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March 12, 1999

Mr. Robert D. Crider, M.S., M.P.A.
Director
Immunization Division,
Texas Department of Health
1100 West 49th St.
Austin, Texas 78756

Dear Mr. Crider,
Good morning and thank you for this opportunity to discuss some critical health issues. My name is Bonnie Dunbar and I am a research scientist and medical 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 am not here today as an official representative of Baylor College of Medicine but as a concerned citizen of Texas and the United States. In fact, I am sure that some of my colleagues would not approve of my appearance. Especially those that are benefiting handsomely from pharmaceutical company income as consultants and expert witnesses while carrying out vaccine clinical trials.

I was honored a few years ago by the National Institutes of Health in Washington D.C. as the "First Margaret Pittman" lecturer for my pioneering work in vaccine development. This was a most special event for me because of Dr. Pittman's contributions to early vaccines 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 our research to understand, and hopefully, help to solve world population as well as disease problems.

I am speaking to you today, however, in reference to my experience with the 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 these individuals developed severe and apparently permanent adverse reactions as a result of this vaccine. Both of these individuals were completely healthy and very athletic before this vaccine and have now suffered severe, debilitating autoimmune side effects from this vaccine. I know the complete medical history of one, Dr. Bohn Dunbar, who is my brother who developed serious rashes, joint pain, chronic fatigue, multiple sclerosis-like symptoms, and now, has been affirmatively diagnosed with POTS (an autoimmune cardiovascular neurological problem) and finally 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 around a half million dollars in the Worker's Compensation Program to date, a figure that 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 which resulted in long term hospitalization. Personal communications are that her eye-sight is continuing to deteriorate. Because she is in medical school she has been (understandably so) afraid to pursue investigation into her medical problems in the event that they might effect her medical career.

As I have worked extensively in vaccine development I am extremely sensitive to the need to evaluate the risk vs. benefits of any vaccine. Because of my established expertise in this area, it became immediately apparent to me that these two active, healthy individuals working in my laboratory developed "autoimmune" syndromes at a predictable immunilogical time frame following their booster injections to the Hepatitis B vaccine. After carrying out extensive literature research on this vaccine, it became immediately apparent that the serious adverse side effects of this vaccine (which appear to be related to the nature of the viral protein itself), may be more significant than generally known (or admitted).

I have now been in contact with numerous physicians from several countries, who have independently described the identical severe reactions in thousands of Caucasians. It is obvious that 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. I can assure you that 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 children) with severe health problems and life long disabilities resulting in major medical costs following the administration of this vaccine. In my experience, as with my colleagues, virtually all of these individuals are Caucasians (clearly indicating a genetic linkage).

In my detailed investigation over the past four years it is apparent to me, (as well as others who have been investigating this) that adequate long term follow up information was not collected in clinical trials for this vaccine. This is especially true with respect to the Caucasian populations in which many of these adverse effects would have predictably been observed. In any event, the vaccine inserts which give long lists of serious potential side effects, which I have been told that physicians do not show or discuss with their patients, are ominous!

Many physicians 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 also 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 or protein (regardless of the source of that protein,native or from genetic engineering) 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 immune reactions. Sadly, in basic science curriculums of medical schools, many of these details of immunology (a medical research field that has exploded over the last decade) are not taught. In fact, I recently was invited to speak at the Institute of Medicine at the National Institutes of Health 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."

As the result of extensive literature research as well as our advanced knowledge in the mechanisms of autoimmune disease and Hepatitis B infection, I have discussed these issues with international teams of experts. We have submitted proposals to investigate the scientific basis for these adverse reactions, many which are similar to those reactions from individuals having the virus itself. It is apparent that there are major histocompatability genetic linkages among patients who are having the severe reactions. As many as 10 to 30% are not developing antibodies since they do not respond to this vaccine and are likely not to be protected from the disease anyway.

