A recent publication in the Annals of Medicine   has reported the fraudulent nature of the anti-human papillomavirus vaccine (HPV), as Gardasil and Cervarix. Key messages in the report of the researchers are lack of scientific evidence of HPV vaccines in the prevention of cervical cancer and the lack of assessment of risks to health.

This is not a big surprise, since no vaccine has ever been fully evaluated in humans to evaluate the long-term health risks. The HPV vaccines are no exception.

In 2002, the US Food and Drug Administration (FDA) said that HPV vaccines represent a special category of drugs intended primarily for prophylaxis against diseases to which an individual can never be exposed.

This, according to the FDA, places significant emphasis on the safety of HPV vaccines.

In other words, contrary to conventional pharmacological treatments aimed at diseases of existing target, in a preventive vaccination, a compromise in terms of effectiveness for the benefit of safety should not be seen as an unreasonable expectation.

In addition, physicians are ethically obliged to provide a thorough explanation of the risks and benefits of the vaccine to their patients and, where applicable, a description of the alternative courses of treatment. This in turn allows patients to take a fully informed decision about vaccination.

The problem is, since the HPV vaccines are preventive, how to ensure safety because the doctors will never provide accurate explanations of the risks and benefits of the vaccine considered who do not know.

Doctors can only rely on the information packaged by manufacturers of vaccines and since pharmacokinetic effects on long-term human body studying the absorption, distribution, metabolism and \’excretion of vaccines and their ingredients have never been examined or analyzed, a doctor can not fully inform patients of any benefit or risk.

In many countries, informed consent can be legally relevant if the risks were judged and benefits and have been explained alll\’individuo. This includes adequate information on which patients may base their decision to accept or refuse a vaccine. In most cases, you have to have a complete explanation of the vaccine risks and side effects.

Surprisingly, the United States, there are no legal requirements for informed consent for vaccination. Such an omission leaves the door open to a failure to obtain informed consent. However, there are regulatory agencies such as the FDA, who have the power to ensure that vaccines are demonstrably safe and effective in reaching the market.

L \’ Italian legal system by Law 28 March 2001 n. 145   ratified, or validated, the Convention on Human Rights and Biomedicine promulgated in Oviedo on 4 April 1997.

The Oviedo Convention devoted to the definition of consent Chapter II (Articles 5 to 9) in which establishes as a general rule that:

• \”An intervention in the health field may only be carried out after the person concerned has given free and informed consent. This person shall beforehand be given appropriate information on the purpose and nature of the intervention and its consequences and risks. The person concerned may, at any time, freely withdraw consent. \” (Art. 5)

The Oviedo Convention also establishes the need for the consent of a \”representative\” of the patient in case this is a minor or is prevented to express themselves. Finally, the Convention establishes that:

•  \”The previously expressed wishes relating to a medical intervention by a patient who, at the time of surgery, is unable to express her wishes shall be taken into account.\”

In addition, following a European Directive of December 2009 , informed consent is mandatory for all types of vaccination, for all citizens. Informed consent is a legal document to release the doctors and the companies that produce the drug administered to claims for compensation for damage caused to the patient\’s health from medical treatment. However, the release has no value and claims are \”legitimate\” for all the information that has been \” omitted \” and \” improperly reported \”!

Since no vaccine has ever been proven safe in human studies, the FDA does not succeed in providing their guarantee each time approving a vaccine.

A vaccine can never be proven safe unless the pharmacokinetic effects have been fully studied in humans (non-animal) in a long-term setting which extends at least in 10 years. Since this has never done before a vaccine obtain all permits, vaccines are theoretically illegal in almost every country in the world!

The manufacturer of Gardasil, Merck says on its website that Gardasil does not only help to prevent cervical cancer, but also protect against other HPV diseases. Merck also claims that Gardasil does not prevent all types of cervical cancer. Similarly, the US CDC and the FDA say that this vaccine [Gardasil] is an important cervical cancer prevention tool that potentially offers benefits to the health of millions of women and based on all the information we have today, the CDC recommends vaccination against HPV for the prevention of most types of cervical cancer. All four of these claims are in significant contrast with the scientific evidence available since they imply that Gardasil may actually protect against some types of cervical cancer.

There are no significant data showing that both Gardasil and Cervarix (made by GlaxoSmithKline) can prevent any kind of cervical cancer, as the control period used is too short to assess the long-term benefits of vaccination HPV. The follow-up data in the longer stretch of Phase II trials for Gardasil and Cervarix are 5 and 8 years, respectively, while the invasive cervical cancer takes at least up to 20 -40 years to develop from the time of acquisition \’ HPV infection.

Persistent HPV infections caused by high-risk HPV, usually do not lead to the immediate injury, not to mention longer term of cervical cancer. The reason for this is that up to 90% of HPV infections resolve spontaneously within 2 years, and those that are not solved, only a small percentage can develop into cancer over the next 20-40 years. In addition, the research data show that even higher levels of atypia can solve or stabilize over time. Thus, in the absence of a long-term follow-up data, it is impossible to know whether the HPV vaccines can prevent some types of cervical cancer or simply send them back.

Currently, the health government agencies around the world say that the HPV vaccines are \” safe and effective \” and that the benefits of HPV vaccination outweigh the risks. In addition, the CDC of the United States claims that Gardasil is an important tool for the prevention of cervical cancer and recommends HPV vaccination for the prevention of most types of cervical cancer. However, the motivation behind these claims that the HPV vaccine prevents cervical cancer is yet to be proven.

Other key messages in the report include:

– To date, the effectiveness of HPV vaccines in cervical cancer prevention has not been demonstrated, while the risks of the vaccine are yet to be fully evaluated.

– Currently worldwide HPV immunization practice, with one of the two HPV vaccines, it seems to be justified either by long-term benefits to health nor economic, nor is there any evidence that HPV vaccination (even if proven effective against the cervical cancer) would reduce the cervical cancer rate more than screening with the Pap test has already achieved.

– In total, and currently, the list of serious adverse reactions related to HPV vaccination worldwide includes deaths, convulsions, paraesthesia, paralysis, Guillain-Barré syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis , autoimmune disease, deep vein thrombosis, pulmonary embolism, and cervical cancers .

– Since the vaccination program against HPV is a global coverage, long-term health of many women can increase the risk versus the benefit of the vaccine still unknown.

– Physicians should take a more rigorous approach based on scientific evidence [not the one supplied by the numbers cooked by pharmaceutical companies], in order to provide a balanced and objective assessment of the risks and benefits of the vaccine to their patients.

Its almost complete reliance on studies sponsored producers, which are the basis of the increasingly controversial vaccination policy in terms of quality, should be discontinued!

The authors conclude by adding their evidence and argue that the presentation of partial information and not in fact, as regards the risks of cervical cancer and the usefulness of HPV vaccines, as mentioned above is neither scientific nor ethical .

None of these practices is useful to public health interests, nor are they able to reduce the levels of cervical cancer.

The independent assessment of the safety of the HPV vaccine is urgent and must be a priority for the research programs sponsored by a government. Any future vaccination policy should adhere more strictly to evidence-based medicine and strictly follow the ethical guidelines for informed consent.