Fear-Mongering Over Gardasil

In what could almost pass for a Merck ad, an NYT editorial today takes up the drug maker’s propaganda and glosses over all the evidence countering it.

Teenage girls and their parents need to read the latest government study of sexually transmitted diseases. The infections are so prevalent they are hard to avoid once a girl becomes sexually active. One in four girls ages 14 to 19 is infected with at least one of four common diseases. Among African-American girls in the study, almost half were infected.

***

By far the most common of the four S.T.D.’s was the human papillomavirus, or HPV, which infected 18 percent of the girls. Chlamydia infected 4 percent, trichomoniasis — a common parasite — 2.5 percent, and genital herpes 2 percent.

The study did not look at such feared diseases as H.I.V./AIDS, syphilis or gonorrhea, but the four it did look at are worrisome enough. Although most HPV infections cause no symptoms and clear the body in less than a year, persistent HPV can cause cervical cancer and genital warts. S.T.D.’s can cause infertility, pelvic inflammatory disease and other painful symptoms.

***

The new findings strengthen the case for providing HPV vaccine to young girls and for regular screening of sexually active girls to detect infection. There is also a clear need to strengthen programs in sex education. Exhortations to practice abstinence go only so far.

Teenage girls who are sexually active need access to contraceptives and counseling. They need to understand that the numbers are against them and that a serious infection is but a careless sexual encounter away.

Look at the bolded part and remember what we’ve just learned: HPV does NOT cause cancer and the CDC knows it. Has known it for several years. Yet it’s still barkering for Merck and fear-mongering around girls having sex.

The agenda of the Bush Administration couldn’t be clearer: it’s terrified of sexual females and determined to promote Big Pharma profits no matter who gets hurt. The HPV Scam is a neat way to accomplish both objectives with a single initiative.

But we knew that. What a lot of us don’t yet realize is how far the Bushies have taken their hatred of science, how far they’ve gone to turn science into a political tool. The CDC used to be an independent, more or less trustworthy agency that by and large did good work. It has now morphed into just another propaganda outfit for the ideologies and biases of conservatives and the religious right. Since we know they know they’re lying about the connection between HPV and cervical cancer, there’s no other rational explanation.

Gardasil Update

Someone responded by email to the Jack’s email on the Gardasil story. PeterT wants to point out that vaccinations in general are far more dangerous than we think and that no long term studies have been done on the Gardasil vaccination despite the fact that there’s at least one case of Gardasil (made by – who else – the infamous Merck) having caused partial paralysis in a patient.

When it comes to vaccines, it’s important to note also that skewed science and even malevolence are not limited to this one.

To the contrary, then: This is not best “saved” (although we’re getting plenty of rain), but given reading priority. Otherwise, a “rainy day” of a different kind may be in store for someone’s daughter (and they’ve even tried to push this on boys). It might be wise to get on the horse and protect our kids (and everyone) from the PetroPharma cartel–which, often enough, has demonstrated little interest in health, but much in profits. This mindset has much to do with having instilled the public notion that vaccines are the best way to prevent illness, or to “keep you healthy,” which, unbiased history and even science show, couldn’t be further from the truth.

Maurice Hilleman, at one time the world’s foremost vaccine expert and one of Merck’s (maker of Gardasil) most famous and prolific vaccine researchers and inventors (now deceased) said, “I think that vaccines have to be considered the bargain basement technology for the 20th century.”

The Gardasil Scam: HPV Does NOT Cause Cancer

Some time ago at Matewan I expressed doubts about Gardasil, the vaccination that was being forced on teenage girls supposedly because it acted to prevent cervical cancer. I suggested then that there was something fishy about all the political wheeling and dealing behind the scenes that had resulted in various governors – Texas’ Rick Perry for one – making Gardasil vaccinations mandatory.

It all sounded cooked. To begin with, Perry had very heavy connections with the pharmaceutical industry, including the companies that manufacture and distribute Gardasil. Secondly, studies show that some 94% of sexually active women have some form of HPV and in almost all those cases, it goes away by itself. Why, I wondered, would we be making the injections mandatory for a disease that cures itself without troubling the patient for the sake of maybe protecting the small slice of the population that might develop cervical cancer from HPV?

