- The Washington Times - Thursday, March 15, 2007

A Georgia member of Congress yesterday introduced legislation to prohibit federal money from being used by states to make vaccines against the human papillomavirus (HPV) mandatory for school-age children.

“Mandating the HPV vaccination is both unprecedented and unacceptable,” said Rep. Phil Gingrey, a Republican, who is an obstetrician and gynecologist. “Whether or not girls get vaccinated against HPV is a decision for parents and physicians, not state governments.”

Because HPV is unlike communicable diseases such as measles and mumps, which children are routinely vaccinated against, Mr. Gingrey said HPV vaccines should be taken voluntarily. He is chairman of the Republican Healthcare Public Affairs Team and chairman of the Healthcare Reform subcommittee of the Republican Policy Committee.

HPV is a sexually transmitted virus that can lead to cervical cancer. Data on the time HPV takes to develop into cervical cancer is scant, but some physicians estimate it can take 15 years.

Last year the Food and Drug Administration approved Merck and Co.’s HPV vaccine Gardasil for females between 9 and 26. Following federal approval, at least 22 states and the District quickly acted to make Gardasil a requirement for girls entering the sixth grade. So far, Texas has made the vaccinations mandatory for sixth-grade girls, and the New Mexico and Virginia legislatures have approved bills doing the same.

The Washington Times has reported that Gardasil is known to be effective for only five years, leaving a high percentage vulnerable to cervical cancer. Data from the American Cancer Society show that women between 40 and 55 overwhelmingly get cervical cancer more than any other age group. The Centers for Disease Control and Prevention said the reasoning behind its recommendation that girls ages 11 and 12 get the vaccine is to protect the girls before sexual contact.

Mr. Gingrey’s hope is to persuade states to take a voluntary approach rather than mandatory by blocking the use of any federal funds for the expensive vaccine, which costs about $400 for a series of three shots.

The prospects of Mr. Gingrey’s bill passing Congress as a stand-alone piece of legislation is remote. However, Mr. Gingrey will increase the bill’s chances by attempting to attach the bill as an amendment to the 2008 spending bill for the Health and Human Services Department, according to Becky Ruby, spokeswoman for Mr. Gingrey. Appropriations bills often include an array of legislative proposals that are difficult for lawmakers to notice or block.

“I can’t think of a single Democrat who will push to move the bill,” said a House staffer close to health care issues. “But putting it in an appropriations bill will make for an interesting floor vote.”

The legislation would not prohibit states from enacting mandatory legislation for HPV vaccines but would put up a significant roadblock to states’ ability to resort to using federal Medicaid or education dollars to ensure children from low-income families receive the vaccine.

“If this bill were enacted, it would signal the end of state vaccine mandates [for HPV],” said Lawrence Gostin, director of the Center for Law and the Public’s Health at Johns Hopkins and Georgetown universities. “No state could forgo the considerable federal funds.” Mr. Gostin added that it is very common for states to use federal money to help children receive vaccinations.

In Virginia, Gov. Timothy M. Kaine, a Democrat, has requested $4 million in state tax money to provide the vaccine to children from low-income families.

“We are using general fund dollars, not federal money,” Kaine spokesman Kevin Hall said, adding Mr. Kaine has indicated that he will sign the bill making HPV vaccines mandatory in Virginia schools.

Merck has run into a swarm of opposition from both sides of the political spectrum. Some conservative groups contend that a HPV vaccine will promote sexual promiscuity, while Democrats across the country question Merck’s motives for contributing to legislators’ campaigns and helping to write proposed legislation making Gardasil mandatory.

While the American Cancer Society supports mandatory legislation, some physicians, including the chairman of the federal advisory committee that issued a recommendation for girls ages 11 and 12 to take the vaccine, are opposed to making it mandatory because Gardasil has been on the U.S. market for less than one year.

Gardasil is widely considered one of the best new Big Pharma products to reach the market in years with sales totaling $225 million in 2006, according to Merck. Another pharmaceutical company, GlaxoSmithKline, is developing its own vaccine that targets the most problematic strains of HPV. That vaccine could be available by the end of the year.

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