Universal Hepatitis B Vaccination: Is it a Sword of
Over the Head of the American People?
Burton A. Waisbren, MS, MD, FACP, FASID
"Spontaneous reporting by alert physicians will in the foreseeable
future remain the most important sources of new leads about drugs ."
In 1985, a young nurse presented herself with classic early symptoms of
a central nervous system demyelinizing disease. The symptoms started one month after she
received a hepatitis B vaccination . Her case reminded me of a patient I had seen in
1980 who developed a progressive multiple sclerosis-like disease shortly after he had
received a swine flu vaccination in 1976 . Surprisingly, I saw two other patients in
1986 and 1987 whose cases almost exactly mirrored that of the young nurse, and in each
instance symptoms started one month after they received a hepatitis B vaccination . In
1988, Shaw et. al. reported on a post-release surveillance study of hepatitis B vaccine
. Thirty-eight neurologic complications that followed hepatitis B vaccination were
found in what was essentially a voluntary reporting system. They discounted most of these
cases by using the dubious rationalization developed by the government to deny that
central nervous system damage had occurred after the swine flu vaccination . This
rationalization states that if the rate of a complication reported after a vaccine via a
voluntary reporting system is less than the spontaneous occurrence of that complication as
determined by a 100% reporting system in Olmsted County, Minnesota, then the reported
complication is due to chance .
Since 1985, an additional 266 cases have been found in which the
hepatitis B vaccines have been followed by demyelinizing or autoimmune diseases
These cases, plus the recommendations of the National Ad Hoc Advisory Committee on
Immunization, the Center for Disease Control and Prevention, and the American Academy of
Pediatrics, that promote the universal vaccination of infants, have prompted this
The thrust of this commentary is not to prove the incidence of
occurrence of adverse effects of this vaccine, nor to denigrate its usefulness in
high-risk patients. It is rather to ask, in view of the above, whether it is conscionable
or wise to administer hepatitis B vaccine to all infants, with the informed consent
suggested by the American Academy of Pediatrics (which is used by most of the hospitals in
the Milwaukee area), which reads "no serious reactions have been linked to this
To help the reader answer this question, information will be summarized
with regard to: Why, based on animal studies and experiences with other vaccines,
complications from hepatitis B vaccine should be expected; what should have been learned
from the swine flu vaccine experience; the reports of damage apparently due to the
hepatitis B vaccination; the probable mechanisms by which hepatitis B vaccine causes
neurologic damage; how and why the push for universal vaccinations came about; and the
steps that will be necessary to address the serious problems posed by this and other
1. Animal experimentation that should have alerted manufacturers and
government agencies to the dangers of neurologic and autoimmune complications from
hepatitis B vaccine.
Stohlman and Weiner in 1981 showed that the mouse DNA virus JHM causes
acute and chronic demyelination . They suggested with supporting data that an antibody
mediated the chronic disease. This was because during the course of the disease no active
virus was found.
Buchmeir, et al, in 1983 found in their model system of JHM infection
in mice that "antibody response to precisely defined regions on a viral glucoprotein
may induce profound changes in the pathogenesis of the infection" . Dal Canto, et
al, in 1982 reviewed experimental models of virus-induced demyelination . They cite
the work of Lindsley and others that demonstrated that a specific MHC class 1 antigen from
the host must coexist in affected animals . This suggests that the antigenic make up
of the recipient will be a factor in the development of an autoimmune demyelination.
2. Experiences and authoritative discussions that suggest viruses,
including the hepatitis B virus, can cause demyelination and autoimmunity in humans and
that vaccines have the same propensity. This information should have forewarned
pharmaceutical companies and government agencies about the demyelinating and autoimmunity
dangers of hepatitis B vaccine.
