Making a 'Charter for Ethical ME/CFS Research'

[Jonathan Edwards]

Do you really want to see patients pick and choose which studies get funded?

I am not saying that and I remarked to Hutan that I agree with you on that.

But look at it this way. As a seasoned biomedical scientist with a track record it is very clear to me that the combined expertise and knowledge base of S4ME members in terms of worthwhile research in ME/CFS is way ahead of any individual researcher currently out there. And yes, including Chris Ponting, Øystein Fluge, Maureen Hanson, Ron Davis or whoever.

That may be a rather unusual situation for a disease but maybe not unique. Patients have driven solutions to medical problems in the past - including the eradication of Hepatitis B from renal dialysis units I believe. Things that nobody else can be bothered to sort out. Of which ME/CFS is one.

 

[bobbler]

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

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.

I just don't know much/enough layperson's stuff about this, so would be interested in anything you can point me to, whether it is articles or your own summary @poetinsf

I think it is interesting to learn lessons from all sides of history and of course I'm intrigued to know more generally

 

[Jonathan Edwards]

some obscure group called 'Recovered ME/CFS patients' that gets their morning teas sponsored by Phil Parker

The reality is more depressing. Big national patient organisations for big common diseases of which an example might be hmm nudge nudge, maybe that one, can be as misguided as the Science Media Centre if they want to be. I have been there done that.

 

[duncan]

That may be a rather unusual situation for a disease but maybe not unique.

Almost a quarter of a century back, the first of three RCTs for Lyme disease was conducted at the NIH. Many Lyme patients were highly skeptical and demanded a seat at the table. Despite continued patient misgivings about the protocol, the trial appeared poised to proceed. Patient blow back got so loud that a sister study was approved - before the trial went ahead - using primates at Tulane U, in great measure supposedly to placate the patient bloc.

Although somehow the sister study was delayed 12 years(!), its results were finally published and it substantiated the patients' concerns.

Even so, to this day, the results of that initial RCT haunt LymeWorld and help to limit treatment options. If the patients had truly been part of the governance, the Lyme narrative today would probably be very different.

 

[poetinsf]

But look at it this way. As a seasoned biomedical scientist with a track record it is very clear to me that the combined expertise and knowledge base of S4ME members in terms of worthwhile research in ME/CFS is way ahead of any individual researcher currently out there. And yes, including Chris Ponting, Øystein Fluge, Maureen Hanson, Ron Davis or whoever.

Sure, I can agree with that. And I could add quite a few more names to your list.

 

[poetinsf]

I just don't know much/enough layperson's stuff about this, so would be interested in anything you can point me to, whether it is articles or your own summary @poetinsf

I don't have an article or summary for XMRV debacle, but google search would turn up articles like this: Science Journal Retracts Chronic Fatigue Syndrome Paper - The New York Times (nytimes.com) by David Tull. (Whoops, a paywall. Please have it corrected if you know how to make it accessible).

The study, published in October 2009, had been hailed by people with chronic fatigue syndrome as proof that their condition had an organic rather than a psychological origin.

The aftermath of the XMRV paper was a great political event, with patients bringing CFIDS Association and Dr. Vernon, their medical director, to the knees.

 

[Hutan]

The reality is more depressing. Big national patient organisations for big common diseases of which an example might be hmm nudge nudge, maybe that one, can be as misguided as the Science Media Centre if they want to be. I have been there done that.

Yes, it's a problem. The national patient organisation in my country has promoted some odd ideas and I certainly would not have wanted it to be the only organisation able to endorse research. However, its influence has waned, and there are other organisations around which mostly seem to be more sensible. And the national one seems to be heading in a better direction.

I guess I just feel that if a researcher can't convince any organisation of the people with the disease they are trying to investigate, then it probably isn't a very good idea or it hasn't been presented very well, and they might need to rethink things. Organisations might not be very discerning to start with, but I think they could get better with practice.

I think there are strong parallels between what I am talking about and what has been happening with research about particular ethnic groups. It is becoming almost inconceivable in some countries for research specifically about a racial/ethnic group to be done without the involvement of representatives from that group. And I have seen that be a very good thing. I think the reasons for it apply equally well to ME/CFS research.

 

[duncan]

With proactive patient involvement (not just reactive), it would likely make it more difficult for malign interests to exploit the patients. That's not to say groups like the BPS ilk wouldn't still spin, but helping erect safeguards is important to many like me. It's not just picking a horse, it's trying to prevent the horse from being stolen.

 

[Sean]

OK, it is the psychosomatic theory that patients are against today.

