MEGA research for M.E./CFS: White & Crawley listed as involved

[Yogi]

Full link to Invest In ME statement on "MEGA study - #ProjectSinkhole"

http://www.investinme.org/IIME-Newslet-1609-02.htm

We have been asked our opinion on the so-called MEGA study which patients are being asked to support by signing a petition.

From the little information we can ascertain -

We believe this will, if it gets accepted, suck away all funding for ME research for the next few years and give an impression that something is being done that will produce benefits for people with ME.

Yet we do not have confidence that this will lead to any effective remedy for people with ME.

A lot of data is proposed to be collected on a broadly defined patient cohort.

What is this data being used for?

It is stated –

“If we do this, we think we may be able to develop new treatments. We also think we may be able to target treatments more effectively for those that will benefit.”

We wonder what treatments they are thinking of developing whilst including those investigators who believe that ME is a faulty illness belief amenable to changing one’s thoughts.

We feel the petition has no other meaning but showing an element of patient public involvement.

And we also wonder if this proposal has already been accepted by some in positions of influence and that this petition may be mere cosmetics rather than substance.

There is no description of how “ME/CFS” patients are diagnosed before entry. Are there enough trained doctors to diagnose 12000 ME patients in a consistent way or can anybody with unexplained fatigue put themselves forward?

This resembles the shambles of the PACE Trial again and patients are already falling for it.

The history of MRC policy toward ME does not engender trust – numerous “expert” panels that produced nothing, PACE Trial funding, funding of research into other illnesses such as Sjogrens under the banner of ME research – yet we are still no wiser, patients are still ill.

We have already requested that the MRC refuse to allow grant applications from, or provide funding to those investigators who were involved in the flawed PACE Trial. This project proposes some of those behind PACE or supporting it will be involved.
We have no confidence in these people.

Like a sinkhole we feel this will suck away available funding for ME - and also remove many years of additional opportunity for good research.

We feel this is yet another way that patients will be given a line that something is happening – yet based on the experiences of the past it will be just more years waiting – and then little to show for it other than to benefit some whom we feel should not be involved in research into ME and some organisations.

Having scarce funding sucked away like this is one thing – losing more lives to it through delays is another and we cannot accept that.

This research will take years and require so much further analysis that it is difficult to see how it benefits patients any time soon.

We cannot support this.

 

[Simon]

The study, as currently presented, would seem to be of very limited value, regardless of inclusion criteria, since the amount of money per patient will not be enough to do detailed -omics characterisation of the sample, it will just cover the costs of researchers' salaries, recruitment and useless epidemiological questionnaire based research into psychosocial risk factors which, as @Woolie pointed out, will then be spun into prognostic factors for response to CBT/GET.

Where is the budget figure from? I think we can be certain, though, that a bunch of omicists haven't just signed up for a questionnaire study.

I don't see why such a large, unfocused investigation is a good idea. A large sample does not make a study good, often it's quite the opposite...

There is no need for a cohort of 12,000 since GWAS is not needed. This is an acquired not genetic disease

1. Huh? GWAS are usually done on diseases that are not aquired genetic ones - that's the point. The huge samples can find genetic evidence of which pathways are involved (SNPs in these linked to risk of disease) giving clues as to the biology. Eg Alzheimer's Parkinsons etc. But each individual affect eg mutliple enzyme genes in a pathway have a v small effect, hence the huge sample size needed to pick it up.

Also, the big sample sizes allow teasing out of different subgroups within mecfs, which are likely to be important. That's always been as big part of theh rationale: A Dozen Different Diseases? Stephen Holgate Calls for Radical Change in ME/CFS Research

 

[Sidereal]

1. Huh? GWAS are usually done on diseases that are not aquired genetic ones - that's the point.

I know, and it's a useless approach.

 

[Cheshire]

This petition is a whitewash program. There's no need for such a thing to start a trial. No valid reason. Unheard of.
Imagine how Peter White and Esther Crawley coud (will) use it. There's a vocal minority shouting outside, but look, we have the support of the real patients.

I don't see any other reason for launching it.