In 1983 Roos reviewed the literature regarding viral diseases that can
cause chronic central nervous system demyelination in humans . He stated, "We
know that viruses can cause demyelinating disease in animals" and cited 106 articles
to this effect. There is specific information regarding the relationship of hepatitis B
virus itself and the development of a chronic autoimmune hepatitis . In 1975, this
fact caused Zuckerman to warn against assuming that a viral vaccine would not cause a
similar reaction . Berger, et al's, finding of antibodies to hepatitis B in a case of
severe Guillain-Barre syndrome, an admittedly demyelinating autoimmune disease, emphasized
the importance of this warning since in their case a natural infection seemed to have set
up this autoimmune process . An article by Miller and Stanton in The Quarterly
Journal of Medicine in 1954 reviews the neurological sequelae of prophylactic
inoculation up to that time . They cite 144 articles on the subject which, taken as a
whole, should leave no doubt that neurologic complications were a well-recognized
complication of vaccination as early as 1954. Their article is well worth reading if one
has any skepticism regarding the occurrence of severe neurologic complication after both
passive and active immunizations with bacterial or viral vaccines and antisera. Miller and
Stanton's remarks in the introduction of the paper also seem as relevant today as they
were in 1954. "Finally, it must be admitted that, in the heat of the emotional battle
provoked for and against prophylactic inoculation, there has been a tendency on the part
of the medical profession to turn a blind eye to unfortunate individual complications of
procedures which have indisputable social value" . One of the most ironic
citations in the article is that of Guillain-Barre who in 1918, reported a fatal case of
the syndrome which now bears their name . The patient had received an inoculation of
antiserum . The reader is asked to remember their names because as the subject has
unfolded the Guillain-Barre syndrome, which will be discussed in detail in a later
section, turns out to be the bellwether or more serious complication of vaccines.
In 1967, Miller, et al, reported on multiple sclerosis and vaccinations
. They detailed nine cases in which development of or exacerbation of multiple
sclerosis followed a smallpox, yellow fever, tuberculosis and typhoid vaccination .
They cited four other authors who had reported similar findings in [20,21,22,23]. They
mentioned that there might be a latent period between the vaccination and the onset of
symptoms. One of the explanations they offered was, "It is possible that the
bacterial proteins injected in the course of the vaccination against typhoid fever and
yellow fever may also belong to the class of intermediate antigens shared by
microorganisms and cerebral white matter." Thus, we see that the concept now termed
"molecular mimicry," which will be mentioned later, is based on pre-existing
In 1971, Wells reported in the British Medical Journal nine
cases of central nervous system disease that followed influenza vaccination ,
In 1973, Rabin, in a letter published in the Journal of the American
Medical Association discussed the problems and politics involved in gaining
recognition of the fact that central nervous system disease can follow vaccination. He
then reported a convincing case of retrobulbar neuritis that followed influenza
In 1973, Adams, et al, reported a case of severe demyelinization
occurring years after primary smallpox vaccination . This report and that of Wells
lend doubt regarding the efficacy of surveillance after viral vaccinations that only takes
into account reactions occurring a few weeks after vaccination [24,26].
In 1974, Bellanti discussed the adverse effects of viral vaccines. In
one division of his paper he discussed adverse effects of viral vaccines which are seen in
normal hosts and which appear to be related to the nature of the viral antigen .
In 1980, Owen, et al, reported a case of multiple sclerosis that was
exacerbated after hepatitis. He reviewed reports in the medical literature, which
suggested that nonspecific immune stimulation such as that caused by virus infections,
skin tests and vaccines can cause exacerbation of demyelinating disease .
The fact that vaccines and viral infection could be involved in
autoimmune diseases other than those presenting by demyelinization has been brought out by
Keane, et al . He reported a case of Richter's syndrome that followed a typhoid
vaccination. Gocke, et al, reported an associated case of polyarteritis and the Australian
antigen . A review by Schattner and Kager-Zisman in 1990 discussed fully the topic of
virus-induced autoimmunity .
As early as the 1970s specific warnings appeared about the potential
dangers of hepatitis B vaccine and the dangers of relying on a voluntary reporting of
adverse reactions. In 1975, Zuckerman published a paper in Nature entitled,
"Hepatitis B Vaccine: A note of Caution" . He noted the finding of Neurath
that antigen determinants related to human plasma are constituents of hepatitis B surface
antigen. These antigens are the active principles of hepatitis vaccines, whether made from
serum or by yeasts. He postulated that anti-immunity evoked by these antigens might cause
the chronicity of hepatitis B. His final statement was to the effect that studies of
hepatitis B vaccine should include careful assessment of their effects on the immune
system. As far as can be determined, this admonition still has not been followed since
there have not been published studies regarding whether hepatitis B vaccine causes an
increase in antimyelin T-cell clones. These studies, which are easily within the
capabilities or pharmaceutical companies, have not been reported .