It sounded like another Bog Pharma scam but it may be far worse. Turns out that studies actually show that not only does HPV NOT cause cervical cancer, the Gardasil itself does.

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 was sent to me via email from a friend and comes from a websight called NaturalNews. Below is the entire text, with links. Read it and make up your own mind. It’s long but if you have or know a teenage girl or her family, it’s crucial information worth taking the time to read.

NaturalNews) 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 cervical cancer.

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 like Texas. 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 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

Click the NEXT button below to continue reading…

The Trail of Evidence

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 Text of the Petition

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.NaturalNews.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.

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 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.

Do HPV 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:

“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”

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: http://www.NaturalNews.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?

Interrogating Young Virgins

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.

Next: Do HPV vaccinations help anyone? We reveal a four-quadrant comparison that shows the vaccine to be more harmful than helpful.

The Four 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 Active No Gardasil Vaccine	Quadrant II: Non-Sexually Active Receives Gardasil Vaccine
Quadrant III: Sexually Active No Gardasil Vaccine	Quadrant IV: Sexually Active Receives Gardasil Vaccine

Based on what we’ve learned from the FDA’s own documents, here are the likely outcomes of each of the four quadrants:

Quadrant I: Non-Sexually Active, No Gardasil Vaccine
Outcome: No risk of cervical cancer.

Quadrant II: Non-Sexually Active, Receives Gardasil Vaccine
Outcome: No medical benefit from vaccine.

Quadrant III: Sexually Active, No Gardasil Vaccine
Outcome: HPV presence is self-limiting and does not lead to cervical cancer.

Quadrant IV: Sexually Active, Receives Gardasil Vaccine
Outcome: 44.6% Increased risk of precancerous lesions. No reduction in cancer risk.

In other words, Gardasil adds no benefits to any quadrant! There is no subgroup that actually benefits from a Gardasil vaccination. But there is at least one quadrant in which Gardasil achieves an increased risk of disease. Put another way, Gardasil helps no one, but it harms some.

This is hardly a position from which to mandate the vaccine for everyone, especially since the vaccine has been widely prescribed as “completely safe” for everyone. It is widely claimed by medical authorities that the vaccine has no downside: No health risks, no increased risk of disease and no potential to cause harm in women. Clearly, these assumptions have no basis in scientific fact.

Keep in mind, too, that Merck, the manufacturer of Gardasil, has publicly suggested that young boys should receive Gardasil vaccinations! Why? Because they might engage in oral sex with girls who carry the virus. Therefore, the story goes, young boys should be vaccinated against this virus that they claim causes cervical cancer! (Never mind the fact that boys don’t have a cervix…) There is no end, it seems, to the pseudoscientific nonsense that will be spouted in an effort to sell more Garsasil vaccines to people who don’t need them.

Next: New clinical study shows Gardasil to be medically useless.

Research Shows 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 yourself.

Just in case that copy disappears, we’ve also hosted the PDF here: http://www.NaturalNews.com/downloads/HPV-Vaccine-Effects.pdf

This document reveals startling information about the ineffectiveness of the Gardasil vaccine. It reveals that the HPV vaccine often caused an increase in the presence of HPV strains while utterly failing to clear the viruses in most women.

These shocking results caused the study authors to publish this sobering conclusion, printed in JAMA:

“No significant evidence of a vaccine therapeutic effect was observed in analyses restricted to women who received all doses of vaccine or those with evidence of single HPV infections at entry (Table2). We observed no evidence of vaccine effects when we stratified the analysis on selected study entry characteristics reflective of [various parameters] (TABLE3). Similarly, no evidence of vaccine effects was observed in analyses stratified by other study entry parameters thought to potentially influence clearance rates and efficacy of the vaccine, including time since sexual initiation, oral contraceptive use, cigarette smoking, and concomitant infection with C trachomatis or N gonorrhoeae (Table 3).”

In other words, the authors found no evidence that the vaccine worked at all. This observation led the authors to offer this damning conclusion that appears to render Gardasil nothing more than a grand medical hoax:

“… rates of viral clearance over a 12-month period are not influenced by vaccination.”

