HPV Vaccine: Too Soon To Be Mandatory

The New Republic: Moral, Medical and Mental Obstacles Mean It's Too Early To Require New Vaccine

(The New Republic)  This column was written by Arthur Allen.

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Jon Abramson, chairman of the Centers for Disease Control and Prevention's (CDC) Advisory Committee for Immunization Practices, would seem like a logical proponent of compulsory vaccination against the human papillomavirus, or HPV. The virus causes cervical cancer, and Merck's Gardasil vaccine proved in trials to be safe and to prevent two-thirds of the growths leading to such cancers. Abramson's committee, whose pronouncements are followed religiously in the public health world, has already recommended that sixth-grade girls get three shots of HPV vaccine.

So compulsory vaccination seems like the next step. HPV leads to cancers that kill 3,700 women each year and sicken another 6,000. That's a lot of death, misery, and medical expense — certainly more than what's caused by diseases like mumps or chicken pox, for which vaccination became mandatory in the 1980s and late '90s, respectively.

Merck launched a major direct-to-consumer advertising campaign after its vaccine was licensed last spring, and it lobbied fiercely to get state legislatures to mandate the vaccine. But HPV, unlike, say, chicken pox, spreads only through sex — so, naturally, vaccination has its opponents: Religious conservatives worry that it would make teens likelier to sin (by easing the threat of an STD). Of course, vaccines don't put ants in your pants anymore than safety belts cause road rage, and, besides, nearly everyone gets laid eventually. The purpose of public health is to protect everyone, and the vaccination of young girls is based on solid data showing that 13 percent of girls have already had sex by the time they turn 15. (It's important to vaccinate before sexual debut, because HPV infection risk increases about 15 percent with each new partner.)

Yet Abramson — and most of the other leading vaccinologists — opposes requiring HPV vaccination for school entry. "I do not think that HPV should be mandated at this time," says Abramson, who is also a professor of pediatrics at Wake Forest University School of Medicine.

Abramson is right. HPV might be a good candidate for compulsory vaccination, but it's far too soon for states to order it now. To understand why, you have to grasp the slow, three-way dance that builds public support for vaccination programs.

Vaccines, unlike other medicines, are "imperfect" goods, in the economic sense. When you're sick, you want to buy a drug — whether it's an antibiotic for strep throat, chemotherapy for cancer, or insulin for your diabetes. But vaccines — with a few exceptions, such as Jonas Salk's 1955 polio vaccine, which was balm to the soul of a polio-panicked nation — aren't an obvious sell. When you bring your baby to the pediatrician, he or she is healthy. A vaccine, like any other medicine, has a (small) chance of causing a side effect, so there's a risk analysis to impose on a healthy infant. What's more, as vaccines eliminate the diseases they are designed to fight, it's easier to believe you won't need them. As a parent, especially one who reads scary websites that blame vaccines for things they aren't to blame for, a vaccine might not seem like an unalloyed benefit.

For the commonweal, however, the benefit is clear. The diseases we vaccinate our children against — such as rubella, measles, and whooping cough — can and will come back if we stop vaccinating against them. So it falls to states — federal and professional medical organizations offer advice on vaccines, but states lay down the law — to choose which vaccines are mandatory. But before public health officials mandate a vaccine, they must be able to buy it for those who can't afford it. At $360 for the series, Gardasil is very expensive. And President Bush's new budget cuts federal vaccine-purchasing aid; states can barely afford to pay for currently mandated vaccines against diseases like hepatitis B and pneumonia, let alone spring for Gardasil. "I certainly would not want to see a child removed from school because their parents could not afford the vaccine," says Abramson (who stresses that his CDC committee has not taken an official position on the mandate).

Then, too, though it is legitimate to ask parents to contribute to the public good, you can't push too hard for acceptance of a new vaccine — especially one like Gardasil, which has been tested on only about 20,000 women, including just 1,500 young girls. Parents may be willing to accept that their daughters will have sex at some point, but they may still (quite reasonably) believe that it won't be in the sixth grade. Why not wait a few years?

Like all new medicines, HPV vaccine will contribute to cultural as well as medical change. That is why its introduction calls for a measure of patience. It's understandable that Merck — a very good vaccine maker — would like to corner a big share of the market before competitor GlaxoSmithKline's HPV vaccine is licensed later this year. Incentives to Big Pharma, including mandatory vaccination, are part of what keep them in the business of making vaccines. But one would have hoped that Merck learned its lesson after pushing for broad use of Vioxx — a drug whose side effects wouldn't have been as problematic if they were occurring in only people who desperately needed the drug for pain medication.

In the case of HPV, demand from parents and young women will presumably boost sales enough to provide good data, over a few years, on whether Gardasil is as safe and effective as it seems. If it is, then popular support will slowly build for the mandate to get the vaccine to the girls who need it. And since mandates increase vaccine coverage by just 10 to 20 percent (in most states, people can opt out of vaccination if they are strongly opposed to it), it hardly seems prudent to reignite a culture war issue until there's a long trail of documentation to support vaccination.

