July 12 2013
Assessing the Overall Impact of the HPV Vaccine
By Sharlene Bidini, RD, CSO
A new study, published in the Journal of Infectious Diseases, provides new data regarding the effectiveness of the Human Papillomavirus (HPV) vaccine in reducing HPV prevalence.
The Advisory Committee on Immunization Practices (ACIP) started recommending routine Human Papillomavirus (HPV) vaccination in June 2006. In order to estimate the effectiveness of the HPV vaccine, researchers used data from the National Health and Nutrition Examination Surveys (NHANES), 2003-2006 and 2007-2010.
Here is the conclusion from the study: Within four years of vaccine introduction, the vaccine-type HPV prevalence decreased among females aged 14-19 years despite low vaccine uptake. The estimated vaccine effectiveness was high.
The study conclusion (drawn from the NHANES survey 2007-2010) was based on 740 girls, aged 14-19. However, only 358 were sexually active, and of those, only 111 had at least 1 HPV shot. If the study authors were trying to determine vaccine effectiveness, why did they include the girls who had not received a single HPV shot or did not report having sex?
An interesting fact that was not shared, was that among those 740 girls, the HPV prevalence of high-risk, non-vaccine types declined 20.7 percent (from 20.7 percent to 16.4 percent).
Table 1 from the journal article compares 1,363 girls, aged 14-19, in the pre-vaccine era (2003-2006) to all 740 girls in the post-vaccine era (2007-2010) regardless of sexual history or immunization status.
Table 3 narrows down the data to include only the sexually active girls. It then provides additional data to further compare the 111 vaccinated to the 239 unvaccinated girls (8 females without vaccination status).
In 2003-2006 (pre-vaccine era) it was estimated that 53.1 percent of sexually active girls, aged 14-19 had HPV. In 2007-2010, the overall prevalence of HPV in the same demographic declined by 19.2 percent to an overall prevalence of 42.9 percent.
Some healthcare professionals may be quick to assume that the HPV reduction was an obvious outcome after mass immunization. However, the data provided in Table 3 clearly demonstrates that the unvaccinated girls in this group had the best outcome. The study table separates the HPV prevalence into three categories: overall, vaccinated, and unvaccinated.
The overall prevalence of HPV in the study period 2007-2010 was 42.9 percent when the vaccinated and unvaccinated girls are combined. In 2007-2010, the overall prevalence of HPV was 50 percent in the vaccinated girls (14-19 years), but only 38.6 percent in the unvaccinated girls of the same age. Therefore, HPV prevalence dropped 27.3 percent in the unvaccinated girls, but only declined by 5.8 percent in the vaccinated group.
In four out of five different measures, the unvaccinated girls had a lower incidence of HPV. In the one instance where the unvaccinated girls had a 9.5 percent higher prevalence, there was a note under the table that read “relative standard error greater than 30 percent.” I suspect that the confidence interval values must have been extremely wide. Therefore, this particular value is subject to too much variance and doesn’t have much value.
I had a discussion about this study with one of the physicians that I work with, and this is what he had to say:
The percentage decrease is severely confounded by the number of unvaccinated girls that are included in the 2007-2010 group. It is not easy to isolate the effect of the vaccine when the 2007-2010 group is not stratified by vaccine status (those who were vaccinated and those who were not vaccinated). This would indicate poor design methodology and we must wait for a more authoritative study that uses improved methodology to make any conclusions.
This study left me with many unanswered questions. Do you think the ACIP should continue to recommend the HPV vaccine for all preteen girls and boys?
CDC: HPV Vaccine Is Lowering Infection Rates in Teen Girls. Medscape. Jun 19, 2013.
July 16, 2013
Oncology Dietitian Exposes Fraud in CDC’s HPV Vaccine Effectiveness Study
By Dr. Mercola
There are currently two HPV vaccines on the market, but if there was any regard for sound scientific evidence, neither would be promoted as heavily as they are. The first, Gardasil, was licensed by the US Food and Drug Administration (FDA) in 2006. It is now recommended as a routine vaccination for girls and women between the ages of 9-26 in the US.
On October 25, 2011, the CDC’s Advisory Committee on Immunization Practices also voted to recommend giving the HPV vaccine to males between the ages of 11 and 21. The second HPV vaccine, Cervarix, was licensed in 2009.
Serious questions about the vaccine’s safety and effectiveness have circulated since its inception, and for good reason. Even a lead researcher in the development of the HPV vaccine, Dr. Diane Harper1, has publicly questioned the safety and presumed effectiveness of it.
