Are we sure Gardasil is safe?

By Melinda Tankard Reist and Dr Renate Klein

December 05, 2007 07:16am

Article from: The Daily Telegraph,23599,22870759-5007146,00.html


WHEN reports first emerged a few months ago of Melbourne school girls fainting, suffering dizzy spells and paralysis after their Gardasil injections, the anti-cancer drug's inventor Ian Frazer put it down to auto-suggestion.

Dr Stephen Downes said it was mass sociogenic illness - hysteria.

Now it has been revealed that, as of November 30, 496 adverse reactions have been lodged with the Therapeutic Goods Administration (TGA). In the US it's fast approaching 3500 reported cases.

There are too many unanswered questions about the drug, which has also been linked with other symptoms such as temporary blindness, convulsions, disorientation, hyperventilation and tinnitus.

Why are we pushing ahead with a $450million program when there is so little information about safety and whether the drug actually works?

Only a small number of randomised trials have been reported - all with funding from the vaccine's manufacturer.

Gardasil was tested on fewer than 1200 girls under 16. It is essentially an untested product in this age group.

There is little evidence that the drug, when administered to very young girls, will still be active later in life - when most cervical cancers develop.

There are more than 100 strains of the human papilloma virus (HPV). At least 13 of these can cause cancer. Gardasil covers only two. Yet all the advertising for the drug leads you to think that if you get the jab, you won't get cancer.

Are girls being given the opportunity to understand and avoid risks factors for cervical cancer such as smoking, a weak immune system, the pill, multiple sex partners and unprotected sex?

Are girls told pap smears are still necessary - or do they not bother because they think they are now safe?

An editorial in the Journal of the American Medical Association this year stated: "It is important to emphasise that the vaccine is supported by limited efficacy and safety data."

Why doesn't the health department want to give us details of the 17 girls a week experiencing adverse reactions?

No one's asking for their names and addresses. But those of us concerned about women's health want to know what happened to them and give other young women the opportunity to make an informed decision about Gardasil.

* Melinda Tankard Reist is an author and director of the think tank Women's Forum Australia. Dr Renate Klein is a long-term health researcher