Thank you for
allowing me to speak.
My name is Sandy Mintz and I live in Alaska.
The points I would
like to raise in my testimony today revolve around 3 main areas of
problems with the 1991 report I hope the current committee can avoid,
specific concerns about vaccines, using measles as a model, and 3)
for the direction and design of future vaccine safety and efficacy
In the 1991 IOM
review, the Committee quite fairly pointed out that it had been
the lack of adequate studies, including the poor design of many.
The Committee also properly concluded that
the absence of appropriate studies meant that there was insufficient
to indicate whether or not there was a causal relationship between many
adverse reactions being studied and vaccination. Imponderably,
however, similarly flawed information was cited as
evidence AGAINST causality in their report in a number of instances.
conclusions concerning SIDS and DPT vaccine are a case in point.
Although they admitted in their review, and
I quote, "Prior to the 1960's, little was known about the epidemiology
sudden infant death syndrome (SIDS)", they concluded, and again I
"Studies showing a temporal relation between these events
are consistent with the expected occurrence of SIDS over the age range
DPT immunization typically occurs".
Without information on the background rate of SIDS in historically,
socioeconomically, and otherwise comparable never vaccinated groups,
the expected frequency of SIDS merely reflects its incidence among
populations, rather than absent vaccinations, and cannot be considered
or meaningful. Given that such
background information was not presented by the Committee, conclusions
the absence of a relationship between SIDS and vaccination were not
Nor were any studies
cited - in fact, to my knowledge none exist - in which the only proper
group, never vaccinated children, was used.
If, as is the case in most studies, "less recently", but
nonetheless vaccinated, children were used as controls, and an adverse
can be either a delayed or long-term consequence of vaccination, one
EXPECT to find no differences between the study groups, even if
caused an adverse event. Conclusions
about causality drawn from any study with such serious limitations are
The fact is, all
controls are not equal. More
importantly, many groups are improperly designated as controls.
The 1991 IOM statement that a nontreatment
group, i.e., control, might be one using an established alternate
an example of an improper definition of a control. In no way can
any form of vaccination, whether
"established" or less recently administered, be considered lack of
intervention. The extent to which
various established vaccines and times since administration of vaccine
similar to non-vaccination should be studied, not assumed. Only a
placebo, which in the case of
vaccination studies equals the absence of vaccination, is appropriate.
As to the notion that
it is unethical to withhold vaccination due to "widespread
acceptance" of vaccination, I would submit that to the contrary, if
anything, it is unethical to administer vaccinations of unknown safety
efficacy. It is unsound to argue we
can't withhold vaccines because of "widespread acceptance", as the
1991 IOM Committee did, when the reason there is such widespread
vaccinations is that we have been told the vaccines are safe and
effective. Their argument is
particularly ironic given their finding that serious consequences can
from the two vaccines, and lament about the absence of adequate
information. To the contrary, the
conclusion that must be drawn from their review is that randomized,
long-term, placebo-controlled, prospective clinical trials are urgently
needed, in spite
of ethical concerns about ADMINISTERING vaccines of unknown
safety. Indeed, no reassuring claims about the
infrequency of any linked adverse event should be made until and unless
false premises underlying study designs and the many study design
the lack of reasonable and time appropriate controls, and reporting
inadequacies, are corrected.
Please note that in
any study of long-term vaccine consequences, in which proper
control groups are used, a comprehensive and longitudinal medical
necessary in order to discern all observable and measurable effects of
vaccination, both good and bad, known and unknown.
An insidious way in
which the risks of vaccination can be incorrectly estimated is by using
number of doses of vaccine which appear to result in injury, rather
number of children that are administered how ever many doses it takes
them. Since nearly all vaccines are
currently being recommended to be administered in multiple doses, using
rather than children can result in gross underestimation of actual
risk. We also cannot ignore confounding which
occurs when high-risk children are eliminated, either by not receiving
vaccine in question at all, or by receiving only one dose.
Take as an example
convulsions resulting from either whooping cough vaccine or whooping
cough. The CDC says that 1/1750
vaccinations result in convulsions but that 2/100 children who get
cough have convulsions. If we divide
the 1750 vaccinations by the between 4 and 5 doses children are
get, the result is 1/350 to 1/438 children getting convulsions after
cough, not nearly as dramatic a difference.
If we further try to
factor in the impact of underreporting of adverse reactions, the actual
incidence of which is unknown but presumed to be significant, it
that there may be no difference, and in fact, that it is possible
are more likely to result after vaccination than after disease.
