tiredofthebs -
I am SO SORRY you've been through all this. My heart just melts with posts like this. It's late and I need to get to bed so I'm going to post a ton of info for you to look through. This is what you need to be sharing with your doctors and family members and implore them to get you help.
First, abx don't CURE Lyme. They might help it from spreading but it's not going to happen in a few days. There's a reason why even the least effective Lyme treatment guidelines (IDSA) promote abx protocols lasting at least 4 wks... The more effective ILADS guideliness suggest at least 6 wks for symptomatic, early cases. For chronic cases like yours (your case was unsuccessfully resolved after early treatment), the abx protocol is ongoing tx until sx are resolved. Many people also have success with herbal protocols and/or a hybrid approach, which you won't find in the conventional guidelines but absolutely do work.
Step 1
Please go ahead and get an appt w/ a qualified Lyme specialist. Chances are, the wait will be a few months. If you can stomach it and maybe get help from the MDs in your life, you might be able to talk someone into giving you various courses of abx to tide you over until you start working w/ a Lyme specialist. You can also start on some antimicrobial herbs.
Step 2
So then your second challenge is to get past the incorrect diagnosis according to the CDC tests and interpretation of your results. Your strategy is to get your MD to realize how the tests are calibrated and why, and to understand that even the CDC recommends that Lyme is a CLINICAL diagnosis --that the tests are NOT to be used solely for diagnosis, which is exactly what she did.
Sorry - I'm cutting and pasting all this info for you but if you have q's just let us know. MANY informed members on this forum can answer your questions.
There was a recent study that showed the CDC serology tests (like the test you took) was 50% inaccurate. Lyme is the fastest-growing infectious disease, according to the CDC. Can you imagine any other infectious disease with a 50% diagnosis rate? It's criminal.
Step 3:
Learn about
these tests and the context for their poor track record in diagnosis. Here's info to learn and share w/ the MDs in your life:
The MAIN reason these ill-informed MDs keep misinterpreting tests and misinforming people... is because of 3 issues I'll describe below:
1) Misunderstanding of CDC's role:
While the CDC has no formal medical authority whatsoever, it is what the medical industry follows. The CDC developed surveillance method criteria to track trends in infectious diseases, incl. lyme disease. To satisfy these surveillance proposes, the CDC developed a specific case definition for lyme disease that is used in qualifying "new lyme cases" per the testing results.
Note: "Surveillance methods" and "case definition" are two key concepts every lymee needs to understand and need to be able to talk about
when MDs try to manipulate test results and/or simply are ignorant about
what they mean!
2) Misunderstanding of purpose of CDC's criteria:
To this end (utilizing their "case definition" to implement their "surveillance" purposes) the CDC and IDSA developed a two-tiered serology testing "decision tree."
The 1st tier ELISA is required because (I need to figure out a more succinct statement here so will have to update later)
The 2nd tier WB test is to be administered ONLY to confirm a positive 1st tier ELISA because it is possible for people who were vaccinated with the OspA Bb DNA to be "falsely positive" on the ELISA.
Note: You'd think the CDC/IDSA could just have MDs ignore this criteria for people who have never had the vaccine, which is the majority of this country but that wouldn't serve their end game.
3) Misinterpretation of results:
The CDC developed a specific list of bands that are required in order for the tests to qualify as "positive" according to the "case definition" necessary to fulfill their "surveillance" requirements.
The CDC CLEARLY states that this criteria should NOT be utilized for diagnostic purposes, which is exactly what MDs all over the country are using them for.
The CDC states specifically that two lyme-specific bands kDa 31 and 34 OspA and B were used for the creation of a vaccine administered to XXXX number of people so they have removed these from their "criteria"
(Note: Again, why can't they simply allow those bands for people who have not been vaccinated... perhaps because they know most people already have Bb DNA in their bodies???)
Buried at the very bottom of this web page is the CDC's recommendation that LD be a clinical diagnosis... took me 15 minutes to find and I've been all over this CDC website for 2 wks:
www.cdc.gov/lyme/healthcare/index.htmlIt states:
"Surveillance case definitions establish uniform criteria for disease reporting and should not be used as the sole criteria for establishing clinical diagnoses, determining the standard of care necessary for a particular patient, setting guidelines for quality assurance, or providing standards for reimbursement." In addition to the gross misinterpretation of the CDC's criteria, the problem with the tests and misinterpreting the test results, very few MDs understand that the Bb have been proven to "inactivate" the immune system, which is the primary reason that serology tests are inappropriate for LD diagnosis.
