NIH post-infectious CFS study

[viggster]

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

The name-brand specialists who we all see will be selecting patients and sending them to Bethesda.

 

[viggster]

And who are the actual ME/CFS researchers who will be part of the team for this study,

The study is being run at NIH, so it's being run by NIH employees. Avindra Nath is the PI - he's been studying viral infections of the CNS for decades and discovered a lot of HIV's neurological impacts.

 

[duncan]

Which name-brand specialists? I like coke, but not pepsi.

Let me qualify that: I have been to two name-brand specialists in the last few years that recommended GET to me. So, yes, who matters.

 

[viggster]

Susan Levine is the name I heard + others involved in CDC 5-site study.

 

[duncan]

Thanks.

Look, I would rather the NIH has input from one of our experts than not. From what they have generated so far, if they have such guidance, it's from the wrong experts imo.

 

[viggster]

Ian Lipkin consulted. Boy this is a tough crowd.

 

[Scarecrow]

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

There has been talk of only 40 PI-CFS patients in this study (and of possibly only 40 participants in total). I do hope neither figure is true but either way, it would be meaningless if they took a pick n mix approach.

Can any statisticians wade in to elaborate? What sort of PI-CFS numbers might they need before they could start subsetting?

 

[duncan]

@viggster, you live and learn. If you don't speak up - BAM! 20 years go by and you've lost two more decades.

PEM needs to be an essential criteria. Deep-six the Lyme and FMD control groups. These are major issues that don't reflect on us, but rather this NIH effort to date.

 

[Scarecrow]

PE< needs to be an essential criteria.

I think that part, at least, has been confirmed for the better. For the Lyme and FMDs, we will just have to wait to hear the rationale.

 

[viggster]

Do you think Susan Levine will be sending anything but "real" patients? Good grief, she's spent her career on this illness. She knows what's she doing.

 

[halcyon]

To demonstrate the absurdity of the current criteria, where would the NIH place me?

I (and potentially 82% of other patients if Chia's results hold up) would be excluded from this study due to having an active enterovirus infection. That being the case, this proposed study has no relevance to the disease I suffer from.

 

[duncan]

I apologize, @viggster - I am likely not expressing myself well.

I am sure there are some experts who will well qualify their patients. I fear they may be some who do not.

But as the protocol appeared over the weekend, the NIH effort scares me, and appears to me that the appropriate guidance is either being ignored, or isn't being heard, or isn't there.

Ultimately, though, this falls back to the NIH and what that institution is putting together.

@halcyon, yes, the way this seems presented so far, many of us would be left out potentially.

 

[halcyon]

Ian Lipkin consulted. Boy this is a tough crowd.

30 years of history are not simply erased by the creation of this study. If done wrong, this study has the potential to bury us big time.

Do you think Susan Levine will be sending anything but "real" patients? Good grief, she's spent her career on this illness. She knows what's she doing.

This disease has no biomarker. So yes, any of the disease experts could send them something other than "real" patients.

 

[Bob]

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.

If you had a Lyme diagnosis that met their criteria, then you'd be excluded from the study because you still have symptoms that could be associated with Lyme. I think that's a good thing in case there's any possibility that you still have Lyme disease.

 

[Bob]

I (and potentially 82% of other patients if Chia's results hold up) would be excluded from this study due to having an active enterovirus infection. That being the case, this proposed study has no relevance to the disease I suffer from.

I understand what you mean but, from their point of view, if you have an active infection that could be causing the symptoms then it's not ME but it's an infection that needs treating.

 

[viggster]

This disease has no biomarker. So yes, any of the disease experts could send them something other than "real" patients.

How do you think patients should be chosen then, if not by experts like Levine who have 25+ years experience with ME?

 

[Bob]

There has been talk of only 40 PI-CFS patients in this study (and of possibly only 40 participants in total).

It's now been clarified that there will be 40 PI-ME/CFS patients, and it will be a longitudinal study of those patients.

They seek to have 40 PI-ME/CFS patients, and they will study them longitudinally, hoping to learn how and whether the disease changes over time.

 

[Bob]

Making sure everyone has seen the update and clarifications from NIH on ME Action that Brian posted earlier:
http://www.meaction.net/2016/02/09/...al-questions-re-nih-clinical-center-protocol/

 

[Bob]

From a scientific point of view, I think the Lyme control group is well thought through and appropriate. It's well known that some Lyme patients don't fully recover after treatment, and go on to develop an ME-like illness. So it will be useful to have data from Lyme patients who no longer have symptoms to compare with post-infectious ME patients (i.e. patients who develop ME after an infection.) The question they are asking is: "What are the subtle immunological (and other) differences between the two groups?" The two groups being: those who recover after an infection and those who develop ME. An answer to that question could give us the answer to ME. So I think it's an excellent control. (Unless I've missed something.)

 

[duncan]

@Bob, you may have missed parts of the Lyme wars, and a major front for the last many years has been in Bethesda, MD, USA.

I've been to the NIH for Lyme. I am familiar with the mindset.

The collateral damage to this CFS study might be substantial if Lyme remains in the protocol.

That doesn't even touch upon FMD's.