officials keep pressing for inoculation of babies and toddlers. Another: it is easier to prick a child than it is to round up at-risk populations such as addicts and prostitutes.

In the face of this approach, the medical journals are full of studies reporting symptoms of chronic immune and neurological disease symptoms after HepB shots: lupus, arthritis, diabetes, chronic fatigue, vascular disorders, various neuropathies, optic neuritis, and multiple sclerosis-like afflictions.

A huge debate is brewing over the scope and attribution of these reactions.

Typical is a recent study in the respected Journal of Rheumatology, a Toronto medical publication, in which Canadian scientists studied group reactions – including a cluster of five Swedish firefighters – among HepB vacinees.

Of the total 11 individuals studied, 10 developed "persistent arthritis," after the shots. The study concluded the vaccine "may trigger the development of rheumatoid arthritis" in genetically susceptible individuals.

There is no confirmed evidence that indicates that Hepatitis B vaccine can cause chronic illnesses, "the CDC’s National Immunization Program insisted.

Barbara Loe Fisher, president of the National Vaccine Information Center child advocacy group, said that’s just the point – no one has looked for it.

Testifying at the New Jersey public hearings on the HepB shots, she noted that even though public health officials and vaccine-makers admit the shot provides only temporary immunity, "It can take months and sometimes years for chronic auto-immune disease to develop such as diabetes, multiple sclerosis, and rheumatoid arthritis."

A HepB shot for children, she contended "is a national experiment; on our children; for a disease that is not highly contagious, except in high risk populations, and is not in epidemic form in the United States."

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