NIH intramural research program update

[Kati]

Kati, may I post these on Simmaron Research, if I give you credit, and how do I identify you for that credit?

There is no need to credit me, use the slides as you wish for education, advocacy, sharing purposes. However should you profit financially from them I would ask that you share the dividends

 

[viggster]

The CFIDS Assoc. under KK thought they could be friends w/ CDC and NIH. It set us back decades.

Did NIH ever propose a study like this in that era?

 

[A.B.]

Even if mouse 'models' were any use at all (doubtful), how on earth can they create a model of an illness with unknown aetiology and unknown biology? Not to mention such complexity that it requires sufferers to be able to describe how it affects them.

This blogpost of mine details what a cancer researcher thinks of 'mouse models'.

What a waste of time, money and innocent lives.

I don't think there's a mouse model.

They will inject cerebrospinal fluid and antibodies into normal and humanized mice, to see if they become sick.

My understanding is that the humanized mice are obtained by essentially transplanting the immune system from patients into mice.

 

[viggster]

I don't think there's a mouse model.

They will inject cerebrospinal fluid and antibodies into normal and humanized mice, to see if they become sick.

My understanding is that the humanized mice are obtained by essentially transplanting the immune system from patients into mice.

Thank you for clarifying...that is correct. A little bit of semantics here...what they are proposing is a type of mouse model, but not a mouse that is bred specifically to have ME traits. Many mouse models of other illnesses are bred with certain genetic profiles, which is not the case here.

 

[Denise]

Did NIH ever propose a study like this in that era?

In 2011, NIH held a SOK (State of the Knowledge) Workshop on ME/cfs. They were supposed to develop (and release) a research plan based on info from the SOK.
NIH later claimed that the plan would be internal only. (I am not referring to the report which was released quite some time after the SOK.)

I want things to be changing. I want forward movement. I want agencies to truly have patient's best interests in mind. But I also want to SEE for myself, all of the documents pertaining to this study.
I would also like to know how much cross-coordination is going on for the study between CDC and NIH (Unger mentioned that the NIH study would use many of the same instruments the multi-site study is using....).

 

[Sasha]

Principal investigator: Avindra Nath.
Lead clinical investigator: Brian Walitt.

So there are some concerns about Walitt, while Nath is looking good with his comments on welcoming patient involvement and AIDS activism.

Does anyone know what their roles are exactly? I suspect ultimately Nath is in control here.

I don't know enough about the AIDS experience but when researchers talk about involving patients, they usually mean in terms of patients telling them what it's really like to be ill, rather than telling them that they've got their theoretical models and hence study designs wrong. I hope Dr Nath is up for the latter.

 

[A.B.]

I don't think there's a mouse model.

Okay, maybe it is a mouse model after all... but it sounds sensible, unlike other mouse models (I recall mice exhausted from exertion being described as mouse model for CFS somewhere).

 

[bullybeef]

Epidemic Myalgic Encephalomyelitis: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1604957/pdf/brmedj00128-0006b.pdf

 

[viggster]

I don't know enough about the AIDS experience

AIDS patients were very involved in study design at NIH starting around 1991. Nath mentioned ACT Up positively today & said a patient advisory committee will help out with this study. Those are both very positive developments.

 

[Valentijn]

This is not a study of those two illnesses.

Well, he seems to think they're all due to central sensitization, so he probably doesn't see any distinction.

 

[viggster]

@viggster I know you wrote that fine letter, and have done some other advocacy work.( For which I am truly grateful -- Thank you) I am guessing you feel heard on a more personal level than most of us b/c of that. Please understand that 30 years of non stop pain and being fed only shit can change one's perspective.

Thank you, and I understand that. I know I look like a cheerleader for NIH. I know not everything is perfect with this study and there are things some people will be unhappy about. But I really think this study looks very deep & thoughtful. It is building on previous work by Klimas, Lipkin, etc. They're investigating just about everything - immune profiles, antibodies, microbiome, protein expression, brain activity, etc. The plan is to a) document abnormalities, b) find biomarkers, c) run treatment trials. That is a long-term commitment. The 40-patient inpatient study is just the beginning. Patients will be involved in all of it. Nath seems like he 'gets it'. There is a LOT to be positive about here.

 

[beaker]

Did NIH ever propose a study like this in that era?

ETA It seems you posted while I was writing. So I think we're good ?

Brian, I am not interested in arguing. I'm not against this at all. For the most part, I'm happy about it actually. I do have specific concerns, which I haven't yet had the chance to mull over more and put down in writing.
My response to you was to explain why some who have been around longer would feel the way they do. I think it would be nice if you could respect that. Wounds run deep. Lives have been lost. You don't have to agree. Some understanding of feelings and reactions would be nice. We are all in this together. I am not interested in dividing patients, or taking sides. I just want to be well.


