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

[Esther12]

shows that 65% of the chronic Lyme patients who tested negative on the ELISA also tested positive on one or more of the Borrelia-specific bands on the Western Blot. These are bands which are not known to cross-react with any other infections.

What do you think of that paper? It didn't look great to me. And it's from 1997 when testing was less good (although I'm still not confident in the paper's findings, even then - again, post XMRV I think we were all shown how important it is to get independent validation of claims about testing).

At http://www.cdc.gov/lyme/faq/ the CDC (sort-of) implies that false-negative rates are under 35%: But a correct (true) positive of 65%+ only suggests that false positives are 35% or less, and says absolutely nothing about true or false negative results. They also do not say what the accuracy numbers actually are, and do not cite to any source for their claims. They also do not specify the rates for the first step of the test in isolation, which is where testing usually stops.

Additionally, the CDC has recently increased the estimated number of new cases of Lyme per year by a factor of ten, from 30,000 to 300,000: http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html

This would seem to suggest that even some at the CDC believe that there is a major problem with testing and/or reporting.

There have been problems with how Lyme has been treated, and I think that some 'mainstream' approaches have become politicised and affected by a desire to 'reassure' people and discredit 'alternative' approaches rather than just speak honestly to patients. I also think that has affected how people with symptoms following treatment for Lyme have been treated. This is bad, but doesn't legitimise 'alternative' approaches (or at least, not much). I'm not starting from a position of faith in authority (given my concerns about other areas around CFS, I reckon you realise that), but a concern that the problems with 'mainstream' approaches to CFS and Lyme is making room for ,and encouraging patients to pursue, dodgy alternative approaches.

 

[duncan]

Don't throw out the baby with the bath water, @Esther12 , is an old US adage that may be appropriate.

Also, tests are not that much better today than they were in 1997.

Please keep in mind that there would be no need for alternative diagnostics, or alternative treatments, or even ILADS, if so many people sick with Lyme weren't being abandoned by the architects of, and subscribers to, current diagnostic and treatment protocols, and being driven to search for remedy on their own. Worse, they are stamped as fakes and malingerers, and are marginalized, rendering their efforts even more desperate and futile.

Fix mainstream, and all that that entails, and the rest should follow.

Then again, maybe that's what some - admittedly not necessarily all - of these alternative solutions are striving toward.

 

[Esther12]

Don't throw out the baby with the bath water, @Esther12 , is an old US adage that may be appropriate.

I don't see any evidence that there's a baby in there.

Please keep in mind that there would be no need for alternative diagnostics, or alternative treatments, or even ILADS, if so many people sick with Lyme weren't being abandoned by the architects and subscribers to current diagnostic and treatment protocols, and being driven to search for remedy on their own. Worse, they are stamped as fakes and malingerers, and are marginalized, rendering the efforts even more desperate and futile.

I think that a lot of people who have been given an 'alternative' diagnosis of Lyme do not have it, and have been misled by unreliable testing. They often are badly treated, and that is something we all should be working to try to change, but their mistreatment doesn't mean that they have Lyme, or that they claims of their more kindly seeming alternative Lyme doctors are supported by any good quality evidence.

Fix mainstream, and all that that entails, and the rest should follow.

I agree - I just think that's a mighty challenge.

 

[duncan]

@Esther12 , the thing is, there is some merit to what you say. But the focus is...off, at least in my opinion.

The focus needs to be on the cause, primarily speaking. That cause, in part, is the vacuum left from the audacious paucity in Lyme research for better diagnostics, and treatments that work in a sustained fashion for everyone infected, i.e. treatments that cure people, and don't just work in vitro. The cause can also be traced, in part, to the entrenched leadership of conventional Lyme dogma.

An example might be what some associated with the IDSA have done to the terms "chronic Lyme." Every one knows what chronic Lyme should mean. But take a look and see how apparently elements loyal to the IDSA Guidelines have mangled it. They promote an idea that chronic Lyme refers to an alleged affliction claimed by individuals (or their doctors) that never had Lyme. Period. Never, ever had Lyme. Not that this is true for some with chronic Lyme, but rather, this is the defining criteria of everyone claiming to suffer with chronic Lyme.

Talk about your sweeping misleading characterizations.

Do frauds and bogus therapies need to be exposed? Yes. But remember what enabled those, and where their genesys can be found. Remedying that needs to be the driving initiative behind vigilance against wrong-doing in the Lyme community.

 

[Esther12]

@Esther12 , the thing is, there is some merit to what you say. But the focus is...off, at least in my opinion.

