NIH post-infectious CFS study

[viggster]

Email from NINDS Director Walter Koroshetz to several patient advocates today:

"Dear colleagues,

Thank you for communicating your concerns. Having spoken to multiple patients with ME/CFS we believe that some of the concerns about the NIH intramural ME/CFS protocol are due to miscommunication on our part.

Please see posted notice. http://www.nih.gov/mecfs/eligibility-requirements-me/cfs-clinical-study-nih

Note that the NIH intent was always that the ME/CFS patients enrolled in the NINDS study would have post exertional malaise and qualify under multiple consensus criteria including the Canadian crieria. Reeves was being used only for stratification purposes. A detailed protocol will be posted soon.

We look forward to working together with the ME/CFS community to develop the science that leads to meaningful solutions for those who are suffering.

Best wishes,
Walter"

 

[ScottTriGuy]

I'm having a really hard time getting past this control group:

"have a functional movement disorder"

This seems very much like a neurological disease that has been psychologized. Sound familiar?

 

[duncan]

I get the sense that they figure saying less is better, at least for the time being.

It would seem, too, that fatigue still may be the key symptom - at least based on the Lyme cohort, whose only symptom exclusion apparently is fatigue. So, PTLDS patients (sans fatigue) can be part of this control? Man, this could be a proverbial minefield.

 

[viggster]

I get the sense that they figure saying less is better, at least for the time being.

Good grief. Did you read this? "patients enrolled in the NINDS study would have post exertional malaise and qualify under multiple consensus criteria including the Canadian criteria"

This is NOT a study of fatigue as a symptom.

 

[duncan]

I can't tell based on this short write-up what the focus will be.

I will want to see their definition of PEM as well.

I'm not trying to be unreasonable, merely trying to cover all bases.

You infer nothing from that Lyme cohort write-up @viggster?

 

[Denise]

I hope it doesn't take long for NIH to clear up its miscommunications.
I want to read the full protocol and as much additional information as possible about this study.

 

[viggster]

I will want to see their definition of PEM as well.

You infer nothing from that Lyme cohort write-up @viggster?

They are using the CCC - so what is the CCC definition of PEM?

They want to compare us to other groups...ok, that's fine by me. I'm ready to hear more about why they chose these two & what they hope to achieve.

 

[duncan]

I think most of us are ready to hear more about the entire effort - as detailed as possible.

I would not assume they will be using the CCC definition of PEM. They may be, but I think it dangerous to assume that.

As for comparing us to different groups - I feel it matters which groups, or it should. It clearly matters to the NIH; after all, they did select these control groups for a reason.

So, hopefully we will be getting Round 2 of the details very soon. I, too, am a fan of transparency.

In the meantime, I will probe for mines.

 

[viggster]

I would not assume they will be using the CCC definition of PEM. They may be, but I think it dangerous to assume that.

IT'S NOT AN EFFING ASSUMPTION, IT JUST CAME FROM THE HEAD OF NINDS

 

[duncan]

I think you and I may be disagreeing about that.

I do not see in that new paragraph where they define PEM. I think where they do refer to fulfilling multiple consensus criteria (and PEM is mentioned there), they are talking about ME/CFS.

 

[Denise]

IT'S NOT AN EFFING ASSUMPTION, IT JUST CAME FROM THE HEAD OF NINDS

@viggster - I am concerned about the intensity of your response. (edit to add - It feels like an attack on those who are more skeptical than you are.) Please understand that this disease has robbed us of many many years/decades of our lives and during that time we have heard many platitudes and "promises". I find trust difficult after being let down so many times. The let down is painful.
Hopefully when all of the study information comes out, we will be able to review it and see if it is good as we are being told it will be.

 

[Aurator]

(edit to add - It feels like an attack on those who are more skeptical than you are.)

Except that I'm pretty confident that viggster is in a much closer position to what's going on behind the scenes than most of us are. So instead of being less sceptical than others he may simply be more knowledgeable. We'll find out soon enough what the deal with the CFS study is, assuming we haven't already put all the researchers off the idea by now.

 

[Sean]

Please understand that this disease has robbed us of many many years/decades of our lives and during that time we have heard many platitudes and "promises". I find trust difficult after being let down so many times. The let down is painful.

