NIH post-infectious CFS study

[Bob]

Well, I suppose I am trying to be optimistic.

I have little doubt that something like a 2-day CPET test will unequivocally distinguish ME/CFS patients from FMD patients. Such a comparison is going to have to be made sometime. In fact, I can't imagine a positive ME/CFS finding that someone in the psychogenic camp won't claim might also be found in psychological illness. We want to find a biomarker that is specific to ME/CFS and that means ruling it out in other diseases that might overlap with ME/CFS, psychological and otherwise.

There may well be a reason why we do not see those researchers who favor a psychological explanation racing to see if the 2-Day CPET results, or Columbia's cytokine results, are also found in psychological illnesses. They may recognize that such a test carries with it the potential to crumble their edifice.

Making this kind of comparison is a risk we are going to have to face at some point.

Yes, if the abnormal two-day CPET test results are unique to ME, then this study will identify the ME patients and distinguish them from other patients, whatever the initial diagnosis. Even if there is some overlap between ME patients and FMD patients, the biomarkers should identify them as having the same, or a different, biomedical illness, that is distinguishable from healthy controls. As long as the motives of the researchers are proper, then this study seems much better than people's worst fears on this thread. But it depends on the small print, which we've yet to see.

 

[jimells]

On Cort's blog, however, it's reported that the NIH study PI has said that FMD and Post Recovery Lyme were included in order to contrast them with ME/CFS.

But why those two groups in particular? Did they just throw a dart at a poster of illness names? According to their logic, they could pick *anything* to "contrast" with "PI-CFS". Why not "contrast" the illness with cardiac disease, the "common cold", or a broken leg? Those problems are also different from "PI-CFS".

 

[jimells]

I have little doubt that something like a 2-day CPET test will unequivocally distinguish ME/CFS patients from FMD patients.

We have no evidence that they intend to carry out a 2-day CPET. The now invisible protocol only specified "to make the patient tired". There was no mention of anaerobic threshold or gas analysis or anything else that one would expect to see if they intend to do an actual CPET, one day or otherwise. There was lots of mention of "fatigue", over two dozen times, in one short document.

 

[Valentijn]

Yes, if the abnormal two-day CPET test results are unique to ME, then this study will identify those patients and distinguish them from other patients, whatever the initial diagnosis.

I'd agree ... if they had committed to using a two-day maximal CPET. So far there's just some vague fluff about exercising patients to make them "tired".

 

[BurnA]

I'd agree ... if they had committed to using a two-day maximal CPET. So far there's just some vague fluff about exercising patients to make them "tired".

I agree also, however i think its worth waiting for details before we make too many conclusions. I'd like to think if Ian Lipkin advised on this then it cant be all that bad. But that's not to say they completely ignored any or all advice.

 

[duncan]

We got quite the glimpse at some of those details on Sunday.

It is difficult to reconcile those details with an intent that is good, at least for me. It shouldn't matter if the release was premature or inadvertent - we got an idea as to how some involved with this effort perceive patients stricken with this disease: Fatigued and tired people.

There is an argument that says they couldn't have made it much worse than what they did.

Oh wait - they actually managed to... when they decided to contrast us with patient groups hit with two other controversial diagnoses.

I, too, hope there will be a major reversal, that this was all some kind of bad joke. Let's hope so.

 

[Bob]

We have no evidence that they intend to carry out a 2-day CPET. The now invisible protocol only specified "to make the patient tired". There was no mention of anaerobic threshold or gas analysis or anything else that one would expect to see if they intend to do an actual CPET, one day or otherwise. There was lots of mention of "fatigue", over two dozen times, in one short document.

I obviously don't know the answer, but it looks to me as if they've put some thought into using Lyme...

Lyme can have similar signs and symptoms to ME but has a different causal mechanism. I think it's actually very good science to use a control with overlapping features. It has potential show biomedical pathways that are similar in Lyme and ME but different to healthy controls, or it can show pathways that are unique to ME. I think this has potential to show lots of interesting results and lead to interesting questions/answers.

