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Universal Hepatitis B Vaccination: A Moratorium Should Be Placed On This Experiment
by Burton A. Waisbren, Sr., M.D., F.A.C.P., F.I.D.S.A.


My position in this point-counterpoint essay is that the program of universal hepatitis B vaccination in the United States (U.S.) is an experiment being performed on our babies. A moratorium should be placed on this experiment until risk/benefit ratios are clearly defined.

First, I will explain why and how this experiment was implemented. I will then analyze the rationales used to sell the program to the public health establishment, state legislatures, and then the pediatricians. I will discuss the methods used to implement the experiment. Finally, I will offer opinions as to why a moratorium on universal hepatitis B vaccination would be beneficial to all concerned.

The concept of universal hepatitis B vaccination in the U.S. was conceived by Dr. Harold Margolis, the head of the hepatitis branch of the CDC and his staff. The concept was based on the following assumptions: Hepatitis B vaccine is safe; the attempt to vaccinate high risk individuals in the U.S. is failing to stem the spread of the disease; five percent or more of the individuals in the U.S. can be expected to get this disease; hepatitis B infection is spread by those without known risk factors; the "only way" to solve the problem of hepatitis B infection in the U.S. is by universal vaccination of babies.

Let us first examine these rationales.

Hepatitis B vaccination is safe.

Safety is not even mentioned in the initial presentations regarding universal hepatitis B vaccination. In later discussions flat assertions are made that the vaccine is safe.

We all know that no vaccine, medication, or procedure is completely safe. The question always is, how safe? One wonders how the CDC continues to claim safety for this vaccine when they must be aware of thousands, yes thousands, of reports to the Vaccine Adverse Event Reporting System (VAERS) of adverse events that followed hepatitis B vaccination. Included among these are numerous autoimmune diseases such as multiple sclerosis (M.S.), Guillain Barre Syndrome, and autoimmune arthritis. One wonders how the CDC and FDA continue to reassure the public about the safety of the vaccine when the government program to pay individuals who have had adverse reactions to vaccine has paid out millions of dollars. One wonders how these agencies can continue their claims of safety when they must be aware that pharmaceutical companies have settled millions of dollars worth of claims for "failure to warn" vaccine sufferers about adverse reactions. They did this rather than letting the cases go to trial. Secrecy was always the caveat of these settlements. One wonders how these agencies and pharmaceutical companies continue to make flat statements regarding safety when there are at least twenty articles in the peer reviewed medical literature about diseases such as M.S. and optic neuritis that occurred after hepatitis B vaccination.

The attempt to vaccinate high risk individuals in the U.S. is failing to stem the spread of the disease.

This may well be true but data presented about this is not entirely convincing.

The incidence of hepatitis B infection is such that 5% of the population can be expected to get the disease in their lifetime.

The basis for this assertion was a study done by the National Center for Health Statistics entitled the National Health and Nutrition Examination Survey (NHANES II). The values in the NHANES reports were estimates extrapolated from data obtained from 14,488 persons who were chosen as representative of the U.S. population. One wonders about the accuracy of values based on such a relatively miniscule sample (.000054 percent of the population). This concern has recently been voiced in an editorial in the January issue of the American Journal of Public Health, which was written by physicians from the CDC. They said: "While these conclusions may be valid, they fail to provide a context that takes into account the sample size limitations of NHANES…"

Thirty percent of cases of hepatitis B occurred in individuals with no known contact to risk factors.

Evidence used to support this assertion was based on questionnaires sent to sufferers of the disease. Does anyone truly believe that individuals who got the disease from promiscuous sexual activity or drug use would "finger" their contacts on a questionnaire? I could find no other proof of significant lateral transmission in the literature.

Universal hepatitis B vaccination is the "only way" to stem this infection in the U.S.

Who among us will agree that in science there is only "one way" to accomplish a goal? One wonders why the CDC has not used its energy and influence to see to it that every woman in the U.S. who delivers a baby in a hospital is mandated to have a blood test for hepatitis B (and for that matter AIDS). We hear the argument that this might violate the woman's civil rights. One might wonder about the civil rights of the babies being experimentally vaccinated. Certainly, universal blood testing of pregnant woman would be a way to stem the problem. Wider use of chemotherapy, which even at this early stage, is said to cure a significant number of people with chronic hepatitis B, would be another way to approach the problem.

