It aint over, said Yogi Berra, until its over, and the debate over what to do about Gardasil, the vaccine developed by Merck against the strands of the human papilloma virus (HPV) that cause cervical cancer. is still raging hot and heavy in many states. While the vaccine has been recommended for routine use by the CDCs vaccine advisory committee and a number of professional groups such as the American Cancer Society and the American Academy of Pediatrics, the question of whether states should mandate the vaccine for school girls has been more controversial. Only one stateTexashas formally mandated the vaccine to date, but over 30 states are reportedly considering some form of mandate.

As frequently happens in politics, the debate over mandating has in many places been about things other than the merits of the vaccine. HPVs are sexually transmitted, and many conservative groups have complained that mandating the vaccine will encourage sexual activity and promiscuity. Other groups have complained about the intensity of Mercks campaign to sell the mandate. The company has mounted strong lobbying campaigns in favor of a mandate in a number of states and has financed a major cervical cancer awareness and pro-mandate initiative by Women in Government, a advocacy group of women state legislators. Merck is charging $360 for the three shot vaccine regimen, and there have been charges that the company is trying to secure market share before a competitive vaccine being brought out by GlaxoSmithKline hits the market later this year, which will almost certainly cause the price to come down. The backlash against these activities has been so severe that Merck has announced it is terminating its lobbying efforts.

All this political flap seems unfortunately likely to divert attention from the vaccines merits, which seem considerable. Cervical cancer is not the problem in this country than it is elsewhere, because most women get regular PAP smears, but there are some 10,000 new cases a year and over 3,500 fatalities. The CDCs most recent prevelance estimates (published in this weeks JAMA) for HPV infection detected the two strands of the virus that cause cervical cancer in over two percent of the women in the United States, with an additional 10 percent or so being infected with other high risk forms of the virus. Gardasil also vaccinates against two low risk HPVs which are associated with genital warts and other low level cervical changes. Overall, HPV infection and cervical cancer are most common among low income women who may have trouble accessing or affording regular PAP smears. In clinical trials, Gardasil demonstrated close to 100 percent efficacy in preventing the precursors of cervical cancer, and side effects appear infrequent and mild.

The case for mandating is weaker, but still reasonable. Typically vaccine mandates take a longer time to roll out after there has been more experience with the vaccine in the general population and side effects or other problems have had time to emerge. The professional groups that have endorsed the vaccine have typically not taken a position on mandating. The vaccine is currently very expensive, but the price may come down once the competing vaccine hits the market. Federal vaccination support programs typically cover younger children, but not the teenagers and young women who are also major targets for a vaccination effort, so insuring adequate access remains an issue. Absent a mandate, access to the vaccine will remain limited to those who know about it and can afford it, which are not those groups at greatest risk who need the vaccine the most. Past mandates do appear to have been relatively successful in expanding vaccination rates and equalizing access to vaccines, but additional funding would be required. Medicaid and CHIP are obvious possible funding sources for girls under 18.

What seems likely to happen is that different states will do different thingssome states will mandate with a variety of different conditions and some will not, and there will be significant disparities across the states in who does and doesnt have access to the vaccine. I know were getting boring about this, but what happens in state capitals is more important than whats happened in Washington.

Jim Fossett
AMBI/Rockefeller Institute
Federalism and Bioethics Initiative

Labels: hpv vaccine, state bioethics