FDA Tells Sen. Blumenthal, et al, to Eff-Off re: *VALID* Lyme disease tests

News, Sunday, 20 Nov 2016

You’ll remember from reading the criminal charge sheets against mainly Yale and the CDC staff, in the first charge sheet:
that the FDA has, in their reply to the demands of the Senators, mentioned what ARE the criteria for a valid Lyme test (meaning of course they know and will be held to this standard criteria), which is naturally what we have been telling you all along; Dearborn was not only research fraud, but the ELISA criteria invalid and the opposite of what the FDA requires for a validation:



The following excerpt is from the FDA’s 31 July 2016 response to the senators, explaining that, yes, they know what a validation is and here is the criteria (what you have heard from us all along):


Had the FDA met their obligation, they would have had to throw out the CDC’s criminal Dearborn standard with the ELISA screen-out of all neurological cases, where all but the late arthritis-only cases could be “positive,” and where the Western Blotting would be reduced to only one band, the Yale-validated Band 41 or Bb-specific anti-flagellar antibody (US Patent 5, 618,533).

Criminal charges would have followed.  Yale validated this test in 1991, per the FDA’s rules on the validation of an analytical method.  See the criminal charge sheets:

Yale owns the patent for LYMErix also.  They did not use their valid test to assess their other patent, LYMErix.

The original letter by the Senators to the FDA about invalid LYME DISEASE TESTS:

Jul 03,2014 – Markey, Blumenthal, Warren, Brown and Durbin Call for Immediate Action on Critical Diagnostic Tests

Laboratory developed tests increasingly used to help diagnose conditions such as Lyme disease and cancer, and determine treatments

Washington – Senator Edward J. Markey (D-Mass.) was joined by Senators Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), and Dick Durbin (D-Ill.) in calling on the Obama administration to release draft guidance to ensure appropriate oversight of laboratory developed diagnostic tests (LDTs), which are used to help diagnose specific forms of cancer and other diseases and are not approved by the Food and Drug Administration (FDA). Laboratories initially manufactured LDTs that could be used for low-risk diagnostics or for rare diseases, but with new technology, they have become a staple of clinical decision-making and are being used to diagnose high-risk but relatively common diseases such as ovarian cancer. Recently, the Centers for Disease Control and Prevention (CDC) reviewed a frequently utilized LDT to detect Lyme disease and found “serious concerns” about false-positive results and misdiagnosis. The CDC recommended that the diagnosis of Lyme disease should instead be left to tests approved by the FDA. In 2008, a company that sold a diagnostic test used for ovarian cancer pulled the product from the market after receiving complaints that women who did not have cancer were undergoing surgery to remove ovaries as a result of incorrect test results. Several years ago, the FDA submitted draft guidance to ensure oversight of these diagnostic tools. However, the Office of Management and Budget (OMB) has yet to act and release the draft guidance, causing confusion for doctors, patients and the marketplace.

“For years this draft guidance has languished at OMB causing continued unpredictability and uncertainty for industry, clinicians, patients and the general public,” write the lawmakers in the letter to OMB. “These tests and their results are increasingly relied on by patients and medical professionals to help predict the most appropriate course of treatment and care. These tests hold great promise to customize healthcare to be more efficient and targeted for an individual patient.”

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