 

[ukxmrv]

Also, the big sample sizes allow teasing out of different subgroups within mecfs, which are likely to be important. That's always been as big part of theh rationale: A Dozen Different Diseases? Stephen Holgate Calls for Radical Change in ME/CFS Research

Or is it going to be "50 shades of fatigue" and how this that going to be of advantage to ME and CFS research?

 

[Yogi]

She has been asked to respond directly. Will she? Will she heck.

https://twitter.com/i/web/status/781832710109233154

https://twitter.com/i/web/status/781476636009127937

 

[aimossy]

A massive study in omics could change everything. I personally feel we need to work to make sure there is solid patient involvement in the planning of the study, to make sure it becomes what it needs to be. A lot of questions need asked and answered right now.

If we react to the abuse we've had by white et all due to fear of what they've done in the past and we kill off this study - it would be like he gets away with ruining the chances of us getting actual decent research yet again. This just seems to continue to give him power. I would rather not be in a victim role and prefer us to have an actual stake in planning of the work making sure the research goes where it needs to and is the good science design it needs to be.

 

[Sasha]

A massive study in omics could change everything. I personally feel we need to work to make sure there is solid patient involvement in the planning of the study, to make sure it becomes what it needs to be. A lot of questions need asked and answered right now.

If we react to the abuse we've had by white et all due to fear of what they've done in the past and we kill off this study - it would be like he gets away with ruining the chances of us getting actual decent research yet again. This just seems to continue to give him power. I would rather not be in a victim role and prefer us to have an actual stake in planning of the work making sure the research goes where it needs to and is the good science design it needs to be.

Agreed. I don't want White to have the power to wreck this study by provoking a patient backlash against his involvement.

If we start demanding and yelling to have things done our way or not at all we risk having the reasonable researchers withdraw and we risk pitting patients who want the study - and remember, over 1500 have already signed up - against those protesting.

Questions and two-way communication. That's what we need right now.

And let's not be in such a tearing hurry. That's a recipe for knee-jerk, rash, ill-conceived action.

Edit: Make that nearly 1800 patients have signed. Let's keep them on-side and make them our allies in getting a study that will benefit us all.

 

[Yogi]

@Sasha Agreed we shouldnt' "demand and yell" and give White too much power. Agree we shouldn't do somthing knee-jerk, rash or ill-conceived.

I agree with open two way communication. However based on experience they will not give us proper responses but just non-responses.

This petition was very underhand and deceptive.

Andy Hugh says:
September 29, 2016 at 9:10 pm
Some who read the title ‘biomedical research’ signed but since seeing the issues, no longer wish they’d signed. There’s no way to retract support. The title is misleading and clearly designed to deceive to get as many signatures as possible. How can anyone now trust any of the people behind such a misleading claim?

Like

Reply

1. 
   mrspoonseeker says:
   September 29, 2016 at 11:28 pm
   Yes, it’s annoying there’s no way to retract support. My wife fell into that trap. Look, this may well be a very good biomedical research proposal – it’s just that some of the people involved ring alarm bells. What flabbergasts me is that our objections to such people – and our concerns about the criteria to be used – seem to be greeted with surprise. They just don’t seem to understand that they’re dealing with patients who’ve been messed around too many times and aren’t going to put up with it any more. They need to do better than this. Nothing we are saying is unreasonable, but if they want our support, they have to treat us as partners who have a voice about what is done in our supposed best interests.

 

[Sasha]

There are potential big wins for MEGA if they get their comms right - that is, make them two-way rather than just pronouncing from the mountain-top.

Patient involvement is a big thing in medicine now but we're seeing how badly done it can be - how superficial, ill-informed and lip-servicey.

MEGA could make itself a model of how to do it, and we could help them genuinely do that, in what must be one of the most controversial, poisoned medical arenas for a generation.

Great big win for MEGA, great big win for us.

 

[worldbackwards]

Make that nearly 1800 patients have signed. Let's keep them on-side and make them our allies in getting a study that will benefit us all.

How many of those will have signed before they knew the track record of those on board?

 

[Sasha]

I agree with open two way communication. However based on experience they will not give us proper responses but just non-responses.

