NIH post-infectious CFS study

[Nielk]

Koroshetz emailed at least 5 individuals/organizations today - including an organization petitioning him to not conduct the study. I'd say that shows a willingness to engage. Part of the communication problem is that people at NIH do not know who to deal with in the patient community. It's a fractured community with no big organization speaking for a majority of patients. That leaves a bit of a messy situation.

Is there another organization petitioning to stop the study? Because the one I know of did not get any communication from Dr. Koroshetz.

 

[Denise]

Apologies if that was a little too intense. I guess I'll say this: It's one thing to take the position of "I don't believe anything anyone at NIH ever says." That's not real helpful, but I can sort of understand it for long-term patients. Another step beyond that is, "I'm not even going to listen to them." And that is a distinctly unhelpful and unproductive stance to take.

@viggster - I hope you aren't implying that I won't listen/read.
(I tried to be clear when I said "I want to read the full protocol and as much additional information as possible about this study" and
"Hopefully when all of the study information comes out, we will be able to review it and see if it is good as we are being told it will be.")
There have been numerous miscommunications from NIH (and other agencies) and believing that they have changed and are understanding us will take time.

If I understand you correctly, the email from NINDS was sent to 5 groups/advocates. That is a small group. The ME/cfs Trans-NIH WG might want to resurrect their listserv and send out communications such as the information in Dr. Koroshetz' email via the listserv so that it reaches a wider audience sooner.

 

[medfeb]

Excuse me if I missed this already being posted.

A group of advocates submitted questions to the NIH on the study and have posted those questions online to get additional input which will also be submitted.

For those who are interested, you can add questions and comments at this link:
http://www.meaction.net/2016/02/12/usawg-submits-questions-to-the-nih/

The questions that have already been submitted are at this link:
http://www.meaction.net/wp-content/uploads/2015/05/QuestionstoNIHreclinicalstudyFeb102016.pdf

 

[anciendaze]

For those who don't know, I'll mention that rare diseases most doctors don't know about do get classified as functional movement disorders. The problem here is that there is no way within psychiatry to falsify such a diagnosis. Every case I know which has been misdiagnosed had the diagnosis changed after biological evidence of a cause was found. The existence of sane people with mysterious neurological diseases is generally settled at autopsy. If the disease is not progressive a misdiagnosis can persist indefinitely.

Reading the tea leaves to discern organizational intent, assuming any intent exists, is beyond me. I want to concentrate on very legitimate objective questions.

The way this seems to have come together is that the Wichita cohort put together using the "empirical definition" was just sitting there with the label CFS, and somebody decided to use it rather than admit the organization had pissed away money. We then hear that participants will also meet several other criteria with better reputations. Unfortunately, the introduction of new criteria after you have a cohort is likely to mean no more than a check box on a form saying "PEM", and a question by a researcher, "Do you feel worse after exercise?". This approach has obvious defects.

One problem of using a cohort produced by another definition is the propagation of selection effects from the earlier definition, which excluded just about any organic cause of fatigue, even if this was of unknown etiology. Specialists who have been treating "CFS" patients typically find about 3/4 have some kind of thyroid problem, just for example. Even detection of anti-thyroid antibodies doesn't tell us the cause. These patients will probably have been excluded. So will many others with conditions that are labeled rather than understood.

It is also possible to have a range of other autoantibodies affecting liver, heart, muscles, mitochondria, etc. Every autoimmune disease I know about has a problem with diagnostic thresholds, and the typical solution to ambiguity in testing is to choose those levels associated with convenient clinical signs, like the pathognomonic rash in lupus. This will not help in diseases without convenient clinical signs. No law of nature requires such.

Another problem has to do with attribution when a sign is present. Consider Raynaud's phenomenon, in which fingers and toes turn white or blue "in response to cold or emotional stress". The secondary form is definitely associated with connective tissue diseases like lupus, scleroderma or Sjögren’s syndrome. (All generally treated as exclusionary conditions.) There is no good way to distinguish primary from secondary disease. You can read a good bit of medical literature on the subject without ever encountering mention of possible damage to autonomic nerves. One assumption is simply that causation runs "emotional stress" => "reduced blood flow in fingers", not that perception of onset of reductions in blood flow for a condition that can be painful, or even result in tissue damage and gangrene, could produce emotional stress. Please note: autonomic dysfunction which reduces blood flow to extremities may well reduce blood flow to the brain, with perceptible effects long before syncope.

Because of common attribution this kind of sign is often considered evidence of emotional problems rather than physiological disease. Even a patient who exhibits objective measurements showing a substantial drop in pulse pressure during prolonged standing is blamed for deliberately causing something that might only be under voluntary control in certain yogis. It appears that neurally-mediated hypotension is "somebody else's problem", despite objective evidence. This is associated with almost pervasive reports of orthostatic intolerance in CFS. Anyone know how that has been handled in producing cohorts?

