Making a 'Charter for Ethical ME/CFS Research'

[poetinsf]

I'm somewhat agnostic on the Charter idea, however I don't think the XMRV case is a substantial example of where a Charter would fail - though of course I take the points about the specifics of that disaster.

XMRV probably was an extreme example since it happened (not the paper, but the political action in the wake of it) in an atmosphere of "nothing but virus" whereas the charter idea is more in the context of "anything but BPS". (You can talk about better communication or minimal standard, but ultimately it is about preventing another Walitt-like paper, I would think).

If the goal is to ensure the scientific integrity and standard, that is really the job of scientific community, not patients. Patients could take political action against "shoddy science" because they feel victimized by it. But that is how anti-vaccers feel and what they do. The question is, how do we differentiate? Once we go public with the Charter, I think the collective response from the scientific community will be eye-rolling. And that is even before worrying about how this Charter could evolve to prevent something else in the future.

 

[glennthefrog]

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.

you're absolutely right, this is a NECESSITY. I thought about this same thing when the highly harmful NHI study results came out

 

[bobbler]

Yup.

And the protocols for major projects should be subject to a patient ethics approval committee (comprising individuals as well as organisations) before they go to a university board.

But I like the idea that a charter could help this and spell out some of the things that have occured and do tend to occur that need to be avoided.

I'm afraid that for various reasons relying just on that as a tick-box without guidance of what is expected will be picked up is insufficient. ie being a patient and having a committee claiming to look at ethics doesn't mean the job gets done.

And we have to remember many patients who are well enough and in a position to attend such things are not those who are in the worst positions - which sadly many are encouraged to think don't exist or an exaggeration for other patients. Just because someone is a mild-moderate patient with a job that made adjustments but isn't perfect and doesn't get as much help from their GP as they'd like they think they 'get it' without realising the sheer vulnerability of someone iller, without support, experiencing abuse would be under with regards coercion for example in any research.

Like whether children would be able to give honest replies to something if it was the same team who might be liaising with their school or able to accuse parents of FII. Or those who can still move about not imagining that being utterly bed-bound would be a good idea. And don't forget there will be a greater preponderance probably of those from certain public sector positions where they have been trained in BPS attitudes combined with those who will be less ill who will be on these things merely due to how recruitment will work. Nevermind someone being a physio or OT or psychologist first who then happens to get it as their own experience and compares their own mild situation to their own tools rather than reading up on the wider situation.

A lot of people think of these things as 'votes' and like allegiances for their areas of what they know. Unless there is a framework that spells out what they are there for as being something specific and different. Particularly when they sit down and its matey-matey and they'd rather be the nice patient their colleague-types all relate to vs the awkward patient. Social effects are so powerful. And these things are intimidating when you turn up and you might only ever do one in your lifetime and aren't completely sure or tooled up to how they actually work. A bit like if its the first time you get dragged onto being part of an interview panel for a job. What is involved with 'doing it right' or 'doing the right thing' isn't that straightforward unless we tool people.

Particularly when, for bad research, patients who might have been selected with pats on the head, are then given spiels about 'don't listen to those doommongerers/catastophisers' type nonsense in order to encourage dismissal of others' concerns and keep the circle turning of there always being a newbie happy to naively sign off something. That sort of aggression is hard to fight, however, it is done (as an implicit threat where it is said about 'others who do those things' and thereby intimidates those there 'to not be like Dave').

And those who are most affected by it are most exhausted and easy to steam-roller or isolate due to the condition meaning they can't just keep in there if length of meetings or tasks get extended should there be differences in opinion.

And of course those 'things' that constitute bad research often just wouldn't be occurring for a lot of other conditions, for a start because the individuals who do that kind of thing tend to collect/be drawn to areas they can get away with it and have been pushed into the only places that their 'ideas' will be accepted and because of the lack of competition and all the rhetoric that can be thrown of 'well you've got nothing else' and so on.

