NIH post-infectious CFS study

[Bob]

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.

I understand your scepticism, but I couldn't disagree with you more, jimells. I think this is exciting research. It's exactly the type of research we need, in my opinion, and it's the same type of research as Ron Davis is doing. And they may have some tools and procedures available that Ron doesn't have.

(Whether they can do the study competently or not is another matter, but I don't think it can harm us to have an extra team on the case if they get the criteria right, and if they are honestly looking for biomedical differences. But I can't imagine that the lead investigator would get involved if he wasn't serious about it. Why would he bother? And, like others, I've also been very impressed by Vicki Whittemore.)

The two-day exercise test is interesting, in itself, and suggests they've been listening. But the study is so much more interesting than that; They're using cutting edge technology to investigate cellular, genetic and immunological changes during and after exercise. And that's another reason to suggest that they've been listening. (i.e. They're investigating the cellular effects of PEM!) How many studies have comprehensively investigated post-exertional genetic/immunological/cellular changes like that?

To me, this looks like a hugely important study. (But I have a habit of being over-optimistic, and I rely on the community to keep me grounded.)

 

[Nielk]

From MEadvocacy

MEadvocacy published a blog yesterday about the posted NIH Clinical Study 16-N-0058 Chronic Fatigue Syndrome Clinical Summary. We have initiated a petition calling on NIH to cancel the study, and calling for the CDC to cancel Dr. Nath’s presentation of this study at CDC’s Grand Rounds fast approaching, this Tuesday February 16th.

Since then, unofficial NIH responses to criticisms of the study protocol have been circulating on social media. Tracey Smith has written a great analysis of the remaining issues present with this proposed work.

Critical issues remain with the choice of comparison cohorts as well as the inclusion/exclusion requirements.

Please read about it here - http://www.meadvocacy.org/further_analysis_of_nih_clinical_cfs_study

 

[alex3619]

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.

FMD is an hypothetical illness category. There is not a mechanism that withstands scrutiny. These patients probably have serious things wrong, many many different serious things, and are jumbled together on the basis of a few symptoms. That is one of the issues that crippled CFS research. Even ME is not untouched, for while we can reasonably surmise that patients from one cluster outbreak have the same disease, we cannot be sure that two different clusters or any sporadic case are part of an homogeneous ME cohort.

FMD is psychobabble so far as I am concerned, though it shouldn't be if interpreted literally. Something is affecting movement and since gross abnormalities are not known its presumed that its to do with how body systems are functioning. The babble comes in if you presume this is due to mind, rather than physical causation. People holding this view are closet dualists on theory of mind.

 

[BurnA]

From MEadvocacy

I don't understand why the first step is a petition to cancel the study. Seems like a knee-jerk reaction.
Wouldn't it be more logical to engage in dialogue and see what repsonses are forthcoming ?

 

[alex3619]

It's only if they find nothing abnormal in both diseases that they could say that the lack of findings suggests that both diseases are functional.

Key word: suggest. It would still prove nothing.

 

[alex3619]

Wouldn't it be more logical to engage in dialogue and see what repsonses are forthcoming ?

The rational next step is to get more information. We have tidbits. If more information is not forthcoming (and they have claimed it will be soon) then we have an action point. Once we have the information, that is when the analysis can begin.

 

[anciendaze]

Two comments about large institutions: they never actually admit they have made serious errors which might have consequences for liability; they never throw past work away because that would be tantamount to admitting waste. (Causing waste is quite a different matter.) Like the IOM study this one seems to be a kind of institutional juggernaut which is already in motion. Admitting the Wichita cohort is based on a seriously flawed definition that removed anyone with physiological disease and is dominated by mental illness would not serve institutional purposes. There doesn't have to be any malice involved, we are dealing with something comparable to a glacier rather than intelligent life. Individuals you talk to are simply along for the ride.

Don't expect centralized change to go in any direction that helps. Problems are best solved elsewhere. The institution is dysfunctional.

 

[Aurator]

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.

I totally understand; the long history of ME patients getting shafted, the uncertainty whether it's destined to happen again, and the possibility that we may be having to wait patiently for several more years only for the privilege of discovering that our fears were well founded - all of this is terrible. I can't offer you any words of consolation except to say that it might still be too early to despair.

 

[anciendaze]

I understand your anguish jimells, but hope you are wrong. For myself, I'm just in a holding pattern that might last, not declining much. However, to a first approximation, I am already dead at my age, and would not represent a good subject for experimental treatment. My concern is for those who are younger, who might be able to salvage some life.

Even if research provides some therapeutic intervention we will still face the problem of our ranking in allocation of resources. Currently we come in behind hay fever. This is a problem which needs addressing.

