Why is the CDC Trying to Block an Accurate Lyme Disease Test

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
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duncan
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by duncan » Sat 22 Nov 2014 14:30

Henry, I think everyone would like a diagnostic that was accurate across the board, and also offered clarity.

Conspiracy is the wrong word.

Look, do you know what the study was that Steere spearheaded where he defined what he meant as recovery? That, along with the July '83 study may demonstrate flaws in logic. Not conspiracy. Weaknesses in logic, perhaps. I am trying to look back at those old studies.

Henry, are you familiar with the PACE trials associated with ME/CFS sponsored by the NHS over in England? That debacle? NOT what is written on the CDC website, but all the background drama that has been unfolding for the past few years, and continues unabated?

I am sorry, I have to walk away from this discussion for a bit. But I will return to it.

Henry
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by Henry » Sat 22 Nov 2014 14:54

Duncan: I'm sure Alan Steere would agree that he has learned a lot more about Lyme disease since 1983. He is a rheumatologist by training and was trying to deal with and explain cases of antibiotic refractory Lyme induced arthritis. During the course of this work, he discovered that the joint were sterile, i.e., free of viable Borrelia. How then to explain the inflammatory process that acts as a adjuvant to heighten the antibody response generated against residual Borrelial antigens? Various hypotheses were formulated and tested to explain this phenomenon; this included the possibility of an autoimmune reaction. One thing was clear though; when the inflamed tissue was removed (by synovectomy), the inflammation subsided significantly or disappeared completely.

Incidentally, while all this was going on, another investigator noted that these arthritic events could be eliminated or greatly relieved by treatment with tetracyclines, suggesting that they were due to an infectious process. Mycoplasma were implicated in the phenomenon, and even a new species of mycoplasma was christened as a result (Mycoplasma arthritidis). Later, the anti-inflammatory effects of tetracyclines were discovered and the infectious disease hypothesis was soon discarded.

Being a pioneer in the field -- like Alan Steere-- can be a hard row to hoe. Searching for the truth to solve difficult problems is never an easy task. One must be persistent as he was -- and is.

P.S. In my preceding post, I attempted to focus on experimental results to support the points that I made. I prefer such an approach since it is more informative and educational.

duncan
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by duncan » Sat 22 Nov 2014 15:55

Being a pioneer in any arena or endeavor is a dicey thing, agreed.

So I'm not trying to point fingers here. I'm trying to retrace steps.

If today's treatment and diagnostic platforms incorporate miscues made early on, that does not make anything deliberate or conspiratorial. It may simply means flawed dogma emergent from definitional missteps has gotten in the way of progress. The trick is demonstrating when and where that error or errors occurred - and, of course, if they occurred.

This very process is going on in England right now, but with possibly definitional problems that only date back a few years, not decades. But is interesting - and relevant in more ways than one - in that the problem may be rooted in the early definitional stages.

So if the definition of the disease - and purportedly Steere bifurcated late manifestations in major and minor, and that construct is artificial and subjective - is improperly characterized, then everything else that builds from that definition could be off to varying degrees.

Same thing holds true for how the term "recovery" was defined and wielded. This is the reason I brought the UK PACE Trials into the conversation: The current controversy surrounding them is illustrative of what can ensue if the parameters of what the authors mean by "recovery" are fumbled or in any way manipulated or perceived as being manipulated.

If a belief structure is based on faulty data, that structure can skew all kinds of processes depending on the environment in which it flourishes, and that needs to be remedied. It may be that we are seeing such ramifications unfurl right in front of our eyes in the Lyme community. That would explain all sorts of miscommunications amongst multiple parties, and quite possibly impede any meaningful progress, from development of accurate diagnostics, to treatments that are effective for all touched by the disease.

Henry
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by Henry » Sat 22 Nov 2014 16:26

What you proposed to do may be a fruitless and frustrating process, Duncan. I'll pass on that one and prefer to stick with what I know best.

duncan
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by duncan » Sat 22 Nov 2014 16:39

Can't say that I blame you...

