Gardasil: the denial continues

These “mild problems” are a far cry from Shannon’s and Jade’s serious illnesses or from Julie’s experience of grand mal seizures and the woes of Philippa who continues to suffer from pancreatitis - all developed after the Gardasil injections.

In the USA by May 2009 more than 16,000 adverse reactions were reported (these figures represent only between 1 and 10 per cent of all adverse reactions) and 47 deaths have been associated with Gardasil: four times the number of deaths associated with Menactra (a vaccine against meningococcal).

The Gardasil manufacturers maintain that these deaths are not directly linked to the vaccines. With respect to the deaths of healthy US teenagers from cardiac problems the suggestion has been made that these girls might have suffered from a pre-existing undiagnosed weakness (for example, a heart murmur). For the tragic testimonial of a heartbroken mother who lost her child, see here.

Gardasil is not recommended for pregnant women but there have been reports of spontaneous abortions and fetal abnormalities when pregnant women were inadvertently injected with Gardasil during the Merck trials. Merck is sufficiently concerned that it has set up a registry to follow pregnant women who have received Gardasil. It is unknown if Gardasil will affect fertility.

While the promoters of Gardasil continue to assert that these health concerns are unwarranted and that their vaccine will greatly reduce the incidence of cervical cancer, such claims are far from uncontested. In November 2008, 13 scientists from Germany’s Bielefeld University challenged the STIKO (the equivalent of the TGA) to reconsider their endorsement of Gardasil for health insurance reimbursement. Their main point is that results from the manufacturer-sponsored research trials resulted in only 17 per cent reduction of cervical lesions - nothing like the 98 per cent of reductions Merck is claiming.

In April and May 2009 in the UK and Scotland, groups of parents have started to sue GlaxoSmithKline, the manufacturer of the “sibling” vaccine Cervarix (from which CSL also gains royalties) for seriously injuring their children. In New Zealand, up to 80 schools are refusing to implement the HPV vaccinations. Even one of the scientists involved in the Merck research of Gardasil, Diane Harper, has since 2007 called it a “great public health experiment” and voices long-term concerns about safety and effectiveness, especially when girls as young as 11 are vaccinated. As she put it, “We don't know the vaccine will continue to be effective. To be honest, we don't have efficacy data in these young girls right now.” (“Vaccination campaign funded by drug firm”, Sarah Boseley, March 26, 2007). Two years later, the situation hasn’t changed: fewer than 1,200 girls under 15 have ever been in Gardasil trials. And yet millions of 12-13 year old girls have already received the three shots.

On June 9, 2009, the US Food and Drug Administration (FDA) approved a new label for Gardasil which now includes fainting (syncope) and seizures in its Warnings and Precautions. And, crucially, in Australia ordinary citizens are beginning to be critical of the HPV vaccination - quite simply because more and more personally know injured girls and young women or hear about them from friends or teachers.

But the Australian government remains silent and thereby continues its denial about problems with Gardasil. The TGA hasn’t even issued a new communiqué that details the June FDA warnings. It is high time that the Federal Health Minister, Nicola Roxon, showed leadership. Today, June 30, 2009, brings the end of free vaccinations for women up to age 26: a good time to suspend all Gardasil vaccinations (those for schoolgirls included) and check the health status of every single woman and girl who was vaccinated with Gardasil since April 2007. This should be done with the help of the belatedly implemented HPV Register. Such a serious investigation will show the world that Australia cares about the health of its young female population and will hopefully give the victims of Gardasil the rightful acknowledgment and care that so far has been sorely lacking.