Why I am signing the petition to oppose MEGA

mega

MEGA has many facets: is it a thing of beauty or are its flaws too great?

MEGA is a proposed study into ME/CFS. There are good and bad aspects to it, so reaching a conclusion on whether to support it, or not, is not straightforward. But after careful consideration I have decided I am going to sign the petition opposing the study.

The MEGA alliance asked patients to endorse their study by signing a petition in support of them gaining funding to take the project forward (yes, there are two separate petitions). In the bit at the bottom were details about who was involved which includes the principal investigator of the PACE trial, and another researcher who has spoken highly of PACE and is running a trial similar to PACE in kids. Both promote a biopsychosocial (BPS) model of the disease.After some debate, someone launched a counter petition opposing the study. Right now what we have is a binary choice:

– Support the petition endorsing the study

OR

– Support the petition in opposition to the study.

You can of course do nothing but then you get no say at all, stuff just happens to you.

There are lots of potential problems with MEGA and these have been discussed on Facebook pages, blogs and forums such as Phoenix Rising. But these are the things that for me mean that I cannot support MEGA:

* Peter White’s involvement – he led the PACE trial. He promotes a BPS model of the disease that his own research does not support.

* Esther Crawley’s involvement – she ran a treatment trial of the Lightning Process on children with ME. She is now doing a graded exercise therapy trial on children despite there being concerns over the safety of the treatment.

* AYME involvement – Esther Crawley is an adviser for this organization so there is a clear conflict of interest. In my view AYME does a bad job of representing the interests of patients, one recent example I wrote about on my blog this spring.

I also have concerns over the definition that will be used to pick patients for the study, though I believe this may be something that those involved in the study may be willing to change, so it is not currently a reason why I am signing the petition. I don’t see any realistic prospect of them resolving the three issues above though, hence I will be signing the petition to oppose MEGA.

Some have pointed out that there are some good people involved in this study too, and I agree that is the case. There are researchers involved who have a track record of carrying out good quality science and I hope these people will do research into ME/CFS in some form. I want to find myself in a position where I can support them wholeheartedly.

I would like to specifically state that every patient I have interacted with wants these new researchers involved. The concerns are solely with certain individuals and organizations that I feel have let patients down over the years.

It has also been pointed out that as well as mental health questionnaires for 12,000 patients we will also get some omics data, and I think if genuine patients are picked this will be very interesting. The problem though is that patients are being asked if they want this study as it is and we are not being given a one or the other option. We are being told we get the good bits but must also accept the bad bits.

Given the new researchers involved are not considered experts in ME/CFS the study will be dependent on the advice of the so called experts White and Crawley. This could limit the good side of what we could potentially get out of this study and given its size and cost, if this study is not done properly it will set in stone an omics view of the disease forever. No one is going to be given funding to do something similar on this scale again if this study fails to show compelling evidence of something going on in omics. So the stakes are high.

Additionally, omics research takes time, a lot more time than it takes for mental health questionnaire and chalder fatigue scale results from the same study to be published and start being applied to all of us. If lots of people without ME/CFS but with mental health problems are entered into the study (highly likely based on the definition they tell us they will use) then a lot of those 12,000 study participants will demonstrate mental health dysfunction and not have ME/CFS.

It would probably seem quite reasonable to add these questionnaires to the study (it’s not hugely expensive). But off the back of the biggest ever study of mental health in ME/CFS (even though that is not the primary aim of the study) White, Crawley and other researchers who promote behavioral models of the disease will use this data to further research in that area rather than biological models.

So the question is, are you willing to take the risk of endorsing the bad as part of the deal to potentially get something good? Right now, as it stands, I cannot support it.

Some people who I like and respect a lot are in support of MEGA. I understand their reasons, and I too would love to support large-scale biomedical research into ME/CFS from some of the names involved in this project. I have found it very tempting to ignore the major problems I’ve raised, because of my desire for some of the big names involved in this project to have a crack at the disease. But I simply can’t do so under the present circumstances, I feel the downsides are currently too significant.

