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Gardasil® and Free Choice: Holy Grail or Population Control?

Gardasil® and Free Choice: Holy Grail or Population Control?
PJ Langhoff
http://www.americanchronicle.com/articles/viewArticle.asp?articleID=48132

“I want to be one less.” You’ve probably seen the commercial with many young, hip, smiling female faces making paid declarations of interest in big pharma’s newest vaccine brainchild, Gardasil. Developed by Merck & Company, Inc., (Whitehouse Station, New Jersey), Gardasil is the promise of a new horizon in preventative female reproductive cancer medicine. It is actively being served to the masses in palatable 60-second segments of expensive air time. These commercials are designed to convince young women and their parents that cervical cancer is the new “boogey-man” threatening their existence. No need to fear, Gardasil is here as a “safe” and “effective” preventative vaccine. The consensus is that recipients will be “one less” victim of cervical cancers, but is the vaccine truly safe, effective, or even necessary?

Has anyone else noticed that American television ads seem primarily funded by big-name pharmaceutical companies attempting to reach a mass consumer market and create a demand for their products? The mindset being broadcast into our homes is, “Do you have any of these symptoms? Then try our product, we’re on your side.” Listening closely, you hear a gentle, reassuring voice ramble off a long list of side-effects which seem far worse than most of the symptoms we already may have. But the images of smiling people leading picturesque lives, quickly reassure the less in tune that drug companies have our best interests at heart. And perhaps they do, or perhaps not.

From their perspective (in my opinion), consumers are sheep, (commonly referred to as sheep-le) able to be directed into our cars to run, (not walk) to our nearest managed-care facility, pay a co-pay, smile at our privileged 5-minute face time with our physician while we happily diagnose our own ills and request pharmaceuticals by name. Many doctors are happy to write a prescription for the symptoms we explain so eloquently because we saw them first on TV, and because many are receiving incentives from their drug suppliers, like free lunches, and financial and other perks of the sort I cannot mention here. In fact, when I must go to the doctor’s office, I cringe at the sight of whom I consider the new drug “pushers”, a/k/a pharmaceutical reps who seem to have carte blanche over my appointment time slot that I waited for up to a month to get. In fact, big Pharma’s brazen presence in my physician’s office causes within me a form of intellectual nausea untreatable by any prescription, even those recommended on TV.

Any time I learn of yet another vaccine, my knee-jerk reaction is, “Great, now what are ‘they’ (big Pharma and/or perhaps some oft government-funded body) trying to do to us now?” Like many Americans, I believe that drug commercials and the permeating presence of Pharma in medical centers are having quite the opposite reaction than intended. People do not want to see drug advertisements on television and do not want to be told what medicines or vaccines are “good” for them. Indeed many of us can, and do prefer to think for ourselves, thank you very much. Personally, I find it insulting that certain corporate giants imply that consumers are not intelligent enough to understand the bodies they inhabit, or otherwise determine their own health needs, and that the manufacturers must do it for us.

I spent a little time studying the Gardasil vaccine (and others), and present some of my findings here for your examination. Pardon me if there is a subtle detectable prejudice for self-preservation as an undertone. It is hard to be objective when you see apparent negativity about a product, even when FDA-approved. I am not a doctor, therefore you must do your homework and decide what is right for you or your child(ren).

HPV is short for the human papillomavirus, one of the causative agents of cervical cancer. According to the FDA, cervical cancer is the most common sexually transmitted infection in the U.S. It is estimated by the CDC that approximately 6 million Americans become infected with this family of viruses each year. About 9,000 new cases of cervical cancer are reported in the U.S. annually, with an approximate one-third mortality rate. Across the globe, cervical cancer is the second most common cancer in women, with about a half million new cases each year. In general, routine Pap tests remain an important (but not 100% accurate) screening tool to detect precancerous changes in cervical cells that may develop into cancer. It is recommended to have a Pap test annually, once a woman becomes sexually active, or beginning around age 21. Men also transmit the virus, however there is currently no official test to screen males. A study was published out of the Pathology Dept. of West Virginia University (Urology, 1991 Feb; 37(2):110-5), describing the immunostaining of urethral smears for HPV antigens. This process proved to be more sensitive than conventional observations, including visual examinations. Unfortunately this technique is not routinely used in male reproductive health exams. Perhaps it may prove to be a useful tool which should be considered.

