NIH phonecall and Q&A, Tues 8 March

[Justin30]

I just wanted to point out one other thing that Wallit, Gill, and the Other have not been exposed too the attrocity of severe or moderate severe ME as it stays almost hidden.
Dr Petterson, KDM, Goldstein, Klimas and a handful of others have seen it. But not many.

This Trio by no means i feel are true experts, true experts have been exposed to over 10,000 + patients which i can almost surely guarantee these individuals have not seen.

And I have to say it that even though it looks like ME, Smells like ME, and is duscussed about as ME...Doesnt mean its always me....there is no biomarker yet

Their are 300 or more autoimmune mediated neurological illnesses with symptom overlapp to ME....and many have a viral or bacterial onset as the trigger....as per Mayo Clinic and many Pubmed Articles....many will become bedbound prior to getting answers because they cant make it to the Mayo Clinic or another Expert specialist cause they are too sick, dont have insurance or dont have the finances.

I actually go half insane reading all the shit thats out their. I bet you many of us fit the bill for a ton of different rare autoimmune diseases...with know known cause...or cure...or marker....

The VO2 Max test should weed us out right away.....and hopefully NK cell function...and IL17...cd3 and 4...and who knows what else.

ME as disccussed many times is likley a group of subsets under the category of ME or is stages like in Cancer.

I think we should use our brains elsewhere and focus on planning and goal setting with our organizations.

 

[Simon]

NIH: Solving ME/CFS will need “an army of really good researchers working together”

Brief blog on the NIH strategy for tackling mecfs

 

[Valentijn]

Are you referring to the FM video of Wallit? Or do you have actual proof of other illness that are being contested by these reearchers yet substantiate by a body of knowledge arguing that they are indeed a biological illness.

Please see http://forums.phoenixrising.me/inde...the-upcoming-post-infectious-nih-study.43223/ for the highlights regarding the problematic research and statements made by 6 of the investigators. Links to some of the research is there.

But yes, Hallett's team (includes Maurer and Horovitz) has explained abnormalities in the brain as being part of the psychosomatic perception of symptoms, rather than the cause of actual symptoms, specifically in the case of Functional Movement Disorders.

Walitt & Saligan have worked together on a paper proclaiming a relationship between genetic expression and the catastrophization of symptoms in Fibromyalgia, but don't seem to entertain the possibility that it could be the direct cause of the symptoms themselves.

Gill is on the record stating that routine testing of CFS patients should be very minimal, and that positive results are probably a false positive. That includes advocating that CFS patients should not be tested for OI despite that it is an extremely common and disabling symptom, yet is often treatable. And there is the infamous caution against disagreeing with the patient regarding whether CFS is a biological or psychogenic disorder.

 

[TiredSam]

And there is the infamous caution against disagreeing with the patient regarding whether CFS is a biological or psychogenic disorder.

Which is exactly what Walitt seems to be doing now. The BPS crowd regard it as perfectly ethical to not contradict the patient or to even lie to the patient. So he starts off with a very encouraging:

My patients taught me just how real these disorders are. They are not just in one’s head. They do not reflect some unconscious choice and it is not possible to simply push through the symptoms.

He then remembers to include the words biologic, biological, biology, physical, and biological in his following sentences, before rather letting himself down with the following Walitt salad:

If chronic fatigue syndrome / myalgic encephalomyelitis is all in your head, it’s only because your head is part of your body.

You tell me what that's supposed to mean.

I can't ignore the fact that people who believe ME/CFS is psychosomatic/somatoform/whatever feel they have no duty to be honest with the patient, and are on record as saying that it is ethical to deceive and lie to the patient. Once Walitt has nailed his flag to that mast, how can anything he says to patients be believed? How are we supposed to be able to tell whether he's ethically lying to patients or has had a sincere change of heart? He can't be trusted and it's his own fault.

 

[Valentijn]

I can't ignore the fact that people who believe ME/CFS is psychosomatic/somatoform/whatever feel they have no duty to be honest with the patient, and are on record as saying that it is ethical to deceive and lie to the patient. Once Walitt has nailed his flag to that mast, how can anything he says to patients be believed?

Good point. Walitt has quoted Wessely at some length in the past, and quite possibly would agree that it's preferable to mislead the patient, when outright lying isn't permitted and the truth is too abhorrent.

 

[Comet]

I just want to say regarding psychosomatic or somatoform illness: Doesn't pretty much every living being on the planet feel worse under stress? This seems 100% normal to me.

