HPV Vaccines: Science versus Reality

By Dr. Lucija Tomljenovic

My greatest concern is over the fact that parents and children are not being told the truth about the real benefits and legitimate risks on HPV vaccines and that the medical authorities and regulators rely exclusively on information provided by the vaccine manufacturers as a base for making vaccine policies and recommendations.

This practice is disturbing to say the least, especially in the light of independent research which has repeatedly warned that drug companies may manipulate clinical trial designs and subsequent data analysis and reporting to make their drugs look better and safer. The reporting of results from clinical trials on HPV vaccines Gardasil and Cervarix illustrates this point.

In brief, here is for example what we know versus what is claimed in terms of HPV vaccine efficacy:

We don’t (yet) know if the vaccine will prevent any cases of cervical cancer. It might, but this fact has not been demonstrated. This is because the disease takes years to decades to manifest from first infection, if it manifests at all. Given the time frame of the initial trials, virtually none of the women in these trials will have reached the age where cervical cancer will occur. What we do know is that the vaccine may prevent some of the pre-cancerous lesions associated with HPV infection, a large fraction of which would spontaneously resolve regardless of vaccine status. The lesions are considered to be a “surrogate markers” for vaccine efficacy, yet do not really justify the claim of cervical cancer prevention.In this regard, Drs Gerhardus and Razum have recently noted that the,

“unwarranted confidence in the new [HPV] vaccines led to the impression that there was no need to actually evaluate their effectiveness” (J Epidemiol Community Health. 2010; vol 64, no 5).  http://www.ncbi.nlm.nih.gov/pubmed?term=gerhardus%2Csurrogate

In spite of this Merck, states on their website that,

“Gardasil does more than help prevent cervical cancer, it protects against other HPV diseases, too.”

Similarly, the US CDC and the FDA claim that,

“This [Gardasil] vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women” and  “Based on all of the information we have today, CDC recommends HPV vaccination for the prevention of most types of cervical cancer”.

The American Academy of Pediatrics (AAP) describes Gardasil as a  “life-saving vaccine that can protect girls from cervical cancer.”

All four of these statements are demonstrably false as they imply that Gardasil can indeed protect against some types of cervical cancer.

Consider also the fact that although the results from the 3-year follow-up pre-licensure trials inspired much confidence in Gardasil’s prophylactic potential as they showed >97% vaccine effectiveness against HPV-16/18 related CIN 2/3+ lesions, the corresponding figures against CIN 2/3+ caused by all HPV types were well below 40%. This information is frequently overlooked even though it is crucial for assessing the long-term protective effi­cacy of the vaccine. Indeed, because of the possibility of infections with HPV types not covered by the vac­cine and/or multiple infections including these types, any meaningful assessment of a true prophylactic value from Gardasil vaccination, which would likely result in a real clinical benefit (i.e., a global reduction of the cervical cancer burden), must take into consid­eration analysis of vaccine efficacy against CIN 2/3+ caused by all relevant (high risk) HPV types. When taken together, the results from pre-clinical trials that the true HPV vaccine efficacy lies anywhere between 16.9% and 70%. Given the demonstrable success of Pap screening programs in achieving a 70% reduction in cervical cancer mortality in developed countries, it is unlikely that vaccination with Gardasil would have a notable impact in reducing further the global cervi­cal cancer burden beyond that accomplished by Pap screening.

for more details see:

http://www.ncbi.nlm.nih.gov/pubmed?term=gerhardus%2Csurrogate

http://www.ncbi.nlm.nih.gov/pubmed/23061593

http://www.ncbi.nlm.nih.gov/pubmed/23016780

http://www.ncbi.nlm.nih.gov/pubmed/22813421

http://www.ncbi.nlm.nih.gov/pubmed/22188159

Bottom line is that the optimistic claims made by the world’s leading health authorities (that HPV vaccines will prevent 70% of cervical cancers) rest on assumptions which are misinterpreted and presented to parents as factual evidence.