I can't work out what the thinking behind FMD might be. It's a bit mind boggling. But I wonder if perhaps FMD falls within their responsibility at NINDS? I guess their thinking depends if they believe that FMD is a genuine illness and appropriate diagnosis, or if they are as sceptical of the diagnosis as we are. Are they using MRI scans in this study? If so, they might be interested in comparing MRI scans between FMD and ME patients. They might be interested in contrasting a neurological disorder (ME) that has no biomarker with what they consider to be a pseudo-neurological disorder also with no biomarker. That might actually be quite good reasoning. The differences could be interesting.

But I'm guessing.

 

[Scarecrow]

Lyme can have similar signs and symptoms to ME but has a different casual mechanism. I think it's actually very good science to use a control with overlapping features. It has potential show biomedical pathways that are similar in Lyme and ME but different to healthy controls, or it can show pathways that are unique to ME. I think this has potential to show lots of interesting results and lead to inbreeding questions/answers.

Except that the Lyme group comprises people who have been treated with antibiotics, are asymptomatic, including no symptoms of a post-Lyme syndrome. There was also no requirement in this group that anybody ever had symptoms - as opposed to signs - of an active infection. I don't recall the exact inclusions and exclusions (I copied them somewhere on this thread) but, essentially, having been seropositive for Borrelia or having had an erythema migrans rash is sufficient. So it confirms infection but not an active disease process at any stage. Would any of these people have remained symptom free if they hadn't had the antibiotics? Is Lyme disease an inevitable consequence of Borrelia infection? Exactly how homogenous is that group going to be? So many unknowns.

 

[duncan]

@Bob, I think the way many at the NIH perceive Lyme (other than acute cases) might surprise you. There was a big deal associated with some emails from NIH Lyme people, and a lot of other associated history that in many ways deteriorated to an NIH/CDC vs the Lyme patient community.

I don't think the reason a Lyme cohort was selected is necessarily what some imagine. But that's just me speculating.

 

[Bob]

@Bob, I think the way many at the NIH perceive Lyme (other than acute cases) might surprise you. There was a big deal associated with some emails from NIH Lyme people, and a lot of other associated history that in many ways deteriorated to an NIH/CDC vs the Lyme patient community.

But these are acute cases of Lyme, that they want to use for controls. Or, to be precise, acute cases that have been resolved. As far as I understand.

 

[duncan]

Perhaps so. My point is that "Lyme" has taken on a perceived value within the NIH. The label is looked at as a negative, imo, across many disciplines in Bethesda.

So, a study associated with Lyme, for some, might have a strike against it simply by virtue of that association.

Remember, many of these tests, if not most, will not be done by the CFS study team.

Besides, I don't trust who will decide who is cleared of Bb, or even that they can. Ask most any mainstreet Lyme expert and they will have to admit that there is no way to prove the disease has been eradicated.

Sorry, @Bob, I keep remembering stuff. Another issue with Lyme, is the issue of coinfections and different species and strains. It is not so easy to say, "This person had Lyme and recovered." Many people infected by ticks have several diseases - diseases that come and go. Like babesia and bartonella and miyamotoi. And those diseases/parasites just don't always register positive the same time as Lyme. Why, I don't know. It's just the way it is.

Inviting "Lyme" patients to this party, even asymptomatic ones, is a little strange in light of they may be walking petri dishes.

 

[shannah]

Some research on Lyme released today.

This would tend to lend credence to the idea of how muddy the waters can become when dealing with Lyme, wouldn't it?


https://www.ucsf.edu/news/2016/02/401581/gene-signature-could-lead-new-way-diagnosing-lyme

From the article:

"Researchers at UC San Francisco and Johns Hopkins may have found a new way to diagnose Lyme disease, based on a distinctive gene “signature” they discovered in white blood cells of patients infected with the tick-borne bacteria."

