Is Gardasil More Effective in Older Teens?

The Tragic Truth behind the Gardasil Nightmare

Friday, February 13, 2009 by: Herb Newborg, citizen journalist

(NaturalNews) Why have the pharmaceutical and biotechnology industries chosen to experiment with the first ever, large scale application of a new, unproven, genetically modified, inter-species gene mixing vaccine technology on the female youth of an entire generation?

Under the ruse of attempting to eradicate cervical cancer, Merck is actually engaged in the first large scale, real world deployment and testing of genetically modified DNA, genetically engineered proteins and genetics produced by the combining of genetic material from more than one origin or species in a vaccine.

The wide spread promotion and attempts to mandate the use of this drug in the United States is clearly not predicated on preventing deaths from cervical cancer as the drug has only been approved in the U.S. for use in girls 9-26, ages when deaths from cervical cancer happen rarely, if ever. Cervical cancer has been steadily decreasing in the U.S. since 1955.

The American Cancer Society states:

"Cervical cancer was once one of the most common causes of cancer death for American women. The cervical cancer death rate declined by 74% between 1955 and 1992. The main reason for this change is the increased use of the Pap test. This screening procedure can find changes in the cervix before cancer develops. It can also find early cervical cancer in its most curable stage. The death rate from cervical cancer continues to decline by nearly 4% a year. Cervical cancer tends to occur in midlife. Most cases are found in women younger than 50. It rarely develops in women younger than 20. Almost 20 percent of women are diagnosed with cervical cancer when they are over 65."

According to a 2001 presentation by Elizabeth R. Unger Ph.D., M.D., then Acting Chief, Papillomavirus Section of the U.S. Centers for Disease Control and Prevention (CDCP):

*HPV infection is very prevalent in the population

*OVERALL 75% of population exposed

*Genital HPV is acquired around the time of sexual debut

*Consistent epidemiologic association of HPV with cervical cancer precursor lesions

*Plausible biologic mechanisms for HPV oncogenesis (cells becoming cancerous)

*HPV oncogenesis is a rare event with long interval between infection and cancer

*Infection alone is insufficient to cause cancer

*Additional factors required for neoplasia (abnormal proliferation of cells)

Paraphrasing, more than 75% of the population is exposed to HPV. HPV exposure typically occurs when a woman becomes sexually active. There is an association between HPV and cervical cancer. HPV causing cervical cancer is plausible, yet it alone does not cause cervical cancer. Cervical cancer is a rare event and there is a "long interval" between infection and development of cervical cancer.

Now follow closely. Cervical cancer typically develops in mid life (around 48 years old) even though HPV exposure typically occurs at sexual debut. This new vaccine is purported to protect against a disease that occurs, if ever, 20 to 35 years after HPV infection. Yet the duration of protection from the vaccine is unknown.

According to the FDA Gardasil approval announcement: "For most women, the body`s own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later (emphasis added) can turn into cancer."

The clinical trials on this vaccine only lasted 5 years. It is chronologically impossible to have determined efficacy in preventing cervical cancer as a result of administration of this vaccine in the study population. Speculation as to whether the protection against HPV offered by this vaccine lasts beyond the five years of studies conducted to date is just that, speculation.

By the FDA`s own statement: "For most women, the body`s own defense system will clear the virus". Combined with the frequent Pap tests of study participants who were participating in a study of sexually transmitted disease, it is fair to say that the 20,541 sixteen to twenty-six year old participants in the clinical trials were far from a random representation of the average female`s risk for contracting HPV or developing cervical cancer.

The studies on nine to fifteen year old girls included far fewer participants and were halted prior to completion.

Speculation as to whether or not girls vaccinated with Gardasil will experience a lower rate of cervical cancer 10 to 30 years from now is also merely conjecture. As such, there is currently no official schedule on required booster doses of the drug.

In the FDA`s approval announcement, they state: "While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers."

Believed highly likely?

Is the role of the FDA to ensure that a drug has been proven to be a safe and effective or have we reduced the burden down to "likely to convey some benefit, maybe, sometime down the road"?