Parenthetically, the fact that there are multiple ways in which the spread of hepatitis might be blunted makes the endpoint selected to see if universal hepatitis B vaccination is of value illogical. It is stated that we will see if universal hepatitis B vaccination is of value, if twenty-five years from now the incidence of cancer of the liver in the U.S. decreases. Do the proponents of this experiment think that universal hepatitis B vaccination will be the only factor influencing cancer of the liver in the next twenty-five years?

In view of the questions raised above, one asks: How did the proponents of universal hepatitis B vaccination get their experiment implemented? It seems that one method used was their participation in seminars sponsored by drug companies and published in journals as supplements. This avoided vigorous peer review of the original articles because the presentations were invited. Another method was to get acceptance of the program by national pediatric organizations that apparently accepted the rationales on face value. A third method was the personal visits by CDC members to State Boards of Health. Whatever the methods used, a question can be raised as to how an experiment proposed by an agency of the federal government and supported and published about in pediatric journals by an executive of a pharmaceutical company could have been accepted and implemented by the entire public health establishment and many state legislatures. This acceptance occurred in spite of the fact that the babies vaccinated could not be assured of the time-honored criteria for vaccination, a proven positive risk/benefit ratio.

I submit that the information discussed to this point makes it reasonable to declare a moratorium of the experiment of universal hepatitis B vaccination in the U.S.

This moratorium should be called for jointly by the CDC, FDA, the congressional oversight committees of the CDC and the FDA, and the state and local health departments. While the moratorium is in place, federal injunction relief should be obtained in regard to the laws forcing babies or children at no risk for hepatitis B to get vaccinated. This would be on the basis of their civil rights being violated.

This moratorium would be good for all concerned.

Babies-This moratorium would protect babies with no risk factors from a potentially dangerous vaccine that has no benefit.

CDC-This moratorium would help the public regain confidence in the CDC. It would give the CDC a chance to rethink their vaccination strategies on the basis of risk/benefit ratios rather than on other theoretical grounds. They would then be able to present to their congressional oversight committees for approval, programs for vaccination initiatives that meet all ethical standards.

FDA-This moratorium should act as a wake up call for this agency to strengthen its VAERS program so that it will be more sensitive to reports of adverse reports received from clinicians. During the moratorium, the FDA also might demand that pharmaceutical companies face up to the theoretical causes of vaccine toxicity. These would include studies for molecular mimicry, studies for complimentarity between viral antigens, and attempts to make synthetic vaccines that only have immunogenic polypeptides.

Pharmaceutical Companies-This moratorium would increase public confidence in their companies. It would also give them time to boost up their reactions to VAERS reports. At present, they seem to shift this responsibility to the FDA. "A firestorm" of lawsuits is developing against these companies for "failure to warn" about complications. Rather than stonewalling these suits or settling them in secrecy, pharmaceutical companies might be better served by accepting responsibility when it is theirs. If they are reticent to do this they might talk it over with their counterparts at Dow Chemical and the tobacco companies. At the end of the moratorium, detailed package inserts should be ready that clearly delineate that the vaccine is to be used only for patients with bona fide risk factors.

State and local health departments-This moratoruim would allow them to reassess their relationship with the CDC to see whether they have been too compliant in following suggestions that may not be applicable to their locale. They might consider whether programs of the federal government that pay them for each child they vaccinate might be clouding their judgement.

Primary physicians-This moratorium will help physicians realize that they might need more information about the risk/benefit ratio before they advise that babies be vaccinated with hepatitis B vaccine. The practitioner who reads this should ask: How many children with hepatitis B have I seen in the past 5 years?

Dr. Margolis has stated that his universal hepatitis B vaccination strategy is to act as the forerunner of future vaccination programs. Already there is a campaign in place for mandatory chicken pox and rotovirus vaccination. Both of these diseases have very effective treatments so there can be serious doubts as to whether a universal vaccination program is indicated.

There will be those who think that bringing reservations such as I have voiced out into the open will be detrimental to the excellent vaccination programs that have been in place in the U.S. for many years. To the contrary, truth never has hurt any program and facing it should only be advantageous to any worthwhile public health effort.

Finally, it should be pointed out that my remarks here only pertain to universal hepatitis B vaccination in the U.S. The World Health Organization has instituted this concept in many parts of the world where the disease is rampant. I have no argument with this program.

 

A more detailed and documented discussion of this topic is available on my website (http://www.waisbrenclinic.com).

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