In 1971, Finney, who was the statistician involved in the infamous
thalidomide incident, wrote an article entitled, "Statistical Aspects of Monitoring
for Dangers in Drug Therapy." . This authoritative article seems to have been
ignored entirely by those who set out to promote the safety of hepatitis B vaccine via
epidemiologic methods that relied on voluntary reporting of toxicity . Finney stated
that a special United Kingdom inquiry showed that only 14% of women on the pill who
died from thrombosis or embolism had been reported independently to the committee
responsible for monitoring its safety .
3. Why the development of the Guillain-Barre syndrome after the
swine flu vaccination in 1976 and 1977 should have forewarned manufacturers and government
agencies about the probable development of central nervous system demyelination after
hepatitis B vaccination . How the same techniques used unsuccessfully to
rationalize and deny central nervous system complications after the swine flu episode are
now being used to do the same thing with reports of central nervous system complications
from the hepatitis B vaccine [4,34].
The swine flu vaccine debacle will be discussed in some detail since
the self-serving rationalizations that the government evoked after the event has been
pivotal in the way virus vaccines are promoted to this day.
Morris was the first to report central nervous system demyelination
that occurred after the swine flu injection . His statement that, "In some
instances, at least the inducing factor in Guillain-Barre syndrome also served as the
inducing factor in multiple sclerosis", appears to have been supported by the
additional clinical observations of multiple sclerosis-type illness that developed after
the swine flu vaccination [3,35]. I saw and reported six cases of demyelinating disease
that occurred after the swine flu vaccination without knowing of Dr. Morris' observations
. By 1982, Dr. Morris and I had personally seen 35 cases of central nervous system
disease that appeared to result from the swine flu injection .
By this time, the Justice Department, in association with the CDC and
the Public Health Service was faced with a surge of lawsuits claiming neurologic damage
from the swine flu injection. These eventually amounted to claims of over three billion
dollars . The claims were against the United States government because in order to get
the pharmaceutical companies to participate in the swine flu program, a law had been
passed in which the government agreed to assume liability for damage done by the vaccine
. The full extent of the swine flu vaccine litigation damage control program mounted
by the government will probably never be known, but in essence a decision was made to
settle complaints of damage due to Guillain-Barre syndrome and to fight all other
complaints in federal courts. This decision was buttressed by a group of experts that was
impaneled by the government . The following assertions were made: Any complications
that occurred more than six weeks after vaccination could not have been due to the swine
flu vaccine: Guillain-Barre syndrome was rigidly defined in a way that rejected cases that
in any way deviated from that definition; and a distinction was made between the
peripheral nerve damage that admittedly occurred in Guillain-Barre syndrome and any
central nervous system damage. This distinction cannot be justified scientifically because
of the known similarities between myelin of the central nervous systems and the peripheral
nervous system and because of known clinical associations between the two syndromes
Finally, the government attorneys brought up epidemiology theories that
emanated from the Mayo Clinic which claimed that if the incidence of a complication was
not any higher than occurred in the 100% actuarial system used in Olmsted County,
Minnesota, then the incidence of the complication occurred by chance . These
epidemiologic arguments are patently transparent knowing that only a small portion of
adverse reactions to a drug are reported . Further, their incidence cannot be compared
to incidences derived from a 100% reporting system connected to the Mayo Clinic in a
single county in Minnesota . Poser's comment regarding dependence upon this type of
epidemiological statistics to establish causal relationships are probably most to the
point [4,43,44]. He said in 1983, "The dependence upon epidemiological statistics to
establish causal relationships appears to be a new dimension in our clinicopathological
tradition. It sweeps aside the experience of clinicians and neuropathologists, it
denigrates the work of the experimentalists, and it substitutes calculations of
probabilities for the recognition that variability in the manifestations of disease
reflects the diversity of humanity's genetic attributes." [43,44]. The government
approach to swine flu litigation started to fall apart when Dr. Goldfield (who first
brought the swine flu problem to the attention of the government) was allowed to see all
the case reports of reactions that had been turned over by the CDC to the Justice
Department . He found many cases of central nervous system toxicity that had not been
accepted by the CDC. He reported this fact to an attorney who was suing in a case of
multiple sclerosis . The Justice Department refused to provide these records and was
subsequently sanctioned by Federal Judge Harold Baker as follows: "The order of the
court is that the government is in willful, deliberate, continuous disobedience to the
order of the court for discovery. This discovery order is relevant on the issue to which
the discovery is directed, that is causation. And the appropriate sanction in this case is
that the issue of causation is taken as decided against the government. That the swine flu
vaccination was a proximate cause of the nonphysical condition of the plaintiff .
