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(NewsTarget) 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, NewsTarget 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 cervical cancer.
NewsTarget 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 like Texas. The health and safety of tens of millions of young girls is at stake here, and what this NewsTarget 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 percent.
• The FDA has, for four years, known that HPV was not the cause of cervical cancer.
• Why mandatory HPV vaccination policies may cause great harm to young girls.
• Why HPV infections are self-limiting and pose no real danger in healthy women
• Little-known FDA documents that reveal astounding facts about Gardasil
• How Big Pharma promoted its Gardasil vaccine using disease mongering and fear mongering
This story begins at a company called HiFi DNA Tech, LLC (https://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 https://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: https://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf
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: https://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 https://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: https://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 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:
Observed Efficacy
– 44.6%
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.”
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?
he 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.
Next: Do HPV vaccinations help anyone? We reveal a four-quadrant comparison that shows the vaccine to be more harmful than helpful.
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