NIH intramural research program update

[Kati]

Characterizing ME/CFS as normal life experience may indeed be a result of this study. Or at least it would seem some investigators may hold this bias.

If so, I suspect it is not limited to Walitt.

"...symptoms appear to be more related to the aches and pains of everyday living..."

Sound familiar? Notice an emerging theme? This last quote is from Lyme guidelines that some key players in the NIH and CDC have had a history of supporting.

Just so happens that Lyme is playing an important role in this study, coincidentally.

"normal life experience" and "the aches and pains of everyday living."

Unacceptable misrepresentations or foregone conclusions, or both?

Well with the noise patients are making about this, it is impossible that NIH disregards the protests.

 

[duncan]

I hope you are correct, @Kati

 

[Kati]

For those keen and willing, go on tweet Jeannette's blogpost
Mention @nihDirector @NIAIDSNews and @NIHclinicalCNTR
Let's see if NIH is serious about making it right for patients, and making sure there are no bias within their investigators. A little weeding might be required.

 

[Sean]

Jeannette Burmeister has a post about Walitts:
Brian Walitt’s Radical Bias: Disorders of Subjective Perception, ME/CFS as Normal Life Experience?

So Walitt believes the solution is just a better sales pitch from doctors.

Where have we heard that before?

 

[searcher]

Yes, we have channels of communication between the patient community and the people running the study. ME Action is collecting questions and concerns that will be relayed by the US Action Working Group (which includes 30 patients & advocates from all over, including PR). The NIH is also setting up a patient advisory committee, although we don't have any details on when that will happen.

I don't know if we have clear channels of communication yet. NIH has said they are setting up a communication plan to reach out to the community and a website to answer questions, which I will hope will cover all of the questions submitted by USAWG (including the new set of questions from the entire community.) I don't think that Dr Koroshetz, Dr Nath, or Dr Collins have spoken yet with any organizations other than SMCI (http://www.solvecfs.org/newsletter/2015/november/). Some patients did speak informally with Dr Nath outside of the CDC event and they all appear to have came away impressed by his intelligence and openness, but I don't know if he has spoken with any other patients. I am cautiously optimistic that we will see changes in the upcoming week though despite the bureaucratic slowness because they need to respond quickly to all of the serious concerns expressed by the community.

 

[Ecoclimber]

CLICK here for more info on Bushnell treatment protocol
"People are starting to realize, more and more, that the effects of non-pharmacological interventions such as exercise, reducing anxiety, and changing one’s emotional state and attentional focus have effects on the brain that are just as powerful as clinical doses of opiates or other pharmacological treatments."

Why is that name meaningful. She shared a NIH symposium with Walitt on Pain/Fibromyalgia/Fatigue, functional disorder and BPS view that seems entrenched at the NIH. Explains the Functional Movement Disorder group. If anyone wants to take notes and post
Demystifying Medicine 2013 - Pain: How It Happens and What Can Be Done?

 

[Kati]

I don't know if we have clear channels of communication yet. NIH has said they are setting up a communication plan to reach out to the community and a website to answer questions, which I will hope will cover all of the questions submitted by USAWG (including the new set of questions from the entire community.) I don't think that Dr Koroshetz, Dr Nath, or Dr Collins have spoken yet with any organizations other than SMCI (http://www.solvecfs.org/newsletter/2015/november/). Some patients did speak informally with Dr Nath outside of the CDC event and they all appear to have came away impressed by his intelligence and openness, but I don't know if he has spoken with any other patients. I am cautiously optimistic that we will see changes in the upcoming week though despite the bureaucratic slowness because they need to respond quickly to all of the serious concerns expressed by the community.

i don't think Dr Nath is at issue here. However the community is worried about who he will be working with' the 'experts in ME/CFS at NIH'.

There will be an urgent need for Drs Collins and Nath to check what's been happening on social media and what the patients have been saying over the week end. The message is loud and clear.

