I am a Board Certified Obstetrician Gynecologist and have several objections to the ACIP "recommendations".

Most of the following is taken Directly form the Gardisil package insert.

First, the endpoint is the preventions of "High Grade disease", this encompases CIN II-III and adenocarcinoma insitu (AIS) which are "immediate and necessary precursors" for squamous cell and adenocarcinoma of the cervix. The MAXIMUM of the median followup in any of their studies is FOUR years. However, the time course from CIN III to invasive cancer averages between 8.1 to 12.6 years. To say that this vaccine "prevents cervical cancer" with the longest median study subject being 4 years is ludicrious.

Furthermore, the vast majority of women clear or suppress the virus to levels not associated with CIN II or III and for most women this occurs promptly. The duration of HPV positivity (which is directly related to the likelihood of developing a high grade lesion or cervical cancer) is shorter, and the likelihood of clearance is higher, in younger women.

Therefore, vaccinating these children against HPV with a vaccine that is of uknown duration of efficacy will only postpone their exposure to an age which they are less likely clear the infection on their own and be subject to more severe disease. This would require an unknown number of boosters and is a setup for complacency in the older population that is a recipe for disaster. Futhermore the likelihood for regression to a normal pap from CIN II is 40%. This beats Gardisils "best" reduction of CIN 2-3 of only 12%. In this case, "first do no harm rules."

Furthermore the vaccine only "protects" against 4 high risk HPV subtypes. We are currently screening for 13 "high risk" HPV subtypes. This may lead to an increase in infection with other and possibly more aggresive subtypes.

The study of the vaccine in children and adolescents is limited to only measuring the developement of antibodies to the HPV subtypes in the vaccine. There is absolutely no evidence that the vaccine prevents anything when administered at this young age. Merck expects you to extrapolate their adult data to the immune response in children. If they were really interested in vaccine efficacy in children, should it not be studied properly in children.

Currently, precancerous lesions are readily identifiable and treatable in the developed world. The only utility of this vaccine may be in third world countries in which regular screening is not available and cervical cancer is still a major cause of morbidity and mortality. All of the data reported and advertised by Merck is based on world wide morbidity and mortality related to cervical cancer. Nowhere will you find specific data related to developed nations.

I have personally witnessed the devastation caused by severe vaccine reaction, inculding patients, their children, nurses and my own family. To proceed with mass vaccination against this embelished "threat" is irresponsible.

Clayton Young, M.D., F.A.C.O.G.