New MEGA study website (30 November 2016)

[docsimsim]

Presumably that's why The 25% M.E. Group, The Young ME Sufferers Trust and Invest in ME Research decided to stay out of the CMRC from the start. I thought they were right then and so nothing surprises me coming from the CMRC and I'd not have bothered about MEGA if they hadn't posted that dreadful petition. The petition was a patient-relations mistake but, like any political party, they just plough on regardless.

On the same theme that for medical doctors they make good politicians, perhaps keeping Charles Shepherd in the dark was to save him any embarrassment that may be caused by contradicting Stephen Holgate's opinion of FITNET, as Charles' comments always suggest to me that he holds Stephen Holgate in high regard.

ETA - also, to be fair, it would have been better for another (or two other) non-CMRC representative to have been interviewed alongside Jane Colby (as there was Stephen Holgate, Esther Crawley, and Mary-Jane Willows representing support for FITNET).

As far as I know, the SMC have a mailing list and have refused to add the medical advisor of our main national medical charity namely Dr shepherd to the list, this shows the extent of their corruption. For instance Jane Colby of the TYMES trust was not even briefed when asked to appear on BBC 2's Victoria Derbershire programme, where a fully rehearsed Crawley and Mary J willows were present to plug FITNET. Jane Colby went into the studio not being aware the interview was about FITNET! Is she had known, she'd have been prepared to explain that the Dutch study on which FITNET was based failed to show any benefits at 6 month follow up. They should be called the anti science centre.

 

[docsimsim]

PACE TEAM: jeez that was close, I think we got away with it.

PACE SUPPORTERS: don't be so sure, what if they find out that ME/CFS really is biological? And NICE is reviewing next year too.

PACE TEAM: yikes, we need to delay that. And what can we do about them finding out ME/CFS is biological?

PACE SUPPORTERS: why not set up a biobank of sleepy people, make them dig around for a needle in a haystack trying to find a common denominator.

PACE TEAM: yes! And if we drag our heels about it, we can force NICE to delay their review too.

ALL: perfect!

Yep a nice straight talking easy to follow summation of the situation.

 

[Snowdrop]

Having previously worked in both primary care (general practice) and various specialities in hospital medicine (including psychiatry) I know that chronic fatigue is an extremely common symptom in the general population.

Chronic fatigue can be a key symptom in both existing physical and psychological/psychiatric illnesses as well as resulting from a combination of less well defined physical, psychological and social components.

But in many cases a simple neat cause/explanation for chronic fatigue just cannot be given.

So there are obviously many different causes of chronic fatigue and whilst we can debate, criticise and question the way in which the MEGA study is going to be carried out (which is to be encouraged and should be part of the scientific process), MEGA is not going to be a study that is going to try and sort out clusters involving the huge numbers of patients who have some form of chronic fatigue.

Rightly or wrongly, and this again is being debated, the MEGA study is going to be looking at a much smaller but still very heterogenous group of patients who meet one of the 20+ clinical or research definitions of ME, CFS or ME/CFS - Canadian, Fukuda, IoM, International Consensus, Ramsay ME, London ME, NICE etc - where there is no general agreement as to which is the most accurate or helpful and where we do not have any consistent and robust associations between symptoms and pathological abnormalities.

In other words, a situation which is very messy to say the least.

The prime intention of MEGA (and I am again open to opinions as to whether this is the most effective way of doing this) is to investigate a large group of patients that meet with one of more of these definitions of ME, CFS, ME/CFS to see (as is the case in asthma and a growing number of other conditions) whether there are symptoms and/or abnormalities as identified by the new technologies that will be used (genomics, epigenomics, metabolomics, proteomics etc) that form clusters that could then help with both sub-grouping under the ME/CFS umbrella, as well as helping us to move away from the dreadful 'one size fits all' approach to management with CBT and GET for everyone who comes under the ME/CFS umbrella that is applied by NICE in particular here in the UK.

This is why I am willing to support the AIMS of the MEGA study, am willing to take part in the discussions on how the study will be designed, and at the same time listen to critical and opposing views from both people with ME/CFS and researchers such as Jonathan.

At the conclusion of this process the MEA will again be consulting with its members.

We will then be making a decision as to whether the charity is going to support a research grant proposal for the protocol that has been decided.

The MEGA study is also on the Agenda for a meeting of the ME Biobank Steering Group (which I chair) on Wednesday next week - which will give us an opportunity to discuss this particular aspect of the MEGA study.

My reading of this suggests that MEGA is not then really a study of ME at all.

