NIH intramural research program update

[duncan]

By virtue of his very presence, I think it pretty fair to surmise not only have we been ignored already, but also the ME/CFS expert researcher/clinician community, and the IOM report.

 

[Ecoclimber]

As I mentioned in a previous post. Researchers should be agnostic. As in judicial proceedings where impartiality is an issue, judges recluse themselves. I have problems with any researcher exhibiting pre-existing confirmation bias with regards to ME/CFS research. I find this troubling. Confirmation bias is a form of cognitive bias and as such is deeply rooted in ones way of thinking. Good scientific practices can diminish the effect of this bias, but they are not always followed nor infallible.

This crticial issues concerning Walitt has to be addressed by the NIH. Otherwise, you could end up having a 'kangaroo court' type research trial.

 

[Kati]

You can voice your thoughts about Walitt at #MEAction by adding your comments here : http://www.meaction.net/2016/02/20/nih-lead-clinical-investigator-thinks-cfs-is-psychosomatic/

 

[Zombie_Lurker]

This crticial issues concerning Walitt has to be addressed by the NIH. Otherwise, you could end up having a 'kangaroo court' type research trial.

I agree. Joseph Stalin said, "The people who cast the votes don't decide an election, the people who count the votes do." In the case of this study it may be: "The raw data collected in this study doesn't matter, how the people (Walitt) interprets the data and write out the final study does.

 

[Snowdrop]

Brian Walitt on the NIH study.

Study hasn't started yet. There's still time for a change.

 

[searcher]

Ok but maybe before we go viral is there a more direct way ? I think it's better to try official channels first. Petitions and social media are for getting attention, but if we have a channel to the NIH either via Lipkin or the patient advisory committee we should try that first I think.

#MEAction is sharing all of the comments on that page with NIH. We have received text submissions for a few petitions, and will try to finish a single petition incorporating everyone's input in the next few days. I do believe that official channels will help though since NIH is now listening and (slowly.....) setting up communication processes. I realize I may be wrong, but I don't think this will be like the Lancet where Horton ignored all the controversy and said he couldn't respond because he was on vacation.

And Nath said the study is at the very beginning and everything is subject to change based on patient input, so now they have the opportunity to prove it.

 

[Old Bones]

(I'd have more time and be more practically helpful with this advocacy if I wasn't working on a project targeting the Canadian problem.)

Hi @ScottTriGuy . If you feel comfortable doing so, I'd love to hear a bit more about your work on a project targeting the "Canadian problem".

 

[A.B.]

By virtue of his very presence, I think it pretty fair to surmise not only have we been ignored already, but also the ME/CFS expert researcher/clinician community, and the IOM report.

The study itself means we are not being ignored. The NIH may simply lack experience dealing with ME/CFS research, or have problems transitioning from a psychosomatic to a biological view, or whatever. Do not assume the worst. Nath made a good impression to me, and welcomes patient feedback. I think now is the time to speak clearly and calmly about our concerns. So far we are being listened to.

 

[Comet]

#MEAction is sharing all of the comments on that page with NIH. We have received text submissions for a few petitions, and will try to finish a single petition incorporating everyone's input in the next few days. I do believe that official channels will help though since NIH is now listening and (slowly.....) setting up communication processes. I realize I may be wrong, but I don't think this will be like the Lancet where Horton ignored all the controversy and said he couldn't respond because he was on vacation.

And Nath said the study is at the very beginning and everything is subject to change based on patient input, so now they have the opportunity to prove it.

Commented. That article is stunning. We're the ones who are delusional? The egos on these people are astounding. For them to think that if they can't find an answer to something that it simply can not exist is mind boggling.

 

[duncan]

I agree, @A.B. , that we have not been completely ignored, and the NIH study appears to be evidence of that.

However, I am not so convinced about study architects not ignoring various of our communities about ME/CFS being a biological disease, and not a psychological disorder.

I am concerned by what placement of individuals like this Walitt in positions of influence says to overall intent.

 

[Ecoclimber]

Since Dr. Nath encourage patient participation, I believe the patient community should take advantage of his offer. The question with confirmation bias is in the danger that a reseacher may unknowningly, design trials, conduct tests, interpret results, sway other researchers that will confirm their confirmation bias in their final analysis as we have seen with Wessely et al. We have seen a great example of confirmation/selection bias under Tuller's spotlight on the PACE Trials -makes for a great title, Under the Spotlight, The PACE Trials.

Dr. Walitt believes strongly in using the Polysymptomatic Distress Scale in reseach
The Polysymptomatic Distress Scale Is Simple, Useful, and Effective in Clinical Care and Clinical and Epidemiology Studies.

