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Dr.
Bonnie S. Dunbar
Molecular Biologist
Baylor College of Medicine
May 18, 1999
Good morning and thank you for this opportunity to discuss these critical
health care issues. My name is Bonnie Dunbar, and I am a research scientist
and medical and graduate student professor who has worked in the areas of
autoimmunity and vaccine development for over twenty five years (the past 17
years at Baylor College of Medicine in Houston).
I have been honored by the National Institutes of Health as the first
Margaret Pittman lecturer for my pioneering work in vaccine development. This
honor was special for me because Dr. Pittman’s contributions were
instrumental in early aspects of vaccine development and because I understand
the impact that some vaccines have had, and will continue to have, on our
society. My ongoing research in the area of vaccine development continues to
be a major commitment. I have worked extensively with the US Agency for
International Development and the World Health Organization programs and have
a life long commitment to carrying out research to understand, and hopefully,
to help solving problems associated with world population as well as disease
problems.
As I have been invited to speak to this distinguished subcommittee, it is
important to discuss my experience with the clearly apparent severe adverse
effects of the Hepatitis B vaccine. About five years ago, I had two
individuals working in my laboratory who were required to take the Hepatitis
B vaccine. Both of those individuals developed severe and apparently
permanent adverse reactions as a result of the vaccine. Both of them were
completely healthy and very athletic before this vaccine and have now
suffered severe, debilitating autoimmune side effects from the vaccine. I
have studied the complete medical history of my brother, Dr. Bohn Dunbar, who
developed seriously chronic joint and muscle pain, fatigue, and multiple
sclerosis-like symptoms. And now he has further been diagnosed with POTS (an
autoimmune, cardiovascular, and neurological problem) and subsequently with
chronic inflammatory, demyelinating polyneuropathy. His problems have been
attributed to the Hepatitis B vaccine by over a dozen different specialists
around the United States of unquestionable medical expertise. He has now been
rated permanently and totally impaired at greater than 90%. His health care
has already cost the state of Texas about a half million dollars in the Texas
Worker’s Compensation Program to date, and that figure will continue to rise
given the severity of his health condition.
My other student went partially blind following her first booster
injection, a medical condition that was markedly exacerbated by her second
booster that resulted in hospitalization. Personal communications are that
her eyesight is continuing to deteriorate. Because she is in medical school
she has been, understandably in my opinion, afraid to pursue investigation
into her medical problems because of her concern that they might affect her
medical career.
I am extremely sensitive to the need to evaluate the risk vs. benefits of
any vaccine. Because of my experience in this area, it became intuitively
clear to me that these two active, healthy individuals working in my
laboratory developed autoimmune syndromes within a predictable immunological
time frame following their booster injections of the Hepatitis B vaccine.
After carrying out extensive literature research on the nature of this virus
and this vaccine, it became intuitively obvious to me that there is a
significant scientific probability that the vaccine is the cause of those
adverse reactions. Both the published studies of reactions to viral infection
and the temporal relationship of vaccine administration to adverse events
suggest strongly that these adverse reactions are related to the nature of
the viral protein, the recombinant surface antigen of which is the principal
component of the vaccine.
I have been in contact with numerous physicians and research scientists
from several countries who have independently described identical severe
reactions to the vaccine in thousands of Caucasians. Their observations have
been, for the most part, denied or ignored by the public health systems, as
is evidenced by the serious charges against healthcare officials and
pharmaceutical companies brought recently in France. The reversal of the
vaccine mandate for children in France was not based on lack of
documentation. I have now been contacted personally by hundreds or more
individuals (including parents of infants and children) who have reported
deaths, severe health problems and life long disabilities, resulting in major
medical costs following the administration of this vaccine. It appears that
the adverse events related to this vaccine are within a gene pool that is
capable of genetic definition. I respectfully submit that rigorous scientific
studies into the possibility that the vaccine can cause severe autoimmune
disorders is necessary.
The following points specifically address the issues listed in my
invitation to speak to this committee.
1. The Food & Drug Administration has set up a system for reporting
adverse reactions to the vaccine. How does this system work? What is being
done to study these adverse reactions.
My first experience with this reporting system followed my observation of
the two individuals in my laboratory who developed serious medical problems
within a time frame predictable for immunological reactions. After seeing
that these reactions were listed in the Physician’s Desk Reference text as
reported reactions to this vaccine, I learned about the VAER’s reporting
system. When I first called the FDA about this, I was told by an individual
that "this vaccine is a problem and it is a big one." I was
initially sent some information on reports of reactions that were similar, if
not identical, to those of these two individuals. I attempted to initiate a
dialogue with individuals at the FDA but was simply told that I could obtain
the information under the Freedom of Information Act. I subsequently paid to
obtain copies of these documents; and I was overwhelmed by the thousand of
pages of documents I received listing thousands of reports, hundreds of which
were identical to the reports I had filed for the two individuals working in
my laboratory. Unfortunately, the details on these lists were insufficient
for studies to critically evaluate the mechanisms by which these reactions
occur.