The study goes on to state words that should cause every doctor, Governor and health authority across the United States (and around the world) to rethink Gardasil vaccination policies:

“…given that viral clearance rates did not differ by treatment group and that persistent viral infection is the best established predictor of risk of progression, it is unlikely that vaccination could have a significant beneficial impact on rate of lesion progression.1,17

Results from our community-based study provide strong evidence that there is little, if any, therapeutic benefit from the vaccine in the population we studied. Furthermore, we see no reason to believe that there is therapeutic benefit of the vaccine elsewhere because the biological effect of vaccination among already infected women is not expected to vary by population.

In other words, the vaccines didn’t work on the population studied, and there is no reason to believe that those same vaccines would magically work on other populations, since the biology of women and HPV is so similar across various populations.

Next: Is Gardasil a grand medical hoax?

The Conclusion: 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:

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. NaturalNews 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.NaturalNews.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.NaturalNews.com/Merck.html

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.

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Sources Cited

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

New England Journal of Medicine Prints Report Critical of GlaxoSmithKline Drug (Updated)

The Boston Globe reported today that a new study released early by the New England Journal of Medicine on its website questions the safety of one of the largest-selling diabetes medications in the country, Avandia.

Avandia, the world’s top-selling oral diabetes drug, significantly increases the risk of heart attacks, a prominent cardiologist said in an article that the New England Journal of Medicine deemed important enough to post on its website yesterday, weeks before the scheduled print publication date.

Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic and the article’s lead author, pored through summaries of dozens of studies and found a 43 percent higher risk of diabetics suffering a heart attack if they took Avandia compared with other drugs or sugar pills. Nissen was unable to determine whether the risk is affected by how long Avandia is used or how much is taken.

***

“The leading cause of death in diabetes is heart disease. It causes between 65 to 80 percent of all diabetes mortality,” Nissen said in an interview. “When a diabetes drug, which is intended to reduce the risk of diabetes complications, actually increases it, it has profound public health consequences.”

In an accompanying editorial published by the New England Journal of Medicine, Bruce Psaty and Curt Furberg, doctors who are critics of the FDA’s drug-approval process, said there is little reason for doctors to prescribe Avandia….

(emphasis added)

The drug is produced by GlaxoSmithKline, a major player in Big Pharma, and is worth over $$$3BIL$$$/year in sales worldwide. GSK immediately attacked the report, claiming it’s “flawed”.

That’s not particularly surprising, nor is it surprising that after the Vioxx debacle, the release of the report triggered a nosedive of GSK’s stock.

Since the Food and Drug Administration approved Avandia in 1999 doctors have written tens of millions of prescriptions for the drug. The Journal released the paper in advance of its June 14 print publication date partly because of its public health impact, according to executive editor Dr. Gregory Curfman.

Investors and others, including members of Congress, yesterday reacted strongly to the article.

GlaxoSmithKline shares closed at $53.18, down 7.85 percent, in heavy trading.

(emphasis added)

The big question here is, “Where was the FDA?”

Medicare Drug Benefit Turns Into Bonanza for Big Pharma

It didn’t take a genius to figure out that Bush’s prescription drug plan – you know, the one that expressly forbids Medicare from bargaining over prices – was going to turn fairly quickly into a bonanza for Big Pharma, so I don’t imagine it will be much of a surprise to learn that that’s exactly what’s happening.

After some initial success containing drug prices, private insurers in the new Medicare prescription drug program may be losing their leverage over drug manufacturers as they try to hold down medicine costs for seniors and the federal government, House investigators have found.

Prices for 10 of the most prescribed brand-name medications have shot up an average of 6.8 percent since December under Medicare private insurance plans, while wholesale prices for the same drugs have risen just 3 percent, House Oversight and Government Reform investigators say. The cost of a month’s supply of cholesterol-controlling Lipitor had climbed 9.6 percent, to $84.27 in mid-April, from $76.91 in mid-December. Over the same time, list prices climbed 5 percent.

Premiums for Medicare drug plans have jumped 13 percent over the past year, when the drug plans went into effect, the investigators say.