Most recently, an oncology dietitian pointed out significant discrepancies2 in a new HPV vaccine effectiveness study published in the Journal of Infectious Diseases3, which evaluated data from the National Health and Nutrition Examination Surveys (NHANES), 2003-2006 and 2007-2010.
The study pointed out that HPV vaccine uptake among young girls in the US has been low but concluded that:
“Within four years of vaccine introduction, the vaccine-type HPV prevalence decreased among females aged 14–19 years despite low vaccine uptake. The estimated vaccine effectiveness was high.”
Assessing the Overall Impact of the HPV Vaccine
In her article4, Sharlene Bidini, RD, CSO, points out that the study’s conclusion was based on 740 girls, of which only 358 were sexually active, and of those, only 111 had received at least one dose of the HPV vaccine. In essence, the vast majority was unvaccinated, and nearly half were not at risk of HPV since they weren’t sexually active.
“If the study authors were trying to determine vaccine effectiveness, why did they include the girls who had not received a single HPV shot or did not report having sex?” she writes.
“Table 1 from the journal article compares 1,363 girls, aged 14-19, in the pre-vaccine era (2003-2006) to all 740 girls in the post-vaccine era (2007-2010) regardless of sexual history or immunization status.”
In the pre-vaccine era, an estimated 53 percent of sexually active girls between the ages of 14-19 had HPV. Between 2007 and 2010, the overall prevalence of HPV in the same demographic declined by just over 19 percent to an overall prevalence of nearly 43 percent.
As Bidini points out, this reduction in HPV prevalence can NOT be claimed to be due to the effectiveness of HPV vaccinations. On the contrary, the data clearly shows that it was the unvaccinated girls in this group that had the best outcome!
“In 2007-2010, the overall prevalence of HPV was 50 percent in the vaccinated girls (14-19 years), but only 38.6 percent in the unvaccinated girls of the same age.
Therefore, HPV prevalence dropped 27.3 percent in the unvaccinated girls, but only declined by 5.8 percent in the vaccinated group. In four out of five different measures, the unvaccinated girls had a lower incidence of HPV,” she writes.
Furthermore, in the single instance where unvaccinated girls had a 9.5 percent higher prevalence of HPV, a note stated that the relative standard error was greater than 30 percent, leading Bidini to suspect that “the confidence interval values must have been extremely wide. Therefore, this particular value is subject to too much variance and doesn’t have much value.”
Another fact hidden among the reported data was that among the 740 girls included in the post-vaccine era (2007-2010), the prevalence of high-risk, non-vaccine types of HPV also significantly declined, from just under 21 percent to just over 16 percent.
So, across the board, HPV of all types, whether included in the vaccine or not, declined. This points to a reduction in HPV prevalence that has nothing to do with vaccine coverage. Besides, vaccine uptake was very LOW to begin with.
All in all, one can conclude that there were serious design flaws involved in this studywhether intentional or notleading the researchers to erroneously conclude that the vaccine effectiveness was “high.” Clearly the effectiveness of the vaccine was anything but high, since the unvaccinated group fared far better across the board.
Case Report of a Gardasil Death Confirms Presence of HPV DNA Fragments
Earlier this year, a lab scientist, who discovered HPV DNA fragments in the blood of a teenage girl who died after receiving the Gardasil vaccine, published a case report in the peer reviewed journal Advances in Bioscience and Biotechnology5. The otherwise healthy girl died in her sleep six months after receiving her third and final dose of the HPV vaccine. A full autopsy revealed no cause of death.
Sin Hang Lee with the Milford Molecular Laboratory in Connecticut confirmed the presence of HPV-16 L1 gene DNA in the girl’s postmortem blood and spleen tissue. These DNA fragments are also found in the vaccine. The fragments were protected from degradation by binding firmly to the particulate aluminum adjuvant used in the vaccine.
“The significance of these HPV DNA fragments of a vaccine origin found in post-mortem materials is not clear and warrants further investigation,” he wrote.
Lee suggests the presence of HPV DNA fragments of vaccine origin might offer a plausible explanation for the high immunogenicity of Gardasil, meaning that the vaccine has the ability to provoke an exaggerated immune response. He points out that the rate of anaphylaxis in girls receiving Gardasil is far higher than normalreportedly five to 20 times higher than any other school-based vaccination program!