There was no response to my subsequent correspondence with members of this
branch of the FDA. (I am aware that the cutbacks in FDA funding may have
played a role in this issue.) It became apparent that the essential medical
details (e.g. patient identity, genetic background, family history of
autoimmune diseases, etc.) are not provided by this reporting system and that
there is no way to contact physicians reporting these reactions. This
information is, therefore, inadequate and not accessible to those of us who
are studying the serious adverse reaction events apparently related to this
vaccine. It was also apparent that there is no follow-up on these reactions
since the two patients I reported were never contacted to evaluate their
deteriorating health conditions.
What was obvious from the information I obtained from the VAERS reports
were that there are thousands of reports listing such conditions as
neurological damage, arthritis symptoms, and other serious immunological
disorders. These are the same types of medical conditions that, in my
extensively detailed investigation of the literature, have been published in
dozens of medical journals that cite the correlation of this vaccine and
severe immunological reactions. (Table of references to be provided at time
of hearing). The fact that this reporting system is "passive", i.e.
not mandatory, also suggests that only some fraction of adverse events (estimated
by FDA officials as 1-10%). In summary it is my opinion that the VAERS
system, as currently structured, is highly inadequate to collect
scientifically useful information.
I have now been in direct contact with hundreds of severely ill patients (as
well as with physicians who have hundreds more patients) having developed
adverse reactions to this Hepatitis B vaccine. I feel that it is critical to
investigate the early onset effects as well as subsequent development of
autoimmune adverse reactions in the hope that we might find more directed
treatments to avert the long term effects in those already afflicted with
these problems. I believe this is possible in view of new technologies for
treatment of autoimmune diseases that are targeted to the identification of
specific autoantibodies to defined epitopes.
2. Do the benefits of administering the vaccine to infants outweigh the
risks?
To date my studies have concentrated on the adult population. Sadly, even
less is known about immunological reactions in infants, especially since they
cannot communicate, as can older children or adults, their severe pain,
fatigue, or other neurological or physical disturbances. In the event of
deaths following vaccination, there is generally inadequate information collected
by pathologists to adequately evaluate these reactions.
I would challenge any colleague, clinician or research scientist to claim
that we have a basic understanding of the human newborn immune system. It is
well established in studies in animal models that the newborn immune system
is very distinct from the adolescent or adult. In fact, the immune system of
newborns in animal models can easily be perturbed to ensure that it cannot
respond properly later in life.
In contrast, it is highly improbable in the US that a newborn has any
significant risk of contracting Hepatitis B as a child because the disease is
caused by a blood-borne virus. Newborns are not likely to engage in
intravenous drug use or promiscuous sex. Nor are they likely to suffer an accidental
needle stick, as might a medical worker. About the only way they are likely
to be exposed to the disease is by being born to an already infected mother.
In view of this lack of scientific and medical information of neonatal
immunology, it is remarkable to me that newborn infants, especially those not
at risk for the Hepatitis B disease itself are being administrated multiple
injections of this vaccine and that there have been few, if any, clinical
trials to adequately evaluate the potential long term effects of neonatal
immunization especially as it relates to genetic diversity.
3. What process does the CDC employ to make a recommendation for a
vaccine: What role do pharmaceutical companies play in that process? Do
conflicts of interest exist?
As I am not an expert on public health policy, I am not familiar with all
of the nuances of policies for recommending vaccine mandates. It is well
documented, however, that committee members advising the CDC and members of
organizations (such as the American Academy of Pediatrics, and the World
Health Organization) obtain substantial funding from pharmaceutical
companies. Furthermore, it is well documented that investigators who have
carried out clinical trials on this vaccine also benefit personally and obtain
laboratory funding as consultants promoting the vaccine and as expert witness
in legal conflicts. It is also documented that lobbyists who consult for
pharmaceutical companies are the same lobbyists for medical health care
providers. I leave it up to this distinguished committee to investigate and
evaluate the seriousness of these apparent conflicts of interest.
However, it is also apparent to me that the lack of government funding
specified for independent scientists to evaluate adverse vaccine reactions is
a major reason for scientists to seek funding for experiments dictated by
pharmaceutical companies.
4. What disclosure is required before the vaccine is given? Is it
adequate?
It is apparent to me, as it is to many others who have been investigating
this issue, that adequate long-term follow-up information was not collected
in clinical trials for this vaccine. This is particularly true with respect
to the Caucasian population. One might therefore ask: "Is there is
sufficient information concerning risks of this vaccine to be
disclosed"? The ominous lists of potential reactions listed in the
vaccine inserts appear not to be given to patients by their physicians. The
physician-patient relationship is fiduciary. That is why the lawyer
representing my brother, who had an adverse reaction to this vaccine, made a
claim of fraud, a claim which this lawyer says has a strong basis in the
Restatement of Torts.
Many physicians and medical students have told me that, if this vaccine is
recommended and mandated by government officials, "why should they look
at it or discuss it with their patients?" Others have said that their
colleagues do not report these incidences because they "don’t want to
get involved." They further tell me that they have been informed that this
vaccine is the safest ever developed because it is a recombinant DNA vaccine
and "therefore you can’t get the disease". Unfortunately, they have
clearly missed a major point of basic immunology. Any peptide (a limited
sequence of amino acids of a protein) or a full length or truncated protein
(produced by purification from a biological source or using recombinant cDNA
technology) when introduced into the body will be "processed by the
immune system" and, depending on the nature of that protein, could result
in long term autoimmune reactions.
