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In searching for resources on this topic, I came across this post (pretty high up in the Google results) disparaging the vaccine as "worthless" and "potentially dangerous." Says the author, Dr. Mercola: "By the way, Gardasil is completely worthless if you already have one of those viruses. The other bad news: Five women treated with Gardasil near the time of conception eventually had children who now suffer from birth defects, a problem for which Merck denies responsibility." Vaccines are intended to prevent infection with a virus, not to treat those who already have a virus, by definition. As to the second point, I haven't read through all of the trial reports, but the product labeling (PDF) states:
"During clinical trials, 2266 women (vaccine = 1115 vs. placebo = 1151) reported at least 1 pregnancy each. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received GARDASIL and subjects who received placebo. Overall, 40 and 41 subjects in the group that received GARDASIL or placebo, respectively (3.6% and 3.6% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse experience during pregnancy. The most common events reported were conditions that can result in Caesarean section (e.g., failure of labor, malpresentation, cephalopelvic disproportion), premature onset of labor (e.g., threatened abortions, premature rupture of membranes), and pregnancy-related medical problems (e.g., pre-eclampsia, hyperemesis). The proportions of pregnant subjects who experienced such events were comparable between the vaccination groups. There were 15 cases of congenital anomaly in pregnancies that occurred in subjects who received GARDASIL and 16 cases of congenital anomaly in pregnancies that occurred in subjects who received placebo. Further sub-analyses were conducted to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of GARDASIL or placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL compared to 0 cases of congenital anomaly in the group that received placebo. The congenital anomalies seen in pregnancies with estimated onset within 30 days of vaccination included pyloric stenosis, congenital megacolon, congenital hydronephrosis, hip dysplasia and club foot. Conversely, in pregnancies with onset more than 30 days following vaccination, 10 cases of congenital anomaly were observed in the group that received GARDASIL compared with 16 cases of congenital anomaly in the group that received placebo. The types of anomalies observed were consistent (regardless of when pregnancy occurred in relation to vaccination) with those generally observed in pregnancies in women aged 16 to 26 years."Do you see what that's saying? Rates of complications were basically the same between the vaccine and placebo, except when the vaccine was administered 30 days or less from the onset of pregnancy. This is actually not that uncommon - I received an MMR vaccine recently was told in no uncertain terms that I was not to get pregnant for a month. It's a complication worth noting, but could presumably be significantly reduced by educating women at the time of vaccination. It turns out that Dr. Mercola has "natural" medicine wares to sell - here's the FDA's warning letter to Mercola with regards to misleading claims about some of his products.
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Technorati Tags: cervical cancer; FDA; Gardasil; HPV; Merck; vaccine
MeSH Tags: Papillomavirus, Human; United States Food and Drug Administration; Uterine Cervical Neoplasms/prevention and control; Vaccines
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