The Great HPV Vaccine Hoax Exposed
Part 1 - The Trail of Evidence
A NewsTarget Special Report by Mike Adams
http://www.newstarget.com/Report_HPV_Vaccine_1.html
This story begins at a company called HiFi DNA Tech, LLC
(http://www.hifidna.com) a company involved in the manufacture of portable
HPV testing devices based on DNA sequencing analysis. HiFi DNA Tech has
been
pushing to get the FDA to classify its HPV detection technology as a
"Class
II" virology testing device. To understand why this is a big deal, you
have
to understand the differences between "Class II" and "Class III" virology
testing devices.
Based on FDA rules, a Class III virology testing device is one that is
considered by the FDA to have "premarket approval," meaning that it cannot
yet be sold to the public. In order for such a device to be marketed to
the
public, it must be downgraded to Class II status, which is considered a
"special controls" status. Class II devices are, "...those devices for
which
the general controls by themselves are insufficient to provide reasonable
assurance of safety and effectiveness, but for which there is sufficient
information to establish special controls to provide such assurance,
including performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines, recommendations,
and any other appropriate actions the agency deems necessary."
In other words, a Class II device may or may not actually be safe, but the
FDA considers is safe enough to release to the public.
HiFi DNA Tech has been trying to get its HPV detection device downgraded
to
a Class II device based on the following arguments:
. For more than 20 years, the FDA had regulated the HPV test as a "test
for
cervical cancer."
. But since at least 2003, the FDA has changed its position on the
relationship between Human Papilloma Virus and cervical cancer, stating
that
the HPV strain is "not associated with cervical cancer."
. Accordingly, HiFi DNA Tech is arguing that the HPV test it has developed
is no longer a test for cervical cancer, but is merely a test for the
presence of Human Papilloma Viruses -- a shift that makes the test far
more
reliable in its primary purpose. In other words, the test is merely
detecting the presence of a virus, not making a diagnosis of a disease
(which would be a much higher standard to meet).
On October 12, 2007, HiFi DNA Tech sued the Food and Drug Administration
in
an attempt to force it to downgrade its HPV detection technology to Class
II
(see
http://www.news-medical.net/?id=31180 ). Earlier in the year -- on
March 7, 2007, HiFi DNA Tech filed the HPV PCR test reclassification
petition with the FDA. It is the information in this petition document
that
led us to the FDA's knowledge that HPV is not linked to cervical cancer.
Got all that? This is a somewhat complex story to follow, so here it is
again in summary:
. A company that manufacturers a DNA testing device that can detect the
presence of HPV (Human Papilloma Virus) is petitioning the FDA (and suing
the FDA) to get it to reclassify its medical device as a "Class II" device
based on the revelation that the FDA has already adopted the position that
HPV infections do not directly cause cervical cancer.
. This would mean that the FDA has been aware for years that HPV does not
cause cervical cancer, which means that the FDA's approval of the Gardasil
vaccine -- as well as the national push for Gardasil vaccinations -- is
based on a grand medical hoax that, not surprisingly, appears to be
designed
to exploit the fear of cancer to sell vaccines. The victims in all this,
of
course, are the young girls who are apparently being subjected to a
medically useless (and potentially dangerous) vaccine.
. None of this information was apparently known during the more recent
debates over the safety and efficacy of Gardasil, the HPV vaccine now in
use. This means that the public debate over mandatory HPV vaccinations
lacked key elements that now seem essential to reaching rational,
evidence-based conclusions over the safety and efficacy of such vaccines.
Next, we reveal the FDA's statement that HPV is "not associated with
cervical cancer."
The Reclassification Petition, dated March 7, 2007, is still posted on the
FDA's website:
http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-...
In case the FDA removes this document (as it has been known to do), we've
posted a backup copy of the document on our own servers:
http://www.NewsTarget.com/downloads/FDA-HPV.pdf
This document reveals the following text:
The FDA news release of March 31, 2003 acknowledges that "most infections
(by HPV) are short-lived and not associated with cervical cancer", in
recognition of the advances in medical science and technology since 1988.
In
other words, since 2003 the scientific staff of the FDA no longer
considers
HPV infection to be a high-risk disease when writing educational materials
for the general public whereas the regulatory arm of the agency is still
bound by the old classification scheme that had placed HPV test as a test
to
stratify risk for cervical cancer in regulating the industry.
