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» LymeNet Flash » Questions and Discussion » Medical Questions » Studies on lyme disease and false negatives???

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Author Topic: Studies on lyme disease and false negatives???
disturbedme
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Anyone have any GOOD lyme studies on false negative test results and how false negatives don't mean much and does NOT rule out chronic lyme and could possibly mean the immune system is immunocompromised???

Thanks so much for any help you can give.

--------------------
One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

Posts: 2965 | From Land of Confusion (bitten in KS, moved to PA, now living in MD) | Registered: Jun 2007  |  IP: Logged | Report this post to a Moderator
nenet
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Here are a couple data points to start with. I have to dig through my files for some more.

Try looking at www.lymeinfo.net - they have gathered a ton of studies and research, including about testing insensitivity/failures.

1.
http://www.ncbi.nlm.nih.gov/pubmed/16207966

"A Johns Hopkins 2-yr study (2005) finds that the CDC 2-tiered testing procedure misses 75% of positive Lyme cases. Coulter, P, et. al. 2005. ``Two-Year Evalution of Borrelia burgdoferi Culture and Supplemental Test for Definitive Diagnosis of Lyme Diesease'', J Clin Microbiol. 2005 Oct;43(10):5080-4."


2.
"The NY Dept. of Health (1996) told the CDC that its 2-tiered testing procedure misses 81% of positive Lyme cases. Source: (Source: Fritz, C. 1996.)"

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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3.
Another study, of 4 WB (and 11 EIA) tests:
http://www.ncbi.nlm.nih.gov/pubmed/10517192

Eur J Clin Microbiol Infect Dis (1999) 18:551-560 Q Springer-Verlag 1999

Evaluation of Fifteen Commercially Available Serological Tests for Diagnosis of Lyme Borreliosis

H.A.T. Goossens, A.E. van den Bogaard, M.K.E. Nohlmans

Abstract

"The performance of 11 commercially available enzyme immunoassays (EIA) and four Western blot (WB) tests for the detection of IgM and IgG antibodies against Borrelia burgdorferi were compared.

A total of 229 serum specimens were used: 26 from patients with early Lyme borreliosis, 13 from patients with late Lyme borreliosis, 62 from healthy controls and 128 from patients with disorders clinically mimicking Lyme borreliosis and/or known to cause cross-reactivity in Lyme borreliosis serological tests (patient control group)...

The maximum sensitivity of Western blotting for detecting IgM in patients with early Lyme borreliosis and IgG in patients with late Lyme borreliosis was 50 and 46%, respectively."


Note: It doesn't change the overall value of the information gathered about low sensitivity and failure of WB testing, but the the study language indicates they are mistakenly expecting Late-Stage Lyme to only show IgG antibodies, and Early Stage to show IgM. This is another mistake unknowingly committed by many Doctors in their analysis of Lyme patients' WB results.

In reality, Chronic or Late-Stage Lyme can cycle through and continually cause your body to create early stage (IgM) antibodies throughout the entire infection. Dr. C speaks to this in his WB Explanation:

http://flash.lymenet.org/ubb/ultimatebb.php/topic/1/42077

"With most infections, your immune system first forms IgM antibodies, then in about 2 to 4 weeks, you see IgG antibodies. In some infections, IgG antibodies may be detectable for years.

Because Borrelia burgdorferi is a chronic persistent infection that may last for decades, you would think patients with chronic symptoms would have positive IgG Western blots.

But actually, more IgM blots are positive in chronic borreliosis than IgG. Every time Borrelia burgdorferi reproduces itself, it may stimulate the immune system to form new IgM antibodies.


Some patients have both IgG and IgM blots positive. But if either the IgG or IgM blot is positive, overall it is a positive result."


Something to keep in mind is being very clear on the different test terminology: sensitivity, accuracy, and specificity. I am pretty sure that Dr. C explains these to a degree, but it is important to be read up on these terms because it can be confusing when discussing the failures of current Lyme antibody testing. This caveat is more for any new-to-Lyme-research members that might not be familiar with this.

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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4.
And here's a study that will get you chuckling. Our own IDSA buddies back when they were telling the truth (to a degree) about Lyme Disease:

http://www.ncbi.nlm.nih.gov/pubmed/3054554

"In a New England Journal of Medicine study, Drs. Dattwyler and John Halperin (also of the IDSA) "studied 17 patients who had presented with acute Lyme disease and received prompt treatment with oral antibiotics, but in whom chronic Lyme disease subsequently developed."

