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Vaccine plan sparks debate

Bills would make shots against a sexual disease mandatory.

By MELANIE AVE
Published February 11, 2007

Let's be real, says Josyln Vito, a straight-talking Pasco County mother of four. Teenagers have sex no matter what their parents want or believe.

"I'm not going to be a person who is going to be in denial," said Vito, 29, who lives in Port Richey.

That's why Vito is more than ready to get her 9-year-old daughter Paige the new vaccine that can prevent cervical cancer by blocking the nation's most common sexually transmitted disease.

If bills recently filed by three Florida legislators become law, Vito's daughter would be among the first girls statewide required to receive the new vaccine called Gardasil.

It prevents four types of the human papillomavirus, or HPV, which causes genital warts and up to 70 percent of all cervical cancer.

The Florida legislation, filed in the House and Senate, would require 11- to 12-year-old girls to get the vaccine starting in the 2008-09 school year.

Parents could opt out of the vaccination without a specific reason, said state Sen. Mike Fasano, a New Port Richey Republican and one of the bill's sponsors.

"The bottom line here is saving lives," he said. "Children right now get many immunizations required by law. One more, that's actually going to save lives, I think that is very much needed."

Gov. Charlie Crist has not taken a public stand on the bills, which mirror legislation pending in about 19 other states.

Texas Gov. Rick Perry, a Republican, recently caused a political firestorm when he issued an executive order requiring the vaccine, making Texas the first state to do so.

Another sponsor of the Florida bill, state Rep. Dr. Ed Homan, a Tampa Republican, said his support of the vaccine is simple.

'Mandatory' raises hackles

"It works," he said. "It's hard to argue against this bill."

State Sen. Jim King, R-Jacksonville also is sponsoring the bill.

Some Christian groups such as Focus on the Family and the Family Research Council oppose making the vaccination mandatory saying it removes parental rights.

Others have questioned the financial ties between the vaccine's manufacturer, Merck & Co., and the nonprofit group Women in Government that is pushing the vaccine.

"I think the vaccine assumes something about the nature of the girls, that they're going to be sexually active," said Steve Sinclair, headmaster of Keswick Christian School in St. Petersburg.

"You always wonder, 'Where is the government going to stop?' "

The Florida Catholic Conference also opposes making the vaccination a requirement, said associate director for health Michael Sheedy.

The group prefers parents to opt in rather than opt out.

"Parents really have the right and the responsibility to be the main decision makers in terms of their kids' health," Sheedy said.

Demand for HPV is high

Eligible patients at the Pediatric Health Care Alliance - which has 13 offices in Pinellas, Pasco and Hillsborough counties - are being encouraged to get the vaccination. But F. Lane France, a pediatrician and medical director of the practice, questioned if it should be required.

"When you mandate something, it's taking it out of hands of the people," said France.

Still, demand is high for the vaccine. Some local doctors, including France, are running low.

Vito, the Port Richey mother, dismisses all the controversy and sees the vaccine like the others, which primarily protect against infectious diseases.

The HPV vaccine, which cost about $360, is given in three separate shots in the upper arm over a six-month period.

"Children get flu shots and chicken pox shots," Vito said. "If there was even a 1 percent of chance of saving my daughter's life, why wouldn't I do it?"

Many major health insurance companies cover the vaccine's cost. And if it were made mandatory, Fasano said, state funds would be set aside to help cover its cost for uninsured families.

The Food and Drug Administration approved the drug's use in June 2006 for use in females ages 9 to 26 years old.

The vaccine is now manufactured only by Merck & Co., which helped develop the Florida legislation and has frequent television ads promoting the vaccine. GlaxoSmithKline also is working on a version of the vaccine.

For some, safety an issue

St. Petersburg mother Melissa May, 42, said she hopes her three daughters, ages 5, 7 and 18, abstain from sex until marriage. But she's open to the vaccine.

Her biggest concern is safety, since some drugs have been shown to be unsafe even after FDA approval.

"If I knew it had been researched and could save their lives, I'd do it," said May last week while she watched her daughters romp on a playground.

Ellen Daley, an assistant professor in public health at the University of South Florida, said clinical trials of the vaccine conducted over a five-year period on about 21,000 females showed it to be safe.

The bulk of the side effects centered on pain, swelling and redness at the injection site.

"When it gets approved for boys, my son will get it," Daley said. "I don't waffle on this vaccine at all."

The Centers for Disease Control and Prevention estimate that about 6.2 million Americans become infected with genital HPV annually. More than half of all sexually active adults become infected at some time during their lifetime.

There are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year.

The vaccine, the first developed to prevent a cancer, is being hailed as a major public health discovery.

"We potentially have a vaccine that could eradicate 70 percent of the invasive cervical cancer in this country," said Dr. James Orr, a Fort Myers gynecologic oncologist and president of the Florida Obstetric and Gynecologic Society.

"It's a phenomenal opportunity."

On Friday, Tampa resident Tammy Scarbrough took her two daughters, Sarah, 11, and Ashley, 13, to get the shots at the Pediatric Health Care Alliance on Gunn Highway.

Law, or not, 42-year-old Scarbrough said she would have done it. "It's some prevention," she said. "To me, some prevention is better than no prevention at all."

Times researcher Caryn Baird contributed to this report. Melanie Ave can be reached at (727) 893-8813 or mave@sptimes.com.

Fast Facts:

Required vaccinations for Florida schoolchildren:

5 doses of DTP vaccine

4 doses of polio vaccine

2 doses of measles vaccine

1 dose of mumps vaccine

1 dose of rubella vaccine

3 doses of Hepatitis B vaccine

1 dose of varicella, chicken pox, vaccine

Opt out:

Parents can opt out of vaccinations for either religious or medical reasons.

Source: Florida Department of Health

Bill summary

House Bill 561 by Ed Homan, R-Tampa, and Senate Bill 660 by Mike Fasano, R-New Port Richey, and Jim King, R-Jacksonville.

The bills, filed in the Florida Legislature last month, would require public and private middle schools to give 11- and 12-year-old students and their parents or guardians information about the human papillomavirus, the vaccine and the virus' connection to cervical cancer beginning in the 2008-09 school year. It would prohibit the enrollment of girls without the vaccination or signed exemption from their parents.

Source: State of Florida

. Fast facts

Vaccine facts

What: Gardasil, marketed by Merck & Co., is the world's first vaccine against a cancer. It protects against four types of the human papillomavirus, which cause genital warts and about 70 percent of cervical cancer cases.

When: Approved by the Food and Drug Administration in June 2006 for girls and women ages 9 through 26.

Cost: About $360 for three injections over a 6-month period.

Ingredients: Inactive proteins of the virus.

Efficacy: It's most effective when given before a person becomes sexually active. Clinical trials involved about 21,000 women ages 16 to 26 over a five-year period.

Common side effects: Pain, swelling, itching and redness at the injection site.

Source: Merck & Co.

[Last modified February 10, 2007, 21:51:19]