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ACTA SCIENTIFIC PAEDIATRICS
Volume 2 Issue 1 January 2019
The Denial of Adverse Event Risk Following Immunization and the Loss of
Informed Consent - A Perspective
K Paul Stoller*
Fellow, American College of Hyperbaric Medicine, USA
*Corresponding Author: K Paul Stoller, FACHM, USA.
Perspective
Received: November 16, 2018; Published: Decembber 29, 2018
HHS: Department of Health and Human Services; CDC: Centers for
Disease Control; FDA: Food and Drug Administration; WHO: The
World Health Organization; AEFI: Adverse Event Following Immu-
nization; AAP: American Academy of Pediatrics; DTP: Diphtheria-
Tetanus-Pertussis; OPV: Oral Polio Vaccine; PIC: Physicians for
Informed Consent; VAERS: Vaccine Adverse Event Reporting Sys-
tem; EMA: European Medicines Agency; AAHS: Amorphous Alumi-
num Hydroxyphosphate Sulfate; NACCHO: National Association of
Abbreviations
"Any preventive, diagnostic and therapeutic medical interven-
tion is only to be carried out with the prior, free and informed con-
sent of the person concerned, based on adequate information...The
interests and welfare of the individual should have priority over
the sole interest of science or society." 2005 UNESCO Universal
Declaration on Bioethics and Human Rights” [1].
Vaccines are public health measures that are not evidence-
based as portrayed by authorities such as the United States De-
partment of Health and Human Services (HHS) or the Centers for
Disease Control (CDC). For example, despite political propaganda
to the same kind of clinical trials as other drugs are. They are clas-
Introduction
safety, while at the same time actual evidence of vaccine harm is
systematically ignored by vaccine manufacturers and authorities
Consequently, vaccines are a grave threat to public health and med-
ical ethics. Furthermore, informed consent in vaccination is deeply
endangered today both in medical practice and as an ethical prin-
ciple in society. Natural immunity is similarly endangered today
due to modern vaccination policy. Promoting categorically unsafe
vaccines and discouraging the responsible development of natural
immunity has become state sponsored policy where the policy it-
self is what gets protected – not the public.
In the U.S., the Food and Drug Administration (FDA) has stated
their policy on this issue clearly, “any possible doubts, whether or
not well founded, about the safety of the vaccine cannot be allowed
to exist in view of the need to assure that the vaccine will continue
to be used to the maximum extent consistent with the nation's pub-
-
biguous policy that has nothing to do with science or public health.
Considering how much of the world seems to blindly follow the lead
of U.S. health agencies, or is coerced into following them, that FDA
policy statement should be very alarming. The trust placed in U.S.
agencies ignores that they have been compromised and captured
by industry;1 furthermore, physicians and scientists who criticize
this system of rampant corruption2 will be increasingly pilloried
and attacked as incompetent, dishonest, and a dangerous menace
to the public’s wellbeing.
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
1
2https://usrtk.org/wp-content/uploads/2016/10/CDC_SPIDER_Letter-1.pdf
The World Health Organization (WHO) stated, “the physical pres-
ence of the child or adolescent, with or without an accompanying
parent at the vaccination session, is considered to imply consent”.
A child sent to school on the day they are holding a vaccine clinic is
now consenting by implication. A parent could refuse to send the
child to school on vaccine day, but that assumes they knew about
it. However, implied consent is Orwellian doublespeak inconsis-
tent with the UNESCO declaration, and emblematic of an erosion of
fundamental rights by the misinformed to protect marketing goals
[2] what they would accept as
an Adverse Event Following Immunization (AEFI). Only reactions
that have been previously acknowledged in epidemiological stud-
ies would now be considered as vaccine-related. Deaths seen in
in deaths in the Phase III trials. For example, Sri Lanka suspend-
Nam shelved the pentavalent vaccine because it had been associ-
ated with 12 deaths. However, in both cases, the WHO teams which
investigated the deaths declared they were “unlikely” to be related
to the vaccines used.
Puliyel, and Phadke wrote a letter to the editor of the Indian
Journal of Medical Ethics expressing their dire concerns as there
administration of a pentavalent vaccine between 2012 and 2016.
Fifty-four of these children died. When these adverse events were
analyzed using the new WHO criteria, not one of the deaths was
.
“AEFI reporting is said to be for vaccine safety. In view of the
above, it is necessary that the AEFI manual be re-evaluated and
revised urgently. Safety of children (child safety) rather that safety
for vaccines (vaccine safety) needs to be the focus” . In other
words, Puliyel and Phadke are saying that reporting on AEFI’s is
supposed to be about identifying problems so that if there are
reporting is not meant to obfuscate safety issues to protect the vac-
cine from scrutiny. Apparently, Puliyel and Phadke are either naive
(“possible doubts, whether or not well founded, about the safety of
the vaccine cannot be allowed to exist”) or they are attempting to
inform their colleagues in the most politically polite manner pos-
sible that protecting vaccine policy, terminating informed consent,
and AEFI denialism has become the global vaccine agenda.
It is worth noting that the American Academy of Pediatrics
(AAP) published a summary of vital statistics on the trends in the
health of Americans during the 20th Century: “Thus vaccination
does not account for the impressive declines in mortality seen in
th) century” . Perhaps, it would be more
prudent for the WHO to state that the physical presence of a child
on this planet implies consent to clean water, sanitation and a
healthy diet, rather than eroding individual and parental rights for
invasive medical interventions of questionable value.
