STATEMENT of the ASSOCIATION OF AMERICAN PHYSICIANS &
to the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee
on Government Reform
U.S. House of Representatives
RE: HEPATITIS B VACCINE
Submitted by Jane Orient, M.D.
June 14, 1999
Mr. Chairman and Members of the Subcommittee:
My name is Jane Orient, M.D. I am a practicing internist from Tucson, Arizona, and
serve as the Executive Director of the Association of American Physicians
& Surgeons ("AAPS").
AAPS is a nationwide organization of physicians devoted to defending the sanctity of
the patient-physician relationship. AAPS revenue is derived almost exclusively from
membership dues. We receive no government funding, foundation grants, or revenue from
vaccine manufacturers. No members of our governing body (the Board of Directors), have a
conflict of interest because of a position with an agency making vaccine policy or any
entity deriving profits from mandatory vaccines.
AAPS thanks this Committee and Chairman Mica for leaving the record open for a longer
period to permit an opportunity to review the hearing transcript, written testimony, and
raw data from the Vaccine Adverse Event Reporting System (VAERS).
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. Even if such members recuse themselves from specific votes,
they are permitted to participate in discussions and thus influence the decision.
Moreover, there is the potential for deal-making. Or there may be a simple disinclination
to cause problems for one member's agenda in the expectation that that member will
Once a vaccine is mandated for children, the manufacturer and the physician
administering the vaccine are substantially relieved of liability for adverse effects. The
relationship of patient and physician is dramatically altered: in administering the
vaccine, the physician is serving as the agent of the state. To the extent that the
physician simply complies without making an independent evaluation of the appropriateness
of the vaccine for each patient, he is abdicating his responsibility under the Oath of
Hippocrates to "prescribe regimen for the good of my patients according to my ability
and my judgment and never do harm to anyone."
Should a physician advise against a mandated vaccine, he faces increased legal
liability should the patient acquire the disease. Moreover, he may risk his very
livelihood if he is dependent upon income from "health plans" that use vaccine
compliance as a measure of "quality."
It is perhaps not surprising, although still reprehensible, that physicians sometimes
behave in a very callous manner toward parents who question the need for certain vaccines.
Federal policy of mandating vaccines marks a profound change in the concept of public
health. Traditionally, public health authorities restricted the liberties of individuals
only in case of a clear and present danger to public health. For example, individuals
infected with a transmissible disease were quarantined. Today, a child may be prevented
from attending school or associating with others simply because of being unimmunized. If
there is not an outbreak of disease and if the child is uninfected, his or her unimmunized
state is not a threat to anyone. An abridgement of civil rights in such cases cannot be
With hepatitis B vaccine, the case for mandatory immunization with few exemptions 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.
AAPS awaits the release of full information concerning the licensure of hepatitis B
vaccine and the mandate for newborn immunizations, as requested under the Freedom of
Information Act by the National Vaccine Information Center. It is imperative that
independent scientists have the opportunity to review the raw data. In the meantime, all
coercive means for increasing the immunization rate should be immediately discontinued.
Fully informed consent should be sought before vaccine is administered. This requires full
and honest disclosure of the risks and uncertainties of the vaccine, in comparison with
the risks of the disease.
Information given to parents about this vaccine often does not meet the requirement for
full disclosure. For example, it may state that "getting the disease is far more
likely to cause serious illness than getting the vaccine." This may be literally
true, but it is seriously misleading if the risk of getting the disease is nearly zero (as
is true for most American newborns). It may also be legalistically true that "no
serious reactions have been known to occur due to the hepatitis B recombinant
vaccine." However, relevant studies have not been done to investigate whether the
temporal association of vaccine with serious side effects is purely coincidental or not.
An independent review of the VAERS data; publications by governmental, pro-vaccine, and
anti-vaccine groups; and a sample of the medical literature leads to the following
� For most children, the risk of a serious vaccine reaction may be 100 times greater
than the risk of hepatitis B. Overall, the incidence of hepatitis B in the U.S. is
currently about 4 per 100,000. The risk for most young children is far less; hepatitis B
is heavily concentrated in groups at high risk due to occupation, sexual promiscuity, or
drug abuse. VAERS contains 25,000 reports related to hepatitis B vaccine, about one-third
of which were serious enough to lead to an emergency room visit, hospitalization, or
death. It is often assumed that only 10% of reactions are reported. (This committee has
heard testimony about persons being actively discouraged from reporting, even if they are
aware of the reporting system.) Thus, if there have been some 80,000 serious adverse
reactions associated with 20 million doses of vaccine, the risk is about 4 in 1000. (This
calculation depends on many assumptions. Moreover, many of the patients experiencing
temporally associated adverse reactions had simultaneously received more than one vaccine.
Nevertheless, a better estimate has not been put forth.) It should be noted that a less
than 1 in 1,000,000 purely hypothetical risk may be used to justify costly federal
regulations on highly useful products that are used voluntarily.