Henry
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by Henry » Sat 22 Nov 2014 17:41

Obviously, there is room for improvement with respect to all diagnostic testing. However, when used in the proper clinical setting in which there is a reasonable high incidence of Lyme disease, two-tiered testing has performed quite well. Most experienced diagnosticians believe that IgM Western blots have way too many problems with false positivity and should be discontinued. Since detectable amounts of serum antibody do not appear before 5 weeks after infection, it would be best to rely on the results of an ELISA which --if positive-- should be confirmed by an IgG Western blot using the criteria established by the CDC. These criteria are based on a statistical analysis of those types of antibodies that are relevant and most representative of active infection. Not all (e.g. antibody vs flagellin) are specific for Borrelia; but, most if not all are likely to be present during active infection. One runs into trouble and a high percentage of false positives when selecting fewer than 5 of 10 possible bands on an IgG Western blot (e.g., the criteria used by IGeneX) . There is abundant data to support all of these points.

Quite frankly, I would like to getaway entirely from the use of Western blots and rely solely on the results of quantitative ELISAs using well-defined peptides known to be relevant to pathogenesis as ligands -- much like the C6 ELISA. Several such peptides are now being tested for use in ELISAs by Dattwyler and others. Promising results have been obtained; however, as is the case for any new diagnostic tests, comparative studies must be done to determine if they are superior to currently used procedures. I suspect that in the final analysis, a "cocktail" of ligands for more than one of these defined peptides will be used.

duncan
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by duncan » Sat 22 Nov 2014 18:19

Pshaw, Henry. The diagnostic morass that is Lyme testing today, is profoundly and, most likely, irreparably flawed. Just exchanging out one misleading test for another ain't going to cut it. Besides, one has to wonder if a truly good test WERE generated that could be applied equally to acute and late stages, that the same agencies possibly responsible for limiting tests' utility historically wouldn't do so again. (We all know those dark tales of the good tests that hung around with the wrong crowd, only to be never heard from again. I still have nightmares, as I know we all do...)

It would be wise to first drill down and reveal where the fundamental assumptions went haywire back in the early '80s, and for diagnostics, the early 90's. Otherwise, any new entry into the diagnostic pageantry is doomed to the same choppy and inconsistent relevance as its predecessors; and accordingly, the same contested and controversial existence. It means sick people will remain sick. It means the Lyme wars will continue.

But, there will be new profits, as old products give way to new. Explain to me again, please, why we even need new diagnostics since it seems like just yesterday the rank and file of mainstream Lyme followers claimed the 2T system was virtually foolproof? How does one improve on 99% sensitivity and 99% specificity - both claims that have been made for the Two-Tier protocol? Actually, I'm pretty sure I have even seen 100% claims from time to time attached to both qualifiers...How do we improve on perfection?

nnecker
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Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by nnecker » Sat 22 Nov 2014 19:16

Getting back to the main topic:
Henry said;
As far as I can tell, none of the work done by Sapi et al on their new culture method was supported by an NIH grant. So, they don't have to play by the aforementioned rules. Once they get enough suckers to buy into their bogus method, they can really make a bundle and charge what the market will bear. Their biggest threat is that the method has not been validated or independently confirmed.
As I said previously, the actions of Sapi et al. precipitated the difficulties that they now face. All this could have been avoided had they sought independent confirmation of their work and published the results thereof BEFORE putting their test on the market as though it were a proven and validated entity. Had they done so, their incompetency would have been discovered and handled in a quiet manner. Clearly, they were not interested in doing this and appear to be more interested in making money.
I could not agree with Henry more.

This is my perspective on the culture.

Medscape article:
Dr. Burrascano said that a paper reporting the data has been submitted for publication and that "2 university-based research labs are each separately well on their way in validating the results of Advanced Labs."

LTCHTom said:
My understanding is that the ALS culture is being validated by 2 University studies right now. I was told this by 2 people close to the company.

What Beth Daley said when she asked ALS about the validation tests:
"Every time the response was the same,"no comment."

What Claudia said about ALS:
There was zero response from this lab, and I do find that questionable. THE TWO OTHER TIMES THAT I HAVE CONTACTED OTHER DIAGNOSTIC LABS IN THE PAST,MY CALL WAS TAKEN AND MY EMAIL ANSWERED
I find this quote from Dr MacDonald also interesting:
I am not a privy to any information concerning the validation of Dr Sapi's
Novel method for the isolation of borrelia species in pure culture from
Human blood specimens.
Here is a picture of Dr Mac with Sapi and Burrascano on May 26th 2014.

http://rel-risk.blogspot.com/2014/10/no ... sense.html


This is after ALS publicly promised to come out with their validation tests.Dr Mac has promoted the Sapi culture on this form many times and has written a response to the CDC's contamination claims.You would figure that with all of his socializing with Sapi and Burrascano, he would have asked them how the validation studies are coming along, wouldn't you?????I know I would have.What is the big deal?Why all the secrecy?

