STUDY FINDS NUMEROUS LIFE-THREATENING INJURIES, HOSPITALIZATIONS & DEATHS AFTER GARDASIL (HPV)
VACCINE
BY ROBERT F. KENNEDY JR.
A new study published in Clinical Rheumatology exposes how vaccine manufacturers used phony
placebos in clinical trials to conceal a wide range of devastating risks associated with
HPV vaccines.
Instead of using genuine inert placebos and comparing health impacts over a number of
years, as is required for most new drug approvals, Merck and GlaxoSmithKline spiked their placebos
with a neurotoxic aluminum adjuvant and cut observation periods to a matter of months.
Researchers from Mexico�s National Institute of Cardiology pored over 28 studies published
through January 2017�16 randomized trials and 12 post-marketing case series�pertaining
to the three human papillomavirus (HPV) vaccines currently on the market globally.
In their July 2017 peer-reviewed report, the authors, Manuel Mart�nez-Lavin and Luis
Amezcua-Guerra, uncovered evidence of numerous adverse events, including life-threatening
injuries, permanent disabilities, hospitalizations and deaths, reported after vaccination with
GlaxoSmithKline�s bivalent Cervarix vaccine and Merck�s quadrivalent or nine-valent
HPV vaccines (Gardasil and Gardasil 9).
Pharmaceutical company scientists routinely dismissed, minimized or concealed those injuries
using statistical gimmicks and invalid comparisonsdesigned to diminish their relative significance.
Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo.
Ten of the sixteen compared the HPV vaccine against a neurotoxicaluminum adjuvant, and
four trials used an already-approved aluminum-containing vaccine as the comparison.
Scientific researchers view double-blind placebo trials as the gold standard for testing new
drugs.
To minimize bias, investigators randomly assign patients to either a �treatment� group
or a �control� (placebo) group and then compare health outcomes.
The standard practice is to compare a new drug against a �pharmacologically inert�
placebo.
To minimize opportunities for bias, neither patients nor researchers know which individuals
received the drug and which the placebo.
However, in clinical trials of the various HPV vaccines, pharmaceutical researchers avoided
this kind of rigor and instead employed sleight-of-hand flimflams to mask the seriousness of vaccine
injuries.
Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo.
Ten of the sixteen compared the HPV vaccine against a neurotoxic aluminum adjuvant, and
four trials used an already-approved aluminum-containing vaccine as the comparison.
One does not have to be a scientist to understand that using aluminum-containing placebos is
likely to muddy the comparison between the treatment and control groups.
Critics of the HPV vaccine have pointed to the aluminum adjuvant as the most likely cause
of adverse reactions, and some researchers have questioned the safety of using aluminum
adjuvants in vaccines at all, due to their probable role as a contributor to chronic
illness.
The aluminum-containing placebos appeared to provoke numerous adverse reactions among
the presumably unwitting patients who received them, allowing the pharma researchers to mask
the cascade of similar adverse reactions among the groups that received the vaccines.
Although both placebo and study groups suffered numerous adverse events in these studies,
there were minimal differences between the two groups.
The similar adverse outcomes in both groups allowed industry researchers and government
regulators to claim that the vaccines were perfectly safe, despite manifold disturbing
reactions.
The Mexican researchers� meta-review confirms the difficulty of ascertaining vaccine-attributable
differences from this mess; the researchers identified only a few indications of �significantly
increased systemic adverse events in the HPV vaccine group vs. the control group� across
the 16 pre-licensure trials.
The HPV promoters found it more difficult to employ deceptive devices in the 12 post-marketing
safety reviews, and the Mexican authors summarize some of the more noteworthy findings.
In Spain, they found a ten-fold higher incidence of vaccine-related adverse events following
HPV vaccination compared to �other types of vaccines.� In Canada, they found an astonishing
one in ten rate of hospital emergency department visits among HPV-vaccinated individuals �within
42 days after immunization.� Still, the industry researchers did what they could to
minimize these injuries.
The Mexican reviewers criticize the authors of the various post-marketing studies for
failing to ask essential questions, to evaluate the many serious adverse events, or to elaborate
on their often-troubling findings.
Abbreviated Trial Times Typically, FDA requires drug companies seeking
approval for a new drug to observe health outcomes in both the placebo and study groups
for 4-5 years.
Vaccine manufacturers take advantage of FDA regulatory loopholes that allow fast-tracking
of vaccines and cut that period down to a few weeks or even a few days.
This means that injuries that manifest, or are diagnosed, later in life�most neurodevelopmental
disorders, for example�will escape attention entirely.
Further Smokescreens Mart�nez-Lavin and Amezcua-Guerra point
to clinical trial data posted on the FDA webpagefor the quadrivalent Gardasil vaccine approved
in 2006.
Those clinical trials deployed a panoply of the kind of cunning deceptions used by industry
and government researchers.
Unlike many of the other HPV vaccine clinical trials, these clinical studies employed a
true saline placebo.
Across the Gardasil clinical studies, a group of 15,706 females ages 9-45 and males ages
9-26 received the quadrivalent Gardasil vaccine.
A control group of 594 individuals received an inert saline placebo.
The industry researchers never explain the tiny relative size of the saline placebo group;
it�s noteworthy that small size would have the effect of keeping unwanted signals weak.
But a second control group of 13,023 received a so-called �spiked� placebo loaded with
an aluminum adjuvant (amorphous aluminum hydroxyphosphate sulfate or AAHS).
