Leslie Carol Botha: Only the Facts Ma’am – When one reads the politics and the science behind the marketing and the safety and efficacy of the Gardasil HPV vaccine approved for use for women ages 27 to 45 in Canada, one begins to wonder – is this vaccination really going to benefit this age group from getting cervical cancer or is it just another way for Merck make a profit on an unwitting demographic.
O Canada! Gardasil Vaccine May be a Medical Experiment on Older Women
Society for Menstrual Cycle Research
It appears that women ages 27 to 45 in Canada are being subjected to the same type of Gardasil® advertising campaign adolescents and their families are in the United States. The full page advertisements are running continuously in magazine supplements in Sunday newspapers north and south of the border.
‘Now women ages 27 to 45 can benefit from Gardasil®’. Say what? Benefit from what? ‘Talk to your health care professional today.’ Now, I am not sure of what is going on in Canada – but in the U.S., healthcare professionals have nearly become pharmaceutical sales representatives, and women cannot go in for a doctor’s exam without being pressured to go on the birth control pill or get vaccinated. In fact, a stamp is now placed on a patient’s chart to remind doctor’s if the adolescent is in the process of getting the three-shot Gardasil® series or has been ‘counseled and refused’ vaccination.1
According to the U.S. FDA, there is no health benefit to getting Gardasil® for women ages 27 to 45. Then why is the vaccine being offered to older women in Canada?
Only the Facts Ma’am
In April 2011, after a long awaited decision the U.S. FDA ruled against Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil® use to an older population of women.
In a brief statement Merck stated that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL® was updated to state that GARDASIL® has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.”1
Within the same month Merck issued a press release announcing Health Canada had approved use of Gardasil® for women ages 27 – 45 for preventing cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by HPV strains 6, 11, 16, 18. Health Canada was surprisingly silent on the HPV vaccine issue and did not release a statement of their own.2
This should have been the first red flag for Canadian women. According to Pharmalot, “Although Canada is a smaller market than the U.S., the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue.”3
The needed revenue is due to the decreasing uptake and non-completion of the three-shot series in the U.S. Health insurance records have shown that among 19 to 26-year-old women who received their first Gardasil shot, the number of 19 to 26-year-old women completing the 3-shot series dropped from 44 percent in 2006 to 23 percent in 2009. A similar decline was seen in the pre-teen demographic where 57 percent of girls in 2006 completed the vaccine series, compared to 21 percent in 2009.4
Perhaps another notable step for Merck will be to go back to the FDA with data from Canada to prove that Gardasil® can be demonstrated to prevent cervical cancer in this older demographic. This is a highly likely scenario, since the CDC has stated: “While there are well-established cancer registries in the United States, it will take decades before the impact of the vaccine on cervical cancer is observed.”5
What is potentially wrong with Gardasil® use in older women?
The CDC estimates approximately 20 million Americans are currently infected with HPV. Another six million people become newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives. 6
Gardasil® was not designed to treat pre-existing HPV infections – and therefore it was tested on women who were not exposed to HPV. This type of pre-screening prior to vaccination is not available to medical consumers in the U.S. or in Canada and was actually discouraged by the FDA.
This alone gives rise to a major concern because women are mostly unaware they have been exposed to HPV. In addition, women who are not aware they have the virus but get the vaccine could suffer outbreaks of genital warts or abnormal precancerous lesions. Both conditions require extensive treatment. 7
Why is this happening? A chart in the May 2006 FDA Vaccines and Related Biological Products Advisory Committee’s report clearly shows that women who have been previously exposed to HPV and who are vaccinated with Gardasil® have a vaccine efficacy rate of -44.6%, and -32.5% post Cervarix, placing those vaccinated at an increased risk of developing cervical cancer, as well as suffering from other adverse reactions. 8
According to American Cancer Society estimates, deaths from cervical cancer fell by 74% between 1955 and 1992, mostly due to Pap smear screening. The rate continues to fall 4% annually without Gardasil®. Hopefully, there will not be an increase in cervical rates due to the HPV vaccines. That unfortunately will remain to be seen, although reports of cervical dysplasia and cervical cancer are being reported by young women post vaccination.
One thing is clear – women are the only ones who can protect their pelvic goldmines from exploitation. Meanwhile, unsuspecting women of all ages, all over the world are receiving a vaccine that will no doubt be become known as the great travesty of the 21st century. Our sisters in Canada need to be paying attention to what is happening in the U.S. before they partake in what may be a potential medical experiment with dire consequences for them and more profit for Merck.
1. Ob. Gyn News, May 17, 2012
2. Pharmalot, FDA Rejects Gardasil For Use In Most Adult Women, April 6, 2011
3. Pharmalot, Canada Approves Gardasil For Use In Most Women, April 28, 2011
4. Fox News, Fewer girls completing all three HPV shots, May 18, 2012
5. Post-licensure monitoring of HPV vaccine in the United States, Centers for Disease Control and Prevention, Vaccine. 2010 Jul 5;28 (30):4731-7. Epub 2010 Feb 25.
6. Cervical Cancer Prevention, Health Professional Version, National Cancer Institute (NCI)
7. Judicial Watch Special Report on Gardasil: How Safe And Effective Is It?, September 22, 2011