To respond to your question :

This technology was not available then. It's hard to compare the studies.

Strauss had in patient studies that supposedly did all sorts of thorough testing of the day. I know someone who was there. It's been a long time ago.... the details escape my brain.

 

[Sidereal]

Strauss had in patient studies that supposedly did all sorts of thorough testing of the day. I know someone who was there. It's been a long time ago.... the details escape my brain.

I think this was mentioned in Osler's Web or somewhere else. My memory of it is foggy but (using technology of the 1980s) the CDC did have ME/CFS patients stay there to be poked and prodded and they were sent home told there was nothing wrong with them.

 

[duncan]

I want to say up front - since I was responsible for so much ass-dragging on earlier threads - that I thought there was some real merit to this NIH study in terms of the biologics (?) involved. Some of this looked very impressive to me.

In fact, I would consider volunteering for the study, only I cannot; they won't let me because I have been sick longer than five years. I'm curious about that, btw.

But here's the thing. I've seen other very comprehensive NIH studies that generated very little. Arguably, they hurt their respective community. Severe patient complaints were reduced to echos of the aches and pains of every day life. That can happen when there are few established and relevant objective tests - Hell, I've seen it happen even when there ARE objective tests. And it certainly can happen with subjective metrics.

With that in mind - and not losing sight of the need to have the control groups adequately explained - I think it would be a big positive if integrated into the protocol was a patient oversight committee, to act as contributors and overseers of not just the broad process, but which would have leeway into monitoring some of the subjective or interpretative results.

It's just a suggestion.

 

[beaker]

In fact, I would consider volunteering for the study, only I cannot; they won't let me because I have been sick longer than five years. I'm curious about that, btw.

n.

Lipkin's studies published last year showed a differentiation of immune profiles for first few years( I think they had cut off of 3 yrs in their study) of illness versus later on. Which basically proved what MEcfs docs and patients have long known that if you are going to get better it's in the first few years and that many get at least a small bump up or change of some kind at 3-5yr mark. Since Lipkin is advisor, I would guess it is based on that. They want the more acute phase of the illness, and to keep a more homogenous group of immune profiles.

 

[viggster]

Lipkin's studies published last year showed a differentiation of immune profiles for first few years( I think they had cut off of 3 yrs in their study) of illness versus later on. Which basically proved what MEcfs docs and patients have long known that if you are going to get better it's in the first few years and that many get at least a small bump up or change of some kind at 3-5yr mark. Since Lipkin is advisor, I would guess it is based on that. They want the more acute phase of the illness, and to keep a more homogenous group of immune profiles.

I also suspect that the 5-year cut-off is because as time goes on, patients develop more co-morbid conditions and untangling all of that gets harder and harder.

 

[duncan]

thanks, @beaker .

Maybe they could double up and cover 80 patients (40 from less than 3-5 years, 40 from more), and differentiate between the two stages.

Probably too little $'s would be the objection. But the economies in terms of logic and time and effort, and yes, dollars, would be hard to dispute.

 

[Scarecrow]

if you are going to get better it's in the first few years and that many get at least a small bump up or change of some kind at 3-5yr mark. Since Lipkin is advisor, I would guess it is based on that. They want the more acute phase of the illness, and to keep a more homogenous group of immune profiles.

As they are going to be tracking patients over time, I think that they will be looking for other changes as the generally high cytokine levels transition to generally low, assuming the cytokine findings are reproducible.

 

[BurnA]

I genuinely don't understand enough to comment on specific testing. But when I see the amount of testing they have planned and compare it to many previous studies published recently, I get the impression the initial phase of this study dwarfs anything previously done. And that is only the initial testing which is there to point them towards more specific testing.
This has huge potential from what I can see.

 

[Snowdrop]

I agree that the study looks very hopeful--something that might yield very relevant data.

NIH has some very big trust fences to mend though. This community has been repeatedly burned--so I would say that there needs to be a lot of open dialogue/transparency-- a lot of listening on their part--and then clear responses from them that show they understand ME from our point of view.

While everyone of us I'm sure hopes this is the day we move forward--I am concerned about some of the names put forward as investigators. They need to be communicating to us that they are not looking to spin this as somatic in any way--they are not looking to suggest our perpetuating this illness--effectively that they will not interpret the data beyond what is supportable.

The CSS view is too narrow to truly be useful. And the interpretation that we can think ourselves out of it is not even supportable.
It is the interpreting that goes way beyond anything supportable that worries me. They need to come clean about their preconceptions/bias/assumptions.

And Im talking about some official statement of position regarding their views on ME.

Also, do these people support investigating PACE?

This is more than would normally be expected from a group of researchers. But our circumstances in this illness vs the medical community are not normal.