In a letter addressed to Dr. Harold E. Varmus, director of the NCI, and Dr. Margaret Hamburg, FDA commissioner, Ms. Norma Erickson, president of S.A.N.E. Vax, Inc., requested that these two federal agencies recommend a reliable human papillomavirus (HPV) genotyping test to support the national virology-based cervical cancer prevention program for patient care. Erickson stated: "The NCI knows reliable HPV genotyping is based on using a PCR system with short target sequencing."
“Common sense tells us that the damage to the public will be extensive if the FDA waits for a known safety or efficacy issue to become obvious during postmarketing monitoring before addressing the issue”
In the letter, Erickson pointed out that a senior NCI official had confirmed in a recently published comment, the NCI's agenda is to replace the traditional Papanicolaou (Pap) cytology with a virology-based program for cervical cancer prevention. The virology program relies on prophylactic vaccination of adolescents against carcinogenic HPV infections and HPV testing followed by colposcopic biopsies for cervical cancer prevention.
"This agenda is dangerous because HPV vaccines have not been proven effective for cervical cancer prevention, and the HPV testing is in chaos," said Erickson. "A recent NCI report stated that one FDA-approved HPV test generates two to four times more positive results than the other. No one knows for sure which HPV test result is correct."
Since the HPV test is approved "to screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy," positive test results are used by gynecologists as a triage tool to channel women into harmful 4-quadrant cervical biopsies. More false positive HPV test results lead to more unnecessary biopsies on women at a greater cost to society.
In the published comment, NCI officials "agreed that the increased detection of HPV by Hologic Cervista in the data submitted to the FDA is a concern that must be addressed in the mandated post-marketing studies."
The SaneVax team found this disclosure highly disturbing. If the data submitted to the FDA in support of a Class III medical device premarket approval application (PMA) raised a concern about its safety and efficacy, why did the governmental regulatory agency approve the device to be marketed to general consumers without resolving the concern at the reviewing stage?
"Common sense tells us that the damage to the public will be extensive if the FDA waits for a known safety or efficacy issue to become obvious during postmarketing monitoring before addressing the issue," said Erickson.
The same published comment disclosed that the senior NCI official in charge of the HPV project works with the FDA, the vaccine manufacturer, and the HPV test device manufacturer in developing the virology-based cervical cancer prevention program and knows the fact that "increased detection of HPV by Hologic Cervista in the data submitted to the FDA is a concern."
"Based on this information, the FDA and the NCI have a responsibility to protect American medical consumers by establishing a short target sequence-based reliable HPV genotyping method to support any virology cervical cancer prevention program," said Erickson.
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