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Researchers reconsider Gardasil vaccine

By Lauren Salem

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Published: Sunday, September 21, 2008

Updated: Friday, December 26, 2008

Each year in the United States 3,700 women die from cervical cancer and 9,710 more women develop cervical cancer, according to the Centers for Disease Control and Prevention.

But in the past two years, medical professionals have advocated widely for a vaccine that they have claimed could lower those startling numbers: the Gardasil vaccine.

"I chose to get my daughter vaccinated because I want her to be one less woman affected by cervical cancer," a mother says in a Gardasil commercial as she sits down beside her daughter on the couch smiling.

In 2006, the Food and Drug Administration (FDA) approved and reported Gardasil to be "the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16, and 18." HPV infects about 6.2 million Americans a year, which makes it the most common sexually transmitted infection in the United States. The FDA reports that the Gardasil vaccine "is effective against HPV types 16 and 18, which cause approximately 70 percent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 percent of genital warts."

The Advisory Committee on Immunization Practices advises that girls between the ages of 11 and 12 get vaccinated before they become sexually active; so many state legislators are introducing legislation that many require, fund, or educate the public about the HPV vaccine. According to The National Conference of State Legislatures, 17 states have enacted this legislation. Michigan and Ohio were the first states to introduce legislation that requires the HPV vaccine for girls entering sixth grade, but it was not enacted in either state.

Texas was the first state to enact a mandate requiring the HPV vaccine for school entry (with some exceptions) by executive order. Legislators in Texas passed H.B. 1098 to override the executive order and the governor withheld his veto, according to The National Conference of State Legislatures. In 2007, Virginia legislators also passed a school vaccine requirement, which is currently in the process of being removed. Charlotte J. Haug, M.D. Ph. D., stated in the New England Journal of Medicine that "we lack sufficient evidence of an effective vaccine against cervical cancer" and that "the overall effect of the vaccines on cervical cancer remains unknown… How can policymakers make rational choices about the introduction of medical interventions that might do good in the future, but for which evidence is insufficient, especially since we will not know for many years whether the intervention will work or-in the worst case-do harm?"

On August 20, 2008, ABC reported on "World News with Charles Gibson" that the HPV vaccine potentially caused a series of serious side effects including 78 outbreaks of genital warts, 18 deaths, and 6 cases of Guillain-Barre Syndrome (which can cause paralysis). Out of roughly 8 million girls who have been vaccinated, 9,000 of them reported that they had serious side effects shortly after their shots. Dr Richard Haupt, the executive director of Merck Research Laboratories, stated, "these reports of conditions that have occurred following vaccination do not necessarily mean they are causally related." According to the FDA, Merck & Co., Inc, conducted four studies on 21,000 women between the ages of 16 and 26 by giving them either the vaccine or placebo to see how Gardasil affected different age groups. Results show that Gardasil "was nearly 100 percent effective in preventing precancerous cervical lesion, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed," but "the study period was not long enough for cervical cancer to develop."

It is unclear whether or not Gardasil prevents cervical cancer, but the FDA believes it is highly likely.

Enough research has not been conducted to show what long-term side effects Gardasil may cause or whether or not the serous side effects reported on ABC were even caused by the Gardasil vaccine.

Many state legislatures are still processing legislation that would require girls to be vaccinated for school entrance. Some of which include the District of Columbia, Georgia, Illinois, and Kentucky.

Most states would allow parents to op-out their daughters from being vaccinated, but a vaccine should not be mandatory for school entrance if examinations have not proven it to be completely safe and effective.

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