Control group for vaccine safety research
In
the 1991 IOM review, the Committee quite fairly pointed out that it had been
handicapped by 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 evidence to indicate whether or not
there was a causal relationship between many of the 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.
The
Committee's 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 of sudden infant death syndrome
(SIDS)", they concluded, and again I quote, "Studies showing a
temporal relation between these events are consistent with the expected
occurrence of SIDS over the age range in which DPT immunization typically
occurs". Without information
on the background rate of SIDS in historically, socioeconomically, and otherwise
comparable never vaccinated groups, data on the expected frequency of SIDS
merely reflects its incidence among vaccinated populations, rather than absent
vaccinations, and cannot be considered accurate or meaningful.
Given that such background information was not presented by the
Committee, conclusions about the absence of a relationship between SIDS and
vaccination were not justified.
Nor
were any studies cited - in fact, to my knowledge none exist - in which the only
proper control 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 event can
be either a delayed or long-term consequence of vaccination, one would EXPECT to
find no differences between the study groups, even if vaccination HAD caused an
adverse event. Conclusions about
causality drawn from any study with such serious limitations are not justified.
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 vaccine, is 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 are 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 and 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 acceptance of 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 result
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 the false premises underlying study designs and the many
study design flaws, including the lack of reasonable and time appropriate
controls, and reporting system inadequacies, are corrected.
Bartlett Democratic Club Speech
Which
brings us to the poor quality of the research.
The Institute of Medicine, or IOM, which was mandated by Congress in 1986
to review the safety of the childhood vaccines, reported that it was
“handicapped” by the lack of good research.
Handicapped! How ironic is
it that they used that term? In
spite of being handicapped, however, they found “evidence was consistent
with” or “indicates a causal relation” in a number of cases, including
between encephalopathy and the pertussis component of the DPT vaccine.
That’s brain inflammation. Brain
inflammation in developing infant brains. Imagine
what that could be doing to our kids.
The
“experts”, by the way, denied there was a connection right up until the IOM
report was published. Dr. James
Cherry wrote an editorial, which appeared in the Journal of the American
Medical Association about one year prior to the IOM report.
It was entitled, “'Pertussis
vaccine encephalopathy': it is time to recognize it as the myth that it is.”
Shortly after it was published, however, JAMA issued a “correction”
– it seems Cherry had failed to disclose his financial ties to the industry…
Always
remember who’s paying for the research.
There
are many ways to skew research results. One
way is to compare the wrong groups. How
do you do it in the case of vaccinations? By
only comparing the vaccinated to other vaccinated children.
You use either the less recently vaccinated, or those receiving another
vaccine, and then call them “unvaccinated”.
Any
study which finds no adverse effects from vaccination, which does not use never
vaccinated subjects as controls, is meaningless, and, in fact, has no
control.
Any
vaccination whatsoever is intervention. A
control group represents those who are not receiving whatever intervention is
being studied. When you are
studying the effects of vaccination, the only legitimate, meaningful control
group is the NEVER vaccinated. End
of story.