Which would be a telling response in itself.

 

[Sasha]

How many of those will have signed before they knew the track record of those on board?

Unknowable.

 

[AndyH]

@Sasha Agreed we shouldnt' "demand and yell" and give White too much power. Agree we shouldn't do somthing knee-jerk, rash or ill-conceived.

I agree with open two way communication. However based on experience they will not give us proper responses but just non-responses.

This petition was very underhand and deceptive.

Andy Hugh says:
September 29, 2016 at 9:10 pm
Some who read the title ‘biomedical research’ signed but since seeing the issues, no longer wish they’d signed. There’s no way to retract support. The title is misleading and clearly designed to deceive to get as many signatures as possible. How can anyone now trust any of the people behind such a misleading claim?

Like

Reply

1. 
   mrspoonseeker says:
   September 29, 2016 at 11:28 pm
   Yes, it’s annoying there’s no way to retract support. My wife fell into that trap. Look, this may well be a very good biomedical research proposal – it’s just that some of the people involved ring alarm bells. What flabbergasts me is that our objections to such people – and our concerns about the criteria to be used – seem to be greeted with surprise. They just don’t seem to understand that they’re dealing with patients who’ve been messed around too many times and aren’t going to put up with it any more. They need to do better than this. Nothing we are saying is unreasonable, but if they want our support, they have to treat us as partners who have a voice about what is done in our supposed best interests.

It seems there is a way to unsign. Shame it's not clearer though. I was given this link earlier ...
https://www.change.org/p/change-org-offer-a-simple-way-to-unsign-a-petition-on-change-org

 

[Yogi]

There are potential big wins for MEGA if they get their comms right - that is, make them two-way rather than just pronouncing from the mountain-top.

Patient involvement is a big thing in medicine now but we're seeing how badly done it can be - how superficial, ill-informed and lip-servicey.

MEGA could make itself a model of how to do it, and we could help them genuinely do that, in what must be one of the most controversial, poisoned medical arenas for a generation.

I agree with this in theory. However in practice it most likely will not happen. It is naive to believe it might (no disrespect to you and not calling you naive). Need to be realistic about who we are dealing with.

Am just basing it on 1. The players behind this PW, EC (Magenta), SC 2. History of AFME with PACE trial (MRC funded) 3. No involvement to date of patients (I don't regard AFME as patient group) 4. This "honey trap" petition for "cheerleaders"

Leopards and spots

 

[Simon]

I can't keep up with this whole thread but I wanted to respond to what I think are important comments as they got a lot of attention. They are almost all by the same person and I think Woolie is a very smart poster, but I don't think the interpretation is right on this occasion - at least I want to suggest different interpretations for consideraton.

I think you have a point here, @Yogi. Its crucial that we don't get blinded by the word "biomedical", because some of the new types of measures and theoretical frameworks the BPSers are using do look "biomedical". But at the core of them is the same old "illusory perceptions of illness" crap.

That might be the case, but also we know that genomics, epigenomics, transcriptomics [gene expression] and metabolomics (last one as per Naviuax) were developed by biomedical types looking at biomedical problems. And that's the kind of things the MEGA omicists use them for in their main work away from this study. So I think biomedical is fair enough in this context.

We need to know what exactly will be done before we support anything. But in my view anything that focuses on "the brain" should not receive our highest support right now for two reasons.

...No, we need to support basic research into the role of more peripheral systems in CFS - e.g., immune, metabolic - ones where new discoveries might actually lead to new and effective treatments.

I think Dolphin mentioned there's nothing specific on the brain, but it's worth saying that the technqiues planned by MEGA are well placed to identify immune and metabolic issues, plus a ton of other stuff. I don't think we should limit ourselves to one particular area - one of the strengths of omics approaches is they probe many different areas.

we think we may be able to develop new treatments. We also think we may be able to target treatments more effectively for those that will benefit.

Alert! Alert! Look at this sentence! There's something odd about it. Like the word "existing" was originally there after "target", and was deliberately scratched. If you haven't developed the treatments yet, why would you say you're going to target them more effectively? More effectively than what? These treatments haven't been tested before, right?

