Drugmaker Assists In Pushing for Mandate For HPV Vaccination

February 10, 2007

Amy Gardner, Washington Post Staff Writer

RICHMOND -- In Virginia and 17 other states, lawmakers are considering requiring young girls to be immunized against a little-known virus that public health officials say is responsible for nearly 7,000 cases of cervical cancer each year.

Legislatures are doing so at the urging of New Jersey-based pharmaceutical giant Merck & Co., which in June earned approval from the U.S. Food and Drug Administration for Gardasil, its new vaccine against human papillomavirus (HPV).

Merck, which posted revenues of $22.6 billion last year, stands to earn hundreds of millions of dollars annually on Gardasil, according to Wall Street estimates. And the public, research shows, stands to reap the benefits of the first vaccine against cancer. It is one of those moments in the public discourse, say several advocates for the mandatory vaccine, in which the interests of a deep-pocketed private company converge with the public good.

"The medical community is very excited about having a vaccine that can prevent cancer," said state Sen. Janet D. Howell (D-Fairfax), who sponsored a measure that is nearing approval in the Virginia General Assembly requiring that all rising sixth-grade girls be immunized against HPV. "It's everybody's dream that we'll be able to get more vaccines and prevent more cancers."

HPV is a sexually transmitted virus that can cause cervical cancer, genital warts and a variety of other, less common forms of genital and oral cancers. It is remarkably prevalent: At least half of sexually active men and women will carry it at some time in their lives, according to the federal Centers for Disease Control and Prevention. Most will never know it, and the virus will go away on its own. But in some cases, the virus lingers, causing cell changes that lead to cancer.

There is little doubt that the HPV vaccine will prevent cervical cancer. In clinical trials leading up to its approval, Gardasil was found to be nearly 100 percent effective in preventing infection by two strains of HPV responsible for 70 percent of all cases of cervical cancer. The vaccine also prevented infection by HPV strains responsible for about 90 percent of cases of genital warts.

With a national TV advertising campaign underway, Merck has led the effort to spread such information. It has also fanned out across the country to push for two kinds of state action: mandated vaccines for young girls, proposals for which were introduced in 18 states and the District this year; and millions of dollars of state spending to purchase vaccines for use in health clinics.

In Virginia, for example, Merck, a longstanding contributor to political campaigns in the state, has spent nearly $40,000 in contributions over the past two years. It has also hired Williams Mullen Strategies, a prominent lobbying firm, to spearhead the company's efforts to persuade lawmakers in Richmond to vote for a mandatory vaccine. On the team is Sandra D. Bowen, a well-known Richmond lobbyist and Cabinet secretary under two governors.

"School requirements is one approach that has been used very successfully in the past to improve vaccine rates," said Margaret McGlynn, president of Merck's vaccines division. McGlynn added that a mandate tends to lead to state funding of vaccines for public health clinics, improving access for lower-income and uninsured girls.

In the District, council member David A. Catania (I-At Large) said that he introduced legislation requiring girls to get the vaccine after hearing about the issue in the news and that his efforts have nothing to do with Merck.

"I have had no contact with Merck," said Catania, who chairs the council's Health Committee. "Any benefit this would have on the pharmaceutical industry is unintended. This is good medicine and makes sense."

Merck is not alone in pushing for broad access to Gardasil, which costs $360 for the recommended series of three shots. The American Cancer Society, the Centers for Disease Control, the American Academy of Pediatrics and the U.S. Advisory Committee on Immunization Practices all have recommended that girls receive the vaccine. These public health organizations are encouraging states to spend millions on the vaccine to make it available through clinics that primarily serve the poor or those without health insurance. They are also encouraging private insurers to cover the cost of the vaccine.

But they are stopping short of pressing for the mandate that Merck wants state lawmakers to impose. Some of the groups say they are not ready to endorse a mandate so soon after the vaccine gained approval from the FDA.

"A cancer vaccine is a relatively new concept," said Wendy Selig, the American Cancer Society's vice president for legislative affairs. "We have not reviewed all the policies regarding school mandates."

Some state-level health groups are promoting the mandate, including the Virginia chapter of the American Academy of Pediatrics and the Virginia Council on the Status of Women. But several lawmakers, including Howell, said Merck is doing most of the legwork. Howell added that it is useful to have the resources of a large company to provide research and meet with lawmakers. She said she is convinced of the public health benefit of mandating the vaccine.

That confluence of interests is commonly part of the legislative equation. In the late 1990s, drugmakers teamed with advocates for the mentally ill to encourage states to buy a new generation of antipsychotic drugs. The push netted hundreds of millions in profits for the manufacturers, but it was also promoted by the advocates as sound public policy. New psychiatric medications have been credited not only with improving the lives of the mentally ill, but also with saving states millions of dollars in unnecessary hospital stays.

In the case of mandating the HPV vaccine, there are good political reasons for nonprofit health groups to stay out of the debate, which has engaged critics who believe requiring a vaccine against a sexually transmitted disease would undermine parental authority and also encourage promiscuity. In Maryland, a proposed mandate was withdrawn after such objections were raised. Sen. Delores G. Kelley (D-Baltimore County) said her office received numerous complaints that the vaccine would increase the already high number of vaccinations children must receive. Another lawmaker has submitted legislation that would set up a task force to study the matter for two years.

In Texas, Gov. Rick Perry (R) was criticized last week for issuing an executive order that made his state the first to mandate the vaccine for sixth-grade girls. Perry has also been accused of being influenced by his former chief of staff, Mike Toomey, who is now a lobbyist for Merck.

Merck, best known for such blockbuster drugs as Singulair for the treatment of asthma and Zocor, a cholesterol-lowering medication, has a powerful financial incentive to push for the mandate sooner rather than later. A rival drugmaker, GlaxoSmithKline, is pushing its own HPV vaccine through the approval process. Mandating the vaccine quickly would help Merck corner the market before then -- helping to explain the intensity of the company's marketing and lobbying campaign toward consumers, physicians and politicians.

"We're certainly very proud of our efforts," said McGlynn. "We spent over 10 years developing Gardasil. We think this is a very important advance in women's health."

Staff writers Ovetta Wiggins and Nikita Stewart contributed to this report.

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