NIH post-infectious CFS study

[Bob]

Sorry my posts aren't angry or outraged enough for some people. I guess we have different ways of responding to news. I can't sustain anger over a long period, or repeatedly get angry about every piece of news, because I find it unhelpful to my well-being. We get bad news every day and I have to find an equilibrium for my emotions. And I can't do anger-on-demand.

But that doesn't mean I don't want change, and a better life for us all. And I'm not entirely sure that, if i ranted on this thread, it would change much for anyone.

I think we need a strategy that involves communication with the NIH. A lobbying strategy. e.g. A petition. Letters. Emails. Get CFSAC involved. Ask if Ron Davis would have the chance, and time/willingness, to have a word with Collins. Ask Brian Vastag if he could write another letter. Get Solve ME/CFS to lobby.

But, first of all, we need to obtain all the details of the project so we know precisely what were dealing with and what we need to lobby for.

 

[daisybell]

The thing that concerns me the most in this is the inclusion of FMD in the study... Why is it there? It's another wastebasket diagnosis with no evidence, and should have no relevance for CFS/ME at all. It just smacks of the psychosomatic viewpoint, and that's a HUGE red flag for me.

 

[mfairma]

I don't rant to make a difference, but to express my sadness and disgust. I don't think a difference will be made anymore, not in any large way over a reasonable time span, by any of the people involved in advocacy. Jen Brea's documentary might help catalyze change, as will Tuller's analysis and, more importantly, the 2018 Rituxan study, but this is too little on too long a time frame. The factors we'd need to bring the change we could just aren't here. Change will come, certainly, but I don't think it will ever feel like a real, smashing win. I've been sick for six years now, which is frankly trifling in comparison to how long many in this disease have been ill, and it tears me up to think of another generation having to live through the same old shit. We all, including myself, collectively acquiesce to that by how we approach this disease. I choose now to try not to think about this disease as much as I can and I live an easier and happier life for it.

Speaking about his experience in Dresden in World War II and about Slaughterhouse-Five, Kurt Vonnegut once said, "I would have given my life to save Dresden for the world's generations to come. That is how every one should feel about every city on earth." That quote encompasses how I feel about this disease. This situation is so miserably, incomprehensibly bad for so many people, and the treatment of this disease has such dire effects on the treatment of other similar unexplained diseases and yet I don't feel like I see that magnitude honoured in how we think about and advocate for this disease. It's depressing.

I'm just venting, I guess. I don't mean to imply any criticism of you, Bob, or anyone else for that matter. You are all great and this situation just sucks.

 

[jimells]

Sorry my posts aren't angry or outraged enough for some people. I guess we have different ways of responding to news.

It's OK Bob. I have enough anger for both of us.

I find this situation particularly frustrating because I *know* how to make trouble in person. In fact I was a full-time volunteer labor agitator when I got sick. So trouble-making's my game. But I don't know how to do it from a couch.

Everyone is ga-ga over using Twitter and Facebook for social change. Well, yeah, they are tools like any other, but there's no magic, and it still takes live bodies in the street to get the attention of Our Dear Leaders. We can send them a truckload of petitions, and NIH will happily spend research money on hiring a company to shred them all - we have to find a better way to raise the social costs of the policies.

 

[medfeb]

I don't rant to make a difference, but to express my sadness and disgust. I don't think a difference will be made anymore, not in any large way over a reasonable time span, by any of the people involved in advocacy. Jen Brea's documentary might help catalyze change, as will Tuller's analysis and, more importantly, the 2018 Rituxan study, but this is too little on too long a time frame. The factors we'd need to bring the change we could just aren't here. Change will come, certainly, but I don't think it will ever feel like a real, smashing win. I've been sick for six years now, which is frankly trifling in comparison to how long many in this disease have been ill, and it tears me up to think of another generation having to live through the same old shit. We all, including myself, collectively acquiesce to that by how we approach this disease. I choose now to try not to think about this disease as much as I can and I live an easier and happier life for it.