After this sanction the government settled the case with the promise that the settlement
remain secret [45,46]. Several other lawsuits of this type were then lost by the
government usually with a federal judge's support . The data regarding how many of the
three billion dollars worth of cases are still pending or were settled would have to be
obtained through the Freedom of Information Act since as in the Johnson
case, the settlements probably were kept a secret. However, in a deposition, Dr. Arnason,
an expert, who often testifies for the defense in trials against the government, stated in
a legal deposition that the Justice Department now settles for CNS cases as well as for
the Guillain-Barre syndrome cases following swine flu vaccination. An example of the types
of awards made appeared in the Medical World News in April 1981. A
Federal court awarded Dr. Katherine Wolfe 2.9 million dollars for central nervous
system damages caused by the swine flu vaccine .
The foregoing swine flu incidents are dwelt upon here because both the
Center for Disease Control and Prevention and the manufacturer of hepatitis B vaccine
applied the same reasoning in regard to the cases of toxicity appearing after the
hepatitis B vaccine was released . They agreed that Guillain-Barre disease might occur
more frequently than they would expect in vaccinated populations, but they chose to
rationalize the reported cases of central nervous system diseases and autoimmune diseases
as occurring by chance or that there is no evidence to support causality . Their main
arguments have been that central nervous system complications that were reported by
physicians via the voluntary reporting system represented all cases that occurred . The
fallacy of comparing voluntarily reported complications with those delineated by 100%
accurate reporting systems such as are in place in a single county of Minnesota has been
commented upon by many qualified person [43,44]. This type of comparison fails to take
into account Retailliau's authoritative remark to the effect that, "wide spread
underreporting of illness and death in the passive phase of this type of surveillance
system impairs the ability to draw conclusions about reactions to vaccines from the
reports of illness is received" . Kaplan admits in a paper that came from the
Center for Disease Control and Prevention that, "as in any national surveillance
system we are aware that not all cases of Guillain-Barre syndrome diagnosed by
participating neurologists are reported on a case report" . This type of
comparison also fails to take into account the authoritative report of Finney which
pointed out that usually only 15% of adverse reactions are voluntarily reported .
The discussion in this section strongly suggests that when the
Guillain-Barre syndrome turned up as occurring after the hepatitis B vaccine the swine flu
experience should have alerted both pharmaceutical companies and government agencies to
the fact that central nervous system demyelinization would also turn up . It also
points out the fallacy of rationalizing the central nervous system reports of
demyelination by the same type of reasoning that failed so miserably in the swine flu
4. Reports that have appeared in the literature and in the VAERS
(Vaccine Adverse Experience Reports) reporting system that show that demyelinating and
autoimmune diseases have occurred after the hepatitis B vaccination.
On September 8, 1983, a letter appeared in the New England Journal
of Medicine in which Dr. Ribera and Dr. Dutika of the San Diego Naval Hospital
reported on a case of polyneuropathy that followed a vaccination with hepatitis B vaccine
. They stated, "Since inflammatory polyradiculopathy has occurred after many
different types of vaccines, this may be an interaction of a nonspecific immunologic
stimulus with unidentified factors present in the vaccine .
In March 1985, Snider and Gogate, in a letter to JAMA reported a case
of a possible systemic reaction to hepatitis B vaccine in which there was polyneuropathy
. They felt that, "large scale epidemiologic studies are needed" .