The large size of this �spiked placebo� group suggests that the decision to keep the
saline placebo group small was strategic.
Putting aside the thorny ethical question of whether study participants were told that
they were being injected with a neurotoxin with probable associations with Alzheimer�s,
dementia and other forms of brain disease, the inclusion of both saline and aluminum
placebos provided these researchers a chance to do some genuine science.
But the FDA webpage shows the troubling gimmick that was then employed by the FDA and Merck,
which seems deliberately designed to blur datasets in order to mask adverse effects
during the clinical trials.
The table showing relatively minor injection-site adverse reactions�one to five days post-vaccination�displays
three distinct columns for the three groups: Gardasil recipients, the aluminum �placebo�
recipients, and saline placebo recipients (see table below).
In the table, �Intergroup differences are obvious,� in the words of the Mexican researchers.
For example, roughly three and a half times more girls/women experienced injection site
swelling in the Gardasil group compared to the saline group (25.4% vs. 7.3%).
In fact, by all five measures, both the Gardasil recipients and the aluminum placebo recipients
fared two to three times worse than the saline recipients.
When it came time for Merck to report on the occurrence of more serious reactions, �Systemic
Adverse Reactions� and �Systemic Autoimmune Disorders,� for example, the company scientists
switched to a very different format.
In these tables, the third column that reported results for the saline placebo recipients
disappears.
Instead, Merck combined the groups receiving the spiked aluminum placebo into a single
column with the group receiving the genuine saline placebo (see example below).
The merger of the two control groups makes it impossible to compare results for Gardasil
versus the saline placebo or the aluminum placebo versus the saline placebo.
In this way, Merck�s researchers obliterated any hope of creating a meaningful safety comparison.
Risks and Benefits Given aluminum�s known neurotoxicity and
its association with debilitating autoimmune conditions, it is unsurprising that there
are no observable differences between the Gardasil and AAHS/saline groups.
But, despite the researchers� efforts to paper over adverse effects, they were not
able to conceal the devastating health injuries to their human guinea pigs.
The bottom line of these trials reveals a shocking truth: An alarming 2.3% of both their
study and control groups had indicators of autoimmune diseases!
These data are even more alarming when one considers that the observation period was
curtailed after only six months.
With this level of risk, it would seem that no loving parents would allow their daughter
to receive this vaccine�particularly given the comparatively low risk posed by HPV in
countries with appropriate cervical cancer screening tests.
Even in countries such as India, where cervical cancer mortality is high due to late detection,
leading Indian physicians argue that comprehensive screening should be the country�s top priority
rather than the �panacea� of HPV vaccination.
Consider the math: According to the National Institutes of Health (NIH), an estimated 2.4
women per 100,000 die of cervical cancer in the US each year.
On the other hand, the FDA�s Table 2 (above) shows that 2.3 per 100 girls and women developed
an �incident condition potentially indicative of a systemic autoimmune disorder� after
enrolling in the Gardasil clinical trial.
It is difficult to understand how any rational regulator could allow more than two in 100
girls to run the risk of acquiring a lifelong autoimmune disorder, particularly when Pap
smears are already doing an effective job of identifying cervical abnormalities.
The NIH notes that the incidence and death rates for cervical cancer in the US declined
by more than 60% after introducing Pap smear screening.
Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood
of being actually �helped or harmed by the 9-valent HPV vaccine.� Their �worrisome�
finding is that the �number needed to harm� is just 140, whereas 1757 women would need
to receive the vaccine for a single one of them to enjoy its projected benefits.
Mart�nez-Lavin and Amezcua-Guerra make their own effort to illustrate the zany risk-benefit
ratios associated with these vaccines when discussing the results of one of the 16 clinical
trials.
That study compared approximately 14,000 women who received either Gardasil 9 or the original
quadrivalent Gardasil.
Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood
of being actually �helped or harmed by the 9-valent HPV vaccine.� Their �worrisome�
finding is that the �number needed to harm� is just 140, whereas 1757 women would need
to receive the vaccine for a single one of them to enjoy its projected benefits.
Implications for Aluminum Adjuvants Merck found that astronomical casualty counts
were equal among both Gardasil and aluminum �placebo� recipients.
The inescapable implication is that aluminum adjuvants may be a principal culprit in the
flood of injuries reported for the various HPV vaccines.
This conclusion, if true, requires reevaluation of the use of aluminum adjuvants in several
other vaccines, including some given to infants.
Aluminum adjuvant levels have mushroomed since the 2003 removal of thimerosal from three
pediatric vaccines.
The following chart, prepared by Dr. Sherri Tenpenny, illustrates the stunning amount
of aluminum in vaccines.
Multiple peer-reviewed studies have connected aluminum exposures to a range of autoimmune
and neurological disorders, including dementia and Alzheimer�s disease, that have become
epidemic coterminous with these aluminum exposures.
A review in the European Journal of Clinical Nutrition warns of dangerous accumulation
of aluminum in the brain when, as in the case of vaccination, �protective gastrointestinal
mechanisms are bypassed.� It�s time to go back to the drawing board on HPV vaccines
and aluminum adjuvants.
More importantly, FDA needs to start requiring the same rigorous pre-licensing safety testing
for vaccines that it has long required for other drugs.
All existing vaccines, particularly those containing aluminum, should be safety-reviewed
according to these more stringent standards.
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