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U.S. food and drug administration 60 articles

Despite risks, pediatrics group now recommends Gardasil vaccine for boys

The American Academy of Pediatrics (AAP) is now including Gardasil® on its list of recommended vaccines for boys as well as girls, claiming the vaccine can effectively prevent the spread of the human papillomavirus (HPV), which in rare cases can lead to genital warts and cervical cancer. It’s a significant win for manufacturer Merck, which had positioned the vaccine to be its next big moneymaker after it had to pull its blockbuster drug Vioxx from the market in 2004 over safety concerns. Although the AAP has maintained that Gardasil® is appropriate for boys, until now the shot has never been ... Read More

New recommendations for Gardasil vaccine may put boys at risk

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. When it was introduced by manufacturer Merck, Inc., in 2006, Gardasil was marketed as a preventative treatment for cervical cancer. A ... Read More

Overestimating benefits of HPV vaccines could lead to increased risks

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 ... Read More

Gardasil marketing: putting the profit cart before the proof horse?

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. The study was published in May 2007, about one year after Gardasil was approved by the U.S. Food and Drug Administration. The drug was approved for girls and young women, as protection against the human papillomavirus, or HPV, a sexually-transmitted virus linked to ... Read More

Vaccine watchdog group asks FDA to review Gardasil for possible contamination

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. In its official news release, SANE Vax reports that 100 percent of the ... Read More

Aggressive marketing of Gardasil plays on public fear of cancer

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. Gardasil was recommended for girls beginning as young as age 9, and presented as an “anti-cancer vaccine.” The drug actually protects against four of hundreds of strains of human papillomavirus (HPV), two of which are high risk, responsible for about ... Read More

FDA approves Gardasil for use in preventing anal cancer

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. The approval expands the audience for the Merck & Col. manufactured drug to include all people – boys and girls – ages 9 through 26. Gardasil protects against four kinds of HPV – 6, ... Read More

Cervical cancer expert discusses report questioning Gardasil safety

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. Gardasil, which was released by manufacturer Merck in 2006, has recently been approved ... Read More

FDA records raise new concerns about Gardasil safety

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. Last week, Judicial Watch, a government watchdog group, obtained reports from the U.S. Food & Drug Administration (FDA) that contain extensive new documentation of deaths and adverse events linked to the Gardasil vaccine. The FDA report documents incidents that occurred between May 2009 ... Read More