 

[Trish]

If the goal is to ensure the scientific integrity and standard, that is really the job of scientific community, not patients. Patients could take political action against "shoddy science" because they feel victimized by it. But that is how anti-vaccers feel and what they do. The question is, how do we differentiate?

I think the anti vaxxer parallel is actually quite insulting and the complete opposite of what is being suggested on this thread. Nobody is suggesting we are against the BPS paradigm on the basis of belief. The evidence that it's wrong for ME/CFS is clear even from the BPS proponents own research. There is no long term benefit to CBT/GET and no evidence of benefit on objective tests.

And it's not about BPS versus biomedical. We find lots of instances where biomedical studies and clinical trials of all sorts of treatments, including drugs, supplements or herbs are badly done. For example trials of individual doctor's favoured medication are often no more than retrospective reviews of clinic notes dressed up to pretend to be clinical trials, but with no blinding, subjective outcomes, no long term follow up, high dropouts etc - just as bad as BPS trials.

Many of these could have been so much better if they had knowledgable pwME involved in running the studies. You don't have to know how to extract DNA in a lab. or formulate a drug to understand limitations of studies that claim more than they should and have poor methodology.

To me the point is that there is so little research done on ME/CFS we need to advocate not only for more funding in total, but for better quality research with the highest scientific standards.

There are some patients who are also scientists and some who are self educated to a very high standard in research methods relevant to ME/CFS research. I see no reason why they can't be equal partners in running research projects at all stages.

 

[Jonathan Edwards]

If the goal is to ensure the scientific integrity and standard, that is really the job of scientific community, not patients.

Part of the problem is that there is no scientific community any more. It has been destroyed by the publication companies and by politics related to commercial pressures with universities. The science community I grew up in with people like Andrew Huxley and Francis Crick simply no longer exists. Most of what is produced is garbage now. The change is mind-blowing. Not long ago I asked if I could attend some physics lectures, as a senior member of staff. I was told no, it would have to be part of a specific funded project that paid them. I said things have changed. The physicist apologised and agreed.

Disinformation is the norm. And that is because almost all journals are now run by people who don't understand the subjects they are supposed to represent. To use an old analogy the moneylenders have taken over the temple.

The NICE Guideline committee was a notable demonstration of the problem. You bring together 'stakeholders' who are supposed to be experts in the field and discover that they are nothing of the sort. The haven't a clue. Fortunately, the outgoing chairman appointed two genuinely disinterested and intelligent people to chair the committee, and doubled the allowance of patient members. A sensible answer emerged but by the skin of its teeth and to a large part because contributions from intelligent patients made it possible for the chairman to hold things together. Moreover, the 'scientific community' within the British medical establishment mostly wanted to tear it up.

I have spent a lifetime in the 'scientific community' and over time I became more and more aware that it is largely run by self interested idiots. Those of us who made progress tended to do it despite that community. In complete contrast we have on S4ME a group of people who are actually interested in constructive debate, many of whom have razor-sharp critical skills. When I formulated the theory that led to the use of B cell depletion I was visited in my office by a very eminent immunologist who basically told me to piss off and get out of his hair. I said I was interested in critical scientific debate and hoped to engage in constructive dialogue. He shocked me by saying 'there isn't any in science, don't be stupid'.

So the reality is that the 'scientific community' are a load of Wally's and would benefit from some help from people who actually care. I think the Charter proposal is logistically a bit tricky but I think we have already thrown up some useful thoughts about how it might actually work well in the right context - just by arguing it out.

 

[JemPD]

If the goal is to ensure the scientific integrity and standard, that is really the job of scientific community, not patients

of course it is but they arent doing it! Not just in ME research, its everywhere, peer review is broken.

Once we go public with the Charter, I think the collective response from the scientific community will be eye-rolling.

yes this is a concern, it needs to be professionally done. but they roll their eyes at whatever we do, so thats not a good resona not to do it.

