Making a 'Charter for Ethical ME/CFS Research'

[Jonathan Edwards]

Many studies, some good and some bad, have been promoted by patient organisations. DecodeME is a good one. There still has to be screening of participants.

Biobanks and patient registries are a source of research participants. Those two sorts of organisations must surely have some requirements of the researchers that they provide data and samples to? Those requirements might provide a start on a standard set of requirements. Does anyone have copies of existing researcher criteria for biobanks and patient registries?

Promoting is different from recruiting. DecodeME was a bit unusual in that every possible route was used to try and attract lots of people. I had misgivings about bias but in this unusual case it may have been the least problematic approach.

My memory of the requirements set up by the UK ME Biobank were chiefly to do with data access, adequate blinding, etc. Diagnostic criteria were determined by Biobank staff rather than researcher users. Inappropriate psychological interpretation and patient denigration tend not to be an issue with blood samples!

 

[Caroline Struthers]

Copying from a post I made elsewhere, this idea arose in forum committee discussions about researchers' responsibilities to act ethically.

..What if we and/or patient organisations developed a charter for all ME/CFS (and ME/CFS-like LC) researchers or research studies? There could be a commitment to

• a criteria including PEM if the disease is labelled ME/CFS;
• an undertaking to not interpret or report results or make comments about the ME/CFS community through a deficit thinking lens

​

and not to involve researchers with a clear history of applying deficit thinking or disrespecting the patient communities they have worked with;​

• have meaningful patient involvement in the research design, management and write up, proportionate to the size and funding of the study;
• have lines of communication with the ME/CFS community during and immediately after the study;
• no collection of psychological data such as perfectionist scores or childhood trauma unless it is directly and clearly relevant to the question being studied
• declaration of conflicts of interest ....

I don't know, the content would take some thinking about.

But, then, the patient organisations could use that charter with the research they fund, and the research they promote. They could ask NIH to adopt it for the research it funds. They could tell the ME/CFS community - 'don't engage with researchers who don't ascribe to the Charter for Ethical ME/CFS Research', or whatever name is used for it. They could ask good researchers to mention compliance with the charter in their papers, alongside compliance with the Helsinki Declaration rules.

It wouldn't solve all the problems, but it could start to take some control of what research is done about us. We do have power, and that is our funding of research and our participation in research.

This fantastic charter idea chimes with my Trialblazers project proposal which has been on hold whilst I'm writing up a previous project. I am presenting a poster on it in June at the World Conference on Research Integrity - have attached the abstract which I suppose represents my latest thinking.
I think the idea of widening the scope to create an ME/CFS research charter (rather than a protocol for a clinical trial) is a brilliant idea.

 

[bobbler]

Copying from a post I made elsewhere, this idea arose in forum committee discussions about researchers' responsibilities to act ethically.

..What if we and/or patient organisations developed a charter for all ME/CFS (and ME/CFS-like LC) researchers or research studies? There could be a commitment to

• a criteria including PEM if the disease is labelled ME/CFS;
• an undertaking to not interpret or report results or make comments about the ME/CFS community through a deficit thinking lens

​

and not to involve researchers with a clear history of applying deficit thinking or disrespecting the patient communities they have worked with;​

• have meaningful patient involvement in the research design, management and write up, proportionate to the size and funding of the study;
• have lines of communication with the ME/CFS community during and immediately after the study;
• no collection of psychological data such as perfectionist scores or childhood trauma unless it is directly and clearly relevant to the question being studied
• declaration of conflicts of interest ....

I don't know, the content would take some thinking about.

But, then, the patient organisations could use that charter with the research they fund, and the research they promote. They could ask NIH to adopt it for the research it funds. They could tell the ME/CFS community - 'don't engage with researchers who don't ascribe to the Charter for Ethical ME/CFS Research', or whatever name is used for it. They could ask good researchers to mention compliance with the charter in their papers, alongside compliance with the Helsinki Declaration rules.

It wouldn't solve all the problems, but it could start to take some control of what research is done about us. We do have power, and that is our funding of research and our participation in research.

I like this. I think it is important.

And underlining how vulnerable a population we are for various reasons - because I think we've been targeted by this activity because of our inability of many to speak, nevermind speak in a convincing (because we come across as sick) and unending against the filibustering (and yes that is used to push our buttons of our illness) tactics

Phrasing our ask in such a way that basically just shows these are basic rights others assume and get as normal, that have been undermined (for whatever reason) and need to be protected in special ways (for whatever reasons) makes absolute sense to me.