There are different types of HPV virus, and the Gardasil vaccine addresses four of them. Types 6 and 11 cause about 90% of genital warts; and types 16 and 18, cause about 70% of cervical cancers. The vaccine is administered intramuscularly as a series of three injections over a six-month period. Costs for the vaccine are $300-$500. Since males can transmit HPV to females, studies are underway to determine if the vaccine would be safe and effective for men. Trials are underway to study the vaccine in young men ages 16-23 years of age. Gardasil is only approved for use in females at this time, between the ages of 9 and 26.[1] Like most parents, I have more than one young adult child fitting neatly into this wide age bracket. And with the skyrocketing rates of infertility climbing in today’s generation, as a mother I would have concerns about a vaccine being promoted as a “safe and effective” preventative for any reproductive purposes, especially when I find much indicating that vaccines may contain various contaminants, leading to unknown autoimmune or other illnesses.

The FDA approved the vaccine in June of 2006. Gardasil was determined to be “safe” after evaluations of about 11,000 study individuals. Most adverse experiences in study participants were limited to “mild” or “moderate” local reactions, like pain or injection site tenderness. This would seem to put the mind of women at ease, right? Read on. Although the FDA claims that the vaccine is “safe,” it also noted “compelling evidence” that it could actually make cancer worse in women who were already exposed to HPV when they received the vaccine.[2] And most people who have HPV are unaware they are infected. The FDA stipulated, and manufacturer Merck agreed to continue studies to further evaluate the vaccine’s safety and long-term efficacy. The company will also monitor the pregnancy outcomes in women who unknowingly become pregnant, who subsequently receive the vaccine.

This makes me feel more than a bit nervous about the reproductive consequences of an entire generation of young women (and men if approved for that use), with voluntary (or mandatory) involvement in a global laboratory experiment...especially when governments are pushing for compulsory vaccinations which have less than adequate safety studies.

After learning recently that certain vaccines may have had unintended contaminants in them like hCG, I feel grave concern over vaccines in general. Human chorionic gonadotropin hormone is responsible for aspects of egg maturity and ovulation, and the administration of it as an “unintended” contaminant in tetanus vaccines issued to women in the Phillipines, is shocking. Many women receiving these vaccines are said to have been caused to become sterile.[3] The ability to utilize hCG as a contraceptive in women was known several years previous to a 1997 article, published by the American Journal of Reproductive Immunology, out of the National Institute of Immunology in New Delhi, India. From this article’s abstract, we learn of the utilization of hCG in tetanus, and diphtheria vaccines.[4] How do we as parents, know whether hCG has been deliberately or “accidentally” snuck into the newest vaccines also geared toward the supposed “health” of young women, including Gardasil, and which may therefore cause an epidemic of infertility in the next generation? Infertility rates in our nation have already skyrocketed. Who’s to say that the vaccinations we received as children didn’t already contain agents designed to cause a decrease in population?

The idea of forced vaccinations and possible involuntary “experimentation” by pharmaceutical companies on the human population, brings up civil rights issues of the right to be informed of the ingredients of the medications and vaccines we receive, as well as whether we wish to relinquish the right to decide our own medical care to any government entity. When asked, most people do not want medical or reproductive choices being dictated, mandated, or hidden for any reason within drugs, vaccines, or other medical delivery devices without our consent. Our desire for freedom of choice is made stronger when we know that pharmaceutical companies stand to profit in the billions of dollars for mandated vaccines and other devices, whether “safe and effective,” or not. And history has shown that the vaccine process in general, is embroiled in controversy, with long-term consequences poorly understood and much profit being made at the expense of human lives.

