MEAction: Join Our Values and Policy Initiative! September 2019

I've inserted this version ("..assumed to be correct") in the text.

Thanks for your help.

 

A "community" which needs to extend to clinicians, researchers, research institutes and labs. The WPI had been very quick to offer an expensive, non FDA approved test for XMRV, via its subsidiary lab, which probably served to increase patient interest in XMRV and patient confidence in a (at that point unreplicated) test, the results of which, in any case, would likely be disregarded by patients' clinicians. So I'd like to see lack of caution on the part of clinicians, researchers, research institutes and labs acknowledged, as well as "ME/CFS community"/patient caution.

 

How is "scientific evidence" and "science" interpreted? Does this mean only RCTs, only research studies? Or does it include the scientific knowledge and expertise of ME clinicians developed over many years - 35 or more for some.

The statement...

Skeptical: ME Action has a commitment to remain skeptical towards scientific hypotheses, proposed treatments and reported findings, as long as these have not been established by robust scientific inquiry from multiple research groups.​

could imply that only scientific knowledge generated through research studies is valid, not scientific knowledge generated through clinical practice. And that until we have such studies, we need to be skeptical about any proposed treatments.

While it's not considered to be at the same level of standard as RCTs in evidence-based medicine, disease experts' scientific knowledge and expertise about treating and managing ME can be a valid basis for treatment recommendations. And for ME, that scientific evidence is certainly much more valid evidence than the bulk of the CFS RCTs that have driven treatment recommendations to date.

 

I don't use the term scientific as a synonym for good, valid or reliable. I use it to refer to the scientific method involving experimenting, testing and replication.

So expert opinion is not scientific evidence in my view. The idea behind the scientific method was to no longer believe what wise and experienced men had to say and to come up with something better.

I think patient organisations can refer to the expert opinion of ME/CFS clinicians as long as they present it correctly, namely as low-quality evidence that has a high chance of being wrong. Eminence based medicine, or recommendations based on the knowledge and experience of experts, might be better than nothing but I think history has shown that this method is prone to mistakes (here's a good example: https://en.wikipedia.org/wiki/Cardiac_Arrhythmia_Suppression_Trial). I think it's justified to remain sceptical towards such recommendations until we have more reliable evidence.

I don't think that's true. The studies I think you are referring to are GET/CBT studies. These aren't randomized controlled trials, the gold standard in medical research. As others have explained here on the forum, these trials were randomized but not controlled and not blinded.

RCT's in ME/CFS can usually be considered reliable. This includes the phase III rituximab trial, but also hydrocortisone RCT's or even the Prozac-study of Bleijenberg/Vader Meer. I think such studies are more reliable than the intuition of expert clinicians, especially if we have multiple large RCT's coming from different groups.

Even in the case of the PACE and FINE trial, we have some reliable evidence from the objective outcomes as these are less prone to bias. They indicate that GET and CBT do not increase fitness, work employment etc. So they do not rehabilitate ME/CFS patients. For me, these trials are much more reliable evidence for that, than whatever 'experts' have to say about it.

 

first the standard of care question, then a general point,
then what i'd most like #meaction to do.


1. standard of care

regarding effective, adequate, etc. care:


the who constitution and later documents hold that humans
have a fundamental right to [paraphrase] the highest attainable standard of health without discrimination.

for what it is worth, this is law. in addition, it is, unusually, non-derogable, which means something like "you can't !@$# with it".

therefore, for #meaction documents i would suggest considering the standard of care language of un factsheet 31 or general comment 14 as a coordinated strategy with an explicit human rights model. m.e. politics is fundamentally a human rights issue.


imo these documents need the additional context of misopathy -- an attack on our population -- to say why the work of the
charity is profoundly needed and urgent.


meaction has expressed new potential leanings toward a few
models and communities. i have not seen this outlined more precisely, but perhaps i just couldn't find it. email got no response.

this potentially matters for standard of care.


i strongly oppose the social model of disability for m.e.
for health reasons i cannot defend this point atm. it would be disturbing if meaction leans toward it. i don't know if it does or not.


thus, just in case, i need to emphasize that standard of care and similar topics should always reflect that we are:

1) profoundly disabled (we're all in agreement here)
2) impaired (de-emphasized in fashionable disability discourse)
3) and ALSO have a disease process (ignored in
fashionable disability discourse)
4) and ALSO that our population is being systematically
attacked, globally, as such (disability discourse does
not sufficiently take this on board as such)

m.e. needs are a SUPERSET of disability discourse.

some of disability discourse is extremely regressive. in some
cases even distorted toward the perpetrators, and that is not always noticed by observers.


a disability activist is or was famous for saying: "My disability comes not from the fact that I’m unable to walk but from the presence
of stairs". that is practically the most famous disability
quote ever. try that on whitney dafoe.

in contrast, for standard of care, we need

1) a /biomedical/ model, not de-emphasized, not ignored
2) human rights, in the tradition of human rights
3) services for our populations, not
de-emphasizing or ignoring bedridden and housebound
4) accommodations for our populations -- including
but not limited to intolerances


THEREFORE, while collaborating with the disability community
can be good, imo we need to emphasize our needs -- and the
concepts of /biomedical disease/ and misopathy -- EXPLICITLY, or
they WILL be sidelined in basically all discourse.

imo there is direct conflict between social model and our needs.


article 25 of the disability convention might be usable as a reference for standard of care. we are profoundly disabled. there might be more there that is useful for meaction if it is not covered in the previous documents.


