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December 23, 2011
Science Journal Exposes Gardasil and HPV Vaccinations as Unproven, Unjustified and Lacking Evidence-Based Medicine


A recent publication in the Annals of Medicine has exposed the fraudulent nature of Human papillomavirus (HPV) vaccines such as Gardasil and Cervarix. Key messages the researchers report include a lack of evidence for any HPV vaccines in preventing cervical cancer and lack of evaluation of health risks.

That's not a big surprise to most advocates in the natural health community, since no vaccine has ever been fully evaluated in humans to assess long-term health risks. HPV vaccines are no exception.

  

In 2002 the US Food and Drug Administration (FDA) stated that
vaccines represent a special category of drugs aimed mostly at
healthy individuals and for prophylaxis against diseases to which
an individual may never be exposed. This, according to the
FDA, places significant emphasis on vaccine safety.

In other words, contrary to conventional drug treatments aimed at targeted existing diseases, in a supposed preventative vaccination, a compromise in efficacy for the benefit of safety should not be seen as an unreasonable expectation. Furthermore, physicians are ethically obliged to provide an accurate explanation of vaccine risks and benefits to their patients and, where applicable, a description of alternative courses of treatment. This in turn enables patients to make a fully informed decision with regard to vaccination.

The problem is, vaccinations such as HPV are not preventative, they do compromise safety and physicians will never provide accurate explanations of vaccine risks and benefits because they do not know themselves. Physicians can only rely on the information from vaccine manufacturers and since long-term pharmacokinetic effects which study the bodily absorption, distribution, metabolism and excretion of vaccines and their ingredients are never examined or analyzed, a Physician can never fully inform of patient of ANY benefits or risks.

In many countries, for a consent to be legally valid if risks and benefits have been explained to the individual. This includes adequate information on which patients can base their decision on whether to accept or refuse a vaccine. In most cases, it requires having a full explanation of the vaccine risks and side-effects.

Surprisingly, in the United States, there are no governmental requirements for informed consent for vaccination. Such an omission leaves the door open to a failure to obtain informed consent. Nonetheless, there are regulatory agencies such as the FDA which are empowered to assure that only demonstrably safe and effective vaccines reach the market. Since no vaccine has ever been proven safe in human trials, the FDA fails in their assurance every time they approve a vaccine. A vaccine could never be proven safe unless the pharmacokinetic effects were fully studied on human beings (not animals) in a long-term setting spanning a minimum of 10 years. Since this is never done before a vaccine is released, all vaccine approvals are theoretically illegal in almost every country in the world.

Gardasil s manufacturer, Merck, states on their website that Gardasil does more than help prevent cervical cancer, it protects against other HPV diseases, too. Merck further claims that Gardasil does not prevent all types of cervical cancer. 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. All four of these statements are at significant variance with the available evidence as they imply that Gardasil can indeed protect against some types of cervical cancer.

At present there are no significant data showing that either Gardasil or Cervarix (GlaxoSmithKline) can prevent any type of cervical cancer since the testing period employed was too short to evaluate long-term benefits of HPV vaccination. The longest follow-up data from phase II trials for Gardasil and Cervarix are 5 and 8.4 years, respectively, while invasive cervical cancer takes up to 20 -40 years to develop from the time of acquisition of HPV infection.

Persistent HPV infections caused by high-risk HPVs will usually not lead to immediate precursor lesions, let alone in the longer term to cervical cancer. The reason for this is that as much as 90% HPV infections resolve spontaneously within 2 years and, of those that do not resolve, only a small proportion may progress to cancer over the subsequent 20 - 40 years. Moreover, research data show that even higher degrees of atypia can either resolve or stabilize over time. Thus, in the absence of long-term follow-up data, it is impossible to know whether HPV vaccines can indeed prevent some cervical cancers or merely postpone them.

Currently, governmental health agencies worldwide state that HPV vaccines are "safe and effective" and that the benefits of HPV vaccination outweigh the risks. Moreover, the US CDC maintains that Gardasil is an important cervical cancer prevention tool and therefore recommends HPV vaccination for the prevention of most types of cervical cancer. However, the rationale behind these statements is unclear given that the primary claim that HPV vaccination prevents cervical cancer remains unproven.

Other key messages in the report include:

- To date, the efficacy of HPV vaccines in preventing cervical cancer has not been demonstrated, while vaccine risks remain to be fully evaluated.

- Current worldwide HPV immunization practices with either of the two HPV vaccines appear to be neither justified by long-term health benefits nor economically viable, nor is there any evidence that HPV vaccination (even if proven effective against cervical cancer) would
reduce the rate of cervical cancer beyond what Pap screening has already achieved.

- Cumulatively, the list of serious adverse reactions related to HPV vaccination worldwide includes deaths, convulsions, paraesthesia, paralysis, Guillain-Barre syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and cervical cancers.

- Because the HPV vaccination programme has global coverage, the long-term health of many women may be at risk against still unknown vaccine benefits.

- Physicians should adopt a more rigorous evidence-based medicine approach, in order to provide a balanced and objective evaluation of vaccine risks and benefits to their patients.

The almost exclusive reliance on manufacturers sponsored studies,
often of questionable quality, as a base for vaccine policy-making
should be discontinued.

The authors conclude by summing up their evidence and stating that the presentation of partial and non-factual information regarding cervical cancer risks and the usefulness of HPV vaccines, as cited above, is neither scientific nor ethical. None of these practices serve public health interests, nor are they likely to reduce the levels of cervical cancer. Independent evaluation of HPV vaccine safety is urgently needed and should be a priority for government sponsored research programmes. Any future vaccination policies should adhere more rigorously to evidence-based medicine as well as strictly follow ethical guidelines for informed consent.

Dave Mihalovic is a Naturopathic Doctor who specializes in vaccine research, cancer prevention and a natural approach to treatment.

Source: Annals of Medicine 2011


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