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

Despite outcry from parents of girls who have received the HPV vaccine Gardasil, and criticism about the vaccine’s effectiveness from one of its own creators, this month the American Academy of Pediatrics endorsed its use for boys. This follows a similar recommendation from the Centers for Disease Control and Prevention (CDC). Critics of the vaccine, which has been linked to thousands of complaints of serious adverse side effects, are left to wonder why their voices are not being heard.

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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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On first glance, a  study published by drug manufacturer Merck & Co., in the New England Journal of Medicine appears to declare the Gardasil vaccine a resounding success. The pharmaceutical giant points to numbers that show its cervical cancer vaccine has an unbelievable 98 percent efficacy rate. On closer examination, however, perhaps unbelievable is the right word.

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A consumer watchdog group that specifically focuses on vaccine safety, SANE Vax, Inc., sent a certified letter to U.S. Food & Drug Administration (FDA) Commissioner Dr. Margaret Hamburg on Sept. 6, asking the agency to review the possibility of contamination involving the vaccine Gardasil. Gardasil, manufactured by Merck & Co., is promoted as a preventive against the Human Papillomavirus (HPV), which is linked to the development of cervical cancer. SANE Vax reports independent testing indicates samples of the Gardasil vaccine may be contaminated with recombinant HPV DNA.

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A recent lecture presented by Southern Methodist University’s Cary M. Maguire Center for Ethics and Public Responsibility, in collaboration with SMU’s Department of Anthropology, examined the ethical questions of pharmaceutical company Merck’s marketing of its Gardasil vaccine. The drug, fast-tracked for approval in 2006 by the U.S. Food and Drug Administration, was aggressively marketed as a preventive for cervical cancer.

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The U.S. Food and Drug Administration (FDA) has approved the use of the Gardasil vaccine for the prevention of anal cancer. Previously, the drug was approved only for use in girls and young women, for the prevention of cervical cancer. Gardasil targets the human papillomavirus (HPV), a sexually transmitted virus that can cause cervical cancer. Recent studies have also show the virus can cause anal cancer.

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Recently, WTVR CBS-6 News in Richmond, Virginia, brought viewers a troubling report of serious adverse events and 16 deaths linked to the Gardasil vaccine. The vaccine, which is intended to prevent four types of human papillomavirus (HPV) that cause cervical cancer, is required for girls in Virginia prior to entering the sixth grade unless their parents object. The story, which is based on a new FDA adverse event report obtained by the government watchdog group Judicial Watch, sparked debate in the area and is generating interest nationwide.

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Parents in Virginia are worried following the release of a new report that links the Gardasil vaccine to 16 deaths and nearly 4,000 adverse events. Currently, the vaccine, which protects against four types of human papillomavirus (HPV) linked to cervical cancer, is required for girls in the state prior to entering the sixth grade, unless parents object.

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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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Merck and Co. announced yesterday that Dr. Julie Gerberding, the former director of the U.S. Centers for Disease Control and Prevention, will head the pharmaceutical giant’s vaccine division. Dr. Gerberding served as the CDC director from 2002 to 2009, stepping down when President Barack Obama took office.

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