2. general point

in a negotiating context, minimum needs are problematic
as an opening volley. our perception is already too low,
then the demands get bargained down even more.

more generally, it can be dangerous to think in terms of
changes from status quo. overton and stockolm are
some of our enemies. i prefer starting fresh with a correct
understanding of the disease and standard of care.

this might cover it http://thekafkapandemic.blogspot.fr/2015/11/make-it-unthinkable-please.html


3. what i want meaction to do

i want meaction to initiate and support bold
legal action, including but not limited to criminal charges.

i view meaction as the only charity that can really do this at this time.

===

meaction can aim higher than many charities. this is one of the reasons i support it. to me, we will not succeed until we aim higher.

===

@Wilhelmina Jenkins @JaimeS .
[does meaction have an account?]

thanks for reading.

p.s. the linked pages mention inclusion. a lot of us, including myself, are limited in talking, cannot talk, cannot deal with webinars/chats/voice chats, have sleep or geography issues, etc. is bluejeans as inclusive as email or even forum?

[edited]

 

I agree that its lower quality evidence than RCTs and systematic reviews but we will have to disagree on the point in bold and probably the rest as well.

Yes, you are correct of course. The more relevant point I was trying to make is that in the spectrum of "evidence-based medicine," these trials are supposedly a higher level of validity than expert clinician recommendations. But obviously are not.

But reliable evidence for what condition? A study that selects patients with Oxford and uses a disease theory that ignores all evidence of ME/CFS biological pathology can hardly be considered reliable or valid evidence specifically for ME. I'm less skeptical of the consensus of a group of ME experts than I am of evidence from studies that select patients with Oxford and/or are based on a flawed disease theory even if perfectly executed RCTs by multiple research groups. (Interesting S4ME thread here on scientifically implausible therapies)

@Hutan - thanks for pointing that out. I've seen what you are referring to and appreciate that can be an real problem when its just a single person.

 

As far as I am concerned knowledge and expertise of clinicians that is not based on hard research evidence is worthless. It is as simple as that. Medicine has moved on from ‘clinical judgment’. Doctors who do not recognise this are stuck in the 1970s. Unfortunately there is popular political pressure to go back to the bad old days.

What makes a doctor an ‘expert’ if they do not understand what makes evidence reliable? You are left just with choosing the ‘experts’ who do the stuff that takes your fancy. ME advocacy will get nowhere until that is understood.

 

I just tested 'skeptical' versus 'neutrality/neutral' on an innocent victim. Just one person, but an outsider's perspective.

"Neutrality/neutral" was interpreted close to what I think you're trying to say, that ME Action not take any position - neither for nor against - hypotheses etc. until there is significant, sound evidence for doing so.

"Skeptical" was was interpreted differently, that ME Action do take a position - against - hypotheses etc. until there is significant, sound evidence for doing so.

So "neutral" looks to be the better choice here.

The test person also commented that the negative in last part of the sentence "as long as..." was difficult to compute and had to be reread to be understood. So how about:

Neutrality: ME Action has a commitment to remain neutral towards scientific hypotheses, proposed treatments and reported findings unless robust (scientific) evidence has been established (from multiple research groups).​

[The bits in brackets could be left out to leave room for current best practice guidelines from clinicians where no scientific evidence exists as yet (to address @Medfeb's concerns).]

Or a slightly different approach:

Cautionary principle: ME Action has a commitment to interpret scientific hypotheses, proposed treatments and reported findings with caution until robust evidence has been established for them.​

 

Thanks for the suggestions @Ravn.

I don't know how @Medfeb sees it, but I suspect our views on this matter might simply be too different. So I rather not try to reconcile them by making major changes to the text. The view that the opinion of a group of ME experts is good evidence, can be trusted or should not be met with scepticism, is contrary to the point I was hoping to make. But that's not a problem. Not everyone has to sign or agree with this statement, of course. No hard feelings towards those who prefer not to.

I think that your contact is misinterpreting the work skeptical though. I'm pretty sure it's the correct word to describe an attitude of doubt and questioning without necessarily taking a position against something. I think there's an unfortunate misuse of the term. Here in Belgium it seems to be mostly used by people who like to ridicule unscientific beliefs or treatments. That's contrary to the meaning of the term, namely questioning, doubting and recognizing uncertainty.

