Ounce of Prevention, Pound of Misery?
By Aimee Howd
Taken from Insight Magazine - Vol. 15, No. 11 -- March 22, 1999
Thousands have claimed bad reactions to their hepatitis B inoculation. So why isn't the health
bureaucracy's mass vaccination policy being investigated by Congress?
When nurses gave her newborn son another injection, the room filled with the sound of his healthy
cry. Julienne Jack recalls wondering through the haze of her postlabor exhaustion what that one was
for. In fact, it was the hepatitis B vaccine, which Ohio mandated for all its newborns -- a safe
inoculation without known side effects, according to the Centers for Disease Control and Prevention,
or CDC, in Atlanta.
But as she took her tiny firstborn into her arms again, coaxing him to nurse, Jack sensed
something disturbing in the sound of his cry, the strange restlessness of his movements, a sudden
yellowing of his skin. It was a relief when he seemed to slip into peaceful stillness in her arms.
Just 27 hours old, she remembers thinking. She daydreamed of the future for their family of three
until the night nurse came to return the baby to his crib. Something in his appearance as the nurse
lifted him from her arms, however, tore a cry from her throat: "What's wrong with him?"
The nurse rushed Brandon out of the room and down the hall in search of help. After an hour,
bed-bound by the lingering effects of an epidural, Jack faced the news alone: Little more than an
hour after receiving the hepatitis B vaccination, her baby was dead.
No explanation was offered. The mystified coroner marked the cause of death unknown. Two years
later a death certificate still has not been issued.
In Jack's eyes, the chain of events that day in the hospital implicates the vaccination.
Brandon's doctors, though they voluntarily waived the family's medical bills, deny any such
connection. The lawyer whose help the family enlisted to obtain copies of the medical records sent a
letter saying the Jacks had no case against any of the medical professionals involved because he
could find "no reports of any serious reaction to the vaccination."
In fact, "no confirmed reactions" is the standard line of federal officials in most
cases, although since 1990 more than 24,000 reports of possible adverse reactions to the hepatitis B
vaccine have been registered with the Food and Drug Administration's Vaccine Adverse Event Reporting
System, or VAERS, including a significant number of severe injuries and deaths.
Federal guidelines issued in 1991 recommending three doses of the vaccine for health
professionals coming into contact with blood, at-risk groups including intravenous drug users and
people with multiple sex partners -- and every child born after 1990 -- remain unchanged. At least
35 states mandated the vaccine for entrance to kindergarten by 1996, and in 1977 the Advisory
Commission on Immunization Programs reported vaccination of 84 percent of America's 19- to
In January 1999, the CDC further expanded its goals, calling for universal immunization of
children up to age 18. Government agencies and pharmaceutical groups categorically deny that the
VAERS reports are cause for alarm, explaining that the purpose of the data collection merely is to
reveal unexpected patterns, that the adverse-reaction numbers may be inflated due to double
reporting and that no scientific data prove the vaccine is the cause of the problems.
"Bad things happen to people all the time. It's unfortunate that we don't know the causes of
many of those," says Neal Halsey, a leader in the American Academy of Pediatrics and director
of the vaccine safety center at Johns Hopkins University in Baltimore. But Barbara Fisher, founder
of the watchdog group National Vaccine Information Center, or NVIC (on the World Wide Web at
www.nvic.org), objects. "Why can no one confirm or deny a causal relationship in these tens
of thousands of adverse reports?" she asks. "Because the kind of scientific studies that
could reveal the link have not been done." And, alas, they haven't.
"When vaccine coverage reaches high levels like they do in the U.S., essentially anyone with
a negative medical event will have previously been vaccinated," Robert Chen of the CDC's
National Immunization Program tells Insight. His solution to the dilemma raises the eyebrows of
privacy advocates. "What is needed is a database with all vaccinations and all medical events
linked in a large cohort to see if those vaccinated recently are more likely to develop the adverse
event of interest," he says. "The CDC has established such a cohort with 5 million members
of four large staff-models [health-maintenance organizations] on the West Coast in the Vaccine
Safety Data Link Study."
Other approaches also are being examined. Bonnie Dunbar, a professor of cell biology at Baylor
College of Medicine in Texas, is a leader among the growing number of scientists who are joining
consumer advocates, parents'-rights groups and undiagnosed patients in searching for answers about
adverse reactions to the vaccine.
