ME/CFS ≠ CFS/ME, @AndyPR . Surely you know that! 
MEGA Questions and Answers: Latest Petition update
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I think this is a step change in the UK.
It would be unethical, if not illegal, to share data without consent, especially when it includes things like DNA profiles which are very personal. I would consent to having my data shared, but I'd want the choice.
The researcher limitation doesn't bother me. I'm not sure if that's a common feature of open data, or what OMF are doing. But going back to the example of PACE, a major problem was that the authors would not share the data with any researcher who wanted it, only ones they felt comfortable. Which is no way to do science.
This committment to share data with any researchers that want it, to speed up understanding of the biology, looks good to me - and I don't think it's been done in the UK yet. I suspect it also represents the influence of the omicists joinging MEGA - open data is common in many omics fields.
And the world's largest bioresource of data and samples? Sounds good to me too.
It would be unethical, if not illegal, to share data without consent, especially when it includes things like DNA profiles which are very personal. I would consent to having my data shared, but I'd want the choice.
The researcher limitation doesn't bother me. I'm not sure if that's a common feature of open data, or what OMF are doing. But going back to the example of PACE, a major problem was that the authors would not share the data with any researcher who wanted it, only ones they felt comfortable. Which is no way to do science.
This committment to share data with any researchers that want it, to speed up understanding of the biology, looks good to me - and I don't think it's been done in the UK yet. I suspect it also represents the influence of the omicists joinging MEGA - open data is common in many omics fields.
And the world's largest bioresource of data and samples? Sounds good to me too.
My understanding, and I could be wrong, is that the London School of Tropical Med biobank contains both patients who meet CCC and Fukuda patients who do not meet CCC. But they use different names for the two groups so you can tell which is which. This is important because its separating the two groups right up front based on hallmarks like PEM. Maybe someone else who is more familiar with that effort can provide more information on what they do.
As AndyPR posted, the response said
It sounds like the approach taken in PACE - first select with an overly broad definition and then characterize with other definitions. But as David Tuller said in his 2015 article about PACE:
I appreciate the value of a large cohort but a cohort of what? I am struggling to see how a big cohort will compensate for poorly characterized and selected patient cohorts. This sounds like it is essentially a cohort of medically unexplained fatigue. Will the man-made heterogeneity of such a cohort confound interpretation even with the big-data, genomics approach being taken?
Leaving aside the problem that Levin notes for the moment I'd want to know:
As AndyPR posted, the response said
It sounds like the approach taken in PACE - first select with an overly broad definition and then characterize with other definitions. But as David Tuller said in his 2015 article about PACE:
Bruce Levin, the Columbia University biostatistician, said the PACE investigators should not have assumed that the experience of a subgroup within an already defined population would match the experience of a group that hadn’t been pre-screened. “I would not accept an extrapolation to people diagnosed with alternative criteria from a subgroup comprising people satisfying both sets of criteria rather than just the alternative set of criteria,” he said, adding that reviewers should catch such questionable assumptions before publication.
Maybe I am wrong but it sounds like they are stepping into the same problem again.I appreciate the value of a large cohort but a cohort of what? I am struggling to see how a big cohort will compensate for poorly characterized and selected patient cohorts. This sounds like it is essentially a cohort of medically unexplained fatigue. Will the man-made heterogeneity of such a cohort confound interpretation even with the big-data, genomics approach being taken?
Leaving aside the problem that Levin notes for the moment I'd want to know:
- what specific definitions and how they are being applied including what inclusion and what exclusion criteria. PACE claimed to characterize patients according to Fukuda but they only required symptoms to be present for 1 week and even their own publications acknowledged that that change could have resulted in diagnostic inaccuracy. Will they apply e.g. CCC's exclusion of all mental illness?
- What specific tools and methods they are using to qualify patients as having the hallmark criteria of ME, particularly PEM. Jason's written lots on the problems with identifying these symptoms depending on how the questions are asked and whether a certain level of severity and frequency is required
I am not suggesting that they do anything illegal to satisfy my desire for freedom of data. It, in the main, is the vagueness of the words that they use here. Why can they not just say that every patient involved would have to agree to data sharing at sign up? It may be what they intend to say but it's not what they actually say.