 

[searcher]

I am fairly confident that they will be overwhelmed by email when they come into work tomorrow. I have no doubt the message will come through loud and clear. They didn't have patients involved in the protocol while it was being designed and the team was being compiled which could have prevented all of this from happening.

I mention communication with those three because they are the ones who need to make the changes to the team and the protocol. I doubt Dr Collins was involved much before but he needs to get involved now.

 

[LiveAgain]

Hi, I haven't posted here in a while but have been following news about the NIH study and have some concerns. I don't have a medical background so please bear with me. Agree about Dr. Walitt and left a comment at MEAction but am also really confused about the FMD control group. Two of the assigned neurologists (Hallett and Maurer) both study movement disorders, but also have an interest in FMD/ conversion disorder and have done research in this area. I don't understand the selection of these two for an ME/CFS study. What is their role here?

And I find the study below to be a problem. They look at autonomic nervous system function in FMD and find abnormalities but don't seem to change their position on FMD being a conversion disorder. And we know they will find autonomic nervous system abnormalities in some or many of the ME/CFS patients being studied... so what conclusions can be drawn when comparing the two groups? Doesn't it seem this control group can cause confusing and hard to interpret results? I just hope their motives are pure and there isn't a second hidden agenda.

http://www.neurology.org/content/84/14_Supplement/P3.008

 

[beaker]

Hi, I haven't posted here in a while but have been following news about the NIH study and have some concerns. I don't have a medical background so please bear with me. Agree about Dr. Walitt and left a comment at MEAction but am also really confused about the FMD control group. Two of the assigned neurologists (Hallett and Maurer) both study movement disorders, but also have an interest in FMD/ conversion disorder and have done research in this area. I don't understand the selection of these two for an ME/CFS study. What is their role here?

And I find the study below to be a problem. They look at autonomic nervous system function in FMD and find abnormalities but don't seem to change their position on FMD being a conversion disorder. And we know they will find autonomic nervous system abnormalities in some or many of the ME/CFS patients being studied... so what conclusions can be drawn when comparing the two groups? Doesn't it seem this control group can cause confusing and hard to interpret results? I just hope their motives are pure and there isn't a second hidden agenda.

http://www.neurology.org/content/84/14_Supplement/P3.008

Thank you for your insight. There motives are pure.-- Purely interested in putting #ME to rest w/ some conversion order BS. People don't change their specialty from FMD / CD to #ME bio illness . If it looks like a duck, and quacks like a duck.... it's a duck.

 

[Anika]

What's the protocol for data disclosure with this type of study? Does the high number of tests relative to the small number of subjects suggest they may not be able to share enough data without concern of identification?

Perhaps this is common knowledge, but it hasn't reached me. I'd like to know when and how we, and other researchers, will have access to data, data, data.

As PACE has taught us, never assume.

 

[Ecoclimber]

The fix is in. The first protocol they placed on their servers was no accident. How one say that they are going to use the Reeves criteria which allow chronic depression and fatigue into the study but say that everything with be CCC or ICCC. Didn't make any sense. They then did about face and said that Reeves will not be used...sure.

Why not take one of Walitt's research papers on fibromyalgia or chronic pain and load the file up in MSWORD Click on Find fibro or chronic pain or cfs and click Replace with ME/CFS. NIH could have that published and out the door in two weeks. The NIH can save a ton of money since the NIH already knows the result of this testing from the previous paper and in a sense this will be like replication of those results. I'm being sardonic here

Better yet, abort this damn research trial and give the funds to Institute of Medicine Foundation so Ron Davis and his staff can conduct the research trial appropriately which will lead the way to new discoveries on 'the Last Great Disease' and can be trusted as he has interest to make it right.

Over the last few years, recent research headlines have herald new and exciting descriptions as textbook altering discoveries.
https://news.virginia.edu/content/r...ook-altering-link-between-brain-immune-system
https://www.sciencedaily.com/releases/2015/06/150615094258.htm
https://www.sciencedaily.com/releases/2015/12/151208134116.htm

These discoveries will no doubt impact scientific research in the foreseeable future. This will give researchers greater knowledge on the pathogenesis of many diseases. How the brain drains into the lymphatic system will play a significant role concerning immune dysfunction.