I personally think coercion for example - through 'perceived threats' - has played a large and increasing part in some of the research results and 'treatment' of pwme. And I've never understood why it isn't just 'seen as obvious' by others looking at certain things - I do know why/this is behind why pwme don't/can't call it out however.

And I'd add in safety protocols regarding being aware of impact of travel, waiting and comfort etc - almost with a 'by severity' list of protocols. As I suspect this eg for the Walitt study is also relevant and increasingly so where there are many things going on in one trial.

I'd also require them to define due to this where they are putting people into PEM before the study, and how they are if not controlling for it making sure that it is being reported and measured ?

I'd also add in that I have concerns that access to the data [EDIT: or participants themselves] for certain groups is only possible/gatekept by those who are conflicted eg children who have ME/CFS all get sent to one national centre. HOw are applications regarding analysis of that data assessed and by whom to get access to it? is it at the behest of the person running it? And does that mean the ability for any data or even numbers on patients and progression by someone independent is stymied? WIth no comparators in the sector like you might have if eg there were many centres for something to do with cardiac or diabetes or whatnot?

I also think that potentially it could be even more powerful (and resilient to individuals just throwing unevidenced tropes when they don't like it, or using said tropes to influence less well-experienced patients etc with the 'believability claims') if it is possible to list the 'whys' alongside these as evidence that not only does it happen, but has underpinned harm etc.

I mean some of this shouldn't happen anyway so it would just be a case of pointing to some of the shonky stuff being genuinely 'true' of what has gone on.

I'm partly thinking that us thinking of some of the worst might also help to make sure we don't miss some points so it could be an iterative process?

Sorry I'm probably sounding like I'm being one of those people making it into a bigger than can bite off and chew project, but I just wanted to throw these brainstorms out there - and if they are covered or put to one side or noted or whatever at least we know etc. ?

 

[rvallee]

We are getting into the domain of politics when we talk about power and control. Not sure if that is compatible with science. I would think it's better to battle shoddy science with good science and logics, and let the evidence fall where they may. Unless the science community is conspiring against ME/CFS community, I do think bad science will eventually get culled and snuffed out. We just need to stay vigilant and call out when it happens.

All science is political. All of it, even more so when it comes to health. It would be amazing if it were above it, but it's not. Scientists and MDs are humans, with all the flaws and nonsense that comes with it.

When it comes to medicine, I'd even say that it's more political than scientific. Science is what cuts through the politics, but when the science isn't there yet, it's all politics. There are too many arbitrary decisions and judgments that have to take place between a patient's health problems and the science and technology that makes an objective determination.

It's important to work with the context we have, not the one we wish for. This needs to happen. It happened with AIDS. It happened with MS. And most scientific progress in medicine is pure chance, so letting scientists be directed by their self-interest just doesn't work. Here they're not studying inert objects or natural phenomena, they're working on real people, millions of us.

This is the most political anything ever gets: strangers making decisions about the lives of people they will never meet and will never face any consequences for it if they fail. They have no stakes. We have all the stakes. We will do better.

 

[rvallee]

Who decides who is entitled to put on political pressure?

Right now, people have already been doing that for decades and they do not have our interests in mind. It's not ideal, but someone always makes the decisions in the end, if those decisions go explicitly against our interests, if the people making those decisions do not have a stake in our well-being, what we have is... right now, and the last half-century.

The current standard is already that some people are putting political pressure. That pressure goes against us. It would be amazing if there were no pressure and all we had was motivated research taking the issue seriously and building on itself over time. But this is not how things are, so we have to apply our own pressure or nothing will change.

We have to move from a standard of pseudoscience to real science, and it won't happen unless we make it so, because the people making the decisions for us, in secret behind closed doors, do not give a fig about our lives. Their interests explicitly goes against us, and their desires drive them to run through us at every turn.

Science is never apolitical. This is a pipe dream. There is politics driving what science is made, and there is politics within the culture and community of science itself. And then there's mass pseudoscience, the worst of all states, and this is where doing nothing about it has led us.

 

[poetinsf]

All sorts of people are currently deciding; I'm suggesting giving those people some sensible guidelines.

I suppose anybody can suggest guidelines as long as researchers are free to heed or not heed. And a non-political guidelines might be a good idea. But the question still remains what is "sensible", particularly if it involves control? Requiring the approval of patient organization, for example, is problematic. If we had that in the US, we'd still be researching XMRV and real researchers like Jay Levy, who I heard walked away from CFS research because of the toxic atmosphere back in the 90s (?), would never enter. (Jay Levy later wrote a "definitive" paper about no XMRV in CFS patients). The patients did manage to force CFIDS to change their position in favor of XMRV and Judy Mikovits. As well-intentioned as it may be, patients politicizing the research is more likely to be counterproductive than helpful.