A lot of disingenuous talk about how ME can't properly be identified--although it seems that the US researchers don't seem to have the same level of difficulty identifying those who probably have ME as patients understand it. It also explains why the initial intent was to not include the severely affected as they may in fact be the most likely to represent ME proper.

The study is looking for a cohort that eliminates people with ME IMO so that EC can carry on promoting her treatment on the rest of people with chronic fatigue who as yet have no illness identified.

 

[Hip]

Other than a fresh look, the main feature of this website appears to be the impossibility to post public comments. Unlike on this project's page on petition.org, no one can see that the patient community has a number of concerns and reservations about this.

I remember around 15 years ago, as the Internet was just taking off, an Israeli company devised a product that would allow you to comment on any website, whether that website had a comments section or not.

It was just a bit of software you downloaded onto your computer, something like a browser extension, and this then added the facility to post comments on any page on any website, which would then be readable by anyone else who had the same software installed.

Such a brilliant idea, I thought at the time; but this idea seems to have completely disappeared. I am not sure why, as it would be very useful.

 

[Jo Best]

I was just reading this from 2001, am only about half-way through, and have to log off now for the night, but what a lot of deja vu - http://www.margaretwilliams.me/2001/concepts-of-accountability_montague-and-hooper_25aug2001.pdf

 

[Jo Best]

They should be called the anti science centre.

Another good reason to have seen the writing on the wall when CMRC was formed in 2013.
I expect you've seen this 2013 review of the first three years of the mental health research function at the SMC -
http://www.sciencemediacentre.org/w...arch-function-at-the-Science-Media-Centre.pdf

 

[Snow Leopard]

So there are obviously many different causes of chronic fatigue and whilst we can debate, criticise and question the way in which the MEGA study is going to be carried out (which is to be encouraged and should be part of the scientific process), MEGA is not going to be a study that is going to try and sort out clusters involving the huge numbers of patients who have some form of chronic fatigue.

Rightly or wrongly, and this again is being debated, the MEGA study is going to be looking at a much smaller but still very heterogenous group of patients who meet one of the 20+ clinical or research definitions of ME, CFS or ME/CFS - Canadian, Fukuda, IoM, International Consensus, Ramsay ME, London ME, NICE etc - where there is no general agreement as to which is the most accurate or helpful and where we do not have any consistent and robust associations between symptoms and pathological abnormalities.

In other words, a situation which is very messy to say the least.

Generic approaches, lack of specificity and small sample sizes are precisely what plagues existing research. Surely the goal should be to not repeat the mistakes of the past?

 

[Wildcat]

.
@charles shepherd wrote:
'Rightly or wrongly, and this again is being debated, the MEGA study is going to be looking at a much smaller but still very heterogenous group of patients who meet one of the 20+ clinical or research definitions of ME, CFS or ME/CFS - Canadian, Fukuda, IoM, International Consensus, Ramsay ME, London ME, NICE etc - where there is no general agreement as to which is the most accurate or helpful and where we do not have any consistent and robust associations between symptoms and pathological abnormalities.'




Of course there is no general agreement about clinical or research definitions if biopsychosocial researchers are involved (or actually in charge of research), because they are the people responsible for the manufactured 'controversies', and who profit the most from keeping a heterogenous fatigue based model going (Oxford and NICE criteria).


How difficult would it be for well intentioned researchers to agree on using the Canadian or International criteria for the MEGA research. Not difficult at all. But we are yet again being fed a string of excuses about why UK researchers cannot use those criteria for research.

I wonder, @charles shepherd, if you have actually grasped the full breadth and depth of disillusionment within the ME community at this point in relation to MEGA and due to the fact that the continuing CBT/psychosocial research has no sign of stopping .... do you not realise how many patients now think the CMRC and MEGA leaders (whoever they are as we don't know who is on the Planning Group), that Stephen Holgate and Esther Crawley, are taking us for fools.

There is no respect left amongst the ME community for the CMRC .... and clearly rapidly diminishing respect for MEGA, in fact widespread stated opposition to it. Stephen Holgates recent statements do not inspire confidence in him. Esther Crawley's studies, and her recent media antics, have destroyed any possibility of her being an acceptable part of MEGA research.


There is a massive communication breakdown.

We know it, but Stephen Holgate appears not to..

.

 

[charles shepherd]

Generic approaches, lack of specificity and small sample sizes are precisely what plagues existing research. Surely the goal should be to not repeat the mistakes of the past?

I don't think MEGA could be described as having a small size: 10,000 adults and 2'000 children and adolescents !

But do we really need all these people?

