KIRKLAND, QC, May 31, 2011 /CNW Telbec/ – Today, Merck announced that Health Canada has approved a new indication for GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] for the prevention of anal cancer in both men and women caused by HPV types 16 and 18 and anal precancerous lesions caused by HPV types 6, 11, 16 and 18.
“Anal cancer affects both men and women. It is not a disease restricted either to homosexual men or to people who
engage in anal sex,” said Dr. Jennifer Blake, Professor and Associate Chair, Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Toronto. “This newest indication for the quadrivalent HPV vaccine increases the reasons for vaccinating both genders.”
Efficacy against anal cancer
The efficacy of GARDASIL® against anal disease – anal intraepithelial neoplasia (AIN) and anal cancer – was evaluated in a population of 598 men who have sex with men between 16 and 26 years of age. The primary analysis was conducted in the per-protocol efficacy (PPE) population, which consisted of individuals who received all three vaccinations within one year of enrolment, did not have any major deviations from the study protocol, and were naïve to HPV types 6, 11, 16 and 18 when they started the study and remained free of infection from these four HPV types through one month after receiving their last vaccine dose.1
The efficacy of GARDASIL® in reducing the combined incidence of AIN grades 1, 2 and 3 related to vaccine HPV types 6, 11, 16 and 18 was 77.5% (95% CI: 39.6%; 93.3%). The efficacy against the more advanced pre-cancers, AIN 2/3, in the post-hoc analysis was 91.7% (95% CI: 44.6%; 99.8%).2
Anal cancer on the rise
“Anal cancer is on the rise in Canada and around the world,” said Dr. Marc Steben, a family physician and expert in sexually transmitted diseases. “Given there are no screening tests for anal cancer, doctors should talk to their patients about preventing anal cancer and other HPV diseases through vaccination.”
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[Note from SaneVax: Number one, why is the government of Canada not making this announcement. Number two, Gardasil has not been demonstrated to prevent cervical cancer, much less anal cancer. Number three, a bold statement about anal cancer being ‘on the rise’ without any reference to any particular evidence to back up the statement makes this appear to be nothing more than more scare tactics to induce medical consumers to purchase mass quantities of vaccine.]
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