More Questions raised on cervical cancer vaccine

The Gardasil cervical cancer vaccine is facing renewed questions about its safety and value, three years after its introduction was hailed as a public health breakthrough.

In Wednesday's issue of the Journal of the American Medical Association, a federal government analysis of 12,424 voluntary U.S. reports of post-vaccination "adverse events" ranging from headaches to deaths concludes 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 to be answered, including whether it really will reduce the toll of cervical cancer. The disease annually kills 250,000 women worldwide.

And a JAMA article by Columbia University public health researchers provides a disturbing history of Merck & Co.'s marketing strategy, contending the company coopted professional medical societies to promote and recommend Gardasil.

Merck - already on the defensive over Gardasil's second-quarter sales, which slumped sharply in the U.S. and worldwide - said in a statement, "we welcome continued study and discussion" of the product's safety.

"The bottom line is that Gardasil has a very positive benefit-risk profile," Merck's Richard M. Haupt 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. The vaccine also wards off two HPV strains that cause 90 percent of genital warts in both men and women.