And it's not about BPS versus biomedical. We find lots of instances where biomedical studies and clinical trials of all sorts of treatments, including drugs, supplements or herbs are badly done. For example trials of individual doctor's favoured medication are often no more than retrospective reviews of clinic notes dressed up to pretend to be clinical trials, but with no blinding, subjective outcomes, no long term follow up, high dropouts etc - just as bad as BPS trials.

precisely.
Think of CCI!!!! shudder

 

[Kitty]

Once we go public with the Charter, I think the collective response from the scientific community will be eye-rolling.

I don't think it would include all scientists, and nor do I see it as un-useful. Those who roll their eyes at the idea of patient involvement aren't to be trusted.

Not yet, anyway. Some people react like this because they can't envisage how a thing could work, and when they're shown, they change their minds.

 

[Sean]

TBH I just be happy with a charter that said 'no research with only subjective outcomes & lack of blinding', that would weed out a lot of crap, also adequate controls.

That on its own would just about fix the problem.

ultimately it is about preventing another Walitt-like paper,

Correct. But not because it is BPS. Because it is methodologically dodgy. The small sample size alone simply forbids reaching any firm conclusions.

Once we go public with the Charter, I think the collective response from the scientific community will be eye-rolling.

That will depend mostly on how scientifically defensible a charter is. I am certainly not suggesting anything outside of mainstream scientific principle. More like making sure that those principles are actually followed in practice.

I think it is very clear at this stage that we cannot depend on the medical scientific pros, as a community, to do the job properly or promptly. They have not so far, for reasons that escape me. Nobody is riding in on a white horse to save us, we are going to have to do it ourselves.

Just because something has never been done before, or carries serious risks with it, is not an argument against trying it.

 

[poetinsf]

I think the anti vaxxer parallel is actually quite insulting and the complete opposite of what is being suggested on this thread.

That may be what it is from inside, but from outside it may look indistinguishable: it's a political action by patients who feel victimized by the scientific community (and their shoddy practice).

One way to distinguish would be to emphasize the patient communication and acceptable standards. No reference to "deficit thinking", etc., in other words. And I don't think inserting patient groups in every stage of the study will fly. (It immediately conjures up USDA inspection process for meat packing.) Even then, it will still look "beyond bizarre", to borrow Sean's words, for patients to set the standards.

There are some patients who are also scientists and some who are self educated to a very high standard in research methods relevant to ME/CFS research. I see no reason why they can't be equal partners in running research projects at all stages.

In what other disease do we have this? The shoddy practices that you mentioned is not limited to ME/CFS research. If it weren't for BPS, and how we feel misunderstood by the BPS champions, would we even have the need for this action?

 

[JemPD]

If it weren't for BPS, and how we feel misunderstood by the BPS champions, would we even have the need for this action?

YES!
because

We find lots of instances where biomedical studies and clinical trials of all sorts of treatments, including drugs, supplements or herbs are badly done. For example trials of individual doctor's favoured medication are often no more than retrospective reviews of clinic notes dressed up to pretend to be clinical trials, but with no blinding, subjective outcomes, no long term follow up, high dropouts etc - just as bad as BPS trials.

 

[poetinsf]

So the reality is that the 'scientific community' are a load of Wally's and would benefit from some help from people who actually care. I think the Charter proposal is logistically a bit tricky but I think we have already thrown up some useful thoughts about how it might actually work well in the right context - just by arguing it out.

So, should all patient groups now have Charter for the researchers? Whatever is going on in the scientific community can't be unique to ME/CFS. But ME/CFS community feel the need for action because ME/CFS patients are particularly misunderstood. Saying that we are taking action because of shoddy scientific practices is not too convincing.

 

[JemPD]

But ME/CFS community feel the need for action because ME/CFS patients are particularly misunderstood. Saying that we are taking action because of shoddy scientific practices is not too convincing.

Its not the practices themselves is it, its the results of them, the trickle down effects of them. We feel the need for action because those shoddy practices are, quite literally in some cases, killing us.

