NIH post-infectious CFS study

[Bob]

The @NIH press officer just told me that this protocol was "inadvertently posted."

I'm glad they inadvertently posted it if it gives us a chance to give feedback and to correct their prejudices.

 

[BurnA]

I'm glad they inadvertently posted it if it gives us a chance to give feedback and to correct their prejudices.

Haha yep hopefully we can get our oar in there before it's too late.

 

[jimells]

It appears that the protocol may have been unintentionally released.

Hahaha, this reminds me of the politician who gets caught with his pants down then announces he is resigning "in order to spend more time with my family".

Which is the worst excuse:

1. We are totally incompetent when it comes to ME, all the time

2. We thought we could quietly slip this in but it went over like a lead balloon

 

[daisybell]

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?

I wonder if the healthy post-lyme patients are there for allowing an argument that we should be like them - we're post-infection.... So we should be healthy. If FMD is there as the psychiatric comparison group, and post-lyme as the physical comparison group, we can be labelled any which way they like if the data can be interpreted to allow that.

The more I think about this protocol, the more worried I feel. The only positive I can see that might emerge is that the two day exercise testing will clearly differentiate ME/CFS as a group. However, if for some reason the FMD group performs worse on day two, what then....???

Plus, we can't know how that FMD group will perform - given that FMD is a hypothetical disorder....

 

[TiredSam]

I'm glad they inadvertently posted it if it gives us a chance to give feedback and to correct their prejudices.

Can't help wondering how on earth this could even be the first draft of something?

 

[Nielk]

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

Where was this posted?

 

[Nielk]

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

It's more like spin.

 

[Nielk]

How is this an acceptable excuse? Someone's fingers just slipped and blindly typed up this protocol which was accidentally published by a bird landing on the "enter" key. Since then, No one in the NIH office knows how to delete or edit this page because a squirrel is running around the room. Where is the real protocol which will be presented in a few days by Dr. Nath? The monkey must have eaten it.

 

[ScottTriGuy]

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.

Sounds like an opportunity to disrupt, protest and get media attention.

 

[jimells]

Sounds like an opportunity to disrupt, protest and get media attention.

You are probably on their blacklist by now. Good luck getting across the border. That big green statue at the entrance to New York Harbor, the lady with a torch and a crown? It's actually holding a sign that says

KEEP OUT

 

[halcyon]

I can't think of a good reason to include healthy post-lyme patients when a healthy control group already exists.

They want to compare someone who is not fatigued post infection with someone who has fatigue post infection. Lyme was a really bizarre choice though. Why not EBV? Or an enterovirus? You know, one of the pathogens actually suspected of triggering the disease.

Given that one of the largest hypothesis surrounding this disease is that we have active persistent infections, how do they justify excluding patients with active infection from the study?

 

[duncan]

The Lyme thing is puzzling. Notice they don't say "cured" of Lyme. They say candidates must have received treatment, and they mention Lyme infection asymptomatic group...

And combine that with the FMD group.

Top it off with the whole fatigue schtick, and the exclusion of PEM.

I cannot help but wonder if this is the first volley in trying to migrate ME/CFS into an NIH-stamped MUS disorder.

 

[alex3619]

I doubt MS studies would include this make-believe disease as a comparison group

This is another grab-bag diagnosis, a total waste of time. Unless ... they are hoping that they can sneak some of these patients in and find out what is really wrong with them.

 

[Bob]

Solve ME/CFS Initiative response:
http://solvecfs.org/NIH+Begins+Recruitment+of+ME/CFS+Study+Participants

 

[TiredSam]

The protocol might not be the final version:

Well if they've already started recruiting, it looks like it was intended to be.

 

[A.B.]

This is another grab-bag diagnosis, a total waste of time. Unless ... they are hoping that they can sneak some of these patients in and find out what is really wrong with them.

I suppose it's possible that NIH is trying to also rescue patients diagnosed with a psychogenic movement disorder. I have not checked but I'm pretty sure this diagnosis results in ineffective psychotherapy justified by quack science akin to PACE trial.

