Source: www.philly.com Author: Marie McCullough Three years after the world's first cervical-cancer vaccine was hailed as a public-health breakthrough, Gardasil is facing renewed questions about its safety and value. In today's Journal of the American Medical Association, federal researchers analyze 12,424 voluntary reports of post-vaccination "adverse events" ranging from headaches to deaths. They conclude that only two complaints - fainting and dangerous blood clots -- are more common than expected and may be related to the immunization. But an accompanying editorial points out that many questions about Gardasil remain - key among them, whether it really will reduce the toll of cervical cancer. Another opinion piece in JAMA looks at Merck & Co.'s marketing strategy, contending the company coopted professional medical societies to promote and recommend the vaccine. Merck - already on the defensive over Gardasil's second-quarter sales, which slumped sharply in the United States and worldwide - said in a statement that "we welcome continued study and discussion" of the product's safety. "The bottom line is that Gardasil has a very positive benefit-risk profile," Richard M. Haupt, head of Merck's clinical program for the vaccine, said in an interview. Gardasil, a series of three shots, protects against two strains of the sexually transmitted human papillomavirus (HPV) that cause 70 percent of cervical-cancer cases. Gardasil also wards off two other HPV strains that cause 90 percent of genital warts in men and women. Next month, advisers to the Food and Drug Administration will consider whether to recommend expanding Gardasil's current [...]