These factors make selection of cohorts for "CFS" problematic, and I don't have a comprehensive answer to the problem. What I can say is that the current muddle is nowhere near satisfactory, unless the goal is continued confusion.

 

[Nielk]

Koroshetz emailed at least 5 individuals/organizations today - including an organization petitioning him to not conduct the study. I'd say that shows a willingness to engage. Part of the communication problem is that people at NIH do not know who to deal with in the patient community. It's a fractured community with no big organization speaking for a majority of patients. That leaves a bit of a messy situation.

Is there another organization petitioning to stop the study? Because the one I know of did not get any communication from Dr. Koroshetz.

I just found out that MEadvocacy did receive this e-mail as well. This is unacceptable. MEadvocacy did not ask to receive this type of covert unofficial communication. We demand open direct public communication by the US government health agencies to build a foundation of trust by being transparent to the entire ME community, not just to a select few people off the record without accountability.

 

[John Mac]

MEadvocacy did not ask to receive this type of covert unofficial communication.

How is an email from a public body representative to a patient organization "covert" or "unofficial" ?

 

[Valentijn]

I just found out that MEadvocacy did receive this e-mail as well. This is unacceptable. MEadvocacy did not ask to receive this type of covert unofficial communication.

If you don't want the NIH to email you, you probably should mention that when you email them to complain about things. Otherwise it's usually considered "courtesy" to respond, and can be a quick way to disseminate information pending something more official.

 

[Nielk]

If you don't want the NIH to email you, you probably should mention that when you email them to complain about things. Otherwise it's usually considered "courtesy" to respond, and can be a quick way to disseminate information pending something more official.

The only email MEadvocacy sent to Dr. Dr. Koroshetz was the petition last night. This e-mail predates that and is a reply to the group who sent in questions. We were not part of that group. If NIH or any other US governmental health agency wants to communicate with the ME community, they know very well how to do that. The CFSAC listserv serves that purpose. That is how they have communicated with us in the past.

 

[Nielk]

How is an email from a public body representative to a patient organization "covert" or "unofficial" ?

It was sent to a handful of individuals. I'm not sure why it was sent to this one organization as well.

 

[jimells]

It's one thing to take the position of "I don't believe anything anyone at NIH ever says."

Words are useless. We need action, real action, not crumbs. That means a real commitment to stable research funding at a level commensurate with disease burden. That means an actual plan, with goals, milestones, what resources are needed, and how they will be acquired, and who will do what. Project management is not a new concept. They should try to learn about it.

Here is their "plan" so far:

http://www.nih.gov/mecfs/eligibility-requirements-me/cfs-clinical-study-nih

The narrow scientific focus of this study is only the first step of what NIH hopes will be a broader national approach to better understand the biological basis of ME/CFS and the development of effective therapies.

So their grand plan is to "hope" that "a broader national approach" will spontaneously develop on its own? Meanwhile they continue to reject nearly every recommendation of CFSAC as they have done from the beginning. I take that back. CDC did finally remove the ridiculous "CFS Toolkit" from its website, after people screamed about it for years and years.

I've already lost a dozen years of my life to this illness and the social stigma created by 30 years of NIH and CDC neglect and abuse. I'm not trusting what little is left of my life to institutions that would very much prefer if I just shut up and died.

SHOW ME THE MONEY

 

[chipmunk1]

any details on what patients they are recruitung? What lyme cases do they look for?

You know a lot of lyme cases are very controversial and believed to be due to somatisation and all in the head.
You know that ME is very controversial believed to be caused by somatisation and all in the head.
You know that functional movement disorders are somatisation and all in the head.

See a pattern here?

You know for many physicians "Lyme" means "psychiatric". Funcional movement disorder means you were sexually abused in childhood and ME means you are depressed.

Harassment of researchers[edit]
In 2001,The New York Times Magazinereported thatAllen Steere, chief of immunology and rheumatology atTufts Medical Centerand a co-discoverer and leading expert on Lyme disease, had been harassed, stalked, and threatened by patients and patient advocacy groups angry at his refusal to substantiate their diagnoses of "chronic" Lyme disease and endorse long-term antibiotic therapy.[45]Because this intimidation included death threats, Steere was assigned security guards.[46]

https://en.wikipedia.org/wiki/Lyme_disease_controversy

http://www.medscape.com/viewarticle/748084_4

The latter is a puzzlingly understudied field, but it has promise to improve the lives of many who suffer chronic symptoms attributed to Lyme disease – whether or not a history of Lyme disease is ultimately to blame. Furthermore, these may be far safer than prolonged antibiotics and indwelling vascular access devices. A variety of such interventions have proved useful in patients with functional pain syndromes, chronic fatigue syndrome and other debilitating chronic medical illnesses. These include antidepressants, pregabalin and gabapentin, analgesics, biofeedback and complementary and alternative medicine.

