September 29, 1997
Department of Health & Human Services
Food and Drug Administration
Rockville, MD 20857
I am a research scientist and medical student professor who has worked in the areas of autoimmunity and vaccine development for over twenty years (the past 15 years at Baylor College of Medicine in Houston). I was honored three years ago by the National Institutes of Health as the “First Margaret Pittman” lecturer for my pioneering work in contraceptive vaccines. This was a most special time for me because I understand what the impact of vaccines has had ( and will continue to have) on our society. My continued work in this area of vaccine development continues to be a major commitment because I have worked extensively with the AID and WHO programs and have a life long commitment to working to understand, and hopefully, help solve world population and disease problems.
I am writing to you, however, in reference to the adverse effects of the Hepatitis B vaccine because within the past three years, I have had two individuals working in my laboratory who have developed severe and apparently permanent adverse reactions clearly as a result of being forced to take the Hepatitis B vaccine. Both of these individuals were extremely brilliant, healthy and very athletic before this vaccine and have had severe, debilitating autoimmune side effects from this vaccine. I know the complete history of one, Dr. Bohn Dunbar, who is my brother who had serious rashes, joint pain, chronic fatigue, multiple sclerosis like symptoms, and now, affirmatively diagnosed with POTS (an autoimmune cardiovascular neurological problem). His problems have been attributed to the Hepatitis B vaccine by 5 different specialists of unquestionable medical expertise (including MD/PhD’s in major medical schools).
My other medical student went partially blind following her first booster injection and virtually completely blind in one eye following the second with hospitalization for several weeks. Personal communications are that her eye-sight is continuing to deteriorate (now in both eyes). Because she is in medical school she has been (understandably so) afraid to pursue her medical problems in the event that they might effect her medial career.
Because of my extensive work in vaccine development I am extremely sensitive to the balance of risk vs. benefits in vaccine development. Because of my expertise in this area, it became apparent to me that these two active, healthy individuals working in my laboratory at the same time developed “autoimmune” syndromes at the same prolonged immunological time frame following their booster injections to the hepatitis B vaccine. After carrying out extensive literature research on this vaccine, it is apparent that the serious adverse side effects of this vaccine (which are clearly related to the nature of the virus itself) may be much more significant than generally known (or admitted). I have recently been in contact with physicians from several countries, who have long since described the same problems, (in white Caucasian populations), although it is clear that their observations have been, for the most part ignored. I have had visits in the past month with physicians in England and France who have serious concerns about their large numbers of patients who they believe have been effected by this vaccine. As in my experience, the effect on white Caucasians (clearly an HLA genetic linkage) is dramatic. In all of my queries, it is not clear to me, (or others who have been investigating this), that there was adequate long term follow-up information collected in the clinical trial data (especially with respect to the white Caucasian population) in which many of these effects might have been observed. In any event, even the vaccine inserts giving reported side effects, which I have found physicians do not show or discuss with their patients, are ominous!
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 an international team of experts to prepare a grant proposal to investigate the scientific basis for these adverse reactions which are identical to those reactions from individuals having the virus itself. It is very apparent that there are major histocompatability genetic linkages among patients who are having the severe reactions (as opposed to those who do not respond to this vaccine at all!). We wish to determine the long term prognosis for patients having such adverse reactions. 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. Although our initial proposal was not funded, due mainly to criticisms of lack of patient populations with clearly defined adverse responses to the vaccine, I have since collected large numbers of reports of patients (with legitimate physician diagnoses) who wish to be involved in this study which we are including in our revised proposal. We also have preliminary evidence of a patient with a major autoantibody response to a human brain protein. We will, therefore, continue to seek funding from private as well as federal sources to carry out these studies.
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 and 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. (I feel the December 26, 1996, New York Time’s article on molecular mimicry which discusses theories for viruses causing autoimmune diseases is 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. I have obtained the FDA adverse reaction list of over 8000 individuals with reported adverse reactions for a 4 year period from 1992 to 1996 (Merck vaccine only, does not include the Smith Kline vaccine which I have been told includes another 15,000 or more). The vast majority of adults who have these same symptoms including rash, joint pain, chronic fatigue, neurological disorders, neuritis, rheumatoid arthritis, lupus like syndrome and multiple sclerosis like syndrome. (It has been reported by the head of the FDA that these reports indicate only about one tenth of the total numbers of adverse reactions.) Clearly, these reactions are HLA linked which may provide us with the basis to evaluate which individuals might have adverse reactions to this vaccine and who might be non-responders and therefore not be protected by this vaccine. I have no doubt that the pharmaceutical companies are 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 dozens of severely ill patients (as well as with physicians who have hundreds more patients) clearly having adverse reactions to the hepatitis B vaccine and 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 which are targeted to the identification of specific autoantibodies to defined epitopes.
No one, especially myself, would ever assert that the hepatitis B virus is not causing serious health problems in the U.S. as well as abroad. The questions that remain to be answered: 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 (i.e. inducing autoimmune disease)? and as (or more) importantly; Can this vaccine be modified to avoid these immune reactions or is this a virus which needs to be controlled or eradicated by early treatment or other methods? If this vaccine, by nature of the peptide (native or produced from a cDNA as a recombinant protein), has the ability to adversely effect the immune system and turns out to have severe adverse reactions in some populations, then the public reaction to ALL vaccines, including those that clearly DON’T have adverse reactions may be doomed in the public’s eye. That includes new vaccines to new, and clearly major population threatening viruses as well as to such newly designed vaccines which might be critical for controlling world population. 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.
If those of use who are looking into these adverse effects of the Hepatitis B vaccine could have access to clinical samples reported to the FDA for our research (at complete confidentiality) from patients claiming adverse reactions to the hepatitis B vaccine who are willing to participate in these studies it would be most critical. Any assistance we can obtain on this study would be greatly appreciated. I can assure you that my commitment to this project, both personal and professional, has become a major priority. I understand your position in this issue and I would like to see that there is some positive outlook for these severely devastated patients having these adverse reactions.
Bonnie S. Dunbar, PhD
Department of Cell Biology
Baylor College of Medicine
One Baylor Plaza
One Baylor Plaza