By: Norma Erickson
12 September 2010
The National Cancer Institute (NCI) announced on August 2, 2010 that it has awarded a $13.5 million contract to a Dutch diagnostic laboratory to perform reliable human papillomavirus (HPV) genotyping using a polymerase chain reaction (PCR) system with short target sequences for the cervical biopsy samples collected at the NCI.
Such reliable HPV genotyping technology was not used by the drug manufacturers in validating the efficacy of the genotype-specific HPV vaccines during the clinical trials required for Food and Drug Administration (FDA) approval, and has been rejected by the FDA for commercial distribution to clinical laboratories in the U.S. for general patient care.
This NCI contract confirms that the current FDA-approved HPV test kits for patient care in the U.S. are not reliable.
According to the pre-solicitation notice, HPV infections are very common in sexually active women and only a small subset progress to cervical cancer. When precancerous lesions appear, they may contain multiple types of HPV. It is difficult with the currently available FDA-approved HPV tests to determine whether the HPV strains present are responsible for causing the lesions, or simply there as a passenger.
The notice goes on to explain, “…all sensitive HPV detection methods suited for paraffin embedded tissues (as many pap cytology samples are) require target amplification via PCR.”
Just so we have this straight, this means that the United States Government, Health and Human Services, via the National Cancer Institute has just spent $13.5 million of your hard earned tax dollars for a one year contract with a laboratory in the Netherlands to perform HPV testing that could have been done in the United States, had the FDA approved the technology for American medical consumers.
This technology has been potentially available in the United States since 2000. In fact in 2007, the FDA refused to approve a test kit based on the same technology that could have been used in virtually any medical facility in the United States. They did not grant approval for its use even though they knew via Merck’s own documentation that prior infection by vaccine-relevant genotypes of HPV could increase a woman’s potential risk of contracting cervical cancer, or precancerous lesions, by up to 44.6%.
The FDA, CDC, and HPV vaccine manufacturers could have used this technology in their safety and efficacy studies, but instead chose to accept the use of admittedly ‘unreliable’ HPV tests. Could this be because it is easier to manipulate the statistics from unreliable data?
The point for medical consumers to understand is no one but you is going to watch out for your health and well-being. It is up to you to be an informed and active participant in your health care.
SaneVax, Inc. is taking the first step to help you do just that. We are offering HPV testing with PCR amplification and DNA sequencing to any female who is considering HPV vaccination so they will know if there is a potential increased risk of cervical cancer before they consent to an HPV vaccination.
We are also offering the same test to anyone who has an abnormal Pap test after HPV vaccination. The reasoning here is, if you experience an abnormal pap test after vaccination the vaccine did not work. That means either a vaccine-relevant genotype of HPV has been in your body all along, even before vaccination, in which case you need a closer Pap screening for your own safety; or, there will is another genotype of HPV present, which could mean the vaccine manufacturers targeted the wrong strains of HPV in the United States. In the latter case, they would need to go back to the drawing board.
It is up to you—will you be an informed and active medical consumer? Or, will you continue to trust the government with your health?