Speaking about his experience in Dresden in World War II and about Slaughterhouse-Five, Kurt Vonnegut once said, "I would have given my life to save Dresden for the world's generations to come. That is how every one should feel about every city on earth." That quote encompasses how I feel about this disease. This situation is so miserably, incomprehensibly bad for so many people, and the treatment of this disease has such dire effects on the treatment of other similar unexplained diseases and yet I don't feel like I see that magnitude honoured in how we think about and advocate for this disease. It's depressing.

I'm just venting, I guess. I don't mean to imply any criticism of you, Bob, or anyone else for that matter. You are all great and this situation just sucks.

This is obviously very personal for me as mfairma is my son. But whether he is my son or not, I think we need to think about his words.

I've been in advocacy for almost 5 years. When I first started, I naively thought if we could just explain how bad it is to HHS, they would certainly change course. If we could just get all the organizations to go to HHS with a collective voice, we could influence them to do what is needed. If we could analyze another study and highlight the flaws, they would stop. I've written more letters, more position papers, attended more CFSACs, and visited more congressional offices than I can count. I've been involved on CFSAC workgroups and involved in a few efforts to form coalitions with the idea that that would be harder to turn down.

Yet little has changed for all that effort and all the effort that has gone on for so long. Why? One thing I learned from thirty years spent in an large corporation is that things can change very quickly when the leaders decide they want it to change. And when its not important to them, its like swimming in sludge. And make no mistake - we are swimming in sludge. The fact that we are even having to spend energy getting them to not use the Reeves criteria - criteria rejected by everyone - is absurd on so many levels that I am left stunned. Its hard to imagine that any patient or any disease expert endorsed that position. It's one small example of what we are up against on so many levels. And its not just HHS. UpToDate, a medical education provider, issued new guidelines in late 2015 that recommend the IOM criteria for diagnosis and CBT and GET based on PACE for treatment. Another stunner. Did they even read the IOM report? Worst thing about it, they are not the only one doing that.

I don't disagree with Bob's point that we need to get more information on the study. But we have to look for Plan B and Plan C and not just keep turning the same broken crank over and over. And we have to demand what we deserve and need, not just learn to accept or make the best of what we are given. What has happened to ME patients over the last 30 years is immoral and needs to stop. This study is not on the path to getting there in a time that matters to ME patients. And so far, one year after P2P and IOM, its the only real thing that's happened. Not cutting it.

Mary

 

[Kati]

The only thing that come to my mind is outraged.

Clearly NIH has no clue and believes this is a fatigue problem.

It is a disgrace and worst case scenario: getting into clueless clinical research of tired people. Amd let's get them even more tired to see what happens.

 

[roller]

what information (insight) as a result should such a CFS study ideally provide?

what should they aim for to find out?

 

[Bob]

Exclusion criteria for all participants:
...
-Any medical condition (eg, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, poorly controlled asthma) that would make the study procedures risky for the participant (e.g. exercise-induced angina and asthma) or that may confound the study results (e.g. untreated obstructive sleep apnea, severe osteoarthritis).

With the two-day exercise test, that rules out ME patients then!

 

[Nielk]

This is not just NIH. CDC's Dr. Unger will be presenting Dr. Nath at the CDC's Grand Rounds February 16. He will talk about this study of fatigue as if this is ME/CFS TO THOUSANDS OF CLINICIANS NATIONWIDE.

 

[halcyon]

There is so much wrong with this study but it's hard to imagine the bizarre choices were accidental. It seems that it was designed to fail. And worse, with poor patient selection criteria, carefully thought out exclusions, and an FMD control arm, they are going to show that there are no differences between "CFS" patients and those with a psychogenic disorder. They are going to shove us back in the closet for another 30 years.

 

[Valentijn]

I don't understand the thinking behind the inclusion of a FMD control group either.

The thing that concerns me the most in this is the inclusion of FMD in the study... Why is it there?

There will be a heterogenous "CFS" group of patients, which will almost certainly include people who lack PEM or other key features of ME/CFS. This will obviously dilute any abnormal results from ME patients who happen to get into the study. Such dilution may result in seemingly normal results in a measurement which would not be normal if only CCC/ICC ME/CFS patients were used.

Their 2nd definition of FMD (atypical symptoms, with no diagnosis for them) allows for people who have undiagnosed neurological or muscular disorders to be included. This allows biological abnormalities to be introduced into one of the control groups. Thus the "FMD and Friends" group may show abnormal results which would not be abnormal if they had been properly diagnosed.