Elsewhere I've mentioned the cost a friend was faced with, fortunately mostly covered by insurance, for the treatment of hepatitis C acquired via transfusion: $32,000/month for three months. Treatment costs generally run about $90,000 for a cure, now that one is available. The pathogen was identified years ago. You might want to keep $100,000 set aside if possible, since the predictable delay to approval would run into years.

Such cost increases cause me to speculate on new mechanisms for allocating funds. How about gladiatorial combat between patients with different diseases? Whatever the outcome there would be one patient removed from the rolls, leaving funds to treat the other.

 

[ScottTriGuy]

Such cost increases cause me to speculate on new mechanisms for allocating funds. How about gladiatorial combat between patients with different diseases? Whatever the outcome there would be one patient removed from the rolls, leaving funds to treat the other.

Finally I can put my Krav Maga skills to use.

 

[anciendaze]

Finally I can put my Krav Maga skills to use.

This is one situation where ordinary rules don't matter. You may also appreciate this pre-game pep talk Livia, in "I, Claudius", gave to her team of gladiators back in the good old days when rulers could be openly contemptuous of their subjects:

Gather ‘round . . . Now, these games are being held in honor of my son Drusus Nero, who is worth the whole lot of you put together. It’s my intention that these games shall be remembered long after you’re all dead and forgotten, even by your nearest and dearest. You’re all scum and you know it. But you have a chance here, some of you, to prove that you’re a bit more than that, and for those whom death doesn’t liberate, there will be plenty of freedoms handed out afterwards, to say nothing of gold plate and coin. But, I want a good show. I want my money’s worth. I don’t want any kiss in the ring stuff, and I don’t want my family watching two grown men pussyfooting around each other for half an hour before one of them aims a real blow. There’s been much of that in the past. And don’t think you can fool me either because I know every trick in the book, including the pig’s blood in the bladder to make it look as if one of you is dead, there’s been too much of that too lately. These games are being degraded by the increasing use of professional tricks to stay alive, and I won’t have it. So put on a good show, and there will be plenty of money for the living and a decent burial for the dead, and if not, I’ll break this guild up, and send the lot of you to the mines in Numidia. That’s all I’ve got to say to you.

Remind anyone of interactions concerning ME/CFS?

 

[dancingstarheart]

True............but then, they seem to have managed to reduce PI-CFS to just fatigue (as they lie to keep bolding throughout the description), so I wouldn't read to much into that.

Wouldn't the arthritis symptoms potentially come under post-Lyme disease syndrome or would they be more likely to be considered general arthritis. Is there anything specific about Lyme arthritis?

I have heard there are some Lyme patients after treatment that development arthritis in the knees but don't have the other symptoms common to chronic lyme patients such as fatigue, pain, etc.. But all I have found are studies on Lyme patients with arthritic knee pain compared to osteoarthritis patients (results shows each cohort has different abnormalities in the knees). http://www.ncbi.nlm.nih.gov/pubmed/8006888 So I would not worry about this except to provide this link that shows sometimes treated Lyme patient may eventually develop chronic Lyme disease. https://www.lymedisease.org/lyme-basics/lyme-disease/chronic-lyme/

Oh well. Strange cohort to choose.

 

[Valentijn]

Were they to find similar biological abnormalities in FMD and ME/CFS, it would not prove that they were both functional. It would prove the opposite, i.e., that they are both biological illnesses. Functional illnesses do not reveal biological abnormalities.

Certain psychobabblers are quite happy to suggest that changes in the brain, immune system, etc, are the result of the psychosomatism. And regardless of cause versus effect, they are even happier to throw behavioral and psychological therapies at it.

If that did happen, it would not be the first study to proclaim a physical indicator (or even cause) of a disorder the same authors assume to be completely psychosomatic. Such papers look quite ridiculous when reading them closely, but the resulting abstracts, titles, press releases, and media coverage won't reflect that.

It's only if they find nothing abnormal in both diseases that they could say that the lack of findings suggests that both diseases are functional.

If FMD patients are a control for ME patients, then the FMD patients are 100% assumed to have a psychosomatic disorder by the researchers. Controls are used to reduce independent variables, not introduce a vast array of new ones. Introducing a control group who the researchers feel might not have an accurate diagnosis would be weakening the trial, not strengthening it.

Hence FMD patients are not suitable controls for the exploratory study of another disease. They only make sense in the context of searching for similarities, or controlling for presumed similarities. And the only plausible presumed similarity between ME patients and a group that they steadfastly believe is psychosomatic, is that neither group has a physical illness.

 

[anciendaze]

There is an aspect of the argument about the role of functional mental illness which seems to completely elude researchers. There may well be biological similarities between ME/CFS patients and those commonly diagnosed with mental illness. What everyone seems to be overlooking is that we can demonstrate there exist some patients without the gross disturbances in cognitive and emotional function called mental illness, yet who do have impaired physical functioning indicating a chronic pathological process, not progressive disease. This is actually a rare opportunity to make progress in understanding physiological causes of mental illness apart from studying that illness itself.