A second, and equally fallacious claim often told to parents is that HPV vaccines have an impressive safety profile, a notion which is only supported by highly flawed designs of safety trials. This notion is further contrary to accumulating evidence from vaccine safety surveillance databases worldwide and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities). For example, compared with all other vaccines, Merck’s HPV vaccine Gardasil alone is associated with > 60% of all serious adverse reactions (including 63.8% of all deaths and 81.2% cases of permanent disability) in females younger than 30 years of age. Placed into context, while females in this age group have a near-zero risk of dying from cervical cancer, they are faced with a risk of dying and a permanently disabling condition from a vaccine that has not prevented a single case of cervical cancer to date.

Although a report to a passive vaccine safety surveillance system does not by itself prove that the vaccine caused an adverse reaction, the unusually high frequency of adverse reactions related to HPV vaccines reported worldwide, as well as their consistent pattern (i.e. nervous system-related disorders rank the highest in frequency), points to a potentially causal relationship. Furthermore, matching the data vaccine surveillance databases is an increasing number of case reports documenting similar serious adverse reactions associated with HPV vaccine administration, with nervous system disorders being the most frequently reported.

http://www.ncbi.nlm.nih.gov/pubmed/20869467

http://www.ncbi.nlm.nih.gov/pubmed/20388462

http://www.ncbi.nlm.nih.gov/pubmed/20211914

http://www.ncbi.nlm.nih.gov/pubmed?term=CNS%20demyelination%20and%20quadrivalent%20HPV%20vaccination

http://www.ncbi.nlm.nih.gov/pubmed/23061593

http://www.ncbi.nlm.nih.gov/pubmed/23016780

http://www.ncbi.nlm.nih.gov/pubmed/22813421

http://www.ncbi.nlm.nih.gov/pubmed/22188159

http://www.ncbi.nlm.nih.gov/pubmed/22540172

In summary: the vaccines may not work as well as advertised and their safety profile is not as good as claimed.

A clear evaluation of risks is important for vaccines, which, contrary to other drugs, are administered predominantly to healthy individuals and often to prevent a disease to which an individual may never be exposed. Because of this, according to the U.S. FDA,

“there is low tolerance for significant adverse events associated with vaccines-that is, caused by vaccines.”

 Thus in view of the above information, it may be worth re-considering whether it is prudent to put pre-adolescent girls at risk of death or a life-long neurodegenerative/autoimmune condition for a vaccine of still uncertain efficacy against cervical cancer, when the same can be demonstrably prevented with regular Pap screening and loop electrosurgical excision procedure, neither of which carry such risks.

Medical ethics demand that vaccination should be carried out with the participant’s full and informed consent. This necessitates an objective disclosure of the known or foreseeable vaccination benefits and risks. The way in which HPV vaccines are often promoted to parents indicates that such disclosure is not always given from the basis of the best available knowledge.

I personally know several mothers whose daughters have died following HPV vaccination.  One of them stated the following:

“My daughter and I and millions of others were deceived by false marketing and a failure to be informed of the true risks and benefits. Be informed. Investigate, don’t just inoculate.”

Yet another mother emailed me with these words:

“I have to tell you I have never seen a more promoted vaccine, EVER!!!

On TV, magazines, inserts in news papers. After my daughter passed I even got an advertisment in the mail to have my children vaccinated. It was like pouring salt into a wound. I wanted to scream at them!!!!! It is all about Money!!!”

…..

“I had even contacted the CDC about the tissue sample that had been sent to them. They never contacted me back after so many attempts to get that information!!!!!! The head of the medical examiner stated,”he did not know what had caused XX’s death but he did not think it was Gardasil”. Does that make sense? How would he know that it was NOT the Gardasil when he did not know the cause of death.”

Unwillingness to investigate legitimate concerns  is a re-current theme I encounter on a weekly basis receiving emails from parents whose children have either died or were severely disabled following vaccinations. They continually express their frustration over the FACT that the health authorities have by large without adequate investigation dismissed even the possibility that the vaccine might have caused harm.

One mother mentioned  that she approached 60 medical and research professionals and they all declined to investigate.

Obviously, no answers will be found if scientist refuse to look for them.

It is easy to see how the view that vaccine only cause severe adverse reactions on rare occasions has been generated.

It is because this possibility is simply dismissed and no research is undertaken.