HPV Fights - Once Again, the States Decide!

It ain’t over, said Yogi Berra, until it’s 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 CDC’s 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 state—Texas—has 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. HPV’s 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 Merck’s 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 vaccine’s 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 CDC’s most recent prevelance estimates (published in this week’s 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” HPV’s 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 things—some 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 doesn’t have access to the vaccine. I know we’re getting boring about this, but what happens in state capitals is more important than what’s happened in Washington.

Jim Fossett
AMBI/Rockefeller Institute
Federalism and Bioethics Initiative

Labels: hpv vaccine, state bioethics

posted Feb 28, 2007 | link | jump to the comments (9)

tags: state regulation, vaccines

comments

Actually, since the vaccine was recommended by the ACIP, States must buy and distribute the vaccine to those eligible under Medicaid, (S)CHIP, and Vaccines for Children (uninsured, Native Americans). The system may accidentally work!
From what I've read and heard, the providers in VfC and Medicaid are pretty pushy about the "recommended" vaccines, since they get them for free and can charge MC or the patient a small injection fee.
So, the actual effect will be that the States will pay for quite a few doses, regardless of whether the vaccine is mandated by that State. And the lower income girls will find it relatively easy - or even hard to avoid - when they come in for other shots and medical care.
The girls whose families have private insurance may have a harder time accessing the vaccine, since private docs and clinics can hardly afford to have $120 per dose vials sitting in the refrigerator.
Eventually, probably within a couple of years, the insurers will notice the real costs and potential savings: that the girls who got the shot have less abnormal paps, with repeat paps, colposcopy and biopsy.
Then, the insurers will push it.

- by Beverly on Mar 1, 2007 at 7:18 AM | link

Thanks for correction, but I'm still more pessimistic than you. Lot of girls don't come in regularly, and take-up seems to have gone down--at least around here,some very high percentage of increasing number of uninsured kids are eligible for Medicaid/CHIP--Mandate would, I think, still give some improved access.

- by Jim Fossett on Mar 1, 2007 at 4:08 PM | link

I think this vaccine is still too new to mandate it. I've only just started seeing commercials about HPV on tv. I think more information needs to be available and presented to the public before we start mandating women to get a vaccine that they may not know what the disease is.

- by Samantha on Mar 3, 2007 at 12:23 AM | link

I can understand how some states can mandate that certain vaccines be mandated (Polio, Measles, etc.) for school age children who are attending public school to protect against an epidemic. But mandating such a vaccine as this is very close to crossing the line as to a woman's right to choose what to do with her body.

- by Stacy S on Mar 7, 2007 at 12:01 PM | link

I don't know about this. This vaccine is too knew for me. I think it should be optional not forced. It should be up to the individual not the product makers. I do think if there was a vaccine from AIDS or HIV people would be running for it.

- by Melissa S on Mar 22, 2007 at 1:48 AM | link

How can a drug company who is only concerned about the mighty dollar be allowed to influence the government decision to mandate this vaccine? Furthermore how can the government mandate a vaccine such as HPV? Does this not infringe upon a womans rights? I agree with vaccinations for those diseases which cause epidemics. However, preventive care and education need to be the focus with HPV. The government should be helping those who can not afford the care, not mandating a vaccine that may or may not help.

- by maberg on Mar 22, 2007 at 2:44 AM | link

It does seem weird that we are lining up young girls, forcing them to get a vaccine they may or may not want. Something about it does seem very Aldous Huxley. Also, I do agree there is much we do not know yet about the vaccine. However, if there is a limited window for age that the shot may be given, action should be taken sooner than later. Something seems exploitative about the process as much as I want every female to be as protected as possible, it is a very bizarre way of enforcing policy.

- by Jill Braver on Mar 25, 2007 at 5:51 PM | link

I am a mom of a 15 year old. If my pediatrician offers the vaccine to my child, I trust him to do the right thing. We have a rapport with our MD. I know this is not true of everyone. I also have access to research and education as I know alot of parents don't. I have to say I did not see controversy over the varivax so I would not ponder much over the HPV vaccine.

- by Diane c RN on Mar 26, 2007 at 12:34 AM | link

My problem with the entire thing is the drug company lobbying. Are they lobbying for the protection of American women or for their stockholders and CEO? If the American Academy of Pediatrics was sending lobbyists to Capital Hill to get legislation passed to require this vaccine, it would seem a lot more believable that this was definately a health related problem. Seeing a drug company send lobbyists smacks of only financial gains and grabbing for market share. Is this not truly just reinforcement of our double standard toward men and women and sex? Women and girls are not infected with HPV without sexual contact - where is the treatment for men in the prevention of HPV?

- by rbilan on Mar 27, 2007 at 10:52 AM | link