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
• 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
• 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
The Reclassification Petition, dated March 7, 2007, is still posted on
the FDA's website:
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.
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.
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
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."
In other words, the FDA knew in 2003 that HPV infections are not associated with
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!
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:
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.
"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.
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:
Sure enough, this document reveals startling information about the extreme
dangers apparently posed by Gardasil vaccinations. On page 13, this document
"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
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 table:
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."
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)."
When considering the safety and effectiveness of Gardasil vaccinations on young
teens, there are essentially four quadrants to consider, as shown in the table
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
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
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.
|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
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
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
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"
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.
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:
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
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
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
Next: Is Gardasil a grand medical hoax?
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:
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
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Next: Sources cited (with links).
HiFi DNA Tech files lawsuit against FDA
Reclassification Petition - Human Papillomavirus (HPV) DNA Nested Polymerase
Chain Reaction (PCR) Detection Device (K063649 )
FDA Approves Expanded Use of HPV Test
VRBPAC Background Document, Gardasil™ HPV Quadrivalent Vaccine, May 18, 2006
Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among Young
Women With Preexisting Infection
Journal of the American Medical Association, August, 2007