In 1988 Brion, et al, reported a case of myasthenia gravis that
occurred after hepatitis B vaccination .
In 1988 Shaw, at el, published the results of a postmarketing
surveillance study based on physicians reports of complication due to hepatitis B vaccine.
They used Kurland, et al, as the statistical monitor. They found even by this generally
discrete method of analysis 43 cases in which hepatitis B vaccinations were followed by
serious neurologic adverse event . There were 5 cases of convulsion, 10 cases of Bell's
palsy, 10 cases of Guillain-Barre syndrome, 9 cases of lumbar neuropathy, 3 cases of optic
neuritis and 4 cases of transverse myelitis .
In 1987, Fried, Conen, Corzelman and Stienman reported in the Lancet
a case of uveitis that occurred after hepatitis B vaccination . They pointed out that
immune complex disease did occur during the natural hepatitis B infection and that it was
reasonable to suppose that this would happen after vaccination with the same antigen that
the patient was exposed to in the natural infection [55,56].
In 1990 the first case of multiple sclerosis that had ever been seen in
an Alaskan child occurred after the 8-year-old child had received hepatitis B vaccine
I saw my first case of chronic severe central nervous system disease
that appeared after a hepatitis B vaccine in 1986 . I reported this to the Center for
Disease Control and Prevention and to Merck, Sharpe & Dohme, but it was never
acknowledged. A complete case report was turned down for publication by JAMA. To my
surprise I saw a second identical case the next year and a third case a year later .
Case reports of these patients were not accepted for publication by the Lancet in
1990 or by the Wisconsin State Medical Journal in 1991. Six months after these
rejections, the Lancet did publish a report by Herroelen and his colleagues in
Belgium of 8 cases of demyelination that followed hepatitis B vaccination . Dr.
Herroelen by personal communication now states that he has seen over 30 cases with this
In 1992, I was able to share briefly with my colleagues my experiences
of posthepatitis B vaccination which by that time had grown to 6 cases of bizarre
neurologic disease that appeared like atypical multiple sclerosis which had surfaced in my
consultation practice . Only two of these had presented themselves with any knowledge
that hepatitis B vaccine might be the cause of their illness.
In 1993, Nadler reported a case of multiple sclerosis that followed the
hepatitis B vaccination that was identical to three of the cases I mentioned in my report
By mid-1993, through the Freedom of Information Act, a printout was
obtained regarding adverse neurological reactions that had been reported to
Vaccine Adverse Experience Reports, the agency contracted by the government to accept
adverse reaction reports . When this printout was culled to reject reports that did
not seem relevant, there were 252 instances in which reporting physicians had felt an
adverse immunological reaction had taken place . The cases reported to VAERS were
broken down as follows: neuropathy-102, facial paralysis-38, paralysis, area not stated-3,
multiple sclerosis-13, Guillain-Barre-31, polyneuritis-2, optic neuritis-16, myelitis-12,
peripheral neuritis-37, encephalitis-3, (Table 1). As a result of my letter to the Infectious
Disease News I have heard of 5 additional cases of severe neurologic damage that
follow hepatitis B vaccination . They are for the most part strikingly similar to the 6
cases I have seen. These cases are not included on Table
1, which summarizes experiences
published for the most part by VAERS and others (Table 1).
Table 1 summarizes 305 cases in which professional observers have
concluded that hepatitis B vaccine has caused serious nervous system or autoimmune
complications. If we apply Finney's statistics to this value, the cases of this type
probably run into the thousands since we can expect to know of only 15 percent of adverse
reactions based simply on voluntary reporting .
5. Some of the mechanisms by which hepatitis B vaccine could have
caused both demyelination and autoimmunity.
