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Monsanto asked the FDA for Gardasil ® What are they doing? 3 decks

Doctors from around the world and the public welcomed the recent decision the FDA not to extend the use of Gardasil for women older than 26 years of age. Now they want to know when the FDA admitted that the original approval for girls was a mistake. Last week, the FDA refused to approve Merck's application to approve the use of Gardasil ® in women over age 26. According to a recent article in MedPage Today: "The decision was based on a study in 3,253 women ages 27 to 45. There was no significant benefit to the most important outcomes, such as high-grade lesions or cervical cancer or when All participants were included regardless of baseline HPV status. " The team SaneVax respectfully suggests that if this is the case of women between the ages of 27 and 45, may also be the case for younger women (ages 9 to 26 years), for which Gardasil ® was originally approved as prevention of cervical cancer potential. Gardasil ® s Eguren, too, is ineffective in men, although their use in the male gender has recently received FDA approval as a preventative for anal cancer. The efficacy analysis presented by Merck to obtain FDA approval and include the use of Gardasil ® in the male population in November 2010 contains poor results and do not prove that the vaccine prevents cancer. Then, one has to wonder where the hell was I thinking when the FDA approved a vaccine to a wide range of possibilities 'effectiveness', especially when there is no check on it. SaneVax team wants to know: Why Gardasil ® was approved by the FDA as a cervical cancer prevention when there is no clinical evidence attesting to the reduction of precancerous lesions from the medication?

SaneVax team wants to know: Does this vaccine, which is being promoted as protection against various types of cancer, saying that they are caused by HPV, not violates the law?

SaneVax team doctors and consumers around the world, once again asking the FDA to revoke its approval of Gardasil ® until studies are conducted with appropriate endpoints.

Leslie Carol Botha
Vice-President Public Relations, SANE Vax, Inc.