The value of vaccines is called into question when unvaccinat-
ed and vaccinated populations are compared, which may be why
so little is published in this area as the implication of such com-
rather unique study was published [5] that examined the intro-
duction of the diphtheria-tetanus-pertussis (DTP) and oral polio
in the early 1980s. The conclusion of this study stated, “DTP was
associated with 5-fold higher mortality than being unvaccinated.
Unfortunately, DTP is the most widely used vaccine, and the pro-
performance of national vaccination programs.
“It should be of concern that the effect of routine vaccinations
on all-cause mortality was not tested in randomized trials. All cur-
rently available evidence suggests that DTP vaccine may kill more
children from other causes than it saves from diphtheria, tetanus
or pertussis. Though a vaccine protects children against the target
disease it may simultaneously increase susceptibility to unrelated
infections”.
But vaccines save lives, right?
One might assume the intentions of most vaccine advocates is
to help and protect children; however, by design (it seems) there
is a pernicious lack of understanding about the risks involved. The
indoctrination of today’s medical community that “vaccines save
lives” is so ingrained no room is left for the reality that many vac-
malevolent aspects of this level of indoctrination has its own risks
that reach far beyond medical malfeasance.
22
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The guiding principle that one simply does not expose a child
to any unnecessary risk has apparently been abandoned if they
are on the receiving end of a vaccine. Of course, many medical in-
terventions have the risk to cause harm but the risk of that harm
may be very small provided effective measures are in place, such
as making sure, in the case of vaccines, the child does not have a
known medical (physical, genetic or immune) problem that would
tolerated, because the science in this area is not complete. In the
case of vaccines, without a previous vaccine reaction in the child
in question or one in an immediate family member who shares a
common genetic pattern, it really isn’t possible to calculate accu-
precisely calculated.
Today, with our current knowledge base, risk is balanced against
the risk. It is reasonable to accept a level of risk if the risk from all
the other alternatives, including doing nothing, is even greater. A
risk is not acceptable if there is a reasonable alternative that offers
routinely assume the risk of the disease is greater than the risk of
the vaccine. The reality is quite different. And this goes right to the
heart of informed consent, because it involves comparing relative
risks of a medical intervention.
For example, it has not been proven that the MMR vaccine is
Informed Consent (PIC) recently reported in The BMJ that every
-
from measles
children with febrile seizures progress to epilepsy, the estimated
number of children developing epilepsy due to the MMR vaccine, in
the past 10 years, is 2,850. In addition, PIC found that the Vaccine
Adverse Event Reporting System (VAERS) receives only about 90
PIC contends that VAERS, as a passive surveillance system, does
not adequately capture vaccine side effects and that serious side ef-
fects, including permanent neurological harm and death from MMR
and other vaccines, may similarly be underreported.
Moreover, there are multitudes of medical alternatives to vac-
cines, whereby patients prevent and heal infectious diseases and
build their natural immunity. Another foundational premise is that
good sanitation practices, coupled with well-balanced diet and sen-
sible exercise, encourage a lifestyle conducive to strong natural im-
munity.
Public health authorities act callously and dismissively toward
-
to predict, prior to vaccination; furthermore, the costs involved in
screening children are not compatible with priorities or budgets
are potential tools of science that could provide indicators (bio-
markers such as pre-existing Th2/Th1 skew, certain genetic poly-
morphisms, family history or autoimmunity).
Vaccine mandate proponents (and those who would take away
the rights to exemptions) use the tools of speculation and obfus-
vaccine mandate proponents to propagandize the morality of the
children. If it is acknowledged that screening for risk is appropri-
ate, then that risk itself is being acknowledged and that will in-
crease the perception of risk with the public and obviously there
will be those (vaccine mandate proponents) who would not want
to take the risk, so risk-denialism has emerged as a part of compul-
sory vaccine programs.
-
ease entities alone to truncate our understanding of co-causations
of several conditions, such as the role pesticides play, for example,
DDT in Acute Flaccid Paralysis/Myelitis or in Burkett’s Lymphoma,
are considered solely the cause of an infectious agent.
Ponder the huge increase in infant deaths in countries like In-
dia when polyvalent vaccines were introduced, but political and
economic interests muddle decisions about safety. Indeed, safety is
routinely and systematically ignored in the face of these interests.
adverse event does not sell vaccines, and in the U.S. the only way a
vaccine manufacturer becomes potentially liable is if they deliber-
ately hide safety problems they learn about their product and were
not transparent or forthcoming about those safety issues. Thus,
functional safety research has almost completely ended. New vac-
cines are tested against false placebos (i.e., comparables to other
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
vaccines) instead of using inert or saline placebos - then children
the child doesn’t immediately report adverse events (especially the
predetermined adverse events on the list provided by the manufac-
turer) then the vaccine is considered safe. However, what is taking
place goes beyond using placebos that contain the full complement
the FDA’s June 2006 Clinical Review Table 210 shows that the vac-
cine formulation in Protocol 018 contained only half the amount of
the marketed vaccine, containing 225 mcgs of AAHS, against the
carrier solution control, suggests the intent to mislead. It also sug-
gests reckless overexposure of children worldwide who received
the marketed vaccine to double the AAHS amount in Protocol 018,
worldwide.
