July 26, 2011
Dear Dr. Markowitz:
Thank you for your letter dated July 14, 2011 in response to the SaneVax Inc. letter of 28 May 2011, concerning the post-licensure monitoring project on Gardasil™, which was approved for marketing under the Fast Track Drug Development Programs in 2006.
Your letter stated, “Beginning in 2003, cervicovaginal swabs have been collected from women participating in the National Health and Nutrition Evaluation Survey (NHANES). These swabs are tested to determine individual HPV types. Types will continue to be monitored to evaluate changes after vaccine introduction.”
We are now eight (8) years past the inception of said program and five (5) years since Gardasil™ was first approved for marketing in the United States. Therefore, on behalf of concerned medical consumers, S.A.N.E. Vax, Inc. respectfully requests a copy of the monitoring data over the past 8 years. We would like to know specifically if mass vaccination of young women has indeed reduced the prevalence of the vaccine-relevant HPV genotypes as compared to other HPV genotypes in theU.S. population.
Your letter also stated, “CDC is participating in two ongoing special projects to evaluate HPV types in women who have cervical precancer lesions. Sites in five states (California,Connecticut,New York,OregonandTennessee) have developed a population-based system for monitoring cervical intraepithelial neoplasia (CIN) grade 2 or 3 and adenocarcinoma in situ and associated HPV types. In addition to collecting standard basic surveillance data on all reported cases, this project is determining HPV types in the precancers.”
In order to be able to assure medical consumers that these “ongoing special projects” are effectively implemented, we would like to ask you to fill in the numbers of HPV genotypes as supplied by these five states in the past 5 years in the Table attached so that we can post the results on our website to inform the public. The purpose of the Table is to present the number ofCIN2/3 and AIS associated with HPV type in each case from 2006 to 2011 to determine if the prevalence of the vaccine-relevant HPV genotypes is indeed decreasing in the precancer lesions among the vaccinated population, as compared to the non-vaccinated population.
In this era of government budget crisis, we would like to know the cost for the CDC’s ongoing special projects to evaluate HPV types in women who have cervical precancerous lesions in those five states mentioned above. Taxpaying medical consumers need some assurance that their money is being wisely spent. If these projects have not generated any meaningful data in the past five years, perhaps they should be abolished and replaced by some other more cost-effective means of post-licensure monitoring.
The SaneVax Team finds your statement “Since HPV genotyping is not done in clinical practice, it is not feasible to have HPV genotypes from all patients with Pap test results indicating cervical precancer or cancer reported to CDC” to be quite disturbing for two reasons. First, the CDC should have known that HPV genotyping has been done in clinical practice for years in the U.S., and there are two FDA-approved commercial test kits for HPV genotyping on the market now. Second, if the CDC believes HPV genotyping is not done in clinical practice, then the CDC should have known that “determining HPV types in the precancers” for post-licensure monitoring in clinical practice is not possible. However, the CDC felt quite comfortable to endorsing the vaccine Gardasil™, whose approval requires post-licensure monitoring based on using HPV genotyping, for use in clinical practice. The CDC should recommend that since HPV genotyping is not done in clinical practice, Gardasil™ should not be endorsed for use in clinical practice.
We are looking forward to your further comments on behalf of the CDC.Sincerely, Norma Erickson, President SaneVax Inc.
cc.Director of CDC- Thomas R. Frieden – firstname.lastname@example.org FDA commissioner – Margaret Hamburg – Margaret.Hamburg@fda.hhs.gov Secretary of HHS – Kathleen Sebelius – Kathleen.Sebelius@hhs.gov