And the same applies to researcher, it is the vagueness of the term. As you acknowledge, the PACE definition of researcher was extremely limited. So who will count as a researcher and who wont for this study? As we know that the only way we have got to the truth with PACE is by having a patient relentlessly pursue the data - would Alem Mathees count as a 'researcher' here? (Rhetorical, I know you don't know that answer).
And the same applies to researcher, it is the vagueness of the term. As you acknowledge, the PACE definition of researcher was extremely limited. So who will count as a researcher and who wont for this study? As we know that the only way we have got to the truth with PACE is by having a patient relentlessly pursue the data - would Alem Mathees count as a 'researcher' here? (Rhetorical, I know you don't know that answer).
Fantastic point!
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This fairly short Q and A from those involved in the MEGA study has come back very quickly - presumably in response to the email to Prof Stephen Holgate from Andy that was sent out only yesterday
I don't know if those of you on PR who were in the process of preparing a more detailed letter that outlined all the key concerns, criticisms and questions that need answering got round to finalising it for dispatch
If not, my suggestion would be to follow this Q and A up with a response that outlines where you feel that the Q and A has not dealt with your concerns and criticisms, along with any other questions that still need answering
As far as public opinion and the MEA is concerned, I think we now need to consult our membership (through our magazine as well as the internet) to see what they feel about this trial - which will have to be on the basis of where we are now, or where we are in two weeks time
The next issue of the MEA magazine goes out in early November - which is important because a significant proportion of our members do not use the internet
Whilst it is interesting to read the comments (most of them negative) about MEGA on MEA Facebook, the very negative (and often repeated) ones are often from people who are not members of the MEA and, as often happens in this type of situation, there are people are being asked to join in and express negative opinions on MEA Facebook who do not normally contribute to our social media pages
So the view being expressed on our Facebook page has to carry a note of caution - it may not be representative of overall public opinion on this issue
In addition, there are other people out there who would support this trial - provided certain conditions were met - but they will not join in internet discussions when they feel that their views are not going to be listened t,o or are going to be opposed by a very vocal group
It is also worth noting that we have not had a single MEA member contacting the MEA office, or writing to me at the MEA, to say that they do not support the aims of the MEGA trial
I don't know if those of you on PR who were in the process of preparing a more detailed letter that outlined all the key concerns, criticisms and questions that need answering got round to finalising it for dispatch
If not, my suggestion would be to follow this Q and A up with a response that outlines where you feel that the Q and A has not dealt with your concerns and criticisms, along with any other questions that still need answering
As far as public opinion and the MEA is concerned, I think we now need to consult our membership (through our magazine as well as the internet) to see what they feel about this trial - which will have to be on the basis of where we are now, or where we are in two weeks time
The next issue of the MEA magazine goes out in early November - which is important because a significant proportion of our members do not use the internet
Whilst it is interesting to read the comments (most of them negative) about MEGA on MEA Facebook, the very negative (and often repeated) ones are often from people who are not members of the MEA and, as often happens in this type of situation, there are people are being asked to join in and express negative opinions on MEA Facebook who do not normally contribute to our social media pages
So the view being expressed on our Facebook page has to carry a note of caution - it may not be representative of overall public opinion on this issue
In addition, there are other people out there who would support this trial - provided certain conditions were met - but they will not join in internet discussions when they feel that their views are not going to be listened t,o or are going to be opposed by a very vocal group
It is also worth noting that we have not had a single MEA member contacting the MEA office, or writing to me at the MEA, to say that they do not support the aims of the MEGA trial
I think the norm is not to make data sharing mandatory, but to give every patient an opt out. I'd be unhappy if patients had to agree to open data to be accepted (while I'd hope they'd all agree) - ultimately I think this has to be patient choice. And AFAIK, MEGA are not proposing anything unusual here.
