NIH intramural research program update

[Snowdrop]

As a person with ME I want to see Walitt removed from doing anything in an ME study.
There is no trust. Even if he promised to adhere to following good criteria for selection--it's simply his word.

 

[Sasha]

Why is this a concern. As long as the ME/CFS patients are nominated by recognised Dr.s and fulfill the criteria then we should be ok ?

No, because:

No, it's "functional movement disorder", which the NIH consider to be a psychological disorder presenting as a neurological one - hence everyone's concern that this is another bunch of patients with a poorly understood organic illness who are being inappropriately dismissed as psych patients and who would therefore be catastrophic for us as a control group if we look similar to them.

 

[BurnA]

No, because:

Yes but you said : If we look similar to them.

Do you not believe the testing being done is thorough enough to detect an ME / CFS patient from a non patient.?

Why on earth would we look similar to them?

I don't think you can argue for the exclusion of a group of controls based on a hypothetical result that you don't like.

 

[Sasha]

Yes but you said : If we look similar to them.

Do you not believe the testing being done is thorough enough to detect an ME / CFS patient from a non patient.?

Why on earth would we look similar to them?

I wonder if we might look similar to them in some respects. Doctors don't know what's wrong with them - suppose something is wrong with them organically and there's some overlap with our condition?

I think the NIH study has healthy controls as well. I don't understand why an FMD control group is necessary.

Here's Wikipedia on FMD:

Functional Neurological Symptom Disorder (FNsD) is a neurological disorder for which very little is currently known. It is an umbrella term for a variety of symptoms which look similar to those caused by neurological conditions such as Multiple Sclerosis (MS) or Parkinson's Disease, including weakness, fatigue and seizures. It is currently believed that Functional Neurological Symptom Disorder arises from a problem with the patient's Central Nervous System, which is not sending and receiving signals correctly.[1] The brain of a patient with Functional Neurological Symptom Disorder is structurally normal, but functions incorrectly.[2]

Currently, traditional tests and investigations such as blood tests, MRI and CT scans will show no abnormalities in patients with FNsD; however, it has been discovered that there is a difference in blood flow to certain key areas of the brain when scanned using Functional Magnetic Resonance Imaging (fMRI). Although currently there is no way to 'see' whether a patient has FNsD, their symptoms are real, and often cause disability and distress to the individual.[3] It is widely accepted that those with FNsD are equally disabled as those with Multiple Sclerosis or Parkinsons, and often are more distressed.

The first mention of Functional Neurological Symptom Disorder in literature dates from Ancient Egypt, and little progress has been made in understanding the condition since. FNsD has also previously been referred to as Hysteria and Conversion Disorder (CD). The term Conversion Disorder is still used by some clinicians, however refers specifically to those who have a psychological stressor causing their symptoms, such as a traumatic event or mental illness. It is "a psychoanalytic concept that describes the occurrence of motor or sensory neurological symptoms other than pain and fatigue that cause distress, are not explained by disease, not malingered but are thought to relate to psychological factors"[4]

 

[Sasha]

@Jonathan Edwards, do you have a view on this?

 

[Jonathan Edwards]

@Jonathan Edwards, do you have a view on this?

I am finding it confusing.
I have never heard of any of these people except Ian Lipkin, which worries me a bit.
The animal model stuff sounds suspiciously like animalmodellobabble to me, although very rarely animal models of this sort do actually show something surprising - like the B27 rats for ank spond. So maybe worthwhile.

I worry that nothing is said about getting patients from an unselected primary population based cohort. If this is not done the recruits could easily be people who are unrepresentative - especially if derived from a clinic or the internet.

The cohort number also looks small - 40? I would start with 200 or 500. Everybody who has tried to get biomarkers with ME has struggled with sizes like 40.

But on balance I think it must be good that money and time is being put in to ME. If they make mistakes then that can be brought to light. One thing that I think we have achieved in the last two years is a means of getting critique of bad studies into the light of day. I realise that Tom and Alem and others have been doing this for years but for whatever reason if a bad study is now published the authors are likely to be made aware of their errors very sharpish. And if they bullshit they are likely to be taken apart much more publicly.