According to the watchdog organization Judicial Watch, 3,461 complaints have been filed with VAERS (Vaccine Adverse Event Report System) since Gardasil’s June 8, 2006 approval. Judicial Watch President Tom Fitton said the adverse event reports suggest that “the vaccine not only causes serious side-effects, but might even be fatal.”[5] So far 11 women were reported to have died after exposure to the vaccine. The complaints more than doubled compared to the original 1,637 adverse events reported by the Alliance for Human Research Protection, of which 371 were serious, including 3 deaths. For example, one female patient died of a blood clot 3 hours after the vaccine injection; and two girls, aged 12 and 19, died from heart problems and/or blood clotting. A VAERS report shows a 17-year old girl died the same evening she received the first dose of Gardasil, and her cause of death was listed as “unknown.” It was noted that she had dental surgery a day before the vaccine.

Another VAERS report lists an 11-year old girl who died within days of receiving Gardasil. Her cause of death was noted by her physician as “due to an anaphylactic reaction to Gardasil”.[6] A May 10 to September 7, 2007 VAERS report obtained from the FDA shows a 22-year old woman who received the vaccine May 21, and died 2 days later. An autopsy report showed “no findings,” and the party reporting the death said the vaccine was “not” the causative factor. How would they know, I ask, when the autopsy doesn’t prove a relationship either way?

Of 77 women who received the vaccine while pregnant, 33 had side effects. Of 42 women vaccinated while pregnant or around the time of conception, the FDA reported that 23 had complications ranging from miscarriage to birth defects in their children. Nevertheless, vaccine manufacturer Merck says that birth defects caused by the vaccine it developed were “highly unlikely.”[7] Other side effects reported as a result of receiving the vaccine, were paralysis, Bell’s Palsy, seizures, blood clotting and circulation disorders, and Guillain-Barre Syndrome. According to the FDA in documents received by a Judicial Watch FOIA request, an October 4 report indicated that since May 15, 2007, there have been an additional 1,824 reports of Gardasil vaccine adverse events. Unfortunately, the FDA only supplied partial records to the FOIA request. On October 3, 2007, Judicial Watch filed a lawsuit against the FDA to force full compliance to the FOIA request as required by law.

There are insufficient long-term safety and efficacy studies, and an article in the New England Journal of Medicine questioned the general effectiveness of the vaccine. Filed with the FDA/CBER (Center for Biologics Evaluation and Research), is an executive summary including the duration of efficacy. It notes, “No immune correlation of protection was identified from the Phase III trials.” It also notes a “higher proportion of cases of respiratory illnesses and gastroenteritis among infants of mothers who were administered Gardasil during the time they were breastfeeding their infants,” and discusses adverse events, including fetal abnormalities and recipient deaths.

According to the summary, Merck is collaborating with four Nordic countries (Norway, Sweden, Denmark and Iceland) to assess the long-term outcomes of 5,500 recipients of the vaccine over a period of 14 years. If approved by the European Union, the Norwegian government intends to incorporate HPV vaccination into its national guidelines.[8] Vaccinations are already compulsory in Australia and are becoming so in the UK and Europe, although parents and children are largely protesting the intrusion on the “right to choose.”

The vaccine has not been tested for effectiveness in girls, such as those as young as 9. The youngest girls participating in clinical trials were ages 11-12, but the vaccine is approved in children as young as 9; an age group not studied. Without good evidence of side effects and safety, it is astounding that governments are attempting to mandate the vaccine. Still, several U.S. state and local governments have requested that the vaccine become mandatory. On September 12, 2006, Michigan became the first state to propose compulsory vaccination in girls entering the 6th grade. Fortunately, provisions in the bill were given for parents wishing to opt-out as in other vaccines. New Mexico followed suit. In Texas, Governor Rick Perry bypassed the legislative process entirely and issued an executive order mandating vaccination against HPV for girls entering sixth grade as of September 2008. He was accused of sidetracking parents’ rights groups and any legislative opposition by doing this; in effect, making HPV a public health issue of greater significance than parents’ rights to decide medical care for their children.