It was also very tempting to sit on the fence. This is not the same situation as PACE, for instance. This is not PACE 2. PACE was 100% bad, there were no redeeming features. MEGA, in contrast has both good and bad features. But I felt it was my responsibility to reach a conclusion and to voice it and my conclusion is that there is too much bad wrapped up with the good.

Also, as you can remove your signature from these petitions if you change your mind, if the issues blocking my support of MEGA are resolved — and I hope they are — I will happily withdraw my signature and support the study. That gives me the confidence to make a decision based on the information I have right now.

I welcome comment on my blog from both sides of the debate, it’s not something that patients should fight over, it’s OK to disagree on such important matters. There is no clear right or wrong, and even if we disagree on this I am sure we will continue to agree on a great deal else.

21 thoughts on “Why I am signing the petition to oppose MEGA

  1. Another issue with Esther Crawley is that some of her research is extremely sloppy. In her ‘CFS at age 16’ study, she included patients on the strength of simplistic questionnaires about ‘feeling tired’ and there was no doctor involved to exclude other conditions. Yet she claimed this study would ‘resolve uncertainties about prevalence’. As you suggest, she will get her questionnaires and will have chance to examine them long before we get any bio results. She’ll be able to publish a string of studies with the same level of quality as ‘Age 16’. Goodness knows how much misinformation she’ll be able to put out there. I haven’t signed the OMEGA petition yet but maybe it’s time I did. As you say, we can always take our signatures off later if things improve, though I suspect it’s going to be difficult to get rid of Crawley. She seems to be running the show.

    Liked by 1 person

  2. I signed the petition as soon as I heard that some of the people involved are still pushing the PACE results. That is a scandal.

    Then I went on to read the rest of your post – and wish I could sign the opposing petition twice. Thrice. Enough.

    Knowing how hard I crash when I overdo it, and how I’ve been unable, in years, to extend my ability to exercise, I also know that anything pushing people into crashes is a very bad idea.

    I’m not even sure my vote counts – I’m not in the UK – but you have to divert this money to real research. I’m almost at 28 years with this stupid disease, and there is no end in sight.

    Liked by 1 person

    • I believe both the petitions are global, but I’m not 100% sure. If anyone wants to sign one of the petitions it is best to do so, and if your vote doesn’t count because you are outside the UK I guess the owners of hte petition can exclude it

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      • We seem to have gone from almost nothing of the activist persuasion, to a lot, this past year.

        But during the past sixteen years, I was writing Pride’s Children, about, among others, a ME/CFS main character, and publishing it.

        Fiction is MY contribution. I just wish it weren’t so hard to get it to the people who might like my writing. I am very bad at marketing – OR it is a difficult subject to market. I’m hoping it’s the latter: I’ve done a lot of things for it, the people who love the book write wonderful reviews, but it hasn’t taken off yet.

        I want the whole world to know, in the gut, how it FEELS to have CFS, to live with it, to have it overshadow every decision you make, including personal happiness.

        To know you can’t count on yourself. To want – and tell yourself you shouldn’t.

        Fiction is the only way you can do that.

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  3. Thank you for clearly listing the reasons that have made you choose to sign the Omega petition. I found it very helpful.

    May I ask how you have concluded that this study will include mental health questionnaires? Is it from the information in the MEGA Q and A post on the MEGA petition site that says:

    “We will collect symptom data on all patients to allow us to identify which patients will be identified as having CFS/ME using different diagnoses. We will also include data on fatigue, disability, anxiety and depression. We would like to collect detailed data on pain. How much data we collect will depend on what our patient advisory group says will be acceptable to consenting patients and how much funding we get.” Thank you

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    • Hi Annie, I’m glad you found it useful. Yes, the bit you quoted is the bit I read which led to my conclusion that they’ll be running questionnaires on mental health issues. I probably should have expanded that to include fatigue, disability and pain also because a lot of the questionnaires that are commonly used to collect such data in CFS studies have flaws that mean that data is not necessarily accurate. My guess is that the ones they will use are the ones that Crawley and co say they should use But a lot of them are unsuitable, or have limitations meaning they should not be used to reach certain conclusions. One of Crawley’s recent studies shows such a situation, which someone else commented on already, so it is a very real problem – only this will be on a scale we have not before due to the mega size of this study.

