Gardasil Contamination and the ‘State of Play’ Down Under

By Naomi Snell, Australian Contributing Author, Gardasil Victim and Advocate

A Senior Executive of the Australian distributor of Gardasil, CSL, has allegedly admitted to an Australian journalist that, “Gardasil may potentially have detectable fragments of DNA,” which she described as “expected residuals from the manufacturing process, present in very small quantities.” This revelation came after SaneVax discovered a genetically modified DNA contaminant in 13 separate vials of Gardasil, sourced from around the globe from four separate manufacturing facilities.

The statement made by CSL Spokeswoman, Sharon McHale, flies in the face of the product information supplied by CSL, Merck, The Therapeutic Goods Administration (TGA) of Australia and The Australian Department of Health and Ageing. In fact, Section 3.2 of the GARDASIL package insert states:

“GARDASIL is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”

An Australian journalist, exclusively revealed to SaneVax that a statement issued by the Australian Health Department following Ms McHale’s pronouncement said,

“There is no evidence from manufacturing records currently available to the Department or the medicines regulator, the TGA, that there is detectable recombinant HPV DNA in Gardasil. Nevertheless, the TGA is investigating this report.”

A group of Sydney lawyers and barristers is now investigating the initial marketing of Gardasil. Their aim, under the Trade Practices Act 1974, is to prove the marketing claims made were deceptive and adequate testing of the product was not carried out – meaning Gardasil is unfit for its stated purpose.

An Australian Gardasil victim stated she was part of a group that were, “very much looking forward to their day of reckoning.”

Australia’s SaneVax delegates await reply from the Federal Labor Party on the issue of discovery of viral HPV DNA in the Gardasil vaccination. However, members of the Opposition, have offered to raise this concern with the Federal Health Minister, Nicola Roxon and Ian Frazer (the inventor) himself.

In 2008, in NSW Parliament, Reverend the Hon. Dr Gordon Moyes spoke of Gardasil, saying:

“I ask the Attorney General, representing the Minister for Women, and Minister Assisting the Minister for Health (Cancer), a question without notice. Is the Minister aware that the Gardasil vaccine, which is used to protect young women from developing the human papilloma virus and cervical cancer, is administered in three separate doses several months apart? Is the Minister aware that many women may not return for the second and third doses because of fainting, dizziness, seizures and pain reported after the first dose? Is the Minister aware that as of 7 March there have been 775 adverse reactions to Gardasil reported to the Therapeutic Goods Administration? Could the Minister indicate what proportion of women in New South Wales who qualify to have this vaccine have had the whole course of three doses administered? What measures are in place to reassure women that it is both safe and important to complete all three doses of the Gardasil vaccine?”

In an ABC article released in 2010, the Federal government was accused of having too close a relationship with Gardasil distributor CSL. Professor Nikolai Petrovsky from Flinders University, called for, “an independent inquiry into the Federal Government’s relationship with CSL.” He went on to accuse Health Minister Nicola Roxon of not getting “impartial advice.”

Several years later, the same concerns exist. So, from an Australian point of view, it is very much a case of “Game On.”

http://www.parliament.nsw.gov.au/prod/parlment/hansart.nsf/V3Key/LC20080401027

http://www.abc.net.au/news/2010-04-28/government-too-cosy-with-flu-vaccine-maker/413860