Mercks Gardasil Shrinks Abnormal Pap Tests, Cervix Procedures
The product, Gardasil, reduced the incidence of cervical biopsies by 22 percent and cut by 42 percent the number of procedures in which part of the cervix is removed to prevent disease, according to data released today by the International Papillomavirus Conference in Sweden.
In 55 million pap tests a year, the results of about 6 percent are deemed abnormal, according to the National Cancer Institutes Web site. In such cases, there may be cancerous cells on the cervix. The doctor may follow up with a more detailed examination, and may perform a cervical biopsy, in which a piece of tissue is removed. If the biopsy result is also abnormal, cervical tissue may need to be excised to prevent cancer from forming. Garadil may lead to a drop in biopsies and follow-up procedures, a Merck scientist said.
“You are going to see a real-world impact of this vaccine,” said Richard Haupt, Mercks executive director of Gardasil clinical research. “You arent talking about a disease in the abstract when you show this data.”
Of 4,616 women on the vaccine, 728 had cervical biopsies, Merck said. That compared with 935 of 4,679 women on placebo in a control group, according to the data.
So-called definitive therapy, involving removal of part of the cervix, was received by 131 of the women on vaccine, compared with 229 women in the control group, according to the company.
Merck Database
The findings came from Mercks database of patients enrolled in its clinical trials used to win U.S. regulatory approval for the vaccine. Gardasil is cleared to protect against strains of the human papillomavirus, or HPV, that cause about 70 percent of cervical cancers.
The analysis by Merck, based in Whitehouse Station, New Jersey, looked at women who enrolled in studies of the vaccines safety and effectiveness. None tested positive for having HPV before enrolling.
A separate study presented at the conference showed that the component of Gardasil that protects against one of the viral strains, called HPV 16 and linked to cervical cancer, protected women for at least nine years on average. The Gardasil vaccine has been shown to be effective for at least five years, Haupt said.