I wouldn't judge my overall focus and priorities from just the Lyme threads I comment on here. In different venues, where different views are being promoted, I am much more likely to speak critically of aspects of the mainstream approaches to Lyme. On this forum, I tend to think that I don't need to speak out about those things. With CFS stuff, I spend much more time criticising 'mainstream' approaches than 'alternative', even though I am concerned about lots of alternative things too.

 

[Valentijn]

What do you think of that paper? It didn't look great to me. And it's from 1997 when testing was less good (although I'm still not confident in the paper's findings, even then - again, post XMRV I think we were all shown how important it is to get independent validation of claims about testing).

Do you really want to use the same "BUT XMRV!!!!" line routinely used by psychobabblers to deny any immune involvement at all in ME? The XMRV testing referred to was done in a laboratory, which is exactly where it belonged at that stage.

There are other papers showing various high levels of false negatives in the official Lyme tests. And they are the same tests which were used in 1997. They are also designed to test for one specific type of borrelia, despite that about a dozen strains are known to infect humans, several of them known to be present in the US.

And why aren't you asking the CDC to prove that their endorsed testing method is accurate? You've demanded that from every other test repeatedly, so why should they get off the hook? All we get from the CDC are vague reassurances that the tests aren't quite as inaccurate as some people are saying, with no actual numbers and apparently no actual research into the issue. Private labs manage to engage in some sort of verification of their results, yet this not seem to be done or required by the CDC to endorse the two-tier method.

How about you come up with some studies showing that the CDC's two-tier testing is as reliable as you keep believing?

 

[Esther12]

Do you really want to use the same "BUT XMRV!!!!" line routinely used by psychobabblers to deny any immune involvement at all in ME? The XMRV testing referred to was done in a laboratory, which is exactly where it belonged at that stage.

I don't know how other people use it, but I think that the XMRV saga was a useful illustraion ofthe danger of unvalidated testing.

There are other papers showing various high levels of false negatives in the official Lyme tests. And they are the same tests which were used in 1997. They are also designed to test for one specific type of borrelia, despite that about a dozen strains are known to infect humans, several of them known to be present in the US.

And why aren't you asking the CDC to prove that their endorsed testing method is accurate? You've demanded that from every other test repeatedly, so why should they get off the hook? All we get from the CDC are vague reassurances that the tests aren't quite as inaccurate as some people are saying, with no actual numbers and apparently no actual research into the issue. Private labs manage to engage in some sort of verification of their results, yet this not seem to be done or required by the CDC to endorse the two-tier method.

How about you come up with some studies showing that the CDC's two-tier testing is as reliable as you keep believing?

I did look into the evidence used to support claims about the value of mainstream testing, and they had some.

I didn't save the links from then, but a quick google found things like this, indicating that these tests have been assessed under blinded conditions: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC85863/

I had found a review article on this from around 2002 that seemed pretty thorough, but I now can't re-find it. On searching I found a protocol for a new review that is being carried out now, so when that's published it should provide us with more up to date info.

As with XMRV, where there are disputes about what is a 'true' case, there can be difficulties saying exactly how reliable a test is, but if the alternative tests claiming higher prevalence rates haven't been shown to hold up under blinded conditions, I don't think that matters too much. These more alternative claims haven't got over the first hurdle yet.[/QUOTE]

 

[Valentijn]

I don't know how other people use it, but I think that the XMRV saga was a useful illustraion ofthe danger of unvalidated testing.

It was lab contamination, which is a completely different issue.

I didn't save the links from then, but a quick google found things like this, indicating that these tests have been assessed under blinded conditions: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC85863/

That's great ... as long as only people who get the bullseye rash or have already tested positive are the only people who can get Lyme (they aren't). They only used samples which had the rash or had already tested positive with the same method they were supposedly testing the accuracy of. Yes, people who had already tested positive using the CDC system still tested positive using the same system. That is not a useful way to determine accuracy of a test.

They are also explicitly only testing for one strain of Borrelia. Even if the test is highly sensitive to that strain (doubtful), it leaves anyone with a different strain of it without a diagnosis or treatment or even acknowledgement of illness.

 

[Esther12]

It was lab contamination, which is a completely different issue.

That's great ... as long as only people who get the bullseye rash or have already tested positive are the only people who can get Lyme (they aren't). They only used samples which had the rash or had already tested positive with the same method they were supposedly testing the accuracy of. Yes, people who had already tested positive using the CDC system still tested positive using the same system. That is not a useful way to determine accuracy of a test.

They are also explicitly only testing for one strain of Borrelia. Even if the test is highly sensitive to that strain (doubtful), it leaves anyone with a different strain of it without a diagnosis or treatment or even acknowledgement of illness.