[6] Puliyel and Sathyamala describes a
shocking dereliction of duty on the part of regulators who were
presented with vaccine data carefully tailored to obscure serious
risks. Tackling concerns about infant deaths that have occurred fol-
lowing vaccination in several European countries, the authors of
report to regulatory authorities that there was a statistically sig-
-
apparently whitewashed data at face value.
In the U.S., the FDA estimates that passive surveillance captures
about one percent of vaccine-related adverse events. A study in
Africa that compared passive with active surveillance found that
passive surveillance “failed to identify half of all AEFIs (adverse
surveillance, including all of the serious AEFIs”.
and Sathyamala note a “clustering” of sudden deaths among infants
The authors state: “The fact that the rate of death decreases rap-
idly with the passage of time following immunization suggests that
the deaths could be related to vaccination…. If one glosses over the
deaths after vaccination, one can prevent/delay the evaluation of
The WHO and government health agencies are quick to dismiss
as a “myth” any possible link between vaccines and sudden infant
-
to a 2011 SIDS death. Nevertheless, following Hexavac’s withdrawal
from the European market, the EU has gone on to grant marketing
vaccine in non-EU regions.
Vaccinologists at the CDC give lip-service for need to invest in
vaccine safety infrastructure [8] “at a level commensurate with
investments in vaccine development,” particularly through post-
licensure studies that compensate for the “well-known limitations”
of prelicensure clinical trials. In what seemed like a lucid moment,
these vaccine researchers also state there should be “increasing
emphasis…on proving, rather than assuming, that no problems are
associated with a vaccine”. But actions speak louder than empty
words. One action was to ignore CDC whistleblower, Dr. William
Thompson, whose confession is hard to ignore: “I have waited a
long time to tell my story and I want to tell it truthfully. I have been
involved in deceiving millions of taxpayers regarding the potential
-
ings. The CDC can no longer be trusted to do vaccine safety work.
Can’t be trusted to be transparent. The CDC can’t be trusted to po-
lice itself”.
William E. Thompson PhD, Senior Scientist, US Centers for Dis-
-
er in the documentary Vaxxed).
Puliyel and Sathyamala state, that as a result of the EMA’s fail-
ure to perform due diligence on Infanrix hexa, “numerous children
were unnecessarily exposed to the risk of death”. They admonish
that the “proof” offered by vaccine manufacturers cannot be ac-
cepted uncritically and that regulatory agencies must scrutinize
pharma-authored/pharma-funded reports rather than simply rub-
ber-stamping them. The problem is in not recognizing the extent to
which regulatory agencies have been bled out from the inside by
the vaccine industry. For example, in the U.S., the National Associa-
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
-
der a written policy to eliminate all exemptions to vaccines “to the
greatest degree possible,” other than medical exemptions, which
they want to allow only on their terms. The elimination of personal
belief exemptions (PBEs) is code for eliminating informed consent.
Agencies in collusion with medical boards encourage attacks on
those with opposing opinions be that to discredit, silence or dis-
cipline them.
Indoctrinated by the “vaccines are, safe, and the science is set-
tled” groupthink all risks associated with vaccines are now con-
sidered acceptable risks– there is no room for discussion or de-
bate (“any possible doubts, whether or not well founded, about the
safety of the vaccine cannot be allowed to exist”.) However, even ac-
ceptable risk may become unacceptable over time or because cir-
cumstances change – such as the changing to a hexavalent vaccine
or the health status or clinical condition of a child. Note that the
schedule of vaccines for children has never been clinically evalu-
ated for safety either prospectively or retrospectively. Having no
science is not settled science, it is non-science, pseudo-science and
often fatally fraudulent.
Few would argue that having a life-threatening anaphylactic
reaction to a previous vaccine might be an almost certain conse-
quence of receiving another vaccine, but should that be held out as
-
a previously given vaccine. You don’t withhold a white cane from a
blind person until they can demonstrate that they might be hit by
a bus whilst walking down the street. The fact that they are blind
calls for a white cane. In the same way, in the war against disease,
a public health army any more than you would send soldiers in
wheelchairs to the front line.
Proponents of compulsory mass vaccine programs might argue
that giving white canes to all the blind is too expensive, or if the
blind actually found out walking down the street without a cane
could cause them harm, they might not walk down the street at all.
Should anyone question how inappropriate it is to withhold white
-
canes.
What is unacceptable risk?
That might seem sadly humorous, but adverse events (AEs) are
not to be trivialized: [9] “AEs not only affect patients and their fami-
lies but also may have devastating effects on health care providers,
who may suffer emotional consequences both from preventable
AEs and from subsequent malpractice litigation. Affected clinicians
may feel guilt, shame, and isolation, and these feelings may be ex-
acerbated by negative reactions from their colleagues. Anticipated
or actual punitive consequences can add additional emotional and
healthcare workers in the U.S. for contributing to AEFI. Indeed,
there are no punitive consequences. And given there is a lack of un-
derstanding about AEFI, there is no remorse either.
-
pensation Act (VICA) – this was at a time when there was no co-
required, but there were a lot of legal actions taking place against
vaccine manufacturers and they insisted on liability protection or
they would no longer make vaccines. The law removed all liabil-
ity from vaccine manufacturers and gave 100% responsibility for
determining and evaluating vaccine safety to the Department of
Health and Human Services (HHS). Not only was HHS responsible
for safety, but it was legally required to report on same to the U.S.
Congress every two years. A recent court settlement had HHS ad-
even though the law required same.