Sadly, in basic science courses in medical schools, many of these details
of immunology (a medical research field that has exploded over the last
decade) are not taught. I have taught in the basic science curriculum for
over 15 years so I am well aware of this limitation. In fact, I recently was
invited to speak at the Institute of Medicine at the National Academy of
Sciences on this subject. I was quite shocked when a senior member of a
national health committee (involved in recommending mandates for childhood
vaccines) came up to me and said: "Very interesting talk. I know you
teach beginning medical students. Could you recommend me a basic immunology
textbook? I think I need to catch up on some of this immunology stuff."
In summary, it is essential in my opinion that physicians be better
educated on the potential risks of this vaccine, as well as the interactions
with other vaccines and the increased risks of vaccinations of sick children.
It is also critically important to conduct the research necessary so that
they will have better information to identify people at risk for adverse
reaction. In any event early diagnoses of these reactions will result in more
effective therapies.
My colleagues and I have submitted proposals to investigate the scientific
bases for these vaccine adverse reactions. Many of these reactions are
similar to those reactions from individuals having the virus itself. It is
also apparent that there are major histocompatability, genetic linkages among
patients who are having the severe reactions. It has already been shown that
as many as 10 to 30% have been reported as not developing antibodies when
they are vaccinated and, therefore, they may not to be protected from the
disease. This non-responsiveness may be attributed to the individual
histocompatability genes.
We have proposed to carry out research to determine the long-term
prognosis for patients having such adverse reactions for two purposes: (1)
Developing a prophylactic strategy of identifying those likely to react
adversely so they can avoid the vaccine if at risk; and (2) developing a
therapeutic strategy by early and more effective identification of those who
have had adverse reactions with the hope of developing more specific therapies.
I and my collaborators have well equipped laboratories for state of the art
immunological and biochemical analyses and we have already collected blood
samples throughout the period of these adverse reactions. We therefore, have
unique samples to begin to scientifically pinpoint the reasons for the
adverse reactions. We have significant preliminary evidence that may explain
these responses and we will continue to seek funding to continue these
studies. We have obtained some limited funding from private sources but as
yet there are no government funds allocated for studying adverse reactions to
this vaccine, so the progress of these studies is slow.
It is apparent that the Hepatitis B virus (and vaccine developed from the
Hepatitis B surface antigen) is very unique from many other viruses and
vaccines. New theories and experiments (i.e. molecular mimicry and
anti-idiotypic antibodies) have been developed which could explain reasons
for autoimmune reactions caused by this virus or the viral protein used in
the vaccine. (The December 26, 1996, New York Time’s article which summarizes
studies on "molecular mimicry" theories for viruses causing
autoimmune diseases may be right on point.) The fact that there are dozens of
publications on the correlation of this virus as well as the vaccine with
autoimmune and other connective tissue disorders provides strong evidence for
the correlation of this viral antigen causing autoimmune diseases.
In summary, no one, especially myself, would ever assert that the
Hepatitis B virus is not causing serious health problems in the world.
However, if this, or any other vaccine, by nature of the protein or parts of
the protein (native or produced from a cDNA as a recombinant protein), has
the ability to adversely effect the immune system of large numbers of
individuals resulting in severe adverse reactions (even if restricted to some
genetic populations), then the public reaction to ALL vaccines, including
those that clearly DON’T have related adverse reactions will be doomed in the
public’s eye. That includes the development of vaccines to evolving airborne
viruses that might become a serious threat to the world population. Thanks to
the success of the Government funded Human Genome Project and advances in
computer programs, it may soon be possible to evaluate potential molecular
structure to predict these problems with vaccine in advance or early in
vaccine development.
I will conclude by relating an observation. In my research on vaccines
that have been used for the humane control of animal populations, I have had
the opportunity to observe first hand African elephant family behavior.
Whenever a baby cries, the entire herd of up to a hundred will immediately
trumpet, and charge with great flurry to surround the infant elephant. When
it is apparent that there is no danger, they will one by one touch trunks
with that infant, ensuring that he is okay before going about their business.
They would certainly never allow a single baby or family member to be exposed
to unknown danger.
I ask you in your task of investigating our public health system that as
do our friends the elephants, listen to the cries of babies (and family
members) that might have been adversely affected by this vaccine or who may
be at risk. Please demand adequate scientific documentation and medical
information to make responsible decisions concerning mandating vaccines for
children. In addition to your investigation on the adverse reactions of this
vaccine I would urge you to help to provide research funds which are currently
not available to study the serious adverse reactions of this vaccine as well
as other vaccines.
Thank you for the opportunity to appear before this distinguished
subcommittee. I will be glad to answer any of your questions or provide you
with additional information you may request.
Sincerely,
Bonnie S. Dunbar, PhD, Professor
Department of Cell Biology
Baylor College of Medicine, One Baylor Plaza
Houston, Texas 77030
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