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John Bisnar
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Merck's Cervical Cancer Vaccine Under Investigation

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Should we trust Merck after Vioxx?

Is mandating innoculations the way to go?

The National Vaccine Information Center has asked state officials to investigate the safety of a Merck-produced “breakthrough cancer vaccine,” which is said to prevent the sexually transmitted virus that causes cervical cancer, the Washington Times reported.

According to the Feb. 3 article, negative side effects are being reported in the District of Columbia and 20 states including Virginia to Gardisil, which got the Federal Drug Administration’s stamp of approval last year. The reactions, officials say, range from loss of consciousness to seizures.

Texas recently became the first state to make this vaccine mandatory for school-age girls.

Vicky Debold, health policy analyst for the National Vaccine Information Center, a nonprofit watchdog group created in the early 1980s to help prevent vaccine injuries, says girls who have been given this vaccine are suffering from serious side effects.

“Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures,” she said.

Gardasil received federal approval in July and since then several states have introduced various legislations that would make this vaccine mandatory in schools. On Feb. 2, Texas Gov. Rick Perry signed an order making Texas the first state to require the vaccine for girls 11 and 12 before they enter the sixth grade starting in September 2008.

Merck has been aggressively marketing Gardasil since it won FDA approval for use on females ages 9 to 26. The vaccine is reportedly the first of its kind to build immunity against two strains of HPV, which lead to 70 percent of cervical cancer cases in the United States.

The American Cancer Society is however assuring the public that the types of side effects reported are not cause for alarm.

“We have not been informed of an instance that would call into question the overall safety of the vaccine,” said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society, adding that about 70 similar events had been known in October 2006.

The Center for Disease Control is also standing firm and will not alter its approval of the vaccine despite the reports of side effects. CDC officials say the vaccine has been tested all over the world and has been found safe and effective.

That said, several doctors object to Merck’s claim that Gardasil is the best answer to cervical cancer.

Gardasil is delivered in three separate injections that cost $120 to $150 per injection. Merck revenue from Gardasil reached $155 million for the fourth quarter of 2006 and $255 million for the entire year. If anyone can direct me to information on the amount of money $pent by Merck on lobbying efforts to get regulations passed mandating vaccination, please pass it on to me.

This concerns me because Merck has a history of aggressively pushing their new drugs into the marketplace. Consider the quarter million heart attacks attributed to Vioxx usage. Merck failed to disclose early findings of a five-fold increase in heart attack risk.

If my daughters were still of primary school age, they certainly would not be subjected to being the guinea pigs for Merck’s latest drug. I’d wait for at least five years before considering inoculating my daughters. I’d wait to see if there are any birth defect issues as well. This is an area where I prefer to be a follower, rather than a trail blazer.

Let’s hope that Gardasil’s positives outweigh the negatives. Let’s hope that Gardasil is a miracle drug that wipes out HPV with no significant side effects and that Merck makes a ton of money. Let’s make sure our elected officials are not mandating inoculations to gain political equity and campaign contributions.

I have a bad feeling about Gardasil. Merck spending a million dollars on advertising concerns me. I wonder how much they spent lobbying and testing?