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.
UPDATE 5/3/10: New Mexico Woman Sues, Alleges HPV Vaccine Hurt Daughter
UPDATE 9/29/09: FDA delays decision on GlaxoSmithKline's vaccine after teen death
UPDATE 9/17/09: One-third of girls now vaccinated
UPDATE 8/21/09: Virginia schools require sixth grade girls be vaccinated
-- From "Cervical-cancer vaccine Gardasil still faces questions" by Marie McCullough, The Philadelphia Inquirer Staff Writer 8/19/09
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.
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 approval for females ages 9 to 26 to include males of the same age. Vaccinating men would reduce HPV transmission to women and protect men from very rare HPV-related anal, head, and neck cancers.
The FDA panel will also review data on would-be rival Cervarix, the cervical-cancer vaccine for which GlaxoSmithKline is seeking FDA approval. Cervarix does not protect against genital warts.
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