+++++++
The three issues above are explained in more detail below (BTW---I ADDED MORE LINKS AFTER MY INITIAL POST):
1) CDC'S CASE DEFINITION IS BASED ON NEEDS OF SURVEILLANCE PURPOSES, NOT FOR DIAGNOSTICS AND TREATMENT
The CDC’s primary function is to report statistics of disease in this country as reported to them (contrary to what most people believe, the CDC is not a medical entity of any authority nor does it have jurisdiction over the FDA, which regulates testing, etc.). Generally, labs report to state health depts., which in turn report to CDC. But even the CDC states that valid LD cases could be excluded by their own reporting criteria—the strictness of criteria for surveillance purposes can result in under-reporting.
The CDC’s reporting criteria drives its method of case definition required for the purposes of surveillance and is based on "uniformity, simplicity and timeliness." The CDC’s case definition is not based on science but was designed to serve its primary function (reporting trends in diseases) and also to promote commercial interests.
Unfortunately, LD is not a simple disease and the CDC website itself acknowledges that it requires a clinical diagnosis and most MDs aren't qualified to do that.
According to Dr. David Volkman, Ph.D., M.D. (Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook, Board certified in Immunology, Diagnostic Laboratory Immunology and Internal Medicine, and Board Eligible in Infectious Diseases), who was a member of the original Committee (along with IDSA’s Wormser) to Develop a Surveillance Case Definition for Lyme Disease and helped write the surveillance definition.
Volkman states that “the CDC explicitly cautioned against using this restrictive case definition or clinical diagnosis and reiterated this proscript
ion with every rei-issuing of it’s ‘Surveillance Definition.’ It has been a source of frustration and confusion that some in the medical community wrongly insist that a LD patient must satisfy CDC criteria.”
georgialymedisease.org/yahoo_site_admin/assets/docs/ws_-Volkman_1_comments_IDSA_guidelines.100215315.pdf
And, according to Daniel Cameron, president of the International Lyme and Associated Diseases Society, "In epidemiology, every time you have a surveillance system, you always at least have a tenfold underreporting. There have been studies that show it might be as much as 40 times that."
He also questions the fact that 95 percent of the reported cases come from just 13 states, mostly in the Northeast, along with Minnesota, Virginia, and Wisconsin. People in other states are less likely to report cases if the official view is that Lyme is rare and geographically restricted, according to Cameron. "That's a little bit of a reporting problem."
2) CDC’s CASE DEFINITION METHODOLOGY RELIES ON AN INSENSITIVE "TWO-TIERED TESTING DECISION TREE" OR SCREENING PROCESS BUT QUALIFYING "CDC POSITIVE" RESULTS ARE GEARED TOWARD THEIR SURVEILLANCE NEEDS, AND NOT TO BE INTERPRETED FOR DIAGNOSTIC PURPOSES:
www.cdc.gov/lyme/healthcare/clinician_twotier.html
1st tier test ELISA (Enzyme-linked Immunosorbent Assay) with confirmatory 2nd tier test Western Blot (immunoblot). These are both serology tests that rely on detecting antibodies produced by a healthy immune system.
The 1st tier ELISA test is highly questionable for early localized disease. This very general test is intended to detect general immune activity (looks for a collection of the B31 strain antibodies), not a response to a specific infection. The theory employed by the CDC is intended reduce ‘false positives’ since the ELISA can show positive reaction to antibodies associated in people previously vaccinated for LD. Virginia Governor Bob McDonnell and Secretary of Health and Human Resources 2011 Lyme Disease Task Force Report /www.cga.ct.gov/2012/rpt/2012-R-0149.htm,
(Molloy, Berardi, Persing, Sigal Detection of Multiple Reactive Protein Species by Immunoblotting after Recumbant Outer Surface Protein A Lyme Disease Vaccination) m.cid.oxfordjournals.org/content/31/1/42.full
I am still searching for a good source that effectively explains or debunks the purpose for the sequence, instead of going straight to the more specific WB.
