NIH intramural research program update

[LiveAgain]

Yes @viggster speculation based on fear and history. Can you think of why else they would include the FMD group? On the Eligibility Requirement page for the study it says the groups (including FMD) "were selected so that comparisons can be made between the groups to look for differences and similarities."

Why are they looking for similarities and differences between ME/CFS and a "psychosomatic" disorder? This should not even be on the table since they supposedly know we have a true organic illness. So my speculation/ fear is that yes, they think this could be a true disease and will look for biologic markers, but there is some suspicion it could be a "functional" (somatoform/ conversion) disorder and they aim to test that via comparison with FMD.

A few posts back I linked a study by the same neurologists involved in the ME/CFS study who found autonomic abnormalities in the FMD group - uh oh, already a similarity with ME/CFS. And the original premise that FMD is psychosomatic might not even be correct! but are they going throw away years of work, research, their reputation, their biases and admit that (in fairness to patients) - probably not. I'm not a scientist but this just seems like a really bad control group that makes no sense and could hurt us. Hopefully others with a science background who also see this group as problematic can express coherent concerns to NIH. (as Janelle did above - amazing.)

I'm glad NIH is open to patient feedback and hope they will answer some of these questions soon. It's sad because after all these years they finally commit to studying the disease and instead of being happy, patients are frightened.

 

[Ecoclimber]

To piggyback above

After35+ years of misdirection, you would not expect ME/CFS patient community to go by words? It is action that gets notice. One must remain objective and not lose sight of this fact and not be influneced based on "connections".

Besides as patients, citizens, taxpayers and to those who have pave the road before us, the patients have earned the right in pain and suffering, years of stigma related neglect, abuse and marginalization to stand on the wall of inspection, to scan the horizon into the NIH study to determine if there is problem. Narth encourage such participation. Any opposition to that effect is not helpful by painting in posts, patients as conspiracists. I certainly wouldn't place as lead clinical investigator someone who has repeatedly stated a confirmation bias in their research.

I get the implicit attitude that the patient population shouldn't be objective, shouldn't investigate, should just simply trust and accept the direction of the NIH. This isn't the first rodeo for this group.

Walitt could not assume Narth's postion as clinical director as he is over in NINR in the Division of Intramural Research
Symptom Management Branch as medical officer. Why choose him from that position, I don't know but he has investigated thorougly symptomatic dysfunction using neural imaging.

Alter is in NIAID so he wouldn't be considered appropriate for NIND directed intramural research project

We don't need someone that assumes the belief that the pathogensises of chronic illenesses are caused by a psychological response which gets back to the notion of the uselessness really of trying to divide things up into mind and body – they are one and the same thing. Thoughts affect chemicals and chemicals affect thoughts.

Anyway, I must take my leave from this conversation.

 

[Valb626]

Walitt isn't the only problematic investigator involved. Here's a recent publication in which Carine Maurer and Mark Hallett appear to make fun of FMD patients: The “Whack-a-Mole” Sign in Functional Movement Disorders http://onlinelibrary.wiley.com/doi/10.1002/mdc3.12177/abstract

 

[daisybell]

Walitt isn't the only problematic investigator involved. Here's a recent publication in which Carine Maurer and Mark Hallett appear to make fun of FMD patients: The “Whack-a-Mole” Sign in Functional Movement Disorders http://onlinelibrary.wiley.com/doi/10.1002/mdc3.12177/abstract

Nasty. I just love the fact that patients can so easily be viewed as sub-human, don't you?

 

[Kati]

i thought I'd share Dr Fred Gill, a co investigator''s slides from his 2011 State of Knowledge presentation. i am doing this blindly as my IPAD can't open it.

https://demystifyingmedicine.od.nih.gov/DM11/02-22-2011/2011-02-22-Gill.htm

 

[CFS_for_19_years]

Walitt isn't the only problematic investigator involved. Here's a recent publication in which Carine Maurer and Mark Hallett appear to make fun of FMD patients: The “Whack-a-Mole” Sign in Functional Movement Disorders http://onlinelibrary.wiley.com/doi/10.1002/mdc3.12177/abstract

That paper has been cited a whopping (drumroll) one time! By the author himself, Mark Hallett.
Congratulations Mark.

