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Presentation to the Committee on Government Reform
Topic: Vaccines: Finding a Balance between Public Safety and Personal Choice

Marcel Kinsbourne, M.D.
August 3, 1999

The remarks that follow are based upon my training and experience as a
pediatric neurologist and my familiarity with the scientific method, as well
as my participation as a medical expert in proceedings that evaluate alleged
vaccine injury under the terms of the National Vaccine Injury Compensation
Act.

Types of Vaccine Injury

Offsetting their undoubted public health benefits, vaccinations incur the
risk of a range of adverse side effects, some of which rarely cause long
lasting or even permanent impairment of health. Depending upon the nature of
the vaccine, major side effects fall into three categories, as follows:

Toxic: Killed bacteria may release toxins as their cell bodies break up. An
example is pertussis vaccine, which contains at least one substance that can
be poisonous to brain cells. When the toxin injures the brain, this occurs
anywhere from a few hours to a few days after the vaccination.

Infectious: A vaccine that consists of attenuated virus particles may cause
the very infection that it was intended to prevent. An example is oral polio
vaccine. The infection presents after an incubation period of a number of
days during which the virus multiplies. The virus may even remain latent in
cells of the body for much longer periods of time, and then cause disease.

Autoimmune: The body responds to the vaccine with an immune reaction that
attacks its components. Sometimes the immune reaction also attacks a
constituent of the body itself, which bears some chemical resemblance to a
constituent of the vaccine. Reports of cases in which nerve cells have been
attacked have been published for tetanus, influenza and measles vaccines.
The "self-attack" is the result of a cascade of biochemical changes which
takes at least five days to cause clinically observable disease, and may
take at least up to six weeks.

In view of these hazards, safety precautions are called for. This task is
not straightforward, for reasons such as the following:

Factors that Complicate Safety Precautions

Any disease that can be caused by a vaccine can also be caused by other
agents. To help distinguish causation from chance association,
epidemiological studies are often required. These studies are typically
time-consuming and resource-intensive. Many potential adverse effects of
vaccines have not been systematically studied with the methods of
epidemiology. The inventory of side effects of vaccines remains incomplete.
Common adverse side effects are likely to be detected during pre-marketing
clinical trials. Rare side effects would most likely be overlooked, given
the modest number of participants that is customary in clinical trials.
Not all adverse effects occur within days or a few weeks of vaccination.
Autoimmune disorders may take a month or two to emerge. Virus particles may
even remain latent for lengthy periods of months or years, before they begin
to trigger diagnosable disease. An example of a combination of vaccines that
can cause an autoimmune disorder is MMR (measles-mumps-rubella). Another
example may be Hepatitis B vaccine.
Even when an injury occurs soon after a vaccination, this may not
immediately be noticeable. This applies generally to injuries of the
developing nervous system, regardless of the cause. Such neurological
syndromes as cerebral palsy and developmental language disorder may come to
light months or years after the brain damage was inflicted. The effects of
severe injury may take years to show up, for example as learning and
attention problems.
When several vaccines are given at the same time, they may have adverse
effects that none of the individual vaccines have when they are given by
themselves. Giving many vaccines at the same time is becoming increasingly
prevalent, especially to "captive audiences" like infants. A possible
example is measles and mumps vaccines as administered simultaneously in MMR.
There is reason to suspect that this combination may cause inflammatory
bowel disease and developmental regression into an autistic state in some
children in the second year of life.
Post-Marketing Monitoring

The implications of points 1 through 5 are that, at the very least, after
vaccines come on the market, they should be monitored comprehensively and
for long periods of time. In many instances, particularly for vaccines that
have been newly introduced, large-scale prospective epidemiological studies
are required. The ongoing passive post-marketing surveillance (VAERS) has
shortcomings. Pertussis vaccine illustrates this point.

Whether an adverse event that immediately follows DPT vaccination is
reported depends on pediatricians' quite variable levels of awareness of,
and index of suspicion for, such events. The ability of agency personnel to
evaluate the adverse effects that are drawn to their attention can also be
unreliable. It is well known that some lots of pertussis vaccine are
associated with a disproportionately high number of notifications of adverse
events. These are termed "hot lots". However, the manufacturer is protected
by law from disclosing the number of doses that derive from a given lot.
Therefore, one lacks the denominator of the function which would reveal
whether a given lot appears "hot" because it is more toxic, or because it is
the source of more doses. Be that as it may, hot lots offer the possibility
of danger to children. Nonetheless, I have never heard that a hot lot has
been ordered withdrawn on the basis of VAERS surveillance.