And the rebates that insurance companies are wringing out of drug manufacturers are expected to total 4.6 percent of total drug costs, down from 5.2 percent last year. A year ago, Medicare actuaries had expected insurers in 2007 to secure manufacturers’ rebates of 6 percent, then pass those savings on to seniors and the government.

“Essentially as an economist this is just what I would have predicted,” said Marilyn Moon, director of the health program at the American Institutes for Research and a former trustee for Medicare and Social Security. “When you introduce a new program, with all of the fanfare, everyone is anxious to get the best prices, the best look and demonstrate the private sector can handle it. But over time, when you’ve gotten your customers lined up, prices tend to slip upward.”

“Slip upward”? Slip?! They didn’t slip. They were pushed.

Economists and accountants always like to talk as if the market is a force of nature with its own rules that’s beyond any human’s control, but that’s bullshit. Actually Moon explains the problem quite competently if you put aside the force majeure thang: once a corporation’s got you hooked, it can abandon loss-leader pricing and return to its comfort zone – unrestricted greed.

Prescription Drugs in America: A Daughter Turns Smuggler

This is a personal anecdote, it’s true, but it’s a story that is being replicated by the millions every day. The Bush Administration’s fawning over the heavily-contributing pharmaceutical industry has made America into a Third World country where everyone except the very rich may have to break the ‘laws’ that govern drug sales in the US if they want to keep sick relatives from dying. The FDA, originally intended to protect us from dangerous or poorly manufactured drugs, has become under Bush the profits-protector and dogsbody of the pharmaceutical industry, cracking down on Americans trying to find alternate foreign sources for drugs they can’t afford to buy legally here.

The new drug my father’s oncologist was prescribing for him was well known to me (for legal reasons, I will omit its name and the manufacturer’s name), for it had a fearsome reputation from decades earlier. How expensive could this drug be, I wondered, when all the research and development had been done 40 years ago, at a fraction of the modern costs? A hell of a lot, was the answer. I still don’t know why. But in my father’s case, it was about $47,000 a year, with the potential to triple, based on his clinical response, to $141,000 a year. At this rate, in seven years, he could conceivably have spent a million dollars. Although he had profited from decades of employment in North America, he had not profited well enough to pay for that, and he was realistic enough about his medical future to resist becoming “spent out”—the current jargon for those who have anted up all in pursuit of staying alive—leaving him and my mother financially ruined (at which point, ironically, they would have been eligible for free drugs).

Like millions of frustrated others, I turned to the Internet, hoping to find some way of acquiring what my father needed. There was a whole cadre of us out there, I learned, seeking drugs for ill parents, or spouses, or children. There were those looking, and those giving—including the survivors of the deceased, who were willing to pass along the remnants of no-longer-needed prescriptions.

This was new to me, this drug-recycling, and sadder perhaps than the need to go outside the US to find affordable medications. The idea that in the United State of America, the richest and most powerful country on earth, its citizens–and not just the poor–are being reduced to stockpiling old, left-over prescriptions in order to pass them on to others who cannot afford to pay the outrageous prices drug companies charge for them, almost made me cry–and scream in rage at the same time.

I know what this means. It means going through the drawers and the medicine chest and the bedside table of a deceased relative after the funeral, and then checking the wastebaskets for what might have been thrown away and the closets and pockets and nooks-and-crannies where medicine may have been left and forgotten in the last days. It means knowing that someone’s life may be saved by your doing this, yes, but it also means understanding that someone else may die who doesn’t have to if you don’t.

Think about that: people are conceivably dying in America because bereaved survivors either don’t know of the need or can’t bring themselves in their grief to separate a loved one’s drugs into what is useful and needed and what is not. In other words, someone is dying because someone else isn’t picking through the trash of one who has passed. Like vultures, we have been reduced to feeding off the leavings of the dead. I’m having a hard time getting my head around that.