The problem with the term neutral, as I've come to see it, is that it suggests that ME Action should remain neutral towards different types of hypotheses or treatment recommendations that have the same level of evidence. And that was not exactly what I had in mind. I do not want to oblige ME Action to treat the expert advise of Wessely, Sharpe, White, Crawley, Chalder etc. at the same level as the ME/CFS clinician coalition in the US. ME Action is allowed to think and take a position if they think one makes much more sense than the other. Want I intended, is that they should not overstate the evidence behind such treatment recommendations and acknowledge that it takes "robust scientific inquiry from multiple research groups" for something to be considered reliable. So I now prefer to use skeptical and not neutral.

Instead of "as long as" or "unless" perhaps we could just fix the sentence with the word 'that'...

"ME Action has a commitment to remain skeptical and neutral towards scientific hypotheses, proposed treatments and reported findings that have not been established by robust scientific inquiry from multiple research groups."​

I do like the term cautionary principle. Perhaps we can use it instead of factfulnes? So the whole section would read:

Science-based: ME Action has a commitment to science and evidence-based medicine. Our advocacy, policy proposals and information resources are based on the best available science while recognizing the limitations of current research.

Skeptical: ME Action has a commitment to remain skeptical towards scientific hypotheses, proposed treatments and reported findings that have not been established by robust scientific inquiry from multiple research groups.

Cautionary principle: ME Action has a commitment to stick to established facts. We strive for high accuracy and prefer to err on the side of caution.​

 

https://www.meaction.net/2019/09/25/why-we-must-build-an-open-grassroots-movement/

 

I still have some trouble with this sentence. What about: .... "when promising but preliminary findings are misinterpreted?"

I think I will leave out this sentence, as it might be a barrier for others to support the statement. I used it to explain things and make my arguments more concrete, but it's not really my intention to criticize others or point fingers.

Unless someone else would like to add or change something, I would then post the text in a new thread, asking who's willing to sign and support it. And after a week or so, I would officially send it to ME Action, hoping that they consider the proposal.

 

I think I know what you want to say and it's not easy to express.

The high disease burden and neglect of the illness by the medical profession means treatment is in high demand by patients. At any sign of an effective treatment, the despair of patients easily turns into enthusiasm that is excessive relative to the strength of evidence. XRMV and Rituximab are two examples where initially promising findings were refuted by subsequent research. Meanwhile, a number of patients had already sought treatment.

 

Thanks for the suggestion. The sentence has become quite complicated though. What about :

"The XMRV-saga and the more recent enthusiasm about Rituximab are but two examples of how easily things can go wrong when the uncertainty of preliminary findings is overlooked."​

Yes that, but there's also, I think, a tendency among the ME/CFS community (including myself until recently) to be insufficiently skeptical towards biomedical finding. Perhaps it's because of the popularity of psychosomatic theories and frequent disbelief of doctors towards the illness, that we feel we have to root for biomedical findings to be correct and significant? In my view, it's not just about desperate patients and the eagerness to come to effective treatment, but a broader issue.

 

"when promising but preliminary and therefore uncertain findings are overinterpreted?"???

 

The reason patients overlook this (as a group) is because they aren't good at interpreting research findings.

I feel that the BPS model and the general behaviour of its proponents and therapists has alienated patients. The patients then sought support elsewhere and became strongly attached to biomedical explanations. The problem is that these explanations are often weak or put forth by quacks and not all patients realize this.

 

One major detail about XMRV is that ME advocates are painfully aware of how fragile research funding is and how susceptible it is to failure. Failure is a normal part of research, but with us it often becomes an argument to defund all research. The psych brigade can't help themselves every time, they gloat at failure and loudly argue this is all the evidence anyone should need that no further research is needed.

This is seriously abnormal. Abnormal situations lead to responses and behavior that may seem abnormal, but are simply responding to circumstances. There are many people who aggressively want to sabotage this disease and will use any small thing to promote their viewpoint, they have done that at every opportunity in the past. So a success here would have literally changed everything.

People only pin their hopes in one small thing when the success of the one small thing may decide their fate going forward. We have nothing to do with that, this is imposed on us and no one should feel bad about hoping for good news.

And personally I view the Rituximab trial as a success because it showed the exact same false subjective improvement as the psychosocial research with the same lack of objective improvement. It exposed the fraud at the core of the dominant paradigm. Not that it made any difference, sadly, but the evidence speaks for itself.

 

But at least from the sources I've read, the standards for "evidence-based medicine" accept the best practices of clinical experts as evidence - admittedly at the lowest level of evidence but still acknowledged as evidence. How do we reconcile that with the statement above?