So instead of just making the ME group look more biologically normal, they've taken the additional step of making a psychosomatic group which is likely to appear more biologically abnormal. This could make it a lot easier to show that the two groups are supposedly similar.

This study reeks. Their mere definition of FMD makes them sound like uber-psychobabblers. And I can't imagine anything good coming from such a study.

If the 2-day exercise is to make people "tired" then they really do not know what the fuck they are talking about. They do not know what ME/CFS is, they do not know why the CPET is important (compared to cycling), and they should not be funded. Or they do know, and they are deliberately setting this trial up to fail while trying to make it sound good on paper.

 

[beaker]

saw this on twitter first. Lost of action there.

Here are a couple of mine you might want to consider retweeting/liking. I asked for help from our me/cfs drs/clinics and also from journalists who have written us well in the past :

https://twitter.com/i/web/status/696652351533420544

https://twitter.com/i/web/status/696636498800701440

There are many other pwme busy tweeting about this. Tom Kindlon has already started a petition against use of Reeves.

 

[A.B.]

@Jonathan Edwards what do you think? Are we overly pessimistic or does this look like poor study design?

 

[ScottTriGuy]

...

I don't disagree with Bob's point that we need to get more information on the study. But we have to look for Plan B and Plan C and not just keep turning the same broken crank over and over. And we have to demand what we deserve and need, not just learn to accept or make the best of what we are given. ..
Mary

Bingo!

 

[BurnA]

I think we need a strategy that involves communication with the NIH. A lobbying strategy. e.g. A petition. Letters. Emails. Get CFSAC involved. Ask if Ron Davis would have the chance, and time/willingness, to have a word with Collins. Ask Brian Vastag if he could write another letter. Get Solve ME/CFS to lobby.

But, first of all, we need to obtain all the details of the project so we know precisely what were dealing with and what we need to lobby for.

Maybe Ian lipkin could help. Here is what he had to say about Bill Reeves

I knew Bill Reeves.He was a problem. But he’s no longer on the face of the earth.So that’s not an issue.

He also said this

I’m on the advisory committee for Francis Collins, and I can tell you that Francis Collins, the director of the NIH, believes that chronic fatigue syndrome is a problem.

 

[A.B.]

Does anyone know how to contact Lipkin? We need him to talk with Collins about the problems here. If progress is to be made, old mistakes must not be repeated.

Of course the best would be to talk directly with Collins but I think Lipkin is more approachable and probably knows how to formulate it better than us.

 

[jimells]

Here's something strange. The announcement has a link at the bottom that jumps to the Clinical Trials website. But the trial ID is invalid, and a search of the trials database came up empty for me. So this trial is not registered in the clinical trials database. What does this mean?

I have a general question about these intramural NIH studies. Who acts as the institutional review board for ethics approval? Is it possible to influence the IRB?

 

[BurnA]

Simon - I think there will be opportunities for patients and advocates to have input in how the research at NIH is conducted. Already, Carol Head and Zaher Nahle of the Solve ME/CFS Initiative have met with the team at NIH that is organizing the intramural study. At some point (I don't know when), the NIH will begin recruiting patients for the study in Bethesda. I am sure Carol and Zaher will be informed of all this and I am working with others to make sure information gets to the community. It's all about building bridges and open channels of communication.

Reading the above post from @viggster I'm wondering if there was a breakdown in communication ?

 

[Sasha]

#MEAction have posted their analysis:

http://www.meaction.net/2016/02/08/nihs-intramural-study-protocol-raises-many-questions/

 

[A.B.]

The protocol might not be the final version:

https://twitter.com/i/web/status/696788892704333824

Fingers crossed for seeing a stricter case definition in an updated version of the protocol.

Also I'm curious on the inclusion of the healthy post-lyme and FMD groups.

I can't think of a good reason to include healthy post-lyme patients when a healthy control group already exists. Take post-lyme patients with ongoing symptoms instead, that's another group of patients in desperate need of help.

Including a group with another illness is good, but the choice of FMD seems strange to say the least. Why not MS?