If these patients have the same pathological process as those who are mentally ill then one obvious conclusion is that they have somehow acquired superior coping skills which keep them sane. Studying what they are doing right would be of value to psychiatry, (not that I really expect this to happen.)

If the pathology differs only in degree, then these represent a research opportunity to study the pathological process without the substantial confusion caused by severe and possibly irreversible cognitive and emotional impairment.

Either assumption leads to an emphasis on creating cohorts that do not include patients with diagnosed mental illness, a serious confounding factor. Should the pathology be quite distinct, we have a more traditional argument for choosing research cohorts without mental illness.

Personally, I think there must be an overlap in conditions, but I also think secondary depression due to quite reasonable causes is a serious complication that should be avoided in initial research, since this appears possible, even if that means I would be excluded from a research cohort. Solving the problem is more important than my fate.

 

[lansbergen]

Personally, I think there must be an overlap in conditions, but I also think secondary depression due to quite reasonable causes is a serious complication that should be avoided in initial research, since this appears possible, even if that means I would be excluded from a research cohort. Solving the problem is more important than my fate.

Yes

 

[Forbin]

@Valentijn
I share your concerns, given what's happened in the past, both in the press an in academia.

However, it would be incredibly easy to attack the "science" of the researchers if they claimed that since disease (A) shows certain abnormalities (or the lack thereof), and disease (B) shows the same abnormalities (or lack thereof), and since disease (A) is presumed functional, therefore disease (B) must also be functional.

I was trying to remember what this fallacy was called, but I couldn't. Then, just a little while ago, this new thread lead to an article that described the "Fallacy of the Undistributed Middle." Basically, the fallacy is: if (A) and (B) share some characteristic they are the same.

It's not like this kind of fallacy hasn't been tried in ME/CFS before - just read the article - so, it is obviously something we need to be concerned about.

On Cort's blog, however, it's reported that the NIH study PI has said that FMD and Post Recovery Lyme were included in order to contrast them with ME/CFS.

I realize that you can read "contrast" in different ways, but perhaps it does suggest that the NIH knows that when two different entities have different characteristics then they are not identical, but when they share some characteristics (particularly null results) that does not then make them identical.

 

[duncan]

I'm not so optimistic.

Before they can contrast CFS with anything, they need to qualify it. Their track record so far, based on that inadvertently released copy (heaped upon decades of gross indifference), suggests to me they don't have a good grasp on what CFS is. The same holds true for Lyme and FMD's. They seem to be comparing ideas or popular story lines. This isn't Comparative Literature at community college.

Moreover, when will we learn that most agencies involved in ME/CFS research have some agenda, and it seldom includes our well-being. So when flags are raised because of what appears to be an outrageously stereotypical interpretation of what constitutes CFS, or what many deem inappropriate controls, we should take this seriously.

I am also concerned that some NIH investigators will be negatively influenced when they see the three diseases listed in concert in the study's criteria. It buggers the imagination why they are including straight from the start THREE contested diseases to compare. Can you stack the deck any worse than this house of cards has?

Like most, I want to see the NIH involved. But brand only goes so far.

I hope the re-write they release eases these concerns, but I'm not banking on it. They spurned my trust, and earned my distrust; now they need to earn that trust back.

 

[Valentijn]

However, it would be incredibly easy to attack the "science" of the researchers if they claimed that since disease (A) shows certain abnormalities (or the lack thereof), and disease (B) shows the same abnormalities (or lack thereof), and since disease (A) is presumed functional, therefore disease (B) must also be functional.

Sure, it'd be easy to attack. And that attack could very well be completely ignored like it has been for the past several decades when similar obvious flaws have been used to support psychogenic theories and treatments.

Personally, I'd rather not have to attack another worthless piece of flawed research. I'd rather we get quality research in the first place. And that FMD group is offering a significant opportunity for quackery with no apparent benefit at this point in time.

 

[Forbin]

Well, I suppose I am trying to be optimistic.

I have little doubt that something like a 2-day CPET test will unequivocally distinguish ME/CFS patients from FMD patients. Such a comparison is going to have to be made sometime. In fact, I can't imagine a positive ME/CFS finding that someone in the psychogenic camp won't claim might also be found in psychological illness. We want to find a biomarker that is specific to ME/CFS and that means ruling it out in other diseases that might overlap with ME/CFS, psychological and otherwise.

There may well be a reason why we do not see those researchers who favor a psychological explanation racing to see if the 2-Day CPET results, or Columbia's cytokine results, are also found in psychological illnesses. They may recognize that such a test carries with it the potential to crumble their edifice.

Making this kind of comparison is a risk we are going to have to face at some point.

 

[ScottTriGuy]

When will the NIH realize the incredible value in the untapped resource that is the ME patient population? (rhetorical)