To Dunbar and her colleagues, preliminary evidence indicates some people might be genetically
disposed to an adverse autoimmune or neurological response to the recombinant hepatitis B vaccine.
In an open letter last November, Dunbar wrote, "After carrying out extensive literature
research on this vaccine, it is apparent that the serious adverse side effects of this vaccine ...
may be much more significant than generally known (or admitted)."
Halsey tells Insight he doubts the credibility of people questioning the vaccine. But Dunbar's 25
years as a research scientist and medical-school professor and her National Institutes of Health
honors for pioneering work in contraceptive vaccines are sturdy credentials.
Today's recombinant hepatitis B vaccine derives from a surface protein of the virus molecule.
Dunbar suggests that similarities between the antigen and proteins in human nerves and tissues could
trick the autoimmune systems of the genetically susceptible into attacking themselves. In Science
magazine last summer, Halsey scoffed at that theory, asking how a fragment of virus protein used in
a vaccine could cause symptoms not even caused by the virus.
Dunbar explains that any part of a virus molecule introduced into the human body can be met by a
unique immune response. "The same rigorous testing [is required] every time you change the
vaccine. The companies don't want to hear that because it is going to cost them a lot of
William Hildebrand, an immunogeneticist at the University of Oklahoma, plans to take a close look
at the five or six genes that are responsible for controlling the immune response. Three
observations lead him to conjecture that an individual's HLA genotype may mediate how he or she
responds to the vaccine: Almost all negative responses occur in Caucasians, the number of genes
determining autoimmune responses varies from race to race and the reported adverse responses are
consistently autoimmune in nature. "It justifies asking what are the reactions and how frequent
are they," Hildebrand says, "and that's all I would argue needs to be done at this time.
If you understand which genes are involved in the adverse response, you can begin to understand the
Until the research is done, however, Hildebrand remains skeptical of both sides of the debate.
"One side is saying you can't prove [a cause-and-effect relationship]. The other side is
saying,'You know something is going on here.' I say let's find out. If you say that the world is
flat and you don't do research, maybe the world will stay flat."
Denied government grants, funding for this research is being supplied by private donations, often
from patients and surviving families. The initiatives of the inquiring scientists are important to
bewildered survivors such as the Jacks, who have moved to Pennsylvania where they have been assured
they can obtain a medical exemption for a second child they are expecting this summer. For two years
they believed they were alone in their suspicions about the vaccine. Then a friend told them about
an investigation and televised report by the TV newsmagazine 20/20.
While searching for the Internet version of the TV report, Jack found contact information for a
father who had appeared on the show. That man is Michael Belkin, a New York financial adviser whose
search for answers after his 5-week-old daughter died hours after her vaccination led him to apply
his statistical training from the University of California at Berkeley to the tangled web of
epidemiological studies at the core of the hepatitis B vaccination controversy.
Does the risk/reward ratio for administering the hepatitis B vaccine to the typical American baby
justify the national vaccine mandate? Even questions about the incidence of the disease are
difficult to answer. For example, 1996 and 1997 issues of the CDC's Morbidity and Mortality Weekly
Reports, or MMWR, show only about 10,000 cases of hepatitis B reported in the United States. Yet the
CDC estimates the total annual incidence of the disease at 150,000 to 300,000. The CDC believes the
vast majority of cases go unreported because the hosts are asymptomatic or mistake the reaction for
Undoubtedly, asymptomatic chronic infection by the disease (which studies show is more likely to
occur the earlier the virus is contracted) can lead to devastating cancers or cirrhosis late in
life. Marketing materials for the vaccine produced by the International Task Force on Hepatitis B
Immunization and the Program for Appropriate Technology in Health begin by warning doctors that
three-quarters of the world's population lives in high- or midrange risk areas for hepatitis B and
that the virus causes up to 80 percent of the world's liver-cancer deaths.
The materials claim a need for mass vaccination in the United States despite low endemicity in
most of the nation: Certain narrow populations, such as Alaska natives, Southeast Asian immigrants,
gay men and others experience moderate to high levels of infection.
