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Tuesday, May 15, 2007Among women who tested negative for both HPV-16 and HPV-18 at enrollment (4693 in the vaccine group and 4703 in the placebo group), high-grade cervical disease developed in 95 subjects in the vaccine group and in 130 in the placebo group, a reduction of nearly 27% in the vaccine group... The raw numbers are here. It does give a leg-up against infection with the virus, but not so much against cancer. Adverse events weren't much different than with placebo. So why the rush to mandate? This editorial says perhaps we should think about that for a while: What can be inferred from these data about the potential effect of vaccination on populations that include sexually active women? In the FUTURE II trial, 93% of subjects were nonvirgins. With grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ as the outcome, the difference in risk so far appears to be modest: 219 of 6087 vaccinated women (3.6%) received this diagnosis over an average of 3 years, as compared with 266 of 6080 unvaccinated women (4.4%). The absolute risk difference of 0.8% indicates that 129 women would need to be vaccinated in order to prevent one case of grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ occurring during this period. If grade 3 cervical intraepithelial neoplasia or adenocarcinoma in situ were the most relevant outcome, evidence was insufficient to infer the effectiveness of vaccination. Grade 3 dysplasia is more likely to progress to cancer than Grade 2, which can regress spontaneously. The question remains whether this vaccine is worth its price, although the media has already decided it is. (With some exceptions.) UPDATE: Merck's Canadian campaign. posted by Sydney on 5/15/2007 04:18:00 PM 3 comments 3 Comments:
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