Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A new study published in the Archives of Pediatric & Adolescent Medicine indicates girls who receive HPV (human papillomavirus) vaccines like Gardasil and Cervarix may overestimate the amount of protection the drug offers. According to the report, funded by the National Institutes of Health, some girls think they no longer have to practice safe sex after receiving the vaccination, or that they are protected from all types of HPV or protected from HPV indefinitely. In fact, vaccines such as Gardasil only protect against four of hundreds of types of HPV, and the vaccine’s effectiveness diminishes after about five to seven years.

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As expected, a U.S. Centers for Disease Control and Prevention (CDC) advisory committee this week recommended expanding the use of the Gardasil vaccine, manufactured by Merck, to include boys and young men. The vaccine, which targets the human papillomavirus (HPV), previously has been recommended for girls, as a way to prevent cervical cancer caused by certain types of HPV. Gardsil use had already been approved by the FDA to treat boys in October 2009, although it was not yet given “recommended” status. The CDC reports that approximately 32 million doses of the vaccine have been distributed in the United States since the vaccine was initially approved in 2006.

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In this week’s GOP Presidential debate, candidate Michele Bachmann criticized Texas Governor and presidential candidate Rick Perry for his attempt to mandate the use of Gardasil in his state. Gardasil, manufactured by Merck, is promoted as a preventive treatment against human papillomavirus (HPV), a sexually transmitted virus linked to the development of cervical cancer. Following a public outcry in the state of Texas, the mandate was overturned. Bachmann objected to the mandate for political reasons, but also expressed concerns that any parent might feel about being required to give their child a relatively new vaccine, about possible adverse side effects.

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There is much debate about the vaccine Gardasil, which was introduced in 2006 for girls, and marketed as a weapon against cervical cancer. The vaccine actually targets human papillomavirus (HPV), a sexually transmitted virus that is linked to the development of cervical cancer. While originally targeted only at girls and young women, the FDA recently expanded approval of the drug for use in boys and young men, to prevent the spread of HPV.

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Gardasil, a vaccine manufactured by Merck and promoted as a prevention for cervical cancer, was approved by the FDA in 2006. Later the same month, the vaccine was added to a list of recommended vaccines for girls ages 11-12 years. This, despite the fact that the first phase 3 trials of the vaccine were not yet complete. It would be almost a year later – May 2007 – before these studies were complete. Why the big rush?

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A writer on the blog site buzzle.com, a news and information clearinghouse website, recently posted an article urging parents to use caution when making a choice about the Gardasil vaccine. The mother of an 11-year-old girl, author Anastacia Mott Austin says young girls receiving the human papillomavirus (HPV) vaccine are like “guinea pigs,” because the vaccine has not been properly tested for long-range consequences on a large sample of girls in its target age group. The vaccine is currently recommended by the FDA for girls beginning as young as age 9, through about age 26, for the prevention of cervical cancer.

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SM Mohammed Idris, president of the Consumers Association of Penang, recently wrote an opinion piece for the Malaysia Kini website, asking that the government reconsider its decision to vaccinate all 13-year-old girls in the country with Gardasil or Cervarix. According to the column, the country’s Ministry of Health (MOH) will spend RM 150 million annually for the vaccinations, which will affect about 300,000 girls. Idris warns the vaccine is “unnecessary, unscientific and unsafe.”

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The Centers for Disease Control and Prevention recently rescinded its controversial and, some argued, discriminatory requirement that all girls and women ages 11 to 26 immigrating to the United States receive at least one injection of Gardasil, Merck’s human papillomavirus (HPV) vaccine.

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The Advisory Committee on Immunization Practices, which informs the U.S. Food and Drug Administration on vaccine use and policy, declined to advocate for Gardasil’s systematic and widespread use in boys and men. The human papilloma virus, or HPV, does not present the same risks of cancer in males as it does in females, but it can lead to the development genital warts.

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