News Tagged ‘FDA

New recommendations for Gardasil vaccine may put boys at risk

risk vs benefit New recommendations for Gardasil vaccine may put boys at riskDespite 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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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 () 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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Gardasil marketing: putting the profit cart before the proof horse?

risk vs benefit 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 has an unbelievable 98 percent efficacy rate. On closer examination, however, perhaps unbelievable is the right word.

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CDC recommends expansion of Gardasil use to boys

cdc logo 300x220 CDC recommends expansion of Gardasil use to boysAs 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 (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 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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Vaccine watchdog group asks FDA to review Gardasil for possible contamination

SANE Vax logo Vaccine watchdog group asks FDA to review Gardasil for possible contaminationA consumer watchdog group that specifically focuses on vaccine safety, SANE Vax, Inc., sent a certified letter to U.S. Food & Drug Administration () 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 (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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Vaccine watchdog group promotes letter writing campaign against Gardasil

gardasil logo Vaccine watchdog group promotes letter writing campaign against GardasilS.A.N.E. Vax, Inc., a non-profit organization established to promote safe, affordable, necessary, effective vaccines and vaccination practices, has announced a combined effort of concerned citizens worldwide to insist on government compliance with regulations and guidelines in the implementation and monitoring of vaccines. In particular, the outreach effort is focusing on Gardasil, manfuactured by Merck and marketed as a preventive for cervical cancer by targeting the (HPV). According to a recent news release, SaneVax is encouraging an open letter writing campaign addressing the issue of vaccine safety.

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Writer urges parents not to make daughters ‘guinea pigs’ for Gardasil

Gard 100x100 Writer urges parents not to make daughters guinea pigs for GardasilA 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 (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 for girls beginning as young as age 9, through about age 26, for the prevention of cervical cancer.

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Aggressive marketing of Gardasil plays on public fear of cancer

smu logo1 272x300 Aggressive marketing of Gardasil plays on public fear of cancerA 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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Parents advised to cautiously weigh pros and cons of Gardasil vaccine

The American Academy of Pediatrics recently added Gardasil to its list of recommended vaccines for young men starting at age 9, for the prevention of genital warts. The vaccine, which protects against four strains of the (HPV) already was recommended for girls by the age of 11 or 12 as a preventive measure against cervical cancer. However, parents should carefully weigh the pros and cons of this relatively new vaccine, which was approved by the in 2006. Thousands of adverse event reports are attached to the vaccine, and it has been linked to more than 50 deaths.

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FDA approves Gardasil for use in preventing anal cancer

The U.S. Food and Drug Administration () 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 (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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