These "chronic Lyme" patients tested negative on currently-available blood tests:

"Although these patients had clinically active disease, none had diagnostic levels of antibodies to B. burgdorferi on either a standard enzyme-linked immunosorbent assay or immunoflourescence assay.

We conclude that the presence of chronic Lyme disease cannot be excluded by the absence of antibodies against B. burgdorferi and that a specific T-cell blastogenic response to B. burgdorferi is evidence of infection in seronegative patients with clinical indications of chronic Lyme disease."


Dattwyler RJ; Volkman DJ; Luft BJ; Halperin JJ; Thomas J; Golightly MG. Seronegative Lyme disease. Dissociation of specific T- and B-lymphocyte responses to Borrelia burgdorferi.

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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You didn't specify which tests you wanted info on, so I assume you want info on as many of the different kinds of tests as possible. So far I have given you WB, ELISA, and EIA Lyme testing info.

5.
Here's one on PCR (Polymerase Chain Reaction)-testing of CSF (Cerebrospinal fluid - what they gather when they do a lumbar puncture)

http://www.ncbi.nlm.nih.gov/pubmed/16094225

Diagnostic Utility of Borrelia burgdorferi Cerebrospinal Fluid Polymerase Chain Reaction in Children with Lyme Meningitis.

Pediatric Infectious Disease Journal. 24(8):705-708, August 2005.

Avery, Robert A. DO, MA *[S]; Frank, Gary MD, MS *+; Eppes, Stephen C. MD ++[S]

Abstract:

Background: Cerebrospinal fluid (CSF) laboratory tests are frequently collected to help differentiate Lyme meningitis from other causes of aseptic meningitis.

Previous studies using Lyme CSF polymerase chain reaction (PCR) have yielded varied results (sensitivity between 10 and 90%). No studies have specifically examined the diagnostic utility of Lyme CSF-PCR in North American children with Lyme meningitis.

Methods: Retrospective chart review of children presenting to a children's hospital in a Lyme-endemic region between October 1999 and September 2004. Patients were included if they had both Lyme serology and Lyme CSF-PCR performed during the same hospital encounter and had documented meningitis.

Patients were considered to have Lyme meningitis if they had meningitis and met CDC criteria for Lyme disease. The Lyme CSF-PCR assay amplified a Borrelia burgdorferi DNA flagellin gene sequence.

Results: Of 108 patients with meningitis who qualified for the study, 20 patients met criteria for Lyme meningitis and 88 were classified as aseptic meningitis. Positive Lyme CSF-PCR was found in 1 patient (1 of 20, 5%) with Lyme meningitis and one patient classified as aseptic meningitis (1 of 88, 1%).

Lyme CSF-PCR had a sensitivity of 5% and a specificity of 99%. The only Lyme meningitis patient with positive Lyme CSF-PCR had the highest CSF white blood cell count and CSF protein values compared with the other Lyme meningitis patients.

Conclusions: This is the first study to evaluate Lyme CSF-PCR exclusively in North American children. This commercially available laboratory test is not generally helpful for identifying Lyme meningitis because of its low sensitivity.

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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I'll look for some more for you later, disturbedme - I need to take a break from posting and get some things done for now. I hope these are helpful for you!

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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OK I lied, haha. Here is one more for now, that speaks to your question about Lyme evading the immune response, and persistance of Lyme infection. Basically, the lyme spirochete has certain characteristics that can evade the host's immune system response, and therefore highten its virulence (or worsen its affect on the victim). It's a BRAND NEW study, too!:


6.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2644780


A chromosomally encoded virulence factor protects the Lyme disease pathogen against host-adaptive immunity.


1: PLoS Pathog. 2009 Mar;5(3):e1000326. Epub 2009 Mar 6.

Yang X, Coleman AS, Anguita J, Pal U.

Department of Veterinary Medicine, University of Maryland, College Park, Maryland, United States of America.

"Borrelia burgdorferi, the bacterial pathogen of Lyme borreliosis, differentially expresses select genes in vivo, likely contributing to microbial persistence and disease.

