HPV vaccine benefits outweigh the concerns

Posted: September 21, 2006

Something new is happening every day in the world of public health. It's hard to know when you ought to hop on the latest medical bandwagon to help your family and your community. Here is one worth the ride: the cervical cancer vaccine.

New immunization programs always raise legitimate ethical concerns, and the recently proposed cervical cancer vaccine programs are no different. But the particular ethical concerns raised by the HPV vaccine should not stand in the way of public acceptance. The potential health benefits of the vaccine are enormous.

America's most common sexually transmitted virus is HPV - the human papillomavirus. Every year, more than six million Americans are infected with HPV. Merck Pharmaceuticals, based in New Jersey, has developed a vaccine that researchers say can greatly reduce a woman's chances of getting a potentially deadly form of cancer. Virtually risk-free, the vaccine also protects against vaginal warts.

Merck's Gardasil vaccine was shown to be nearly 100 percent effective in four clinical trials involving 21,000 women. Gardasil worked not only against the two types of HPV that cause 70 percent of cervical cancers, but also against the other two, which cause 90 percent of cases of vaginal warts. Merck plans further research on Gardasil, including research on administering the vaccine to men. Glaxo Wellcome UK Ltd. is also working on an HPV vaccine for the marketplace.

The U.S. Food and Drug Administration approved the Gardasil HPV vaccine in June for females between the ages of 9 and 26. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention subsequently recommended the HPV vaccine for all girls between 11 and 12 years of age, and as young as 9, with catch-up immunization of 13- to 26-year-olds. The vaccine is expensive, but the committee also recommended that the federal Vaccines for Children program pay for the HPV vaccine for children whose families lack adequate health insurance.

Critics have voiced the ethical concern that, unlike the vaccines for measles and chicken pox, the HPV vaccine could make things worse rather than better. They worry that a vaccine that protects against a sexually transmitted virus will lead some women to let their guard down when it comes to safe sex and annual gynecological exams. This legitimate ethical concern can be readily addressed by patient education.

Other concerns are stickier.

Conservative moralists fear that any vaccine that protects against sexually transmitted infections will encourage promiscuity. The fear may be purely speculative - but it is heightened by the knowledge that parents could soon be asked to authorize the vaccine for their middle-school daughters. Whatever your sexual morality, however, there is good reason to support making this new vaccine routine.

An estimated 10,000 women will contract cervical cancer each year. Nearly 4,000 will die from it. That's surprising, given the availability of the familiar "Pap test" for detecting cervical malignancy in its earliest stages. Detected early through gynecological screening, cervical cancers can be stopped in their tracks and fully cured. But not all women get the Pap test or get it as often as they should. Some who get the test don't follow up with their doctors when they get abnormal test results. African American women receive more Pap tests than any other group, but die in significantly higher numbers.

It's time for a fresh approach. It's time to give a vaccine a try. All the evidence suggests that the vaccine works and that it may cut the death rate.

Cervical cancer is a known killer, and before it kills, it can cause bleeding, incontinence, kidney failure and tremendous pain. According to data provided by the New Jersey State Cancer Registry, as many women in Newark and other major municipalities get cervical cancer as get leukemia, brain or thyroid cancer. Yet cervical cancer has kept a dangerously low profile in some communities, tragically and unfairly reduced to the lowly status of embarrassing "female troubles."

If young women get three doses of the recently licensed HPV vaccine, they have a dramatically reduced chance of contracting cervical cancer. The ideal time to administer the vaccine is before a girl becomes sexually active, though the vaccine could also benefit a girl already active.

International clinical trials established that the vaccine is not dangerous in the approved dosage and delivery. (To be sure, the very, very rare individual could have an unexpected allergic reaction, just as she could to other medications.) Because the HPV vaccine can clearly benefit women and their eventual sex partners, the idea of introducing it into routine pediatric primary care makes a whole lot of sense.

Anita L. Allen is a professor of law and philosophy at the University of Pennsylvania.

Contact Anita L. Allen at aallen@law.upenn.edu.

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