But according to the CDC's figures, among infants, only those born to mothers infected with the
virus are at any measurable risk for the disease. Belkin estimates that his daughter, like other
infants of the average American family, had a .001 percent chance of contracting the disease. Of the
279 total reported cases of hepatitis B infection in American children under the age of 14 (as
documented in a 1996 issue of MMWR), only 54 of those cases occurred in the newborn to 1-year-old
age group in a total of 3.9 million babies born in the United States that year.
The need for American children born to families without the disease to receive the vaccine
hinges, in most cases, upon their likelihood of engaging in promiscuous sexual behavior or sharing
drug needles later in life. But even if this is satisfactory justification, Belkin notes, no
conclusive evidence exists to indicate that immunity lasts beyond 10 years. Therefore, the
inoculation would appear to protect only the sexually promiscuous and heroin-addicted under age 10.
Despite the unified rhetoric of government and industry officials, the roar of the victim mice is
being picked up by mainstream media. Reports on the possible dangers of hepatitis B vaccinations
have appeared not only on 20/20 but in the Washington Post, the Chicago Tribune, Gannet News Service
and Science, among others.
Infants are not the only ones in whom adverse events or reactions have been reported. Dunbar
began to look into adverse reactions when her adult brother and her lab assistant each experienced
autoimmune or neurological dysfunction after they were injected with the vaccine as professional
precautions. Dunbar tells Insight that she personally hears each day from an average of four people
who believe they were injured as a result of the hepatitis B vaccine.
One of them was Eric Jeffries, a former Fulbright scholar at Cambridge and a young father on his
way to the top in the banking industry. He tells Insight that he was vaccinated prior to a tropical
vacation but four days later began experiencing severe autoimmune dysfunctions ranging from fever,
headaches and extreme pain to rashes and gastrointestinal troubles. He immediately thought of the
vaccine, but a phone call to his doctor assured him the vaccine is not associated with adverse
reactions. As his condition deteriorated, he was tested for everything from rheumatoid arthritis to
fibromyalgia and AIDS. Finally, a doctor seconded his suspicion that, whatever the disorder, it had
been triggered by the vaccine. Today, no longer able to work or even to walk, Jeffries still is
looking for answers.
Betty Fluck was told that she needed to have the hepatitis B vaccine when she returned to her
work as a registered nurse after taking a few years off to raise her three boys. Just hours before
the vaccine was administered, she was helping to run her three school-age sons' soccer games with
her husband, a coach, and was working on her yellow belt in karate. On Dec. 2, 1997, she received
the vaccine. Twelve hours later she suffered severe pain, a high fever, swollen joints and
respiratory problems. Until her fever broke, Fluck lost the use of her legs. "At the
time," she says, "the damage was already done or started. I didn't know at that point what
the whole disease process was."
As did so many other victims, Fluck went from doctor to doctor until one finally told her that
the symptoms might indicate a reaction to the hepatitis B vaccine. But vaccine manufacturers
repeatedly told her that they never had seen problems like this. As months passed, Fluck needed a
walker, and by September 1998 she required full leg braces and elbow crutches to get around. Now she
receives weekly intravenous gamma-globulin treatments for severe demyelination (a progressive
condition in which the sheath surrounding and protecting human nerves deteriorates).
Since Fluck's brief appearance on the 20/20 episode, she says, "Every day I hear people with
stories that are just like mine and doctors telling them it can't be the vaccine. Essentially, we're
write-offs. Just the casualties of war [on disease]."
This month Fluck testified before an Indiana state Senate hearing considering whether to set a
July 1999 mandate for all children to receive the vaccine before they enter kindergarten. As a
result of the hearings, the committee tabled the bill and voted unanimously to recommend that the
vaccine be administered only at the parents' request.
For now, the federal health bureaucracy devotes its resources primarily to expanding and
enforcing its mass vaccination policies rather than to evaluating adverse reports. Samuel Katz of
the Vaccine Initiative of the Infectious Disease Society of America called Insight from the Atlanta
airport enroute from the February 1999 ACIP conference where his colleague, Chen, of the CDC's
National Immunization Program, presented an update on hepatitis B recommendations. Katz said the
committee "reaffirmed the value of the vaccine" and of "moving ahead with the program
to vaccinate children, teenagers and adults at risk."
But the French and Canadian governments already are funding research on hepatitis B adverse-event
reports, says Dunbar. "There are many of us who are not going to go away." And Congress
should take notice.