HPV Vaccine Is Associated with Serious Health Risks, Including Sudden Death
Many women are not aware that the HPV vaccine Gardasil might actually increase your risk of cervical cancer. Initially, that information came straight from Merck and was presented to the FDA prior to approval6. According to Merck’s own research, if you have been exposed to HPV strains 16 or 18 prior to receipt of Gardasil vaccine, you could increase your risk of precancerous lesions, or worse, by 44.6 percent.
Other health problems associated with Gardasil vaccine include immune-based inflammatory neurodegenerative disorders, suggesting that something is causing the immune system to overreact in a detrimental waysometimes fatally.
Between June 1, 2006 and December 31, 2008, there were 12,424 reported adverse events following Gardasil vaccination, including 32 deaths. The girls, who were on average 18 years old, died within two to 405 days after their last Gardasil injection
Between May 2009 and September 2010, 16 additional deaths after Gardasil vaccination were reported. For that timeframe, there were also 789 reports of "serious" Gardasil adverse reactions, including 213 cases of permanent disability and 25 diagnosed cases of Guillain-Barre Syndrome
Between September 1, 2010 and September 15, 2011, another 26 deaths were reported following HPV vaccination
As of May 13, 2013, VAERS had received 29,686 reports of adverse events following HPV vaccinations, including 136 reports of death,7, as well as 922 reports of disability, and 550 life-threatening adverse events
Lawsuit Reveals Payouts of Nearly $6 Million to HPV Vaccine-Damaged Victims
On February 28, 2013 the government watchdog group Judicial Watch announced it had filed a Freedom of Information Act (FOIA) lawsuit against the Department of Health and Human Services (DHHS) to obtain records from the Vaccine Injury Compensation Program (VICP) related to the HPV vaccine8. The lawsuit was filed in order to force the DHHS to comply with an earlier FOIA request, filed in November 2012, which had been ignored. As reported by WND.com9:
“Judicial Watch wants all records relating to the VICP, any documented injuries or deaths associated with HPV vaccines and all records of compensation paid to the claimants following injury or death allegedly associated with the HPV vaccines... The number of successful claims made under the VICP to victims of HPV will provide further information about any dangers of the vaccine, including the number of well-substantiated cases of adverse reactions.”
On March 20, Judicial Watch announced it had received the FOIA documents from the DDHS, which revealed that the National Vaccine Injury Compensation Program has awarded $5,877,710 to 49 victims for harm resulting from the HPV vaccine. According to the press release10: "On March 12, 2013, The Health Resources and Services Administration (HRSA), an agency of HHS, provided Judicial Watch with documents revealing the following information:
- Only 49 of the 200 claims filed have been compensated for injury or death caused from the (HPV) vaccine. Of the 49 compensated claims, 47 were for injury caused from the (HPV) vaccine. The additional 2 claims were for death caused due to the vaccine.
- 92 (nearly half) of the total 200 claims filed are still pending. Of those pending claims, 87 of the claims against the (HPV) vaccine were filed for injury. The remaining 5 claims were filed for death.
- 59 claims have been dismissed outright by VICP. The alleged victims were not compensated for their claims against the HPV vaccine. Of the claims dismissed, 57 were for injuries, 2 were for deaths allegedly caused by the HPV vaccine.
- The amount awarded to the 49 claims compensated totaled 5,877,710.87 dollars. This amounts to approximately $120,000 per claim.
- This new information from the government shows that the serious safety concerns about the use of Gardasil have been well-founded," said Judicial Watch President Tom Fitton. "Public health officials should stop pushing Gardasil on children."
Review of HPV Trials Conclude Effectiveness Is Still Unproven
Last year, a systematic review11 of pre- and post-licensure trials of the HPV vaccine by researchers at University of British Columbia showed that the vaccine’s effectiveness is not only overstated (through the use of selective reporting or “cherry picking” data) but also unproven. In the summary of the clinical trial review, the authors state it quite clearly:
“We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We found that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate. Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications).
Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odds with factual evidence) and significant misinterpretation of available data.
For example, the claim that HPV vaccination will result in approximately 70% reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer (let alone cervical cancer death), nor that the current overly optimistic surrogate marker-based extrapolations are justified.
Likewise, the notion that HPV vaccines have an impressive safety profile is only supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities).
