> June 28, 1999
>
> Dear Colleague:
>
> Thank you for keeping me up to date about the concerns I share with you
> regarding the universal hepatitis B vaccine program in the United
> States.  I have appended a recent summary in which you might be
> interested.  Detailed references are available on my web site
> (http://www.waisbrenclinic.com).
>
> In my opinion, the primary objective is to publicize the need for a
> moratorium on universal hepatitis B vaccination.  The reasons are as
> follows:
>
> 1. The statistics upon which the program is based on are flawed and are
> extrapolations from estimates that have never gone through a peer review
> process.
>
> 2. The civil rights of the babies are being compromised because they are
> being used as an experiment.
>
> 3. There is mounting evidence that the vaccine causes, in some
> individuals, acquired autoimmunity such as multiple sclerosis and
> postvaccinal encephalomyelitis to name but a few of the complications
> reported in the peer reviewed literature.
>
> You may use the attached material as you see fit.
>
> You may want to communicate with the others to which I am sending this
> e-mail.
>
> Sincerely,
>
> Burton A. Waisbren, Sr., M.D.
>

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 US 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
US is failing to stem the spread of the disease; five percent or more of
the individuals in the US can be expected to get this disease; hepatitis
B infection is spread by those w/o 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.
1. 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.

2. The attempt to vaccinate high risk individuals in the US is failing
to stem the spread of the disease. 
This may well be true but data presented about this is not entirely
convincing.

3. 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."    
 
4. 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.

5. Universal hepatitis B vaccination is the only way to stem this
infection in the US. 
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).

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.