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Tuesday, August 26, 2014

Labcorp and the Lyme Western Blot

As many are aware, Labcorp will no longer allow physicians to order Western Blots for Lyme disease. The only test available is the ELISA with reflex to Western Blot if positive.

They have also taken away the C6 peptide.  The results are presented as only negative if less than 0.91.

These changes are not going to get Labcorp any more business.  What motivated the change?

One can only guess that someone affiliated with the IDSA influenced the policy change. In the past, when the Western Blot was ordered, the laboratory informed us the ELISA test should be ordered as well. Should be? According to whom?

Some ID doctors are inappropriately applying the HIV testing paradigm in the case of Lyme testing. When testing for HIV it is crucial to do the ELISA first because it is possible to have a positive Western Blot and a negative ELISA rendering a negative test.  Luckily with HIV there are other, better,  confirmatory tests available.

There is no evidence the same applies with Lyme testing.  The IDSA has claimed there are a lot of false positive Lyme Western Blots because of cross reactivity.  This claim remains largely unreferenced.  I recently saw a patient with a history of syphilis, RPR positive. The Lyme Western Blot was entirely negative. Many patients test positive for rheumatoid arthritis and Epstein Barr Virus and have negative Western Blots. (these are the common scenarios said to cause false positive tests). The ELISA is known to have many false negatives. Skipping this test and going to the Western Blot increases the sensitivity of the test.  If there is some decrease in specificity it would seem to be minimal at best.  In other words, patients are more likely to get an accurate result when the physician orders the Western Blot directly and skips the ELISA.

The CDC still states that Western Blot testing should only be done when the ELISA is first positive. The Website states that IgM results found after the first 4-6 weeks are likely false positive unless 5/10 IgG bands appears at that time. These facts are referenced back to findings from 1994-95. As you may recall this finding was based on an assay using the discarded N40 strain of Lyme and B31 has become the standard strain.

1) These results are based on a meeting which occurred 20 years ago. When the testing remains so controversial why hasn't there been a more recent reassessment?

2) At best this is revisionist history. The test was developed for surveillance (an epidemiology or research tool) not for diagnosis.  How a test developed for an entirely different purpose (monitoring the relative number of cases in different locations over time) morphed into a bullet proof test for diagnosis of Lyme disease is far beyond my ability to comprehend. 

Why are we going backwards. Why is there a problem with giving physicians and their patients more information?

The CDC stubbornly says on their website that there are no borderline positive tests. There is an absolute requirement to have 5/10 bands because at least this many always shows up.  According to the logic presented by the CDC the finding of a positive ELISA followed by the appearance of 4 IgG Western Blot bands is absolutely, 100% negative for Lyme.

One would like to know who wrote this tripe.

The long arm of the IDSA has managed to promote its agenda by manipulating the CDC and now Labcorp.

I caught Ben Beard, the chief of the bacteria section (Lyme included)  of vector borne diseases for CDC off balance when I had the opportunity to meet with him along with members of Nat Cap Lyme some years ago. Dr. Beard was flustered when I pointed out the contradictions in the CDC pronouncements especially about the appropriate use of the two tiered Lyme test.

When I asked him if the CDC wasn't speaking out of both sides of its mouth on the topic he hemmed and hawed and then ultimately responded "well, that's the party line."

What party was he referring to? Democrats? Republicans? Perhaps the IDSA vs ILADS. Dr. Beard's s comment to me was an admission that politics have trumped reason, logic and science. The IDSA has extended its mandate. They are no longer a professional society for infectious disease physicians. They are in fact a political party. Triumphantly they can say, Labcorp: Welcome to the party!  As with all political parties, the truth is frequently abandoned when its application leads to undesired results.

In the wake of emerging science and changes in the very nature of the pathogens responsible for Lyme disease this discussion is becoming more and more a moot point.

Its a win for:  Quest, Clongen, IgeneX, Stony Brook and a few others.  Lyme patients who are insured by health insurance companies that insist Labcorp be used should complain and lobby for a change to another lab.  As they say: vote with your feet.

Monday, August 4, 2014

Are staunch supporters of the IDSA admitting they might have been wrong all along?

