Just a few months after federal regulators approved a vaccine against a sexually transmitted virus that causes cervical cancer, more than a dozen states - including Maryland - are considering a requirement that girls entering middle school get it.
One of the primary drivers behind the legislative push: Merck & Co., the pharmaceutical giant that manufactures Gardasil, the only vaccine for human papillomavirus, or HPV, on the market.
The vaccine is expected to reach $1 billion in sales next year, and state mandates could make Gardasil a mega-blockbuster drug within five years, with sales of more than $4 billion, according to Wall Street analysts.
Merck, which has been arming its lobbyists across the country with information on the vaccine, has been getting an assist from Women in Government, a nonpartisan organization of female legislators whose agenda includes cervical cancer prevention. The group, like breast-cancer activists before it, works through political channels. It also takes corporate donations from Merck.
But some medical experts say lawmakers are moving too fast in their efforts to vaccinate all school-age girls. The American Academy of Pediatrics, for instance, is urging a go-slow approach, with an initial focus on raising public awareness of HPV and more monitoring of the safety of the vaccine, which had minimal side effects in clinical trials but hasn't been observed in larger-scale rollouts.
"A lot of us are worried it's a little early to be pushing a mandated HPV vaccine," said Dr. Martin Myers, director of the National Network for Immunization Information. "It's not that I'm not wildly enthusiastic about this vaccine. I am. But many of us are concerned a mandate may be premature, and it's important for people to realize that this isn't as clear-cut as with some previous vaccines."
He added, "It's not the vaccine community pushing for this."
Lawmakers and other backers of widespread vaccination say cervical cancer - like the measles and other childhood diseases - could be largely eradicated in the United States, and Gardasil has been widely hailed as a medical breakthrough with enormous potential. Cervical cancer is the second leading cancer killer of women worldwide.
State legislatures that are considering requirements for school-age girls to be vaccinated against HPV include California, Indiana, Kentucky, Mississippi, New Jersey, Texas and Virginia, according to the National Conference of State Legislatures.
In addition to vaccination mandates, Merck supports measures that would require private insurers and Medicaid to cover the cost of the vaccine, which has a retail price of $120 per dose, or $360 for the full, three-shot series.
The company also backs increased funding for government programs that help defray costs for low-income or uninsured children, such as the Maryland Children's Health Program.
The company has not only dispatched lobbyists but medical experts to speak with groups that request information, spokeswoman Jennifer Allen said, including social conservatives who oppose mandates.
"Our goal is to support state efforts to implement policies to ensure Gardasil is used to achieve what it was designed to do, and that's to reduce cervical cancer and other HPV-related diseases," she said. "It's a public health goal that every one has."
The measure in Maryland, introduced by state Sen. Delores G. Kelley, a Baltimore County Democrat, would require all sixth-grade girls to be vaccinated by September 2008. Del. Adrienne A. Jones, also a Baltimore County Democrat, said she plans to file a companion bill in the House of Delegates.
"Cervical cancer is a terrible disease, and nobody should have to suffer that way," Kelley said. "And we can help stop it."
As for calls to hold off on a school mandate, she said: "The point is the FDA [Food and Drug Administration] has approved the vaccine, and that's the standard in America." She added that if parents object to the vaccine, the state allows exemptions on religious and medical grounds for all childhood vaccinations.
The issue came to Kelley's attention, she said, through contacts with Women in Government. The nonprofit group was formed in the late 1980s as an educational association for elected women in state government, and later joined forces with the Legislative Business Roundtable, a group of business leaders.
The organization holds forums and provides educational resources to legislators. One of its early cervical cancer initiatives was to advocate for legislation to ensure insurance companies covered the cost of HPV tests. Such a bill passed the Maryland General Assembly in 2005.
Digene Corp., a Gaithersburg company, makes the only HPV test approved by the FDA. It's also a corporate donor to Women in Government.
Similarly, Merck is the only maker of an HPV vaccine.
Susan Crosby, president of Women in Government, which advocates school requirements for the vaccine, said Merck is an information resource and provides "unrestricted" grants so that her group determines the content of educational efforts. The group doesn't disclose details about its corporate funding.
"They've got their own marketing team," Crosby said of Merck. "We don't go hand-in-hand with a lobbyist to talk to a legislator."
But some critics say the arrangement enables Merck to promote its products to lawmakers through a seemingly unbiased third party.
"This is a time-honored practice for companies to underwrite these things so that they're basically buying platforms," said Bruce F. Freed, co-director of the Center for Political Accountability, which advocates transparency for corporate political activity. "Merck and Big Pharma are doing this the way Big Tobacco has done it for years."
Groups such as the Maryland Family Protection Lobby also took issue with Merck's lobbying.
"If Merck wants to come up with a drug and advertise it, and people want to buy it, that's fine. I'm for capitalism," said Doug Stiegler, executive director of the group. "What I don't want is for Merck to come to the state and say we want to make millions of dollars from this, and we want you to mandate this for every schoolgirl who comes down the pike."
Stiegler joins groups such as Focus on the Family, a politically active Christian organization, in opposing the mandate on the grounds that parents, not the government, should make such decisions. Some parents, they say, may prefer their children practice abstinence and fear that the vaccine could promote promiscuity.
Legislators in Maryland say they are motivated to improve public health, not by corporate interests. Neither Kelley nor Jones, the main sponsors for the legislation, said they have spoken to Merck representatives.
The bill has more than 20 co-sponsors in the Maryland Senate, or nearly half the chamber, including Sen. Edward J. Kasemeyer, the majority leader and a Democrat representing Baltimore and Howard counties. He is married to one of Merck's Annapolis lobbyists, Pamela M. Kasemeyer, who said she is not working on the HPV-vaccine issue for the company. Both say they don't discuss work at home.
After 15 years of research at Merck, the FDA approved Gardasil for sale last June. Within weeks, the Centers for Disease Control and Prevention recommended that the vaccine be given routinely to girls ages 11 to 12, who number about 160,000 in Maryland. The CDC did not take a position on whether the vaccination should be required by law.
By November, Merck had begun a national advertising blitz. The slogan for the new "One Less" campaign: "You could be one less life affected by cervical cancer."
Clinical trials with about 20,000 women showed Gardasil to be effective in preventing four strains of HPV that are linked to 70 percent of cervical cancer cases and 90 percent of genital warts cases.
Cervical cancer afflicts about 10,000 women and kills 3,700 in the United States each year. Minorities are disproportionately affected, with African-American women nearly twice as likely as white women to die from the disease.
At a Wall Street briefing last month, Peter Loescher, president of global human health at Merck, said he emphasizes "speed, speed, speed" in a product launch. Already, he noted, 80 percent of cities and states - including Maryland - have ordered Gardasil to be distributed through Vaccines for Children. The federally funded program provides free vaccines to doctors who serve children with little or no insurance.
Richard T. Clark, Merck's CEO who attended the briefing, said Gardasil's launch has "exceeded expectations" and that the company is seeing "strong U.S. sales right out of the gate."
"Every time I talk about Gardasil, I am reminded of the deep sense of satisfaction all of us at Merck feel by contributing to such an important development in women's health," Clark said.
Raymond James analyst Michael Krensavage said: "It takes ice-breaking to sell a new product, so that's what Merck is doing."