It doesn't mean that if you have an illness and feel worse under stressful conditions that it is psychosomatic or somatoform. Someone who is ill might feel the effects of stress more than someone who is healthy. But isn't that pretty much expected too?

Where do these medical egomaniacs get this stuff? They overlook the simplest explanations and create convoluted theories to explain things they just don't know, because they refuse to admit that they just don't know everything.

 

[TiredSam]

Where do these medical egomaniacs get this stuff?

The truth is revealed to them, either by some cokehead in Austria who hates women, or by their own intuition and inner wisdom. Explaining the mechanisms involved is of course beneath them.

 

[Comet]

The truth is revealed to them, either by some cokehead in Austria who hates women, or by their own intuition and inner wisdom. Explaining the mechanisms involved is of course beneath them.

"First Do No Harm"... It's so sad that in many cases ego gets in the way of this.

 

[LiveAgain]

I don't know how any patient who has been following this could be in the study and comfortably interact with Walitt and some of the others. They are the exact type of doctors I run the other way from. Also, it's great they removed the FMD group, but what the original thinking for including that group and doctors who specialize in FMD to begin with? The control group may be gone, but is the thinking that led to the inclusion of that control group gone? And shouldn't those doctors be out too since there will be no FMD patients? I see no role for them now.

 

[BurnA]

I agree and I want them out. But the impression I get is that they are here to stay.

The question I ask myself now is would I prefer the study to progress as is or not at all and my answer is as is. So I have moved on. I just want the study to start.

If the extramural funding goes ahead as suggested then this study may not be the only show in town. If that's the case the presence of Walitt on this study should not be too worrisome.

Sure this is a landmark study but there is a reasonable chance an important discovery could be made by Lipkin/Hornig and others if funding is made available.

The chances of the NIH publishing a dodgy study result should diminish the more extramural funding is made available.
Why would they give out loads of money if they are not serious themselves ?
And obviously if they 'find' something at odds with a respected researcher or the OMF it would look very strange.

 

[Simon]

Another short report by me
NIH aiming to commit RFA funds to ME/CFS research

Basically, both Francis Collins (NIH Director) and Walter Koroshetz (NINDS Director, Chair of Trans-NIH Working Group) were explicit they want RFAs for mecfs, but both won't commit publicly til it's been approved by the NIH bureaucracy. Could be May/June.

 

[duncan]

Extramural funding comes with no guarantees.

Again, I caution people to examine the Lyme paradigm.

There is a good deal of extramural activity relative to Lyme - but any efforts that are NIH-related are pretty much restricted to those who support the CDC/NIH party line. There is a good deal of sentiment against that party line, but those groups can seldom get grants to prove or support their case. The dogma simply becomes more entrenched, even in light of unsettling reports of Lyme incidence 10 times earlier CDC estimates.

So if this effort comes to a bad conclusion for us, I would be concerned that subsequent extramural efforts may mostly just be postural homage to conclusions already reached.

 

[LiveAgain]

My biggest concern is what if they don't find anything? If all the investigators were *definitely* starting with the premise that ME/CFS is biologic, I wouldn't be so worried. But we have that question mark. Look at what just happened with GWI (below). A lot of money and resources were invested, nothing was revealed (I guess? I don't know?) and the IOM decides to go back to "mind/ body" explanations. That's devastating. I can't even wrap my head around this nonsense.

I do feel reassured that there are several researchers outside the government and in other countries who seem to be making progress and hope they will be influential. Also, I think NIH is now acutely aware their every move is being scrutinized by very intelligent people who will rip apart anything that sounds psychobabbley.

http://www.foxnews.com/politics/201...for-halt-to-research-on-gulf-war-illness.html

 

[BurnA]

My biggest concern is what if they don't find anything?

It may be a legitimate concern but I dont think it's worth worrying about.
If they dont look, they will definitely never find anything, so you should be relieved that they are looking. Also they are looking in ways they haven't looked before.
I'm sure they will find something but that really is just the starting point.

 

[duncan]

At the very least, we need to ensure they are looking for "something" in the right people.

For now, I have concerns that start at the clinician level where patients are selected, and run all the way up to the three psych types that act as a uneasy gateway.

If half of those clinicians down on the streets believe GET, or a variation of GET, is appropriate for ME/CFS sufferers, what does that say about their knowledge of PEM?

If they truly know PEM, what does it say about them if they are prescribing GET for their ME/CFS patients?

