UPDATE: The article below was first published three weeks ago. Today, it was reported that the FDA has approved the vaccine against HPV, making it in effect the first vaccine used to combat cancer, since HPV is a major cause of cervical cancer.
Reviewers for a Food and Drug Administration (FDA) advisory panel have said that Gardasil, the first ever cancer vaccine, appears safe and effective, boosting prospects that the panel, examining the drug today at manufacturer Merck's request, may recommend approval of the drug by the FDA within the next several weeks. In clinical trials, this human papillomavirus (HPV) vaccine was 100% effective at preventing cervical cancers in women.
HPV infection is believed to be the prerequisite for cervical cancer, the second most common cancer in American women. Each year, over 10,400 new cases of cervical cancer are reported in the United States, and 3,700 women die from the disease. With over 20 million Americans currently infected with HPV and over 50% infected at some point in their lives, the virus is the most prevalent sexually transmitted infection in both men and women. There are more than 100 strains of the HPV virus, and although most produce no symptoms, some cause warts, papillomas (benign tumors), precancers, and cancer (most often cervical).
The Gardasil vaccine protects against four different strains of the virus -- strains 6, 11, 16, and 18. The first two are believed to cause over 90% of genital warts, while strains 16 and 18 cause over 70% of cervical cancers. This quadrivalent recombinant vaccine will protect sexually active individuals from a disease against which condoms are not wholly effective. Merck will initially target this vaccine to young women ages 9-26, focusing on the youngest segment of the spectrum.
Religious and family advocacy organizations have been targeted in the media for their supposed opposition to the vaccine on the grounds that administering it at such a young age will encourage promiscuity. In fact, though, many such groups have issued statements in support of this vaccine. We at ACSH fell into the same trap and cited opposition from these organizations.
Disagreements abound, however, regarding the timing of the vaccine's administration. Scientists believe it is most effective when administered to children as young as nine, in order to reach girls before they become sexually active (and thus more susceptible to contracting the virus). Although they publicly support the vaccine, religious-conservative groups criticize its usage on preteens and question whether or not it should be made mandatory. Most use this groundbreaking advancement as an excuse to promote abstinence-only education. Hal Wallace, head of the Physicians Consortium claims, "We're going to be sending a message to a lot of kids, I think, that you just take this shot and you can be as sexually promiscuous as you want and it's not going to be a problem, and that's just not true."
The most important point regarding this opposition is that there is no medical reason to delay the administration of the vaccine, which could save thousands of lives every year. Gardasil's widespread availability will also underscore the importance of comprehensive sex education for teenagers, ensuring that they understand that this vaccination does not make them immune to other sexually transmitted infections, or even all types of HPV.
Jaclyn Eisenberg is a research intern at the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).