In addition, according to the FDA announcement of Gardasil`s approval , somehow the association and plausible mechanism between HPV and cervical cancer with the crystal clear statement that HPV "infection alone is insufficient to cause cancer" stated in the 2001 CDCP presentation magically morphed into "HPV is the cause of 70% of all cervical cancer".

Promoting a new, unproven, vaccine to an entire generation of young girls as a cancer vaccine, without adequate long-term safety or efficacy testing is unethical and in this author`s opinion immoral.

But wait, there is much more.

This is a whole new type of vaccine called a virus-like particle (VLP) vaccine. Anti-viral vaccines have traditionally been prepared by using attenuated, or weakened, forms of the infectious virus. This type of vaccine involves complications in manufacturing.

These brand new virus-like particle (VLP) based vaccines including Merck`s Gardasil and GSK`s Cervarix are the first ever FDA approved VLP vaccines. No long term studies or studies on populations larger than the Gardasil clinical trial (20,541 women for up to 5 years) have ever been conducted on VLP technology or the specific inter-species genetic mixing this technology represents.

According to National Institute of Health (NIH) documents:

"The underlying technology for the vaccine originated in the laboratories of Drs. John Schiller and Douglas Lowy of the NIH National Cancer Institute. Drs. Schiller and Lowy commenced their research on the molecular biology of HPV nearly 20 years ago. Among their numerous findings, they discovered that the major outer coat protein of the HPV virus, called L1, could self assemble into non-infectious virus-like particles (VLPs) that closely resemble the native outer shell of the actual virus.

The principle behind the vaccine is that exposure to VLPs triggers the immune system to produce protective antibodies. If an individual is exposed to HPV after receiving the vaccine, the immune system already contains the antibodies necessary to prevent virus infection. The antibodies primarily function by preventing the virus from binding to the cell which is necessary in order for the virus to reproduce and thrive.

The catch is that for induction of HPV neutralizing antibodies the L1 must be in the same conformation as in the intact virus. Unlike some other viral vaccines, inactivated virus produced in cultured cells was not a viable option because the viruses could not be produced in sufficient quantities in vitro. Also, the inactivated virions would still contain the viral oncogenes, which would preclude use in healthy young people, the primary target population. (In other words, the vaccine would produce cancer, not prevent it.)

Schiller and Lowy demonstrated that large quantities of VLPs could be produced in insect cells (emphasis added) infected with L1 recombinant baculovirus (a genetically engineered protein grown in insect larvae). Critically, they also showed in animal models that the L1 VLPs were able to induce high titers of neutralizing antibodies, comparable to those induced by authentic virions. Furthermore, they and their colleagues demonstrated that L1 VLP vaccination could protect animals from experimental challenge with high dose virus of the corresponding animal papillomavirus (emphasis added) types and that human and animal papillomavirus (emphasis again added) L1 behaved similarly in the ability to assemble into VLP."

While individual papilloma virus types tend to be highly adapted to replication in a single animal species, researchers have already identified inter-species transmission of papilloma virus in rabbits and cattle. The evolution of papilloma viruses is slow compared to many other virus types. It is believed that papilloma viruses generally co-evolve with a particular species of host over many years.

The long term results of introducing into the human body genetically engineered, recombinant human, insect and animal DNA, along with human and animal strains of papillomavirus are unknown, untested and unproven, particularly when used as a vaccine, which effectively bypasses all of the body`s natural defenses against outside pathogens (skin, saliva, mucous, etc.)

The current deaths and maiming of young girls used as guinea pigs to test this new technology may be just the beginning. No one can predict what adverse consequences this newest inter-species gene mixing technology may cause. Remember we are dealing with the reproductive systems of an entire generation of young woman.

Furthermore, the two strains of HPV which the vaccine purportedly protects against account for only 70% of all cervical cancers, leaving at least 30% of these young girls with no protection against cervical cancer. To call this a cervical cancer vaccine is a tragic deception.

