Making a 'Charter for Ethical ME/CFS Research'

[Hutan]

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 they '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?

I agree. Maybe the introduction of such a charter could be a paper giving for each requirement examples of good and bad research, and the impacts of each on the participants and the wider ME/CFS community.

Yes but that is an exceptionally bad paper and not one from the Biobank I think!

For sure it is a bad paper, although to find it I just searched our BPS research forum looking for 'blood' and it was the second paper in a list pages in length. I doubt it is exceptionally bad. And, the fact that research from the UK Biobank is reliably good rather illustrates the point.

If you have people who are aware of the dangers and actively managing the selection of researchers and research to minimise the risk, then the chance of bad research that is both shoddy science and harmful in other ways is much reduced. I'm not saying that the BPS rubbish and other harmful carrying on can't and won't still continue, after all, they seem to have bottomless sources of funding. But, for example, the organisations that are supposed to be working to make things better for us and who are allocating our precious donations for research should have formal and well considered selection guidelines.

I'd like any research that is either funded by donations from the ME/CFS community or taxpayers or promoted/recruited with the help of the ME/CFS community (including sympathetic specialist clinicians) to be better than a basic threshold in terms of both science and ethics.

 

[poetinsf]

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.

Or, for something that meets certain other criteria? As good intentioned it may be, you never know for sure which way the ball will bounce once you insert the patient control into research. It's throwing the baby with the bath water, or burning down the house to exterminate the fleas (aka psychosomatic champions), to borrow Korean proverb.

 

[Jonathan Edwards]

But, for example, the organisations that are supposed to be working to make things better for us and who are allocating our precious donations for research should have formal and well considered selection guidelines.

I can see that getting a set of standards together that can be agreed on by a good range of ME/CFS-specific charitable funders might be a nice idea. It might even be agreed by some of the general funders like Versus Arthritis and Wellcome.

 

[poetinsf]

You have a point there but there is a valid reason for being against the psychosomatic theory.

No argument there. But you never know what will happen once you leave the barn door open (or close the door in this case?) As much as we'd like to prevent it, we will eventually end up preventing something else as well once we insert patient control on all research.

 

[Andy]

Or, for something that meets certain other criteria? As good intentioned it may be, you never know for sure which way the ball will bounce once you insert the patient control into research. It's throwing the baby with the bath water, or burning down the house to exterminate the fleas (aka psychosomatic champions), to borrow Korean proverb.

You never know, it might just bounce in the best direction possible. If we don't try it we won't know - not doing something because one of the possible outcomes might be bad leaves it in the hands of people and organisations who have largely proved that they have no understanding of what the best direction is.

 

[poetinsf]

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

No it wasn't. But patients rose up in arms in support of it because they favored viral theories. If they had choice from the beginning, they surely would've funded it overwhelmingly in favor over others.

 

[Jonathan Edwards]

As much as we'd like to prevent it, we will eventually end up preventing something else as well once we insert patient control on all research.

Except that all research involving patients is already under patient control in the form of informed consent. I think the idea is just to ensure that that process genuinely occurs in good faith - which includes things like patients not discovering later that studies are published behind paywalls.

 

[poetinsf]

You never know, it might just bounce in the best direction possible. If we don't try it we won't know - not doing something because one of the possible outcomes might be bad leaves it in the hands of people and organisations who have largely proved that they have no understanding of what the best direction is.

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.

 

[Jonathan Edwards]

If they had choice from the beginning, they surely would've funded it overwhelmingly in favor over others.

And surely that is entirely their prerogative. Implausible theories sometimes turn out right. The problem there was just poor lab science.

There is a big difference between the influence of direct patient funding without scientific peer review - which until recently has been fairly limited - and patients overriding scientific review, which nobody is suggesting as far as I know.

 

[poetinsf]

Except that all research involving patients is already under patient control in the form of informed consent. I think the idea is just to ensure that that process genuinely occurs in good faith - which includes things like patients not discovering later that studies are published behind paywalls.

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?).

 

[duncan]

But patients rose up in arms in support of it because they favored viral theories

That is an oversimplification of what happened. Cleveland Clinic positive findings, among others, played a role. There was much going on.

Sooner or later, free flow of idea, and progress along with it, will be stopped.