Expression analysis of spirochete genes encoding potential membrane proteins showed that surface-located membrane protein 1 (lmp1) transcripts were expressed at high levels in the infected murine heart, especially during early stages of infection.

Mice and humans with diagnosed Lyme borreliosis also developed antibodies against Lmp1. Deletion of lmp1 severely impaired the pathogen's ability to persist in diverse murine tissues including the heart, and to induce disease, which was restored upon chromosomal complementation of the mutant with the lmp1 gene.

Lmp1 performs an immune-related rather than a metabolic function, as its deletion did not affect microbial persistence in immunodeficient mice, but significantly decreased spirochete resistance to the borreliacidal effects of anti-B. burgdorferi sera in a complement-independent manner.

These data demonstrate the existence of a virulence factor that helps the pathogen evade host-acquired immune defense and establish persistent infection in mammals."

PMID: 19266024

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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Re: my last post, there is a researcher in this field named Mollie Jewett, who is also looking into virulence factors of Bb (Lyme). If you are curious about this aspect, try searching for her name (last name only might bring up more hits), and Lyme or Borrelia, on Google Scholar or PubMed.

My younger brother is in the bio/genetics area, and attended a lecture by her on this very topic a few months ago. He gave me some of his notes, but I'm afraid I am not a geneticist, or anything remotely close to it (read: I am not a scientist, but I like to read about it a lot and try to understand it), so it was mostly over my head. The abstracts of her research are much easier to digest.


Some quick links to start off:

http://www.biomedexperts.com/Profile.bme/640326/Mollie_W_Jewett

http://www.biomedexperts.com/Abstract.bme/17919281/Genetic_basis_for_retention_of_a_critical_virulence_plasmid_of_Borrelia_burgdorferi

http://scholar.google.com/scholar?hl=en&lr=&q=Jewett+borrelia&btnG=Search

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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disturbedme
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Thank you so much, nenet. This is wonderful!!!! Very good information and studies. I will be using a few of them. [Smile] Thanks again!

--------------------
One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

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Hoosiers51
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If this is for your SSI, you could also find things that stress that Lyme is a clinical diagnosis.

Hard to argue with that, in my opinion.

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disturbedme
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Yes, this is for SSDI packet, Hoos. [Smile]

Good idea. Some of the studies up there do say that lyme is a clinical diagnosis due to the false negatives, but it doesn't CENTER on that.

If anyone has studies on that, that would be VERY appreciated for sure.

--------------------
One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

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Hoosiers51
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I don't know if this would be weird, but could you get out a highlighter and highlight the line that says that it's a clinical diagnosis when you send this stuff in?

Not sure if they would look at that as helpful or what, but it's a thought.

Good luck...hope you get it!

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disturbedme
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Hoos, thanks for your ideas. I have actually thought of doing that. Not sure if it's a GOOD idea, but I might do it anyway. Thanks!!!

--------------------
One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

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Hoosiers51
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Also, when I got SSI, I had not yet had a positive Western Blot or anything. I did have a positive Bowen test for Lyme (this was a long time ago), but I'm not sure if SSI understood what it was.

I think we just emphasized that the doctor I was seeing was a Lyme specialist and that he was most qualified to diagnosis it.

I'm not sure if that argument carries as much weight now since unfortunately the IDSA has made their guidelines even stricter and they have been even more vocal past few years it seems. Worth a shot though.

But also as I mentioned, we used a lot of other diagnosises (sp?) too.

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Hoosiers51
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Welcome! [Smile] I know how stressful this is, you are a trooper for just making it through long, drawn out process!!! Good luck!
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disturbedme
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Hoos, yeah, I probably shouldn't have used the lyme diagnosis since I've never had a POSITIVE test for it, but I have had a positive Bart smear... so I am using that. But I also did put lyme disease. I am also using other diagnoses though like my heart issues and CFS and chronic low blood cell counts, etc. I've got a lot wrong with me, but unfortunately never got lucky enough to have a positive lyme test. I chalk that up to immune issues that I have as I am immunocompromised.

--------------------
One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

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nenet
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You're welcome disturbedme. There really needs to be a sticky of this kind of info here in Medical. The question is almost a daily, if not an hourly one sometimes.


