Drug firm pushes vaccine mandate

Merck lobbies Md. on HPV preventive

January 29, 2007|By Laura Smitherman | Laura Smitherman,SUN REPORTER

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.

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