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Fiji Time: 12:10 PM on Monday 22 September

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Are our girls guinea pigs?

By MATELITA RAGOGO
Saturday, October 11, 2008

BARELY three months ago, buried in a government press release of Cabinet decisions, was an approval of Gardasil as a vaccination to be administered to our young girls because it would, apparently, prevent cervical cancer.

The next thing you know, our medical officers are urging parents in a television advert to sign consent forms. This week, three primary school students were reported to have reacted negatively to the vaccination.

The report will hopefully be a catalyst for more research on into vaccine and Merck, the company that's brought it to us.

Like, for instance, Gardasil is still in its testing stages and will not be fully evaluated for safety until September 2009.

Merck is also remembered not-so-fondly for Vioxx, its "wonder-drug" that had to be removed from the market in 2002 after an estimated 88,000 to 140,000 adverse reactions were attributed to it.

The Vioxx recall reportedly decreased Merck's stock value drastically by about $20billion. Less than two years after Merck suffered this severe blow, the company introduced Gardasil, the most expensive vaccine on the market, and it was approved by the FDA.

Like Gardasil, Vioxx was fast-tracked by the America's Food and Drug Administration (FDA - a body that controls this market) in 1999, without a full safety testing and analysis period taking place.

By August 14 this year, Judicial Watch, a non-profit interest group which has monitored the vaccine's progress since it was released. reported "21 deaths and 9749 adverse reactions, including 78 outbreaks of genital warts and 10 miscarriages".

Gardasil was approved by the FDA on June 8, 2006, after only a six-month priority review process; FDA can fast-track new cancer treatments or medications but this is only really after at least ten months to review and process.

A Judicial Watch Special Report released on June 30 this year, reports personal accounts from victims, their families and health professionals of some horror stories; information related to HPV and Merck's new vaccine was released by FDA under the Freedom of Information Act.

The report says at this time, it is unknown whether Gardasil will have long-term effects on fertility or not. Since the vaccine was only released in 2006, it could be years before anyone knows its long term effects.

Effectively, Cabinet approved a vaccine which is still being tested so no one can be sure of its effectiveness or long-term side effects.

Our children are guinea pigs for a money-making, I mean, drug-making, machine.

The drug has received a lot of flak and some states in America have either stopped its administrations or, like the Huron-Superior Catholic District School board, rejected its administration in its school compound.

But of all its critics, perhaps the one we should all "hear" is lead researcher in the development of the HPV virus vaccine Dr Diane Harper and the specialist who helped develop the Gardasil vaccine.

In a television interview with CBS News on May 7, 2008, Dr Harper said she viewed making the vaccination mandatory as "a real danger zone" adding "...the vaccine has not been out long enough for us to have post-marketing surveillance to really understand what all of the potential side effects are going to be."

Dr Harper believes the vaccine will be beneficial in the long run but she cautions: "To put in place a process that says you must have this vaccine means that you must be part of a big public experiment and so we can't do that. We can't have that until we have more data."

Amongst other findings, the report states that Gardasil is not a cancer vaccine or cure.

It "has not been evaluated for the potential to cause carcinogenicity (an agent directly involved in the promotion of cancer) or genotoxicity (may bind directly to DNA or act indirectly to cause DNA damage).

It is designed to protect against only four strains of HPV even though there are over 30 strains including at least 15 that can cause cancer.

During testing, an aluminum-containing placebo was used. Aluminum can cause permanent cell damage and is a reactive placebo unlike most standard saline placebos.

This means tests of Gardasil may not have given an accurate picture of safety levels.

And of the 10 commonly administered adolescent vaccines, Gardasil has only been tested with one - a 17-year-old had involuntary abortion two weeks after because the two vaccines reacted adversely to each other.

There is proof that Gardasil will prevent about half of the high-grade precursors of cancer, but half will still occur.

Hundreds of thousands of women who are vaccinated with Gardasil and get yearly pap testing will still get high-grade dysplasiaa (cell abnormalities).

Gardasil has been shown to prevent precancerous lesions, but it has been impossible to ascertain whether it will actually prevent cancer because the testing period has been so short.

While young women occasionally get cervical cancer, it is far more common in women in their late forties.

The average age of a cervical cancer patient is forty-eight years.

Keeping this in mind, it could easily be decades before anyone truly knows if the Gardasil vaccine prevents cervical cancer.