Either way, are they appropriate sources for study participants?

Then there is the Bethesda Trio. There is also at least one step before them.

I am worried that there are too many opportunities for wrongly-qualified patients to end up in our ME/CFS study.

And THEN we have to be concerned about the political machinery that might clank into gear, and here I speak to the unwarranted influence that some individuals might levy upon interpretive elements as the study progresses, and when it comes time for analysis.

For those who scoff at such possibilities, all I can say - like a broken record - is just look at how the NIH and the CDC have dealt with Lyme to see what many feel is an unraveling of the fair and unbiased scientific method.

Patient advocates need to be a part of this - as much as we can.

 

[Liz_999]

Silly patients don't realise that the NIH is always unbiased and the protocol won't allow any bias anyway.

A bit more seriously though, they surely must be aware that bias is ubiquitous and while protocols and such are helpful in controlling it, they are no guarantee.

I guess it would have been difficult for them to publicly state, unfortunately the NIH sometimes produces biased research results or we realise that we have biased people on this study but we are going to watch them closely. I very much hope that's what they meant though.

I think it's unrealistic to expect any of the contested investigators to be removed now. Perhaps this would have been possible through back channels and before the opposition became widely known. As it is now, this would set a precedence of the patient community vetoing the involvement of researchers which could be argued to introduce a different kind of bias.

Apart from that, while people might silently be excluded from a team because of their views in an organisation like the NIH, a public or formal acknowledgment that having the "right views" is a prerequisite to be able to participate in a study is a different matter entirely. So this ship might have sailed in part because of the strong and vocal opposition to people like Wallitt.

Ideally, they would just step down voluntarily, perhaps under a pretext. This would actually demonstrate their sincerity and acknowledge that there is good reason for the lack of trust in the patient community. I doubt it will happen though.

 

[Valentijn]

For now, I have concerns that start at the clinician level where patients are selected, and run all the way up to the three psych types that act as a uneasy gateway.

Good point. They are getting those patients from the clinics used in the other multi-site study, and Dr Lapp has expressed a belief that a gentle form of GET "can be of great benefit".

Dr Lapp's clinic in North Carolina is the 3rd closest to the NIH out of the 7 clinics, after the clinics in New York and New Jersey. How many CF patients who find that GET is of "great benefit" will be sent to the NIH as potential patients? Will it be enough for the psychosomatic trio of investigators to pack the study with them?

 

[duncan]

Apparently Lapp wouldn't be the only one. There are two others of which I am aware who seem to preach the "keep pushing yourself a little more each day" mantra. "Walk a little further, exercise a little more...Each day set the bar just a bit higher."

When I confronted one with what such advice could result in, i.e., PEM, that clinician shrugged off my concerns. I argued that the knowledgeable ME/CFS patient has learned her threshold (the hard way), and has embraced pacing necessarily. I agreed that deconditioning could be a risk, but we try to do what we can in general...that a greater risk was constantly pushing the envelope until one falls off the PEM precipice. Like a child, I was gently admonished. I firmly disagreed. We did not part on the best of terms.

I am concerned that doctors like this may not fully understand what PEM can do, or else I doubt they would ever put patients at risk that way. I suspect they are in fact at times confusing patients with chronic fatigue, for whom such a therapy might hold some benefit, with ME/CFS patients.

By my estimate, that could be half of the clinicians culling patients for this NIH study.

Accordingly, I worry whether they are the best "experts" to be populating it.

 

[jamie]

So this is getting started soon. What can we going to do? Did all the advocacy groups give up? If we can;t get them off the study I would at least like it on the record that we strongly object to these people being used as and labeled as ME clinical experts in charge of screening patients.

@Valentijn you have done such good work on this. Is there any way you could do a summery of the greatest hits of the new NIH "clinical experts" To share with others who may want to use it or even email to Nath so he knows these are not experts in any way and in fact people who have hurt patients . Also they might mess up his study unless he makes sure to consult with real experts such as...

He seems like the most honest broker of the bunch and seemed genuine about learning from patients.

 

[Valentijn]

@Valentijn you have done such good work on this. Is there any way you could do a summery of the greatest hits of the new NIH "clinical experts"

Most of what I looked at is summarized in the first post of http://forums.phoenixrising.me/inde...the-upcoming-post-infectious-nih-study.43223/

I'm not up to doing much else currently, due to an ingrown toenail which is swollen, pretty painful, and trying to get infected. So I'm on the couch and zoning out mostly.