I didn't read the paper closely, but was pretty sure that they also used samples from controls thought to be free of Lyme but who may had other related problems. That's the sort of assessment I'd like to see for alternative testing.

As with XMRV, a good way to test the testing is to use some samples that are thought very likely to be positive, and some thought unlikely to be positive. It doesn't matter that XMRV positives occurred as a result of contamination - even if there was some other problem with the testing, this sort of procedure would have helped show what was going on.

We could also include samples from those likely to be positive according to alternative testing, but if this alternative testing has not itself been assessed under blinded condition and been shown to be reliable, then many researchers will not see the point of including such alternative samples.

 

[duncan]

There is no meaningful defense of the current two-tier system.

Even its advocates were quick to deflate its status when they sensed they could benefit from promoting the C6. Wanna see a supposed fail-safe diagnostic scheme suddenly become riddled with holes? Review the history of the C6, and see how suddenly the ELISA and Western Blot lost their glow even for some of their staunchest and most vocal supporters.

 

[Valentijn]

I didn't read the paper closely, but was pretty sure that they also used samples from controls thought to be free of Lyme but who may had other related problems. That's the sort of assessment I'd like to see for alternative testing.

That would be used in contributing toward determining false positives. Nothing at all to do with false negatives.

As with XMRV, a good way to test the testing is to use some samples that are thought very likely to be positive, and some thought unlikely to be positive. It doesn't matter that XMRV positives occurred as a result of contamination - even if there was some other problem with the testing, this sort of procedure would have helped show what was going on.

They weren't just "very likely" positive. They were known positives due to the mandatory presence of either having had a rash which is very specific to Lyme infection, or due to already having tested positive using exactly the same testing method which they purport to prove the accuracy of.

We could also include samples from those likely to be positive according to alternative testing, but if this alternative testing has not itself been assessed under blinded condition and been shown to be reliable, then many researchers will not see the point of including such alternative samples.

That sounds like quite a cop out. "Everybody knows alternative testing is junk, therefore we won't bother testing it but will still affirm that it is junk." Additionally, blind testing is used to remove bias - yet when the samples are being automatically assessed by machines and the results generated by software, bias is not an issue. Deliberate fraud potentially could be afterward during the publishing process, but blinding does not correct for that in any event.

 

[msf]

Hi Esther, since you seem to believe everything the IDSA says, you should take their word for it that the tests they advocate result in false positives 80% of the time in certain areas: http://www.ncbi.nlm.nih.gov/pubmed/26195017

Wow, soon there won't be any cases of Lyme anywhere in the world!

 

[Esther12]

That would be used in contributing toward determining false positives. Nothing at all to do with false negatives.

Right - that's the sort of assessment which I think alternative testing also needs to undergo. re false negatives: I respond to that next...

They weren't just "very likely" positive. They were known positives due to the mandatory presence of either having had a rash which is very specific to Lyme infection, or due to already having tested positive using exactly the same testing method which they purport to prove the accuracy of.

I used 'very likely' to account for the difficulty of being 100% certain about things. As with XMRV testing where researchers tried to use those patients who were most likely to have XMRV in order to test the reliability of testing, so it makes sense to use those patients most likely to have Lyme to test the reliability of Lyme tests.

re false negatives and patients who some claim have Lyme, others are less sure/think that they don't, etc: I had said: "We could also include samples from those likely to be positive according to alternative testing, but if this alternative testing has not itself been assessed under blinded condition and been shown to be reliable, then many researchers will not see the point of including such alternative samples."

What samples do you think that they should have used? This assessment of the test was not exhaustive, but it was of the sort we wanted to see done for XMRV, and of the sort I would like to see done for the alternative tests.

That sounds like quite a cop out. "Everybody knows alternative testing is junk, therefore we won't bother testing it but will still affirm that it is junk." Additionally, blind testing is used to remove bias - yet when the samples are being automatically assessed by machines and the results generated by software, bias is not an issue. Deliberate fraud potentially could be afterward during the publishing process, but blinding does not correct for that in any event.

I just repeated that bit above, I don't think that I say what you assume I do. It's not that 'everybody knows alternative testing is junk' it's that 'there is not any good evidence that alternative testing is not just junk' - I think that the responsibility to pursue that evidence lies more with those creating and selling the tests than those who are assessing different testing procedures. Whatever the problems with them, there is evidence that mainstream evidence is not 'just junk'.

Post-XMRV, I think that blinding needs to be used as standard to help account for things that we may not be aware of - including possible fraud by only some members of a group. There's always the possibility of entirely false data being published, but blinding is still helpful - independent assessment under blinded conditions even better.