The statement was clearly about targetting existing treatments more effectively and got edited.

Reading it again now, I suspect the BPS adherents in the group are very interested in the epidemiology data, which they plan to use in various creative ways to demonstrate a the role of psychosocial factors.

There's a simpler and I suspect more accurate explanation, that the original text means what it says. The whole concept driving this study, coming from Stephen Holgate, is sub-groups - which means different mechanisms in different groups, and so different treatments too.

Holgate is also involved in a big, European personalised medicine intiative, which again is based on targeting the right treatment to each patient. A couple of relevant examples are cancer, where genetic analysis of tumours showed that eg breast cancer had (I think) about 13 different types of tumour, eg needing different treatments (Herceptin treatment of HER2+ tumours is one eg), but also some tumour types occurred across different tissues. So for the best treatment you needed to know the tumour sub-type rather than tissue location.

The other example is from Holgate's own field of asthma. I forget the details but I think there are at least four different subtypes of asthma - and the reason that some people don't respond to the usual treatments is that they have molecularly-different asthma needind different treatment.

So while that sentence might be clumisly phrased, the idea it conveys is exactly what Stephen Holgate has been talking about for at least three years. He wants to find the biology of subgroups and develop target appropriate treatments.

Let's see real actual research proposals first, and then we will give you feedback, on our terms.

I think patients deserve more information for something is put out like this, we are interested parties not just a herd of cheerleaders.

I agree with both to those comments as this thread and the conversation on twitter shows. Patients deserve more information, and as @Sasha says, dialogue too. Not to mention meaningful involement in the study: I believe there should be no research about us, without us.

 

[Sasha]

I agree with this in theory. However in practice it most likely will not happen. It is naive to believe it might (no disrespect to you and not calling you naive).

Saying that what someone thinks is naive is disrespectful, IMO. You may disagree with what I say, but that doesn't make it a naive position.

 

[aimossy]

I agree that the petition launch was a really dud move, patients are not going to support something they don't know the details of. They may need the support to help pressure for funding but this wasn't the way to go about it. I think they seem to be lacking a bit of insight as to the depth of hurt and the trust they need to earn.

There is already huge reaction to Whitemort and Crouchley, MEGA and Action for ME screeching about the place like wild fire. I think it's possible the researchers other than those two that "should not be named" could start getting caught up in that reaction from community and not understand why. I don't want us to loose brilliant quality new researchers - it also reinforces the negative view of patients and may make it harder for us to get a meaningful seat at the table on what happens.

I feel we should be asking questions and talking about how we can get that meaningful seat at the table on this research. We don't want some fluff "engagement' of reading their news blogs and some "group work shops" where patients talk about their symptoms and it gets perceived as great engagement but it's all just an oh yes "see we are listening".

I think we need to have patients involved who can literally represent us and be able to explain to them why something might "not be such a good plan". We need to be able to have an open forum from them where people can write in regarding proposed plans that can be published along with written responses. Literally they need to make it possible and respect the community. We can contribute to helping develop stronger research which is supposedly what they all want and what we need. That may be a challenge and challenging to them but if your going to spend a LOT of funding this needs to count it will add rigor to the planning.

If they do this properly they may just garner a huge amount of support, especially if it is going to be needed to pressure for funding as well.

 

[trishrhymes]

Agreed. I don't want White to have the power to wreck this study by provoking a patient backlash against his involvement.

Edit: Make that nearly 1800 patients have signed. Let's keep them on-side and make them our allies in getting a study that will benefit us all.

Just a quick comment. I don't think it's correct to say 1800 patients have signed. For example, at least one of my friends who doesn't have ME but is supportive saw the petition highlighted on Facebook and told me she'd signed. She didn't realise this wasn't a petition I was supporting, and I didn't have the heart to tell her she'd done the wrong thing. I guess there will be lots of others signing who are not ME patients but friends and family trying to be supportive, as well, of course as lots of colleagues, friends etc of the bad guys.

 

[Sidereal]

I have serious petition fatigue at this point.