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Arizona Daily Star
Tucson, Arizona | Published: 06.03.2007
Although doctors say the controversial new vaccine to prevent cervical cancer is proving "hugely" popular with Tucson teen girls, the state has no plans to make it mandatory.
That decision bucks the bandwagon that got rolling shortly after the vaccine — Gardasil — was approved for widespread U.S. use a year ago.
Almost before anyone even heard of Gardasil, two states had tried to make it mandatory for middle-school girls, and more than 20 states had proposed laws to do the same.
That set off a nationwide political and medical argument about Gardasil, which prevents sexually transmitted infections of strains of human papilloma virus (HPV) linked to most cervical cancers and genital warts.
While most physicians and public-health experts laud the vaccine as safe and protective against a potentially deadly disease, many families, conservative Christians and watchdog groups opposed the effort to force a new drug with no long-term safety record into young girls, with the subtle message that sexual activity is now safer.
Critics are starting to call attention to a growing list of "adverse" reactions to the Gardasil shots, including fainting, paralysis and even three deaths.
Criticism also exploded about the hard-sell tactics of the vaccine's maker, Merck, for pushing states to require it immediately, before competitive vaccines come on the market and before the public has had a chance to understand it.
Merck already was in some disgrace for keeping its big-selling painkiller Vioxx on the market despite reports linking it to heart attacks and strokes.
All of this has created a perfect storm of controversy, confusion and even fear around Gardasil. But Arizona families can relax knowing they can make their own decisions about whether to vaccinate their daughters with it, and that no government edict will force them to do so.
"We are looking now at possible new required vaccines for the fall of '08 and the fall of '09, and Gardasil is not one of them," said Will Humble, assistant director for public preparedness at the Arizona Department of Health Services.
"Gardasil is a good vaccine — my 11-year old daughter will get the series this summer — but it is just not on our 'A' list for a mandate, not now and not likely for several years, if ever."
At this point, the vaccine is too expensive — at least $360 for the three-shot series — and too new, and is approved only for girls and young women, Humble said.
"Those are strikes against it. In three to five years, the price will likely come down, it may cover more HPV strains and it may be approved for males," he said. "Those would be more compelling arguments for it."
Even those Tucson physicians who strongly endorse Gardasil for teen girls oppose making it mandatory for school entrance in Arizona.
"That's for vaccines that prevent highly contagious diseases — infections you can get by just sitting in the classroom next to someone who is sick," said Dr. Keith Dveirin, a pediatrician. "That's not how you get HPV."
HPV, the most common sexually transmitted infection in the nation, is a group of about 100 virus strains that can infect both sexes. In most cases, healthy people clear the virus on their own.
But if HPV infection persists, some strains can go on to cause cervical cancer — a disease that strikes nearly 10,000 women in this country yearly, with 3,700 deaths. This cancer has been well-controlled in this country, through regular Pap test screening, which detects cervical cancer when it is curable. But it's a major health threat in developing countries, where such screening isn't widely available.
Gardasil prevents infections by four HPV strains — two that account for 70 percent of cervical cancers and two that cause most cases of genital warts. Most effective when given just before teen girls become sexually active, it is recommended for women and girls 11 to 26.
Tucson pediatricians are reporting that more than 90 percent of families are choosing to have teen daughters vaccinated.
"The response is huge," said Dr. Eve Shapiro, who specializes in adolescent medicine and has given at least 400 doses of Gardasil in recent months, now that most insurance covers it.
"Right now, I'm giving it to 14-, 15-year-olds and older — those who are already or nearly sexually active. We wanted to get them covered quickly."
Even though Pap tests have been highly effective at catching early-stage cervical cancer, Shapiro says she sees at least one abnormal test — showing precancerous cells — a week. That sets off costly, invasive and uncomfortable treatment.
"It's a very big advantage to prevent all that, with this vaccine. This is a safe vaccine that's been rigorously tested. I don't see any downside to it."
Those families that doubt Gardasil usually cite how new it is — that no one yet knows if there will be any long-term harm, she said.
"But I'm not hearing people say they're afraid it will make their daughters sexually promiscuous," she said. "That just has not been an issue."
It is, however, a major issue in Texas, where many families revolted when their governor issue an executive order in February mandating Gardasil for all girls entering sixth grade. The Legislature quickly passed a law in April overturning that order, citing also concerns of safety, efficacy and cost.
It also turned out that Merck gave Gov. Rick Perry a sizable contribution a few months before the order.
"It never even entered my mind that my daughters might think of this as a signal to become sexually active, not once," said Tucsonan Sherri Boyer, whose 15- and 17-year-old daughters are undergoing the Gardasil series.
For Boyer and her daughters, it was their trust in their longtime doctor who advised getting it, and a chance to prevent any form of cancer, that influenced their decision.
"My kids are in high school — they know what infections, what risks are out there, and they thought it was a good idea to do what you can to deal with them, especially if it might prevent a form of cancer," she said.
Alicia Barry, 17, agreed that teens don't see Gardasil as having any influence on their sexual activity.
"Girls my age are concerned about STDs and pregnancy. Getting this vaccine — we think of it as a way to prevent cancer. Everyone would want to do that," said Barry, a student at Salpointe Catholic High School.
"Several of my friends have gotten it, and so have their 11- and 12-year-old sisters."
None of the girls suffered any side effects from the Gardasil, other than a little pain at the site of injection — the most commonly reported reaction.
But a national watchdog group, using the Freedom of Information Act, has uncovered more than 1,600 reports to the FDA of "adverse events" linked to Gardasil. Of those, the FDA has listed 371 as "serious."
Those included three deaths from blood clots and heart problems. Other reactions included seizures, paralysis — including Guillain-Barré syndrome — and injuries from fainting.
The reports "read like a catalog of horrors," Tom Fitton, president of Judicial Watch, a conservative group that monitors government corruption, said in a May 23 statement. "It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug."
The FDA and Merck have said the bad reactions were due to underlying health problems and not the vaccine, according to reports. For example, two deaths occurred in women taking birth-control pills, long linked to blood clots. The third occurred in a girl with heart disease exacerbated by the flu.
And in several cases of Guillain-Barré, a potentially fatal paralysis, the girls also were vaccinated with a new meningitis vaccine that carries a warning it may cause the syndrome, according to the National Vaccine Information Center.
Critics also point to a cautionary essay in a recent issue of the New England Journal of Medicine warning that Gardasil appears only "modestly" effective in the overall group of U.S. women in the recommended age group.
"A cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time," the authors said.
Find the online version of this story to participate in a poll about Gardasil at http://azstarnet.com/metro
● Contact reporter Carla McClain at 806-7754 or at cmcclain@azstarnet.com.
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