NIH post-infectious CFS study

[alex3619]

I'm not exactly clear on why they would find 2 groups of people when it seems by definition there should only be one to begin with.

Because all existing definitions are too fallible. We have no idea who has "PEM" unless they had appropriate testing, which for now is the 2 day CPET protocol. The definitions are flawed. All of them. Of course some are more flawed than others.

For example, if someone has exercise intolerance then they might be diagnosed with PEM, even though they shouldn't be. Others might describe their condition as PEM but it is something else. Without a test we cannot be sure.

 

[mfairma]

This is not primarily an assuming the worst sort of situation, Brian. Maybe their intentions will turn out to all be sound and high-minded, but there are a number of very baffling things about this proposed study, as everyone has noted. I appreciate that you feel that HHS is turning a new leaf and that your personal connections help give color to that belief, -- and I'm not criticizing you in saying that -- but that belief should be qualified by the obviously disturbing elements of this proposal and from the broader realization that we are at their mercy to do as they wish. Should they choose to help, then great, but will they help in the ways and degrees we might want? There is a lot they could do now to make change if they chose, but still we wait.

 

[jimells]

However its possible to bypass a one day CPET in severe patients. I have said before, many times now, that they can just do a gas analysis.

It's not clear from the participant recruitment notice that this will be done. The protocol only discusses making them tired. Unless I missed it.

 

[viggster]

More answers from NIH. I think most people here will like the answers:

http://www.meaction.net/2016/02/09/...al-questions-re-nih-clinical-center-protocol/

 

[mfairma]

"Functional Movement Disorder was chosen to contrast post-infectious ME/CFS patients with a very well-studied group of patients with clear psychological illness with neurological presentation"

Really?

 

[Nielk]

"Functional Movement Disorder was chosen to contrast post-infectious ME/CFS patients with a very well-studied group of patients with clear psychological illness with neurological presentation"

Really?

What is this???

 

[viggster]

This is not primarily an assuming the worst sort of situation, Brian. Maybe their intentions will turn out to all be sound and high-minded, but there are a number of very baffling things about this proposed study, as everyone has noted. I appreciate that you feel that HHS is turning a new leaf and that your personal connections help give color to that belief, -- and I'm not criticizing you in saying that -- but that belief should be qualified by the obviously disturbing elements of this proposal and from the broader realization that we are at their mercy to do as they wish. Should they choose to help, then great, but will they help in the ways and degrees we might want? There is a lot they could do now to make change if they chose, but still we wait.

Ok. Well with the additional information now made public, I'm reassured. Patients will be referred by the specialists we all know. Ian Lipkin advised on the study. PEM will be studied extensively. Some scales from Reeves will be used, but not to screen eligible patients. Patients will meet all published criteria - CCC, IOM, etc.

Someone at NIH published the protocol early, before they had their communications plan in place. A lack of clarity led to rampant speculation, which is usually how it works (and not just in this community). I think the folks at NIH involved in this have learned and they know they need to do a better job with communicating to us.

 

[Kati]

Honestly, if they want to compare with a psychological illness, how about they compare ME with patients with depression? Because clearly, functional movement disorder patients deserve more research.

 

[beaker]

Honestly, if they want to compare with a psychological illness, how about they compare ME with patients with depression? Because clearly, functional movement disorder patients deserve more research.

Agreed.

To quote from the MEactionNet site: a very well-studied group of patients with clear psychological illness with neurological presentation.

I don't buy that. I think they just have something that hasn't been discovered yet. (I feel this is true for most conversion disorder type bs )\
Plus I feel it puts us back to that place again. Would they add a control group like that for a cancer study or AIDS ? No.

 

[Anika]

It looks to me like they picked treated asymptomatic Lyme and FMD so they could get a "three-fer".

They get to count this study against 3 under-studied groups, and count the whole study cost against each. Fine, if it otherwise makes sense. But it looks to me like sub-optimal for ME /CFS.

Perhaps one of the investigators has an interest in the others, or perhaps it's for one of many other reasons not principally concerned with a top notch ME/ CFS study. Or perhaps it's just a big set of goofs.