Yes, we are all in that boat.

But if you don't allow for the possibility of change at the NIH, then you will never see it and take advantage of it.

 

[viggster]

@viggster - I am concerned about the intensity of your response. (edit to add - It feels like an attack on those who are more skeptical than you are.) Please understand that this disease has robbed us of many many years/decades of our lives and during that time we have heard many platitudes and "promises". I find trust difficult after being let down so many times. The let down is painful.
Hopefully when all of the study information comes out, we will be able to review it and see if it is good as we are being told it will be.

Apologies if that was a little too intense. I guess I'll say this: It's one thing to take the position of "I don't believe anything anyone at NIH ever says." That's not real helpful, but I can sort of understand it for long-term patients. Another step beyond that is, "I'm not even going to listen to them." And that is a distinctly unhelpful and unproductive stance to take.

 

[Kati]

Apologies if that was a little too intense. I guess I'll say this: It's one thing to take the position of "I don't believe anything anyone at NIH ever says." That's not real helpful, but I can sort of understand it for long-term patients. Another step beyond that is, "I'm not even going to listen to them." And that is a distinctly unhelpful and unproductive stance to take.

Much agreed. What is important to me at this point is what they have to say for themselves. Did they do their homework? Are their intentions sincere and are they competent.

What I still don't understand is how the study publishing ahead of time, the mention of Reeves criteria, the choice of comparison group come about, because their explanations so far are not making much sense to me.

It makes tomorrow's talk so much more important.

It is essential that they have patients trust. It is important they establish solid communication lines with the patients.They need to realize they cannot deal with one single patient or organization. They also need to realize that this study will not only impact US patients, but international patients.

Anyways... Rambling here... @viggster it's going to be an early one for you... i hope you're an early bird.

 

[medfeb]

I am encouraged by the recent communications from NIH and appreciate Dr. Koroshetz' message. But with the false start and given how screwed up studies have been because of bad definitions and the use of bad methods to assess symptoms, I think its natural that people are going to want to get more information and see the updated protocol. There's a lot at stake.

 

[viggster]

They need to realize they cannot deal with one single patient or organization.

Koroshetz emailed at least 5 individuals/organizations today - including an organization petitioning him to not conduct the study. I'd say that shows a willingness to engage. Part of the communication problem is that people at NIH do not know who to deal with in the patient community. It's a fractured community with no big organization speaking for a majority of patients. That leaves a bit of a messy situation.

 

[Sean]

Part of the communication problem is that people at NIH do not know who to deal with in the patient community. It's a fractured community with no big organization speaking for a majority of patients. That leaves a bit of a messy situation.

Worth repeating.

 

[Forbin]

Personally, I'd prefer that they used the ICC definition of PEM (which they call PENE). It more prominently mentions the possible exacerbation of "flu-like symptoms" and the fact that PEM can be delayed by hours or days. That info is scattered about the CCC and IOM documents, but it is nicely visible in the initial mention of PEM in the ICC.

 

[Anika]

I think they'll do some interesting tests on the group they select. I don't know how well that group will represent long term or more serious illness, but I do not assume bad intent. They may not have a good appreciation of the limits of this cohort, and be tempted to overgeneralize. The selection of inappropriate control groups may haunt us.

In principle, I could understand recovered Lyme
patients as an interesting infectious control. That assumes strict screening and assurances of an enduring recovery (return to full pre-illness activities for a sustained period of time) that I am skeptical we'll see.

However, I can see no justification whatsoever for any "functional disorder," FMD or otherwise, to be used as a purported "control". To me, this seriously undermines the study. It would make more sense to include an inflammatory or neurological illness, not considered as functional.

It is tone-deaf for NIH to include as controls one MUS disorder and another often associated by Dr.'s of a certain age or mindset as MUS when not resolved by a standard antibiotics course. This is not my personal view of those illnesses, but what I have learned through this and other forums about close encounters with the medical system..

Like it or not, there are political dimensions to illness and to medical research. It does us no favor to ignore their potential impact, as hopeful as we are about getting any NIH recognition.

I think NIH should go back to the drawing board and take a few months to fix this.

We don't get many shots at a study like this. Color me very disappointed in the study design insofar as we know it. NIH can do better, and should.