The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 18 No. 8 • December 2015

FDA “Protects” Public From Cancer Detection Blood Test

In another move toward police state medicine, the FDA has notified Pathway Genomics that it cannot market a blood test to screen for various cancers in healthy people because the company didn’t get the FDA’s permission to do so. In a 21 Sept. 2015 warning letter, the FDA declared the company’s test blood collection tubes a “medical device” and therefore, their use comes under the agency’s jurisdiction. The test, which would have allowed the public to determine whether they had cancer cells circulating in their bloodstream at a cost of $299 to $699 will probably never become available because the cost of getting FDA approval is prohibitive. Meanwhile, the FDA calls the test, which simply collects blood for analysis by their Pathway Cancer Intercept Detect service, the results to be sent to the patient’s doctor (who has to order the test), a “high risk test that has not received adequate clinical validation and may harm the public health.”

Where is the “high risk” the FDA claims exists here and how might it “harm” the public health, provided a disclaimer truthfully explains limits to the test’s ability to provide conclusive proof of having or not having cancer, a disclaimer we would be amazed if the company didn’t already provide for legal protection, if for no other reason.

The FDA is a dangerous entity backed by little more than government force that is immensely harmful to the public health. The agency pursues a vigorous agenda of extending its jurisdiction by decree (they simply proclaim authority over whatever suits their fancy), without Constitutional or statutory basis, to more and more of new medical technologies, effectively eliminating most of them from public access. In the meantime, courts regularly “defer” to the FDA and other regulatory agencies, providing little in the way of an effective check to their power-seeking. The result is the shrinking of choices available in the medical marketplace. And for THIS, we pay taxes??? We’d be better off shredding the money.

  • FDA warning on cancer test reported in the 2 Oct. 2015 Science, pg. 12

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