NIH post-infectious CFS study

[viggster]

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



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

That meeting was in 2010 - I'm pretty sure none of those folks are involved in the new ME/CFS effort at NIH.

 

[halcyon]

I'm pretty sure none of those folks are involved in the new ME/CFS effort at NIH.

That's the point. None of the current people seem to have any knowledge of the history or context in which to understand why we are watching so closely and why we respond so strongly. Our response has proved educational.

 

[jimells]

This incident illustrates what can happen when folks forget their fear and make a big noise.

 

[jimells]

That's the point. None of the current people seem to have any knowledge of the history or context in which to understand why we are watching so closely and why we respond so strongly. Our response has proved educational.

Instead of "institutional memory" they seem to have "institutional amnesia" even though managers like Fauci and Collins have been there for decades. Anthony Fauci started in 1968 and Francis Collins has been there since 1993.

One wonders why Director Collins didn't find someone to brief brandy-new Institute Director Koroshetz (started 2015) regarding this contentious illness; it looks like he is getting a real briefing now!

 

[CFS_for_19_years]

both the NIH and CFS patients lost a good fighter for our cause when we lost Strauss

said no patient ever.

That meeting was in 2010 - I'm pretty sure none of those folks are involved in the new ME/CFS effort at NIH.

Yet we the sick patients will be around forever until we die - 25 years sick and counting for me.

 

[dancingstarheart]

That's false.Several patient advocates & two people from Solve met with the NIH team in recent months and gave their input.

Why were these communications not made public, or were they? Where is the transparency this community most definitely needs?

 

[viggster]

Why were these communications not made public, or were they? Where is the transparency this community most definitely needs?

I can't speak for everyone involved, so I don't know why folks have decided not to make meetings with NIH public. These relationships are just developing, and from what I've heard, everyone involved is trying to build trust. More openness is always better, but I think it's sometimes OK to have meetings that aren't made public as people are trying to get to know each other. Solve ME/CFS did write about meeting with NIH people last October.
http://solvecfs.org/SMCI-Team-Meets-with-NIH

 

[Roy S]

http://www.cfstreatmentguide.com/blog/new-nih-study-raises-questions-concerns-hackles

 

[BurnA]

http://www.cfstreatmentguide.com/blog/new-nih-study-raises-questions-concerns-hackles

I'm not sure I agree with Erica's take on things

What was clear from the initial protocol was that NIH was on a fishing expedition. Rather than build on previous research, they decided to conduct a vague series of tests (blood tests, stool samples, etc.) in hopes that something would turn up. This is precisely the sort of study we don't need right now. Why reinvent the wheel when there are three decades of research on brain anomalies, immune system dysfunction, mitochondrial dysfunction, and endocrine dysfunction begging for follow-up? (Some of those studies have lain dormant for over a decade for lack of replication.) Do we really need to start from scratch - again?

It might be a fishing expedition of sorts but that is what we need. We know so little about this disease we need a few broad studies to make sure we are headed in the right direction in future studies.
The reason it might be vague is that they haven't released the full study data yet. I don't think this is a valid criticism of the study per se. Ron Davis study is somewhat similar and I don't hear too many complaints about that study. In fact this study may appear to have some advantages in that it is doing spinal fluid and exercise studies which aren't part of the OMF study.

In answer to the question - Do we really need to start from scratch - again ? I would say,have we ever started from scratch with this disease ?

 

[A.B.]

I'm pleased to see how things are developing. NIH made a mistake. I don't have insight into the NIH but I'm sure within it there are many people who know little about CFS or continue to see it in a certain way for historical reasons. This doesn't need to be an insurmountable obstacle. In fact it would be surprising if attitudes all changed overnight. In any case, the community quickly reacted and was heard. NIH seems to have realized their mistake and has not reacted with defensiveness but appears to be listening. The list of planned tests speaks of a serious investigation.

Of course only time will tell, but if the NIH is ready to seriously investigate patients and is listening it's hard to argue that nothing good can come out of it.

Using Reeves criteria may simply be ignorance and the assumption that the CDC produced a useful case definition. It doesn't necessarily imply malice.

 

[A.B.]

Remember, what we want here is the NIH to start a serious research program. The "fishing expedition", besides being a valuable project in its own, may also serve the purpose of documenting the abnormalities that are required to justify increased focus on ME/CFS in an environment with substantial pockets of skepticism or indifference.

 

[BurnA]

Remember, what we want here is the NIH to start a serious research program. The "fishing expedition", besides being a valuable project in its own, may also serve the purpose of documenting the abnormalities that are required to justify increased focus on ME/CFS in an environment with substantial pockets of skepticism or indifference.

This is a big point. If this study finds something significant it would be difficult to refuse further funding into further related and more focused studies.

 

[Scarecrow]

It might be a fishing expedition of sorts but that is what we need. We know so little about this disease we need a few broad studies to make sure we are headed in the right direction in future studies.

On the plus side, I can see that the NIH have tried to standardise their patients by choosing to focus on post infectious CFS but there's still a risk of a minimum of two subsets and who knows how many actual diseases within those subsets.

There will of course be genuine sudden onset cases and the longitudinal nature of the study means that the common post viral fatigue patients can be weeded out from those who do not recover, assuming the study runs for at least 6 months (and preferably a year). But they will also have staged onset patients, those who know that they were not 100% well but who were also not obviously ill before they got the infection that tipped them over. Some patients report being 'stressed' before contracting the triggering infection - is that due to genuinely stressful life events or an interpretation that somebody makes because they are not fully healthy and not coping as well as they once did with the normal demands of life?

