Cervical cancer vaccine may get OK

WASHINGTON -- Federal advisers are expected to recommend today whether the Food and Drug Administration should approve a vaccine against a sexually transmitted virus that causes cervical cancer, and whether it should be given to girls as young as 9 years old.

A Mayo Clinic doctor said the vaccine, Gardasil, is the most important advance in the fight against cervical cancer in 50 years. Merck & Co., its maker, says Gardasil offers optimum protection when girls are inoculated before they become sexually active.

Prevention is ''the ultimate goal in the war on cancer," said Dr. Bobbie Gostout, an obstetrician-gynecologist at the Mayo Clinic. ''While Pap smears are wonderful, this is the first time we can talk about prevention before any disease is established."

Though analysts say the advisory panel is certain to support the vaccine and that FDA approval of its use in the United States is likely, it is unclear whether the panel and agency will side with Merck's age recommendation. A Centers for Disease Control committee advises vaccinating girls starting at age 11.

The FDA said Gardasil is safe and also prevents genital warts. But the agency noted ''compelling evidence" that it is less effective for women already exposed to the virus and could worsen cervical cancer for women who already have it. Five trial participants vaccinated shortly before conception gave birth to children with birth defects. Merck tested the vaccine in more than 27,000 people, only 250 of whom were 9-year-olds.

Up to 80 percent of sexually active American women have been exposed to the human papilloma virus, which causes cervical cancer. In the United States, where women are routinely screened, there are relatively few cervical cancer deaths -- about 4,000 a year out of 10,000 cases diagnosed. Globally, it causes the second-highest number of cancer deaths among women, Gostout said. She is scheduled to testify at today's public hearing on behalf of the Society of Gynecologic Oncologists, doctors who treat women with cervical cancer.

Concerned Women for America, a conservative group, supports FDA approval of Gardasil.

''We welcome the vaccine," said Wendy Wright, the group's president. Human papilloma virus ''is a serious epidemic. One thing that the vaccine has done is brought attention to the epidemic of HPV," she said.

The vaccine could generate up to $3 billion in annual sales at a time when Merck faces more than 11,000 lawsuits alleging harm from its painkiller Vioxx and generic competitors to Zocor, one of its best-selling drugs.

C. Anthony Butler, a Lehman Brothers Inc. analyst, projects the potential US market for Gardasil could approach 60 million -- including ''catch-up" inoculations for sexually active adult women.

A Morgan Stanley research note co-authored by Steven Harr said the vaccine's failure to protect those who already have infections could increase its attractiveness as a preventive medicine for younger women.

While the FDA generally follows the advice of its outside scientific panels, there have been notable exceptions, including Plan B, the so-called ''morning-after pill."

Federal advisers endorsed selling it without a prescription to women 16 and older in December 2003, but the FDA has yet to issue a final decision.

Gardasil targets four strains of the human papilloma virus. If approved by the FDA, women or girls would receive the vaccine in three intramuscular shots over six months at a cost of about $500. So far, Gardasil has remained potent more than four years after the immunization process.

Merck, the nation's fourth largest drug maker, considers Gardasil its most important drug candidate, as do analysts.

GlaxoSmithKline later this year will ask the FDA for permission to sell Cervarix, a rival vaccine that targets two human papilloma virus viral strains to protect against cervical cancer, but not genital warts.

Butler said he expects today's panel to ''have some discussion" about the age at which women should get Gardasil shots.

Susan Wood, who resigned last August as the FDA's assistant commissioner for women's health due to its handling of Plan B, said the politics of women's health could also play a part in today's session.

Debate about the social ramifications of giving a vaccine for a sexually transmitted disease to children could steer discussion ''away from the critical point, which is to ensure in all cases that we have the best available medicine and science," Wood said.

Dr. C. Thomas Caskey, a former Merck senior vice president for drug development, including Gardasil, said he hoped the FDA does not focus on sexual politics.

''I hope it's more a discussion of how do you introduce a preventive vaccine," he said. ''In this case, a parent is making a selection for a late onset adult disease. That is a different kind of decision. There is no immediate threat to a child."

Diedtra Henderson can be reached at dhenderson@globe.com.