One Less? Understanding Gardasil and the Risks of HPV

Since its FDA approval, Gardasil has been touted as a "cancer" vaccine by some. Cervical cancer is an awful condition, but what are the odds that with the Gardasil vaccine you will be "one less" woman to contract HPV, and therefore "one less" to develop cervical cancer?

According to the Food and Drug Administration medication insert for Gardasil, the HPV (Human Papillomavirus) vaccine for girls and women, protects against vaginal and vulvar cancers caused by the HPV strains 16 and 18. It also protects against genital warts caused by HPV strains 6 and 11.

The commercials for Gardasil tout it as making you "one less" woman to get cervical cancer. But Gardasil does not guarantee that you won't get cervical cancer. It lessens your chance by inoculating your against two strains of HPV that may cause cervical cancer. Not all women who get infected with strain 16 or 18 will develop cervical cancer.

To put it in perspective, here are some facts about HPV and cervical cancer:

There are over 100 different strains of HPV. More than 40 of these strains are considered "genital HPV". Genital HPV can be spread by vaginal, oral or anal sex. The mouth, throat and rectum can become infected with HPV. According to the Centers for Disease Control (CDC), in 90% of cases, the body's immune system clears HPV naturally within two years. Most people have no symptoms of HPV and have no idea that they are infected. The HPV strains that cause genital warts sometimes cause a rare condition called recurrent respiratory papillomatosis or RRP (warts in the throat). Most cervical cancer, but not all, is caused by HPV strains 16 and 18. HPV can also cause cancer of the head, tongue, tonsils throat, neck, anus, penis and vulva.

Gardasil, and the newer HPV vaccine, Ceravix (only for strains 16 and 18), do not help treat women who already are infected with the strains of HPV; they only prevent infection.

One side effect of Gardasil is syncope, fainting, which is why patients are required to stay for 15 minutes of observation post-vaccination. Rare, but serious, side effects have been reported with Gardasil.

According to the CDC's VAERS (Vaccine Adverse Event Reporting System), which includes accounts from doctors and individuals on side effects suspected to be caused by a vaccination, Gardasil has been suspected of causing a range of symptoms as mild as headaches or injection site soreness to as serious as permanent disability and death.

Fifty-two cases of death have been reported associated to Gardasil since its approval in June 2006. Though not all cases can be proven as directly being caused by the vaccine, many of the girls and women who died were apparently healthy and active prior to vaccination. Due to the age range the vaccine is limited to, 9 to 26 years old, all of the deaths were in children and young adults. Recently (October 2009), the FDA approved Gardasil for use in boys and men aged 9-26 for genital wart prevention as well, so adverse events reported for males is relatively small due to the short time on the market for them.

Gardasil may offer benefits, but they should be weighed with the risk. Also, it should be remembered that it is not a 100% guarantee that you won't get cervical cancer or any of the other cancers associated with HPV. Women are encouraged to still have annual PAP exams, as vaginal and cervical health still need to be monitored. Merck, the creator of Gardasil, should promote more information in their marketing efforts to give parents and young women a better understanding of HPV and the benefits and risks of their product. Doctors often don't go over side effects that are rare with a product unless a patient specifically asks about it. Feel free to ask any and all questions about Gardasil before deciding to get you or your child vaccinated. If you have a family history of vaccine-sensitivity or injuries make sure to let your doctor know.

Sources:
Human Papillomavirus, http://www.cdc.gov/hpv/Signs-Symptoms.html

Gardasil FDA Package Insert, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf

Cervarix FDA Package Insert, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf

HPV, http://health.rutgers.edu/hpv/#Vaccination
VAERS Gardasil Adverse Reaction Report, http://wonder.cdc.gov/controller/datarequest/D8;jsessionid=56C1272D3A45B492BCB97A1964834772