Its not the misunderstanding its the policies that come out of those shoddy practices, that are imposed on us when there is nothing else.

If scientists cock up a study into even better treatment for some diseases, so that all the patients get is the status quo - ie at least adequate care and a lack of abuse... then 'all' that happens to them is that progress isnt made for better treatments than the ones already given.

When they cock up ours, then the result is yet more abuse, FII accusations, sectionings, death etc etc etc. Or people inappropriately taking very serious drugs, or having massive life changing surgeries that dont work or make them hugely worse.

 

[CRG]

XMRV probably was an extreme example since it happened (not the paper, but the political action in the wake of it) in an atmosphere of "nothing but virus" whereas the charter idea is more in the context of "anything but BPS". (You can talk about better communication or minimal standard, but ultimately it is about preventing another Walitt-like paper, I would think).

If the goal is to ensure the scientific integrity and standard, that is really the job of scientific community, not patients. Patients could take political action against "shoddy science" because they feel victimized by it. But that is how anti-vaccers feel and what they do. The question is, how do we differentiate? Once we go public with the Charter, I think the collective response from the scientific community will be eye-rolling. And that is even before worrying about how this Charter could evolve to prevent something else in the future.

We have very different perspectives. Part of that perhaps is cultural, and that does have implications for a 'Universal Charter'. However from my UK cultural view I have no difficulty with anything being political - indeed I see illness, disability, medicine and health research to be some of the most politically intense areas of modern societies.

Who makes the decision about what is important, what is a priority, which people are important, how resources are to be headlined or hidden, who should pay and how they should pay are all questions that are highly political and we shouldn't pretend that there is some white coated arbiter who on the basis of some pure logic is defining the 'right' answers to those questions - science may be self correcting but it is not guaranteed to be any more efficient at correction than a troop of monkeys with lap tops. And patients aren't willing to wait for some portion of infinity for medical science to get things right.

BPS is far from being the only problem for ME/CFS research, although 'psychologising' is the single greatest grieveance across the whole ME/CFs patient population, but medical science fails ME/CFS in multiple ways not just by misplaced psychologising, and IMO patients should be political in getting those failutes changed - whether a Charter is a useful tool in that political action is a different question but having an inherently political nature is unavoidable in medical research where everything is contestable. And we have choice about the nature of the politics we pursue - I would shout very loudly that victimhood politics is for multiple reasons a disasterous course to take, but I see no need to use the framing of either victimhood or its ally grievance and I haven't seen anything in this thread implying anyone is suggesting that. As to anti vax - well yes 'victimhood' is at the heart of anti vax sensibilities, but anti vax is also a belief driven ideology, and so inherently anti science. The proposed Charter is the opposite of that - it would be a demand for scientific consistency and integrity - IMO it should require that all ME/CFS research has a clearly stated hypothesis whichis based on established plausibility supported by clear argument of purpose.

I would once have been concerned about the perception of the 'scientific community' - but as Jo has said - it no longer exists as a cohesive entity, in the end we are talking to a small subset of medical researchers and the rest of science has a million plus papers a year to keep their attention well away from ME/CFS. The eye rollers are no use to us so I see nothing to fear in that direction.

 

[Hutan]

The one thing that does worry me about 'patient involveent', is that many many utterly crap and harmful studies have been done with 'patient involvement'. PACE with AfME, all Crawley's stiudies with patient support from her clinics, the Sussex org (whatever thats called). So the problem is this:

Which patients.

It's a risk of course, that the 'wrong' patients end up in decision-making roles. But I think it's a risk that has to be accepted. I think the key is education of people with ME/CFS. I don't think AfME or any major UK ME/CFS charity would allow another PACE. It's important that we get people with ME/CFS on the boards of charities, as they do a lot of the educating of patients, the selection of staff and the choosing of research to support. And I think there has to be accountability. Patients in decision-making roles should be willing to be named.