Physicians don't believe in alternative medicine. If they recommend it they think you need a fancy placebo and someone who spends time with you.

 

[Bob]

How dare staff at the NIH attempt to reach out to the community by communicating with us.

This is getting a bit surreal now.

I sincerely hope that no one is going to complain to the NIH that members of staff have sent informal communications to members of the community. It would be a very confusing message to send.

 

[jimells]

Part of the communication problem is that people at NIH do not know who to deal with in the patient community.

Don't blame this mess on the patients!

Remember CFSAC? It is supposed to represent patient interests. Dedicated committee members have been beating their heads against the HHS blank wall for years in an effort to represent us. If new NIH administrators want to know what patients want, they could maybe read the meeting minutes and over 100 recommendations.

HHS could quit trying to manipulate CFSAC and let it do it's job unfettered, and maybe even try to implement some of its recommendations. A radical idea, I know, but then I'm a radical person.

 

[BurnA]

I just found out that MEadvocacy did receive this e-mail as well. This is unacceptable. MEadvocacy did not ask to receive this type of covert unofficial communication. We demand open direct public communication by the US government health agencies to build a foundation of trust by being transparent to the entire ME community, not just to a select few people off the record without accountability.

Wow.
Speechless.

 

[Kati]

How dare staff at the NIH attempt to reach out to the community by communicating with us.

This is getting a bit surreal now.

I sincerely hope that no one is going to complain to the NIH that members of staff have sent informal communications to members of the community. It would be a very confusing message to send.

I am getting confused too. ME Advocacy complaining they got an email from NIH? Do they simply want to create chaos and disruption?

 

[Nielk]

O

How dare staff at the NIH attempt to reach out to the community by communicating with us.

This is getting a bit surreal now.

I sincerely hope that no one is going to complain to the NIH that members of staff have sent informal communications to members of the community. It would be a very confusing message to send.

What is confusing is the fact that the one official page on the NIH website went dark and nothing replaced it.

If NIH has new information, they should post it on their website.

Since going dark, we have been bombarded by conflicting bits of information coming from personal phone calls or selective emails to a handful of advocates.

NIH knows exactly how to communicate to the entire community. They have chosen not to do so.

The ME patient is left to labirynth through social media trying to catch these selective communications? Not right.

 

[Valentijn]

I am getting confused too. ME Advocacy complaining they got an email from NIH? Do they simply want to create chaos and disruption?

Maybe MEAdvocacy is trying to pretend that the NIH doesn't exist, and resents any intrusion into this fantasy? It's made especially bizarre by MEAdvocacy having emailed the NIH about the study immediately beforehand. Or is it more like last-word-itis? "I get to send the last email, here's what I think, and don't dare respond to me!"

 

[BurnA]

Don't blame this mess on the patients!

I am all for constructive criticism but this getting nonsensical. Nowhere did @viggster or anyone suggest that patients were to blame.

If communication is a problem why don't we try to fix it. We have someone in the NIH willing to reach out send emails and make phone calls.
Now is our chance.
What's the goal here ?

 

[Bob]

@Nielk, perhaps you missed the official notice posted on the NIH website on 13th Feb?
http://www.nih.gov/mecfs/eligibility-requirements-me/cfs-clinical-study-nih

The informal email highlighted it...

Email from NINDS Director Walter Koroshetz to several patient advocates today:

"Dear colleagues,

Thank you for communicating your concerns. Having spoken to multiple patients with ME/CFS we believe that some of the concerns about the NIH intramural ME/CFS protocol are due to miscommunication on our part.

Please see posted notice. http://www.nih.gov/mecfs/eligibility-requirements-me/cfs-clinical-study-nih

Note that the NIH intent was always that the ME/CFS patients enrolled in the NINDS study would have post exertional malaise and qualify under multiple consensus criteria including the Canadian crieria. Reeves was being used only for stratification purposes. A detailed protocol will be posted soon.

We look forward to working together with the ME/CFS community to develop the science that leads to meaningful solutions for those who are suffering.

Best wishes,
Walter"

 

[viggster]

O
If NIH has new information, they should post it on their website.

That was the whole point of Koroshetz's email - to point us to this page. http://www.nih.gov/mecfs/eligibility-requirements-me/cfs-clinical-study-nih