NIH post-infectious CFS study

[viggster]

1. Based on history, many of us don't trust that government agencies want to demonstrate that ME/CFS is not a functional illness.

I understand the long history of neglect etc at NIH, but there's one point a lot of people seem to be missing. The "THEY" has changed. The people working on ME/CFS at NIH now are not the same people who worked on it & blocked research then. Something to consider. It's easy to fall into a mindset that big bad NIH is some monolith populated by brain-washed drones. Vicky Whittemore very clearly understands the severity of our illness and knows it's hugely understudied. And now we have a new researcher on board - Avindra Nath, expert in infections of the CNS. I'm excited about him being on board - don't people always talk about drawing in new, top researchers? Well, we just drew one in.

 

[viggster]

We have no idea who they talked to at NINDS

Yesterday several patients & advocates spoke with Vicky Whittemore at NINDS.

 

[searcher]

I confirmed the accuracy of Courtney's post with Vicky Whittemore before posting because I didn't want to inadvertently post any misinformation. Vicky confirmed that patients will be identified by expert clinicians and will meet multiple criteria, including the CCC.

(Edit: I had never spoken with Vicky before and had not given any input into this study.)

 

[halcyon]

Yesterday several patients & advocates spoke with Vicky Whittemore at NINDS.

Again, that's great for them. The rest of us not privileged enough to be able to contact her directly have to rely on second hand information. I will wait until an updated protocol is published on the NIH website. Again, they said the protocol was inadvertently posted, not that it was incorrect. And I still take issue with several parts of the protocol that were not claimed to be different from what was posted.

 

[Aurator]

There's definitely a hypothesis in this study and it's ill-informed. Their hypothesis is that patients had an infection, the infection went away completely, and the patient was left with fatigue.

I don't for one minute think they can see things in such simple terms; they'd be hard pushed to justify the study if they did. Clearly fatigue alone is not a major cause for concern in anybody's books.

 

[halcyon]

I don't for one minute think they can see things in such simple terms; they'd be hard pushed to justify the study if they did. Clearly fatigue alone is not a major cause for concern in anybody's books.

I'm not sure how else to interpret the "active infection" exclusion.

 

[jimells]

I understand the negativity surrounding this but I am relatively new to this disease I would say that I remain hopeful.

After Dr Francis "Lucy" Collins yanks the football away a few more times you may have trouble staying hopeful

Perhaps the comprehensive studies will follow.

And perhaps not. We have no idea, because if there is a plan, they haven't revealed it. I suspect (yes I am a suspicious person) their plan is to use this study as a crumb to shut us up.

By comparison fluge and mella have a very clear line of investigation ( as does UCL ) as these studies are driven directly from rituximab and how that drug may work.
I dont think you can compare the two studies really. They are different animals.

My point was the transparency. The Norwegian researchers have told us what they are planning, and then they carry it out. A unique concept, perhaps?

Isn't this study more similar to the OMF research which is basically an open book in terms of what happens next ?

No. They are not using a psychosomatic comparison group. And regardless of what they find, no one doubts they will continue their research program as long as they can get funding.

Everything has to start somewhere so why can't this be the starting point ?

We don't know if it is the starting point or both starting and ending point, because there is no public plan.

 

[Aurator]

I'm not sure how else to interpret the "active infection" exclusion.

Qualify it with "known" or "identifiable", or similar.

The way I see it someone is baking us a cake. Some of us might not like the idea of who is making it or what the recipe is, but we really don't know what it's going to be like until we get to taste it. Speculation is fine, as is wanting NIH to listen to patients' concerns, but let's wait till the cake's baked before we pass judgement on it.

 

[jimells]

Their plan was to post this page & answer FAQs at the same time they did announce the protocol.

Apparently their plan did not include consulting patients, advocates, or even their own partner Solve ME/CFS before delivering the finished product.

 

[Nielk]

Apparently their plan did not include consulting patients, advocates, or even their own partner Solve ME/CFS before delivering the finished product.

Lol!

 

[halcyon]

Speculation is fine, as is wanting NIH to listen to patients' concerns, but let's wait till the cake's baked before we pass judgement on it.

None of the alleged clarifications provided via patient advocates addressed the absurdity of using a psychogenic control arm. Use of a psychogenic control arm may have been OK in 1988 but it's not OK in 2016. Now we know that the various CFS criteria select a highly heterogeneous population that can be very difficult to extract statistically significant biological abnormalities from. It is reckless to use such a control arm at this stage because you risk damaging patients with improper conflation with psychogenic disease.

 

[viggster]

Apparently their plan did not include consulting patients, advocates, or even their own partner Solve ME/CFS before delivering the finished product.

That's false.Several patient advocates & two people from Solve met with the NIH team in recent months and gave their input.

 

[jimells]

but we really don't know what it's going to be like until we get to taste it. Speculation is fine, as is wanting NIH to listen to patients' concerns, but let's wait till the cake's baked before we pass judgement on it.