Eventually, these HHS reports to Congress would likely have at-
tracted a great deal of public attention, and open hearings would
have been a likely outcome. The science (or lack thereof) of vaccin-
to ignore the law, hope no one notices, never study vaccine safety,
well founded, about the safety of the vaccine cannot be allowed to
exist”).
"Vaccine safety is initially assessed in prelicensure clinical tri-
als. However, such trials usually have sample sizes that are insuf-
with relatively short follow-up periods, which may limit their gen-
eralizability. Post-licensure drug evaluations have relied on passive
surveillance systems to monitor adverse events. Such systems are
Who is responsible for vaccine safety?
25
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
more practical and less expensive than controlled trials; however,
their data are usually inadequate to determine causality” [10].
and HIV requires the induction of humoral, antibody-dependent
cellular inhibition (ADCI) and effector and memory cell responses
-
netic complexity of the pathogens in question exhibit genetic di-
versity and antigenic variation during the different stages of their
life cycles that either exceed our current ability to create a vaccine
or are not able to be addressed by any vaccine.
Even the vaccines used today don’t necessarily provide protec-
tive immunity. The DTaP vaccine, for example, conveys no such
protection, as that vaccine only mitigates the impact of the toxin
made by the bacteria but is not capable of preventing colonization
and transmission of B. pertussis. Those aP antibodies are also very
[11]. But there are
other reasons for concern, “we conclude that aP vaccination inter-
feres with the optimal clearance of B. parapertussis and enhances
the performance of this pathogen. Our data raise the possibility
that widespread aP vaccination can create hosts more susceptible
to B. parapertussis infection” [12]. Parapertusis does not produce
a toxoid so the vaccine has no activity against a toxin that is not
even present.
For the acellular pertussis vaccine to work, the Bordetella per-
tussis bacteria must have pertactin (PRN)–a key antigen compo-
nent of the acellular pertussis vaccine. A study that screened B.
-
. The earliest PRN-
The CDC [12] found the B. pertussis strains isolated in 2012
from six CDC “Enhanced Pertussis Surveillance Sites indicated that
up-to-date DTaP vaccinations were compared to unvaccinated
-
Send in the vaccines?
-
tive advantage in infecting DTaP-vaccinated persons”.
In case the nuance of this was missed, the CDC did do a vacci-
nated vs. unvaccinated comparison (at least for the DTaP). What
they found was those children vaccinated with the DTaP were far
pertussis, which seem to now comprise almost 90% of the circulat-
ing strains. It means not only does the current vaccine have little to
illness it is meant to prevent.
et al. state “This disease is back because we didn’t really
understand how our immune defenses against whooping cough
worked, and did not understand how the vaccines needed to work
to prevent it….Instead we layered assumptions upon assumptions,
[15].
So, public health authorities are mandating a vaccine that
doesn’t work as advertised, and once vaccinated the child is more
likely to get the infection. Is that a public health intervention you
Suspending the DTaP and explaining the reason for stopping
-
cines; having said that, to continue to use this harmful vaccine is
clearly being done to protect the vaccine program, its policies and
their child to get a vaccine that increases their chance of getting
pertussis up to four times greater than if they had never been vac-
one. It goes without saying that if the public knew the real science
which is as it should be as that would be the catalyst for improved
and safer vaccines, as well as encouraging modalities the enhance
natural immunity.
-
as many vaccines as possible, deny AEFI even exist, and terminate
informed consent.
Is it even a vaccine that should be used at all?
26
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
When compromised government agencies are the providers of
through funding are the providers of vaccine safety information
that makes for a very unsafe situation. The British Medical Journal
(BMJ) states these sources are not reliable [16].
In the Fall of 2018, the BMJ published: Pandemrix vaccine: why
. This article
-
lems with the vaccine’s safety. Editor Doshi asks what this means
for the future of transparency during public health emergencies,
because we are dealing with a situation where truth and safety are
not part of operation. However, a public health emergency is taking
colludes with the very agencies, organizations, and academic in-
stitutions the public relies on to help protect them from disease.
Are safe vaccines even possible?
Using aluminum as an example, in the U.S., children receive over
The American Academy of Pediatrics (AAP) published a policy
in 1996 called Aluminum Toxicity in Infants and Children (18) leav-
ing little doubt that aluminum is a neurotoxin even at very small
amounts.
Mold., et al. [19] looked at the brains of 10 donors who had au-
tism and demonstrated they contain some of the highest levels of
aluminum ever recorded in human brain, and the aluminum was
found in the brain's immune cells, the microglia and the cells which
provide support and protection for the neurons, the glia. How does
a 15-year-old have as much aluminum in his brain as someone who
is many decades older who has died of familial Alzheimer's dis-
receive 5,000 mcg of aluminum in vaccines by the age of 18 months
and up to 5,250 additional mcg if all recommended boosters, HPV
destroying their brains [20].
-
fecting memory, cognition and psychomotor control, altering neu-
When is a poison not a poison?
rotransmission and synaptic activity, damaging the blood–brain
barrier (BBB), exerting pro-oxidant effects, activating microglia
-
lism and mitochondrial functions, interfering with transcriptional
-
tion” [21].
-
scribed by in Asin., et al. [22]
persistent, sterile, subcutaneous granulomas with macrophage-
driven translocation of Al to regional lymph nodes. Local transloca-
tion of Al may induce further accumulation in distant tissues and be
related to the appearance of system”.
