The Federal Drug Administration (FDA) has approved quadrivalent human
papilloma virus recombinant vaccine. The trade name for this product
is Gardasil. This new vaccine helps protect against diseases caused
by the human papillomavirus, which you may know as HPV. You also may
know that HPV is associated with the occurrence of cervical cancer and
genital warts. Our studies show that if we can prevent the acquisition
of HPV, that we can prevent the occurrence of cervical cancer and genital
warts in a very high percentage of patients.
The FDA has approved vaccination in females 9 to 26 years of age for
prevention of the following diseases caused by Human Papillomavirus
(HPV) Types 6, 11, 16, and 18:
* Cervical cancer
* Genital warts (condyloma acuminata) and the following precancerous
or dysplastic lesions:
* Cervical adenocarcinoma in situ (AIS)
* Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
* Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
* Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
* Cervical intraepithelial neoplasia (CIN) grade 1
It is anticipated that the insurance industry will embrace this advance
and pay for the immunizations (which cost approximately $600 for a series
of three vaccinations) in the next several months; so you may want to
see when and if that happens. If you do not want to wait for the medical-industrial
insurance complex pay for this, please consider beginning immunizations
in the immediate future.
As a practical matter, a number of questions arise. Here are the two
most common questions and their answers:
1. What if I am older than 26 and continue to have exposure with sexual
activity? You will want to consider immunization although the FDA has
not endorsed this and the insurance companies may not pay for it.
2. If I have already acquired HPV, should I be immunized? Yes, since
the vaccination immunizes against the 4 most troublesome HPV strains,
you can be protected from acquiring additional strains
Please let us know if you are interested in beginning immediate immunizations.
If you prefer to wait until the insurance company's begin approving
payment, be sure to let us know of your interest in the future. If it
is more convenient for you to receive these vaccinations from you gynecologist,
please let him or her know of your interest. You will want to continue
or incorporate safe sexual practices as a matter of routine both before
and after immunization.
Here some excellent resources if you want to explore more of the details
regarding this wonderful advance:
1. The CDC (Center for Disease Control) is the best site: http://www.cdc.gov/std/hpv/STDFact-HPV-Vaccine.htm
2. The FDA website: http://www.fda.gov/CBER/products/hpvmer060806qa.htm
3. The National Cancer Institute website: http://www.cancer.gov/cancertopics/factsheet/risk/HPV-vaccine