The real Whack-a-Mole sign is how many times we've got to keep whacking away at article writers masquerading as scientists.

Nasty. I just love the fact that patients can so easily be viewed as sub-human, don't you?

Next cerebral palsy patients will be labeled as having the flippity-flop sign.

 

[Kati]

Question for @viggster and others who may know. @leokitten comes to mind too
How common would it be for intra-mural studies to seek out outside help and collaboration in designing and performing a study?

Right now, they are collaborating with Ian Lipkin and Beth Unger, neither of them have clinical contact with patients.
Thx

 

[Valb626]

Kati, it's not impossible to go outside - they already have a few consultants identified as "associate investigators," in addition to Unger (who they don't have to fund) and Lipkin (who may be funded through other grants he has with NIH or other sources). But I'm guessing there's a very low ceiling on how much funding they have and can spend on outsiders (there are probably some limits before the project violates some threshold beyond which it not longer meets the definition of intramural), let alone any quick contracting/grant mechanism to access them.

 

[Kati]

Here is a tweet from Hillary Johnson:

Hillary Johnson (@oslersweb)
2016-02-22, 5:50 PM
@NIHDirector Can you imagine AIDS activists allowing someone denying the existence of AIDS to be in charge of an AIDS clinical trial?


(A retweet will send an extra notification to Francis Collins)

 

[acer2000]

I'm not shocked that an agency that has made it a priority not to study ME/CFS for years doesn't have a deep bench of experts in the field to head up a study. Not making excuses for them, but maybe this is the best they could do? This obviously needs to change for this study to go forward. This is one reason why despite the resources available internally at NIH, they may have been better off giving the funds to extra-mural researchers like Ron Davis at this point. At least he is motivated and has relevant expertise.

 

[Valentijn]

Walitt isn't the only problematic investigator involved. Here's a recent publication in which Carine Maurer and Mark Hallett appear to make fun of FMD patients: The “Whack-a-Mole” Sign in Functional Movement Disorders http://onlinelibrary.wiley.com/doi/10.1002/mdc3.12177/abstract

Full text is available at http://onlinelibrary.wiley.com.sci-hub.cc/doi/10.1002/mdc3.12177/full . Though it's just 4 case studies and the investigators' beliefs presented as fact.

It's pretty stupid. These people have muscle movements, and the investigators repress movement at one end of the joint/muscle, which results in more/new movement at the other end. That is, a limb is basically moving away from the trunk at a fulcrum point (hip, shoulder) due to the muscle flexing in a certain manner.

Because the body is much heavier than the limb, it is normally the limb which moves while the body stays relatively still. That's why when you try to push your right arm to the right, it doesn't send the rest of your body moving to the left.

But if the limb is held in place by a stronger force, the same muscle flexing will result in adjacent movement in the body. And they're attributing that movement to a functional movement disorder, when it's easily explained by basic physics instead.

These people seem to have to understanding about how muscles and movement work. I guess they were napping during their anatomy classes?

 

[Sasha]

I would not characterize patient involvement as an afterthought [...] NIH put together a protocol and a team and now they're getting feedback on it.

I think that's the issue - that they did first, and asked later. If patients had been involved in the planning stage for this protocol, I think the study would have looked very different, and would have had very different personnel.

I'm glad that Dr Nath is taking this issue seriously, though, and I look forward to us being able to work in a positive way with him. It's in no-one's interest to have something that ends up being another PACE - in the sense of a study so deranged that patients and scientists have to protest against it in their thousands. At the moment, that FMD control is making it look very much like that.

Right now, it looks like a Frankenstein's monster of a study, cobbled together out of excellent bioscience and BPS bullshit. It reminds me of the P2P report, which had great stuff about retiring Oxford and a definite statement that ME/CFS is an organic, not psychological disease, and then went on to recommend more homoeopathy research. That's what happens when you get opposing views on a badly configured committee and no one has the power to rule stuff out. Maybe our role here is going to be to shift the balance of power on the committee.