At the end of 2018, the same researchers published a study
a study describing behavioral changes in sheep after having
some of the clinical signs observed in ovine ASIA syndrome (Au-
-
human vaccines and then began aggressively biting the wool from
other sheep, pacing restlessly and overeating. The research effort
was made to understand a new disease that had decimated Spanish
industry between 2008 and 2010 following a government-mandat-
ed bluetongue vaccine campaign.
Obviously, if several toxins are in the mix together the risk of a
toxic synergy taking place being far greater than the additive effects
of each toxin, but if no effort is made to study what that synergy is
there is no appreciation of how toxic a brew is created. It is pata-
physics to believe the toxic metals in vaccines are safe.
most toxic non-radioactive element into the human body. Never-
posted a “fact” sheet that maintains that “Thimerosal in vaccines is
not harmful to children,” in spite of abundant evidence to the
contrary. The fact sheet parades their collection of CDC controlled
thimerosal-related studies (“conducted by CDC or with CDC’s in-
volvement”) that it has used for years to hush-up Thimerosal de-
tractors.
an organic mercury compound with toxicity comparable to meth-
ylmercury [25] but ethylmercury is far more toxic to and persistent
in the brain, where it has a propensity to accumulate as inorganic
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
mercury [26], with an estimated half-life of as long as twenty-sev-
en years .
All eight studies included in the CDC fact sheet involve lead or
co-authors accused of fraud or known to have been involved in be-
hind-closed-doors data manipulation or weighed down by serious
“Thimerosal was not scrutinized as part of U.S. pharmaceutical
products until the 1980s, when the U.S. Food and Drug Administra-
-
ity in topical pharmaceutical products and began to eliminate it
from these. Ironically, while Thimerosal was being eliminated from
topicals, it was becoming more and more ubiquitous in the recom-
mended immunization schedule for infants and pregnant women.
Furthermore, Thimerosal continues to be administered, as part
of mandated immunizations and other pharmaceutical products,
in the United States and globally. The ubiquitous and largely un-
checked place of Thimerosal in pharmaceuticals, therefore, repre-
sents a medical crisis” [28].
Manufacturers use Thimerosal in some single-dose and multi-
dose vaccines to impede bacterial growth during the manufactur-
ing process even when it is not being used as a preservative. The
CDC states that “when Thimerosal is used this way, it is removed
later in the process” and only “trace amounts” remain (no more
than one microgram per dose), which is extremely misleading giv-
en the known toxicity of mercury and some vaccines have as much
as 25 mcg of mercury, but the FDA will obfuscate and state that is
infants rather than orally ingested – indeed most of the mercury in
[29]. The FDA
does promote the faux-science that comes out of other.
brain is uniquely vulnerable to mercury and other neurotoxins,
often “at much lower exposure levels than had previously been
thought to be safe” . The authors also noted that developmen-
tal neurotoxicity occurs at far lower exposure levels than “the con-
centrations that affect adult brain function”. Others have argued
that there is no safe level of organic mercury.
One study showed that Thimerosal diminished the viability of
-
ylmercury
disappears from the bloodstream more quickly than methylmer-
cury as if that means anything if you don’t know where it goes after
that, but we do know - it migrates quickly to organs and stays there
.
Advisory Committee on Vaccine Safety states that “no additional
studies of the safety of [Thimerosal] in vaccines are warranted”.
Don’t expect the WHO to state the reality: “The ubiquitous and
largely unchecked place of Thimerosal in pharmaceuticals, there-
fore, represents a medical crisis”.
“Both the epidemics of type 1 diabetes and metabolic syndrome
correlate with an increase in immunization” .
The consumption of organic food increased at the same time
many chronic childhood illnesses increased in the U.S., and no one
would argue that organic produce has caused that increase, but
when there are known poisons applied to the population at the
same time as the plethora of chronic childhood illnesses increases,
-
ger at organic fruits and vegetables.
When vaccines were found contaminated with glass fragments
-
nation would pose no risk because the manufacturer said so, and
the FDA ignored it. Curiously, they are not ignoring the issue of
retroviral contamination of vaccines and have launched an inves-
tigation into this danger that is not disclosed to those who will get
vaccinated. So, from the FDA website: "These latent, or ‘quiet,’ vi-
ruses pose a potential threat, since they might become active under
vaccine manufacturing conditions”.
That is an interesting admission that the FDA doesn’t actually
know what level of threat these quiet viruses pose, given they did
absolutely nothing when well over 98 million people were given
A thorough review of the iatrogenic transmission of pathogenic
agents via vaccine is beyond the scope here but the facts are readily
available to those willing to observe what the FDA did in the case of
the rotavirus vaccines.
Correlation does not imply causality, but…
28
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
Two new genetically engineered oral rotavirus vaccines entered
the vaccine marketplace in 2006 and 2008, respectively: RotaTeq, a
-
cine made by Merck, and Rotarix, a live-attenuated single-human-
Although pre-licensure trials found no evidence of an association
between the two vaccines and intussusception, post-licensure
of intussusception events for all rotavirus vaccines . The FDA
labeling and prescribing information to include brief statements
about increased intussusception risks but otherwise allowed the
two vaccines to remain on the market.