The 2nd tier Western Blot test also looks for immune response but more specifically identifies antibodies for a specific Borrelia strain (looks for 5 out of 10 possible again B31 strain only antibodies produced by your body).
However, the CDC’s phrasing reads that you should not test with the more specific 2nd tier Western Blot test if the 1st tier ELISA is negative (failure #2). Since Borrelia can inhibit the immune system function, this automatically creates inaccurate test results (failure #2).
Subsequently, general MDs unfamiliar with the inaccuracy issues of these tests often misinterpret the CDC’s methodology to prohibit follow up for a negative ELISA, refuse to administer the more specific 2nd tier and tell patients they couldn’t possibly have LD because the 1st tier was negative. (failure #3)
And since insurance companies generally follow the more restrictive CDC surveillance protocol (even for diagnostic purposes), insurance generally won’t pay for a 2nd tier test after the 1st tier is negative, even if the 2nd tier results are positive for LD (failure #4).
Since these are both serology tests and rely on immune function, it takes awhile after initial infection for your immune system to develop enough antibodies to be detected by the test. However, the most effective impact on killing the majority of the infection and preventing it from proliferating throughout the body requires antibiotic prophylactics immediately after you’ve been infected. So the tests do nothing at all to help MDs decide that yes, you’ve been infected and you need antibiotic therapy before being able to administer a test to confirm your infection (failure #5). And of course, even when MDs wait long enough, the tests are still inaccurate 50% of the time.
Most often general MDs who know very little about
early onset symptoms and the much broader realities for possible transmission, will refuse to administer antibiotics until or unless a test confirms infection (failure #6). You could be waiting a very long time for that.
The unintended consequences are that these tests generally produce false negatives, not false positives and when the guidelines are followed, many infected patients fall through the cracks.
3) CDC SURVEILLANCE CASE DEFINITION INCLUDES SPECIFIC REQUIREMENTS FOR CERTAIN BANDS TO BE PRESENT TO QUALIFY AS “POSITIVE”
This “qualifying bands” criteria for the two-tiered testing methodology are intended for surveillance purposes, only, and were not intended to be utilized in confirming the presence of the infection for effective diagnostics purposes.
The Western Blot essentially makes a map of the different antibodies we make to the bacteria. The map separates the antibodies by size and weight, and is reported in units called kilo daltons or kDa.
Most Western Blot tests will list the DNA “bands” against which the test found detectable levels of antibodies that your body generated and the test will indicate if you are “positive” or not and also if you are “CDC positive” or not. Of course, the “CDC positive” result is intended for surveillance and tracking, not for diagnostics but uneducated MDs will use it to diagnose.
For example, a Western Blot may report bands at 22, 25, 31, 34, 39, and 41 kDa. Each of these bands represents an antibody response to a specific protein found on the Borrelia spirochete (all this means is these bands indicate an immune response to Borrelia DNA stuff). The 41 band indicates an antibody to the flagella protein, and is non-specific. The 31-kDa band represents the OSP-A protein and is specific for Borrelia, as is the 34 band OSP-B and 25 kDa OSP-C.
For surveillance purposes, the CDC generated a list of bands that they deem to be lyme-specific DNA and determined that a person needs to have at least 5 reactive bands (of a specific group of bands) in order to be “CDC positive”. Tests that had four or fewer reactive bands, even if those bands are deemed “lyme-specific” bands, will receive test results back from the labs with a “CDC negative” indication. Misinformed MDs then tell patients they couldn’t possibly have LD.
(I haven’t yet found information for why those who DID receive the vaccine aren’t just screened out or so that the interpretation is more accurate. But I believe this lies within the the IDSA’s strategy of trying to prevent as many diagnosed cases as possible.)
The tests also indicate the “level” of DNA found with “IND” (indeterminate), “+” or “-“. Because the tests aren’t confusing enough, there is also much confusion over whether or not “IND” indicates “enough” of the Borrelia DNA to be considered positive. Currently, the CDC criteria ignores the “IND” results but this is like being “kind of” pregnant.