The other thing is that these things snowball. If there is work going on then it will breed more work. The best team member I ever had always used to ask me if an experiment was worth doing. I usually said I couldn't see much point. She would then always go and do it without my say so. And it is only for that reason that we fell over the answers. We need to be sure that experiments do not breed misinformation, as we have seen before, but if it were me I would not want to try and pull the wool over the eyes of Phoenix Rising Incorporated. It can get expensive.

Let's give it the benefit of the doubt. (And although the FMD controls seem cockeyed, I think they are legitimate. Disease controls are always very powerful.)

 

[searcher]

I put this on another thread but wanted to add it here as well as it shows that we still have the ability to influence the study and that the PI is listening:

Wilhelmina Jenkins (who asked the questions about the Patient Advisory Committee and RFAs during the Q&A) just posted this on the #MEAction fb page:

"I spoke briefly with Dr. Nath after the Grand Rounds presentation and he emphasized that the study is at the very beginning and is open to changes. He repeated his desire that patients be involved in the process."

 

[Comet]

The other thing is that these things snowball. If there is work going on then it will breed more work.

This would be wonderful. The more respected, legitimate research we get, the more respect we will get as patients from the medical community too, I believe. This in turn, could lead back to more research, etc.. etc...

 

[Sasha]

I am finding it confusing.

Glad that's not just us.

But on balance I think it must be good that money and time is being put in to ME. If they make mistakes then that can be brought to light. One thing that I think we have achieved in the last two years is a means of getting critique of bad studies into the light of day. I realise that Tom and Alem and others have been doing this for years but for whatever reason if a bad study is now published the authors are likely to be made aware of their errors very sharpish. And if they bullshit they are likely to be taken apart much more publicly.

Much better to head a bad study off at the pass than try to deal with the fallout later, once it's done and published. We're still fighting against the damage caused by PACE five years after the publication in The Lancet and ME patients' health is being damaged by it every day.

(And although the FMD controls seem cockeyed, I think they are legitimate. Disease controls are always very powerful.)

But that's just the thing - the NIH seem convinced it's not a disease control.

 

[Jonathan Edwards]

I put this on another thread but wanted to add it here as well as it shows that we still have the ability to influence the study and that the PI is listening:

Sounds good.
I think part of the budget should be for a secretary whose sole job is to check PR posts every morning and give feedback to the researchers. Applicants should provide a CV and must be of any gender, less than seven foot six inches tall and have ME/CFS. (Come to think of it there probably already is somebody on the team checking ...)

 

[Jonathan Edwards]

But that's just the thing - the NIH seem convinced it's not a disease control.

In what sense?

 

[A.B.]

The cohort number also looks small - 40? I would start with 200 or 500. Everybody who has tried to get biomarkers with ME has struggled with sizes like 40.

Can you cite some examples that could convince the NIH?

 

[Sasha]

In what sense?

In the sense that they've said they don't consider FMD an organic disease but a psychogenic disorder.

(Has anyone got the quote on that? It was a few days ago now.)

 

[Marco]

I worry that nothing is said about getting patients from an unselected primary population based cohort. If this is not done the recruits could easily be people who are unrepresentative - especially if derived from a clinic or the internet.

At last someone understands Reeves' rationale.

 

[A.B.]

I put this on another thread but wanted to add it here as well as it shows that we still have the ability to influence the study and that the PI is listening:

Maybe Nath is looking for an excuse (read: enough patient feedback) to dump the psychobabblers and whacky control groups?

(this is half joke, half wishful thinking in case it's not obvious)

 

[BurnA]

Has anyone seen a clearly defined goal for this study ?

The OMF project is clearly "The End ME/CFS Project"

It would be nice if the NIH study was called something similar. That way we would know they won't stop until the end.

 

[searcher]

The goal seems to be to find biomarkers and treatments for the disease based on Phases II and III.

 

[Scarecrow]

At last someone understands Reeves' rationale.

Can we just not use his questionnaires.

 

[Jonathan Edwards]

Can you cite some examples that could convince the NIH?

Just about any paper on biomarkers in CME/CFS I would say. They must know this.

 

[viggster]

Just about any paper on biomarkers in CME/CFS I would say. They must know this.

If you look at Nath's slides you'll see the 40-patient phase 1 is a broad investigation of biological abnormalities. Phase 2 is a validation of potential biomarkers found in phase 1. Phase 3 is treatment. There will be ever larger numbers of patients as this research program advances. The 40 patient phase 1 is just the start.