Mike Adams
News Target
December 28, 2007

http://www.youtube.com/watch?v=XK97CHQZhq0

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 (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-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: 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 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.

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.

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.

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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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-vol1.pdf

FDA Approves Expanded Use of HPV Test
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html

VRBPAC Background Document, Gardasil™ 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

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