New doctor wants to treat empirically for Lyme, good idea?

[Valentijn]

I had posted the study which was the only time testing from an alternative lab had been assessed under blinded conditions (where it was found to be internally inconsistent): http://www.amjmed.com/article/S0002-9343(00)00701-4/abstract

And without access to the full text, we cannot examine the methodology used, nor assess whether the conclusions in the abstract are warranted.

And just randomly googled that blinded assessment of mainstream testing, where it was shown to be of some value: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC85863/

Ah yes, the one which you can't be bothered to read. I did bother to read it, and the only thing it confirms is that patients who tested positive with the two-tier system still test positive with the two-tier system. That's nice for test-retest reliability, but says absolutely nothing about false negatives.

 

[Esther12]

Ah yes, the one which you can't be bothered to read. I did bother to read it, and the only thing it confirms is that patients who tested positive with the two-tier system still test positive with the two-tier system. That's nice for test-retest reliability, but says absolutely nothing about false negatives.

That's what I want! That's what we needed for XMRV, and that's what we need to alternative Lyme testing as an important first step to assessing it's value.

Also - that's how the IgeneX testing was assessed and it was found that under blinded conditions split samples were being classed as positive and then negative and vice-versa. It would be great if that paper were open-access, but that's the only paper we have which seems to have done this sort of necessary assessment.

 

[Valentijn]

That's what I want! That's what we needed for XMRV, and that's what we need to alternative Lyme testing as an important first step to assessing it's value.

Why? It doesn't mean it's accurate. It just means that it's wrong or right in an internally consistent manner. Giving a false positive followed by another false positive doesn't make it a useful test.

 

[Esther12]

Why? It doesn't mean it's accurate. It just means that it's wrong or right in an internally consistent manner. Giving a false positive followed by another false positive doesn't make it a useful test.

Right, but if it's not even able to do that then you know it's in real trouble. This was how it was shown that there were real problems with XMRV testing. Showing internal consistency under blinded conditions (and ideally from multiple labs) is a really important step towards getting reliable data.

 

[Valentijn]

Right, but if it's not even able to do that then you know it's in real trouble. This was how it was shown that there were real problems with XMRV testing. Showing internal consistency under blinded conditions (and ideally from multiple labs) is a really important step towards getting reliable data.

Yes. One step. And it's completely useless if those other steps are not demonstrating accuracy. Internal consistency is meaningless if the test is not accurate. Thus it is much more important to address the issue of accuracy.

 

[Esther12]

Yes. One step. And it's completely useless if those other steps are not demonstrating accuracy. Internal consistency is meaningless if the test is not accurate. Thus it is much more important to address the issue of accuracy.

Any attempt to address accuracy will also need to show internal consistency, so it's not one or the other. For a contentious diagnosis like Lyme, where people dispute who is truly positive and truly negative, this sort of assessment of testing is a necessary first step, and it still has not been taken by those selling alternative testing.

 

[xrunner]

Standard tests are only 30%, and IgeneX is only 90% accurate. So a negative lyme test is meaningless.

In the case of Lyme that can never be ruled out with certainty.

Does this mean everyone keeps testing until it's positive? At some point you empirically treat it?

It depends on individual circumstances.
For those of us who have experienced being stuck in bed, crushed by pain (physical and/or mental), getting progressively worse, not having any kind of life, feeling hopeless etc. the decision is a complete no brainer.

He wants me to start with Doxycycline or Minocycline.

That seems a reasonable abx choice.
But again it depends on clinical picture of individual patients. Comparing the costs and risks of a merciless illness and its effects to the costs and risks of a round or more of antibiotics can give the basis for such a decision.
Medicine is not an exact science and never will be.

In my case the diagnosis was mainly clinical. I had a dodgy blood test showing positivity to every type of Borrelia and co-infections. Then I had another blood test showing just past exposure to Bb. I also had negative tests. Based on history, symptoms and outlook the Dr decided to try a course of Doxycycline.
That was over six years ago. It was one of the best decisions I ever made and never looked back.
However, I understand in some cases that's not so straightforward.
Best wishes.

