Saturday, September 5, 2015

"One Less" country--Japan--swallows Merck's lies about its HPV vaccine; Japan establishes guidelines and special clinics to treat HPV vaccine-injured girls/ Medscape

Vaccine injuries are real.  They can be serious and often fail to respond to treatment. The most serious injuries are usually to the brain. Vaccine injuries may cause death. The US' federal vaccine injury compensation program has paid out $3.18 billion dollars in compensation for vaccine injuries since the program was established in 1988. 
Yet with the stoking of fears over measles and the claimed desperate need for vaccine mandates in 2015, these truths about vaccine injuries have been overlooked, or deliberately ignored by the media.
It is hard to believe, but there is lack of proof that HPV vaccines actually prevent cervical cancer.  That is why I have published an excerpt from FDA's initial Gardasil approval letter below.  Gardasil HPV vaccine was licensed under "fast-track" authority by FDA in 2006 with limited data and its manufacturer, Merck, was required by FDA to collect data through 2017 to determine whether Gardasil really does prevent cancer:
  1. You have committed to collaborate with the cancer registries in four countries in the Nordic Region ( Sweden, Norway, Iceland, and Denmark) to assess long-term outcomes following administration of GARDASI®. In this study, approximately 5,500 subjects enrolled in Protocol 015 (one half from the placebo group that will have been vaccinated shortly after approval) will be followed for a total of 14 years. Two major goals of this study are: 1) to assess the long-term effectiveness of GARDASIL® by evaluating biopsy specimens for presence of HPV 6/11/16/18-related incident breakthrough cases of CIN 2/3, AIS and cervical cancer, VIN 2/3 and vulvar cancer, and VaIN 2/3 and vaginal cancer; and 2) to assess whether administration of GARDASIL® will result in replacement of these diseases due to vaccine HPV types with diseases due to non-vaccine HPV types. This study is designed to accomplish these goals as discussed in the June 6, 2006, submission to your BLA. The final protocol for this study will be submitted by December 8, 2006. Patient accrual for this study was previously completed in the context of Protocol 015. This study will be completed by December 31, 2017, (14 years from initiation of the last patient enrolled in Protocol 015 in the four Nordic countries). The final study report will be submitted by December 31, 2018...--from FDA to Merck
Furthermore, the Gardasil label explicitly notes that recipients must still have regular PAP smears, precisely because it is not clear Gardasil prevents the development of cancer, while PAP smears enable early detection and treatment before a cervical lesion evolves into cancer:
"...Limitations of GARDASIL Use and Effectiveness:• GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening..."
So the vaccine may work.  Or it may not.  But that has not stopped some states and countries from recommending or requiring this vaccine (intended for a sexually transmitted disease) for all children in junior high school.  Rhode Island just mandated HPV vaccine for all 7th grade students in July 2015. 

How safe are HPV vaccines? We lack reliable data, but there are many reports of serious injuries. 

Now Japan (after 358 vaccine injuries judged serious and 2,000 adverse event reports) has not only rescinded its recommendation that girls receive this vaccine, but has also established guidelines and special clinics for evaluating and treating illnesses caused by the Gardasil and Cervarix HPV vaccines.
From Medscape:
"Japan has put in place a scheme to manage symptoms, especially generalized chronic pain, that have arisen after human papillomavirus (HPV) vaccination given to adolescents to protect against cervical cancer.
Although there have been assurances on the safety of HPV vaccination from many official medical bodies since the vaccines were first introduced — Gardasil (Merck & Co.) in 2006 and Cervarix (GlaxoSmithKline) in 2009 — there have also been persistent reports of rare cases of adverse events. These include case reports in the medical literature of complex regional pain syndrome and postural orthostatic tachycardia syndrome, as previously reported by Medscape Medical News.
In July 2015, the European Medicines Agency announced that it was conducting a safety review of HPV vaccines, which was requested by Denmark, where reports of adverse events after HPV vaccination have been widely reported in the media.
Japan withdrew its recommendation for HPV vaccine in 2013, and has not reversed that decision because of concerns from the public about adverse events, which included long-term pain and numbness, as previously reported by Medscape Medical News.
Since then, various symptoms, especially generalized chronic pain after injection, have been reported.
Last month, guidelines for the evaluation and management of symptoms that begin after HPV vaccine injection were issued to healthcare professionals. The guidelines were edited and approved by the Japan Medical Association (JMA) and the Japanese Association of Medical Sciences (JAMS).
In addition, the Japanese Ministry of Health, Labor, and Welfare has issued a list of medical institutions where people can visit when they have symptoms after HPV injection; there is at least one in each prefecture. Healthcare workers at those selected institutions are educated by the JMA. However, this does not mean other institutions cannot accept those people with symptoms. The ministry has also issued information regarding HPV vaccine-related health problems and questions, with a telephone helpline..."

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