I have a huge chunk of info for you on the importance of Band 41, if you are interested.

It is discussed here:

Steere's manipulation of importance of band 41

http://flash.lymenet.org/ubb/ultimatebb.php?ubb=get_topic;f=1;t=057714

(there is a deleted thread linked in that thread. It had a lot of great info that I unfortunately was not able to copy, no idea why it was removed)

Flagellin-based [band 41 is the antibody to the flagellin] polypeptides for the diagnosis of lyme disease

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3&f=G&l=50&co1=AND&d=PTXT&s1=5,618,533&OS=5,618,533&RS=5,618,533

quote:
Greatcod
Frequent Contributor
Member # 7002
posted 09 September, 2007 11:30 AM

This is an email I recieved from Randy Sykes in CT. Yale patented an Bbabd 41 test which they claim is 94% accurate, then mothballed it.


"Yale says don't pay attention to band 41 because it means nothing. Yet they have patented a test for lyme that only uses band 41. They also claim the test is over 94% accurate.

These are the people who have been working to hang DR. Jones for treating lyme disease and refuse to respond to Attorney General Blumenthal's subpoena. This test has been put in moth balls.

US patent # 5,618,533

Also the second link, page 5 at the top right, one paragraph down, Dr Steere says that if you have band 41 this means that you either have gum disease, syphilis or lyme disease. He also states that you can tell the difference between these illnesses by a clinical diagnoses. All the lymies have band 41 but few people produce many other bands, Randy Sykes

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3&f=G&l=50&co1=AND&d=P

Steere's manipulation of importance of band 41?

http://flash.lymenet.org/ubb/ultimatebb.php?ubb=get_topic;f=1;t=057714

quote:

TerryK
Frequent Contributor (1K+ posts)
Member # 8552

"Totally weird that a control group would have any known infections, let alone a spirochetal infection. Does this make sense to anyone? Does anyone know or have proof that this is true?

http://en.wikipedia.org/wiki/Allen_Steere
Most troubling, Steere chose to make 20% of his control - 25 serum samples - serum derived from syphilis patients. While this group formed 20% of the control, the disease's annual incidence in the United States is about 3 cases per 100,000 - an incidence of far less, by a multiple of 300, than 1%.

This statistical manipulation dramatically impacted the importance of the 41 KdA band on blotting, because syphilis cross reacts with Lyme blots at 41 Kda due to their both possessing a key flagellar potein structure.

It has since enabled Steere and his cronies to confabulate that seroreactivity to the 41 kDa antigen is 'normal', when in fact it is largely only seen in advanced spirochetal infection - usually only in gingival infections when visible pus-filled pockets are present."

quote:

Aligondo Bruce
Frequent Contributor
Member # 6219

what steere etc. have distorted is the relative importance of the 41 kDa band. I pointed out the israeli frequency because the same studies in america demonstrate that about 40% of the pop carry positivity to the 41 Kda band {in endemic areas}.

In israel, it is something like 8 %. Israel doesn't have Bb, but does have related relapsing fever borrelia. what I am saying is that due to its constitutive expression, the flagellin band is probably the Best indicator of exposure/ possible latent infection, and is probably the mainstay of the ab response no matter stage of infection.

Bb differentially regulates protein expression of surface proteins, such as osp a, b, and c. They are regulated according to stage of infection, tissue type, and microenvironment. VlsE, another surface protein, is also regulated in this manner. However, flagellin is not differentially expressed.

What happens in very late CNS disease? No one really knows, BECAUSE IT HAS NEVER BEEN ADEQUATELY STUDIED. THE STEERE CRITERIA were designed for early, acute disease. As far as I know, VlsE is not transcribed in the CNS, and flagellin is one of the only proteins I know of that IS transcribed.

Steere intentionally 'swift-boated' the relative meaning of the flagellin ab response. Sure, you see a cross-reaction in people who don't have exposure to Bb, BUT IT IS MUCH LOWER incidence than we are lead to believe. Typically, wrt oral spirochetes, a response is only seen when the gums are visibly infected.

As far as the poles go, and other europeans, I'm fairly certain that the 41 band they demonstrate is reflecting exposure to Bb. However, it is NOT the same strain of bacteria we see in the US. And did you know that in Europe, only 3 bands are necessary on WB to be regarded as positive? Did you know that DOGS in america require only 3 bands to rate a positive?