 

[Valentijn]

I had posted the study which was the only time testing from an alternative lab had been assessed under blinded conditions (where it was found to be internally inconsistent): http://www.amjmed.com/article/S0002-9343(00)00701-4/abstract

It looks like I've got access to that one after all. It shows that the Igenex urine test is highly inaccurate and inconsistent. 10 healthy controls whose samples were each sent 5 times got an impressive range of radically different results on each test. They did not send urine samples from the 21 Lyme patients to be tested.

Blood was tested twice via a Western Blot IgG, but not via Igenex, and only at the university medical center where the study authors work. This part seems a bit bizarre - why test 21 patients when their urine samples aren't even being sent to Igenex? It doesn't contribute to the seeming purpose of the study in assessing the false positive rates of the Igenex urine test.

The test/retest concordance in their lab was quite high for the 21 patients, and all 10 controls tested negative on both tests. 7 of the 21 Lyme patients tested and retested negative for IgG via Western Blot at the authors' lab. There was some variations in the number of bands present for most patients at each test, but the ones with 5+ stayed and 5+, and the ones at 4- stayed at 4-. The average variation between test and retest outcomes is one band extra or missing.

The only blinding seems to have been at Igenex, as they did not know the status of the people contributing the samples. Presumably they also anonymized each sample so that Igenex would not know if they came from the same patient. The only thing they say about blinding is:

Frozen urine samples for offsite testing were packaged in insulated boxes containing refrigeration packets and shipped by overnight courier. All duplicate samples were sent blinded to the reference laboratories.

Since the serum samples weren't being sent anywhere, it doesn't sound like the blinding process applies to them. And it sounds like they were reading the output manually for that testing system in 2001 to determine if bands were positive or negative, so the lack of blinding could be a factor ( http://webcache.googleusercontent.com/search?q=cache:XnmrFOS_RSoJ:www.trinitybiotech.com/Product%20Documents/40-5065M,%2040-5065MB-29EN.pdf &cd=1&hl=en&ct=clnk&gl=us )

So the first reliable message from that study is that the Igenex urine test for Lyme was utter crap in 2001. And I wouldn't assume the situation had improved unless there's a very reliable indication of that. And the second message is that even using the mainstream test, false negatives were given for 33% of the known Lyme patients.

 

[Valentijn]

The test/retest concordance in their lab was quite high for the 21 patients, and all 10 controls tested negative on both tests. 7 of the 21 Lyme patients tested and retested negative for IgG via Western Blot at the authors' lab. There was some variations in the number of bands present for most patients at each test, but the ones with 5+ stayed and 5+, and the ones at 4- stayed at 4-. The average variation between test and retest outcomes is one band extra or missing.

Thinking about this a bit more ... the authors' lab might have been blinded to the positive or negative status of the patients and controls, but could have known which samples were from the same person. It might explain why results were so internally consistent between the test and retest for each patient, yet completely wrong for a high percentage of patients.

 

[bertiedog]

@Kina 's suggestion is a good one.

To do it right, it would be smart to show how conventional tests - like the ELISA and Western Blot - got to where they are today. The science, the politics, the legwork behind the scenes.

Then the same for alternative tests.

We're talking about a lot of work.

Doesn't Dr Horrowitz in his book on multisystemic immune disorders explain all this? I have it on my Kindle and seem to remember him explaining what the problems are and why there are these misunderstandings.

Pam

 

[duncan]

Thank you, @bertiedog . I have yet to read Horowitz's book, but I have read Pamela Weintraub's, and I think it is discussed there, too. Still should double check their references - or at least I frequently have (even though I doubt I needed to) with Cure Unknown, which is meticulously sourced.

 

[Esther12]

So I the first reliable messages from that study is that the Igenex urine test for Lyme was utter crap in 2001. And I wouldn't assume the situation had improved unless there's a very reliable indication of that.

That was what I'd cited that study to show, and the possibility of this sort of result is why I think that this sort of assessment needs to be done. If a test leads to results like this, then that shows it should not have been sold to patients.

 

[Valentijn]

That was what I'd cited that study to show, and the possibility of this sort of result is why I think that this sort of assessment needs to be done. If a test leads to results like this, then that shows it should not have been sold to patients.