NewsTarget sought to verify the existence of the FDA news release
referenced
by this petition reclassification document and found that, indeed, the FDA
news release exists. In fact, it's still posted on the FDA website at
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html
In it, the FDA says, "The HPV DNA test is not intended to substitute for
regular Pap screening. Nor is it intended to screen women under 30 who
have
normal Pap tests. Although the rate of HPV infection in this group is
high,
most infections are short-lived and not associated with cervical cancer."
(Emphasis added.)
In other words, the FDA knew in 2003 that HPV infections are not
associated
with cervical cancer.
Furthermore, the FDA states, in the same press release, "Most women who
become infected with HPV are able to eradicate the virus and suffer no
apparent long-term consequences to their health."
In other words, HPV infections do not cause cervical cancer! Remember, the
entire push for mandatory HPV vaccinations of young girls across the
country
has been the urgent call to "save" these young girls from cervical cancer.
The vaccine push has been about "savings lives." But as these documents
clearly reveal, HPV is no threat to the lives of young girls. In fact, as
you will see below, HPV infections are naturally self-limiting!
HPV Infections Resolve Themselves, Without Vaccines
As the reclassification petition reveals, HPV infections are naturally
self-limiting -- meaning that they are controlled naturally, without
requiring intervention with drugs or vaccines. It is not the HPV virus
itself that causes cervical cancer but rather a persistent state of
ill-health on the part of the patient that makes her vulnerable to
persistent infections.
As the petition states:
"Based on new scientific information published in the past 15 years, it is
now generally agreed that identifying and typing HPV infection does not
bear
a direct relationship to stratification of the risk for cervical cancer .
Most acute infections caused by HPV are self-limiting [1, 4-7].
...Repeated
sequential transient HPV infections, even when caused by "high-risk" HPVs,
are characteristically not associated with high risk of developing
squamous
intraepithelial lesions, a precursor of cervical cancer.
A woman found to be positive for the same strain (genotype) of HPV on
repeated testing is highly likely suffering from a persistent HPV
infection
and is considered to be at high risk of developing precancerous
intraepithelial lesions in the cervix . It is the persistent infection,
not
the virus, that determines the cancer risk."
The FDA agrees with this assessment of the relationship between HPV and
cervical cancer, as evidenced by its 2003 news release quoted above.
Next, we reveal evidence that HPV vaccines actually cause precancerous
lesions in women.
The reclassification petition cited above also reveals that Gardasil
vaccines may increase the risk of developing precancerous lesions by 44.6
percent in some groups of women. This is found in a quote referencing a
document mentioned in the petition, which states:
"PCR-based HPV detection device with provision for accurate HPV genotyping
is more urgently needed now because vaccination with Gardasil of the women
who are already sero-positive and PCR-positive for vaccine-relevant
genotypes of HPV has been found to increase the risk of developing
high-grade precancerous lesions by 44.6%, according to an FDA VRBPAC
Background Document : Gardasil HPV Quadrivalent Vaccine. May 18, 2006
VRBPAC
Meeting.
www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf"
NewsTarget tracked down the correct URL of the document referenced above
and
found it in the FDA docket archives. We have placed a safe backup copy at:
http://www.NewsTarget.com/downloads/FDA-Gardasil.pdf
Sure enough, this document reveals startling information about the extreme
dangers apparently posed by Gardasil vaccinations. On page 13, this
document
states:
"Concerns Regarding Primary Endpoint Analyses among Subgroups
There were two important concerns that were identified during the course
of
the efficacy review of this BLA. One was the potential for Gardasil to
enhance disease among a subgroup of subjects who had evidence of
persistent
infection with vaccine-relevant HPV types at baseline. The other concern
was
the observations of CIN 2/3 or worse cases due to HPV types not contained
in
the vaccine. These cases of disease due to other HPV types have the
potential to counter the efficacy results of Gardasil for the HPV types
contained in the vaccine.
1. Evaluation of the potential of GardasilT to enhance cervical disease in
subjects who had evidence of persistent infection with vaccine-relevant
HPV
types prior to vaccination. The results of exploratory subgroup analyses
for
study 013 suggested a concern that subjects who were seropositive and
PCR-positive for the vaccine-relevant HPV types had a greater number of
CIN
2/3 or worse cases as demonstrated in the following table:
Observed Efficacy
- 44.6%
It appeared that subjects in this subgroup of study 013 who received
GardasilT might have had enhanced risk factors for development of CIN 2/3
or
worse compared to placebo recipients."
Revealing the Dangers of Gardasil
This revelation should be quite shocking to anyone who has been following
the debate over Gardasil and mandatory vaccinations of teenage girls.