"In an effort to find better ways of diagnosing the disease, and discovering molecular pathways that might explain how Lyme disease could cause long-term symptoms, researchers used a next-generation sequencing technique, called RNA-seq, to investigate the transcriptome – the genes that are being turned on – in peripheral blood mononuclear cells.

Researchers examined 29 patients before and after they received a three-week course of antibiotic treatment and also six months later. Compared to patients with other active bacterial or viral infections, the Lyme disease patients had distinctive gene signatures that persisted for at least three weeks, even after they had taken the antibiotics. Some differences in the transcriptome lingered for six months."

"Six months after treatment, 15 of the 29 patients in the study had fully recovered, while 13 had persistent symptoms, and one had dropped out. Despite the stark differences in how the patients reported feeling, the researchers could not detect transcriptional differences between the two groups. They said larger studies are needed to confirm this finding.

Researchers found similarities between the transcriptional changes after Lyme disease infection and other diseases. The acute phase of Lyme disease infection had similarities with influenza. At six months, the gene signatures of Lyme disease patients showed some similarities to those from patients with immune diseases like systematic lupus erythematosus, rheumatoid arthritis and chronic fatigue syndrome.

The researchers said measureable and persistent changes to the transcriptome may also be characteristic of a number of other infections, such as chronic hepatitis C."

 

[Never Give Up]

Wow!

http://www.cortjohnson.org/forums/t...ponse-to-clinical-center-study-protocol.3652/

 

[Bob]

Some research on Lyme released today.

This would tend to lend credence to the idea of how muddy the waters can become when dealing with Lyme, wouldn't it?

I think it's interesting research but I don't think it makes any difference to the NIH study. We know that the NIH study is going to be exceptionally complex, and a genetic difference or similarity between the Lyme group and the ME group doesn't make the study redundant. It could give useful answers.

 

[Bob]

In case anyone missed this in shannahs post, above (see bolded text):

Researchers found similarities between the transcriptional changes after Lyme disease infection and other diseases. The acute phase of Lyme disease infection had similarities with influenza. At six months, the gene signatures of Lyme disease patients showed some similarities to those from patients with immune diseases like systematic lupus erythematosus, rheumatoid arthritis and chronic fatigue syndrome.

 

[mango]

Wow!

http://www.cortjohnson.org/forums/t...ponse-to-clinical-center-study-protocol.3652/

here's more about the same phone call:
http://cfstreatment.blogspot.se/2016/02/new-nih-study-raises-doubts-concerns.html

 

[Never Give Up]

here's more about the same phone call:
http://cfstreatment.blogspot.se/2016/02/new-nih-study-raises-doubts-concerns.html

Thank you for finding this, I looked, but couldn't find it. Very good news! Well worth the read.

 

[BurnA]

Wow!

http://www.cortjohnson.org/forums/t...ponse-to-clinical-center-study-protocol.3652/

Wow indeed !
The pre release of the trial information could end up being a very important step in raising the awareness of ME/CFS in the NIH.

Seems like some some people had no idea about the history of how ME/CFS patients have been treated.

I think they will pay more attention to the specific details in the next release.

 

[viggster]

Building a productive two-way relationship with the new ME/CFS team at NIH will take some time. This call from NINDS Director Koroshetz to Carol Head of Solve ME/CFS Initiative was a positive step.

Head said this about Koroshetz after the call: He is "an individual who is committed to doing the right thing and who was shocked by the response [to protocol]. It was/is a wakeup call regarding the intensity of interest and anger in our patient community, and that’s good. We cannot and do not speak for everyone in our patient community (No one can…) and at the same time, I believe that we were able to make incremental progress in closing the enormous gap of understanding that exists between patients and the NIH."

 

[akrasia]

http://www.prohealth.com/library/showArticle.cfm?libid=15587

• Strangely, at least to us patients, Gottesman praised the former CFS point person Dr. Steven Strauss, saying that both the NIH and CFS patients lost a good fighter for our cause when we lost Strauss. No patients nodded their heads in agreement.

Sometimes, it's difficult to comprehend just how clueless and insular institutions can be. Perhaps, we are finally getting through.