That's right folks...under the steere criteria, we are treated worse than DOGS.

VITAL INFORMATION ON BAND 41!!!!

http://flash.lymenet.org/scripts/ultimatebb.cgi?ubb=get_topic;f=1;t=042077

quote:
From a seasoned poster:

the number of people exposed is in the millions. the reason you can't get treated is they have decided that only early disease merits diagnosis and treatment. the bacterium itself is the most bizarre human bacterial pathogen known, and is poorly understood.

they don't know how many people are carrying a permanent relapsing brain infection. you can't get diagnosis or treatment because they have to pretend it doesn't exist and use labels like 'post lyme' and 'CFS' etc. for those who manifest illness.

Look at what steere did in his 1992 study which is the foundation for the CDC serodiagnostic standard. He and others often look back on this and refer to a 'normal' control, but in fact the control was taken from sick people...MS sufferers, CFS sufferers, in sum, conditions which could have been caused or complicated by late Bb infection. Moreover, he threw in 25 syphilitic patients which constituted 20% of the control. Hoever, syphilis itself has an annual US incidence of 3 per 100,000.

this statistical chicanery, which fudged the result at 41 kDa on Bb blot by many multiples, is significant, because syph serum will cross react at 41 kDa to Bb western blots. it allowed them to 'swift boat' the importance of the reaction to 41 kDa, which is the earliest and most consistent human ab response to Bb infection, being present in all stages as opposed to the rest of the proteins which are variably expressed according to stage, tissue type, even temperature.

Flagellin {41kDa} is necessary for Bb to survive under all conditions, and is constantly expressed, including in late CNS infection. Yet they chose to swift-boat this response.

More info from Aligondo Bruce:

quote:

Now, let me tell you about the real DARK SIDE of the steere/dressler criteria.

These criteria were designed to enable one thing: a vaccine trial for the OspA vaccine. That's why the band to OspA at 31 KdA was left out of the criteria for positivity, even though it is very specific to Bb.

Why then was it necessary to distort the importance of the flagellin response? I'll tell you why. It's because they had to test the vaccine in an endemic area.

And a significant percentage of vaccinees were ALREADY SHOWING seropositivity to Bb exposure and possible latent/asymptomatic infection as manifested by the 41 band and maybe a few others, but not enough to be 'positive' by CDC standards. {remember, in europe 3 bands = I have lyme disease, in the US, 3 bands = normal}.

In other words, they had to run a vaccine trial on a group of people who had already been exposed or infected by Bb. If you utilize scientifically honest criteria, then YOU CAN'T DO THE TRIAL, BECAUSE A LARGE NUMBER OF YOUR VACCINEES ARE ALREADY INFECTED OR EXPOSED BEFORE THEY EVER GET THE VACCINE.

So by using less restrictive criteria, you create a situation in which there is no way to distinguish whether or not the vaccine is effective. Basically, a lot of people got a worthless vaccine.

this paradigm...which plunged thousands of vaccinees from infected areas into an unknown realm {what happens when you vaccinate someone who has already been exposed, or is manifesting late stage latency} and MAY have been the reason we saw so many reports of adverse reactions.

Individuals who were carrying latent infection, as manifested serologically by a limited ab response, these people were CUT OUT of the medical community, and they had to pretend nothing was wrong with them.

And wrt [with regard to] lyme encephalopathy, Bb protein expression primarily in brain years after initial exposure, that has never been studied adequately to know what is signficant and what is not. All we really know is that flagellin is constitutively expressed even in brain infection."



--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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quote:
Originally posted by Hoosiers51:
I don't know if this would be weird, but could you get out a highlighter and highlight the line that says that it's a clinical diagnosis when you send this stuff in?

Not sure if they would look at that as helpful or what, but it's a thought.

Good luck...hope you get it!

A good suggestion, but I would make one slight change - I would bold that text you want to emphasize, as well as excerpt it in your claim argument summary (then cite it with reference numbers).

If you highlight it might be missed if they are not reading your claim in the same digital text formatting as you, or if they print it out or copy it on a copier, highlighting will also be lost (black and white print, or black and white copies).