First,
it reveals that Gardasil appears to increase disease by 44.6 percent in
certain people -- namely, those who were already carriers of the same HPV
strains used in the vaccine.
In other words, it appears that if the vaccine is given to a young woman
who
already carries HPV in a "harmless" state, it may "activate" the infection
and directly cause precancerous lesions to appear. The vaccine, in other
words, may accelerate the development of precancerous lesions in women.
This is information that has simply not been made available in the debate
over Gardasil vaccination policies. The pro-vaccination rhetoric has
always
been about "saving lives" and it carried the implied statement that
Gardasil
is perfectly safe for all women, posing absolutely no increased risk of
cancer. What these documents reveal, however, is that Gardasil may, in
fact,
pose a serious increase in the risk of cervical cancer in some recipients
of
the vaccine.
Next: Will health authorities "interrogate" young virgins over their
sexual
activity (or lack thereof)? What are the bioethical ramifications of this
vaccine being mandated to all teenage girls?
The FDA directly admits the vaccine is utterly useless in these women,
stating in the same document, "Finally, there is compelling evidence that
the vaccine lacks therapeutic efficacy among women who have had prior
exposure to HPV and have not cleared previous infection (PCR positive and
seropositive)."
What this essentially means is that the "safe" administering of the
Gardasil
vaccine requires that it be administered only to virgins (because
virtually
all women who are sexually active carry HPV strains). That, of course,
would
require the direct questioning of the sexual habits of all young girls
before administering the vaccine.
Is this what the Governor of Texas really had in mind when he mandated
such
vaccinations for all young girls in Texas? ... a male doctor with a
vaccination needle in his hand and a thirteen-year-old girl sitting in a
private clinic room behind closed doors, with the male doctor asking her,
"Have you ever had sex?"
Clearly, this kind of patient questioning crosses all kinds of ethical
barriers when such vaccinations are made mandatory (as they have been made
in Texas). It puts the State in the positioning of ascertaining the sexual
habits of very young teenage girls and then potentially causing them harm.
It's not hard to suppose that most sexually active teenage girls would
claim
to still be virgins (especially if their parents were present), creating a
situation where vaccines would be routinely administered to precisely the
HPV carrier subgroups for which it has been demonstrated to greatly
increase
the risk of precancerous lesions.
In other words, under a mandatory Gardasil vaccination scenario like what
exists in Texas today, a sexually-active young teenage girl has to make a
tough choice:
1) She can lie to her doctor, claim to be a virgin, receive the vaccine
and
thereby potentially increase her risk of cervical cancer.
2) She can tell her doctor she's sexually active, thereby surrendering her
privacy and possibly subjecting herself to various consequences from her
sexual status being learned by her parents or guardians. (One would hope,
of
course, that such sexual habits were not secrets, but alas, we live in the
real world where many teenage girls do indeed have sex at a very early
age...)
Furthermore, the young girl is unlikely to be given accurate information
about the health risks associated with the vaccine, since virtually all
health authorities are heavily involved in promoting pro-vaccination
propaganda, routinely ignoring scientific evidence that might give
reasonable people pause.
Naturally, the better scenario here is that the young girl is not sexually
active to begin with, but in a society where 8th and 9th graders are
already
routinely engaged in sexual activities -- almost always unbeknownst to
their
parents -- it seems naive to expect that such girls would suddenly honor
pledges of celibacy in order to protect themselves from possible future
dangers posed by a present-day vaccine (especially when doctors blindly
claim the vaccine is harmless).
There are also serious questions about the safety of the vaccine for
non-sexually-active young women. Yet even if the vaccine poses no
increased
risk of cervical cancer for non-sexually-active young girls, there's still
the more serious question of: Does the vaccine work? Does it really
prevent
cervical cancer in the first place? And that question has already been
clearly answered by the FDA's own admission that HPV infections are not
the
cause of cervical cancer in the first place.
When considering the safety and effectiveness of Gardasil vaccinations on
young teens, there are essentially four quadrants to consider, as shown in
the table below:
Quadrant I: Non-Sexually Active
No Gardasil Vaccine Quadrant II: Non-Sexually Active
Receives Gardasil Vaccine
Quadrant III: Sexually Active
No Gardasil Vaccine Quadrant IV: Sexually Active
Receives Gardasil Vaccine
Based on what we've learned from the FDA's own documents, here are the
likely outcomes of each of the four quadrants:
Quadrant I: Non-Sexually Active, No Gardasil Vaccine
Outcome: No risk of cervical cancer.
