MEGA Questions and Answers: Latest Petition update

[JoanDublin]

Yes its an interpretation I agree, but it doesn't specifically say " by any researcher". I wonder why not ?
Who is a researcher ?
Why not make it completely open data available for all - like the OMF Big Data Study.

Good points. You always have to read their words extra carefully

 

[BurnA]

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

Thanks for the update.

It's also worth noting that few, if any, people here, don't support the aims of the trial. And if certain conditions were met we would probably all support this trial so I don't think your members are any different to the general PR members.

It's hard to know what internet discussions you are referring to but in my opinion everyone here gets listened to.

Maybe there is a reason some people are very vocal. One thing that often saddens me is looking back at old threads about the PACE trial where people were raising very valid concerns but nobody listened to them.
Now many years later, their voice is beginning to be heard, thanks to the work of David Tuller and others. It turns out those voices were correct all the time, they spoke up despite being called a vocal minority by the very people who were entrusted to research the disease which was destroying their lives.

I respect people who speak up, it's not easy and it means putting yourself out there for all to criticise.
Please don't try to silence those voices, one day you or your members might appreciate them.

 

[snowathlete]

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.

Agree with the sentiment, but the reference about Afganistan came from Wessely and he's not (so far as we know) involved in MEGA. I think it's important not be careful not to misattribute quotes because otherwise concerns are easily dismissed and those we are raising concerns about have said some shocking stuff, and it's important to quote what they actually did say, if providing an example of why patients won't accept them being involved.

 

[Barry53]

Except the problem is not the involvement of psychiatrists, but the involvement of specific psychiatrists associated with discredited, probably dangerous, and possibly fraudulent research into ME/CFS.

Agreed. I think the idea of multi-disciplinary teams is sound, provided the clinical trial is designed and run properly - with integrity, open mindedness, honesty, competence, "safety engineering", etc, etc. If the trial manages to discover the underlying biology of ME/CFS, nobody could then accuse the trial of skewing the outcome in favour of a physiological cause. If all the team members are genuine, dedicated professionals, then discovering the truth will be their measure of success, not whether the results reside on their patch or not.

 

[daisybell]

I may be wrong but I expect that the NICE criteria are being used because this is a UK study - diagnosis made in a clinic in the U.K. would need to be done in accordance with NICE. So this is a box that must be ticked. Further stratification of patients is the essential bit.

My only big concern at this stage in the process is the inclusion of Crawley. I don't see any evidence of her changing her views or of ever thinking that patients might know something she doesn't which she should listen to. She has been responsible for a great deal of harm and I couldn't sign support unless she was gone.

Otherwise, although obviously there are other details to be ironed out - the overall idea looks promising to me....

 

[Wildcat]

.
Diagnosing according to NICE is one of the main problems. NICE criteria is so broad and vague that it cannot be seen to distinguish ME from fatigue

Even the Director of the Centre for Clinical Practice at NICE (Professor Baker) recently admitted the NICE Guideline for ME should be put out to grass.

.

 

[A.B.]

NICE guidelines

Cognitive behavioural therapy (CBT) and/or graded exercise therapy (GET) should be offered to people with mild or moderate CFS/ME and provided to those who choose these approaches, because currently these are the interventions for which there is the clearest research evidence of benefit.

Presumably this means no referral to NHS clinics for severely ill patients, or those patients who do not think that CBT and GET make any sense. Further evidence that recruiting from NHS clinics is going to result in a biased sample.

 

[daisybell]

NICE guidelines


Presumably this means no referral to NHS clinics for severely ill patients, or those patients who do not think that CBT and GET make any sense. Further evidence that recruiting from NHS clinics is going to result in a biased sample.

The problem is - how are you going to recruit at all otherwise?
Recruitment has to be made as easy as possible in order to get the numbers in a timely manner. Sure, there will probably be people diagnosed who have some fatiguing illness - but the stratification using tighter criteria e.g. ICC, should deal with that. GPs aren't an easy starting point because you have to contact so many, and they are unlikely to feel confident in diagnosis, so I don't see that there is another option but to use the NHS clinics.

 

[charles shepherd]

I may be wrong but I expect that the NICE criteria are being used because this is a UK study - diagnosis made in a clinic in the U.K. would need to be done in accordance with NICE. So this is a box that must be ticked. Further stratification of patients is the essential bit.

My only big concern at this stage in the process is the inclusion of Crawley. I don't see any evidence of her changing her views or of ever thinking that patients might know something she doesn't which she should listen to. She has been responsible for a great deal of harm and I couldn't sign support unless she was gone.

Otherwise, although obviously there are other details to be ironed out - the overall idea looks promising to me....