Recent events in Prince George County, Maryland, prove that those who have no business mandating vaccines, like school boards or county governments, are attempting to side step the rights of parents to choose whether their children should receive vaccines. Under strong threat, many parents felt coerced into giving their children vaccines they otherwise might not have chosen. Indeed, parents had been ordered to appear before a court hearing to prove their children were compliant with state requirements on vaccinations, or face fines and/or jail time. The process of immunization felt to many like a “cattle line” according to a Christian Science Monitor News article. Protesters outside the courthouse claimed parents were not adequately informed of their right to opt-out of the vaccine for religious or medical reasons, and were also not informed of possible harm to their children before receiving the vaccine. As a result, about 100 children received vaccines in November, under what many might call “less than optimum freedom of choice” conditions.

As reported in Reuters February 21, 2007, after pressure from religious organizations and parents, vaccine manufacturer Merck & Co. decided to “re-evaluate” its lobbying practices to make Gardasil mandatory. This is good news for parents and children alike, especially when there is such fierce opposition to the removal of a basic freedom – the right to choose. The problems with compulsory vaccinations go beyond religious or public health concerns. The mandatory assignment of any medical initiative removes the basic civil rights of patients and places our freedom of choice into the hands of government. It is not, and should not be, the right of the government to determine what should or should not be within our own bodies, and we must not relinquish our rights to freedom of choice.

Removing our freedoms are not only fundamentally, morally, and in our country, constitutionally wrong, it is dangerous in my opinion. Especially when we have governments being lobbied by powerful pharmaceutical companies contributing billions of dollars for pharma-friendly legislation designed to net tremendous profits for the vaccine manufacturers, and having unknown risks, including death, for untold populations. The mandating of vaccines on the global population turns civilians into nothing more than laboratory rats to be freely experimented on by pharmaceutical companies and governments alike.

Did you know that it is said that HPV can be treated by anti-viral herbs? Herbs which have been traditionally used include Garlic, Lemon Balm, Thuja, Hyssop and Pau d’Arco. Pau d’Arco has actually been used to prevent HPV infection, as well as cure it. Pau d’Arco was described in 1873 by Dr. Joaquin Almeida Pinto, for treatment of herpes, eczema and other disorders. In the 1960’s in Brazil, two physicians proved the herb had the ability to cure viral-caused warts. Other physicians in Argentina and the US have worked for decades to show that this herb has properties which heal the entire body. It is now used for AIDS, allergies, infectious diseases, asthma, candidia, Parkinson’s disease and a host of other infections and conditions, including warts, skin sores and HPV. It is commonly taken as a tincture or a tea. More importantly, no serious side-effects have been reported from its use.[9]

If we stretch the imagination, the mandating of vaccines is just one not-so-subtle step closer to total population control. Is that really what we want? We are being programmed to “accept” these activities beginning with the media visiting our very own living rooms, under the guise of protection from the “boogey-man”, and in this case, the current agenda is HPV. In reviewing Infectious Disease Society of America (IDSA) documents, the root of the push for global vaccines may be more encompassing, and sinister than imagined. In a letter dated 11/9/06 from Past President Martin J. Blaser to Chairman Jerry Lewis, House Appropriations Committee in Washington D.C., Blaser informs Mr. Lewis of the following. “As you are aware, the recent budget increases for the CDC stem from large earmarks for bioterrorism preparedness, the strategic national stockpile and other specific priorities.” In the letter, Blaser requests an “immediate appropriation of an additional $3 million” for the CDC to begin surveying adolescent immunization rates. Blaser indicates that the CDC is suffering “severe fiscal constraints and ongoing reductions at a time when vaccine needs are growing due to the licensing of several new vaccines including those recommended for adolescents and children.”[10] This would imply that because vaccine manufacturers have licensed new vaccines, societies have the right to, and must therefore push for their implementation. This would not imply that HPV or any other “health threat” actually exists. But the ability to manufacture a “perceived threat” to both the American people and its government, is the art and science of planning future research, grant and special-interest appropriations. The cycle of product/demand/funding self-perpetuates.