Meanwhile, the governmental safety systems, oft purported
to be rigorous, that ushered the two rotavirus vaccines to mar-
ket failed to detect an additional and highly concerning problem,
which an academic research team “unexpectedly”
in 2010. While conducting “a novel, highly sensitive analysis not
routinely used for adventitious agent screening,” …the researchers
discovered that RotaTeq and Rotarix were contaminated with DNA
-
Although the dangers from these viruses are unknown, horizon-
engineered vaccines. Unlike chemical pollutants, nucleic acids are
infectious and can invade cells and genomes, multiplying, mutating
transfer include generation of new disease-causing viruses and
bacteria (or reactivation of dormant viruses); spread of drug and
antibiotic resistance genes among viral and bacterial pathogens;
and random insertion into genomes of cells resulting in cancer.
Of great concern, outside of regulatory circles, is research
demonstrating that the pathogenic potential of Porcine Circovi-
rus-2 to cause an AIDS-like disease in pigs is unleashed when there
is simultaneous vaccine-induced immune system activation.
At a 2010 meeting convened by the FDA to discuss this con-
tami
time of licensure”. The contamination of vaccine with viruses that
virus seems to have done, is downplayed as a “manufacturing qual-
ity issue” and swept under the rug. The space under that proverbial
rug is crowded with one vaccine controversy after another, from
seems to have been the result of a botched military vaccine experi-
ment that went on to cost over 100 million lives, the notorious Cut-
ter incident that left many crippled, and some dead, as a result of
vaccine-induced polio (1955), and the transmission of the cancer-
-
expressed little worry, having framed
the presence of the viral DNA in their vaccine as a simple manufac-
turing issue rather than a safety risk.
that
physicians temporarily suspend use of Rotarix and switch to Ro-
taTeq, but when Merck’s vaccine was found to contain similar
contaminants, FDA reversed course and allowed continued use
of both. Instead of calling for new safety studies and completing a
from rotavirus disease in the U.S. is very low), the FDA once again
-
weighed any “hypothetical” health risks of viral contamination. The
agency’s sole follow-up action was to rubber-stamp updates to the
Circovirus Type-1 and -2 DNA in the vaccine[s]”.
-
-
choroid plexus tumors, bone tumors, and mesotheliomas. A 2002
Institute of Medicine report cited strong biological evidence that
-
sidious long-term health effects remains an unanswered question.
and other inorganic chemicals in them, they also harbored stainless
steel, tungsten, copper, mercury and rare elements that probably
Are unforeseen outcomes inevitable?
29
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
damages when her lab was raided by police and all their research
-
tentially make the public question the safety of vaccines. That kind
and those who question vaccine safety are not “allowed to exist”.
But assume, for the sake of argument, that vaccines are gener-
ally safe, they still will have unintended consequences. From the
article, “Vaccination can drive an increase in frequencies of anti-
biotic resistance among nonvaccine serotypes of Streptococcus
pneumoniae” .
public health concern, being responsible for more than 1.5 million
deaths annually through pneumonia, meningitis, and septicemia.
Available vaccines target only a subset of serotypes, so vaccina-
tion is often accompanied by a rise in the frequency of nonvaccine
serotypes. Epidemiological studies suggest that such a change in
serotype frequencies is often coupled with an increase of antibiotic
can result in a rapid increase in the frequency of preexisting resis-
tant variants of nonvaccine serotypes due to the removal of compe-
tition from vaccine serotypes”.
The Pneumococcal vaccine is not the only vaccine that has the
potential to increase strains not covered in the vaccine that are
much more problematic than the strain covered by the vaccine (for
example the HPV and Hib). If this were about science and in the
interest of public safety, then the use of the vaccine would be sus-
pended until this issue was sorted out.
In 2006, researchers wrote in the Journal of Toxicology and En-
vironmental Health
unpredictability and a number of inherent harmful potential haz-
ards... Horizontal transfer of genes... is well established. New hybrid
virus progenies resulting from genetic recombination between ge-
netically engineered vaccine viruses and their naturally occurring
relatives may possess totally unpredictable characteristics with re-
gard to host preferences and disease-causing potentials.
-
-
tions".
Though this was 12 years ago, little has changed even as the
technology has advanced. Today pharma has several different types
-
pens when foreign DNA is inserted into the human body is an evolv-
ing mystery. Will it trigger undesirable changes in human cells or
is looking.
The Chicken Pox vaccine is an expensive mistake from the point
of view of public health .
“Universal varicella vaccination has failed to provide long-term
protection from VZV disease”. The immunity the vaccine provides
to a more vulnerable adult population which, as Dr. Jane Seward
times more risk of hospitalization compared to chickenpox in chil-
dren”. This is an interesting statement given that it is often stated
that vaccination rarely leads to serious adverse events. But here the
adverse events are not in the vaccinated but in an older population
that didn’t get the vaccine.
Infants who receive several vaccines concurrently, as recom-
die when compared with infants who receive fewer vaccines simul-
-
fects were more likely to lead to hospitalization or death in younger
infants .
of vaccine doses administered and the percentage of hospitaliza-
tions and deaths. Since vaccines are given to millions of infants an-
from synergistic toxicity studies on all combinations of vaccines
that infants might receive. Finding ways to increase vaccine safety
should be the highest priority”.
health of vaccinated and unvaccinated 6- to 12- year old U.S. chil-
dren . The study reported no reductions in the incidence of
having a neurodevelopmental disorder if a child is vaccinated. And
as highlighted above, the incidence of seizures after the MMR is ac-
Vaccine policy is not about public health
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
tually 5x greater than developing seizures from getting the measles
infection itself .