I don't have time to wait five years to see if the cake is made with sawdust or flour, when they finally publish something. I'll be dead by then.

 

[searcher]

None of the alleged clarifications provided via patient advocates addressed the absurdity of using a psychogenic control arm. Use of a psychogenic control arm may have been OK in 1988 but it's not OK in 2016. Now we know that the various CFS criteria select a highly heterogeneous population that can be very difficult to extract statistically significant biological abnormalities from. It is reckless to use such a control arm at this stage because you risk damaging patients with improper conflation with psychogenic disease.

I agree with this (and I am not at all convinced that FMD is truly psychogenic or close to well-studied enough to be a comparison arm.) And I don't think we have much clarification right now except for the fact that patient selection will likely be much better than it first appeared from the protocol itself. But I am looking forward to seeing NIH's full Q&A and walk-through of their plans as I do believe them that this protocol was incomplete and accidentally posted publicly.

 

[Nielk]

That's false.Several patient advocates & two people from Solve met with the NIH team in recent months and gave their input.

I'm so glad this was done in a real transparent way. Apparently, they still messed everything up.

 

[searcher]

And I don't think anyone gave input in any transparent way. Patients should be part of study designs (and the overall research plan) from day 1 as is the case with AIDS research.

 

[jimells]

That's false.Several patient advocates & two people from Solve met with the NIH team in recent months and gave their input.

It's obvious from their response that they were blindsided and had no idea what was in the protocol.

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.

• Is the protocol too broad ...
• Did the protocol examine in-depth the recent advances in the field...
• Is this protocol timely and current? ...
• Has the issue of comorbidity been carefully considered? ...
• Are the study endpoints themselves–both qualitative and quantitative–well defined, established and objective? Additionally, have the number of patient participants been determined according to a bio-statistical analysis for each endpoint?...

http://solvecfs.org/NIH Begins Recruitment of ME/CFS Study Participants

Do these sound like questions from a partner who is being consulted?

 

[Forbin]

Were they to find similar biological abnormalities in FMD and ME/CFS, it would not prove that they were both functional. It would prove the opposite, i.e., that they are both biological illnesses. Functional illnesses do not reveal biological abnormalities.

It's only if they find nothing abnormal in both diseases that they could say that the lack of findings suggests that both diseases are functional.

They don't need FMD for this purpose, since, I assume, they also have a control group.

I can only speculate that they have some amount of money budgeted for FMD and they are including FMD to increase the overall budget for the ME/CFS study. This seems like something you would do if you were told to go "find" money for an ME/CFS study when none had been budgeted.

 

[shannah]

Apparently their plan did not include consulting patients, advocates, or even their own partner Solve ME/CFS before delivering the finished product.

Just to note that Solve ME/CFS had comments about the study as it was posted and registered their concerns yesterday.

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

"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."

"Questions regarding the NIH study protocol that the Solve ME/CFS Initiative will be seeking answers to in the days and weeks to come include:

• Is the protocol too broad in its inclusion and as such has little value, or too narrow in that it excludes by design the bulk of relevant patients? Why is it not based on the Canadian Consensus Criteria, which is regarded as the “gold standard” for this complex disease?

• Did the protocol examine in-depth the recent advances in the field, including the wealth of information compiled in the 2015 Institute of Medicine report and the slew of commentaries and analysis since, especially on criteria definition beyond the 2003 Reeves criteria? While the study does not rely solely on the Reeves criteria, a clear rationale behind the protocol must be provided. For example, have characteristic ME/CFS symptoms like post-exertional malaise been incorporated under this protocol? If not, why not?

• Is this protocol timely and current? In other words, has it benefited from or clearly incorporated the most recent developments in technology, clinical management, basic research or scholarly advances in the field, for instance, the literature and recommendations included in the IOM report?

• Has the issue of comorbidity been carefully considered? More specifically, has a clear distinction been made between primary, pathway-specific diagnoses/manifestations versus secondary and pleotropic symptoms like depression or lethargy often associated with a plethora of chronic diseases, such as cancer and diabetes?

• Are the study endpoints themselves–both qualitative and quantitative–well defined, established and objective? Additionally, have the number of patient participants been determined according to a bio-statistical analysis for each endpoint? Is the control group the one most relevant to assess the changes in each endpoint or between groups? Are there follow-up plans/alternatives built into the protocol, given its focus on the aspect of immunity and inflammation as an initial stage?"

 

[Bob]

Were they to find similar biological abnormalities in FMD and ME/CFS, it would not prove that they were both functional. It would prove the opposite, i.e., that they are both biological illnesses. Functional illnesses do not reveal biological abnormalities.

It's only if they find nothing abnormal in both diseases that they could say that the lack of findings suggests that both diseases are functional.

They don't need FMD for this purpose, since, I assume, they also have a control group.

Great point, Forbin. This is a very important point. Don't know why this went over my head. Yes, they are including healthy controls as well.