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Gardasil Vaccine linked to Sickness

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Herald Sun
By Karen Collier and Jane Metlikovec
May 22, 2007

FEDERAL Health Minister Tony Abbott and health authorities have urged parents not to panic over reports that dozens of teenage girls have been sickened by a new cervical cancer vaccine.

In one case being investigated, a girl was left temporarily paralysed and unable to talk after receiving the Australian-developed Gardasil vaccine.

Health authorities have denied the cases are directly related to the immunisation.

Federal Health Minister Tony Abbott and doctors urged parents not to panic, saying the benefits outweighed the small risk of side effects.

Mr Abbott said risks were taken seriously but there was no evidence of a serious problem with the vaccine.

Schoolgirls across Australia are being immunised with the breakthrough Gardasil, developed by Professor Ian Frazer.

Australian Medical Association president Mukesh Haikerwal said it was important girls were still vaccinated.

"We have got for the first time a vaccine that prevents cancer," Dr Haikerwal said.

Sacred Heart Girls' College student Natasha D'Souza was treated after she was temporarily paralysed and unable to talk for hours after her injection at the Oakleigh school on May 7.

The Royal Children's Hospital said the vaccine was not to blame and tests on the girl were continuing today.

Natasha D'Souza was one of seven Victorian students taken to hospital after vaccinations this month. Most fainted or complained of feeling dizzy.

Sacred Heart Girls' College principal Christopher Dalton said today that 26 girls were taken to the school sick bay after injections.

Five were taken to the Monash Medical Centre, but hospital staff ruled out vaccine complications.

"It is not uncommon for girls of this age group to react to vaccinations in ways that are not necessarily physical in origin," Mr Dalton said.

The school will press ahead with more vaccinations next month.

Parents' permission is sought before students line up for shots, which is given in three doses over six months.

Hundreds of girls in the US have reported reactions such as temporary paralysis, fainting and broken bones from falling over after receiving the shot.

Gardasil protects against strains of the human papilloma virus, or HPV, that leads to most cervical cancers.

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1 Comment

To summarize this published, peer-reviewed medical journal article:

1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the only recognized precursors to cervical cancer.

2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the strongest (and many would argue only valid) precursors to cervical cancer.

3. GARDASIL’s protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer “raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18.”

4. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias — many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That’s about $60,000 per dysplasia prevented.

This is all directly from the article linked above.

I myself would add that the use of a highly pharmacologically alum adjuvant as the sole "placebo" in both the FUTURE I & FUTURE II studies makes it impossible to accurately assess the overall risks of vaccination vs. non-vaccination in the real world. Furthermore, the fact that GARDASIL has been studied for safety in just a few hundred pre-teens (again using an alum injection as the "placebo") is highly problematic.

Finally, even though we don't have any decent quantitative numbers concerning GARDASIL's safety (especially on a pre-teen population), we must consider that vaccines in general are not 100% safe. They can cause juvenile arthritis, Guillain-Barre syndrome and other major complications (such as temporary paralysis, fainting, and persistent pain, swelling and itching) in a small subset of the population. Vaccines are not like other medicines in that they are given to a lot of healthy people who would not otherwise contract any disease with or without vaccination. So vaccines must be reasonably effective for their benefits to outweigh their associated risks.

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