CDC Two-tier Lyme Disease Testing: A Global Threat
GENERAL INFO: Very recently, in yet another obvious attempt to keep their two-tier testing procedure firmly in place as the only approved Lyme disease testing method in the U.S., the U.S. Food and Drug Administration (US FDA) announced at the end of July 2014 that it will be investigating, via a government-appointed oversight committee, the validity of many diagnostic tests, including non-FDA approved Lyme tests (IGeneX, Advanced Laboratory Services, etc). The witch hunt continues . . .
If you were misdiagnosed/harmed by the Centers for Disease Control and Prevention's (CDC's) Lyme disease two-tier testing protocol, please participate! We are calling this the NO MORE TIERS campaign, using word-play to convey that the two-tier Lyme testing protocol needs to be abolished so that no more tears are shed as a result of this highly spurious Lyme testing protocol.
MEDWATCH: Medwatch is an arm of the U.S. Food and Drug Administration (FDA) that serves as a central repository for consumer complaints regarding medications and medical devices, among other things. Medwatch is responsible for investigating consumer complaints. They will be more compelled to investigate a high volume of complaints on the same subject (two-tier Lyme testing protocol), so please make your experience count!
This Call to Action was created to encourage you to report to Medwatch the negative impact that the two-tier Lyme testing protocol has had on your life and/or your loved ones' lives. The U.S. government continues to strongly adhere to a testing protocol that was never intended to detect true Lyme disease in the first place. In fact, it was created to ensure that most people infected with borrelia will NOT test positive. We are using the Medwatch reporting system as a way to send a strong, collective message that this cannot be allowed to continue. There has to be, finally, accountability.
If you were told that you tested negative on this two-tier test, please file a complaint. If you were never given the option of having the two-tier test performed, you may still want to file a complaint.
ACTION: Contact Medwatch to report how the U.S. government's two-tier borrelia (Lyme) testing protocol caused you intractable harm (delayed diagnosis, misdiagnoses, improper/no treatments, etc). Let's flood Medwatch with as many of our reports as possible! If you deem that you or a loved one has been negatively affected by the CDC's two-tier Lyme testing protocol, please participate. The more reports (complaints) that they receive, the more of a chance we have of forcing Medwatch to have to investigate this issue.
BACKGROUND/DETAILS: Currently, the U.S. government only sanctions and promotes what is commonly referred to as the two-tier test, which consists of an ELISA (enzyme-linked immunosorbent assay) followed by a Western blot test, only if you test positive or equivocal to ELISA. This is considered standard procedure and "best practices" at hospitals, clinics and medical practices throughout the U.S., even though studies have shown repeatedly that the ELISA test misses anywhere from 50% to more than 85% of positive Lyme disease cases. Subsequently, the majority of people infected with Lyme disease will test negative via this FDA-approved and CDC-backed testing method, be left untreated, and endure needless and indescribable suffering, sometimes for decades, as the disease progresses.
HOW CAN THIS BE? Because in October 1994, at what is known as the Dearborn Meeting held in Dearborn, Michigan, select participants with special interests, though in the minority, were able to strong-arm and finagle the two-tier testing method into law, even without group consensus. What took place at the Dearborn Meeting is KEY to why so many are suffering, and we need to UNDO ALL falsifications connected to Dearborn.
Let's break the CDC's current stranglehold on Lyme testing procedures. Patients before Profit$! NO MORE TIER$!
https://www.facebook.com/groups/582854858491686/
INSTRUCTIONS/HOW TO PARTICIPATE: Use this MEDWATCH link to file your report:
https://www.accessdata.fda.gov/script
s/medwatch/index.cfm?action=consumer.reporting1
If you have any questions or concerns regarding filing your Medwatch report, please place them on this FB event page wall and everyone will pitch in to help you. The official form is five pages long, so it is not too much of a daunting, energy-draining task. You will need to try to remember specific dates of testing, medical appointments, etc., and there is a section of the form that asks you to write about
your specific complaint.
To assist you, we are creating a sample/template for wording that you can use on your form to help to explain your concerns. We are also creating a reference list of all pertinent info that has to do with Lyme testing, and encourage you to add to this list. These are works in progress. If we pull together, We CAN do this!
****Important: Once you have filed your report, please let us know via this FB event page or send an email to
[email protected] to let us know that you have submitted your report. If possible, please take a screenshot of your report for your own, personal documentation.
For more info on the details of this investigation:
Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) FDA Document
http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407409.pdf
Washington Post (7-31-14): FDA to begin regulating laboratory test devices
http://www.washingtonpost.com/national/health-science/fda-to-begin-regulating-laboratory-test¬devices/2014/07/31/d7a4fd6e-18d2-11e4-9349-84d4a85be981_story.html
Government regulators say the evolution makes it more critical than ever to ensure that the tests are safe and trustworthy and that patients who rely on them aren’t misdiagnosed. Several incidents in recent years have underscored those concerns, including instances in which the reliability of LDTs for cervical cancer, Lyme disease and whooping cough have been questioned.
LYMEPOLICYWONK: Whose Interests is the FDA Protecting? Not Lyme Patients, Apparently (8-21-14)
http://lymedisease.org/news/lymepolicywonk/fda-and-lyme-tests-is-it-simply-vested-interests-protecting-vested¬interests.html
"Lyme patients have been railing against the poor quality of Lyme tests for years. So why aren’t better tests on the market? Blame the vested lab interests that currently control FDA Lyme testing. Among the 28 companies with FDA approved tests, at least 25% have ties to the key IDSA researchers who developed the IDSA Lyme guidelines. Drs. Gary Wormser, Raymond Dattwyler, and Alan [sic] Steere, have disclosed industry ties with at least nine companies who are involved with Lyme diagnostic tests: Biomerieux, Bio-Rad, Biopeptides, DiaSorin, Abbott, Baxter, Chembio, Immunetics, and Viramed."
New England Center for Investigative Reporting article (7-31-14): FDA to regulate Lyme, other diagnostic tests now exempt from oversight:
http://necir.org/2014/07/31/fda-to-regulate-lyme-other-diagnostic-tests/
The US Food and Drug Administration, responding to growing concerns that a host of diagnostic tests for illnesses from cancer to Lyme disease may be inaccurately identifying conditions, announced Thursday that it intends to regulate many of the tests.