tampabay.com

Vaccine bill finds tough opposition

By SHANNON COLAVECCHIO-VAN SICKLER
Published February 26, 2007


TALLAHASSEE - The proposal seemed simple enough: require middle school girls in Florida to get a vaccination that can protect them from one of the deadliest forms of cancer.

But because Gardasil is a new vaccine from a powerful pharmaceutical company, and because it protects against a sexually transmitted virus, the proposed legislation is running into strong opposition from conservatives and medical groups.

Adding to the controversy is consumer skepticism over the motives of vaccinemaker Merck & Co., which had been lobbying across the country to make its vaccine mandatory for school attendance - a requirement that could generate lots of profit.

The resulting backlash is so strong that state Sens. Mike Fasano and Jim King and state Rep. Ed Homan of Tampa are retreating from their initial push to make Gardasil mandatory for school attendance starting in fall 2008.

Instead, the Republican lawmakers will change their proposed legislation HB 561 and SB 660 so that the vaccine requirement for 11- and 12-year-old girls doesn't take effect until fall 2009.

Families would be able to opt out of the vaccine, the first in the world to protect against four types of the human papilloma virus, which causes genital warts and about 70 percent of cervical cancer cases.

Conservative groups such as the Christian Coalition of Florida say encouraging such an immunization for adolescent girls is akin to promoting early sex.

"We're concerned about the age of the kids and the message we're sending," said Bill Stephens, the coalition's executive director. Stephens said the coalition might be more apt to support the legislation if it included education about abstinence.

There also is some wariness in medical circles about mandating a first-of-its-kind vaccine with such a short track record. Moreover, some are skeptical of Merck's aggressive lobbying to make Gardasil mandatory in more than a dozen states.

"I'm not here to push something on parents that they don't want," said Fasano, R-New Port Richey. "I think there are concerns about the safety, concerns from parents about us rushing into it too soon."

The Florida legislators' retreat is a rare example of public outcry and political pressure thwarting the well-financed efforts of a pharmaceutical giant - one that has donated tens of thousands of dollars in recent years to state lawmakers including Homan and Fasano and to the Republican and Democratic parties.

"I haven't met one legislator who wouldn't get the vaccine for his daughter," said Homan, R-Tampa, an orthopedic surgeon.

But Homan said when he asks for support, they back away and say, "Oh no, not the vaccine bill."

"There's a lot of controversy out there," Homan said. "Legislators don't like controversy like that."

The uproar is on a national scale, thanks to Merck's national lobbying efforts. Typically, vaccines are rolled out gradually, giving public health officials time to gather several years' worth of data on their safety and effectiveness.

But Merck took an aggressive approach with Gardasil. The company channeled money for much of the lobbying through Women in Government, an advocacy group of female lawmakers.

According to the Women in Government Web site, there are no Florida representatives.

Merck is represented in Tallahassee by Southern Strategy Group Inc., the powerful Tallahassee lobbying firm of former House Speaker John Thrasher and his associate, Christopher Dudley.

Merck helped develop the Florida legislation and paid for television ads promoting Gardasil, but Homan and King said Merck lobbyists did not approach other lawmakers.

Last week, Merck announced it would suspend all of its U.S. lobbying because of criticism that it pushed too hard, too fast.

"The debate seemed to be focusing on our efforts in making this a requirement, and the battle was shifting away from the fight against cervical cancer," said Merck spokeswoman Jennifer Allen.

Gardasil is the world's first vaccine proven to protect women from HPV, the most common sexually transmitted virus in the United States, according to the American Cancer Society.

The virus can lead to cervical cancer, the second-leading cause of cancer deaths in women worldwide, according to the society.

The Food and Drug Administration approved Gardasil in June 2006 for girls and women ages 9 to 26 years old, though it is most effective when taken during adolescence.

King lost both parents to cancer and saw in Gardasil the kind of medical breakthrough his parents never had.

"It was sort of like an answer to a prayer," said King, R-Jacksonville. "Then came this wave of opposition. I was disappointed. I mean, I can't understand why there aren't marches in the street celebrating this."

Homan, a faculty member at the University of South Florida medical school, has a theory.

"It's a puritanical issue about sex," he said.

He points out that elementary school students have to get immunized against hepatitis B, a disease most commonly transmitted through sexual contact or needle sharing.

"But there is no outcry because that is a disease of the liver," Homan said. "This cancer is a disease of the cervix. It's like, 'Oh my gosh, don't say that! That's like saying vagina!' "

Fasano said pushing the requirement back a year, as he now proposes, will give families more time to learn about the vaccine and allow Florida to learn from the experiences of other states. More than two dozen states are considering mandates. Texas recently approved one, but lawmakers are reconsidering it because of the controversy.

King said he has no problem waiting if it will broaden support for the vaccine.

"My only fear with that is, what about all those girls who won't get the vaccine during that time while we're waiting?"

Times researcher Cathy Wos contributed to this report. Shannon Colavecchio-Van Sickler can be reached at svansickler@sptimes.com or (850) 224-7263.

Q&A

Gardasil

What is Gardasil?

The first vaccine against cervical cancer. It protects against four types of the human papillomavirus, which causes genital warts and about 70 percent of cervical cancer cases.

Who makes it?

Merck & Co., the pharmaceutical company that made Vioxx, the popular arthritis drug pulled in 2004 because of concerns over higher incidences of heart attacks and strokes.

When was it approved?

In June 2006 by the Food and Drug Administration, for girls and women ages 9 through 26.

What does it cost?

About $360 for three injections over a six-month period. Many insurers cover the vaccine.

How effective is it?

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

Are there side effects?

It's common to have pain, swelling, itching and redness at the injection site.

How common is cervical cancer?

It is the second-deadliest cancer in women worldwide. In Florida, the rate of cervical cancer is 26 percent higher than the U.S. average - nine new cases each year per 100,000 women. Every year in the United States, about 10,000 women get the cancer. And in about 3,500 U.S. cases each year, it's fatal.

Sources: Merck & Co., American Cancer Society, Centers for Disease Control and Prevention