In our studies, we wish to carry out research to determine the long-term prognosis for patients having such adverse reactions with the hope of developing more specific therapies. Because I have an immunology and biochemistry laboratory we have already collected blood samples throughout the period of these adverse reactions therefore we have a unique pool of serum to begin to scientifically pinpoint the reasons for the adverse reactions. We have significant preliminary evidence which may explain these responses and we will continue to seek funding from private as well as federal sources to continue these studies.

It is apparent that the hepatitis B virus (and vaccine developed from 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 the 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 disease disorders provides strong evidence for the correlation of this viral antigen causing autoimmune diseases.

The FDA adverse reaction list now reports over 24,000 individuals with reported adverse reactions. If one dismisses the duplications and antibody non-responder reports, the vast majority of adults who have similar autoimmune associated symptoms including rash, joint pain, chronic fatigue, neurological disorders, neuritis, rheumatoid arthritis, lupus like syndrome and multiple sclerosis like syndrome. There are reports by the head of the FDA that these reports indicate only about one percent of the total numbers of adverse reactions.

These reactions clearly appear to be genetic, an observation which may provide us with the basis to evaluate which individuals might have adverse reactions to this vaccine. They may also provide us with information on those that are non-responders and may therefore not be protected by this vaccine even if they receive it. I have no doubt that the pharmaceutical companies are silently working on this because it is obvious from the published literature that these are major issues. In the meantime, how many individuals might be adversely effected before this research has been completed?

I have now been in direct contact with hundreds of severely ill patients (as well as with physicians who have hundreds more patients) clearly having adverse reactions to the 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 of 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 auto-antibodies to defined epitopes.

No one, especially myself, would ever assert that the hepatitis B virus is not causing serious health problems in the world. However, there are serious questions that remain unanswered:

1. Is the Hepatitis B virus (in its elegance of evolution and survival) a master of molecular mimicry which has produced its surface protein (the one used in the vaccine) to weaken the immune system in some individuals (i.e. inducing autoimmune disease)?

2. Can this vaccine be modified to avoid these adverse reactions or is this a virus which needs to be controlled or eradicated by early treatment or other methods?

3. Can we truly justify giving this vaccine to newborn infants? I would defy 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 our animal models that the newborn immune system is very distinct from the adolescent or adult. In fact, we can easily perturb the immune system of the newborn in animal models to ensure that it cannot respond properly later in life.

4. Can we justify mandating this vaccine for all 12 year old children without having clear scientific and medical documentation on:

(a) The duration of the vaccine in children of this age group.

(b) The number of individuals in our state population that will be non-responders to the vaccine. (This is a critical question since section 97.67 of immunization requirements in Texas Elementary and Secondary schools requires that serologic confirmation be given to prove immunity. It is established that a significant percentage of individuals will not have serological immunity against the Hepatitis B vaccine regardless of immunization schedules. Furthermore, large numbers of health care workers who have been subjected to repeated immunization despite lack of serologic immunity have reported serious adverse vaccine reactions.)

(c) The risk of lifelong permanent disability due to this vaccine and the risks among different population groups?

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 adverse reactions will be doomed in the public's eye. That includes the development of vaccines to evolving air born viruses which might become a legitimate threat to our society. Thanks to the success of the Human Genome Project and advances in computer programs it may be possible to evaluate potential molecular structure to predict these problems in advance. While pharmaceutical companies complain that extended clinical trials would cost too much, they brag to their shareholders about profits of mandated vaccines.

In conclusion, I would like to relate an observation. In my research on vaccines that have been used successfully 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 would simply ask you in your serious charge of maintaining our public health system that you, as our friends the elephants, listen to the cry of every baby and family member that might be at risk and demand that you have adequate scientific and medical information to make responsible decisions.

I thank you for your attention and would be glad to answer any questions or provide you with additional information.

Sincerely,

Bonnie S. Dunbar, PhD, Professor
Department of Cell Biology
Baylor College of Medicine, One Baylor Plaza
Houston, Texas 77030

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