Gardasil: Summary of the Vaccine to Prevent Disease Associated with HPV, Cause of Cervical Cancer

Human Papillomavirus (HPV) is the leading cause of preventable cervical cancer in women. In May of 2006, the FDA assigned an advisory committee to address the approval of a new vaccine which will prevent cervical cancer. If approved, this will mark a significant development in medical technology since the development of the pap smear test.

HPV infection, the leading cause of preventable cervical cancer, is a sexually transmitted disease which clears up on its own in 90% of the cases. However, in rare cases, the disease develops into a more serious complication such as genital warts and even cervical cancer. With over 100 different strains, four known strains are responsible for the infections which lead to further complications.

Statistics have shown that as few as 20% of women surveyed knew the significance of HPV. During a Pap test, a screening for HPV is conducted as routine procedure. When positive for a “high-risk” strain, cancer of the cervix, mulva, vagina, anus or penis may ensue. It is believed that up to 50% of all sexually active men and women will acquire genital HPV at some point in their lives. In terms of worldwide exposure, it is expected a vaccine approval will decrease cervical cancer deaths by two-thirds.

Merck, developers of the vaccine, Gardasil, conducted testing on 20,000 women and found the vaccine to be extremely effective. With no cure for HPV, the development of Gardasil, may provide an alternative form of preventative treatment against the disease. While there is a specific DNA test for HPV, the test is only useful in women under the age of thirty. Gardasil, if approved, is anticipated to involve treatment of three injections over a six month period at a rate of approximately $300-$500 per injection. Because of the cost involved, the Advisory Committee on Immunization Practices has indicated they will decide, in June, whether to endorse the vaccine as part of routine immunization program. Merck is seeking approval to administer the vaccine in girls as young as eights years of age.

What is important to understand is Gardasil will not prevent infection; it will prevent cervical cancer from developing if one is infected with HPV. At present, the committee is recommending the vaccine to women in the 13 to 26 age group.

With Merck’s profits significantly impacted by the various lawsuits related to another drug, Vioxx, Merck may find the development Gardasil to bring in sales in excess of $1 billion per year.