NIH post-infectious CFS study

[Bob]

I don't know enough about FMD to have an opinion about it, except that, like others here, I'm suspicious of the diagnosis. I suspect that, in many/most cases, it's a false diagnosis. But that's a suspicion rather than an informed opinion.

But if a researcher were to take the FMD diagnosis at face value (i.e. they believe that the patients suffer purely from a psychological/functional illness) and the researcher believes that ME/CFS is a biomedical illness, then the reasoning for including the FMD control group is excellent and very appropriate. It couldn't be better. Reason being that they would want to contrast ME/CFS with a purely functional illness (with some overlap of presentation?) to demonstrate the immunological differences between the groups. i.e. to demonstrate that ME/CFS is not a functional illness.

But there are a few issues here, and they are mainly trust issues:
1. Based on history, many of us don't trust that government agencies want to demonstrate that ME/CFS is not a functional illness.
2. Many of us don't trust that FMD patients will have been accurately diagnosed, and that FMD is indeed a functional illness. But rather, like ME, the patients are disbelieved, the research has been corrupted, the illness has been mis-categorised and the patient group has been inappropriately 'owned' by psychiatry.
3. The other issue is that ME/CFS patients can have neurological signs and symptoms that are readily dismissed as functional issues, despite MRI research showing brain differences in ME patients. So there may be overlap between the groups. I know a number of ME patients who get various types of partial paralysis and/or epileptic symptoms.
4. We suspect that many PANDAS (and similar) patients are misdiagnosed with FMD, whereas it has a viral cause.

 

[Bob]

I think the webpage has been taken down now:
http://clinicalstudies.info.nih.gov...l?A_16-N-0058.html@chronic@fatigue@syndrome@@

 

[Bob]

@Bob, you may have missed parts of the Lyme wars, and a major front for the last many years has been in Bethesda, MD, USA.

I've been to the NIH for Lyme. I am familiar with the mindset.

The collateral damage to this CFS study might be substantial if Lyme remains in the protocol.

You're right, Duncan, I have no insight into the "Lyme wars". Please feel free to provide more info, if you're feeling up to it. And I'm interested in what you mean by "collateral damage" in this context.

 

[BurnA]

How do you think patients should be chosen then, if not by experts like Levine who have 25+ years experience with ME?

This disease has no biomarker. So yes, any of the disease experts could send them something other than "real" patients.

Just curious @halcyon, if the requirement for being a "real" patient is a biomarker, then how are any of us "real" ?

 

[Scarecrow]

It's now been clarified that there will be 40 PI-ME/CFS patients, and it will be a longitudinal study of those patients.

Thanks, Bob. Was up in the middle of the night reading but missed that bit.

 

[duncan]

It might be hard, I think, to overcome possible institutional bias against CFS at the NIH, even without the baggage associated with Lyme and FMD's.

@Bob asked about Lyme. I can only speak to my experience. My experience is that there is an entrenched bias against continued Lyme symptomology after IDSA-recommended treatment. I experienced what I can only describe as hostility and disdain from some at the NIH.

You have to understand how the testing will be done (at least if it is similar to how I was tested at the NIH). As with medicine in general, many disciplines at the NIH are siloed. It's not as if all of the testing will be done by whoever is assigned to this CFS study. Things are farmed out, both on-campus and off.

So, if there is an inherent bias against CFS held by some who perform the testing, and the groups that are required to contribute also see in the protocol Lyme and FMD's, I worry that some of those tests that are primarily subjective in terms of interpretation could come into play more than one might imagine.

You would think Science would trump the scientist, but I do not believe this is always the case. It seems to me one controversial subject (CFS) to be studied is more than enough - at least at this stage of the game.

 

[Nielk]

Susan Levine is the name I heard + others involved in CDC 5-site study.

Why do we have to get hearsay information from a patient or an advocate? Is this how NIH chooses to disseminate information to the ME/CFS community?

Is this how they go about with their studies in other diseases as well?

I think that we should wait until there is something official coming straight from the NIH.