No. We are against the sloppy standards it is built on and being propped up by to this day, the horrendous (direct and indirect) damage it is doing, and the pathological refusal of its adherents to acknowledge legitimate criticism and modify, or even abandon, their claims as appropriate.

To me, it's akin to free speech. People don't like certain speech, so they start censoring. Sooner or later, free flow of idea, and progress along with it, will be stopped. Doing more harm than good also applies to the remedy to stop things that do more harm than good.

It is not so much about what to research but how, what technical standards are going to be used.

Robust methodology filters out the crap, or at least minimises it.

Nobody is suggesting that patients should be able to arbitrarily veto research. That is a strawman. But we have every right to not participate in poor quality research, especially when done by people with a history of misusing it to misrepresent us and our condition. We have every right to say very loudly why we will not participate, and demand better

It is beyond bizarre that it is patients calling for better technical standards, while a certain and very influential group of clinicians and researchers are demanding the right to arbitrarily lower them for the simple reason that they cannot get a 'result' without doing so. Worse than demanding, they are simply doing it, and have been for decades.

Under no circumstances should we accept that situation. It is exactly why we are in this cesspit now, and why it is proving so difficult to get out of it.

 

[JellyBabyKid]

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.

THIS.

This really gets to me; other people being able to make choices that affect our lives and have no consequences for them. Worse, that this happens over and over to millions of people.

I like the idea of "nothing about us without us" as there needs to be a collective way of saying "enough". I can see why there are objections, but overall I think this is a great place to start. Do any charities or other patient groups have anything like this? is there a precedent we can cite?

 

[CRG]

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.

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.

The XMRV story didn't come out of nowhere. Wise after the event (some might claim to be wise before !) the sequence of interactions between dubious medical authority, income driven medical testing, half baked hypotheses, self promoting politically involved property developers, and impressionable education administrators that led to the ultimate absurdity where a useful scientific finding (XMRV as a contaminant of widely used lab material) - was presented as, despite being absent of any plausible hypothesis - a profound breakthrough in ME/CFS.

Arguably had a workable Charter been in existence prior to Peterson's claims about Incline Valley, prior to De Meirliers Clinics, prior to the creation of the Red Labs businesses (Europe & US), prior to the Whitmore's involvement, prior to the Nevada Uni involvement, prior to the hiring of Mikovits, then the benighted XMRV episode may have had an entirely different complexion.

Of course we might consider that a Charter would have been gamed by any one of the players - each building up their favoured patient grouping to support funding or hypothesis or business or cult status, but that's an argument for a Charter to have well established points of reference outside of the narrow research/business interests of individual clinicians, lab owners, advocacy orgs and any grifter seeing an opportunity to exploit patients, rather than an outright argument against a Charter.

Perhaps one aspect of a Charter would be to demand transparency in all business links (even the saintly Peterson had an interest in the Redlabs set up which I think has never been fully explained) where financial benefit might be deemed to inform direction of research.

Edited for typos

 

[Andy]

To me, it's akin to free speech. People don't like certain speech, so they start censoring. Sooner or later, free flow of idea, and progress along with it, will be stopped. Doing more harm than good also applies to the remedy to stop things that do more harm than good.

No, it has nothing to do with free speech.

Non-sequitur. We are not talking about subjects' informed consent to already designed studies here. We are talking about patient groups getting involved in the study design and execution (and even conclusion?).

Yes, and that is a good thing to have happen.

 

[Kitty]

It is not so much about what to research but how, what technical standards are going to be used.

Robust methodology filters out the crap, or at least minimises it.

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.

 

[CRG]

I just don't know much/enough layperson's stuff about this, so would be interested in anything you can point me to, whether it is articles or your own summary @poetinsf

I think it is interesting to learn lessons from all sides of history and of course I'm intrigued to know more generally

This is still online though the blogger is no longer active: https://cfsmirror.blogspot.com/2012/

 

[Sasha]

Robust methodology filters out the crap, or at least minimises it.

Nobody is suggesting that patients should be able to arbitrarily veto research.... It is beyond bizarre that it is patients calling for better technical standards, while a certain and very influential group of clinicians and researchers are demanding the right to arbitrarily lower them for the simple reason that they cannot get a 'result' without doing so. Worse than demanding, they are simply doing it, and have been for decades.

Under no circumstances should we accept that situation. It is exactly why we are in this cesspit now, and why it is proving so difficult to get out of it.

I think you've put your finger on it, Sean. I'm not in favour of ruling out what can be studied, what theories can be tested, or who should be allowed to do the research. I think that that's against the ethos of science, and would look defensive, as though we were scared of what the science would show.