I understand how frustrated everybody is. But I also remember the fiasco, and almost cult-like atmosphere, about XMRV and Judy Mikovits. I sure don't want to see that happening again.

 

[JemPD]

@poetinsf i'm struggling to understand how any of this that Hutan describes

• a criteria including PEM if the disease is labelled ME/CFS;
• an undertaking to not interpret or report results or make comments about the ME/CFS community through a deficit thinking lens

and not to involve researchers with a clear history of applying deficit thinking or disrespecting the patient communities they have worked with;

• have meaningful patient involvement in the research design, management and write up, proportionate to the size and funding of the study;
• have lines of communication with the ME/CFS community during and immediately after the study;
• no collection of psychological data such as perfectionist scores or childhood trauma unless it is directly and clearly relevant to the question being studied
• declaration of conflicts of interest ....

leads to this

I suppose anybody can suggest guidelines as long as researchers are free to heed or not heed. And a non-political guidelines might be a good idea. But the question still remains what is "sensible", particularly if it involves control? Requiring the approval of patient organization, for example, is problematic. If we had that in the US, we'd still be researching XMRV and real researchers like Jay Levy, who I heard walked away from CFS research because of the toxic atmosphere back in the 90s (?), would never enter. (Jay Levy later wrote a "definitive" paper about no XMRV in CFS patients). The patients did manage to force CFIDS to change their position in favor of XMRV and Judy Mikovits. As well-intentioned as it may be, patients politicizing the research is more likely to be counterproductive than helpful.

I understand how frustrated everybody is. But I also remember the fiasco, and almost cult-like atmosphere, about XMRV and Judy Mikovits. I sure don't want to see that happening again.

Its a genuine question, the XMRV debacle was horrendous.

What i think would be unhelpful is for a charter to dictate specifically *what* we want researching. As long as we dont do that and stick to the manner in which it is done, as @Hutan describes, how does it end up with a repeat of the XMRV fiasco. Draw a line for me.

 

[poetinsf]

A
It's important to work with the context we have, not the one we wish for. This needs to happen. It happened with AIDS. It happened with MS.

Again, I, or anybody else, have problem with advocating. It's the directing/dictating the research that will prove to be counterproductive. I don't think that happened in AIDS or MS, has it? Granted, AIDS and MS didn't have psychosociowhatever champions.

And most scientific progress in medicine is pure chance,

I agree. And you never know which research will end up providing the critical clue to solve MECFS. That is why directing/dictating the research by patients is a bad idea. If patients control, it's more likely that charlatans that cater will flourish while independent minds will walk away.

 

[poetinsf]

What i think would be unhelpful is for a charter to dictate specifically *what* we want researching. As long as we dont do that and stick to the manner in which it is done, as @Hutan describes, how does it end up with a repeat of the XMRV fiasco. Draw a line for me.

Requiring the patients' involvement in design, management of the study, or approval of patient organization, could exert enough pressure on the research directions. I was hanging out in Phoenix Rising back in 2008, and the viral cause, not just viral trigger, was the dominant strain (pun intended) that patients lined up behind. If the patient community dominantly favors a particular theory, that could sip into their control on the research. That could not only hinder finding the solution, I personally don't think any researcher worth their salt would get into an environment where they need the approval of patient groups for the design and execution of their research.[/user]

 

[Trish]

It's the directing/dictating the research that will prove to be counterproductive.

The point is about promoting ethical research.

And for the specific case of ME/CFS, that surely means research not being approved by ethics committees and funded if the assumed paradigm of ME/CFS is psychosomatic, and all results of tests, biomedical and behavioural, are going to be interpreted as supporting that paradigm, as appears to have happened with the NIH study under Walitt's leadership.

 

[Trish]

I personally don't think any researcher worth their salt would get into an environment where they need the approval of patient groups for the design and execution of their research.

DecodeME is a great example of a research team building in patient involvement from the start.

 

[poetinsf]

DecodeME is a great example of a research team building in patient involvement from the start.

I'm not familiar with DecodeME, but I suppose it was designed to be collaborative? The proposed statement is not specific to a project, but a general position on all studies. I don't think making all projects collaborative in such manner is comparable.

 

[Jonathan Edwards]

Science is never apolitical.

