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 (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 over the outcome 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 borreliae 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 greater chance we have of forcing Medwatch 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 TIERS!
INSTRUCTIONS/HOW TO PARTICIPATE: Use this MEDWATCH link to file your report:
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
"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)
"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:
"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."
posted
Hundreds are doing this now. Anyone can join the facebook group that is spearheading the effort.
In fact, if you do fill out the form re Poppy's quick link, it would be nice to join the facebook group to let them know you did the form, so they have an idea of how many are doing this.
Gosh, my complaint case is so clear - I did a Western Blot test first, 4-band positive.
Then a rheumatologist sent out for an ELISA, which came back negative. "Good news," he said, "you're negative."
This after I had been on oral clindamycin for more than a month, with no more fibromyalgia pain, and I was starting to herx.
So I let him have it, he walked out, and then I went out and educated his staff who couldn't walk out on me!
Posts: 13116 | From San Francisco | Registered: May 2006
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Razzle
Frequent Contributor (1K+ posts)
Member # 30398
posted
Is there an alternative to joining the FB page?
-------------------- -Razzle Lyme IgM IGeneX Pos. 18+++, 23-25+, 30++, 31+, 34++, 39 IND, 83-93 IND; IgG IGeneX Neg. 30+, 39 IND; Mayo/CDC Pos. IgM 23+, 39+; IgG Mayo/CDC Neg. band 41+; Bart. (clinical dx; Fry Labs neg. for all coinfections), sx >30 yrs. Posts: 4166 | From WA | Registered: Feb 2011
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Judie
Frequent Contributor (1K+ posts)
Member # 38323
posted
Razzle -
I just went to the link and reported. No need to be on facebook to do so:
There is another fb group who are going to get US prosecution for all the fraud and corruption...
They are recruiting all syndrome sufferers, psych pts. neglected and abused for failure to test and treat the cause of Our Age of Syndromes, Psych, and Cancers the infections they gave us all causes----
SO YOU THE AMERICAN PEOPLE BE SAVING YOUR PENNIES AND MAKE PLANS TO CHANGE OUR WORLD....BECAUSE WE ARE NOT GOING TO LEAVE UNTIL THEY DO!
-------------------- Suspected Lyme 07 Test neg One band migrating in IgG region unable to identify.Igenex Jan.09IFA titer 1:40 IND IgM neg pos 31 +++ 34 IND 39 IND 41 IND 83-93 + DX:Neuroborreliosis Posts: 5850 | From Kentucky | Registered: Dec 2008
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posted
If the filling out the web form is too difficult for you, you can also file a complaint by contacting the FDA Consumer Complaint Coordinator for the state in which you reside:
posted
LYMEPOLICYWONK: Lyme disease testing - the CDC, LabCorp and stories that don't add up
11th September 2014
Dr. Paul Mead of the Centers for Diseases Control and Prevention (CDC) recently stated in the Wall Street Journal that the CDC's recommended two-step process (which requires a positive ELISA test before a Western blot can be given) is accurate and was developed specifically to aid diagnosis of Lyme disease. A stunning assertion given that it directly conflicts with Dr. Mead's previous testimony before the Connecticut Department of Public Health and the Attorney General's office. It is also at odds with the CDC case definition for Lyme disease, which recognizes the validity of a stand-alone Western blot. This turnaround, coupled with LabCorp's recent decision to abandon a stand-alone Western blot, has patients up in arms. And, rightly so. . .
The CDC's blatant rewrite of history only serves to increase public distrust. . .
So I let him have it, he walked out, and then I went out and educated his staff who couldn't walk out on me!
KUDOS to you for doing that. I too refuse to let these IDiots get away with killing us. When the time is right, BLAST them. I have educated several doctors about Lyme, and have gotten four of them to watch UOS.
Some of them are changing their tune. Last week, the surgeon who did my shoulder replacement said he is thinking "fibromyalgia" may be Lyme. No chit Sherlock!
-------------------- Sick since at least age 6, now 67. Decades of misdiagnosis. Numerous arthritic, neuro, psych, vision, cardiac symptoms. Been treating for 7 years, incl 8 mos on IV. Bart was missed so now treating that. Posts: 765 | From nw ct | Registered: Sep 2008
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