Yes, all the ME/CFS clinics here in the UK use what might be described as the NICE diagnostic criteria/guidance - which is obviously looser than Fukuda or Canadian but not as bad as discredited Oxford

The ME/CFS Biobank recruits blood sample donors from the NHS clinics but we also carry out our own (far more detailed) clinical assessment and only recruit patients who meet Fukuda and Canadian criteria

As I keep saying, one of the aims of this research is to sub-group all those patients that come under the NICE ME/CFS umbrella and from the Q and A it appears that that we should know who meets Fukuda, Canadian and other clinical criteria

I would hope that ME Biobank samples - including those with severe (Fukuda and Canadian) ME/CFS - will be included in this study, possibly in the form of a control group. But this is part of the discussion process that is occurring as the proposal takes shape...

 

[TiredSam]

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.

Maybe the hope is that by being part of this study, the NICE guidelines and Esther Crawley can gain some credibility?

 

[charles shepherd]

NICE guidelines


Presumably this means no referral to NHS clinics for severely ill patients, or those patients who do not think that CBT and GET make any sense. Further evidence that recruiting from NHS clinics is going to result in a biased sample.

People with severe ME/CFS can be referred to the ME/CFS clinics if they are able to travel to the OPD or the service has a domiciliary service (home visiting) attached - but very few do.

In practice, there are very few people with severe ME/CFS being seen at hospital based referral services here in the UK.

 

[charles shepherd]

Maybe the hope is that by being part of this study, the NICE guidelines and Esther Crawley can gain some credibility?

More likely the complete opposite if the study achieves what it is aiming to do - i.e. identify a number of clinical and pathological subgroups under the NICE ME/CFS umbrella

If this is achieved, the NICE 'one size fits all' treatment plan (i.e. CBT and GET for everyone) is obviously flawed - as we keep telling NICE!

 

[Sleepyblondie]

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

 

[Sleepyblondie]

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

 

[Sleepyblondie]

if ME Ass strongly supports this project then it is quite possible that many members will be influenced to accept it unless we share alternative viewpoints,

If they just read the ME Ass plea to support the project, then I suspect any poll will be a little skewed, so it's vital that we alert people to,the background to the researchers and the lack of sound methodology, and that this proposal does not include ICC

I see CS says most dissenters are not members, but I don't see how Facebook ID can be accurately matched against membership lists

 

[BurnA]

More likely the complete opposite if the study achieves what it is aiming to do - i.e. identify a number of clinical and pathological subgroups under the NICE ME/CFS umbrella

If this is achieved, the NICE 'one size fits all' treatment plan (i.e. CBT and GET for everyone) is obviously flawed - as we keep telling NICE!

One might wonder if they throw the net wide enough they are bound to find some patients that fit into the CBT / GET category.
Besides why would they need to collect data on depression and anxiety?

 

[TiredSam]

When an invitation appears on PR to take an MEA poll, no-one checks who is an MEA member and who isn't, and the validity of the poll isn't called into question because a lot of non-members may have answered it, it is simply taken on trust that people who respond are interested and concerned ME sufferers. Who else would respond? Nobody talks about a note or caution or calls one section of the responders vocal or talks about respondents being members or not of MEA.

I don't see why the same trust can't be extended to those who are expressing their views on facebook.

 

[charles shepherd]

if ME Ass strongly supports this project then it is quite possible that many members will be influenced to accept it unless we share alternative viewpoints,

If they just read the ME Ass plea to support the project, then I suspect any poll will be a little skewed, so it's vital that we alert people to,the background to the researchers and the lack of sound methodology, and that this proposal does not include ICC

I see CS says most dissenters are not members, but I don't see how Facebook ID can be accurately matched against membership lists

I am going on the basis that most people on Facebook use their real names

As I said, the MEA office has not yet received any emails or phone calls about the MEGA study from our members

But I have just had one email from a PR MEA member expressing concerns!

At this point, because the protocol is still being prepared, I will be asking MEA members to consider the pros and cons and pass on their comments

We might then have a vote when the protocol is finalised

 

[charles shepherd]

When an invitation appears on PR to take an MEA poll, no-one checks who is an MEA member and who isn't, and the validity of the poll isn't called into question because a lot of non-members may have answered it, it is simply taken on trust that people who respond are interested and concerned ME sufferers. Who else would respond? Nobody talks about a note or caution or calls one section of the responders vocal or talks about respondents being members or not of MEA.

I don't see why the same trust can't be extended to those who are expressing their views on facebook.

The MEA monthly poll is open to anyone in the UK who wants to respond

We are not concerned about membership of the MEA in relation to the monthly poll

Where appropriate, the polls are also open to anyone in the world who wants to vote - this applies to the September poll on PoTS

A lot of our members do not even vote because they are not on the internet

 

[charles shepherd]

One might wonder if they throw the net wide enough they are bound to find some patients that fit into the CBT / GET category.
Besides why would they need to collect data on depression and anxiety?

It will be important to collect data on people with ME/CFS who also have some form of mental health/psychiatric co-morbidity (e.g. depression or anxiety) to see if there are any biomarkers, or a group of biomarkers, that differentiate people with ME/CFS with no psychiatric co-morbdity from those who do

I assume you do accept that people with ME/CFS do sometimes develop clinical depression - because it does happen