by Mike Adams
For the last several
years, HPV vaccines have been marketed to the public and mandated in
compulsory injections for young girls in several states based on the
idea that they prevent cervical cancer.
Now, NaturalNews has
obtained documents from the FDA and other sources (see below) which
reveal that the FDA has been well aware for several years that
Human Papilloma Virus (HPV) has no direct link to
NaturalNews has also learned that HPV vaccines have been proven to
be flatly worthless in clearing the HPV virus from women who have
already been exposed to HPV (which includes most sexually active
women), calling into question the scientific justification of
mandatory "vaccinate everyone" policies.
Furthermore, this story reveals evidence that the vaccine currently
being administered for HPV - Gardasil - may increase the risk
of precancerous cervical lesions by an alarming 44.6 percent in some
women. The vaccine, it turns out, may be far more dangerous to the
health of women than doing nothing at all.
If true, this information reveals details of an enormous public
health fraud being perpetrated on the American people, involving FDA
officials, Big Pharma promoters, and even the governors of states
The health and safety of
tens of millions of young girls is at stake here, and what this
NaturalNews investigative report reveals is that HPV vaccinations
may not only be medically useless; they may also be harmful to the
health of the young girls receiving them.
This report reveals startling facts about the HPV vaccine that most
people will find shocking:
How it may
actually increase the risk of precancerous lesions by 44.6
The FDA has, for
four years, known that HPV was not the cause of cervical
HPV vaccination policies may cause great harm to young
infections are self-limiting and pose no real danger in
documents that reveal astounding facts about Gardasil
How Big Pharma
promoted its Gardasil vaccine using disease mongering and
The Trail of
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,
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
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."
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
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
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
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 Text of
The Reclassification Petition, dated March 7, 2007, is still posted
on the FDA's website:
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:
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.
NaturalNews 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
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
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
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
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.
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
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
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.
Vaccines Increase the Risk of Precancerous Lesions?
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:
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.
NaturalNews 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:
Sure enough, this document reveals startling information about the
extreme dangers apparently posed by Gardasil vaccinations. On page
13, this document states:
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
1. Evaluation of
the potential of Gardasil™ 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
It appeared that
subjects in this subgroup of study 013 who received Gardasil™
might have had enhanced risk factors for development of CIN 2/3
or worse compared to placebo recipients."
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
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
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
what exists in Texas today, a sexually-active young teenage girl has
to make a tough choice:
She can lie to
her doctor, claim to be a virgin, receive the vaccine and
thereby potentially increase her risk of cervical cancer.
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.
Next: Do HPV vaccinations help anyone? We reveal a four-quadrant
comparison that shows the vaccine to be more harmful than helpful.
Quadrants of Garsadil Vaccinations
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
No Gardasil Vaccine
Quadrant II: Non-Sexually
Receives Gardasil Vaccine
Quadrant III: Sexually
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:
Non-Sexually Active, No Gardasil Vaccine
Outcome: No risk of cervical cancer.
Non-Sexually Active, Receives Gardasil Vaccine
Outcome: No medical benefit from vaccine.
Sexually Active, No Gardasil Vaccine
Outcome: HPV presence is self-limiting and does not lead to
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...)
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.
Gardasil to be Useless
To further investigate this conclusion, NaturalNews 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
Just in case that copy disappears, we've also hosted the PDF here:
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:
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).
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.
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
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
Results from our
community-based study provide strong evidence that there is little,
if any, therapeutic benefit from the vaccine in the population we
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?
- HPV Vaccinations a 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:
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
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
this is the most likely explanation for events surrounding Gardasil
vaccination policies, but we do not rule out other possible
Profits at Any
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.
what is that
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
In this case, that drug
company is Merck, a powerful corporation with a dubious history rife
with charges of,
large-scale tax avoidance (it set up
offshore accounts to avoid billions in U.S. taxes)
conspiring with the FDA to discredit its critics
negative evidence about its drugs (see the history of Vioxx at
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
You can read the true history about Merck and its crimes
NaturalNews 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.