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Gardasil approved for anal cancer
December 22nd, 2010
07:10 PM ET

Gardasil approved for anal cancer

There's a new tool in the fight against anal cancer. Gardasil, the human papillomavirus (HPV) vaccine approved in 2006 to prevent cervical cancer got the green light Wednesday by the Food and Drug Administration for use in preventing anal cancer and other precancerous lesions caused by the virus. HPV is linked to approximately 90 percent of anal cancer.

"Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure," said Dr. Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.

The vaccine was approved for the same population, people 9 through 26 years of age.

Merck and Co., Inc, Gardasil's manufacturer, tested the vaccine in men who had sex with men because of their high incidence of anal cancer. Merck says Gardasil was 78 percent effective in preventing infection in this population. Because anal cancer is the same disease in men and women, the data was used to support the indication in women too.

"We are pleased that with this new indication for GARDASIL against HPV-related anal cancer and disease, both males and females can be protected against cancer, which further reinforces the importance of vaccinating both genders." said Dr. Richard M. Haupt, M.D., M.P.H., executive director, Merck Research Laboratories.

But not everyone is on board with Gardasil. For years Judicial Watch, an organization that "promotes transparency, accountability and integrity in government" has been keeping a close eye on the number of adverse events reported to the FDA by consumers and health care providers who used the vaccine.

"We would recommend that people go to our website, look at all the vaccine adverse events reporting system reports (VAERS)–FDA's own materials–and then make their own decision with their doctor," says Jill Farrell, Judicial Watch Spokesperson.

HPV is the most common sexually transmitted infection. According to the Centers for Disease Control and Prevention (CDC), there are more then 40 different types that affect the genitals. In 90% of cases the body clears the virus naturally, but certain types, particularly types 6, 11, 16 and 18 can cause various cancers and genital warts.

The American Cancer Society (ACS) says anal cancer is still pretty rare–approximately 5,300 people are diagnosed with the disease each year. The majority of those are women. They say it's a serious disease but treatment is often very effective, and most patients can be cured.


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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.