Maybe this is why?Here is an investigation done by Interfor on Ray Mirra(owner of ALS).They were hired by Mirra's ex-wife and BUSNESS PARTNER.Here are Interfor's credentials;

https://www.linkedin.com/company/interfor-inc.

Here is what they found:

http://www.gigijordantruth.com/assets/m ... part_2.pdf

Excerpts:
Burrascano was also known by insiders in the home infusion business for taking cash payments for referrals from home IV companies in order to get lucrative patient referrals.A sales person who worked for Mirra's company reports that Mirra would meet Burrascano for dinners in the Hamptons on a monthly or bi-monthly basis and make cash drop offs to Burrascano with bags of cash containing up to $10,000.The amount depended on how many of Burrascano's Lyme disease patients he had prescribed for home IV therapy.Other Lyme doctors similarly accepted these types of bribes, but none were as aggressive as Burrascano,either in his willingness to extend patient treatments for extraordinary periods of time,or his thirst for cash.

Another physician who engaged in similar cash for Lyme disease antibiotic referrals,who worked extensively with Mirra had his medical license revoked in 1999,2000,and 2010 for gross negligence on more then one occasion;practicing fraudulently, ordering excessive testing and or treatments,and inaccurate patient records.At the time of the investigations and hearings,Mirra claimed to have paid for Burrascano's legal defense./quote]
ALS now professes to have found a "break through"(Lyme test)claiming that the $595 Lyme test shows positive results when traditional tests are negative.These claims give fringe Lyme disease doctors the opportunity to challenge the denial of unnecessary treatment with prolonged courses of IV antibiotics by insurance companies at least until they catch on.Mirra earns a nifty profit on both sides,bogus lab tests paid for in cash at exorbitant rates by patients,and increased sales for lucrative IV therapy to Mirra,s home IV companies,treatment that would otherwise be denied based on traditional Lyme tests and widely accepted medical practice.
This all makes sense to me.Yeah I know Gigi Jordon was charged with murder but she was found not guilty of it,and instead was found guilty of manslaughter.She could possibly be set free at her sentencing hearing for time already served.

Here is more on Mirra:

http://www.gigijordantruth.com/assets/m ... part_1.pdf

I especially love the photo of Mirra's heathcare companies registered at One Hook RD,Sharon Hill Pa.

Martin is right when he said:
Well well, yet again the new star Eva Sapi and colleagues. How curious that in a short time they manage to come up with all sorts of ground-breaking findings (sometimes contradicting with earlier research).

So now there allegedly is a new fast and sensitive high-quality culture test. The claims remind me of what I have read about Gen Sys, Inc.. So there is all reason to be extra critical here.

I guess those larger confirmatory studies will also be published in the open access Dove press. Sure, this is all very convincing and reliable... NOT. No, I have a bad feeling about all this.

And instead of rushing to make the test commercially available, shouldn't they first have to wait for the outcome of the larger confirmatory studies? And further validation that is published well?
And with what Henry said:
If you are willing to pay someone $550 for a test based on such nebulous information, then that is your prerogative and your problem. I certainly would not be willing to do so and must remain extremely skeptical, if not suspicious that the whole thing is a fraud and an utter waste of money.
Last edited by nnecker on Sun 23 Nov 2014 14:09, edited 8 times in total.

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by duncan » Sat 22 Nov 2014 21:01

nnecker, here's what I need you to do: Please google yellow journalism. Then please explain to me exactly WHAT your perspective on the culture is. You state: "This is my perspective on the culture." Do you mean Henry's perspective is your perspective? Or, are you referring to the perspective expressed in the Medscape article below your declaration? Is the Medscape perspective your perspective?

I'm just trying to understand whose opinion is yours this time.

nnecker
Posts: 215
Joined: Wed 19 Dec 2012 22:57

Re: Why is the CDC Trying to Block an Accurate Lyme Disease

Post by nnecker » Sat 22 Nov 2014 22:28

My perspective is,the Sapi culture IS A SCAM.

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