Testimony before the U.S. House of Representatives Subcommittee on Criminal Justice, Drug Policy and Human Resources

By

Burton A. Waisbren, Sr., M.D.,
F.A.C.P., F.I.D.S.A.

May 18, 1999

I would like to thank this committee for the opportunity to share with them my concerns regarding the vaccination policies of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

I am a physician and clinical investigator who has practiced internal medicine, infectious disease and immunology in Milwaukee, Wisconsin for 48 years. No ulterior motives or special interests are responsible for my being here. I am here because I feel an injustice is being done to the children of this country. Included among these children are my sixteen grandchildren.

I want to make it clear from the onset that I fully support hepatitis B vaccination for individuals who have known risk factors for hepatitis B infection. The risk factors include: sexually active heterosexual adults with more than one sex partner in the prior six months or a history of sexually transmitted disease; homosexual and bisexual men; illicit injection drug users; persons at occupational risk of infection; hemodialysis patients; household and sex contacts of persons with chronic hepatitis B infection; and infants born to hepatitis B infected women.

My involvement in the field of vaccine toxicity began in 1979 when I discovered that central nervous system demyelination (Multiple Sclerosis) had been caused, in some individuals, by the swine flu vaccine. My involvement was heightened when I found the same thing occurred after hepatitis B vaccination. These findings have been confirmed by many others and have been extended to include other untoward reaction to hepatitis B vaccine. Reactions include other autoimmune diseases such as rheumatoid arthritis, optic neuritis, postvaccinal encephalomyelitis and possibly juvenile diabetes.

An autoimmune disease is defined by the fact that it is caused by the body's immune system turning against it own tissue, be it the central nervous system, the heart, or cartilage. Since the discovery of the autoimmune aspects of the vaccine complications and confirmation of this by numerous investigators, I have been searching the medical literature and studying a number of patients to try to figure out the mechanism or mechanisms by which these autoimmune complications occur. While many explanations have been suggested, the exact mechanism is still unknown. However, this study of the medical literature, of the patients, and of a great number of the reports sent to the Vaccine Adverse Event Reporting System (VAERS) has convinced me that a serious, perhaps unique problem, exists in regard to the toxicity of the hepatitis B vaccine. There are at least sixteen articles in the peer reviewed medical literature about the occurrence of diseases of autoimmunity such as multiple sclerosis after hepatitis B vaccination. The editors of the renowned medical journals, in which these articles appear, felt these cases should be brought to the attention of the medical profession. There are thousands, yes thousands, of reports by health professionals to the VAERS that adverse events have occurred after hepatitis B vaccination. I am aware of dozens of cases brought against pharmaceutical companies because of damage due to the hepatitis B vaccine. Many of these cases have been settled with the proviso that the settlements remain a secret.

The fact that these well-established adverse reactions to hepatitis B vaccine have not been acknowledged or are being denied by both the CDC and the FDA, is the root cause of the concerns I am about to share with you now.

The first concern is that caused by the experiment sponsored by the CDC which is designed to determine if vaccination at birth of all babies in the U.S. will eventually decrease the frequency of cancer of the liver caused by hepatitis B infection. To arrive at the end point of this experiment will take many years.

This experiment is based on the following assumptions:

1. The vaccine is safe and effective. While the vaccine is effective we all know that no vaccine is entirely safe as evidenced by the above-mentioned information.
2. Five to twenty percent of the people in the U.S. will eventually contract hepatitis B infection. I doubt these statistics.
3. Up to 25 percent of patients with hepatitis B infection cannot remember where they got the disease. Isn't it understandable that the people with the risk factors such as multiple sex partners and injected drug use will not be able to pin point where and when they were exposed to the disease.
4. There is no other way to control hepatitis B infection in the U.S. Does anyone in this room agree that there is ever only one way to accomplish a purpose?

I hope that this committee will ask for an independent analysis of these rationales.

This brings up my second concern. That is: how can an experiment such as universal hepatitis B vaccination be adopted nationwide without congressional involvement or approval. Apparently this was accomplished by the joint efforts of an official of an agency that stood to gain much influence and power by the program and by an executive of a drug company which stood to make billions of dollars by the project. What techniques were used and were conflicts of interest involved? Were the rights of parents and children infringed upon?

My third concern lies in the fact that the FDA has apparently not been reacting to the many theories in the medical literature regarding the causes of neurologic complications of vaccination. The FDA does not ask if proposed vaccines exhibit molecular mimicry with human tissue. They do not ask if a vaccine exhibits complimentarity with common viruses that may be in the patients. They have not demanded that the HLA patterns of patients who have untoward results be determined. They have not encouraged the development of synthetic vaccines that contain only immunogenic antigens and nothing else. I am concerned that we may see the same or similar adverse reactions to new vaccines. The new Lyme vaccine is a case in point since that vaccine has more theoretic dangers then does the hepatitis B vaccine because of the autoimmune nature of the disease itself.

When the material I have presented here is considered en toto, I believe it indicates that the present universal hepatitis B vaccination experiment being conducted in the U.S. should be abruptly halted for the following reasons:

1. It appears likely that serious untoward events particularly of the nervous system have followed the vaccination.
2. In view of this, it is reasonable to suppose that some babies who have little or no chance of getting hepatitis B will suffer unnecessary damage to their nervous system.
3. Information regarding the risk/benefit ratio of this vaccine is not known and therefore cannot be given to parents in an informed consent.
4. There is some doubt as to whether the rights of babies are being violated when they are subjected to an experiment even with their parent's consent.

France has already stopped their program of universal hepatitis B vaccination of babies because of reports that surfaced about multiple sclerosis following the vaccination. I hope our country will follow their lead. If we do not, I am afraid public confidence in our vaccination programs will decrease. This would be detrimental to the excellent vaccination programs already in place in the U.S.

I would like to thank the committee again for allowing me to share my concerns with them.

Documentation of all that I have said here is available in the supplemental material I have given this committee.