SANE Vax to Dr. Mark Schiffman: HPV Vaccine Accountability

Dear Dr. Schiffman:

Since you are the first scientific officer to promote mass HPV vaccination of women as a means to prevent cervical cancer [1], and have been working with the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) as the Medical Monitor of the human papillomavirus (HPV) vaccine trial [2], you must know that the HPV vaccines currently being marketed were approved by the FDA under the Fast Track Drug Development Programs. You must also be aware of the fact that approval of the HPV vaccine was based on using “CIN 2/3, AIS, or worse by histology – with virology to determine the associated HPV type” as the surrogate endpoint in the evaluation of the efficacy of the vaccine to prevent cervical cancer.

According to the Guidance for Industry, Fast Track Drug Development Programs-Designation, Development, and Application Review, “Where an accelerated approval is based upon a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity, postmarketing studies are ordinarily required “to verify and describe the drug’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome” (57 FR 58942, December 11, 1992).”

Since the clinical endpoint used in the clinical trial for Gardasil and Cervarix approval was not an “irreversible morbidity”, post-licensure studies are required to verify and describe the vaccine’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome, according to the FDA drug law.

This letter is to request you, the official medical monitor of the HPV vaccine trial leading to its final FDA approval under the Fast Track Drug Development Programs, to publish the HPV genotypes which are causing precancerous and cancerous cytologic changes in the women who have been immunized by the HPV vaccines, under the brand names of Gardasil and Cervarix. Based on the VAERS Reports, a significant number of post-vaccinated women are now developing cervical precancer and cancer lesions. It is extremely important for the public to be informed if these cervical precancer or cancer lesions are being caused by vaccine-relevant HPV genotypes or by HPV genotypes not targeted by the HPV vaccines. Since both the FDA [3] and the NCI [4] have acknowledged that the only reliable HPV genotyping is by DNA sequencing, the consumers who have paid a great price to this controversial vaccine want to have the data based on HPV genotype determination by DNA sequencing.

As the official Medical Monitor of the HPV vaccine clinical trial, you are held accountable for supplying the post-licensure monitoring survey results as requested. If no reliable data are forthcoming, you should recommend rescinding its approval until a reliable post-licensure monitoring system is instituted.

I am looking forward to receiving your reply.

Sincerely yours,

Norma Erickson, President

Cc:

References:

[1] http://jnci.oxfordjournals.org/content/93/4/260.full

[2] Schiffman M, Wentzensen N. From human papillomavirus to cervical cancer. In Reply.  Obstet Gynecol 2010; 116:1221-1222.

[3] http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM181511.pdf

[4]https://www.fbo.gov/index?s=opportunity&mode=form&id=da396b97ad6eb7ec4f7d511f85d9e325&tab=core&_cview=0