Quadrant II: Non-Sexually Active, Receives Gardasil Vaccine
Outcome: No medical benefit from vaccine.
Quadrant III: Sexually Active, No Gardasil Vaccine
Outcome: HPV presence is self-limiting and does not lead to cervical
cancer.
Quadrant IV: Sexually Active, Receives Gardasil Vaccine
Outcome: 44.6% Increased risk of precancerous lesions. No reduction in
cancer risk.
In other words, Gardasil adds no benefits to any quadrant! There is no
subgroup that actually benefits from a Gardasil vaccination. But there is
at
least one quadrant in which Gardasil achieves an increased risk of
disease.
Put another way, Gardasil helps no one, but it harms some.
This is hardly a position from which to mandate the vaccine for everyone,
especially since the vaccine has been widely prescribed as "completely
safe"
for everyone. It is widely claimed by medical authorities that the vaccine
has no downside: No health risks, no increased risk of disease and no
potential to cause harm in women. Clearly, these assumptions have no basis
in scientific fact.
Keep in mind, too, that Merck, the manufacturer of Gardasil, has publicly
suggested that young boys should receive Gardasil vaccinations! Why?
Because
they might engage in oral sex with girls who carry the virus. Therefore,
the
story goes, young boys should be vaccinated against this virus that they
claim causes cervical cancer! (Never mind the fact that boys don't have a
cervix...) There is no end, it seems, to the pseudoscientific nonsense
that
will be spouted in an effort to sell more Garsasil vaccines to people who
don't need them.
Next: New clinical study shows Gardasil to be medically useless.
To further investigate this conclusion, NewsTarget took a closer look at
research published in the Journal of the American Medical Association
(August, 2007), entitled, "Effect of Human Papillomavirus 16/18 L1
Viruslike
Particle Vaccine Among Young Women With Preexisting Infection"
This research sought to determine the usefulness of the HPV vaccine among
women who already carry HPV (which includes virtually all women who are
sexually active, regardless of their age).
This document can currently be found at a University of Louisville
document
archive reprinted from JAMA. Click here to read the PDF yourself.
Just in case that copy disappears, we've also hosted the PDF here:
http://www.newstarget.com/downloads/HPV-Vaccine-Effects.pdf
This document reveals startling information about the ineffectiveness of
the
Gardasil vaccine. It reveals that the HPV vaccine often caused an increase
in the presence of HPV strains while utterly failing to clear the viruses
in
most women.
These shocking results caused the study authors to publish this sobering
conclusion, printed in JAMA:
"No significant evidence of a vaccine therapeutic effect was observed in
analyses restricted to women who received all doses of vaccine or those
with
evidence of single HPV infections at entry (Table2). We observed no
evidence
of vaccine effects when we stratified the analysis on selected study entry
characteristics reflective of [various parameters] (TABLE3). Similarly, no
evidence of vaccine effects was observed in analyses stratified by other
study entry parameters thought to potentially influence clearance rates
and
efficacy of the vaccine, including time since sexual initiation, oral
contraceptive use, cigarette smoking, and concomitant infection with C
trachomatis or N gonorrhoeae (Table 3)."
In other words, the authors found no evidence that the vaccine worked at
all. This observation led the authors to offer this damning conclusion
that
appears to render Gardasil nothing more than a grand medical hoax:
"... rates of viral clearance over a 12-month period are not influenced by
vaccination."
The study goes on to state words that should cause every doctor, Governor
and health authority across the United States (and around the world) to
rethink Gardasil vaccination policies:
"...given that viral clearance rates did not differ by treatment group and
that persistent viral infection is the best established predictor of risk
of
progression, it is unlikely that vaccination could have a significant
beneficial impact on rate of lesion progression.1,17
Results from our community-based study provide strong evidence that there
is
little, if any, therapeutic benefit from the vaccine in the population we
studied. Furthermore, we see no reason to believe that there is
therapeutic
benefit of the vaccine elsewhere because the biological effect of
vaccination among already infected women is not expected to vary by
population.
In other words, the vaccines didn't work on the population studied, and
there is no reason to believe that those same vaccines would magically
work
on other populations, since the biology of women and HPV is so similar
across various populations.
Next: Is Gardasil a grand medical hoax?
It is difficult to take an honest look at this scientific evidence and the
statements made by the FDA and not come to the conclusion that mandatory
Gardasil vaccination policies being pushed across U.S. states right now
are
based on something other than science.
There are many theories exploring the motivation for such vaccination
policies. Possible theories include:
Financial benefit: Big Pharma is pushing mandatory Gardasil vaccination
policies so that it can profit from selling more vaccines to the states.
