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