Since different lots of DPT vaccine vary greatly in the concentration of
bacteria per unit volume, and therefore in the amount of potential toxin
they contain, even when they are produced by the same manufacturer, research
to determine whether hot lots contain relatively high levels of bacteria and
toxins would seem important. A chemical/bacteriological study that compares
hot lots with standard lots seems indicated.

We anticipate that the newly licensed acellular pertussis vaccine will cause
far fewer serious adverse neurological reactions, but we do not yet know
this for certain. In any case, many children still receive the whole cell
pertussis vaccine, with its cargo of potentially harmful endotoxin.

Studies of vaccine safety could be supported by initiatives of the National
Institutes of Health, with specially earmarked funds. Requests for
applications for research funding could be issued, and the applications be
subjected to the customary NIH peer review process.

Informed Consent

The remote but real risk of serious disease that attends vaccinations must
be scrupulously and comprehensively disclosed to the parents of the children
that await vaccination. In a busy pediatric practice this is not an easy
matter, and not all parents readily understand what some of the risks
actually entail. It would be helpful if the CDC were to develop handouts
that are both comprehensive and user-friendly, that list possible adverse
side effects for each vaccine. These handouts should include information
about what health and behavior changes parents should be alert for after the
vaccination. I suggest that parents be given copies of such handouts for
each vaccine well ahead of the projected date of vaccination, so that they
have sufficient time to digest the information, and to ask any questions
they might have. This might perhaps even be done before their newborn is
discharged from the hospital.

Personal Choice

Immunization programs most effectively serve the public health if most
members of the target population participate. Nonetheless, personal choice
is a civil liberty that must be respected.

The estimates of risk offered by medical authorities often diverge greatly
from those assumed by some members of the community. It may never be
possible to reconcile these entirely. However, I believe that almost all
parents would favor having their children vaccinated if more research on
risk factors had visibly been performed. This includes not only identifying
adverse events that might happen, but also detecting any predisposition that
children in particular families might have that increase such risks.

A genuine and vigorous effort to identify risk factors would help dissipate
the impression that some citizens have formed that vaccine safety is not a
high priority. The Institute of Medicine (1997) publication, "Vaccine Safety
Forum", presents some promising suggestions for risk factor research,
particularly for those effects that arise from autoimmune reactions.

Compensation for Vaccine Injury

Congress has mandated a compensation program to meet the needs of children
who were injured by a set of required vaccines. Congress made it clear that
this program was to be both generous and expeditious, but in my experience
as a medical expert in many such proceedings, I have found that this has not
usually been the case. Although the Special Masters who adjudicate the
Petitions for Compensation are generally both highly competent and
compassionate, the proceedings in numerous cases extend over many years.
This foils the intent of Congress that the proceedings be non-adversarial
and leaves even those families whose claims are ultimately judged to have
merit, unassisted and often in severe financial straits. The financial
burden of raising a handicapped child can be severe. It also burdens the law
firms that assist Petitioners with expenses that are not met for up to a
decade. This has a chilling effect on the participation of attorneys in the
Vaccine Injury Compensation Program, and thereby limits the choice of
citizens who wish to file petitions. Also, a series of Rule changes as of
1995 has so severely constricted the definition of Table Injury (an injury
presumed by the statute to have been caused by the vaccine) in the case of
pertussis vaccine (the vaccine that is complained of in the great majority
of petitions), that those who nowadays file for compensation must anticipate
a lengthy, complex and arduous proceedings with uncertain outcome.

Statute of Limitations

Compensation for injuries due to Hepatitis B vaccine has recently been
authorized, retrospective to 1990. The Statute of Limitations for claims in
regard to injuries that occurred more than three years ago takes effect this
Friday, August 6th. Efforts to publicize this fact appear to have been less
than enthusiastic. Unnotified citizens who feel that they or their children
were injured by this vaccine between 1990 and 1996 will soon be without
remedy. An outcome so clearly counter to the spirit of the National Vaccine
Injury Compensation Act might be of interest to the Committee on Government
Reform

Pennsylvania Parents for Vaccine Awareness
P.O. Box 173
Mill Village, Pa.  16427
(814)796-4000
Email: ppva@velocity.net
Web Page: http://www.erie.net/~noshotz
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The information contained in this message
should not be construed with medical or legal
advice.  The vaccination decision is yours
alone to make.
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