Indeed. My point was very much a politically driven one!

 

[poetinsf]

The point is about promoting ethical research.

And for the specific case of ME/CFS, that surely means research not being approved by ethics committees and funded if the assumed paradigm of ME/CFS is psychosomatic, and all results of tests, biomedical and behavioural, are going to be interpreted as supporting that paradigm, as appears to have happened with the NIH study under Walitt's leadership.

OK, it is the psychosomatic theory that patients are against today. What would it be tomorrow? As much as we think we are rational, unimaginable things do happen.

 

[duncan]

Most foibles possibly ascribable to patients can be ascribed to researchers as well. They each bring strengths and weaknesses peculiar to their respective places, each their own acquired knowledge and earned perspectives. Each their own respect for the adherence to the scientific method.

Patients just occupy a place with less oxygen. That needs to change.

 

[Jonathan Edwards]

I personally don't think any researcher worth their salt would get into an environment where they need the approval of patient groups for the design and execution of their research.

I think the argument is a bit back to front here.

From my perspective no researcher worth their salt should set up a project without clear approval of patients. I don't think anyone is suggesting that they need to have the approval of any particular pressure group - maybe like CFIDS. When I started doing research with direct impact on patients I had asked many patients in my clinic what they thought and joined several online groups to ask others. They all said yes please so I felt I could take risks on their behalf.

The XMRV fiasco was not to do with researchers being pressured into doing bad research. It was the researcher's idea surely?

--------------

DecodeME may be such an anomaly it may not even be a good example, although with luck there will be more projects like it. It is almost certainly the best project currently in progress. It did not invite in patients to collaborate. Members here were involved scientifically from its earliest genesis.

 

[Hutan]

My memory of the requirements set up by the UK ME Biobank were chiefly to do with data access, adequate blinding, etc. Diagnostic criteria were determined by Biobank staff rather than researcher users. Inappropriate psychological interpretation and patient denigration tend not to be an issue with blood samples!

If only that were true.
Cytokines IL1β, IL6, TNFα & serum cortisol may not constitute reliable biomarkers to identify [PASC], 2024, Fleischer, Kleinschnitz et al.

RESULTS
Cytokine levels of IL-1β, IL-6, TNFα and cortisol levels did not differ between groups analysed.

CONCLUSIONS
This may indicate a non-organic/psychosomatic genesis of PASC; further studies are needed to elucidate the underlying causes of PACS, and non-organic causes should not be overlooked.

Phrasing our ask in such a way that basically just shows these are basic rights others assume and get as normal, that have been undermined (for whatever reason) and need to be protected in special ways (for whatever reasons) makes absolute sense to me.

yes

 

[Jonathan Edwards]

OK, it is the psychosomatic theory that patients are against today. What would it be tomorrow?

You have a point there but there is a valid reason for being against the psychosomatic theory. It was the one thing that PACE disproved conclusively. Despite patients reporting that they felt a bit less symptomatic they had no increase in activity or ability to go to work. The theory stated clearly that the inability to be active and work was due to a belief that symptoms prevented this. The prediction had to be that if patients reported less symptoms they would do more. They didn't. Even if the reporting of symptoms being reduced was a placebo effect and nothing to do with the treatment it should have led to more activity and it didn't.

Long term patients already knew this from personal experience. Of course that could only be reported subjectively and the scientific community was entitled (at least arguably) to retain some scepticism. But now we have objective validation, despite about as much gerrymandering to make the data fit as one could conceive possible.

 

[Jonathan Edwards]

If only that were true.
Cytokines IL1β, IL6, TNFα & serum cortisol may not constitute reliable biomarkers to identify [PASC], 2024, Fleischer, Kleinschnitz et al.

Yes but that is an exceptionally bad paper and not one from the Biobank I think!
I doubt the steering group would have approved sending out samples for a project like that.

It would be nice if groups like Fleischer et al did not undertake such studies and draw such conclusions but I find it hard to see a way to set up a set of ethical standards specific for ME/CFS and expect them to be heeded. I agree with a lot of the suggestions about ethical standards but as far as I can see they should apply to all diseases. Maybe the thing is to join forces with other patient groups and academic bodies to beef up ethical standards for everyone.

 

[Andy]

OK, it is the psychosomatic theory that patients are against today. What would it be tomorrow?

You tell us. Collectively we are against the "psychosomatic theory" because our personal experiences AND analysis of the published literature shows it to be BS. If something else comes along that meets that criteria, then we would be against it - what we wouldn't do is to go looking for something else to be against for no good reason.