The first and most likely mechanism through which hepatitis B vaccine
could have caused neurologic damage has been termed molecular mimicry . Put simply,
this concept, which was first named by Damian in 1964, is that proteins that are presented
to the body defenses by either bacteria, viruses, vaccines or drugs, will evoke an
autoimmune reaction if the polypeptides that constitute their antigenic sites are
homologous or almost homologous to polypeptides present in the body tissue itself . In
1980, Panitch suggested that antibodies to measles and to myelin basic protein were
directed against similar antigenic and other autoimmune diseases . A crucial finding
in regard to this being the probable mechanism by which hepatitis B vaccine caused
demyelination was that of an associate of Oldstone, Fujinami, who showed that the
hepatitis B capsular antigen, the antigen in the hepatitis B vaccine, contained
polypeptide sequences that were homologous or near homologous with myelin . While the
techniques and computer progress to make these comparisons are readily available, as far
as can be determined polypeptide constituent studies that compare vaccine polypeptides
with those in human myelin have not been undertaken by vaccine manufacturers .
Another mechanism by which chronic disease could be caused by hepatitis
B vaccine was first suggested with Zuckerman . He pointed out that since much of the
pathology induced in hepatitis B infection is mediated by immunologic mechanisms, that
inducing immunity to hepatitis virus had theoretical risks.
A third mechanism by which hepatitis B vaccine was suggested to cause
chronic disease was reported by Hilleman, the scientist most responsible for its
development . He states in a discussion regarding the quest for an AIDS vaccine that,
"the message from the hepatitis B example is that the administration of antigens. . .
that directly or indirectly raise antibodies that attach to host cell receptors may carry
large liabilities." He suggests that these liabilities may be responsible for a
variety of autoimmune disorders. It is strange that he never mentions this information in
his many discussions regarding hepatitis B vaccine [65,66,67].
Hellstrom and her associates have suggested another mechanism by which
hepatitis B vaccine might cause damage. They point out that the pre-S antigen (which is in
hepatitis B vaccine) may be a pathogenic factor in the development of chronic autoimmune
liver disease that follows hepatitis B infection and they suggest that it may not be a
suitable component of hepatitis B vaccine .
The concept that much of hepatitis B vaccine toxicity is due to more
generalized phenomenon that allows autoimmune pathology to be evoked is suggested by the
wide variety of the reported autoimmune reactions that have been noted after its use.
These include multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome, optic
neuritis, encephalitis and uveitis (Table 1).
Which of the mechanisms mentioned above causes demyelinating diseases
after vaccination remains to be positively determined. However, the reasonable theories
discussed in this regard should have given pause to those who claim no serious toxicity
has resulted from the vaccine while they now push for universal vaccination against
hepatitis B [5,6,7,8].
6. The push for universal hepatitis B vaccination - An
"off-label (not officially accepted by the FDA) use."
In view of what has been discussed, it is a source of wonderment that
members of the Center for Diseased Control and Prevention, the American Medical
Association, State Medical Societies, the American Academy of Pediatrics and many other
public health agencies have endorsed the idea that hepatitis B vaccine should be given to
every newborn in the United States [5,6,7,8]. How has this come about in spite of the fact
that the Federal Food and Drug Administration has not approved of this use and that this
has to be considered "an off-label use?" An important factor in this regard is
undoubtedly the fact that the market for hepatitis B vaccine can run into billions of
dollars. Merck, Sharpe & Dohme, is said to have sold 240 million dollars worth of this
vaccine in 1992 . Imaginative and effective promotional methods have been developed by
the American pharmaceutical industry. They have hired scientists who publish articles in
prestigious journals about vaccines, but all too often fail to mention their dangers. They
often fail to mention the authors' connection to the manufacturer of the vaccine
[66,70,71,72]. They also hire scientists who just prior to their employment were in charge
of monitoring the safety of their vaccines regulatory agency as government employees .
In addition, the scientists of the Center for Disease Control and Prevention also promote
universal vaccination in articles and appearances before State Medical Society Committees.
For instance, Dr. Harold Margolis of the Center for Disease Control and Prevention
appeared before a committee of the State Medical Society of Wisconsin in 1992. After his
presentation the committee endorsed universal hepatitis B vaccination of all infants. This
was in spite of the fact that the present vaccines are only approved by the FDA for use in
groups who are at special risk of getting hepatitis B (see present package insert of
hepatitis B vaccine). Does this mean every baby in the United States regardless of
environment or social status is a special risk for getting hepatitis B? One wonders
how many pediatricians in this country are aware that they are taking the risky step of
ordering an "off label" use of a drug when they allow babies under their care to
be vaccinated. Parents are usually shown the brochure put out by the American Academy of
Pediatrics that states "no serious reactions have been linked to this vaccine and
most children have no associated side effects." . This brochure patently ignores
the information detailed in the preceding section of this discussion.