Another IDSA letter not authored by Blaser was sent to the HHS Assistant Secretary for Public Health Emergency Preparedness, Dr. W. Craig Vanderwagen, discussing the pandemic influenza implementation plan as part of the White House’s Homeland Security Council Biodefense Directorate. Although the body of the letter emphasizes influenza, it also encourages the department to “consider new paradigms,” and discusses implementation planning, including with a National Biodefense Science Board soon established under BARDA. While I understand the need for preparedness such as with influenza, at what point will the flu vaccine also become compulsory? And subsequent biodefense vaccines such as anthrax? The thinking may be if “we” can get the public to accept compulsory vaccines as “innocuous” as Gardasil, driven by carefully engineered “public health necessity,” how much of a step then is it for us to accept globally mandated vaccinations? Under the guise of “protection” we find a brilliant opportunity for pharmaceutical companies (and the governments and researchers who hold patent interests in vaccines), to exploit populations for trillions of dollars. I am beginning to see a pattern here, and it seems to be more in the line of profit, and not necessarily public health threat or safety.

Gardasil uses a new technology called a “nanoparticle” vaccine that is essentially more effective and cost-effective than past vaccine technologies. The U.S. government holds Patent #7,285,289 Nanoparticle vaccines, which was patented in part from work partially supported by the National Institutes of Health under contract PO1AI37194. The US holds “certain rights” to the invention. Nanoparticle vaccines can be developed for a broad array of infectious diseases, including HPV, influenza, and even bioagents such as tularemia and anthrax. But the process to “get” people to accept mandatory vaccinations is only in the beginning stages. If we accept Gardasil, next perhaps may come Influenza, and then mandatory vaccinations across the board. Then reproductive ability may be subsequently curbed due to yet more government mandates.

Am I sounding too sci-fi? Well, the point is this. When we relinquish our rights to choose, then choices are made for us. And those choices, whether “safe and effective” or not, are going to be made by governments and pharmaceutical companies alike whose for-profit interests may supercede public interests. At this rate, without cautious movement forward with the intent to protect our civil rights to choose, we may yet live to see the day where our younger generation says “I want to be one less.” But the meaning of those words will not be one less victim of cervical cancer, but perhaps one less citizen who has the right to choose.



References


[1] FDA. Product Approval Information – Licensing Action. Questions and Answers. Available at: www.fda.gov/cber/products/hpvmer060806qa.htm.

[2] FDA. New Vaccine Prevents Cervical Cancer. Sept-Oct 2006 FDA Consumer magazine. Access: www.fda.gov/fdac/features/2006/506_cervical.html

[3] Tetrahedron Publishing Group. HcG Vaccine for Population Control. [web site] Access: www.tetrahedron.org

[4] Talwar GP, Singh OM, Gupta SK, et al. The HSD-hCG vaccine prevents pregnancy in women: feasibility study of a reversible safe contraceptive vaccine. Am J Reprod Immunol. 1997 Feb;37(2):153-60. Access: www.ncbi.nlm.nih.gov.

[5] Judicial Watch [web site] Access: www.judicialwatch.org/gardasil.shtml

[6] VAERS Line List Report. Access: www.judicialwatch.org/archive/2007/ GardasilVAERSUpdatedDeaths0907.pdf

[7] Assoc. Content. Cervical Cancer Vaccine and the Controversies. [Internet article]. Access: www.associatedcontent.com/article/34830/cervical_cancer_vaccine_and_the_controversies.html?page=2

[8] FDA/CBER Executive Summary on Gardasil. Access: www.fda.gov/cber/sba/hpvmer060806s.pdf

[9] News Target. 8 More Deaths Caused by Gardasil Bringing Total Number to 11. [web article] Access: www.newstarget.cvom/022140.html

[10] IDSA Letter dated 11/9/06. Access: www.idsociety.org/archive.aspx?fid=16

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