The Gardasil 'miracle' coming undone?

It is quite scandalous that Australia rushed so breathlessly into the world’s first free vaccination program without also simultaneously establishing a Vaccine Registry in which every vaccination recipient would be included and could easily be tracked if any problems emerged or to establish the remaining level of antibodies. Now they have to do it the hard way and shortcuts must not be allowed to occur.

But why this rush to use Australian girls and young women as guinea pigs for this new vaccine? What is the appeal of Gardasil? There is no epidemic of cervical cancer in developed countries. In Australia, about 200 women a year die from it - approximately two per 100,000 - and while every death is one death too many, the numbers have been going down from year to year due to Australia’s screening program.

At least three main reasons account for the vaccine hype.

One, the word “cancer” triggers an incredible fear reaction in most people.

Two, great marketing of the vaccine which, in Australia, is mixed with a good dose of patriotism. We are told that Queensland scientist, Professor Ian Frazer, with his Chinese colleague was the “inventor” of the HPV vaccine. This has made him into a national hero and the Australian of the Year 2006. Frazer: “God’s Gift to Women” proclaimed the cover of The Weekend Australian’s magazine on March 4-5, 2006. In actuality, like Ian Frazer at Queensland University, US Universities of Georgetown and Rochester and the US National Cancer Institute (NCI) all claim “… to be responsible, for original work leading to a cervical cancer vaccine” (see Ruth Beran, July 21, 2006). Is acknowledging others that hard?

In Australia, critics are almost perceived as national traitors and unlike in Germany, Canada and Spain, very few critical voices have been heard in the public debate (www.harald-terpe.de/2637.98.htm June 17, 2008; Lippman et al. CMAJ, August 2007; Juan Gérvas, Rev Port Clin Geral 2007 23, 647-55, accessed here).

In the USA, one of the scientists who worked on the Gardasil trials sponsored by Merck, Professor Diane Harper of Dartmouth Medical School, has been urging caution for some time. “It's not a cure-all for cervical cancers and it's not meant to be a replacement for Pap tests’ she said (Danielle Egan, May 31, 2007 The Tyee, Vancouver, Canada).

The third reason can be found in media reports which too often unquestioningly repeat what is fed to them by vaccine advocates. The fact is that HPV as well as cervical cancer are complicated and messy scientific phenomena with lots of question marks remaining. This complexity is difficult to explain. So the over enthusiastic media message gets simplified to “Gardasil Prevents 70 per cent of Cervical Cancer”. And parents who want to do the responsible thing sign their daughters up for vaccination.

But no one knows if Gardasil will ever prevent a single case of cervical cancer. There is certainly no proof to date because cervical cancer can take 20 to 30 years to develop and research into the HPV vaccine has only taken place for the past five years. What manufacturer-sponsored researchers have claimed as success was seeing fewer benign lesions develop in research participants.

Of course it would be highly unethical not to treat women who develop such abnormal cells in either the vaccine or the control group. And therefore we might never know whether the vaccine really worked or whether perhaps the new “Thin Prep” (PDF 96KB) adjunctive to Pap Smears might be the reason for a higher and more reliable detection rate that further reduces deaths from cervical cancer.

HPV strains appear to be present in 80 to 90 per cent of both women and men (another estimate as no one really knows), but clear up within one to two years. Co-factors that stop the body from naturally clearing abnormal cells are smoking, poverty, a poorly functioning immune system, bad nutrition, use of the oral contraceptive, unsafe sex, multiple sexual partners and a lack of male sexual hygiene (circumcised men have fewer HPV infections; see Zukerman in The Weekend Australian, August 16-17).

On top of all of this, if the vaccination program had indeed been aimed at reducing HPV infection in the general population (i.e. create “herd” immunity), boys should have been included from the very beginning. That they were not, shows once more that it is always women - and now even girls - who bear the burden of dangerous drugs for prevention whether it’s an unplanned pregnancy or an HPV infection. No shared responsibilities here!