One way to resolve this could be requiring the endorsement of X charter-signing organizations, rather than just one. Depends on how many there are in total. Not too onerous, but enough to make it sure that it isn't some fringe issue. The process of endorsement shouldn't be onerous either, it should be simple and charter-signing organizations should be prepared to give a quick assessment.

I think we have to keep in mind that any requirements have to be proportionate. Someone doing a short thesis for their Masters degree should not have to get multiple patient organisations to give their approval.

If the goal is to ensure the scientific integrity and standard, that is really the job of scientific community, not patients.

Others have addressed this, but, no. It's a bit like saying that the goal of democracy is only the job of politicians. Absolutely, the people affected by the science should have a role in deciding who gets funds, and they have a role in setting the standards that should be followed and in holding researchers to account. It's true in any field - AI, genetic modification... - the ideal is an engaged society that helps to ensure scientists deliver benefits, not harm.

No reference to "deficit thinking", etc., in other words.

Yeah, that's an interesting one and I wondered if there would be push-back on that. I had the same reaction when I first came across the term, and it is still a bit challenging, it does feel rather 'woke' or 'wet'. But, it's been used a lot where I live, in relation to research about people of various ethnicities. And I think it does have value in countering entrenched prejudice. Maybe have a read of some of the literature about it @poetinsf. And, think about that study I mentioned upthread, the one that found no differences in a handful of molecules in the blood that we already knew weren't different, and then managed to leap to suggesting that this indicated psychosomaticism. And the effort preference conclusion from a barely significant result of an incredibly poorly conceived and executed test. And the readiness of researchers to label us as hysterical and catastrophising when we disagree with their research. A lot of the CFS research we see is approached with enormous prejudice and with the conclusions written before the results come in.

The phrase 'deficit thinking' is one that I'd be willing to let go, I know it can cause eye-rolling. I know it's a bit tricky to apply to a disease community too - because clearly there is some problem within us that we want to fix. But, 'deficit thinking' is an idea that is gaining ground, and the fierceness with which, for example, Māori communities are challenging prejudice is a bit inspiring. I think it can be a useful label to put on ideas of 'if you thought differently, behaved differently, there would be no problem, the problem is you and you need to fix yourself, so stop complaining', whether that be at the individual health level or the societal level.

And I don't think inserting patient groups in every stage of the study will fly. (It immediately conjures up USDA inspection process for meat packing.) Even then, it will still look "beyond bizarre", to borrow Sean's words, for patients to set the standards.

I don't think that is what anyone is suggesting, for every study. Again, the Masters student doing a project might just have a panel of three people with ME/CFS as their advisory group, or they might chat with the local patient group at the beginning and at the end of their study. For something as ethically and logistically challenging as DecodeME (requiring a huge number of participants to donate extremely personal information), it does make sense to have patients fully integrated into the study. I think the complexities could be covered by a simple statement along the lines of 'there is involvement of people with ME/CFS proportionate to the size and ethical complexity of the study'. Then a bit of discussion about what that might look like for different sorts of studies.

I envisage this Charter as something quite general that biobanks, patient charities, funding organisations and research institutes could all sign up to. And it's not about guaranteeing perfection, but just indicating a movement towards it.

In what other disease do we have this? The shoddy practices that you mentioned is not limited to ME/CFS research. If it weren't for BPS, and how we feel misunderstood by the BPS champions, would we even have the need for this action?

So, should all patient groups now have Charter for the researchers? Whatever is going on in the scientific community can't be unique to ME/CFS. But ME/CFS community feel the need for action because ME/CFS patients are particularly misunderstood. Saying that we are taking action because of shoddy scientific practices is not too convincing.

Absolutely the problems are not limited to ME/CFS or to BPS research. National ethical guidelines and the deliberations of ethics committees should be producing better outcomes. But they aren't, certainly not in every country all the time. We can work on changing that, but, in the meantime, we could start trialling these ideas. Other communities are working on the problems too.


