Update 2014 – FDA approved Gardasil 9: Malfeasance or Stupidity?
“Why did Merck more than double the amount of aluminum adjuvant in Gardasil 9? What long-term health consequences are associated with the injection of 1,500 mcg of aluminum over a period of less than a year via 3 doses of Gardasil 9? Does this risk increase if Gardasil 9 is received at the same time as another vaccine containing an aluminum adjuvant? If so, how much?”
The $900 million federal/provincial funding of a three year Human Papillomavirus (HPV) vaccine program made taxpayer history in 2007-8. Gardasil®, manufactured by Merck Frosst, is the costliest scheduled vaccine yet. Are we getting value for our money? Will we eradicate cervical cancer? Is this vaccine safe? Apart from its drain on health budgets, there is abundant evidence that, despite what Public Health authorities claim, Gardasil® is risky, has NOT been shown to prevent cervical cancer and is unnecessary.
As of January, 2011, the Canadian Women’s Health Network states on their website: “HPV is necessary for the development of cervical changes, but it does not cause cancer by itself. No one knows for sure what else is needed for cancer to develop.” The February, 2007 Statement on HPV Vaccine by the National Advisory Committee on Immunization (NACI), pgs 2, 4 and 9 state: “Studies over the past 15 years have revealed almost all cervical cancers can be traced to infection with oncogenic HPV types” but, although “HPV is extremely common”, “most HPV infections are transient…individual episodes last between 4 and 20 months, less than half of infections still being present after 12 months”. (emphasis ours) According to a March, 2007 article at cancermonthly.com, Dr Elizabeth Unger of the US CDC stated at FDA discussions: “it is believed that infection alone is insufficient to cause cancer…There are certainly lots of questions about HPV infection.” And the medical text book, Cancer: Principles & Practice of Oncology, acknowledges, “HPV infection is not sufficient for cervical carcinogenesis” and, amazingly: “In most studies, HPV status was not a strong prognosticator of outcome in cervical cancer patients; however, there appears to be a trend for HPV-negative tumors to do worse…those tumors containing HPV DNA tend to be of an early stage and low grade.” (emphasis ours) Investigative journalist, Janine Roberts notes that “virus-like particles”, not HPV itself, are present in the vaccine. In her article, ‘HPV Vaccine Mysteries’ she cites a statement by the International Agency for Research on Cancer that HPV “cannot be propagated in tissue culture”, not even cervical cancer tissue, but must be made by cloning. And, in her article, ‘Not So Miraculous’, Moira Dolan, MD, Executive Director of Medical Accountability Network, reveals that, “Some researchers and FDA scientists wonder if the abnormal cells (cancerous or pre-cancerous) may simply be a friendly environment for viruses to grow around, so the virus infection may occur after the changes that cause cancer rather than the other way around.” During pre-licensing trials, rather than measure outcomes according to whether or not cervical cancer developed, the precancerous stages, CIN 2/3 and AIS were used as definitive markers for cancer – but these stages usually do not lead to cancer.
The Canadian Women’s Health Network lists many factors which increase the likelihood of cervical cancer developing:
The Network also notes: “We do know that poverty is linked to deaths from cervical cancer. Poor nutrition, stress and smoking are all linked with poverty.” Abby Lippman, Professor of Epidemiology, Biostatistics and Occupational Health at McGill University and chair of the Network’s advisory committee has noted that, although almost everyone will acquire HPV, healthy, immunocompetent individuals will clear 90% of it within 1-2 years. In the same article which provides Dr Lippman’s thoughts, gynecologist, Christiane Northrup agrees that rather than pouring resources into vaccines, more should be done to foster the overall health of individuals.
An amazing example of the positive effects of good nutrition is provided by Jonn Matsen, ND in his book ‘Eating Alive II’. He relates the findings of a study by Dr Maria Bell of Louisiana State University published in the August 2000 Gynecologic Oncology. Cervical cancer completely disappeared in 47% of women who consumed 400mg/day of a supplement containing indole-3-carbinol extracted from broccoli; women receiving a placebo showed no change at all in their cancers. It’s also interesting to note that only 80% of the cervical cancer patients in this study tested positive for HPV.
In pre-licensing safety trials of HPV vaccine, a sub-set of women who had tested positive for one or both of the “oncogenic” HPVs represented in the vaccine showed a 44.6% increased risk of developing high-grade (later stage) precancerous lesions following vaccination. VRAN sent a letter concerning this and a need to pre-screen for HPVs prior to administration of the vaccine to the Public Health Agency of Canada. A reply from Dr David Butler-Jones denied such a need.
Since Canada doesn’t have a vaccine adverse event monitoring system from which anyone – drug companies, doctors, public health units or the general public – can view reports, we suggest consulting the US Vaccine Adverse Event Reporting System (VAERS) which is open to all and easily accessible. Bear in mind, however, that the data provided by VAERS both understates and overstates vaccine adverse events that are occurring in USA; only 1-10% of all adverse events that occur are reported and some of the events reported may not be due to vaccines. Nevertheless the VAERS does provide a partial picture of what HPV vaccine is doing to the population injected.