This is not a proper communication venue and is open to much misinterpretation.

Has Courtney become the spokesperson for NIH?

If this information is truly already set, why is NIH officially holding back from informing us?

They are so understaffed? They are an agency with a huge budget.

This is not acceptable.

 

[BurnA]

Why do we have to get hearsay information from a patient or an advocate? Is this how NIH chooses to disseminate information to the ME/CFS community?

Is this how they go about with their studies in other diseases as well?

I think that we should wait until there is something official coming straight from the NIH.

This is not a proper communication venue and is open to much misinterpretation.

Has Courtney become the spokesperson for NIH?

If this information is truly already set, why is NIH officially holding back from informing us?

They are so understaffed? They are an agency with a huge budget.

This is not acceptable.

I don't think anyone is using this as an official channel. It's a forum and I am glad we have some insider information here.
Of course I will hold judgement until an official commmunication but I wouldn't want to deter people from sharing information here.

 

[Nielk]

I don't think anyone is using this as an official channel. It's a forum and I am glad we have some insider information here.
Of course I will hold judgement until an official commmunication but I wouldn't want to deter people from sharing information here.

Yes, but this list of answers from Courtney is being posted, published and share on all social media. This is not professional and is very confusing to patients.

 

[jimells]

Their FMD "control" group is still a huge problem in every way imaginable. Those patients need their own quality research, with healthy controls. Comparing two very controversial groups like ME/CFS and FMD with each other seems like a shockingly bad idea at this stage, with no legitimate purpose or potential merit, not to mention added expense. It also looks like they are starting with the assumption that FMD and ME/CFS are basically the same thing, which is an extremely bad sign.

And just for giggles let's throw in a third controversial group of Lyme patients, or ex-patients, or something. A true Trifecta.

Every time I read the protocol I get the feeling they are mocking us:

"Patients abhor Reeves? Then that's the protocol we'll use. They resent the name "CFS"? So make sure the word "fatigue" appears in the participant recruitment notice 26 times. And since patients' biggest obstacle is the psychosomatic nonsense, we'll really slap 'em in the face with a "FMD" comparison group."

I think the folks at NIH involved in this have learned and they know they need to do a better job with communicating to us.

I dunno. I don't think more chocolate sauce from the Public Relations department will improve the taste of this shit sandwich.

 

[jimells]

That should be a rhetorical question. What are the two major competing theories on etiology of the disease? They are testing if there is any difference between CFS and a psychogenic disease.

Except this is allegedly an observational study with no hypothesis. "There is a difference between CFS and FMD" would be a hypothesis, I'm pretty sure.

 

[jimells]

Ian Lipkin consulted. Boy this is a tough crowd.

They've been beating us with hoses for 30 years. In that time, a person either gets tough or they don't survive. Every day that passes lessens the chance that I might live long enough to get some relieve from the daily misery. You are damn right this is a tough crowd - I sure hope it gets tougher, and soon.

(sorry, didn't mean to yell at you. I know it's not your fault)

 

[jimells]

I think the webpage has been taken down now:
http://clinicalstudies.info.nih.gov...l?A_16-N-0058.html@chronic@fatigue@syndrome@@

Haha, it is still there but it is now completely blank. The page has no source code. Maybe they can't find the Delete button.

 

[beaker]

Ian Lipkin consulted. Boy this is a tough crowd.

30 years of eating shit makes us tough.

 

[jimells]

Even if NIH fixes the worst problems with this trial, in the long run it will probably be of limited use because it is not part of a comprehensive research. It feels very much ad hoc, unless there is some strategy that NIH has not bothered to reveal.

When one looks at Fluge and Mella's research program, there are no patients complaining about it. The direction of their research is clear, visible, and comprehensive. Not only are they testing more than one treatment, they want to know why it works and who are most likely to benefit. You know, a real research program.

When one looks at the NIH research program it looks like the inside of a ping pong ball - bright, featureless, and opaque.