This material is going to be passed around like a bureaucratic hot potato for who knows how long, and between who knows how many people and departments, with many different iterations of copies and print outs, more than likely. This way gives you the best chance of data integrity from start to finish.

Bold will show up in most cases, but to be absolutely certain, you should excerpt and cite the reference, and then have the full reference article at the end.

Just my little 2 cents' worth, but it's what I would do.

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disturbedme
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Thanks again nenet!!!! [Smile] Love the band 41 articles and info!!!

Do you have any studies that stress that lyme disease is a clinical diagnosis more than depending on the serum results? That would be especially helpful since I don't have a positive test.

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nenet
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quote:
Originally posted by disturbedme:
Thanks again nenet!!!! [Smile] Love the band 41 articles and info!!!

You bet, glad to help! I hope you win this case!

There is all the evidence in the world to back up your clinical Lyme diagnosis, so it should be successful, if you gather your relevent data properly, as you are doing.
quote:

Do you have any studies that stress that lyme disease is a clinical diagnosis more than depending on the serum results? That would be especially helpful since I don't have a positive test.

Sure, the CDC themselves say it. Should be easy enough to convince them that is a credible source eh? [Wink]


http://www.cdc.gov/mmwr/preview/mmwrhtml/00047449.htm


From the CDC Case Definitions (linked above):


"This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis."


This is stated on most WB results (I know this is printed on the bottom of Igenex WB results).

The case definition calls for a certain number of bands to be positive on a Western Blot test. That is then termed "CDC positive" or "CDC negative" on your results.

The term "CDC positive" means positive for CDC surveillance criteria ONLY, which they never intended to be used as clinical diagnostic criteria. In that link the CDC says again and again, in different ways, that Lyme is currently a clinical diagnosis.


Also from the CDC Case Definitions (linked above):

"The case definitions contained in this report 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."

Surveillance criteria for disease spread is primarily designed to be extremely restrictive, and is expected to miss many real cases of disease (something the CDC also readily admits to in their reported numbers caveat).

It would take some reading up on epidemiological research processes to understand this more fully. But suffice to say, the CDC is kind of the final word on this subject, especially when you are dealing with people that either don't know much about Lyme, or those that want to only refer to the assumed authority, or those that want to try to deny or ignore proof for sero-negative Lyme and Chronic Lyme (for instance, an insurance provider).

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nenet
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OH, and if that isn't enough, here is a GREAT collection of sources on the subject of Seronegativity in Proven Lyme Disease, and proof that Lyme must be a CLINICAL diagnosis. Many many thanks to the www.Lymeinfo.net owner for providing it on their site:


"Seronegativity in Lyme borreliosis and Other Spirochetal Infections"


HTML version (with highlights):

http://74.125.47.132/search?q=cache:Lytil3emFbQJ:www.lymeinfo.net/medical/LDSeronegativity.pdf+clinical+diagnosis&cd=2&hl=en&ct=clnk&gl=us


pdf version (click to download the file):

http://www.lymeinfo.net/medical/LDSeronegativity.pdf


Any time you see these studies of testing and they say that patients were proven to have Lyme (via PCR or another manner) but yet tested negative via serology - that is your argument for clinical diagnosis.

Every post I have made about this contains your argument, but only the CDC comes out and says it in plain words for your purposes. Those other studies are not specifically setting out to prove that Lyme is a clinical diagnosis, they are setting out to determine the value of these tests. I hope that makes sense! I am starting to fade...

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"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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nenet
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One source from that very long list at www.lymeinfo.net (that I linked above), the FDA state it themselves:


1999
Role of serology in the diagnosis of Lyme disease.
JAMA, 282(1): 62-65
Hansen SL;
(FDA Medical Bulletin)
Langone JJ.

"The Food and Drug Administration (FDA) is concerned about the potential for misdiagnosis of Lyme disease based on the results of commonly marketed tests for detecting antibodies to Borrelia burgdorferi, the organism that causes Lyme disease.

It is important that clinicians understand that a positive test result does not necessarily indicate current infection with B. burgdorferi, and a patient with active Lyme disease may have a negative test result.

The tests should be used only to support a clinical diagnosis of Lyme disease and should never be the primary basis for making diagnostic or treatment decisions.''