As of October, 2010, VAERS had received 88 reports of death following injection of Gardasil®. See: VAERS: Vaccine Adverse Events Reporting System—Search for “HPV4″ and “Patient Died”. As of December, 2010, it had received 371 reports of life threatening adverse events following Gardasil® injection. See: VAERS: Vaccine Adverse Events Reporting System—Search for “HPV4″ and “Life Threatening”. Less serious events have included paralysis, seizures, arthritis, fainting, dizziness, nausea, headache and cases of genital warts (which the vaccine is also supposed to prevent). Dr Diane Harper, lead researcher in the development of HPV vaccine, has summarized a 2009 Journal of the American Medical Association (JAMA) report which questions the vaccine’s safety by saying, “The rate of serious adverse events is greater than the incidence of cervical cancer.” This statement is repeated in the January, 2011 report, Gardasil Vaccination: Evaluating the Risks Versus Benefits by Lucija Tomljenovic, PhD. Dr Tomljenovic has analyzed the VAERS reports and compared them to the many health conditions that science research has shown possible from Gardasil®. She notes that some doctors and others don’t even know VAERS exists and most are unaware of all the injuries that are possible. This, she says, means that the 20,915 VAERS Gardasil® incidents reported at the time she wrote her article could in fact indicate “as many as 200,000 to 2,000,000 adverse reactions”. Among the VAERS reports were listed “382 abnormal pap tests”. Dr Tomljenovic asks, “Could the vaccine exacerbate the very disease it is claimed to prevent?”
Allowing for this possibility, the May 2011 Gardasil® monograph, pg 54 admits: “Gardasil® has not been evaluated for the potential to cause carcinogenicity or genotoxicity.” If HPV does play a role in causing cancer, it’s possible that vaccinating against it will give rise to an increase in cervical cancer. This could arise due to replacement of HPV types suppressed by the vaccine with cancer-related types of the other 150 or more HPVs that are known to exist. In an article originally published on medscape.com, Sharmila Makhija, MD, principle investigator for Gardasil trials, noted such a possiblilty. Health authorities Canada-wide have been declaring that the two so-called “oncogenic” HPV types represented in Gardasil® are responsible for 70% of all cervical cancer. They are echoing the 2007 NACI Statement which, on pg 2 cites a 1998 Health Canada surveillance report as their only reference for this, and, on pg 4 admits, “to date, no population-based studies have been published.” A study estimating the prevalence of HPV infection in the US population published in the Feb 28, 2007 edition of JAMA found only 3.4% of women aged 14-59 yrs were infected with one of the four HPV types represented in Gardasil®; only 2% were infected with one of the two “oncogenic” types. Another consideration is that, by being vaccinated, girls may assume they are protected and thus able to continue unhealthy lifestyles with no risk of cervical cancer.
The Gardasil® monograph, pgs 6-7 states: “pregnancy should be avoided during the vaccination regimen for Gardasil®.” and, “It is not known whether antigen [immune-stimulating protein] or antibodies induced by the vaccine are excreted in human milk.
Of all the ingredients listed in the Gardasil® monograph, three in particular are high-risk. One of these, sodium borate, is commonly used in insecticides. Studies of polysorbate 80 suggest this ingredient might increase oxidative stress and impair fertility. Both polysorbate and aluminum are known to cause cancer in lab animals and to alter immune response; aluminum is a neurotoxin; peer-reviewed studies have linked it to macrophagic myofasciitis, chronic fatigue syndrome and Alzheimer’s disease. A 1996 position paper issued by the American Academy of Pediatrics states: “Aluminum is now being implicated as interfering with a variety of cellular and metabolic processes in the nervous system and in other tissues.” The growing number of children with diseases which involve such impairment may result in part from the growing number of vaccines which contain aluminum. The recommended three doses of Gardasil® contain a whopping big total of 675 micrograms of aluminum. This injected aluminum could act synergistically with the body’s accumulation of aluminum from other vaccines as well as from its myriad though much less easily absorbed non-injected sources to increase the toxic effects exponentially.
Pre-licensing trials showed high efficacy against the four vaccine type HPVs only in females who were not and never had been infected with those types at the time the first dose was injected. However, even this limited “high efficacy” may have been an inaccurate assessment. Unreliable testing methods were used to type the HPVs in trial participants; the presence of some vaccine type HPVs in vaccinated participants may have been missed. Condom use wasn’t tracked; condoms can reduce infection by all types of HPV by 70%. Furthermore, no efficacy trials have been conducted on girls younger than 15 yrs. And even if HPV does play a role in causing cervical cancer, its vaccine would have to be effective for a very long time before a reduction in that cancer could be noticed; fewer than 8/100,000 Canadians per year get cervical cancer and the median time for its development is more than twenty years.
One way pathogens can survive as a species is by having a great ability to infect (multiply in) their hosts; another is by inhabiting a great number of hosts. A ‘virology blog’ Jan, 2011 discussion re ‘Are all virus particles infectious?’ provides a table which shows a particle-to-PFU ratio of 10,000 for papillomavirus. This means that of 10,000 papillomavirus particles only one will be capable of infection. From this it appears that HPV has evolved to be so very common because it is so very seldom infective. It’s likely that many of the positive results from highly sensitive DNA HPV tests merely indicate a relatively dormant, “carrier state” of the virus.
Finally, it must be pointed out that Pap tests have reduced the incidence of cervical cancer to less than half of what it was in 1970. For those concerned about the possibility of acquiring cervical cancer, regular Pap testing is advisable. And note that vaccination with HPV vaccine does not guarantee freedom from HPV.
HPV Vaccine Safety Websites
Videos
Further Reading