The Institute of Medicine (IOM) lamented in 2012 that “for the
[50].
The Institute of Medicine (now National Academy of Medicine)
has issued three disturbing reports on the evidence for suspected
and/or reported vaccine adverse events. For 80% of the suspect-
ed vaccine adverse conditions investigated, there wasn’t enough
Schedule and stated: “No studies have compared the differences in
health outcomes… between entirely unimmunized populations of
children and fully immunized children… Furthermore, studies de-
signed to examine the long-term effects of the cumulative number
of vaccines or other aspects of the immunization schedule have not
been conducted”.
-
-
preventing infectious diseases, but by ignoring or denying adverse
events from vaccines and using vaccines as the primary interven-
from vaccine or combating infectious disease.
potential of risk for any given individual of having an AEFI.
“The long-term goal is to identify genetic features that could be
determined before vaccination, allowing practitioners to modulate
terms of feasibility than ever, given the pace of genetic testing.
“It is highly likely that widespread genetic testing will become
a common feature of vaccine testing protocols. In fact, a testing
sequence using genome wide arrays for genetic polymorphisms
followed by transcriptional and proteomic arrays at multiple time
points in association with sophisticated laboratory immunologi-
cal assays and carefully graded clinical scores will likely become
the norm. The guiding biological concept for interpretation of such
massive sets of disparate types of data will be that all of the data
should ‘tell the same story.’ We can foresee a time soon when these
data will not be interpreted individually; rather, integrated analyti-
cal tools will emerge to coordinate the use of genomic, proteomic,
and clinical data from clinical trials. The potential for false discov-
ery of associations is high, but new methods are emerging that will
reduce such random associations” [51].
Risk cannot be precisely calculated from genetic association;
nevertheless, it is still evidence that can be used today to determine
the presence of risk even though the level of risk cannot yet be de-
termined, but you have to ask the right questions.
“Is there a general association between vaccination and a spe-
the right question be: “Who among those who otherwise might be
“how can we identify such individuals and protect them from vac-
“This susceptibility to vaccine-induced autoimmunity is prob-
ably determined also by genetic predisposition… the dilemma of
whom and when to vaccinate remains unresolved”.
The above quote is from the article: Vaccination and autoim-
mune diseases: is prevention of adverse health effects on the ho-
[52].
There is clearly a disconnect between science and policy. If the
science says you don’t, for example, give the Dengue Fever vaccine
to anyone who has not already been infected, then you don’t give the
vaccine to the previously uninfected. For when you do then those
vaccinated get infected serious AEFI will occur, but that would re-
quire only giving the vaccine to dengue seropositive children – that
It is if there is no rapid and reliable test or there is no budget for
testing. The appropriate response is not, “testing for seropositive
children is not standard of care,” or “we don’t have access to reli-
market surveillance”.
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
As highlighted above, there are responsible alternatives to vac-
cines that can enhance the body’s own immunity and heal infec-
-
courages knowledge and practice of such alternatives. Indeed,
even pharmaceutical alternatives that compete with vaccines are
denigrated. For example, the off-patent drug Nitazoxanidehas
activity against dengue and could be available to many given it is
often sold for pennies in certain countries. Who is going to invest
in the research on this drug that is off-patent and for a disease that
is not prevalent in 1st World countries, where it might be sold for
a price that would allow the drug company to recoup the cost of
Informed consent is not some archaic ethos reserved for unen-
forceable global declarations, but for vaccine stakeholders there is
a fear of informed consent becoming informed dissent. We must
respect medical ethics above pharma. If that means vaccine uptake
is poor then so be it, because you don’t place children in unneces-
sary harm’s way. It is not appropriate to misinform the public and
say the chance of a serious untoward reaction is one in a million,
when that is not a truth. AEFI denailism may eventually destroy
the public’s trust in physicians; and moreover, pharma’s presently
respected than the practice of bloodletting.
In the U.S., the public is told by the government that 80,000
peo-
of the population does not even believe the lower number, but
making sure as many are vaccinated as possible, scaring people is
the only way you can sell a vaccine that may have as little as 10%
-
the appropriate source of information for true consent. Informed
consent isn’t even possible when vaccination is a condition of em-
ployment or school entry – and coercion makes informed consent
impossible.
From the article, Peptide Vaccines: New Trends for Avoiding the
Autoimmune. Response “the rate of adverse complications
in association with the combined measles, mumps and rubella
individuals per million vaccinated persons. The complications re-
ported in consequence of the MMR vaccine administration include
a diabetes type I syndrome, thrombocytopenia, arthritis and vari-
ous CNS disorders such as acute disseminated encephalomyelitis
and/or transverse myelitis." The real incidence of adverse events
Many epidemiological vaccine safety studies make the basic er-
-
val of the odds ratio does not span the null value. These conclu-
sions are simply wrong, in fact, epidemiological safety studies are
not only the easiest to manipulate (and they have been by exclud-
ing certain population here or diluting down a certain population
they are utilized routinely by pharma and authorities (working to-
rather than answer important safety questions.
For example, there are 16 epidemiological studies most often
-
dia when trying to refute any evidence of an association between
review panels and even the authors of the studies themselves.
Taken together, the limitations of these studies make it impossible
to conclude there is no association. In other words, from a risk as-
sessment angle these studies are meaningless and provide no as-
surance of safety.