Well, it also shows that the Western Blot shouldn't be sold to patients Or at least, it shouldn't be taken seriously when it gives a negative result.

I also don't think the urine test is the one people are usually referring to when they get tested at Igenex. Though they do still sell a urine test.

 

[duncan]

btw, George Mason U has a cool looking Lyme urine test it's busy validating...

 

[Esther12]

Well, it also shows that the Western Blot shouldn't be sold to patients Or at least, it shouldn't be taken seriously when it gives a negative result.

Internal consistency still indicates it's of some value, but that patients need to be informed about it's limitations, which is what I've been saying.

 

[bertiedog]

Thank you, @bertiedog . I have yet to read Horowitz's book, but I have read Pamela Weintraub's, and I think it is discussed there, too. Still should double check their references - or at least I frequently have (even though I doubt I needed to) with Cure Unknown, which is meticulously sourced.

Dr Horowitz's book is very thorough, he doesn't believe that its just borrelia bacteria that are causing all the problems but co-infections are a real issue as are things like heavy metal toxicity and vitamin/mineral deficiencies and to be aware of genetics too. Its over a year ago since I read it so there are probably several other things he mentions, I keep meaning to reread it.

He does try and explain the different positions of ILADs and the LDA but he is very much on the side of patient who is sick and needs treatment and he gives many examples of patients he has got well but with many of them it involved addressing far more than the killing of borrelia.

Pam

 

[duncan]

@Esther12, the value of the WB arguably is terribly constrained since its positive/negative properties are questionably defined, and its interpretation is easily mishandled/discounted - particularly when used as part of the 2T tandem.

Its potential utility comes into play when the patient is informed, and has enough granularity in the WB report to discern risk factors.

But this appears to be anathema to IDSA/CDC doctrine.

 

[justy]

I would like to ask a question. Could posters please clarify what/who they mean by 'alternative Doctors' who are saying that M.E/CFS is caused by Lyme?

 

[Valentijn]

Internal consistency still indicates it's of some value, but that patients need to be informed about it's limitations, which is what I've been saying.

No, internal consistency is useless when the results are very often wrong. And I'm not sure I trust the internal consistency, given the methodology used (or rather not used) regarding blinding for the Western Blot portion.

 

[GcMAF Australia]

I would like to ask a question. Could posters please clarify what/who they mean by 'alternative Doctors' who are saying that M.E/CFS is caused by Lyme?

In Australia I know of probably 6 Doctors, who are traditional doctors, who have found that most of their ME/CFS patients have Borrelia. I am talking about an average of 1-200 patients each and the positive rates would be over 90%.
As well as Australian Biologics, Infectolabs/ArminLabs in Germany and Igenix in the US are used.
I dont think commercial labs bother to publish their results, and I dont think researchers bother anymore to examine many of the questions about reliability. It is not possible for 1 research group to use the 20-100 tests that are now available in a fruitless programme to validate them.
Some Australians have been found positive for Borrelia in an independent study by the University Of Sydney who set up their own independent non commercialised testing regime.
Borrelia was found in Australia by the CSIRO in 1958, and Lyme disease was recognised.

However in 1994 a flawed study funded by the Medical grants committee "could not find Borrelia". The paper actually shows photographs of Borrelia but the researcher says that there were none!!
Also they used US strain of Borrelia when of course Australia has its own strains. Since then, this so called researcher has twisted the thinking of the medical boards into emphatic denial of Lyme in Australia. Other scientific papers were totally discounted because this 1 person knew everything! Obviously! But hey the medical system run by medicos who are a bit set in their ways must be Right!

In Britain they refused to use citrus fruit to treat scurvy for many years because of stupidity of the naval doctors.
Other famous statements include IBM saying that there is only a market for 4 computors in the world! and The UK Post saying to Alexander Bell that they were not interested in Telephones because only about 4 would be needed in the UK, so Alexander Bell took his telephones back to America. etc etc

OF course the main culprit in this is the NSW Medical Board that was also involved in the Asbestos scandal!! But hey!, Medical boards are law unto themselves and hence above any ethical standard or any real self assesment.
Not to mention the fact that the NSW government has been gripped in massive coruption scandals which have spread into the federal government.