Upon my father’s retirement in 1991, he automatically became covered by Medicare and chose to purchase supplemental AARP hospitalization insurance. He decided against the supplemental prescription-drug insurance because, as he later told me, he could not conceive of any drug costing enough to justify paying $2,400 a year for it. For me, one of the more painful aspects of our predicament was the fact that my father, a son of the Depression and of World War II, prided himself on always being prepared for the bleakest prospects the future might deliver. But not even his darkest imaginings could prepare him for the breathtaking ascent in the price of drugs—costing Americans $213.4 billion in 2003—which he regarded as a personal failure of his preparedness skills.

Because more than a third of Medicare patients have no prescription-drug benefits, Congress enacted the Medicare drug bill last December, at an estimated cost of $400 billion over the next decade. In the weeks following its passage, it became a matter of morbid curiosity to me to assess whether or not the new law would have solved my father’s problems. If he had survived, here is what he might have looked forward to: After paying a $420 annual premium, plus a $250 annual deductible, the government would have covered 75 percent of his prescription costs up to $2,250; he would then have been responsible for all payments up to $5,100, at which time the government’s catastrophic aid would have kicked in, paying 95 percent of his drug expenses. So I estimate that he would have been responsible for $6,115 of his $47,000 cancer drug. Would he have paid that much? I can’t say for sure. Locked into a fixed income that was in decline along with the stock market, he might have decided against it. (emphasis added by me)

She’s probably talking about a pension plan, but that is what the next generation can look forward to if the Pubs go through with their plans to privatize Social Security–people will live or die, literally, based on how well their retirement stock portfolio is doing–if they have one.

If he had been a middle-income senior with modest drug costs, he would probably have fared no better and might have ended up paying more in annual premiums than his drugs cost. If his expenditures had fallen into the “doughnut hole,” between $2,250 and $5,100, he would have found little relief. Ironically, his worst-case scenario under the new plan would have been a complete reversal of what had been the best-case scenario, i.e., a retiree who still enjoys employer-paid health coverage. Such people were once the lucky few; but under the new legislation, all 3.8 million of them stand to lose that coverage entirely. And those whose new Medicare drug bene-fits will be provided via privately run programs could find themselves denied expen- sive drugs, say, ones that cost $47,000.

So who will fare well? Doctors and hospitals will get a boost, because a scheduled cut in their Medicare payments has been eliminated. The insurance companies will receive new subsidies designed to encourage them to cover seniors and the disabled. But the really big winners will be the drug companies, who are estimated to see a 9 percent increase in sales, or $13 billion in additional profits per year.

Hard as it may be to believe, that estimate is low–I’ve seen some reasonably reliable reports that project as much as twice that. The final numbers, according to one study, may depend on how many families choose bankruptcy over death–and how many of the dying choose ‘death with dignity’ over turning their loved ones into paupers in order to enlarge the already obscene profits of drug corporations.

It’s a long article I can only excerpt, but I urge you to read the rest of the story of what this woman went through trying to find the drug that would keep her father alive. It’s a sobering account of the fight we will all one day face if the drug corporations aren’t brought to heel. Along the way, she debunks the ‘R&D’ argument drug corporations use to justify their prices (predictably, they spend more than twice as much on marketing as they do on research–$45Billion to less than $20Billion for R&D) and describes the hoops the FDA made her jump through in order to satisfy the Corporations that her ‘need’ was genuine. It’s a terrifying picture of what happens when govt is ‘friendly’ with Big Business–they work together to give the rest of us the shaft.

I will leave you with this:

We had already tried this—back in the beginning—following the advice of one of my father’s doctors, who suggested that we need not be “entirely truthful” as to his financial situation on the application. So we lied, but only a little, and were rejected. Now, a year later, we would try again, and I was prepared to be utterly ruthless this time. It did not feel like stealing because, in all honesty, I didn’t feel bad about milking a company so willing to do the same to us.