But please go through all the links I am giving you fully, as there may be better quotes or sources that I am skipping over and not copying here. Just wanting to provide you with examples of what lies inside these links. It would behoove every person that might have Lyme to read all of these sources. They will help to quell your doubts on many issues with this disease.

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Dr. C's Western Blot Explanation

Lymenet Success Stories

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"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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disturbedme
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Thanks so much again, nenet!!! This means so much to me. [Smile]

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One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

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nenet
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You're welcome again - I am getting a lot out of doing this too (though I would do it anyway, just saying it's mutually beneficial), and I also hope others might benefit as well. This is a good exercise for learning the facts about Lyme.


Below I am copying an article Tincup just posted at one of your threads today ("Trigger Finger?" http://flash.lymenet.org/ubb/ultimatebb.php/topic/1/80885 ), for the argument towards persistance of Bb infection after antibiotics, and depletion of immune response:


http://www.ncbi.nlm.nih.gov/pubmed/8240439

Arthritis Rheum. 1993 Nov;36(11):1621-6.

"Persistence of Borrelia burgdorferi in ligamentous tissue from a patient with chronic Lyme borreliosis."

H�upl T, Hahn G, Rittig M, Krause A, Schoerner C, Sch�nherr U, Kalden JR, Burmester GR.

Department of Medicine III, University of Erlangen-Nuremberg, Germany.

"OBJECTIVE. To document the persistence of Borrelia burgdorferi in ligamentous tissue samples obtained from a woman with chronic Lyme borreliosis.

METHODS. Spirochetes were isolated from samples of ligamentous tissue, and the spirochetes were characterized antigenetically and by molecular biology techniques.

The ligamentous tissue was examined by electron microscopy.

Humoral and cellular immune responses were analyzed.

RESULTS. Choroiditis was the first recognized manifestation of Lyme disease in this patient.

Despite antibiotic therapy, there was progression to a chronic stage, with multisystem manifestations.

The initially significant immune system activation was followed by a loss of the specific humoral immune response and a decrease in the cellular immune response to B burgdorferi over the course of the disease.

"Trigger finger" developed, and a portion of the flexor retinaculum obtained at surgery was cultured.

Viable spirochetes were identified.

Ultramorphologically, the spirochetes were situated between collagen fibers and along fibroblasts, some of which were deeply invaginated by these organisms.

The cultured bacteria were identified as B burgdorferi by reactions with specific immune sera and monoclonal antibodies, and by polymerase chain reaction amplification and Southern blot hybridization techniques.

CONCLUSION. To our knowledge, this is the first report of the isolation of B burgdorferi from ligamentous tissue.

This suggests that tendon tissues serve as a specific site of spirochete residence in human hosts."

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Dr. C's Western Blot Explanation

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"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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disturbedme
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Thanks so much!

The website is not working for me, however, for some odd reason, but that's okay. I can copy and paste the study elsewhere and print it off that way. [Smile]

I have been learning a lot from this. I just hope my case manager does too and grants me SSDI. [Big Grin]

--------------------
One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

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nenet
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I edited my post with a different abstract link for you (the great pubmed). Hope this one works better!

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Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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disturbedme
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Thanks so much! That link worked. [Big Grin]

--------------------
One can never consent to creep when one feels an impulse to soar.
~ Helen Keller

My Lyme Story

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Amanda
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The ILADS lyme guidelines expressly say that Lyme is a clinical diagnosis, mentions the problems of testing etc..It also has a list of scientific references

ILADS is a medical society, their guidelines are published in the National guideline clearinghhouse.

Go to the ILADS.org website and download the guidelines...

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"few things are harder to put up with than the annoyance of a good example" - Mark Twain

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nenet
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disturbedme, here is a great link with more compiled studies, and links to even more studies, proving persistence of Lyme infection after antibiotics, and proof of Lyme infection (via DNA, culture, etc.) despite seronegative test results:

"Studies On Persistent Borrelia Burgdorferi Inspite Of "Adequate" Antibiotics"

http://flash.lymenet.org/ubb/ultimatebb.php/topic/1/80749

--------------------
Dr. C's Western Blot Explanation

Lymenet Success Stories

ILADS Treatment Guidelines

Medical & Scientific Literature on Lyme

"Long-Term Antibiotic Therapy Improves Persistent Symptoms Associated with Lyme Disease"

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