The fact is, however,
that we do not know the true incidence of vaccine adverse reactions, of
whooping cough itself, of convulsions after whooping cough or many
relevant and critical factors, including the actual number of children
receiving a vaccine once high-risk children have been removed. We
should simply admit it and set about
trying to learn what we can. We should
not, however, be issuing reassuring assessments of vaccine risk.
When evaluating the
risks of vaccines, it is imperative that we look at the big
picture. We simply cannot accurately evaluate vaccine
benefits or risks in a vacuum, nor consider the evaluation static.
many things which need to be considered are the following:
The true risk of contracting a disease, in comparable, never
vaccinated populations, as well as the true risk of suffering serious
consequences from a disease, must be determined. Included in any
such analysis should be historical morbidity and
mortality data from years prior to the introduction of vaccines,
smallpox vaccine. When considering the
true risk of long-term serious consequences of disease, new treatment
strategies, like erythromycin for whooping cough, and vitamin A for
should be factored in as well.
background rate of an event occurring in comparable
never vaccinated populations, should be compared to recently and not so
recently vaccinated ones. However, as
useful and important as background rates are, when making comparisons
groups, such rates should never be used to substantiate claims about
not a particular child suffered "residual effects" from some untoward
event following vaccination, since a particular child's potential can
predicted. This holds especially true
when estimating an infant's potential.
3) Graphs should be presented fairly, and if
they have not
been, primary data, rather than graphs, should be used. Included
in my submissions is a graph found
in the MMWR which provides an excellent example of the dangers of their
unquestioned use and "how to lie with statistics". The Y axis
uses an inappropriately applied
logarithmic scale, the result being that drops in both morbidity and
prior to vaccination are made to appear insignificant, while drops
post-vaccination are made to appear dramatic.
In fact, the opposite is true.
We also cannot ignore
the impact of vaccines on changing epidemiology when considering their
and benefits. For instance, measles may
have been made a more serious disease because of measles
vaccination. Prior to widespread vaccination, once a
population had been exposed to measles, few adults or infants
adults due to lifelong immunity and infants due to maternal
antibodies. Now, adults AND infants are getting the
measles, with serious consequences. I
would like to include reference to a recent Washington Post article
Menace to Infants: Vaccinated Moms Pass Less Immunity to Babies".
In this article it was noted that although
in 1976 3% of measles cases occurred in children less than one, today
25% do. The author also indicated that
prior to vaccination, 3 to 4 million measles cases occurred with around
deaths. This would make the
case-fatality ratio for that period between 1 to 2 per 10,000. In
the years 1989, 1990 and 1991 combined,
however, it was reported that around 55,000 people got the measles and
died, making the case-fatality ratio dramatically higher at 3 out of
1,000. At this rate, fewer than 175,000
cases per year would be necessary to result in the same number of
used to occur when there were millions of cases.
The CDC says that,
although worrisome, the problem would be solved were all preschoolers
vaccinated and measles virus eliminated from circulation. Yet I
would submit that with waning measles
vaccine immunity a fact of life, and subclinical cases of the measles
among the vaccinated and considered to boost vaccine-induced immunity,
vaccinating preschoolers will not prevent measles from
circulating. Indeed, an obvious major source of infection
for infants and unimmunized toddlers has been properly vaccinated
children who developed most of the clinical measles cases, as well as
subclinical ones. It is, in fact,
puzzling that the CDC would offer such reassurances given that they
admitted even 100% vaccinated populations can have outbreaks.
The CDC also says
that about 40% of mothers currently do not have protective antibodies
at the end of the decade that figure will be 100%. This, of
course, means that as the percentage of mothers without
antibodies rises, the death rate should rise as well, since an even
percentage of cases will be infants.
mortality statistics for measles should also rise as fewer and fewer
have natural immunity and more and more adults have waning vaccine
immunity. The scenario is quite
believable in which mothers would get measles and pass them on to their
infants, whereas before they would never have gotten the measles, and
instead of passing the measles on to their infants, have passed on
measles antibodies to them.
In other words,
measles may not be controllable, and may have been made vastly more
the use of measles vaccination. Adults,
in fact, may now be faced with the unsavory prospect of getting measles
receiving a vaccine, neither of which has been proven to be safe for
them. Any risk/benefit analysis should take into
consideration the impact of vaccine-program induced changing
the seriousness of any diseases vaccines are designed to prevent, as
the consequences, including efficacy, of vaccinating adults against
once childhood diseases.
The problems which
can be overlooked if vaccine analysis is taken out of context are well
exemplified in the case of rubella vaccine.
