Christopher Smith's Lyme Disease Bill 2557

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
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Spanky
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Spanky » Thu 22 Dec 2011 16:17

"Henry"
I would place my confidence in recommendations of the CDC and FDA. They derive a lot of their data from specimens and tests conducted at numerous State public health laboratories.


Henry: If I read that right...that means that Lyme patients in the REAL WORLD may or may not have accurate readings of their antibody tests...

...and that in this comparison...

...the tests FAILED to detect Bb antibodies 55% of the time.

That doesn't exactly inspire confidence.
I believe -- and hope that I am not mistaken-- that you had a negative ELISA test, but a positive IgG Western blot for 31 and 34 kDa.

You are indeed, mistaken. NO. Not what I said.

I was tested three times, as I have said.

Each time the screen was POSITIVE. Each time the Western Blot was negative by CDC standards.

(Edited to add): It was third of these that was done by IgeneX. Positve ELISA. 4 of the 10 CDC bands. Someone also advised me to have a IgM blot done, and that is where the OspA reaction showed up. Three years AFTER infection, which I can date precisely.

The first two were done in year two. The third in year three. So, there should have been a full IgG reaction, wouldn't you think?
Last edited by Spanky on Thu 22 Dec 2011 19:12, edited 1 time in total.

Henry
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Henry » Thu 22 Dec 2011 16:45

Spanky: Except for saying that laboratory testing has improved considerably since the 1990s and we certainly have acquired a lot more information since then, I've said all that I have to say on this discussion that has departed considerable from Lyme disease Bill 257. Best wishes for the holiday season.

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Spanky
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Spanky » Thu 22 Dec 2011 16:54

[quote="Henry"
Except for saying that laboratory testing has improved considerably since the 1990s and we certainly have acquired a lot more information since then,
Well, yes...but that last abstract, dated '97, was close to around when I was first tested...which was back in 2000.

And yes, I hope things have improved since then, and the C6 has come along, too, since then...but the two-tiered system is still in place.

Any reason to believe that overall lab proficiency has improved since back then? I can't see any other follow-up analyses since then?
I've said all that I have to say on this discussion that has departed considerable from Lyme disease Bill 257.
Well, that's certainly true, anyway...

But your answer...or should I say, lack of one...in my profession, is usually classified as 'non-responsive'.

So, I guess I am going to have to assume that means "I don't know, either, Spanky"?
Best wishes for the holiday season.
And to you, as well! :D

Henry
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Henry » Thu 22 Dec 2011 19:19

Spanky: Although the FDA has not yet made an official announcement and is reluctant to replace existing tests-- that appear to be working well-- with new tests until "all the facts are in", the results obtained with the C6 ELISA appear to parallel and to be identical to those obtained with the existing 2-tiered testing. I doubt the results of the C6 ELISA are going to change things all that much with respect to seropositivity. One advantage of the C6 ELISA is that it enables one to monitor the effectiveness of treatment for early acute Lyme disease; in other words, as treatment proceeds, the values for the C6 ELISA decline with time. That's just what one would expect if a treatment were beneficial. Unfortunately, the test does not show the same type of effect when used to monitor the benefits of therapy for patients with chronic Lyme disease; it has been tested rather extensively in that clinical situation. So, it can't be used to monitor the success of therapy for treating chronic Lyme disease.

As is the case for other diagnostic tests, background values for the C6 ELISA remain positive -- though at much lower levels-- for long periods of time after antibiotic therapy is completed. That seems to be the nature of the beast. I would like to see what a more quantitative, "real time" 6 ELISA would show. Probably, the results would be the same in general. However, it would provide a bit more precision with respect to the benefits of therapy. I'm sure you must know that the C6 ELISA is based on an antibody response to a rather unique and specific protein that is produced by Borrelia early during infection. In that sense, it should be superior to all of the other ligands used for other diagnostic tests, although once again time must be allowed for sufficient antibody to be produced to be detected by the C6 ELISA. That is the major limitation for all antibody-based diagnostic tests. The situation is not much better for PCR or direct culture tests, in which case time must be allowed for the small numbers of Borrelia delivered by infected ticks to reach a level where they -- or their DNA-- can be detected by those procedures. As you know, Borrelia multiply rather slowly........With all of this in mind, I don't anticipate major breakthroughs in diagnostic technology in the near future.

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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Spanky » Thu 22 Dec 2011 22:49

"Henry": Although the FDA has not yet made an official announcement and is reluctant to replace existing tests-- that appear to be working well-- with new tests until "all the facts are in", the results obtained with the C6 ELISA appear to parallel and to be identical to those obtained with the existing 2-tiered testing.
Yes. And believe it or not, when the C6 came out, I called the contact number listed with the developers and spoke briefly with a representative of the outfit that developed it.

I asked about whether there were efforts underway to replace the two-tiered system with it, because, as you say, the C6 appeared as though it would fill the diagnostic problem with the early stage ELISA results.

Paraphrasing, they said that the Feds wanted them to put up the money to run the necessary tests, and they wanted the Feds to do it. So, they were stalled.

(Now...you are probably wondering why I would bother to do something like that...and all I can say is that I was somewhat excited and relieved back then...and anticipating that this could reduce the chances of anyone else having to experience what I went through. Which...was bad.