Irrespective of who leads the way, the most recent NIH fiasco a case in point. I'd rather patients have more of a role in the steerage; if something goes wrong we will be in a better position to appreciate why, and be able to respond faster and suggest corrections that more likely hold patients' interests as the most important (vs medical politics or patents or legacy concerns).

 

[Jonathan Edwards]

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?).

I think Hutan is talking about all these things.

 

[Hutan]

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. As well-intentioned as it may be, patients politicizing the research is more likely to be counterproductive than helpful.

I think you underestimate the power of good communication between researchers and patient organisations, in both directions.

If it is required that the research funded by a private Research Foundation like the Mason Foundation or a government funding opportunity must have the support of a patient organisation, you are requiring communication between the researcher and a patient organisation. That communication can make the research better and can increase the profile and support for the researcher in the community. Researchers will take pleasure in being able to say that the national organisation for a disease that they are studying has endorsed their work, the interaction helps make their work feel more worthwhile.

But, importantly, it also educates the patient organisation. People within the organisation will learn and can apply what they learn to the next research project that they are asked to endorse. Those organisations are accountable to their members - if they stuff up, they will hear about it. If they stuff up badly, they will hear about it for years. Ask AfME.

 

[poetinsf]

And surely that is entirely their prerogative. Implausible theories sometimes turn out right. The problem there was just poor lab science.

If they are funding with their own money, sure. I meant "voted" or "directed" by "funding". Calling the XMRV fiasco just a poor lab science is being charitable, imo. I'd call it a fraud that took advantage of patients' sentiment.

 

[Jonathan Edwards]

must have the support of a patient organisation

This is where I would worry.

Patient organisations are a very mixed bag. There are very few official 'national organisations'. For rheumatoid in the UK there are several different sorts of organisation, some purely patient run, others mixed. Some have strong links with particular researchers with vested interests - exactly the wrong sort of people maybe. And for some diseases, (particularly non-existent diseases) there are even more seriously problematic organisations.

In this sense I would agree with poetinsf.

 

[Jonathan Edwards]

If they are funding with their own money, sure. I meant "voted" or "directed" by "funding". Calling the XMRV fiasco just a poor lab science is being charitable, imo. I'd call it a fraud that took advantage of patients' sentiment.

Not sure what voted or directed would mean here? If someone else funded it and the patients were keen I cannot see we can object. it might have been better to put money into other things but to be honest there were precious few leads to pick up on.

I don't think XMRV was a fraud in the sense of intentional deception. I am pretty sure the investigator believed in their results, however crazy that seems now. I have had dozens of colleagues who have done the same. People are irrational.

 

[duncan]

Patient organisations are a very mixed bag.

So are state institutions like the NHS or NIH.

 

[poetinsf]

I think you underestimate the power of good communication between researchers and patient organisations, in both directions.

Are we simply talking about communication? Requiring patient involvement in design, management and publication seems a bit more than that. Good communication even before the design may be a good thing; getting involved in every stage probably is not. The purpose there is more of censoring than communicating, it seems to me.

 

[poetinsf]

Not sure what voted or directed would mean here? If someone else funded it and the patients were keen I cannot see we can object. it might have been better to put money into other things but to be honest there were precious few leads to pick up on.

Do you really want to see patients pick and choose which studies get funded? That might be democratic, but democracy is not the best tool to solve a scientific problem.

I don't think XMRV was a fraud in the sense of intentional deception. I am pretty sure the investigator believed in their results, however crazy that seems now. I have had dozens of colleagues who have done the same. People are irrational.

When Judy Mikovits showed up championing the far-right conspiracy theory, I felt vindicated. I suppose even a fraud could make herself honestly believe in what she does.

 

[Hutan]

Patient organisations are a very mixed bag. There are very few official 'national organisations'. For rheumatoid in the UK there are several different sorts of organisation, some purely patient run, others mixed. Some have strong links with particular researchers with vested interests - exactly the wrong sort of people maybe. And for some diseases, (particularly non-existent diseases) there are even more seriously problematic organisations.

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.

But, when it came to assessing the projects against the criterion 'patient support', hopefully the one supported by an organisation with 20 members would score fewer points than the one supported by the national organisation, or the one that has 10000 members and a strong track record in the community. Even if the quality of the endorsing organisation didn't make a difference to the assessment metric, I think it's still a worthwhile requirement. Credible researchers with research ideas they can defend will tend to go for the bigger more credible organisations. And there will be benefit all around from the process of engagement.