Panel OKs Cervical Cancer Vaccine

FDA Expected to Follow Board's Recommendation; Drug Could Slash Deaths Globally

By Judith Graham

CHICAGO - A vaccine with the potential to slash worldwide deaths from cervical cancer, the No. 2 cancer killer in women, should be approved for sales in the United States, a federal panel said Thursday.

The unanimous recommendation inspired cheers from the medical community.

"This gives us the tools to begin to wipe out cervical cancer not only in the United States but across the globe," said Dr. Yvonne Collins, assistant professor of gynecologic oncology at the University of Illinois at Chicago.

The FDA usually follows the recommendations of its advisory panels. It is expected to approve the vaccine in early June.

Despite earlier concerns about the vaccine's potential impact on young people's sexual behavior, conservatives applauded the development.

"It's a huge medical breakthrough," said Linda Klepacki, an analyst who covers sexual health for Focus on the Family.

For the cancer community, "this is a watershed event ... that we hope will help usher in a new era of cancer prevention," said Carolyn Runowicz, president of the American Cancer Society. Gardasil, made by Merck & Co., is the first vaccine specifically designed to prevent cancer, she noted.

Four Strains Targeted

The vaccine targets four strains of the human papilloma virus, the most common type of sexually transmitted infection. Two of the strains are responsible for 70 percent of cervical cancer cases in the United States and across the world.

"Imagine being able to eliminate more than two-thirds of the cases of this cancer. What could be more exciting?" said Dr. Bobbie Gostout, a gynecologic oncologist at the Mayo Clinic.

The vaccine is 100 percent effective against these two strains of HPV in young women 16 to 26 years old, Merck's research demonstrated. It also can help prevent genital warts, also caused by HPV.

Nearly 10,000 women are newly diagnosed with cervical cancer each year in the U.S.; 3,700 succumb annually to the disease. Worldwide, yearly deaths total about 240,000, according to the World Health Organization.

Merck is prepared to make Gardasil available "within weeks" after the FDA issues a final decision on the vaccine, which is expected by June 8, said Dr. Rick Haupt, executive director of medical affairs for the drug company. "We're thrilled," he added.

A full inoculation involves three injections over the course of six months and is expected to cost $300 to $500.

Currently, Merck is recommending girls as young as 9 and women up to age 26 receive the vaccine. Pre-teens are a primary target because "the vaccine has its biggest impact prior to sexual exposure" that can lead to a HPV infection, Haupt said.

Effect on Teens' Choices

Conservative groups initially seemed alarmed that Gardasil might encourage promiscuity.

"Our concern has been that this vaccine not be presented as a shot that makes it safer to have sex," said Peter Sprigg, vice president for policy at the Family Research Council.

But after extensive discussions with Merck officials, the council became convinced this wouldn't happen. Instead, "this could be used as an opportunity to talk to young people about their sexual health and how to manage risks, and that could be quite positive," Sprigg said.

More than likely, parents of pre-teens will tell their children "this is to keep you from getting sick" and leave it at that, said Gostout of the Mayo Clinic.

There is "no evidence" in Merck's clinical trial data that Gardasil altered sexual behavior, she noted.

Currently, the only issue conservatives are balking at is the prospect that Gardasil vaccinations be made mandatory for school attendance, like vaccinations for measles and mumps.

"We feel strongly that this decision should be made by parents, not by state officials or school districts," said Klepacki of Focus on the Family.

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