This idea is at least partially supported by the fact that the first state
Governor to mandate such vaccines (Texas Gov. Rick Perry) had undisclosed
ties to Big Pharma. (A top official in Perry's administration worked
directly for Merck, the manufacturer of Gardasil.)
Conspiracy to poison the people: This theory, which may stretch the bounds
of belief in some readers, proposes that such mandatory vaccines are put
in
place in order to create future disease by poisoning the people with
dangerous chemicals and DNA fragments that are knowingly added to
vaccines.
The poisoning of the people, it is said, will pay off in future profits
for
Big Pharma when those people develop other serious diseases requiring
"treatment" with medications. Many people who support this theory
currently
believe, for example, that AIDS was engineered by human scientists and
then
administered to the gay population in New York in the late 1980's through
vaccines.
Control the sheeple: This theory supposes that the main purpose of
mandatory
vaccines is to train the American public to get used to submitting to
compulsory medicines. Once a certain segment of the population is targeted
and effectively injected with mandatory medicines, these policies can be
extended to other groups and, eventually, can encompass the entire
population.
The first theory -- Financial Benefit -- is the simplest and easiest
theory
to believe. It requires nothing more than simple greed on the part of Big
Pharma, along with the usual level of corruption at the FDA. NewsTarget
believes this is the most likely explanation for events surrounding
Gardasil
vaccination policies, but we do not rule out other possible explanations,
either.
Profits at Any Cost
What's clear in all this is that mandatory HPV vaccination programs are
not
based on anything resembling good science. They seem to be based on a
carefully planted meme -- an idea that, coincidentally, spreads from one
person's mind to the next much like a virus, gaining momentum as the
mainstream media (MSM), health authorities, FDA and drug company reps
repeat
the meme on a regular basis. And what is that meme? That HPV causes
cervical
cancer, and, therefore, HPV vaccinations could halt cervical cancer and
save
lives.
This meme appears to have no real scientific basis. It is more of an urban
legend than anything resembling scientific fact. Furthermore, it appears
to
have been conjured by those in a position to financially benefit from the
adoption of that meme (the drug companies who manufacture, sell, and
profit
from the sale of HPV vaccines). In this case, that drug company is Merck,
a
powerful corporation with a dubious history rife with charges of price
fixing, large-scale tax avoidance (it set up offshore accounts to avoid
billions in U.S. taxes), widespread biopiracy, conspiring with the FDA to
discredit its critics, burying negative evidence about its drugs (see the
history of Vioxx at
www.NewsTarget.com/vioxx.html ) and numerous other
actions that many consider to be criminal in nature.
There is no question that Merck has the lack of ethics, the willingness
and
the means to commit medical fraud on an unprecedented scale. Based on the
information revealed in this report, the mandatory vaccination of young
girls with Gardasil appears to be the boldest medical hoax yet perpetrated
by the company. You can read the true history about Merck and its crimes
at:
http://www.newstarget.com/Merck.html
NewsTarget believes Merck is currently engaged in a massive medical fraud,
and that it has influenced, corrupted or otherwise recruited FDA officials
and state health authorities in a grand scheme to sell vaccines that are
at
best medically worthless, and at worst medically dangerous. Halting
cervical
cancer seems to have nothing to do with the marketing and prescribing of
Gardasil. The entire campaign push for mandatory HPV vaccinations seems to
be based entirely in the realm of sales and marketing.
The "marketing" of HPV vaccines involves classic disease mongering --
spreading fear about a disease as a way of corralling patients into
begging
for the "solution" that just happens to be readily available from the same
pharmaceutical company that promoted the disease in the first place. The
hype over cervical cancer and Gardasil seems to be nothing more than a
classic case of fear-based marketing designed to create such consumer fear
over cervical cancer that a massive public outcry would result in
legislation mandating the vaccines.
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citation.
Next: Sources cited (with links).
HiFi DNA Tech files lawsuit against FDA
http://www.news-medical.net/?id=31180
Reclassification Petition - Human Papillomavirus (HPV) DNA Nested
Polymerase
Chain Reaction (PCR) Detection Device (K063649 )
http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-...
FDA Approves Expanded Use of HPV Test
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html
VRBPAC Background Document, GardasilT HPV Quadrivalent Vaccine, May 18,
2006
VRBPAC Meeting
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among
Young Women With Preexisting Infection
Journal of the American Medical Association, August, 2007
--
Peter Bowditch