In addition, many health care experts have publicly predicted that cervical cancer deaths will increase sharply, with routine Pap tests foregone under a false sense of security that Gardasil has made them immune to cervical cancer (and not just the two strains of alleged cancer causing HPV for which the vaccine claims efficacy).

The fact that the vaccine is not effective in girls already exposed to the virus, yet parental supervision is mandated during the interview to determine if the recipient is sexually active, further undermines the ability to discern "qualified" candidates for this potentially dangerous, new, experimental, unproven, falsely promoted vaccine technology. Imagine a 16 year old girl who does not want to confess that she has been sexually active to a parent stating that she has not and then being administered this drug. According to a reported Merck document, if this young girl has previously been infected with HPV, she has just increased her risk of developing high grade pre-cancerous lesions of the cervix by 44.6%.

It was reported to the FDA as early as October 30, 2006 by letter. Sin Hang Lee, M.D., a practicing pathologist wrote to Dr. Steven I. Gutman, Director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA, enclosing the manuscript of a scientific report titled "Human Papillomavirus Genotyping by DNA Sequencing-The Gold Standard HPV Test for Patient Care," which was submitted to a professional journal to be considered for publication. The purpose of the letter was to inform the FDA that a more sensitive and more specific device is being introduced for detection of HPV in clinical samples and for preparation of materials for HPV genotyping and to request advice and guidance from the agency for making this device available to hospital laboratories at the point of care . With this letter and manuscript, the FDA was informed of the need for a new generation of HPV testing based on new information available because:

1) A sensitive HPV detection device that can provide accurate genotyping information is needed for following patients with persistent infection that is now recognized to be the tumor promoter in cancer induction.

2) A 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.izov/ohrms/dockets/ac/06/br... [14].

Page 10 of the attached document included this statement:

The introduction of the type-specific Gardasil HPV vaccines among the sexually active women also requires genotype monitoring of the HPV infections before and after immunization to develop prevention strategy for the individual patients. Based on a `Background Document" submitted to the FDA by Merck & Co., Inc., injection of HPV vaccines into women who have concurrent vaccine-relevant HPV type infections may increase the risk, by 44 .6%, of developing high-grade precancerous lesions in the cervix. Therefore, it would be prudent to perform a sensitive HPV detection assay with accurate genotype determination on the patients to be vaccinated if prior HPV infection is suspected.

Recombinant DNA, genetically engineered proteins, inter-species gene mixing, questionable new vaccine technology, lack of long term safety and efficacy data, questionable pre-qualifications procedures and now, an extremely high prevalence of reported adverse side effects up to and including miscarriage and death.

This vaccine represents more than just bottom line profit for Merck. This is the first genetically modified drug unleashed across a broad swath of unsuspecting, formerly healthy Americans.

Unfortunately, the target they chose for this grand genetic experiment is the entire female population of mothers to be for all future generations. Can we really afford to allow this fraud and deception to continue?

Sources:

What Are the Key Statistics About Cervical Cancer? via American Cancer Society website

Human Papillomaviruses:Natural History and Virology, Elizabeth R. Unger Ph.D.,M.D. via FDA website

NIH Technology Licensed to Merck for HPV Vaccine via NIH Office of Technology Transfer website

FDA Press Release P06-77: FDA Licenses New Vaccine for Prevention of Cervical Cancer

and Other Diseases in Females Caused by Human Papillomavirus

Christensen ND (2005). "Cottontail rabbit papillomavirus (CRPV) model system to test antiviral and immunotherapeutic strategies". Antivir. Chem. Chemother. 16 (6): 355-62. PMID 16331841

Calleja-Macias IE, Villa LL, Prado JC, et al (2005). "Worldwide genomic diversity of the high-risk human papillomavirus types 31, 35, 52, and 58, four close relatives of human papillomavirus type 16". J. Virol. 79(21):13630-40 doi:10.1128/JVI.79.21.13630-13640.2005. PMID 16227283

RECLASSIFICATION PETITION FOR Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection via FDA website

Teresa Allen of SC 9:45PM March 30, 2009