We thus conclude that further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targeting other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles.” [Emphasis mine]
Talk to Your Kids about HPV and Gardasil
There are better ways to protect yourself or your young daughters against cancer than getting Gardasil or Cervarix vaccinations, and it's important you let your children know this. In more than 90 percent of HPV infections, HPV infection is cleared within two years on its own, so keeping your immune system strong is far more important than getting vaccinated.
In addition, HPV infection is spread through sexual contact and research12 has demonstrated that using condoms can reduce your risk of HPV infection by 70 percent, which is far more effective than the HPV vaccine. Because this infection is sexually transmitted, the risk of infection can be greatly reduced by lifestyle choices, including abstinence. In addition, there are high risk factors for chronic HPV infection including smoking, co-infection with herpes, Chlamydia or HIV and long-term birth control use. Women chronically infected with HPV for many years, who don’t get pre-cancerous cervical lesions promptly identified and treated, can develop cervical cancer and die.
So it is important to remember that, even if they get vaccinated, girls and women should get Pap test screening every few years for cervical changes that may indicate pre-cancerous lesions because there is little guarantee that either Gardasil or Cervarix vaccinations will prevent cervical cancer. After Pap test screening became a routine part of health care for American women in the 1960’s, cervical cancer cases in the U.S. dropped 74 percent and continued Pap testing is recommended for women who receive HPV vaccines.
Why We Must Protect Vaccine Exemptions
There can be no doubt that we are in urgent need of a serious vaccine safety review in the US. Quality science is simply not being done. And very few vaccine recommendations, which prop up state vaccine mandates, stand on firm scientific ground. Your right to vaccine exemptions is also increasingly under threat.
I urge you to get involved in the monumentally important task of defending YOUR right to know and freedom to choose which vaccines you and your child will use. The non-profit charity, the National Vaccine Information Center (NVIC), has been preventing vaccine injuries and deaths through public education for more than 30 years and is leading the advocacy effort in the states to protect vaccine exemptions. Supporting NVIC is one way you can help, in addition to signing up for the free online NVIC Advocacy Portal so you stay informed about threats to vaccine exemptions in your state and contact your state legislators to make your voice heard.
All across the United States, people are fighting for their right not to be injected with vaccines against their will. These threats come in a variety of guises like California bill AB49913, which permits minor children as young as 12 years old to be vaccinated with sexually transmitted disease vaccines like Gardasil without parental knowledge or parental consent! In light of the evidence that HPV vaccines have not been proven safe or effective, how wise is it to allow doctors to give a minor child Gardasil or Cervarix vaccinations without informing and getting the consent of parents? How are parents supposed to monitor their children for signs of a vaccine reaction if they don’t even know their children have been given a vaccine? It’s nothing short of reprehensible.
I cannot stress enough how critical it is to get involved and stand up for your human right to exercise informed consent to vaccination and protect your legal right to obtain medical and non-medical vaccine exemptions. This does not mean you have to opt out of all vaccinations if you decide that you want to give one or more vaccines to your child. The point is, EVERYONE should have the right to evaluate the potential benefits and real risks of any pharmaceutical product, including vaccines, and opt out of any vaccine they decide is unnecessary or not in the best interest of their child’s health. Every child is different and has a unique personal and family medical history, which may include severe allergies or autoimmune and neurological disorders, that could increase the risks of vaccination.
It is your parental right to make potentially life-altering health decisions for your own children. Why wouldn’t you want to keep that righteven if you want your child to receive most or all vaccinations currently available? Tomorrow there might be a vaccine you don’t want your child to receive, but if you’ve failed to support strong informed consent protections in public health laws, which includes the legal right for all Americans to take medical and non-medical vaccine exemptions, you’ve given away your own freedom to choose in the future...
Internet Resources Where You Can Learn More
I encourage you to visit the following web pages on the National Vaccine Information Center (NVIC) website at www.NVIC.org:
- NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
- If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
- Vaccine Freedom Wall: View or post descriptions of harassment by doctors, employers or school officials for making independent vaccine choices.
- NVIC Advocacy Portal: Sign up today to be a user of this free online privacy-protected network of concerned citizens all working to educate legislators to protect vaccine exemptions in public health policies and laws.
Connect with Your Doctor or Find a New One That Will Listen and Care
If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don't want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to stop the change in attitude of many parents about vaccinations after they become truly educated about health and vaccination.
However, there is hope.
At least 15 percent of young doctors polled in the past few years admit that they're starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors, who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families, who decline use of one or more vaccines.
So take the time to locate a doctor, who treats you with compassion and respect and is willing to work with you to do what is right for your child.