A Shot Against Cancer

By Christine Gorman

You'd think that if they invented a vaccine that protects you from cancer, everyone would want it. But last week's approval by the U.S. Food and Drug Administration of Gardasil, a vaccine against cervical cancer, raises about as many questions as it does hopes. At the top of the list: Who will get the vaccine, who will benefit most, and who will pay for it?

Before we tackle those issues, however, a short biology lesson is in order. Almost all cervical cancers are caused by a few strains of a sexually transmitted microbe called human papillomavirus, or HPV. Most of the time, a woman's body can deal with an HPV infection without any trouble--which is a good thing since a majority of sexually active women are believed to develop one at some point in their lives. In a small percentage of cases, the virus persists in the body, and in an even smaller percentage of those cases, the infection triggers a complex process that leads to cervical cancer.

Gardasil offers nearly 100% protection against the two most common cancer-causing HPV strains, as well as two others that cause genital warts. But at $360 for three shots given over six months, the vaccine, which was developed by Merck, is among the most expensive on the market. The price tag alone probably puts it out of reach for many uninsured women in the U.S. (as well as those whose insurance companies balk at the cost), not to mention millions of poor women in the developing world, where cervical cancer is a leading cause of death. The Gates Foundation announced last week that it will spend $28 million over the next five years to determine whether a cervical-cancer vaccine can be made more widely available.

But even those with adequate medical coverage will have to wait a while to get the vaccine. "Doctors probably aren't willing to stock it until they are sure insurers are going to pay for it," says Dr. Cynthia Rand, a pediatrician at the Golisano Children's Hospital at the University of Rochester in New York. The next step is for an advisory committee of the Centers for Disease Control and Prevention (CDC) to decide whether to make the vaccine mandatory for girls in the U.S. and, if so, for which age groups. Research suggests the vaccine is most effective when given before sexual activity begins, so the initial target group is likely to be girls ages 11 through 12. On the basis of the CDC's decision and recommendations from other professional organizations, the Vaccines for Children Program--which provides free shots for eligible children--and private insurers are likely to follow suit.

Tests are also under way to see whether vaccinating boys against HPV is a good idea. Although they obviously don't get cervical cancer, they are at risk of contracting warts as well as penile and anal cancers that may be linked to HPV. Plus, vaccinating boys against HPV should, in the long run, help protect girls and women.

Eventually, if enough children are vaccinated, the number of cervical biopsies and other invasive procedures should begin to drop. But since the vaccine doesn't cover every cancer-causing strain of HPV, women will still need to undergo Pap smears and other preventive tests for the foreseeable future.