In addition, Poul Thorsen, a prominent researcher responsible
for a series of epidemiological studies which utilized the Danish
Psychiatric Central Research Register was indicted by a U.S. federal
based on a scheme to steal grant money the CDC had awarded to
governmental agencies in Denmark for autism research.
The reason it is so easy to manipulate epidemiological studies
-
osemiotics is not part of epidemiology. You can count the number of
people having intercourse, but without an understanding of what
intercourse does biologically, you can’t casually associate inter-
course with pregnancy. So, epidemiological studies allow for a lot
of interpretation, but the truth is that it allows for manipulation of
Epidemiological Obfuscation
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
Null Value for a Risk Ratio: The value indicating no difference between the groups.
-
tistics to reveal, as long as that someone doesn’t have an expert
in epidemiology looking over their shoulder. The CDC has had the
studies that help them push policy not public health.
Right now, there is an explosion of allergies to milk, peanuts,
eggs to name three – it is a big mystery until you realize that vac-
cines contain bovine casein, eggs, porcine gelatin and peanut oil.
They also contain glyphosate – the herbicide. “This combination
contributes to millions developing life-threatening food allergies”
[55].
“No state party shall, even in time of emergency threatening the
life of the nation, derogate from the Covenant’s guarantees of the
without free consent... and freedom of thought, conscience and re-
ligion. These rights are not derogable under any conditions even
for the asserted purpose of preserving the life of the nation” [56].
Medical ethicists have long maintained that a patient who has
-
cal procedure, due to fear of losing access to basic necessities (i.e.,
food, medical care, education) should not be presumed to have
-
cedure .
“As with all forms of medical therapy, informed consent must
precede vaccination administration. In the informed consent dis-
cussion, health care professionals must discuss information cen-
tral to the decision-making process for vaccination, including the
-
natives, as well as possible consequences from nonvaccination…
In addition, healthcare professionals should respect patients’ in-
formed refusal of vaccinations. For some patients, receiving vac-
-
their acceptance of clinical recommendations for vaccination” [58].
The above policy is that of the American College of Obstetri-
this is that most of the members are neither informed and only rely
on the CDC for information. One is not supposed to give a vaccine
without informed consent, but can informed consent be obtained
-
cine. Would said physician know that HPV is only associated with
there is no evidence that the vaccine can prevent invasive cancer let
alone avoid death by this cancer, or that the clinical trial mortality
who have adequate vitamin D levels probably won’t get cervical
[59]. That the clinical trial was run us-
then compared against those who received a faux-placebo that also
How does one obtain informed consent if one is not informed
other than what is printed on a sanitized Vaccine Information Sheet
Vaccine policy in the U.S. is inextricably linked to commercial
interests leading to unconstrained government self-dealing in ar-
rangements whereby the HHS can transfer technology to pharma-
ceutical partners, simultaneously both approve and protect their
disclosed to the medical community, and at worst this is a situation
where the agency in charge of safety is protecting their business
partners and granting them a license to cause whatever harm re-
sults and with no accountability.
How are impartial vaccine safety recommendations even the
least bit possible when the government assumes the vaccine is
safer than the disease, approves the vaccine, makes the market for
it, shields the vaccine from liability with its recommendations and
“that bloodletting survived for so long is not an intellectual
-
nomic, and intellectual pressures, a process that continues to de-
termine medical practice” [60].
Conclusion
Citation: K Paul Stoller. “The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective”. Acta Scientific
Paediatrics
The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
Electricity for refrigerating food, plumbing for toilets and pipes
bringing potable water, are the interventions that have improved
health the most for most of humanity that has had access to them.
There is no evidence that vaccines improved on what plumbers,
a choice between funding a vaccine or a toilet, the priority (based
on evidence) is to fund the toilet. On the other hand, it should be
abundantly clear that vaccines are no magic bullet; nevertheless,
target, the consequences of hitting the target or even how the gun
“Vaccines may have a place in our medical arsenal, but they are
not the silver bullet they’re portrayed to be. Year after year the
churns out new vaccines. They use pseudo-science to convince
the public that these products are safe and effective, and they use
public shaming to convince the citizenry that non-compliance is a
public health threat”5.
In the U.S., the Pharmaceutical industry is the largest campaign
donor to politicians and the largest advertiser in all forms of me-
on human rights and bioethics. For when a medical intervention
becomes shielded from liability and is then mandated by govern-
ments who are often in an unholy partnership with the corpora-
tions responsible for that intervention then we are all in peril.
When coercion becomes part of the equation, a crime against hu-
manity is being perpetrated. The intellectual and social suppres-
sion of views, research and information inconvenient to vaccine
stakeholders and proponents is no different today than it was for
those who opposed the practice of bloodletting and dosing pa-
tients with mercury. The difference today are the economic factors,
billion dollars, so with that amount of money in play vaccine and
public health policies have been made to support the desires of
a criminal cabal where informed consent is perhaps the only re-
While phlebotomy therapy is now restricted to two or three
with mercury (Thimerosal) has not been retired and is almost the
exclusive province of the vaccine industry. As standard-of-care,
bloodletting went on for hundreds of years past when physicians
-
cious. With hundreds of new vaccines in the pipeline, the human
race may not survive a few hundred years more of vaccines as cur-
rently employed. Thus, vaccine risk awareness and informed con-
sent are the real protectors of public health at this critical time in
history.
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The Denial of Adverse Event Risk Following Immunization and the Loss of Informed Consent - A Perspective