We should not be begging for scraps, but insist on something good for us. This is too important. (And others deserve theirs too.)

I remain sceptical, but am persuadable.

 

[Sasha]

More answers from NIH. I think most people here will like the answers:

http://www.meaction.net/2016/02/09/...al-questions-re-nih-clinical-center-protocol/

Thanks for the link, Brian.

This bit is confusingly worded (as this section often is, even in published studies):

• Enrollees will meet all definitions for ME/CFS, including Canadian Consensus Criteria, IOM, Fukuda and Reeves, in addition to post-infectious onset.

It's unclear whether each enrollee will meet all defintions or whether the group will include some of each.

 

[BurnA]

Thanks for the link, Brian.

This bit is confusingly worded (as this section often is, even in published studies):


It's unclear whether each enrollee will meet all defintions or whether the group will include some of each.

To me that means that each enrollee will meet ALL criteria.

(But it's not very clear )

 

[Valentijn]

I'm glad to hear about the diagnostic criteria being used.

But I see no clarification regarding the two-day exercise. If this is not in the form of a maximal CPET, I predict a lot of waffle regarding patients holding back, blah blah blah. And yes, some moderate ME patients would do a two-day maximal CPET - I would be willing to, for quality research, to help put an end to that ME denialist BS.

Their FMD "control" group is still a huge problem in every way imaginable. Those patients need their own quality research, with healthy controls. Comparing two very controversial groups like ME/CFS and FMD with each other seems like a shockingly bad idea at this stage, with no legitimate purpose or potential merit, not to mention added expense. It also looks like they are starting with the assumption that FMD and ME/CFS are basically the same thing, which is an extremely bad sign.

And who are the actual ME/CFS researchers who will be part of the team for this study, and not just providing a little bit of background data? Why is the project being led by someone who knows nothing about ME/CFS? Who else is on the team?

These things need to be clarified and/or changed.

 

[halcyon]

I'm glad to hear about the diagnostic criteria being used.

It sounds nonsensical to me. They're really going to apply all of those criteria to patients? How about pick one or two. This seemed to work well for Lipkin in the blood cytokine study where they used Fukuda+CCC and required viral onset.

As you mentioned several other important questions remained unanswered.

Why do we have to learn about these supposed clarifications second hand from a patient? I'll retain my original objections until the actual protocol is published through official channels, though I'm doubtful that it will differ much or at all from what was "inadvertently" published. Why would that protocol have made it so far as being posted on an NIH website if it didn't resemble the actual planned study.

 

[Anika]

Well said, Valentijn. Really concerning control issues.

 

[duncan]

THREE controversial groups - Asymptomatic Lyme would be controversial as well. Who qualifies those individuals? The NIH Lyme team, arguably still ensnared in 1994?

We should have that good old familiar feeling about the FMD group since the BPS school has left us in this uncomfortable position before.

How can we trust the NIH to select proper ME/CFS patients, when two of their control groups are likely to cause fits?

 

[Sasha]

To me that means that each enrollee will meet ALL criteria.

(But it's not very clear )

It's an ambiguity that's built into the English language and until they spell it out, we're not going to know.

 

[Sasha]

Why pick control patients they believe to have "false illness ideas" at all? They're controlling for false illness beliefs? Why?

Would they do this with any other disease?

@Jonathan Edwards - what do you make of this?

 

[halcyon]

Why pick control patients they believe to have "false illness ideas" at all? They're controlling for false illness beliefs? Why?

That should be a rhetorical question. What are the two major competing theories on etiology of the disease? They are testing if there is any difference between CFS and a psychogenic disease.

 

[duncan]

@halcyon, then if FMD's have their roots in an unknown virus, we are doubly screwed.

They are making too many assumptions likely based in too many errors, and the ink on the protocol isn't dried yet.

ETA: To demonstrate the absurdity of the current criteria, where would the NIH place me? I have been diagnosed with both ME/CFS and Lyme. I guarantee you there are those at the NIH who would claim my Lyme is cured, and therefore my symptoms are ME/CFS, and I am also confident there are individuals who say I have Lyme or PTLDS.

So if I volunteered to enroll in this study, would they accept me?