� In nearly 20% of VAERS reports, the first of eight listed side effects suggests
central nervous system involvement. Examining the first listed effects shows about 4,600
involving such symptoms as prolonged screaming, agitation, apnea, ataxia, visual
disturbances, convulsions, tremors, twitches, an abnormal cry, hypotonia, hypertonia,
abnormal sensations, stupor, somn-olence, neck rigidity, paralysis, confusion, and
oculogyric crisis. The last is a striking feature of post-encephalitic Parkinson's
disease, or it may occur as a dystonic reaction to certain drugs such as phenothiazines.
The CDC admits that the results of ongoing studies on a potential association of hepatitis
B vaccine and demyelinating diseases such as multiple sclerosis are not yet available.
� There may be large genetic differences in susceptibility to vaccine adverse effects.
The committee has been told that serious reported adverse effects seem restricted to
Caucasians. Yet the oft-cited long-term safety study was conducted in Alaskan natives, and
many studies involved Asians. In adults, 77% of the reactions involve women, who are
generally more susceptible to autoimmune diseases. This deserves serious study, not
off-hand dismissal ("nurses always over-report"). Universal immunization could
lead to disproportionate injury to susceptible populations, who might also be the least
affected by the disease one is trying to prevent.
� Striking increases in chronic illnesses have occurred in temporal association with
an increase in vaccination rates. Asthma and insulin-dependent diabetes mellitus, causes
of lifelong morbidity and frequent premature death, have nearly doubled in incidence since
the introduction of many new, mandatory vaccines. There is no explanation for this
increase. The temporal association, although not probative, is suggestive and demands
intense investigation. Instead of following up on earlier, foreign studies suggesting a
greater-than-chance association, the CDC, through vaccine mandates, is obliterating the
control group (unvaccinated children). Dr. Classen testified concerning his opinion that
hepatitis B vaccine could precipitate diabetes mellitus. Of note, VAERS contains more than
4,000 reports of abdominal symptoms that could have been due to pancreatitis, which was
probably not specifically sought and thus missed if present. Even more alarming is the
huge increase in reports of autism and attention deficit/hyperactivity disorder, with
devastating, life-long impacts. Much of this could be due to over diagnosis
by numerous government subsidies). The change in behavior that many parents observe
related to vaccines could be coincidental, or it might reflect a desperate need to explain
a disastrous occurrence. Nonetheless, the implications are so grave that immediate
investigation is needed. Measles, mumps, rubella, hepatitis B, and the whole panoply of
childhood diseases are a far less serious threat than having a large fraction (say 10%) of
a generation afflicted with learning disability and/or uncontrollable aggressive behavior
because of an impassioned crusade for universal vaccination. There are plausible
mechanisms such as molecular mimicry whereby vaccines could have such effects. Basic
research, as well as epidemiologic studies (starting with a long-term follow-up of
reactions reported to VAERS), is urgent.
� Hepatitis B vaccine as a cause of sudden infant death has not been ruled out. The
mere observation that the incidence of SIDS has decreased while hepatitis B immunization
rates have increased proves nothing whatsoever. In other contexts, the Back to Sleep
campaign is credited with a dramatic fall in SIDS; the fall might have been much greater
without hepatitis B immunizations. The presence of findings such as brain edema in healthy
infants who die very soon after receiving hepatitis B vaccine is profoundly disturbing,
especially in view of the frequency of neurologic symptoms in the VAERS. Does SIDS occur
on the day after hepatitis B vaccine with a greater-than-expected frequency? Does it occur
at a younger-than-expected age? Are the autopsy findings different in babies who just
received the vaccine? The fact that vaccine just happens to be given during the time
period that babies are most likely to die of SIDS complicates the analysis. Also, there
are a number of other confounding variables (sleep position, socioeconomic status, and
possibly smoking behavior). The data in VAERS are probably too incomplete to answer the
questions. A very detailed statistical analysis and an aggressive attempt to obtain more
complete information are urgently needed. Glib reassurance, based on the secular trends
shown to this Committee, is dangerous.
Public policy regarding vaccines is fundamentally flawed. 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.
AAPS opposes federal mandates for vaccines, on principle, on the grounds that they are:
1. An unconstitutional expansion of the power of the federal government. 2. An
unconstitutional delegation of power to a public-private partnership. 3. An
unconstitutional and destructive intrusion into the patient-physician and parent-child
relationships. 4. A violation of the Nuremberg Code in that they force individuals to have
medical treatment against their will, or to participate in the functional equivalent of a
vast experiment without fully informed consent. 5. A violation of rights to free speech
and to the practice of one's religion (which may require one to keep oaths).
AAPS would specifically oppose the campaign for universal immunization against
hepatitis B, even if the above did not apply, because the safety of the vaccine is in
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