Part 1 - The Trail of Evidence

a NewsTarget special report by Mike Adams

Part 1 - The Trail of Evidence

This story begins at a company called HiFi DNA Tech, LLC (http://www.hifidna.com) a company involved in the manufacture of portable HPV testing devices based on DNA sequencing analysis. HiFi DNA Tech has been pushing to get the FDA to classify its HPV detection technology as a "Class II" virology testing device. To understand why this is a big deal, you have to understand the differences between "Class II" and "Class III" virology testing devices.

Based on FDA rules, a Class III virology testing device is one that is considered by the FDA to have "premarket approval," meaning that it cannot yet be sold to the public. In order for such a device to be marketed to the public, it must be downgraded to Class II status, which is considered a "special controls" status. Class II devices are, "...those devices for which the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and any other appropriate actions the agency deems necessary."

In other words, a Class II device may or may not actually be safe, but the FDA considers is safe enough to release to the public.

HiFi DNA Tech has been trying to get its HPV detection device downgraded to a Class II device based on the following arguments:

• For more than 20 years, the FDA had regulated the HPV test as a "test for cervical cancer."

• But since at least 2003, the FDA has changed its position on the relationship between Human Papilloma Virus and cervical cancer, stating that the HPV strain is "not associated with cervical cancer."

• Accordingly, HiFi DNA Tech is arguing that the HPV test it has developed is no longer a test for cervical cancer, but is merely a test for the presence of Human Papilloma Viruses -- a shift that makes the test far more reliable in its primary purpose. In other words, the test is merely detecting the presence of a virus, not making a diagnosis of a disease (which would be a much higher standard to meet).

On October 12, 2007, HiFi DNA Tech sued the Food and Drug Administration in an attempt to force it to downgrade its HPV detection technology to Class II (see http://www.news-medical.net/?id=31180 ). Earlier in the year -- on March 7, 2007, HiFi DNA Tech filed the HPV PCR test reclassification petition with the FDA. It is the information in this petition document that led us to the FDA's knowledge that HPV is not linked to cervical cancer.

Got all that? This is a somewhat complex story to follow, so here it is again in summary:

• A company that manufacturers a DNA testing device that can detect the presence of HPV (Human Papilloma Virus) is petitioning the FDA (and suing the FDA) to get it to reclassify its medical device as a "Class II" device based on the revelation that the FDA has already adopted the position that HPV infections do not directly cause cervical cancer.

• This would mean that the FDA has been aware for years that HPV does not cause cervical cancer, which means that the FDA's approval of the Gardasil vaccine -- as well as the national push for Gardasil vaccinations -- is based on a grand medical hoax that, not surprisingly, appears to be designed to exploit the fear of cancer to sell vaccines. The victims in all this, of course, are the young girls who are apparently being subjected to a medically useless (and potentially dangerous) vaccine.

• None of this information was apparently known during the more recent debates over the safety and efficacy of Gardasil, the HPV vaccine now in use. This means that the public debate over mandatory HPV vaccinations lacked key elements that now seem essential to reaching rational, evidence-based conclusions over the safety and efficacy of such vaccines.

Next, we reveal the FDA's statement that HPV is "not associated with cervical cancer."