Making a 'Charter for Ethical ME/CFS Research'

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.

 

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

 

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.

 

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.

 

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

 

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

 

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.

 

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?

 

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

 

No, it has nothing to do with free speech.

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

 

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.

 

This is still online though the blogger is no longer active: https://cfsmirror.blogspot.com/2012/

 

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.

 

We crossed, Kitty, but I agree with you.

 

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

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.

 

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.

 

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.

 

exactly