On the idea of banning research with subjective outcomes and a lack of blinding, I wouldn't want to do that. Fluge and Mella reported on trials like that - they didn't pan out, but it was a reasonable part of the process of doing science. The important point was that they didn't draw any definitive conclusions from those studies, they knew that they needed to proceed on with Phase 3 trials if they wanted to conclude that a treatment helped. So, I think the requirement might be more around a commitment to not make, or publicise, conclusions that go beyond what the data suggests - and then give some examples in the discussion. So, that could stop the conclusion of psychosomaticism on the basis of CRP and IL-6 not being different and the conclusion that GET or a drug cures ME/CFS on the basis of a short term study with only subjective outcomes.

 

[Hoopoe]

To me saying no to a charter or similar is a bit like saying it's better to be silent.

It's better to say nothing if you can't say anything intelligent, but I'm sure we can.

Some of you might be thinking of the criticism and ridicule that might come from some corners. But we patients must fight for the right to have a real voice and influence on what is researched about our illness and how. It's this what we should be thinking about and not the criticism and ridicule.

 

[SNT Gatchaman]

Who makes the decision about what is important, what is a priority, which people are important, how resources are to be headlined or hidden, who should pay and how they should pay are all questions that are highly political and we shouldn't pretend that there is some white coated arbiter who on the basis of some pure logic is defining the 'right' answers to those questions

Or as Laswell wrote in 1936: "Politics: Who Gets What, When, How"

 

[EzzieD]

If the goal is to ensure the scientific integrity and standard, that is really the job of scientific community, not patients. Patients could take political action against "shoddy science" because they feel victimized by it. But that is how anti-vaccers feel and what they do.

It might help to know that many ME/CFS patients (and other patients too, for that matter) were ourselves doctors, scientists, researchers, statisticians, technicians, or similar professions before we got ill. Becoming a patient doesn't cause us to lose our qualifications, our experience or our intelligence - just our livelihood. And, our credibility stolen by those who want to push their bad science at our expense.

 

[Kitty]

Saying that we are taking action because of shoddy scientific practices is not too convincing.

Why not?

Researchers do the best they can manage, the best they can get funded, or the best they can get away with. When it's pointed out that a PI's work falls into the last category, it's not news to him/her. It's not news to anyone.

But every time no one does point it out, it makes it a bit easier for them get away with it again. Silence is complicity.

 

[Hutan]

To me saying no to a charter or similar is a bit like saying it's better to be silent.

It's better to say nothing if you can't say anything intelligent, but I'm sure we can.

Some of you might be thinking of the criticism and ridicule that might come from some corners. But we patients must fight for the right to have a real voice and influence on what is researched about our illness and how. It's this what we should be thinking about and not the criticism and ridicule.

Yes.

And also, organisations that we do have some control over are already making decisions about research. Biobanks are deciding who to give samples to; patient registries are deciding who to give data to. Patient charities are funding research and are promoting studies to their members. And, I don't think we have much idea about what rules they are applying when they make those decisions. Some of them probably are consistently applying really good rules, but some might be muddling through, with the quality of decision-making dependent on who happens to be around. A set of guidelines is a way to ensure everyone on the demand side is thinking about some key issues.

And, perhaps we can get the supply side people - the research institutions, or individual researchers to agree as well, as part of the process of getting the funds or the endorsement from the patient organisations.

 

[Kitty]

Some of them probably are consistently applying really good rules, but some might be muddling through, with the quality of decision-making dependent on who happens to be around.

It's a process, too, the good ones are still listening and learning.

A set of guidelines is a way to ensure everyone on the demand side is thinking about some key issues.

And, perhaps we can get the supply side people - the research institutions, or individual researchers to agree as well, as part of the process of getting the funds or the endorsement from the patient organisations.

And it should be clear that any guidelines are collaborative both ways, and will always be a work in progress. We're not trying to issue the 10 Commandments.