      Liked by 1 person

      • Thank you for your helpful reply and expanding more on how mental health questionnaires could be used to distort the study’s stated primary aim of being an omics study, and if wrongly applied as has been done in past research on ME/CFS by EC garner skewed results which will reverberate negatively for years. As you said, the stakes are high.

        Liked by 2 people

  4. A very well written blog post which covers the issues well. Thanks.

    I see MEGA as a product I am being asked to buy. The product has a pretty wrapping but on closer investigation very little substance, only offering the possible hope of something tangible to me many years downstream. Its principal benefits seem in the interim to be wholly for the product manufacturer, by providing them with good forseeable employment and income.

    Couple this with major concerns about past experiences with some of the major players in the Company and their past highly questionable business dealings and I too conclude that this is a product I cannot buy. The product and the company need a major overhaul to persuade me otherwise.

    There are much better products elsewhere that I would choose.

    I have signed OMEGA.

    Liked by 1 person

  5. I have signed the petition because of the way they say they are going to recruit participants from clinics. These are the least likely to have ME as anyone knowledgeable avoids them at all costs. Many of us would be willing to volunteer to give samples for genuine research. It would not add significantly to the cost and would make the results relevant. The 25% group, the ME association, even Phoenix Rising are all easy to find so getting in touch with a range of patients would not be difficult.

    Liked by 1 person

  6. I’m signing neither petition but this isn’t the same as passively allowing events to unfold. I intend to write a more detailed letter (contents still forming in my mind) as neither petition adequately sums up my position on this. If the study goes ahead as proposed, I won’t be taking part (well I won’t be recruited anyway). I agree with your concerns and have extra of my own. This is proposed research though, the design can change. I’m also concerned about alienating decent researchers and losing mega biomedical money. Unless I’m missing something, turning down this research doesn’t mean that money will go to a project we like.

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    • I think that’s great if you write a letter. The opposition petition is not how I would have worded things perhaps, but I decided there was nothing there that meant I couldn’t sign it. I understand others may not feel the same though and so may take a different action. I think it is good for people to try and decide one way or the other, but it’s also an energy thing – many patients just won’t have the energy to look at both sides of the debate and unless they can I don’t think it’s possible for people to reach a fair decision, so my encouragement for people to try and reach a decision won’t apply to people who aren’t up to it.

      Liked by 1 person

  7. Let me explain why I support MEGA, despite sharing some of the misgivings articulated so clearly by Clark.

    I think the characterisation of MEGA as the world’s biggest mental health survey of mecfs patients first, and an omics study second is a bit misleading. It will measure anxiety and depression (as many studies of biomedical diseases do), partly to exclude any cases where anxiety or depression are the primary cause of fatigue (and therefore are not mecfs cases). That’s hardly a comprehensive mental health survey, and it’s only a fraction of the planned non-omics data collection (symptoms (extensive), disability, other illnesses, BMI, weight etc).

    By contrast, the study will be collecting a warehouse full of omics data on genomics (gene variants), epigenetics, gene expression, metabolites (as in the recent Naviaux study) and proteins. This includes the kind of things that biomedical researchers are looking at all the time: MEGA will do it on a scale never seen before; genomics and epitgenetics have never been done on a big enough scale to generage meaningful results). Amongst other things that will give it the power to detect sub-groups, with different underlying biological mechanisms and different potential treatment targets. The large size will also generate much more reliable results – small sample sizes have been a consistent problem in mecfs research (not least because of the lack of funding).