Hi Esther, since you seem to believe everything the IDSA says, you should take their word for it that the tests they advocate result in false positives 80% of the time in certain areas: http://www.ncbi.nlm.nih.gov/pubmed/26195017

Wow, soon there won't be any cases of Lyme anywhere in the world!

Any testing that has a problem with false positives is going to lead to a lot of false positives in an area when lots of people get tested but few of them have the disease. That's a bad thing and shows a problem with current testing, but I've never said that mainstream testing was perfect, or that I believe everything that the IDSA says.

 

[Valentijn]

@Esther12 - If you want to prove the CDC testing is accurate and the rest isn't, then do it. Stop making vague claims and show me the research. I do not have the time to dig up research which might support your points. You find it, and I'll be happy to look for the problems in it.

The paper which you have provided is obviously inadequate to answer the question of false negatives, so if you want to persuade anyone that the two-tier system is fit for purpose, I suggest you start with false negatives in those "mainstream" tests.

And try not to use "XMRV". Once I see anyone mention XMRV, in pretty much any context, I stop reading and skip to the next paragraph or post. So please try to find a way to support your arguments which instead uses logic, research, and more applicable comparisons.

 

[Esther12]

@Esther12 - If you want to prove the CDC testing is accurate and the rest isn't, then do it. Stop making vague claims and show me the research. I do not have the time to dig up research which might support your points. You find it, and I'll be happy to look for the problems in it.

Mainstream testing has been shown to be of some value, if that's what you mean by 'accurate'. Alternative testing has not shown itself to be superior in any way yet lots of patients are being told otherwise and encouraged to spend their time and money on testing and treatments which are not supported by any good quality evidence. I just want patients to be able to make properly informed decision about their health care.

The paper which you have provided is obviously inadequate to answer the question of false negatives, so if you want to persuade anyone that the two-tier system is fit for purpose, I suggest you start with false negatives in those "mainstream" tests.

And try not to use "XMRV". Once I see anyone mention XMRV, in pretty much any context, I stop reading and skip to the next paragraph or post. So please try to find a way to support your arguments which instead uses logic, research, and more applicable comparisons.

You're free to read of skip whatever you want, but I think that there were useful lessons from the XMRV saga which have helped me understanding how blood tests can mislead and need to be assessed. These lessons are all founded in logic and research, but XMRV is an example which has been widely discussed on this forum and so I find it useful to refer to.

The 'false negatives' issue I'm interested in is whether alternative testing is a reliable way of identifying people who have Lyme, and yet do not get a positive result from mainstream testing. There is no evidence that they are useful in this way, and the only time that IgeneX's alternative testing was independently assessed under blinded conditions it was found to be unreliable.

 

[MadeleineKM]

Dont forget that some healthy people also have spirochete of Borrelia in their blood so if getting positive results from healthy people make someone to think the test is unreliable its not right

 

[Esther12]

Dont forget that some healthy people also have spirochete of Borrelia in their blood so if getting positive results from healthy people make someone to think the test is unreliable its not right

For the blinded assessment of IgeneX's urine testing they split samples and then sent them to be tested twice, finding that the testing was generating different results for samples from the same source. If mainstream testing was missing patients who had Lyme, this alternative testing was not a useful alternative.

One reason why I do bring up XMRV is that they had to deal with uncertainty over who should count as 'positive' and who should count as 'negative', as well as who should be likely positive/negative. A blinded assessment of samples already tested helps us move forward with this sort of uncertainty, working out which tests are useful and which are not. (Although as a new member @MadeleineKM , you may have not been aware of those discussions).

 

[Valentijn]

Dont forget that some healthy people also have spirochete of Borrelia in their blood so if getting positive results from healthy people make someone to think the test is unreliable its not right

Yes, I think more serious studies using culturing to evaluate the various commercial tests is essential. I assumed it was being done at least by the CDC to validate the 2-tier method, but even in that context it is shockingly rare (or the results are just not published). For example, out of the 387 human samples evaluated in the study @Esther12 listed, only 27 had been cultured.

 

[duncan]

This study by Lantos and Auwaerter, whose link @msf kindly provided, is remarkable.

It demonstrates the 2T diagnostic system can be in error at least up to 80% of the time.

I cannot help but wonder what the purpose of the study is. Are the Guideline authors aware of this, but indifferent? I doubt they would be indifferent, and considering who two of the authors are, other Guideline contributors should be more than aware...

 

[msf]

So Esther, you are against clinical diagnoses when they confirm Lyme, as in the original poster's case, but not when they rule out Lyme, as in the study I quoted. Once again I fail to see the logic of your position.