Because patients have rights: the right to share and the right not to share (I hope they all will) but of course the data can still be used by the main MEGA omics study. I don't know what opt-out figures are but suspect it's pretty low.
I didn't say their definition was vague - the were clear on what a researcher was, but only wanted to share with friendly ones. The MEGA statement commits them to sharing with any researcher.
With data freely available to any researcher we wouldn't have had to wait so long, and Alem would not have had to go to such ridiculous lengths, to get the data. The recovery paper came out in 2013 and was criticised immediately - imagine the difference if any researcher could have accessed the data and done the analysis according to protocol straight after the recovery paper came out.
If data can safely be shared with allcomers (and I suspect DNA data is a particular issue) then so much the better from my perspective.
Overall, though, I think this is a very welcome and positive step - and way more than most mecfs studies offer.
Because patients have rights: the right to share and the right not to share (I hope they all will) but of course the data can still be used by the main MEGA omics study. I don't know what opt-out figures are but suspect it's pretty low.
I didn't say their definition was vague - the were clear on what a researcher was, but only wanted to share with friendly ones. The MEGA statement commits them to sharing with any researcher.
With data freely available to any researcher we wouldn't have had to wait so long, and Alem would not have had to go to such ridiculous lengths, to get the data. The recovery paper came out in 2013 and was criticised immediately - imagine the difference if any researcher could have accessed the data and done the analysis according to protocol straight after the recovery paper came out.
If data can safely be shared with allcomers (and I suspect DNA data is a particular issue) then so much the better from my perspective.
Overall, though, I think this is a very welcome and positive step - and way more than most mecfs studies offer.
More reasons they should not be using the NICE guidelines: 1) they are out of date and due for review anyway, 2) They are propped up by the fraudulent and completely discredited PACE study and 3) no other serious researchers internationally use these guidelines (" Our aim is to create a resource that all researchers all over the world can use.")
I would have though that any one of these points should give the proper scientists pause for thought before going ahead with using NICE as their selection criteria. The study instantly loses credibilty if they do.
"Patients with CFS/ME will be identified by clinicians in the NHS clinics."
Again, this is concerning and worries me that the scientists that are newly on board this study do not really understand the disease. There is a huge amount of VITAL information that they will miss if they exclude the severe and long-terms - who are long gone from or never saw sight of an NHS clinic. I worry that Crawley and friends are leading the rest of them up the garden path on this, and the inclusion of these very important patients is a point we should be asking for as a priority.
I would have though that any one of these points should give the proper scientists pause for thought before going ahead with using NICE as their selection criteria. The study instantly loses credibilty if they do.
"Patients with CFS/ME will be identified by clinicians in the NHS clinics."
Again, this is concerning and worries me that the scientists that are newly on board this study do not really understand the disease. There is a huge amount of VITAL information that they will miss if they exclude the severe and long-terms - who are long gone from or never saw sight of an NHS clinic. I worry that Crawley and friends are leading the rest of them up the garden path on this, and the inclusion of these very important patients is a point we should be asking for as a priority.
As MEGA are now talking about a biorepository,, which sounds a lot like a biobank to me, I'd hope the would consult with the UK mecfs biobank on how to go about this. But the mecfs biobank, like MEGA, draws from NHS clinics (I didnt spot anyone complaining about that, but maybe I missed it) and MEGA will define patients according to multiple criteria. All biobank samples meet Fukuda and most meet Canadian; for MEGA all will meet NICE (I'm not sure which is 'better' between Fukuda and NICE, neither are ideal in my book) and will also diagnose according to other criteria..
So ultimately they will be very similar - as I understand from the Q&A, researchers could pull out a sample of CCC-only patients from both.
Worth mentioning that the uk biobank selected on Fukuda, but most of those still met Canadian. I think Lenny Jason has done a similar study finding the same. So I don't think there's any good evidence that using looser criteria (Fukuda or NICE) will exclude patients with a tighter criteria such as Canadian.