A normally benign disease in childhood, usually affording lifelong
immunity, it can result in devastating effects if a non-immune pregnant
is exposed during the critical time period. As devastating as the
can be for an infant, it is important to not only determine the actual
incidence in epidemic years of congenital rubella syndrome, but whether
an unvaccinated child allowed exposure to rubella is more or less
likely to be
immune in adulthood than a previously vaccinated child, given that
immunity is now generally thought to be short-lived. Indeed, it
is entirely possible that the risk to the fetus is
greater from once-vaccinated mothers, given waning vaccine immunity,
overall risk to the population greater, once the risks of adult rubella
vaccination have been factored in.
Aside from my earlier
recommendations concerning properly designed studies (and by long-term,
20-30 years at least), I would also urge that you recommend some
mechanism vis a vis doctors reporting adverse reactions. Although
I realize that adverse reaction
reporting is an extremely flawed method, as we all know, in theory as
in fact, and can neither be viewed as proof of causation or as
still we need to get some idea of the range of possible vaccine
as well as to follow up on those we do know about.
Among the many other
questions which need to be asked and answered, I would recommend the
- Is cancer more or less likely to occur
among the vaccinated? Included in any studies should be reference
to SV40, other vaccine contaminants, the role of chromosomal damage as
a result of vaccination, and immune system suppression. The
notion that a subclinical case of a disease is preferable to a
full-blown case should be studied, not assumed. Submitted is a
tantalizing study by Ronne in The Lancet in which he found that
subclinical cases of the measles resulted in significantly increased
rates of serious disease among adults.
- What, if anything, is the role of
vaccine contaminants in causing adverse reactions and new
Included in any such studies would be the role played by such
contaminants in the outbreak of AIDS and other recent immune system
disorders like chronic fatigue syndrome, Kawasaki's disease and others.
- Why, during polio epidemics, do most
people get polio, gaining lifelong immunity while apparently suffering
no ill effects, while a small percentage of the population gains that
lifelong immunity at a great price? Included in any examination
of this issue should be the role provocation polio and tonsillectomy
play in predisposing a person to paralytic or bulbar polio, and the
extent to which they each effect the incidence of serious polio.
- Can vaccination result in post-polio
syndrome? If it can, then we need to find out if instead of the
small percentage of the population who got polio being susceptible to
post-polio syndrome, whether now the entire vaccinated population is at
- What is the effect of combining
vaccines in vivo and in vitro? Studies of this should include
clinical trials of all vaccines individually, as well as the effects of
their simultaneous administration. The practice of administering
vaccinations in combination without data to support their safety and
effectiveness should stop until the safety and effectiveness of the
practice can be firmly established. Relevant to this discussion,
and included among my submissions is a paper by Javier et al in Science
magazine in which it was found that two harmless herpes viruses
recombined in vivo and became extremely lethal as a result.
- Has a relatively small risk of
long-term consequences from childhood diseases been traded for a
vaccine-induced, larger risk of chronic childhood disease? I
refer you to a New York Times article I have submitted which is
relevant to this question, and can, if you wish, send a journal article
which describes explained and unexplained dramatic, recent increases in
chronic childhood disease.
- Have there been real increases in
behavioral and mental disorders among children, or do increases merely
reflect better diagnosis? If increases are real, has vaccination
played a role, and if so, what?
- How effective is each vaccine?
Given that both disease morbidity and disease mortality were declining
significantly prior to introduction of vaccines, the impact of the
vaccines on their continued decline needs to be determined. The
effect any herd immunity might have on unvaccinated groups, as well as
vaccinated ones, would need to be identified and accounted for, if
determining vaccine effectiveness, the role of replacement disease,
renaming and other similar factors should be included. For
instance, the significance of an
apparent rise in flaccid paralysis should be determined, including
not it represents replacement disease, or perhaps, instead, reflects a
understanding of the differences between polio and flaccid
paralysis. If polio has merely been replaced by flaccid
paralysis, rather than eliminated, the success of the polio vaccine
needs to be
reevaluated. If polio has been renamed,
it should be determined whether or not many formerly classified cases
have instead been classified as flaccid paralysis, thereby effecting
evaluation of the effectiveness of polio vaccine in wiping out
Finally, I implore
you to consider the political and financial agenda of people reading
your report. Please spell out, not only
what conclusions may be drawn, but what conclusions may not be.
These issues dealing
with research design are fundamental to whether or not reliable and
information will be obtained on vaccine safety and effectiveness.
And while I realize that it may not be your
specific charge to deal with all the issues I have raised, I hope you
whatever is in your power to identify the problems with current, and
future, research in order that more meaningful and accurate evaluations
Thank you for
listening to my comments.
Copyright 1993, Sandy Gottstein (aka Mintz)