And...I have had to learn some of this, because of all the lovely 'stuff' I experienced. I really didn't (and still do not) trust the average physician out there insofar as their knowledge of Lyme disease goes. I learned all of this fascinating stuff in order to protect myself. As I have said before, I didn't take up an interest in Lyme disease, rather, it took up an interest in me ).
With all of this in mind, I don't anticipate major breakthroughs in diagnostic technology in the near future.
Yes, and I suppose I should explain and perhaps apologize a bit for throwing the puzzle of my case history at you. The equivalent of a nasty spitball. Messes everyone up. I was told that some of my doctors had themselves a fine old medically- stimulating time arguing with each other about it. :lol:

I am fine, now, and not really looking for help, or answers, even. I will never really know for sure and you learn to make peace with that. That's all in the rear view mirror, now.

I just meant to illustrate the diagnostic uncertainty that a lot of us have had to live with.

And that uncertainty has a cost, too...in terms of wasted medical resources. They ran me through all kinds of torture trying to 'rule out' everything else that it could be...Parkinson's, ALS, MS, Lupus, Syphilis, Leptospirosis, benign essential tremor...probably more that escape me right now...and all of the tests...multiple CT scans, MRIs, echocardiograms, EKGs, halter monitor, ultrasounds...geez, I had to do two separate nerve conduction tests because fasciculations in my thigh muscles and speech problems that resembled ALS symptoms (I have no idea after the first, why I would agree to the second, but I did).

But to this day, those 'negative' blots notwithstanding, both my doctors and I still not only believe it was Lyme, there really seems to be no other viable explanation. And like I said...three screens in a row...near 100% odds.

So, sorry about that...just trying to illustrate a point.

Henry
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Henry » Fri 23 Dec 2011 0:04

Spanky: There is a figure is a publication by Steere et al. showing that the percentage of patients with Lyme arthritis who experience recurrent episodes of arthritis decreases each year after diagnosis and treatment; it doesn't return to zero episodes until about 9 nine years after diagnosis -- and that is without any further antibiotic therapy (Steere, A,C, et al. Ann Intern Med 107: 725-731, 1987). This does not argue in favor of treating as long as the symptoms persist, because they would have gone away in time without further treatment. If there is neurological damage, the symptoms might persist for a long period of time after the infection has been cured because nerves take a long time to heal. Because of issues like this, it is difficult to generalize.

Henry
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Henry » Fri 23 Dec 2011 1:23

In closing, I would like to get back to the original topic of this discussion, namely Lyme Disease Bill 2557. What would do more good than a tick-borne disease advisory panel is to implement a reference specimen repository that would maintain a collection of well-characterized specimens from patients with Lyme disease at various stages (early, late, chronic, convalescent). It would also include normal specimens, as well as specimens from patients with other infectious diseases -- to assess specificity and cross reactions. Coded specimens would be made available to those developing serological tests on condition that they provide the results of their tests to the repository for entry into a computer data base for comparison to the results obtained by other diagnostic tests. That way, all diagnostic tests can be compared objectively to each other by a third party, using the SAME reference standards. This would enable one to compare the performance of one diagnostic test against any other with respect to sensitivity and specificity. It is my understanding that the NIH has agreed to fund such a repository. It would be managed by the CDC who has much experience in the collection and maintenance of specimen repositories. The FDA would be involved in an advisory capacity to ensure that the data collected would be of the right type to permit decisions to be made re: approval of an given diagnostic test. It would cost only about $300K to create and manage such a repository. It would be well worth the expense and greatly accelerate the development of new, more sensitive diagnostic tests. At this time, it is extremely difficult to compare tests that are not always done using the same specimens so that valid comparisons can be made.

RitaA
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by RitaA » Fri 23 Dec 2011 5:55

Henry,

You wrote:
It is my understanding that the NIH has agreed to fund such a repository. It would be managed by the CDC who has much experience in the collection and maintenance of specimen repositories. The FDA would be involved in an advisory capacity to ensure that the data collected would be of the right type to permit decisions to be made re: approval of an given diagnostic test. It would cost only about $300K to create and manage such a repository. It would be well worth the expense and greatly accelerate the development of new, more sensitive diagnostic tests.
I agree that would be money well spent.

Rita A

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Spanky
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Spanky » Fri 23 Dec 2011 14:25

"Henry":
In closing, I would like to get back to the original topic of this discussion, namely Lyme Disease Bill 2557. What would do more good than a tick-borne disease advisory panel is to implement a reference specimen repository that would maintain a collection of well-characterized specimens from patients with Lyme disease at various stages (early, late, chronic, convalescent).
You mean that you actually want to do something that could help people? Instead of forming a committee to talk about it?

Wow. Well, that's something you don't see very often in Lymeland...but since it seems to make good sense...I wouldn't give a notion like that too much chance of success, personally.

You know...around here, we think that annoying people who are trying to do actual work is a positive achievement. And forming committees to talk about annoying them further...well, goes without saying.

You would think that if the Pat and the Wonk had any sense of shame or personal accountability for their actions, they would have climbed into a puke-green convertible and done a 'Thelma and Louise' off a political cliff after the 'antitrust' disaster.

No such luck. Maybe we can hold out for a Christmas Miracle.
It would cost only about $300K to create and manage such a repository.
Or...1/3 of what has been expended on the Jones thing to date.

I wish some people would think about that one. The choices.

Henry
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Re: Christopher Smith's Lyme Disease Bill 2557

Post by Henry » Fri 23 Dec 2011 14:41

Spanky: I am hopeful. It is my understanding that a contract to start the repository has -- or is about to be-- awarded by the NIH. Hopefully, the work will be underway soon. This is such a no-brainer. The approach would be applicable to any infectious disease where diagnosis is a problem. The CDC once supported a specimen repository that worked very well. However, congress --in its "wisdom"-- cut the funds for it.

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