Gardasil raises questions locally, nationally

BY ZHI XIONG | APRIL 01, 2009 7:40 AM

On Tuesday evening, still sporting a pair of scrubs, Shannon Kussatz trailed her daughters Isabelle, 10, and Maddie, 8, to their Girl Scout field trip to the UI campus. They had gone shopping for Maddie’s First Communion dress hours earlier.

If she were to follow federal recommendations, Maddie would receive her first shot of the vaccine Gardasil within the next year or two.

But Kussatz, an oncology nurse at the UI Hospitals and Clinics, isn’t going to do that. Not until health professionals can distinguish Gardasil’s reputation from its public-health value.

“If I’m in the room and I have measles, everyone in here would have to be quarantined,” Kussatz said. “If I have HPV, I’m not giving it to anybody.”

Gardasil was developed to protect against four strains of human papillomavirus — HPV. There are more than 100 types of the virus, and the vaccine covers those that are sexually transmitted and tend to turn normal cells into precancerous ones.

Roughly 20 million Americans are infected with HPV, but the human immune system can fight off the virus in 90 percent of cases, according to the Centers for Disease Control and Prevention.

Cervical cancer is often detected with routine Pap smears, but its symptoms are difficult to detect until advanced stages. Around 11,000 women in the United States are diagnosed each year, compared with 178,000 for breast cancer.

The most common side effect is a sore injection site. But several families now suspect a link between their daughters completing the vaccine series and developing debilitating or fatal paralysis soon afterward.

More than 20 million doses of the vaccine have been administered since Gardasil’s 2006 début. The CDC encourages the public to report complications from the vaccine. In December 2008, 6 percent of side effects reported to the agency were serious enough to land the young women in hospitals or render them permanently disabled.

At $120 per dose, Gardasil’s commercial success make some people suspicious that the U.S. Food and Drug Administration rushed the vaccine through its approval system at the risk of patients’ health.

“It means the FDA directed more resources toward it relative to other health topics, but it doesn’t mean you don’t have the safety data,” said Kevin Ault, an associate professor of OB-GYN at Emory University in Georgia who conducted clinical trials at the UI, where he previously was a faculty member.

More than 21,000 girls and women have participated in five rounds of clinical trials for Gardasil since research began in the 1980s.

With Gardasil’s relatively recent FDA approval, scientists also have more questions about the vaccine. They want to know how long the vaccine protects the girls and whether it is safe for men, who also contract and spread the viruses and can develop different types of cancer. At the UI, scientists are working on a new version of Gardasil that will cover more strains of the virus.

Meanwhile, health professionals are again warning against liberal use of one word: causality.

“Indeed, in many ways it is still an unknown,” said Elaine Smith, a UI professor of epidemiology. “But whatever hype there is for the vaccine, if we have the means to prevent cancer that affects women’s reproductive health and well-being, we should do it.”

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