Another example of a possibly too-close relationship between the
CDC&P and industry was the inclusion of Dr. Guess, a statistician with Merck, Sharpe
& Dohme and formerly with the CDC, as the co-author of the paper which concluded that
hepatitis B vaccine did not cause serious CNS neurologic damage .
Whether the promotional methods mentioned are ethical and desirable
will have to be decided by the profession and perhaps the courts. In this connection, The
New England Journal of Medicine, have taken an initial step in this direction by new
conflict of interest policies regarding articles that appear in their journals . A
recent discussion of this problem in the distinguished medical journal Science has
highlighted the importance and controversial nature of the "conflict of interest
7. What should be done?
In view of the facts presented that show that viruses, and in
particular hepatitis B virus, cause demyelinizing and nervous system damage in both
animals and humans; that these types of damages occur in humans after administration of
the hepatitis B vaccine; that this damage has been discounted by the manufacturers and
government agencies by the use of questionable and discredited epidemiologic methods, and
that there are several very logical theoretic mechanisms by which this damage could occur,
what can and should be done to meet the problems posed by the vaccine? First, synthetic
vaccines should be developed that evoke resistance to the target virus but that do not
contain any polypeptide sequences present in human tissue . As many as three
sequential polypeptides can evoke an antigenic response as shown by AW and this should be
taken into account . Computerized programs can determine these homologies and are
readily available . The age of synthetic vaccine production has arrived. The
technology and expertise to produce vaccines devoid of polypeptides homologous with human
tissue are available [75,77,78]. Further, meticulous studies regarding antigenic
components that are encephalogenic add another avenue to screen potentially dangerous
antigens from vaccines whether they are totally synthetic of yeast produced .
Secondly, modern methods of case finding should be instituted to
determine the rate at which the vaccine causes untoward results. Underreporting cannot
continue to be ignored. The machinery for this critical need was put into force in the
national Childhood Vaccine Injury Act of 1986 . Hepatitis B vaccine should be included
in this governmentally mandated program for pertussis, measles, mumps and polio. If this
is done, complete records of all that receive the hepatitis B vaccine will be available
since this act requires the administrator of the vaccine to record the name of all
individuals who are vaccinated. With this information a complete follow-up can be obtained
since each person who receives the vaccine can be contacted as to whether or not it caused
immediate or long-term toxicity. The second provision of the act that states that the
government must assume fiscal responsibility for untoward vaccine reactions has already
proved unworkable since the money set aside to cover claims was soon exhausted . This
provision would remove the impetus for pharmaceutical companies to insure the safety of
their own vaccines. If it is utilized in regard to hepatitis B vaccine, we can expect a
replay of the billions of dollars of claims against the government that resulted from
similar swine flu legislation and which are now occurring with pertussis vaccine [37,81].
When the rate of serious vaccine complications has been determined by
an accurate surveillance system the rate at which hepatitis B might be expected to attack
various subgroups of population must be determined. Surely the risk for a baby from a
middle class family must be less than that for a baby born into the many disastrous
situations that occur in many of our large cities. Then, when individuals can be told the
probability of them getting hepatitis B and the probability of them getting a serious
complications from the vaccine, they can decide whether they or their children should take
Specific reasonable suggestions have been made in regard to the
problems that have been discussed. At this point, because of the involvement and
commitment of agencies and manufacturers who appear to have vested interest in hepatitis B
vaccine, these problems might not be fully addressed until the victims have had their day
in court. It is hoped that some remedial actions can be taken before this occurs.
Back to Hepatitis B section menu
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NEUROLOGIC AND AUTOIMMUNE DISEASES ATTRIBUTED TO THE HEPATITIS B
|| NO. OF CASES
Shaw, et al
Biron, et al
VAERs up to
- note stated
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