A paper from the Department of Molecular Biology and Immunology from Johns Hopkins is quite remarkable, especially since Paul Auwaerter is one of the authors.  The paper presents ideas which are a complete turnaround from the previous orthodoxy promoted by this institution and this author in particular.  The entity in question is called PTLSD, post-treatment Lyme disease syndrome by the authors. The authors state they do not know the cause of the syndrome. They concede that up to 1/5 of the patients treated for Lyme disease by IDSA standards have persisting or lingering symptoms.
The authors state recruitment for clinical trials has been difficult. Why?  The only patients accepted into the studies were treated for early, classic Lyme and subsequently developed the famous 5/10 CDC IgG bands. Findings these patients is like finding a needle in a haystack.  Recent peer-reviewed literature suggests that patients with chronic symptoms tend to have poor IgM responses and never develop IgG responses. The patients we see in our clinical practices rarely have CDC positive IgG responses. Chronic Lyme studies recruit a small cohort of patients likely to be healthier than the vast majority of chronic patients.

Let me digress.  The IDSA and CDC keep insisting that patients with chronic Lyme develop 5/10 IgG bands in virtually every case. Repeating something over and over again does not make it true.

The 5/10 come from a paper written by Dressler in 1993, one year before the ill-fated Dearborn conference. This is the same Dressler that suggested IgM criteria should be 2/8 bands (sounds an awful lot like IgeneX criteria). The criteria was dismissed because Dressler’s research was based on the N40 strain of B. burgdorferi, not the B31 which has become the standard. Therefore, the “flawed” IgM standard was dismissed. Somehow, the “flawed” IgG criteria based on the same discarded strain of Lyme was allowed to become the standard and this has never changed.

The authors list possible causes of the syndrome:  autoimmune, persisting debris (dead germs) or persisting infection. Only the persistent infection hypothesis is called “controversial,” even though this is the only hypothesis backed by fact.

It is silly to have a discussion about whether animals have chronic Lyme symptoms. The authors state: “a number of prospective, randomized clinical studies demonstrated no significant beneficial effect of additional antibiotic therapy… and no evidence of presence of B. burgdorferi in patients with long-term symptoms.” 

How do they define “significant?”  Patients showed improvements in fatigue, pain and quality of life issues and Dr. Fallon the last author of the famous NIH sponsored studies believes that additional antibiotic therapy helps because there is persisting infection.  The authors claim there is no evidence of presence of B. Burdorferi. There certainly is no evidence that the spirochete is gone. The authors also note that some studies showed a decrease in fatigue. The authors seem to be arguing amongst themselves.

The authors are intrigued by the fact that one patient who had been treated for Lyme gave the germ to a tick allowed to feed on his blood.  This test seem just wrong to me.  Why wasn’t a PCR done of the patient’s blood at the same time? This procedure makes a lot more sense to me. Anyway, I am glad the authors are intrigued.

The authors concede that recent literature demonstrates the persistence of infection in mice.

This is where it gets weird. The authors talk about 3 morphological forms: spirochete, L-form, and cyst. I am I reading this right? This sounds like the ILADS’ pabulum which the same sources have spent a lot of resources on, even in recent months, discrediting.

Without this apparent change of face there would be reason to do this research or publish this paper.

These authors discuss two stages in the life cycle of Lyme: the rapid growth phase and the stationary phase. These authors commit blasphemy. The cross one more line and talk about “biofilm-like aggregates.”

In the test tube, the researchers found there are always persisters.

The purpose of the study was to show the researchers had developed a tool to help identify antimicrobials which may better able to eliminate persisters.

“Our findings may have implications for the development of a more effective treatment for Lyme disease and for the relief of long-term symptoms that afflict some Lyme disease patients.”

I am getting confused.  Was this study written by IDSA proponents or backers of the ILADS’ way of thinking?

Even in a test tube. No antimicrobial was found that could kill all the persisters.  That should be like “shooting fish in a barrel.”

In a real human being things are a bit more complex. The germs hide on the inside and outside of cells. The germs penetrate deep tissues like cartilage with minimal blood flow. The spirochetes invade a panoply of host tissues, all with different characteristics:  brain, nerves, joints, cartilage, tendon, heart, colon and numerous others.

Based on these few facts it seems outlandish to believe that a short course of IDSA sanctioned therapy is likely to eradicate all of the spirochetes.

Novel drugs like: clofazimine, daptomycin, cefoperazone, carbomycin are the best drugs for killing cysts.

Let’s not rush in – please.  Flagyl is said to have no anti-cyst activity, contradicting other work which proves the opposite. Most of these drugs are highly specialized, too potent and should likely not be used.

It seems that the science is catching up with ILADS, leaving the IDSA in it's wake.