Dr Avindra Nath (NIH intramural study) to give Solve webinar, 21 April

[Amaya2014]

@duncan I get you..not sure if it comes across. I share many of the same concerns everyone else has and others do feel the same, I'm sure of it.

I was just reading a thread from '09 or'10 and people were arguing about CBT/GET. Some said it needs to go, some said maybe it's not so bad, etc. They were on the cusp of the PACE trial with no idea how damaging it would turn out.

Vigilance and speaking loudly is what we have to do given the history. Im so in prayer that this comes out right and it's not another decade or more of "idiocracy".

 

[duncan]

Nods.

I guess an easy solution is have ME/CFS experts, ones who will not recommend GET precisely because of PEM, populate the study. We all know they are out there. Why not remove chance from the equation?

How do we verify who they are? Ask them.

 

[BurnA]

Nods.

I guess an easy solution is have ME/CFS experts, ones who will not recommend GET precisely because of PEM, populate the study. We all know they are out there. Why not remove chance from the equation?

How do we verify who they are? Ask them.

I made a similar point during all the Walitt controversy but the community were so focused on Walitt I don't think anybody gave too much thought to the referring clinicians.

Maybe the strategy should be to go after the referring clinicians list instead of Walitt?
NIH would probably be more amenable to that.

I don't know enough about the referring clinicians to comment futher other than to point out that any problem with patient selection will stem from them.

 

[Sasha]

One point to make here, though, is that even BPS proponents who think exercise is great may nevertheless be able to diagnose a patient. They may recognise PEM but fail to understand that GET will make it worse and that it should be avoided. Bear in mind that the PACE trial was dead-flat null at long-term follow-up and that the fitness data indicate that patients weren't able to increase their fitness (and therefore probably didn't comply with either CBT or GET). And those were Oxford-criteria patients chosen by the BPS school. If they'd primarily been depression patients or patients able to increase their activity, the results would have been very different.

 

[BurnA]

One point to make here, though, is that even BPS proponents who think exercise is great may nevertheless be able to diagnose a patient. They may recognise PEM but fail to understand that GET will make it worse and that it should be avoided. Bear in mind that the PACE trial was dead-flat null at long-term follow-up and that the fitness data indicate that patients weren't able to increase their fitness (and therefore probably didn't comply with either CBT or GET). And those were Oxford-criteria patients chosen by the BPS school. If they'd primarily been depression patients or patients able to increase their activity, the results would have been very different.

Yes, i have often wondered how much patient selection really influenced PACE because the results were just so bad.

 

[duncan]

Yes, even BPS proponents might be able to diagnose PEM. This is a fair point.

But what of the ones that do not suffer true PEM? Are the success stories that are achieved thru exercise coming from these individuals? I bet most of us will suggest Yes. Or is exercise actually curing or improving some ME/CFS patients? I think most of us will answer No.

Is there a chance that a clinician will send a group of his favorite patients - ones who adhere to his exercise directives, and even improve because of them? Or is it more likely he will send his failures - ones who actually have ME/CFS?

I imagine it could go either way.

I want to remove that element of chance.

@BurnA , was there a referring physicians list? I cannot recall. I was thinking about simply drafting a list of ME/CFS clinicians and reaching out to each and literally asking them what they thought of recommending GET/CBT. Enlander, Sue Levine etc...

Not that it would matter. The NIH is not likely to change its course at this point. If it were good enough for the CDC yahda yahda.

But if we are looking to the integrity of the NIH study, the ability to populate it - inadvertently - with non-pwME is an area of concern that I would hope the NIH would address.

 

[Sasha]

Is there a chance that a clinician will send a group of his favorite patients - ones who adhere to his exercise directives, and even improve because of them? Or is it more likely he will send his failures - ones who actually have ME/CFS?

If I were improving well on exercise, the last thing I'd do is subject myself to a week in hospital, including a spinal tap. I think the study is going to attract only the most motivated patients, and they're going to be pretty sick.

 

[duncan]

Do we know how the 40 will be divvied up? Will it be roughly 7 per clinician?

Or will proximity and ability to travel decide?

ETA: Does anybody know how the CDC came up with its list? Is every body on that list a pedigreed ME/CFS expert, widely recognized and acknowledged as such by fellow ME/CFS experts and patients alike?

 

[duncan]

BPS people might be able to recognize PEM, but I don't want anyone of them near this NIH study. They clearly are clueless about ME/CFS.

I don't believe we should want anyone who has somehow reached the conclusion that exercise will cure ME/CFS selecting patients for this pivotal NIH CFS study. If they don't get it, they don't get it. They should not be associated with this ground-breaking effort. It's a recipe for deep, deep regret.

We need to be doing all we can to ensure that the integrity of the research process, and those participating in it, is iron clad. Where there are flaws or breaches, we need to correct those before they become systemic issues.

If not, history will kick us in the ass.