---

In response to the high prices, a few states and municipalities are beginning to flex their bargain-hunting muscles too. Springfield, Massachusetts, is reimporting drugs from Canada for its city employees. Burlington, Vermont, plans to follow. Boston announced it will do so for 7,000 employees and retirees, saving an estimated $1 million a year. New Hampshire plans to reimport for its prison population and Medicaid patients. Initially, the U.S. government seemed to take this trend in stride. But last December, when Illinois announced its plan to save $91 million by reimportation, Governor Blagojevich was warned by the feds that such a move would be illegal. “Our law is very specific,” said a government spokesperson. “It’s not ‘will not.’ It’s ‘cannot.'” And drug companies are also being aggressive: GlaxoSmithKline warned Canadian pharmacies to stop selling to Americans or their supplies would be shut down.In the wake of this anarchy, a few in Congress are re-examining a bill sponsored by Rep. Gil Gutknecht of Minnesota that would allow reimportation from FDA-approved facilities in 25 industrialized countries and employ technology to prevent counterfeiting. But if the pharmaceutical industry gets its way, such legislation will die—turning an increasing number of sick and desperate Americans into outlaws, or forcing them into early graves.

Meanwhile, my contact information floats in cyberspace, and I continue to get requests from the others out there with first names only who are looking for the same drug my father once used. I am more than happy to tell them what I know, how to work the system, how to break the law. “Thanks so much!” one contact responded. “(And thank goodness for email and the wonderful network of caring people such as you.) This is terrific information! Until the FDA comes to its senses, it seems that those overseas are truly our friends.”

FITE: Drug Companies Rip Off Seniors

Newsletter #31

We met a truck driver, Bob, about a year ago in the course of our campaign against state budget cuts. “How are you doing?” we asked. “I’m doing OK, but my Mom’s not.” He explained that “Since the budget cuts have started, she isn’t eating.” And, he added, “What good are meds if she can’t afford to eat?”

Hoping the new Medicare cards proudly trumpeted by the Bush people would get her eating full meals again, we asked Bob last week how his mother was doing. He said he had just visited her the day before, and there still wasn’t much food in her refrigerator.

We later found out the reason. According to AARP, the nations largest advocate for seniors, the drug companies started raising the prices of the drugs most used by seniors much faster than usual just before Medicare cards were introduced. The result is that seniors like Bob’s mom, the ones most in need of the discounts, will get no benefit whatsoever. Meanwhile, the seniors who can afford supplementary insurance will help to fatten even more the coffers of the drug companies.

A percentage of these seniors will die prematurely, constituting part of the 18,000 deaths each year of people without health insurance.

Meanwhile, drug companies will make out like bandits they are, making profits that are the envy of the Fortune 500. They will reinvest little of their profits in new drug development. Hundreds of them in the industry invested so little in research that all of them together produced only 7 genuinely new drugs last year.

Instead, they invest in what are, in effect, bribes. These bribes, called “campaign contributions” in the nation’s press, can earn up to 30,000% return on investment. Seventy drug companies paid $5 million dollars for the right to sell the discount cards. In addition, the drug barons of the drug industry bribe doctors to prescribe drugs that are more expensive but no better than the older and cheaper drugs.

And of course these drug barons got an ample share. These CEOs “deserved” it, of course, for the hard work they put into arranging the discount card fraud. Including the value of stock options, many of these embezzlers make well over $100 million a year, which works out to more per HOUR than the average worker makes in a YEAR.

By the way, as of this writing, we heard that Bob’s mother has just been rushed to the hospital.

Charles Palson

—————-

Sources and further reading:

“Study Blames 18,000 Deaths in USA on Lack of Insurance,” Steve Sternberg, USA Today

“AARP: Drug Prices Jumped in Early 2004,” Mark Sherman, AP

“The Truth About the Drug Companies,” Marcia Angell

“Investigators Say Drug Makers Repeatedly Overcharged,” Robert Pear

So are we all shocked and surprised? This is why the bill was written the way it was: drug company lobbyists wrote it, the AARP–which is now bitching about it–supported it, and the Republican Congress dutifully passed it. It was a brilliant piece of stealth legislation, hiding its real purpose behind a ‘compassionate’ front that Junior will campaign on as if it were real, naturally.

People, we have got to stop letting ourselves be suckered like this. We got tricked into a bill that pretends to help seniors pay for their drugs when what it really does is let the drug industry make a lot more money by forcing Bob’s Mom and millions like her to choose between medication and food. We need to start catching these tricks before they become law, not after.