    In any event, many studies have looked at mental health issues in mecfs and found nothing that explains the illness. The whole psychosocial approach was tested definitely by PACE, and found not to work. I don’t think a bigger dataset is going to make any difference to mental health findings.

    I would not choose psychosocial researchers to play a key role in this study, but I’m pretty sure the choice is with them, or not at all. Most of the researchers are biomedical researchers. Mecfs in the UK has struggled to attract new biomedical talent to look at the illness – not it’s finally arrived I don’t want to put it off. They didn’t come before MEGA, if MEGA folds after patient objections, I think they are even less likely to come afterwards.

    So while I understand why many patients have reservations about this study, I still want it to go ahead, and fear that if it folds it will harm the prospects for UK biomedical research.

    Liked by 1 person

    • Thanks for your great comments Simon. It sounds reasonable enough if they are measuring anxiety and depression partly to exclude any cases where those features are primary causes of fatigue, but are you sure that is what it’s for? If this is an ME/CFS study then primary anxiety and depression would have already been excluded at the CFS clinics where patients are recruited from before they are given a diagnosis of CFS/ME. But I am still unclear if this is supposed to be an ME/CFS study or a fatigue study which includes ME/CFS. If it is the former then I guess they’d be taking people with fatigue as a result of mental health problems also in which case it would be more logical. If that is the case then so long as enough true ME/CFS patients were included as a well defined subset of the study I would not necessarily have a problem with that. I saw that one or two asked Charles Shepherd about this on Phoenix Rising forum but I didn’t see a clear answer.

      Liked by 1 person

      • ” It sounds reasonable enough if they are measuring anxiety and depression partly to exclude any cases where those features are primary causes of fatigue, but are you sure that is what it’s for?”

        >Yes, I;m sure that’s one of the reasons: new cases referred to clinics will be diagnosed for MEGA with information captured at that point. I suspect they will analyse depression and anxiety data in it’s own right, but whether it finds anything new is another matter: even Simon Wessely disowned his depression theory of CFS years ago.

        “But I am still unclear if this is supposed to be an ME/CFS study or a fatigue study which includes ME/CFS”

        >It’s purpose is to understand the cause(s) of mecfs.

        “. If that is the case then so long as enough true ME/CFS patients were included as a well defined subset of the study I would not necessarily have a problem with that. ”
        >To what extent it’s useful to look more widely eg to identify boundaries, is another matter. Yes, or assuming the goal if to understand mecfs, I think the non-mecfs cases should be the smaller defined subset. Eg if you want to find a biological basis of PEM, it would help to have similar non-PEM cases for comparison. (personally, I’d want to set a target eg 10% broader cases for comparison, but no one’s asking me so that will have no impact :))

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  8. Just to clarify: I don’t think MEGA have yet nailed down either the exact case definition to use, or the logic on how to sample and the value of non-samples (though at the CMRC confference the discussion was about the value of broad criteria, collecting the data to allow definition according to tighter criteria too). I think MEGA need to sort this out, and do so in discussion with patients, because what they’ve presented publicly to date doesn’t seem properly thought through, to me.

    Liked by 1 person

  9. Why have the organisers of this study not learned their lesson about the importance of trust of the patient community?

    They still seem set in their old ways, giving power to the most politically problematic researchers. Why we ask?

    Liked by 1 person

    • I think that distills it nicely. The problems come down to patients like me having no trust in certain individuals and organizations who are involved. And this is a very large study that I am being asked to endorse. I’m registered at an NHS CFS clinic so I may be asked to take part in the study. The results will effect me. Patients are not research subjects they are real people and they have to be able to trust those involved in the research. For such a massive study as this, 12,000 people, which is a large portion of those registered at NHS CFS clinics, the study should have foreseen there had already been a breakdown of trust that would disable a lot of the potential support.

      Liked by 1 person

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