This is one of the author's views on using PDS
http://www.fmperplex.com/2013/03/01/there-is-only-one-fibromyalgia-and-maybe-not-even-that/

I don't have the time to research any areas of concern but others on PR may be willing.

 

[viggster]

Dialogue is the only way things get resolved. Sometimes protests and petitions are needed to get the dialogue started but ultimately if you can skip them you can still achieve the same result. Of course if we are ignored then they become a useful means of demonstating our objections.

Yes, we have channels of communication between the patient community and the people running the study. ME Action is collecting questions and concerns that will be relayed by the US Action Working Group (which includes 30 patients & advocates from all over, including PR). The NIH is also setting up a patient advisory committee, although we don't have any details on when that will happen.

Researchers should be agnostic

That never happens in medical research. Doctors & scientists want to help patients and when they test new treatments, they want a positive outcome. That's why study design is so important - you design the study to try to remove as much bias as possible.

 

[Snowdrop]

I have a question. From what pool will the study participants be drawn?
I presume they must have to be local in order to be seen by clinicians. If so where is this locale?

And is there a local ME advocacy group that could educate people as to things to look out for as a possible participant?

 

[Ecoclimber]

That never happens in medical research. Doctors & scientists want to help patients and when they test new treatments, they want a positive outcome. That's why study design is so important - you design the study to try to remove as much bias as possible.

I differ.
http://www.virology.ws/2011/05/06/ian-lipkin-on-xmrv/

As I noted there could be a sub-conscious as well as a conscious bias. If all your previous research lead to the same conclusions, why will new research change your conclusions? Why are we here now after some 35+ years even conducting experiments, if it wasn't for Straus/Wessely confirmation bias on the cause of ME/CFS as psychosomatic disorder?

Do you believe Wessely et al will change thier biases as to the cause of ME/CFS if they conduct further research? If so, I have a bridge to sell...

note: edit for clarification

 

[Roy S]

@viggster
Brian, what do you think of Dr. Walitt and his position on this study?

 

[halcyon]

That never happens in medical research. Doctors & scientists want to help patients and when they test new treatments, they want a positive outcome.

Dr. Nath has no apparent background in psychology or ME, just a strong biomedical background. That is the type of researcher we need running a study, with input on study design from disease experts. When disease experts with heavy bias design and run a study, you get PACE.

That's why study design is so important - you design the study to try to remove as much bias as possible.

Indeed, that's why everyone appears to be up in arms about Walitt. I don't think it's unreasonable to assume that the FMD control arm had something to do with his input given his now apparent bias.

 

[halcyon]

I have a question. From what pool will the study participants be drawn?

According to what Dr. Nath said during his recent talk, they will be recruited from the CDC multisite clinicians, so:

Dr Lucinda Bateman (Fatigue Consultation Clinic, UT)
Dr. Nancy Klimas (Center for Neuro Immune Medicine, FL)
Dr Andreas Kogelnik (Open Medicine Clinic, CA)
Dr Charles Lapp (Hunter-Hopkins Center, NC)
Dr. Benjamin Natelson (Pain and Fatigue Study Center, NY)
Dr Daniel Peterson (Sierra Internal Medicine Associates, NV)
Dr Richard Podell (Richard Podell Clinic, NJ)

 

[Denise]

Jeannette Burmeister has a post about Walitts:
Brian Walitt’s Radical Bias: Disorders of Subjective Perception, ME/CFS as Normal Life Experience?

 

[Mary]

Words fail. I wish I could unsee this.

He's beyond horrible. (and also very badly needs a decent haircut!)

When he says:

Well, as physicians, we have a limited amount of time in the office and our training is to use medications to deal with the problems that we see in front of us. And fibromyalgia as a disorder defies all of that. It requires a lot more time and medications do not work very well. And if you try to adhere to how we’ve been trained to treat people, you’ll inevitably fail.

he's saying doctor's training in the main consists of handing out drugs which of course does not restore health nor get to the root of an illness. So he sets out very clearly the extreme limits of traditional medical training - giving out drugs, after a very short office visit.

I wanted to thank everyone here who is looking at this proposed study and the principals involved so carefully - I don't have the wherewithal to do what you are doing, but I am very grateful that you are doing it!

 

[duncan]

Characterizing ME/CFS as normal life experience may indeed be a result of this study. Or at least it would seem some investigators may hold this bias.

If so, I suspect it is not limited to Walitt.

"...symptoms appear to be more related to the aches and pains of everyday living..."

Sound familiar? Notice an emerging theme? This last quote is from Lyme guidelines that some key players in the NIH and CDC have had a history of supporting.

Just so happens that Lyme is playing an important role in this study, coincidentally.

"normal life experience" and "the aches and pains of everyday living."

Unacceptable misrepresentations or foregone conclusions, or both?