A recent study⁴ claimed there had been a significant reduction in cases of human papillomavirus (HPV) among young girls following the introduction of the HPV vaccine Gardasil in 2006.  I was surprised by this claim because I had previously investigated the HPV vaccines and found that the potential benefits were small and were outweighed by the risk of serious side effects. [see my post Gardasil and Cervarix – what’s the controversy about the HPV vaccine?]  Since the CDC considers these vaccines to be a routine part of the vaccination schedule for young girls, and now also young boys, we need to examine these new reports of Gardasil’s effectiveness.

The researchers’ principle claims were that the vaccine had significantly reduced the prevalence of HPV and that “The estimated vaccine effectiveness was high.”⁴

Were their conclusions valid?  Those who have reviewed the reports have found numerous issues with this study. Let’s look at some of these problems:

• The study data were based on self collected vaginal samples. Self collected samples are not considered valid for clinical use, so why were they thought to be valid for this study?⁷
• The accuracy of the test used to analyze the samples is questionable. In fact accuracy could be as low as 39%.⁷
• The claimed decrease in HPV incidence is from baseline data that was estimated.
• Only 19% of the study group had been fully vaccinated which may be too small of a sample size to be conclusive.⁷
• The primary method of exposure to HPV is sexual activity.  Among study participants who were sexually active, there was a greater decrease in HPV prevalence among the unvaccinated than in those who were unvaccinated.⁷
• The vaccine is only effective for a few of the many types of HPV.⁵  The study reported that “the prevalence of high-risk, non-vaccine types of HPV also significantly declined, from just under 21 percent to just over 16 percent.”  [emphasis added] Since these types of HPV are not included in the vaccine, the reduction of those types cannot be attributed to vaccination.¹

This new study does not demonstrate that the HPV vaccine is effective nor does it prove that the vaccine has caused a decrease in the prevalence of HPV.  For a more thorough discussion of the HPV vaccines, please read my previous post: Gardasil and Cervarix – what’s the controversy about the HPV vaccine?

In addition to the issues listed above, another reason to question the safety and effectiveness of Gardasil and Cervarix is the fact that $5.9 million has already been awarded to 49 victims by the National Vaccine Injury Compensation Program (VICP).  Two of the 49 awards were for death and the remaining awards were for injury from the vaccines.⁸   It is significant that almost $6 million has been awarded for damage when the vaccine has been available less than 7 years.  Gardasil was approved for use in the U.S. in 2006.  The U.S. approved Cervarix in 2009.⁹   The amount of damages awarded will likely grow since only 92 of the 200 claims have been evaluated.⁸

In spite of the high number of HPV vaccine adverse events and the lack of proof of its effectiveness, a new campaign is being developed to vaccinate infants with Gardasil or Cervarix.  A recent review states as a “desirable goal” the vaccination of newborns and infants with the HPV vaccine, similar to the requirement for infant vaccination with the Hepatitis B vaccine.¹²  This goal is “now scientifically and technologically attainable, and great progress is being made in obtaining financing for global HPV immunization.”¹¹ [emphasis added]  Who sponsored this review?  The authors have strong ties to Merck, GlaxoSmithKline, Sanofi, and other pharmaceutical companies.  They are dependent on grants and studies funded by the industry for much of their income.  One of the authors “was in charge of a Gates Foundation-funded HPV vaccine trial in India that came under attack for ethics violations by the Indian government.”¹⁰

What will be the next front for vaccination?  Many new vaccines are likely to be introduced because vaccine manufacture and distribution can be incredibly profitable.  As I noted in my previous post⁵ on the HPV vaccines, “in the US, manufacturers of vaccines are shielded from liability by the National Childhood Vaccine Injury Act enacted by the US government in 1986.  The US Supreme Court upheld that shield with a decision on February 22, 2011, ruling that plaintiffs must go through the US compensation plan to seek damages, which are capped at $250,000.”⁵ New drugs are expensive to develop and vulnerable to liability lawsuits; however, although new vaccines may also be expensive to develop, there will be NO lawsuits, even if injury or death results from being vaccinated.

Update August 7, 2013:  A new study, Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants, concluded “We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.”

Sources:

¹ Oncology Dietitian Exposes Fraud in CDC’s HPV Vaccine Effectiveness Study
² Assessing the Overall Impact of the HPV Vaccine
³ Feds sued for secrets on HPV vaccine deaths
⁴ Reduction in Human Papillomavirus (HPV) Prevalence Among Young Women Following HPV Vaccine Introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010.
⁵ Gardasil and Cervarix – what’s the controversy about the HPV vaccine?
⁶ The Lead Vaccine Developer Comes Clean So She Can “Sleep At Night”: Gardasil and Cervarix Don’t Work, Are Dangerous, and Weren’t Tested
⁷ HPV Vaccines: Resounding Success or Future Failure?
⁸ Documents Obtained by Judicial Watch Reveal 200 Claims Filed with HHS for HPV Vaccine Injuries and Deaths, 49 Compensated
⁹ HPV vaccine
¹⁰ The Coming Push to Give HPV Vaccines to Infants
¹¹ Reframing cervical cancer prevention. Expanding the field towards prevention of human papillomavirus infections and related diseases.
¹² Hepatitis B vaccine for US newborns – a good idea?

Additional Resources:
Gardasil: Guarding or Gutting Our Youth?
The Truth About Gardasil

Photo credit: U.S. Centers for Disease Control and Prevention

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