Lyme-specific bands were excluded from the testing criteria because they were used in vaccine development:
- Prior to a 1994 NIH hearing to develop conformity amongst labs, every lab accepted bands 25, 31, and 34 as lyme-specific and significant in diagnoses. Without any clear reasoning, the NIH disqualified those bands from being reportable. The result was that what had been a fair good test had now become poor or even useless.
1995 Rheumatology Conference in Texas. (1995 Rheumatology Symposia Abstract # 1254 Dr. Paul Fawcett et al.)
- When the CDC developed its surveillance case definition it included specific requirements for certain "bands" to be present on the confirmatory western blot. However, two “lyme-specific” bands (kDa 31 and 34, or osp—outer surface proteins—A & B) were excluded. Why? These bands are so specific for LD that they were used for vaccine development. They removed them from the testing criteria otherwise people who had been vaccinated would all be positive for those bands and falsely positive on tests. www.lymeneteurope.org/info/the-complexities-of-lyme-disease
- Because the CDC eliminated the two bands from their qualifying list of “CDC-positive” bands, some people who DO have lyme and have a reaction to those bands (yet were never administered the vaccination) yet lack reaction to enough bands will be considered “negative” for LD. Not only were the vaccinations unsuccessful, the venture now leaves the primary testing methodologies without lyme-specific bands, which would help test accuracy.
- A misconception about Western Blots is that they have as many false positives as false negatives. This is not true. False positives are rare. The conclusion of the researchers WHO? was: "the proposed Western Blot Reporting Criteria are grossly inadequate, because it excluded 69% of the infected children."
1995 Rheumatology Conference in Texas. (1995 Rheumatology Symposia Abstract # 1254 Dr. Paul Fawcett et al.)
- The table mid-page of this article by the leading LD organization indicates the frequency of “false positives” (high specificity) and “false negatives (low sensitivity) – the two-tiered testing misses 44% of positive cases:
www.ncbi.nlm.nih.gov/pmc/articles/PMC2078675/
ALSO...
CDC’s CASE DEFINITION METHODOLOGY RELIES ON SEROLOGY DIAGNOSTICS, WHICH ARE INAPPROPRIATE FOR A BACTERIAL PATHOGEN THAT CAN TURN OFF THE IMMUNE PROCESS:
- No serological test can rule out LD and LD cannot be adequately diagnosed by serology alone. Studies show potent immune suppression induced by Borrelia, which interferes with an appropriate immune response by design so most people don’t produce enough antibodies for the tests to register.
Elsner RA, Hastey CJ, Olsen KJ, Baumgarth N (2015) Suppression of Long-Lived Humoral Immunity Following Borrelia burgdorferi Infection. PLoS Pathog 11(7): e1004976. doi:10.1371/journal.ppat.1004976 journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1004976
- If this spirochete is evolved enough to attack our B-lymphocytes, then it may also be evolved in other ways that we do not yet understand. It is for certain that its ability to kill B-lymphocytes evolved as part of a defense mechanism to evade its own destruction. The observation that it can use the B-cell's own membrane as camouflage indicates that it may be able to go undetected by our immune system. The way our immune system is supposed to work is that it recognizes foreign invaders as being different from self, and attacks the infection.
The Complexities of Lyme Disease: A Microbiology Tutorial: Part 1, By Thomas M. Grier, MS, Excerpt from the Lyme Disease Survival Manual 1997.www.lymeneteurope.org/info/the-complexities-of-lyme-disease
- People who have the worst infections may have the lowest antibody titers, and test negative. Note: It takes four weeks from the tick bite to test positive.
www.lymeneteurope.org/info/the-complexities-of-lyme-disease
- The structure of the Lyme spirochete is unlike any other bacteria that has ever been studied before. Spirochetes have an extra layer of glyco-proteins may act like a stealthy coat of armor that protects and hides the bacteria from the immune system. The human immune system uses proteins that are on the surface of the bacteria as markers, and sends attacking antibodies and killer T-cells to those markers, called outer surface protein antigens (OSP antigens). This nearly invisible layer is rarely seen in washed cultures, but can be seen regularly in tissue biopsies.
Sigal LH, Tatu AH. Lyme Disease patient's serum contains LgM antibodies to Borrelia burgdorferi that cross react with neuronal antigens. Neurology 1988;38:1439-1442 www.lymeneteurope.org/info/the-complexities-of-lyme-disease
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