 

[Valentijn]

i thought I'd share Dr Fred Gill, a co investigator''s slides from his 2011 State of Knowledge presentation. i am doing this blindly as my IPAD can't open it.

https://demystifyingmedicine.od.nih.gov/DM11/02-22-2011/2011-02-22-Gill.htm

Not good. It's a slide show specifically about CFS. Mostly it's fairly mainstream BPS psychobabble, seeming rather influenced by the British approach. It's the somewhat compassionate version, and far less disturbing than Dr Brian Walitt's work (I think my standards got much lower after reading that).

Note that CFS is classified as an "illness", which is distinct from a disease and is supposedly something merely reported/perceived by the patient:

Neurasthenia. Nuff said:

I guess he can't read research, so doesn't think ME/CFS patients have OI. Based on later slides, he might be giving a lot of credence to NICE guidelines, including the DO NOT DO section, and may have misunderstood them:

Stress supposedly causes inflammation, and SSRI's supposedly inhibit cytokines:

Advocating for limited testing is a huge red flag, which has "PSYCHOSOMATIC" printed on both sides:

And if those pesky patients do have an abnormal result, it's obviously a false positive:

Solution - CBT and GET of course:

Deceive the patient as necessary to gain compliance:

Image upload limit has been reached, to be continued in the following post ...

 

[Sasha]

Image upload limit has been reached, to be continued in the following post ...

Even the upload limit is rebelling!

It's good that we're documenting this stuff. We need to collate it and present it to Dr Nath.

 

[Valentijn]

Slide Show of Horrors, Part II.

I bet they can justify hiring a whole team for this:

And finally, several slides devoted to singing the praises of PACE, culminating in this:

I don't think even a mainstream BPS psychobabbler belongs in the NIH post-infectious study. Not all of his stuff is completely bad, and he doesn't dismiss the prospect of new studies. But attributing raised cytokine findings to "stress", advocating minimal investigations, and the presumption of false positive lab results make him pretty unsuitable I think. He's another one who seems to (more gently) spin biological results to suit a predetermined psychosomatic conclusion.

So I'd be quite happy to see Dr Fred Gill appended to the "get rid of Dr Brian Walitt" efforts.

 

[jamie]

Good god are we up to 4 investigators who have public statements supporting the CFS is a psych problem theory?

Talk about whack a mole. We just started trying to get rid of the first guy and three more pop up. At this point if these are the people involved I will advocate to put the whole study on hold. I'd rather have no study than a bad one it takes years to fight. This study will be big news with the full force of the US government backing it, it could affect our treatment for years like the PACE trial.

They say they intend to suggest treatment in the final stage, The learning curve for this disease is very steep and I don't think that have a clue as to how easily treatments can harm us or how diverse we are in symptoms which treatment helps. Even the way the guys we like talk about it is all about fatigue as THE main measurement of disability. I say give money to Ron Davis and others who know the disease or to duplicate previous studies until they get a better grasp.

They really need someone with a lot of clinical experience involved in planning investigation or if they go forward just keep it a fact finding mission and stop there. Ian Lipkin is relatively new to the disease and is not a clinician (even so I'm surprised he was ok with this as is). Maybe there is one but I can't see any of our experts looking at the controls and these 4 investigators and feeling easy about how this ends.

 

[TiredSam]

A protest from the serious scientists involved would be most welcome. If the NIH wants to make good they should be sensititive to the history and make sure this study is whiter than white and squeaky clean, not one shocking disappointment after another.

 

[A.B.]

A protest from the serious scientists involved would be most welcome. If the NIH wants to make good they should be sensititive to the history and make sure this study is whiter than white and squeaky clean, not one shocking disappointment after another.

Yes. We need to get other scientists to speak of the problems with the study.

 

[ScottTriGuy]

Yes. We need to get other scientists to speak of the problems with the study.

The bio researchers must now, or will be very shortly, wondering (because of the concerns we're raising) if their reputations will be tarnished by association with these psychobabblers.

Do they want their name listed in (what is turning out to be a shit show) study along side the likes of Walitt?

If their reputations are tarnished by association, future funding for their studies would be in jeopardy, and there goes their career down the toilet.

It may be in the best interests of the bio researchers to extricate the psychobabblers from this study to preserve integrity.

 

[Roy S]

https://twitter.com/i/web/status/701826226424426496