 

[BurnA]

BPS people might be able to recognize PEM, but I don't want anyone of them near this NIH study. They clearly are clueless about ME/CFS.

Just a comment, i am not sure a consultant who prescribes exercise is necessarily a member of the BPS. I know it might seem like a logical conclusion but there may be consultants out there who fully believe this to be an immunological / neurological disease but that exercise may help people feel better. They have probably been influenced by the BPS school and the newspaper headlines no doubt.
I am not excusing their behavior but maybe they don't see the line as clearly as we do.

 

[duncan]

I think we all agree that we want experts who believe that ME/CFS is an organic disease. That it is strictly biological. that there is no cultural or psych basis to it. That PEM is an integral part of it, and throwing pixie dust at PEM won't make it disappear.

We want these experts to participate in all three stages of the patient selection process. We need to get that right.

We do not want to have to teach so-called experts during the research process because they were allowed to tag along, or because they were politically appointed. Dogma being dogma, I have very little confidence that we can teach them anyway.

So, we state we want to get it right from the get-go. If there are individuals assigned to this endeavor that don't have an appreciation of ME/CFS basics, then they should be excluded. This is not a popularity contest. This should not be an exercise in making disparate camps happy, in trying to appease several different factions because of political protocol.

We are talking Science, and we are not starting from scratch. The NIH has thousands of studies upon which to build, and we don't need to pretend they are not there.

This is reasonable. It is professional.

 

[Sasha]

BPS people might be able to recognize PEM, but I don't want anyone of them near this NIH study. They clearly are clueless about ME/CFS.

I don't believe we should want anyone who has somehow reached the conclusion that exercise will cure ME/CFS selecting patients for this pivotal NIH CFS study. If they don't get it, they don't get it. They should not be associated with this ground-breaking effort. It's a recipe for deep, deep regret.

Unless there's a mechanism for them stuffing up the study, I don't think we can be absolutist about this. I think there are enough safeguards.

 

[duncan]

I wouldn't say absolutist. I'd say meticulous, and I think being meticulous goes hand-in-hand with good Science.

 

[Bob]

Apologies if this has already been posted.

www.youtube.com/watch?v=g8z-v1F6Ax0

 

[Forbin]

Lipkin is not a clinician.

I would assume that patients that come by way of Dr. Lipkin would most likely be recruited from the practices of the co-authors of the Columbia cytokine study: Dan Peterson, Anthony Komaroff, Nancy Klimas, Donna Felsenstein, Lucinda Bateman, Susan Levine, José Montoya.

 

[duncan]

Lipkin is not one I would object to at this point.

If I understand correctly, there are eleven individuals who hold influence over participants' admission to the NIH study.

One along the way, just one, who could somehow allow - inadvertently or not - non-pwME to be admitted into the cohort... would be one too many. With a sample size of only 40, just a handful who don't have ME/CFS could undo the results.

But I believe we've more than one over which to be concerned. Wallit and friends alone could count as three. Any one who doesn't understand the nature of PEM, or who thinks exercise will remedy ME/CFS, and accordingly could misidentify someone as having ME/CFS who does not, could also in my estimation pose a hazard. This potentially includes some participating clinicians.

I could easily put the risk of non-pwME being placed in this study as high as 50%.

 

[BurnA]

Apologies if this has already been posted.

www.youtube.com/watch?v=g8z-v1F6Ax0

Thanks.
He talks about inclusion criteria from about 24:00

 

[duncan]

Nath seemed very focused on the fatigue thing.

He gets that fatigue is just one component of MS - he notes this - but for me if there is a common theme here it's how intent he is on getting to the bottom of the fatigue specter. Is he conflating chronic fatigue with CFS? Is he a victim of the whole 30-year old CDC mis-characterization?

I want to quickly add that I actually kinda like the way this guy is no-nonsense. But if he is starting this quest with a fundamental misunderstanding as to the multi-faceted aspects of this disease, then it's going to be an uphill battle.

 

[Laurie P]

Do we know why they are using "a stationary bike exercise test twice" instead of a 2-Day CPET? If we could get them to use a 2-Day CPET and drop patients from the study that did well on day 1 and day 2, wouldn't that solve our selection problems? Better yet, aren't there already patients that have had these tests done that could be referred from expert clinics? Is this something that we could all agree upon and sign a single letter or petition requesting? If they would do this, it would benefit Dr. Nath as he'd see a smaller flow of negative email and maybe start getting more thank you email. Am I missing something? I'm very ill and can't read or write very much. I've been sick for 33 years after mono and severe strep throat and I would have met the CCC criteria when I got sick in 1983, had it existed. I'm bedridden now, but I would have done a 2-Day CPET for research during certain stretches of those first few years of illness.

 

[Laurie P]

I'm concerned about his emphasis on fatigue too. I have post-exertional sickness - with my worst symptoms being migraines, orthostatic intolerance and vertigo.