Rather, I think that expert patients should be able to act as reviewers for research proposals, where they could flag up methodological problems before the study is allowed to proceed. And I think that should be a public process: no hiding the critical comments behind closed doors. Funding bodies and researchers mustn't be allowed to pretend that they weren't warned that positive study result would be worthless. And those reviews should be presented to the ethics committees who are having to judge whether to allow the research to go forward.

 

[Sasha]

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.

We crossed, Kitty, but I agree with you.

 

[JemPD]

I dont have strength to resply & quote everything & everything i want to, so apologies if this a bit disjointed.

I think you've put your finger on it, Sean. I'm not in favour of ruling out what can be studied, what theories can be tested, or who should be allowed to do the research. I think that that's against the ethos of science, and would look defensive, as though we were scared of what the science would show.

Rather, I think that expert patients should be able to act as reviewers for research proposals, where they could flag up methodological problems before the study is allowed to proceed. And I think that should be a public process: no hiding the critical comments behind closed doors. Funding bodies and researchers mustn't be allowed to pretend that they weren't warned that positive study result would be worthless. And those reviews should be presented to the ethics committees who are having to judge whether to allow the research to go forward.

Yes, this, plus Sean, Kitty etc, this what i was thinking too.

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. All sorts of stuff to do with decent methodology. If PACE had done that it would have debunked the entire beliefs/behavious paradigm right there - in a way that would have been obvious & Unarguable to all,

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.


There are people who are researchers on studies, who are patients themselves, funded by a pateint org, that i really concerned about.

We talk about 'well informed patients', but i'd be surprised to discover that many patients outside this forum knew much or anything about methodology for example. I know i'd never even heard of subjective vs objective outcome measures until i stumbled upon the posts about it intitially on PR & then here, & considered myself well informed.
So it would need to be specified what exactly was meant by 'well informed patient'. I dont know how that gets decided, or who decides it.

ITs very, very tricky, but i dont think the issues are insurmountable.

As long as we stay away from dictating what research is done and only state that we want reliable high quality methodology, ethical practice and to be properly involved, rather than lip service to PPI. I think it could help.

I do hear you @poetinsf in the risks (& FWIW i did get yr comparison with the free speech arguments, it came to my mind too - not that letting researchers do whatever they like should be allowed because its 'free speech' but that the difficulties in regulating free speech - ie 'who decides', is a similar difficulty to who decides what research gets done).

But currently others have been deciding, to our detriment, so any risk of the pendulum swinging the other way will only bring balance, as long as we dont start dictating what research gets done, ie the subeject matter, which, tempting as it is to dictate, i dont think we should do, we have to allow science to go where it will.

If we focus on getting good methodology & good ethical practise, any crap BPS ideas may well still get researched, but it will show their ideas wrong, which can only help us, despite being infuriating in terms of money wasted etc.

 

[rvallee]

Yes, for sure. Some researcher could find some obscure group called 'Recovered ME/CFS patients' that gets their morning teas sponsored by Phil Parker to endorse their study and you'd probably have to allow that in a national call for applications for funding.

Goes without saying that such an organization would not sign the charter.

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.

 

[rvallee]

No. We are against the sloppy standards it is built on and being propped up by to this day, the horrendous (direct and indirect) damage it is doing, and the pathological refusal of its adherents to acknowledge legitimate criticism and modify, or even abandon, their claims as appropriate.

I'd say that it isn't even necessary to name psychosomatic or psychological research directly. All that's needed is stringent requirements and it takes care of itself naturally. Biopsychosocial research cannot withstand rigorous methodology, the only way they can pretend to is to lie and cheat, such as with PACE getting the support of patient organizations by claiming they will have high standards than lowering them as needed.

The requirements can certainly be specified based on the failed history of psychosomatic research, but there is no need to make any reference to psychology, psychosomatic, biopsychosocial or anything like that, it's just naturally low quality and requiring high quality generically excludes all of it. Hell, this eliminates most evidence-based research, since most of it is extra low standard. And that's a good thing. They need to get their shit together and if it takes a patient movement to make it happen then so be it.

 

[JemPD]

The requirements can certainly be specified based on the failed history of psychosomatic research, but there is no need to make any reference to psychology, psychosomatic, biopsychosocial or anything like that, it's just naturally low quality and requiring high quality generically excludes all of it. Hell, this eliminates most evidence-based research, since most of it is extra low standard. And that's a good thing. They need to get their shit together and if it takes a patient movement to make it happen then so be it.

exactly