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HPV Mandate Stirs Protests

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Legislation has been introduced in at least 33 states so far to promote the human papillomavirus (HPV) vaccine for young girls. 21 of those states have considered legislation that would make the vaccine mandatory for school attendance. Across the country, parents, pro-family groups and others have protested, saying that mandating the vaccine is unnecessary, inadvisable, and an assault on parental rights.

The FDA approved Merck & Co.'s Gardasil last June, and the CDC added it to the list of vaccines recommended for children in July. Gardasil protects against four strains of HPV: two of which may cause 70% of cervical cancer cases, and two of which cause 90% of cases of genital warts. The CDC's Advisory Committee on Immunization Practices recommended routine inoculation for 11- and 12-year-old girls, in order to ensure they would be vaccinated before becoming sexually active.

Merck will sell the three-injection Gardasil series for $360, making it the most expensive vaccine on the market. Parents would also need to pay administrative and physician's office fees, which probably would send the total cost into the $500 range, or higher.

Protesters of the vaccine mandate, however, cite not only the cost of Gardasil, but also the mandate's costs to parental rights, children's civil liberties, and the legislative process. The HPV vaccine issue brings significant challenges to all three. Most of the legislation introduced so far has proposed making the vaccine a condition for admission to 6th grade.

Trouble in Texas 
Texas became the first state to mandate the vaccine in early February, when Gov. Rick Perry bypassed the legislature and issued the mandate by executive order.

26 out of 31 state senators signed a letter to Gov. Perry asking him to withdraw the order. Legislators are also considering a bill that would overturn the order. "I don't think government should ever presume to know better than parents what to do with children," said Lt. Gov. David Dewhurst. Perry's action troubled even legislators who might have favored the mandate. They believe the question should have been subject to normal legislative and public debate.

The HPV vaccine is fundamentally different from other vaccines required for school enrollment. Polio, measles, and many other diseases on the recommended vaccine list are highly contagious in a school environment, while HPV spreads only through sexual contact.

In Texas and 19 other states, parents can exempt their children from any vaccine for medical, religious or philosophical reasons. 28 states allow medical and religious but not philosophical exemptions; two states allow medical exemptions only. Although Texas parents will still have this option for the HPV vaccine if they file an affidavit with the state, many would prefer that families have to opt in to Gardasil rather than opt out. They see the mandate as a step in the wrong direction, toward more state control and less parental control over children's lives.

Parents and legislators also pointed out that mandating a vaccine against a sexually transmitted disease appears to contradict Texas' abstinence education policy. The mandate seems to say, We advise abstinence before marriage and fidelity after, but we doubt you'll even abstain from sex while in middle school.

No vaccine has gone this quickly from CDC approval to mandate in Texas. The chickenpox vaccine was previously the fastest, at 5-1/2 years. Gardasil was approved in June and mandated the following February. Partly because it is so new, national medical groups, including the American Academy of Pediatrics, have said they don't support mandating the vaccine. Dr. Joseph DeSoto summarized the objections of such groups: "The number-one problem with the vaccine is that it has not been tested adequately on the group that is recommended to get it." DeSoto is a physician-scientist at the National Institutes of Health, and fellow of the American Institute of Chemists.

The National Vaccine Information Center (NVIC) also warned officials to investigate the vaccine more fully, saying that over 400 patients have reported symptoms including headaches, dizziness, vision loss, fainting and seizures after receiving the vaccine.

Proponents have repeatedly called the vaccine "the first cure for cancer" and an opportunity to eliminate cervical cancer entirely. This may create a false sense of security, since the vaccine will not affect 30% of cases of cervical cancer at all. Scientists and journalists have also pointed out that inoculation at age 12 or younger is not proven to protect against HPV or cervical cancer later in life. The average age of a cervical cancer patient is 48, and the HPV virus may incubate for ten to 15 years before causing cancer. Yet Merck can only prove Gardasil's efficacy for the first five years after inoculation.

Confusion also surrounds the prevalence of cervical cancer. News stories have repeatedly called cervical cancer the "second leading cause of cancer death in women around the world," but the World Health Organization actually ranks it fifth. America is better off than most countries, since the availability here of regular Pap smears has caused deaths from cervical cancer to drop by 74% since 1955. In 2006, there were 9,700 new cases of cervical cancer and 3,700 deaths from the disease in the U.S. This means it causes about 1.5% of all deaths from cancer among American women. By comparison, lung and bronchus cancers cause 26%. While both sides support cancer research and prevention, the numbers matter when it comes to mandating Gardasil for teenage girls.

Significant segments of the population don't receive proper screening against cervical cancer. As Dr. Clayton Young pointed out, if government money for the vaccine went instead toward increasing education and screening, "the results might be quite impressive." But Dr. Young believes that "to invest that amount of health care dollars in an immunization with no long term efficacy or safety data is unwise."

Merck-y waters? 
As if all this weren't enough, accusations of cronyism and special-interest politics are also plaguing mandate proponents. Merck's campaign to promote Gardasil and push for mandates began even before the vaccine was approved. Merck enlisted high-powered Republican lobbyists to bring as many social conservatives on board as possible, and gave large amounts of money to Women in Government, a national organization of current and former legislators, including many Democrats. Women in Government has made mandating the HPV vaccine one of its top priorities. The Institute on Money in State Politics reports that since 2000, Merck has given $2.46 million to state-level candidates and party committees.

Pundits wonder whether "HPV" might stand for "Help Pay for Vioxx." Drug-industry analyst Steve Brozak said, "I could not think of a bigger boost" to Merck than for states to mandate Gardasil.

In Texas, links between Gov. Perry and Merck seem to abound. One of Merck's three Texas lobbyists was Perry's former chief-of-staff. His current chief-of-staff's mother-in-law is Women in Government's state director for Texas. Perry has also received $21,000 from Merck over the years, including $6,000 for his most recent campaign.

Citizens of all political stripes dislike the sound of all this, and have said so in Texas and elsewhere. On Feb. 20, Merck announced it would immediately suspend its lobbying efforts for Gardasil.

In several states, including Michigan and Maryland, legislators rejected the HPV vaccine mandate after objections from the public. Legislators in Maryland have proposed instead to establish a task force on the issue, and reconsider the question in two years.

At the federal level, Rep. Phil Gingrey (R-GA) and Sen. James Inhofe (R-OK) have introduced bills to prohibit states from using federal funds to implement mandatory HPV inoculation. "As an OB-GYN physician, I understand the importance of protecting Americans from sexually transmitted diseases," Gingrey said. "States should require vaccinations for communicable diseases, like measles and the mumps. But you can't catch HPV if an infected schoolmate coughs on you or shares your juice box at lunch. Whether or not girls get vaccinated against HPV is a decision for parents and physicians, not state governments."

The National Conference of State Legislatures has created a website to track the progress of HPV vaccine legislation across the country. View the latest developments in each state at www.ncsl.org/programs/health/HPVvaccine.htm.

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