Gardasil® HPV and A New Anti-Cancer Vaccine
by Dr. Rick Bayer

Gardasil® is Merck’s new vaccine to prevent infection with Human Papilloma Virus (HPV). HPV is a sexually transmitted disease (STD) causing genital warts and cancers. 20 million Americans harbor HPV. Women undergo Pap tests to detect abnormal cells and prevent death from cancer of the cervix. About 1.5 million American women are diagnosed with pre-cancerous Pap test results each year. In spite of Pap testing, the American Cancer Society predicts in 2007 that 11,000 American women will be diagnosed with cervical cancer resulting in 3,700 deaths. There is no cure for HPV. Rare symptoms make it more easily transmitted.

How does Gardasil work? HPV types 16 and 18 cause about 70% of HPV-related cervical cancer while HPV types 6 and 11 cause about 90% of genital warts. Gardasil consists of virus-like particles of these four HPV types. The vaccine causes humans to develop antibodies to the particles without developing warts or cancer. Gardasil won’t prevent all forms of genital warts or cervical cancers so women still need Pap tests.

In 2006, the US Food and Drug Administration approved Gardasil for prevention of cervical cancer in females between ages 9 and 26 years. The vaccine is given in 3 injections over 6 months.

The social evolution of biotechnology is sometimes as fascinating as the technology itself. For starters, it is unclear who should receive Gardasil. For maximum benefit, Gardasil should be given before a person becomes sexually active. The US Centers for Disease Control Advisory Committee on Immunization Practice recommends Gardasil be given to girls when they are 11 or 12 years old. Gardasil can be started as early as age 9 and can also be given to women 13 to 26 years old. There are no reported serious side effects—only soreness at the injection site. After sexual activity begins, it is unclear if vaccination will help since vaccine effectiveness lessens after natural exposure to HPV.

Some parents struggle with a vaccine against any STD, believing their children could never be at risk. Others think that Gardasil might encourage promiscuity, since it could foster the myth that Gardasil protects against all STDs. Reframing discussion as an anti-cancer vaccine may overcome fear, embarrassment, and misunderstanding. Gardasil only protects against four types of HPV—not other STDs such as HIV or herpes. It doesn’t mean ignoring rules of safe sex or Pap tests.

My greatest concern is the $360 cost for the 3-dose-vaccine. This means those at highest risk to die from cervical cancer—the medically poor—are least likely to receive the vaccine. Gardasil again emphasizes our tremendous healthcare inequities. Perhaps Cerarix®, the GlaxoSmithKline competitor awaiting FDA approval, will be less expensive, but not likely. Let’s not fool ourselves; Americans need universal healthcare. Voters will make a huge decision about American healthcare in 2008.

What about other Gardasil controversies? Some believe Merck engaged in intense lobbying to make Gardasil vaccination mandatory. Legislation was introduced in Michigan to make vaccination mandatory but did not pass. In February 2007, Texas Governor Rick Perry issued an executive order mandating Gardasil be given to all Texas girls entering sixth grade starting September 2008. A suit immediately blocked the order. To add to the controversy, Perry’s chief of staff is head of Merck’s Texas lobbying team and Merck gave Perry $6000 in campaign contributions. Some may recall Merck as being the maker of Vioxx®. In spite of Merck’ efforts, there are currently no government mandates for Gardasil.

What should wise healthcare consumers do? HPV vaccination probably decreases genital cancers other than cervical cancer, including vaginal and vulvar cancers. HPV is also related to penile cancer and anal cancer. This is why Australia and the United Kingdom approved Gardasil for boys aged 9 to 15. Vaccinating American boys, although not FDA-approved, is legal. Since the vaccine appears safe, I suggest not only vaccinating American girls but also American boys.

More studies are welcome but death from cancer due to vaccine cost or misinformation is unfortunate—and preventable. Although Gardasil should not be mandatory, all vaccines must be affordable. Preventing STD or cancer will never be easy. But, Gardasil and similar biomedical advances can help if Americans have the will to promote public health.

To learn more, visit www.cdc.gov and search Gardasil or visit www.Gardasil.com (Merck’s site) or type Gardasil into Google or your favorite search engine.

Richard “Rick” Bayer, MD, FACP is board-certified in internal medicine, and lives in Oregon.