To be sure, there is a moral argument for immediacy working against the practical one for patience: The main reason for any mandate is to get the vaccine to children whose parents aren't aware it exists until they are forced to get their child immunized. In the case of HPV, there is probably a large overlap between the daughters of such parents and the women whose lack of access to medical care leads to cancer (regular pap smears can detect cancerous growths caused by HPV, and such growths can be removed if caught early enough).

But, by applying overly vigorous and premature pressure, Merck hurt this cause in the short term by cheesing off public health officials, state legislators, and a variety of vaccine-skeptical parents around the country, before finally ending its lobbying campaign last week. Building consensus for compulsory vaccination in states across the country takes time and persuasion, and now, because of Merck's zeal, it will take even more.

[pamk741]

Merck, one of the largest pharmaceutical companies in the world, is heavily marketing a vaccine, Gardasil, that it touts as 100% effective in stopping strains of the human papillomavirus (HPV) from developing into cervical cancer. The Food and Drug Administration (FDA) went even further, headlining its press release %u201CFDA Licenses New Vaccine for Prevention of Cervical Cancer.%u201D What has gone largely unnoticed, except for a few sharp eyed doctors and researchers, is that these strains of HPV take 8 to 12 years or longer to develop into cancer and Merck has studied women in its clinical trials for less than five years. Because its test candidates %u201Chad normal baseline pelvic examinations%u201D when the clinical trials began and were not likely to develop cervical cancer for 8 to 12 years, Merck has, essentially, created a vaccine that has proven to be 100% effective in preventing what isn%u2019t there.

Here is how Dr. Clayton Young explained Merck%u2019s cancer cure for cancer-free women in a letter to The American College of Obstetricians and Gynecologists: %u201CThe maximum median follow up in any of their studies is four years. However, the time course from CIN II to invasive cancer averages between 8.1 to 12.6 years. Claiming this vaccine prevents cervical cancer, with the longest median study subject being 4 years, is inappropriate.%u201D

Pam Martens

[sandals7]

the original bill in VA mandating HPV vaccination included language that waived the Commonwealth's immunity from lawsuits if women became infertile, or incapable of carrying a child through to a live birth...this language was taken out of the final version (so the Commonwealth remains immune from liability - what a shock), but dontcha wonder why they were toying with that language in the first place? I really hope some of you are doing research and understanding that this vaccine cannot protect your daughter from every case of cervical cancer.

[katg21]

"My main point is this should not be mandatory!We are the parents, we should make the decisions!"
margo77711

I agree with your point. Isn't it crazy how many people attacked you because of it? I think this will be my last post here, I can't handle all of the negativity.

[margo77711]

Thanks katg21! I'll take my chances and teach my young daughter abstinence. I will as well. I have heard of parents taking there daughters to the doctor to get on the pill because it is ok. And it is just wrong. Tell your daughter about pregnancy, tell your daughter about HIV, tell your daughter about all the transmitted diseases that they can get. The government really needs to focus on bigger problems than focusing on our young girls. And this will be a big money maker. My main point is this should not be mandatory!We are the parents, we should make the decisions!

[katg21]

I don't trust this vaccine just yet. You hear about it all the time; people panic, take the pill, vaccine, etc. and there are unexpected side effects. Small pox and cancer... there's a big difference there. Although 9700 effected by cervical cancer may seem like a large number, it really isn't. It certainly isn't enough to make me panic. I'll take my chances and teach my young daughter abstinence. When she decides it's time for *** she can decide to have the vaccination.

[grumpas]

What rock did you slither out from under margo77711???? Just because you teach your daughter abstinence before marriage doesn't mean she is going to practice it! But, I don't suppose you have ever stopped to consider your daughter may not share your dark ages point of view! Most people like you don't! You think a healthy dose of religion daily is the cureall for everything! We have all taught our children abstinence! But, most teenagers are notorious for not listening to what parents have to say! So it's up to a parent to protect them from their bad decisions! But, I can see how good of a mother you really are! You would leave your daughter unprotected and subject to possible disease due to your ignorant superstitions! Way to go Margo!!!!

[opfor311]

jimfinster

I did factor that in, but I also factored in that the rate of HPV infection to Cercival cancer is relatively low. I also factored in that there may be serious long term problems from the vaccine in a mass population.

While my analysis is a rough one, I still believe that it indicates that making the vaccine mandatory at this time is contraindicated.

[jimfinster]

opfor311:

That is not correct. You forget to factor in that the vaccine provides a lifetime of protection. It would take some serious number crunching to figure out the cost/benefit.

[wogerwabbit]

***This treatment must be applied rectally***

[nativewoman]

Yeah the stench of Big Pharma-Political quid pro quo is overwhelming and the cost is a little exhorbitant and it probably should not be manadatory at this time.

I just don't understand the parental mindset that finds the idea of possible pre-marital *** more abhorrent than the possible death of their children from cancer.

A death that possibly could have been prevented by something as simple as a vaccine during their early childhood just like all the other vaccines children take without question.