The Gardasil 'miracle' coming undone?

In fact there is even still disagreement if HPV, a sexually transmitted virus, is at all implicated in cervical cancer. In at least 30 per cent of such cancers this virus is not found. So screening must never be stopped; no HPV vaccine will protect these women. A “quick fix” technology won’t work.

It’s also unclear if HPV “causes” the cancer or, rather, is “associated” with it (e.g. already existing cancer cells might spread more rapidly if HPV is present). Most importantly, there are an estimated 20-40 HPV strains that infect the female genital tract and of those Gardasil covers only two “high” risk strains (16 and 18) and also 6 and 11 which can lead to genital warts. The great worry is that even if strains 16 and 18 were neutralised by the vaccine, other virus strains might become more active.

This is a very important point because it appears that most infections are “mixed”, that is they consist of a number of HPV strains (see “HPV Vaccination - More Answers, More Questions” by George F. Sawaya, M.D., and Karen Smith-McCune, M.D., Ph.D. in the New England Journal of Medicine 356:1991-1993).

We also don’t know if the vaccine-produced immunity will last, nor if and when booster shots might be needed. Further, there are fears that an immunity created early in life might allow for more virulent reactions in later years. And Gardasil is a genetically engineered vaccine; it also contains a high amount of aluminium adjuvant which is known to be responsible for very serious reactions in other vaccinations.

With all these unanswered questions, the worrying rise of serious adverse effects, the lack of independent research, parents of girls and young women themselves should seriously consider if the vaccine is worth the risk.

Let’s not forget that Gardasil was fast tracked through the FDA, a process normally reserved for life saving drugs. And that, amazingly, it received the green light in 2006 for girls as young as nine despite the fact that fewer than 1,200 girls under 16 had taken part in the manufacturer-sponsored research. And that some trials weren’t even finished.

Since then Gardasil has become the fastest selling drug to reach US$1 billion sales - cash much needed by Merck who has started this year to pay compensation to the Vioxx victims (a Cox2 anti-inflammation drug for arthritis that had resulted in thousands of heart attacks and deaths). And great for the Australian manufacturer, Commonwealth Serum Laboratories (CSL) which receives royalties from Merck from its overseas license of Gardasil. CSL reported a 30 per cent rise in full year profit (to June 30, 2008), and is so cashed up that it has recently entered a sales agreement for $3.48 billion for a plasma manufacturing company (AAP, August 13, 2008).

But surely girls’ and women’s health must never be compromised by monetary gains for shareholders. The Gardasil saga reminds me of Hormone Replacement Therapy (HRT) where for 40 years millions of women were told that this “miracle drug” would save them from a life of misery after menopause when, in fact, it increased the risk of breast cancer and heart attacks. Since 2002, when medical consensus finally dealt a blow to HRT, breast cancer rates have been falling both in Australia (in NSW by 6.7 per cent) and the USA (by 12 per cent) (Cathy O’Leary, The West Australian, June 2, 2008).

I hope we won’t have to wait 40 years for the Gardasil “miracle” to become undone.

It is time for Nicola Roxon, the Federal Health Minister, to step into this fray and listen to the girls and women for whom the vaccine has meant pain and debilitating illness. She must suspend the Gardasil vaccination program before it claims more victims and launch an thorough investigation into the health of vaccine recipients.

We need her strong leadership now.