There is a paradigm shift to move away from mind-body dualism in biomedical research and to adopt 'live body' or the BPS model to the point of biomedical denialism. For those representing one school of thought, ( Wessely et al ) would have you believe that psychopathophysiology causes biological abnormalities and functional movement disorders.This philosophy is deeply entrenched into the mindset of the researchers within the NIH. Confirmation/Selection bias guaranteed..

As it stands now, the NIH knows that this reseach trial is just a another exercise of rearranging the deck chairs on the titantic and the results are going to be the same troubling untenable deeply disturbing research papers of the past.

Nath stated something about being vocal like the AIDS group. Patients should boycott participating as patient recruit in this study.

With Nath and Unger going on record stating there is biological or neruoimmune reaction to some infectious agent that effects the immune system, will Walitt be the fall guy for this disaster?

 

[Snow Leopard]

Bushnell
"People are starting to realize, more and more, that the effects of non-pharmacological interventions such as exercise, reducing anxiety, and changing one’s emotional state and attentional focus have effects on the brain that are just as powerful as clinical doses of opiates or other pharmacological treatments."

Why do physicians and even scientists continue to believe this (the "powerful" placebo effect) without any evidence that it is true?

 

[Roy S]

https://twitter.com/i/web/status/701584045407391744

 

[Ecoclimber]

Why do physicians and even scientists continue to believe this (the "powerful" placebo effect) without any evidence that it is true?

Because they cannot find a biological cause in the pathophysiology of this disease, they automatically assume a psychopathophysiology where the patient inability to adjust to the social/psychological/evironmental around them -whether through trauma, child abuse - will manifest in various symptoms and manifestations such as in FMD.

 

[Snow Leopard]

Because they cannot find a biological cause in the pathophysiology of this disease, they automatically assume a psychopathophysiology where the patient inability to adjust to the social/psychological/evironmental around them -whether through trauma, child abuse - will manifest in various symptoms and manifestations such as in FMD.

They fail to notice that while they have spent a lot of time (100+ years and billions of dollars) trying to find biological pathways of "psychopathophysiology", they haven't spent much time (in comparison) looking at biological pathways of our illness...

 

[Roy S]

https://twitter.com/i/web/status/701615706643632129

 

[Valentijn]

However, I am not so convinced about study architects not ignoring various of our communities about ME/CFS being a biological disease, and not a psychological disorder.

This happens even with ME experts and patients. Someone has a good sales pitch, and looks good on the surface, but is really just a psychobabbler with a more obscure vocabulary.

Case in point, Mark Edwards. People who I have no doubt are 100% in favor of biological theories thought it would be great to have a neurologist looking for brain-related abnormalities. They didn't understand that his past and present work is always tied into psychosomatic theories.

 

[TiredSam]

Having just watched the Wallit video I don't know how the NIH expects patients to trust them or take them seriously when they are prepared to involve such a fruitcake, in a beaurocratic or any other capacity. If they were planning to do a Wessely-style M.E. burial job they couldn't have found a better person - seriously, if you wanted to bury and psychologize M.E. again, who could you choose more suitable than Wallit? Didn't anyone at all say "hang on a moment, perhaps not that guy, we're here to do science"? Watching the video I couldn't help noticing that every time Wallit starts to smile, he catches himself and the expression that follows is one of a seriously disturbed individual.

EDIT: I'm not kidding. Watch the smile vanish at 00:50. It's freaky. He does it every time he starts smiling.

 

[ScottTriGuy]

every time Wallit starts to smile, he catches himself and the expression that follows is one of a seriously disturbed individual.

EDIT: I'm not kidding. Watch the smile vanish at 00:50. It's freaky. He does it every time he starts smiling.

coughsociopathcough