 

[jimells]

I suppose it's possible that NIH is trying to also rescue patients diagnosed with a psychogenic movement disorder.

I should think the way to do that would be a study that disproves psychobabble disorders. But that's not likely at this stage.

 

[Simon]

The protocol might not be the final version:

Well, that's something, as is this:

NIH’s intramural study protocol raises many questions | #MEAction

UPDATE #2

From Vicky Whittemore at NIH: “We have received many questions about the study from individuals with ME/CFS, so we sent those off to the investigators at the NIH Clinical Center to provide responses. We will post the responses on the NIH website and I can send you a link when they are posted. ”

Sorry, too rough when this story broke but I just wanted to summarise what concerns me about this study - much of which as been covered already in parts, but not all

Apart from the totally unhelpful choice of diagnostic criteria, it looks like a useful and comprehensive study..

Yes, agree, this could be a great study, if they fix the diagnostic criteria.

More on the problem with Reeves (2005) criteria
So once I was a bit of a case definition geek, and now you are all gonna suffer.. Will try to keep it brief

The main beef over Reeves, as brilliantly shown by Lenny Jason's work, is that it's too lax and brings in a majority of sick people who are non-mecfs cases by other definitions: I think it's something like 2.5% prevalence for Reeves vs 0.25%-0.45% for, say, Fukuda, as more realistic prevlance figures. Applying that to a sample of 40 patients, you might get 10 or fewer Fukuda-patients - and 30 or more non-Fukuda patients - making this study fatally flawed from the off.

One of the worst things Reeves did was introduce a new way to reach the 'serious disability' criterion of Fukuda (Reeves is theoretically simply an 'implementation' of Fukuda) - based on emotional problems alone stopping you doing things

-Functional impairment as determined using the Short-Form 36 (SF-36): score of greater than or equal to 70 physical function subscale, or greater than or equal to 50 on role physical subscale, or greater than or equal to 75 on social function subscale, or greater than or equal to 66 on emotional subscale.

Jason showed that flaw brought in a lot of depressed patients. And as @Bob pointed out, depressed patients are allowed in as long as they are stable (personally I have no problem with including depressed patients, so long as they have mecfs too).

My other big concern is the exercise test:

It even includes a two day CPET test.
...It's a two-day exercise test.

There's no way, in my view, a 2-day test is ready for use in a clinical study like this. As Prof Betsy Keller has made clear, the results are still inconsistent, and more critically there is no safety data other than they know some patients have relapses as a results. See my blog (patients discuss safety concerns further in the comments) New Exercise Study Brings Both Illumination and Questions

But worse in my view, is making the test mandatory for inclusion in the study. I would refuse point blank to do even one maximal test, as my relapses are triggered at way lower activity, and I'm sure I'm not alone. Patients willing to sign up to a 2-day test are likely to be unrepresentative of patients generally, and that's a huge issue - on top of the safety/ethical one.

So as things stand, what could be a terrific study risks recruiting a majority of patients who don't have mecfs, and those that do may well not be representative as they've signed up to do a 2-day max exercise test.
which is a bit of a pity
​

Let's hope the NIH are serious about sorting out these problems - and consult patients properly in future. It could be a beautiful relationship.

 

[jimells]

The Solve ME/CFS Initiative has identified a number of significant questions and concerns with the design protocol of this research effort. Our organization—represented by our Vice President for Research and Scientific Programs—was immediately in contact with the NIH officials we have an existing, ongoing relationship with to express these serious concerns.

As I recall, these folks have tried to play ball with NIH all along, and look how they are treated by their "partner". Obviously there was no consultation, no heads-up, just more disdain. Solve has been played for a sucker, but at least it is in the record for all to see, if they care to look.

I'm writing this Tuesday morning and the recruitment notice is still posted, and the clinical trials database still says "Number not Found".

 

[K22]

I as a UK patient welcome the Solve ME/CFS response and commitment to act on this. Why would they choose Reeves over Fukuda even? Is it because it's the weakest criteria available in the states. They need to add CCC too