What we really need from NIH is actual support for extramural research and re-establishing the Cooperative Research Centers so there is some continuity and a place for researchers to build up expertise and pass it on to clinicians. This is not a new concept; there used to be three research centers, now there are none. Why?

Here are some other disease programs that did not lose their cooperative research centers:

Asthma and Allergic Diseases
Hepatitis C
Muscular Dystrophy
Urology
Sexually Transmitted Infections
AIDS

 

[BurnA]

Even if NIH fixes the worst problems with this trial, in the long run it will probably be of limited use because it is not part of a comprehensive research. It feels very much ad hoc, unless there is some strategy that NIH has not bothered to reveal.

When one looks at Fluge and Mella's research program, there are no patients complaining about it. The direction of their research is clear, visible, and comprehensive. Not only are they testing more than one treatment, they want to know why it works and who are most likely to benefit. You know, a real research program.

When one looks at the NIH research program it looks like the inside of a ping pong ball - bright, featureless, and opaque.

What we really need from NIH is actual support for extramural research and re-establishing the Cooperative Research Centers so there is some continuity and a place for researchers to build up expertise and pass it on to clinicians. This is not a new concept; there used to be three research centers, now there are none. Why?

Here are some other disease programs that did not lose their cooperative research centers:

Asthma and Allergic Diseases
Hepatitis C
Muscular Dystrophy
Urology
Sexually Transmitted Infections
AIDS

I understand the negativity surrounding this but I am relatively new to this disease I would say that I remain hopeful.
To say it is not part of comprehensive research may be true but we don't know what they will find during this study nor what they might follow up with. If this is a hypothesis generating study by it's very nature it would be hard to define it within a comprehensive study. Perhaps the comprehensive studies will follow.
By comparison fluge and mella have a very clear line of investigation ( as does UCL ) as these studies are driven directly from rituximab and how that drug may work.
I dont think you can compare the two studies really. They are different animals.

Isn't this study more similar to the OMF research which is basically an open book in terms of what happens next ? Obviously more funding for all these studies is required, no doubt about that.

I realise this may not be perfect but is it better than where we were this time last year ?
Everything has to start somewhere so why can't this be the starting point ?

 

[halcyon]

How do you think patients should be chosen then, if not by experts like Levine who have 25+ years experience with ME?

My point is that expert referral is not a replacement for use of strict inclusion criteria. Again, I am going to assume that Reeves alone is what will be used until we hear differently directly from the NIH. The Millers aren't the de facto spokespeople for the NIH. We have no idea who they talked to at NINDS. Some of the answers don't make sense (patients will meet all criteria? Using IOM clinical criteria for research?) so it seems like a bad game of telephone to me so far.

 

[halcyon]

Just curious @halcyon, if the requirement for being a "real" patient is a biomarker, then how are any of us "real" ?

None of us truly are until the etiology is discovered and a biomarker is available.

 

[halcyon]

Except this is allegedly an observational study with no hypothesis. "There is a difference between CFS and FMD" would be a hypothesis, I'm pretty sure.

There's definitely a hypothesis in this study and it's ill-informed. Their hypothesis is that patients had an infection, the infection went away completely, and the patient was left with fatigue. This is not a widely accepted model of ME or CFS. If it was then Stanford, Lipkin, Chia et al. wouldn't be doing the research they are doing.

 

[viggster]

Why do we have to get hearsay information from a patient or an advocate? Is this how NIH chooses to disseminate information to the ME/CFS community?

You must have missed my post above.

- Someone at NIH inadvertently made the protocol public. This person submitted the protocol to an NIH Clinical Centers webpage & did not realize it would be published.
- A patient found the protocol and posted it here. Someone mistakenly said NIH had "announced" the protocol. They did not.
- NINDS is working on a webpage with additional information & context for the trial. Their plan was to post this page & answer FAQs at the same time they did announce the protocol.
- After the kefluffle of everyone seeing the protocol, several patients & advocates contacted people at NIH working on the new ME/CFS program to get additional information.