OBGYN Questions HPV Vaccine Gardasil

Editorial Office
Obstetrics and Gynecology
The American College of Obstetricians and Gynecologists
409 12^th Street, SW
Washington, DC 20024-2188

I am writing in response to the recent Committee Opinion 344 Published in the September issue of Obstetrics and Gynecology.  I have several concerns regarding Gardasil.

First, the Gardasil's  product insert states their endpoint is the prevention of "High Grade Disease", this encompasses CIN II-III and adenocarcinoma in situ (AIS) which are "immediate and necessary precursors" for squamous cell and adenocarcinoma of the cervix.¹  The MAXIMUM  median follow up 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.²  Claiming this vaccine prevents cervical cancer, with the longest median study subject being 4 years, is inappropriate.

The vaccine only "protects" against 4 high risk HPV subtypes.  We are currently screening for 15 "high risk" HPV subtypes. This may lead to an increase in infection with other and possibly more aggressive subtypes.

According to ACOG, "The vast majority of women clear or suppress HPV 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."³ Seventy percent of women clear the virus spontaneously after 18 months and 90 % clear the virus after 2 years.⁴  Vaccinating children against HPV with a vaccine that is of unknown duration of efficacy may 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, including the cervical cancer which the vaccine is supposedly preventing. This would require an unknown number of boosters and is a setup for complacency in the older population that is a recipe for disaster.

The likelihood for regression to a normal pap from CIN II with expectant management is 40%.⁵  This beats Gardasil's reduction of CIN II-III of only 39% in the "general population impact group" which is where most people would currently fall.⁶  This includes "all subjects who received at least one vaccination (regardless of baseline HPV status at Day 1."⁷  Since ACOG does not currently recommend serologic testing for HPV before vaccination this will be the endpoint from here out. In this case, "first do no harm" rules.

The study of the vaccine in children and adolescents is limited to only measuring the development 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?  Vaccinating children for this or any other sexually transmitted infection is not without risk. There are over 30,000 immunization reactions reported to the Vaccine Adverse Events Reporting System (VAERS) annually ⁸, and it has been estimated that only 10% or less of vaccine reactions are reported.⁹   In light of these facts the integrity of the post marketing surveillance of vaccines is questionable.  Currently no vaccine has ever been examined for possible carcinogenic, mutagenic, or teratogenic effects, and yet the pharmaceutical industry stands ready to add Gardasil to the list of vaccines mandated for school admission.

Currently, precancerous lesions are readily identifiable and treatable in the developed world.  Cervical cancer causes approximately one percent of all cancer deaths in America.  The  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.  The Committee Opinion states that there continues to be a significant population of women not receiving adequate screening.  If you estimate the cost of the series at $360.00 (the most expensive vaccine on the market) administered to all adolescent girls and use that money to expand and enhance screening, I believe the results might be quite impressive.  To invest that amount of healthcare dollars in an immunization with no long term efficacy or safety data is unwise.

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

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

Cc:  NVIC, AAPS, PROVE

References

1.       Prescribing information for GARDASIL.  Whitehouse Station (NJ):  Merck & Co., Inc.; 2006.

2.       Management of abnormal cervical cytology and histology. ACOG Practice Bulletin No. 66.  American College of Obstetricians and Gynecologist.  Obstet Gynecol 2005; 106:  645-64.

3.       Ibid.

4.       Centers for Disease Control and Prevention.  Genital HPV Infection Facts Sheet. Available at:http://www.cdc.gov/std/HPV/STDFact-HPV.htm.  Retrieved September 16, 2006.

5.       Management of abnormal cervical cytology and histology. ACOG Practice Bulletin No. 66.  American College of Obstetricians and Gynecologist.  Obstet Gynecol 2005; 106:  645-64.

6.       Prescribing information for GARDASIL.  Whitehouse Station (NJ):  Merck & Co., Inc.; 2006.

7.       Ibid.

8.       Vaccine Adverse Event Reporting System, phone representative, interview with the author, September 13, 2006.

9.       Cave, S.  What Your Doctor May Not Tell You About Children's Vaccinations.  Warner Books, 2001. p.xviii.

April 5, 2008