Yes, we need more detail. Eg willl they use Lenny Jason's DePaul symptom questionnaire to diagnose Canadian, as several groups do. The biobank used its own unpublished questionnaire to categorise patients as meeting Canadian criteria (that's not ideal either - but then many of the issues raised about MEGA apply to many other studies).
As for PEM, I think that's a very important question. Jason has done some of the best work on this, but I'm not totally convinced by his questionnaire: his analysis concludes that the single best q for defining PEM is "a dead heavy feeling in the muscles". I wonder how many people here would agree with that.
So I think these are all important issues, and we need to know how MEGA are doing this - but I'm not sure there are lots of perfect solutions out there already.
So ultimately they will be very similar - as I understand from the Q&A, researchers could pull out a sample of CCC-only patients from both.
Worth mentioning that the uk biobank selected on Fukuda, but most of those still met Canadian. I think Lenny Jason has done a similar study finding the same. So I don't think there's any good evidence that using looser criteria (Fukuda or NICE) will exclude patients with a tighter criteria such as Canadian.
Yes, we need more detail. Eg willl they use Lenny Jason's DePaul symptom questionnaire to diagnose Canadian, as several groups do. The biobank used its own unpublished questionnaire to categorise patients as meeting Canadian criteria (that's not ideal either - but then many of the issues raised about MEGA apply to many other studies).
As for PEM, I think that's a very important question. Jason has done some of the best work on this, but I'm not totally convinced by his questionnaire: his analysis concludes that the single best q for defining PEM is "a dead heavy feeling in the muscles". I wonder how many people here would agree with that.
So I think these are all important issues, and we need to know how MEGA are doing this - but I'm not sure there are lots of perfect solutions out there already.
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@charles shepherd
you wrote: "In addition, there are other people out there who would support this trial - provided certain conditions were met - but they will not join in internet discussions when they feel that their views are not going to be listened t,o or are going to be opposed by a very vocal group"
How do you know there are other people out there who would support the MEGA Trial but dare not say so on the internet due to some mythical "vocal group" ? ....
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Please don't characterise the many who have valid concerns about this study, and who make their points cogently, as some minority 'vocal group'.... We have heard that phrase used before, but always in the context of negatively mis-characterising informed patients. The claim that only a minority vocal group opposed PACE was proved to be unfounded.
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@charles shepherd
you wrote: "In addition, there are other people out there who would support this trial - provided certain conditions were met - but they will not join in internet discussions when they feel that their views are not going to be listened t,o or are going to be opposed by a very vocal group"
How do you know there are other people out there who would support the MEGA Trial but dare not say so on the internet due to some mythical "vocal group" ? ....
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Please don't characterise the many who have valid concerns about this study, and who make their points cogently, as some minority 'vocal group'.... We have heard that phrase used before, but always in the context of negatively mis-characterising informed patients. The claim that only a minority vocal group opposed PACE was proved to be unfounded.
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Reads that way to me:
There's no way that we should be green lighting this study. How can 2 people who spread lies about the community and got cought doing so be allowed to be involved. It's crazy. These people told the press that they felt safer in Afghanistan than in the U.K. because of death threats. Regardless of how shitty pace is, this fact alone disqualifies them from any other study that wants to be a legitimate study on me/cfs. How the mega group doesn't see this is concerning to say the least.
I am not sure about the logic of this. All sorts of conditions have to be satisfied before people are selected to take part in the trial. Does this mean that people who it is thought should be excluded on other grounds also have the right to participate, whether researchers want it or not,.or do people who do not wish anonymised data to be shared have a greater set of rights?
Edit. @Simon On reflection I can see why your point would be valid with reference to a treatment trial, in which it would be improper to withhold treatment. However I still see no reason why someone who refused consent to anonymised data being shared should be permitted to insist on wasting everybody's time and effort when the sole purpose of the research trial is to collect data with a view to sharing it.
Edit. @Simon On reflection I can see why your point would be valid with reference to a treatment trial, in which it would be improper to withhold treatment. However I still see no reason why someone who refused consent to anonymised data being shared should be permitted to insist on wasting everybody's time and effort when the sole purpose of the research trial is to collect data with a view to sharing it.
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