A letter to the Australian Government Therapeutic Goods Administration (TGA):
I would like to provide you with the following quote from the Journal of Law, Medicine and Ethics (September 2012 p. 677):
‘Merck’s HPV vaccine Gardasil failed (and continues to fail) to meet a single one of the four criteria required by the FDA for Fast Track approval. Gardasil is demonstrably neither safer nor more effective than Pap screening combined with LEEP, nor can it improve the diagnosis of serious cervical cancer outcomes. In spite of this Gardasil continues to be promoted as if it already had post-phase 4 confirmatory trial approval and proven efficacy against cervical cancer’
On the 24th August 2011 I wrote to the TGA asking for answers regarding the safety and efficacy of HPV vaccine. I have not received an answer to this letter and there is now further evidence in peer-reviewed journals that this vaccine is not in the best interests of the Australian public.The HPV vaccine was fast tracked for approval in 2006 before the clinical trials for this vaccine were completed. At this time Professor Ian Frazer the creator of this vaccine (with funding from CSL pharmaceutical company) was announced Australian of the Year and an aggressive marketing campaign ensured that schools informed girls that this vaccine would prevent cervical cancer. Professor Ian Frazer won the Australian of the Year 2006 award for ‘creating a vaccine to prevent cervical cancer’ yet this vaccine has not been demonstrated to prevent any cervical cancer 6 years after it has been marketed to school children as a prevention for cervical cancer.
The claim that it will prevent pre-cancerous lesions in 16 – 26 year old females is also speculative with respect to the prevention of cervical cancer because the relationship between lesions in this age-group and cervical cancer later in life is unknown and most lesions in this age group clear quickly and without treatment. In addition there are 13 other high risk HPV subtypes that are not covered by the vaccine.
The problem with promoting this drug to healthy teenagers is that it contains sodium borate and polysorbate 80 – two chemicals that are linked to causing infertility in rats. It also contains 225 ug of aluminium hydroxyphosphate sulfate in each injection: a chemical linked to autoimmune diseases. This vaccine has been linked to 21,265 adverse reactions in the US alone from a voluntary reporting system. These reports include 78 deaths, 363 life-threatening reactions and 609 events resulting in permanent disability. The most common adverse reaction to this vaccine has been nervous-system related disorders and there has been no systematic follow up of health outcomes since the vaccine was marketed 6 years ago.
In May 2011 I asked Professor Fiona Stanley (Australian of the Year 2004) to answer the questions that many consumers have about this vaccine and although she did not retire officially from the Telethon Institute for Children’s Health Research until 2012 she did not reply to the these questions. I have placed further questions for Professor Ian Frazer on my website (www.vaccinationdecisions.net) and on The Conversation website but to date he has declined to answer the public’s questions.
I would like to ask the TGA (again) to provide evidence for the safety and efficacy of HPV vaccine in preventing cervical cancer so that the public can have confidence that government immunisation policies are being implemented in the best interests of the public.
