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Special Google Health Search
question safety of GARDASIL vaccine
May 13th, 2008 @ 5:16pm

Dr. Kim Mulvihill reporting

GARDASIL is the world's first vaccine against cervical cancer. Its FDA approval triggered efforts across the nation to mandate shots for school girls, but did doctors jump on the bandwagon too soon?

GARDASIL fast-tracked for FDS approval in 2006 and was aggressively promoted early last year in ads touting the fact that with the vaccine, you could be "one less" to suffer from cervical cancer.

As protection against the cancer, the vaccine targets four types of human papillomavirus, or HPV, that cause most cervical cancers. But two weeks after getting vaccinated with GARDASIL, along with a tetanus shot, 12-year-old Brittany Bell started to have problems. "It's hard for me to lift [my leg] up. You just can't lift it up," she said.

"I was sitting on the porch and looking through the door at her and watched her fall," Brittany's mother, Christina Bell, said.

Today, Brittany walks with a limp. Her mom blames the vaccine, but her pediatrician disagrees. "He doesn't believe it has anything to do with the shot at all," Christina said.

However, a government watchdog group says the problems with GARDASIL are real and adding up. "Paralysis, convulsions, seizures in young girls; very, very scary and very unfortunate," explained Irene Garcia, of Judicial Watch.

A federal vaccine reporting system has received more than 5,000 reports of adverse events, a small percent of them serious, following GARDASIL vaccination. However, a report does not mean the vaccine caused the problem.

Even so, some of the nation's top experts on HPV question the rush to mandate vaccinating very young girls. "I see red lights flashing. This is a real danger zone," Dr. Diane Harper, of Dartmouth Medical Center, said. "To put in process a place that says you must have this vaccine means you must be part of a big public experiment, right? And we can't do that."

GARDASIL is FDA approved for girls as young as 9. Even the CDC (Centers for Disease Control and Prevention) recommends the shots as routine vaccination for girls 11 to 12 years old. But now there's a growing debate over the vaccine's safety and effectiveness

Both UCSF's George Sawaya and Dr. Karen Smith-McCune say the vaccine appears to be safe, but they still want to see the final results of a huge phase-three trial, involving more than 12,000 women from 13 countries.

"What we don't know at this point is what the true benefits and harms of the vaccine are, because the final studies have not been reported," Sawaya said.

The other concern is this high-quality trial only included women ages 15 to 26, not the younger girls for whom the CDC now recommends routine vaccination. "For my own girls, I'm waiting for the end of the trials and for the results to be published before I decide to vaccinate them," Smith-McCune said.

Another unknown: how long the vaccine provides protection. Harper helped test GARDASIL and is now testing a competitor's version. "There'll probably be efficacy for longer than five years, but it's probably not going to be lifelong efficacy. There will probably be some need of a booster," she said.

In a statement, Merck remains "very confident in GARDASIL," saying its research "spans more than 10 years of rigorous study."

To date, more than 26 million doses have been distributed globally. "I think people want this vaccine to work, but our job in academia is trying to distinguish between what we know about vaccination versus what we hope about vaccination," Sawaya said.

As for what Christina Bell hopes, she said, "What do I want today? I want my daughter back to normal."

You should also remember that even with vaccination, women still need to be screened for cervical cancer.