With only 40 patients, I'm still having a hard time understanding how useful this study will be. We need many, many more patients to be included and careful histories taken.

 

[A.B.]

With only 40 patients, I'm still having a hard time understanding how useful this study will be. We need many, many more patients to be included and careful histories taken.

I have decided that having a healthy post-lyme, and a functional movement disorders group is a luxury that we cannot afford. Due to ME/CFS being heterogenous there is the real risk of this study being underpowered. My pessimistic estimate is that 1/3 of patients fall within the largest subgroup, with the other 2/3 falling into several smaller subgroups, probably with some misdiagnoses as well (less likely with obvious post-infectious onset but still possible). We need enough participants to ensure this 1/3 is big enough for statistical significance.

PS: by misdiagnosis I mean patients who have a well defined disease that was missed.

 

[dancingstarheart]

I don't have time to wait five years to see if the cake is made with sawdust or flour, when they finally publish something. I'll be dead by then.

Flour, sawdust, and I will add rat poison to the possibilities. Because previous studies have been poisonous and resulted in the medical establishment treating us with neglect and many times contempt.

 

[dancingstarheart]

I can't speak for everyone involved, so I don't know why folks have decided not to make meetings with NIH public. These relationships are just developing, and from what I've heard, everyone involved is trying to build trust. More openness is always better, but I think it's sometimes OK to have meetings that aren't made public as people are trying to get to know each other. Solve ME/CFS did write about meeting with NIH people last October.
http://solvecfs.org/SMCI-Team-Meets-with-NIH

Who is the historically damaged and disdained group here? That would be the patients. NIH needs to build trust with us, not the other way around.

 

[dancingstarheart]

Remember, what we want here is the NIH to start a serious research program. The "fishing expedition", besides being a valuable project in its own, may also serve the purpose of documenting the abnormalities that are required to justify increased focus on ME/CFS in an environment with substantial pockets of skepticism or indifference.

We have had 30 years of documenting abnormalities. We need large studies to replicate and confirm, not try to re-invent the wheel. How many ME researchers have done or are currently doing small studies over the 30 years showing NK cells not functioning, cytokines profiles that were irregular compared to healthy controls, epigenetic studies showing differences in DNA regulation compared to healthy controls. How many tiny wheels are rolling around out there all by themselves across the globe?

It feels more like a competition between independent researchers, CDC and NIH... who will be the first to find their own unique biomarkers viable enough for quick ramp up into mass production?

And without the massive funding needed, they are all stuck at the initial small study "discovery" phase that is being repeated over and over again. What happened with collaboration that Ron Davis was calling out for in his great speech ? If Lipkin really was involved with advising on protocol design, then why did it not look like his study? Why would it not be a replication of his process? Wouldn't that help to shorten his 5 year prediction of finding the golden holy grail of a biomarker?

Here is an article about Ron Davis which references the his speech http://www.meadvocacy.org/dr_davis_debunks_nih_s_claims_of_fairness . And here is the video

And Ron Davis, still has not received NIH funding for his severe ME patient study.

 

[BurnA]

We have had 30 years of documenting abnormalities. We need large studies to replicate and confirm, not try to re-invent the wheel. How many ME researchers have done or are currently doing small studies over the 30 years showing NK cells not functioning, cytokines profiles that were irregular compared to healthy controls, epigenetic studies showing differences in DNA regulation compared to healthy controls. How many tiny wheels are rolling around out there all by themselves across the globe?

It feels more like a competition between independent researchers, CDC and NIH... who will be the first to find their own unique biomarkers viable enough for quick ramp up into mass production?

If only it was a competition and if only the CDC and NIH were both interested in winning it, we wouldn't be in this mess.

And without the massive funding needed, they are all stuck at the initial small study "discovery" phase that is being repeated over and over again.

There have been very few if any studies of this nature and scope performed to date. This study may or may not confirm a lot of previous studies, we don't know because we don't know the specifics yet.

What happened with collaboration that Ron Davis was calling out for in his great speech ? If Lipkin really was involved with advising on protocol design, then why did it not look like his study?
Why would it not be a replication of his process? Wouldn't that help to shorten his 5 year prediction of finding the golden holy grail of a biomarker?

Because its not his study. He is looking at one particular aspect. This is a much broader study. There is no process of his to replicate. Who knows what his 5 year prediction was based on, but studies like this one can only help. I am sure if he advised on this study then he has included as many tests as he believes relevant.

 

[viggster]

I have decided that having a healthy post-lyme, and a functional movement disorders group is a luxury that we cannot afford. Due to ME/CFS being heterogenous there is the real risk of this study being underpowered. My pessimistic estimate is that 1/3 of patients fall within the largest subgroup, with the other 2/3 falling into several smaller subgroups, probably with some misdiagnoses as well (less likely with obvious post-infectious onset but still possible). We need enough participants to ensure this 1/3 is big enough for statistical significance.

Looks like 40 patients + controls
http://www.meaction.net/2016/02/09/...al-questions-re-nih-clinical-center-protocol/

Ron Davis is starting with only 20 patients & yet I have not heard people complaining that his sample is too small.

 

[Denise]

Looks like 40 patients + controls
http://www.meaction.net/2016/02/09/...al-questions-re-nih-clinical-center-protocol/

Ron Davis is starting with only 20 patients & yet I have not heard people complaining that his sample is too small.

One of the things the ARHQ report (among others) called out was the sample sizes in studies.
I find it disturbing that the sample size for the NIH study is so small. It will be difficult to discern any signal(s) from such a small study.
And that doesn't help us develop the robust evidence base so badly needed in this field!