 

[charles shepherd]

I was just reading this from 2001, am only about half-way through, and have to log off now for the night, but what a lot of deja vu - http://www.margaretwilliams.me/2001/concepts-of-accountability_montague-and-hooper_25aug2001.pdf

Not sure what this document has to do with the new MEGA website....

Anyway, my mate Duncan Campbell was one of the best (possibly the best) investigative journalists of the past 30 years here in the UK

And it's a great shame that we are no longer producing journalists of his calibre

This is from his website and contains links to some of the health fraud stories that we have worked on together:

http://www.duncancampbell.org/content/new-statesman-1989

And I have no regrets whatsoever about what happened to any of the health fraudsters, including the doctors who were struck off by the GMC, and the chap who was producing dirty probiotics in his kitchen in Brighton, that we exposed

But Duncan's main contribution was in exposing dodgy things that governments were up to and did not want the people to know about.......

So Well Done Duncan Campbell!

DC photo: https://pbs.twimg.com/profile_images/714425543832309761/7A4WflKB.jpg

 

[Wildcat]

.

@charles shepherd wrote about investigative journalist Duncan Campbell:

'This is from his website and contains links to some of the health fraud stories that we have worked on together:
http://www.duncancampbell.org/content/new-statesman-1989 '


~~~~~~~~~~~~


So, can Duncan Campbell write a major exposee of the healthcare and research scandal of the PACE Trial, about the hijacking of ME policy by UK psychiatrists, and about the attendent decades long abuses of sick ME patients, including children, by those enacting a damaging treatment policy (CBT/GET) based on unsubstatiated models but no evidence ?

.

 

[Chrisb]

I don't think MEGA could be described as having a small size: 10,000 adults and 2'000 children and adolescents !

But do we really need all these people?

I do not understand this comment. Can you expand upon it?

The natural interpretation would be that it indicates a lack of support for the scale of MEGA. Such an expression appears to be at odds with the impression that you are not publically critical of the project.

 

[Barry53]

I don't think MEGA could be described as having a small size: 10,000 adults and 2'000 children and adolescents !

But do we really need all these people?

From a big data perspective (not specifically talking about medical research here), I suspect there can be trends and correlations hidden within data, that only become apparent when the data is large enough to statistically discriminate between them, together with the big data analytic technologies that can help to make sense of it. Sometimes finding answers to questions people had not even realised to ask.

 

[charles shepherd]

I do not understand this comment. Can you expand upon it?

The natural interpretation would be that it indicates a lack of support for the scale of MEGA. Such an expression appears to be at odds with the impression that you are not publically critical of the project.

It was in reply to a comment (which has some validity) which stated:

……and small sample sizes are precisely what plagues existing research

 

[charles shepherd]

.

@charles shepherd wrote about investigative journalist Duncan Campbell:

'This is from his website and contains links to some of the health fraud stories that we have worked on together:
http://www.duncancampbell.org/content/new-statesman-1989 '


~~~~~~~~~~~~


So, can Duncan Campbell write a major exposee of the healthcare and research scandal of the PACE Trial, about the hijacking of ME policy by UK psychiatrists, and about the attendent decades long abuses of sick ME patients, including children, by those enacting a damaging treatment policy (CBT/GET) based on unsubstatiated models but no evidence ?

.

Simple answer is I don't know because I have not worked on a health fraud story with DC for quite some time - mainly because he has moved away from doing this type of investigative journalism

 

[charles shepherd]

From a big data perspective (not specifically talking about medical research here), I suspect there can be trends and correlations hidden within data, that only become apparent when the data is large enough to statistically discriminate between them, together with the big data analytic technologies that can help to make sense of it. Sometimes finding answers to questions people had not even realised to ask.

Yes, that is certainly the reasoning that is being put forward by Professor Holgate and some of the -omic and 'big data' researchers who are on the MEGA planning group

They would argue that if you are going to obtain the sort of meaningful cluster analysis under the ME/CFS umbrella that has helped researchers to make progress in sub-grouping all the various types of asthma (and other conditions), and the resulting effect of targeting different treatments far more effectively, then you do need very large numbers of ME/CFS (Canada, Fukuda, Ramsay, IoM, ICC, NICE criteria) patients taking part.

 

[Cinders66]

Yes, that is certainly the reasoning that is being put forward by Professor Holgate and some of the -omic and 'big data' researchers who are on the MEGA planning group

They would argue that if you are going to obtain the sort of meaningful cluster analysis under the ME/CFS umbrella that has helped researchers to make progress in sub-grouping all the various types of asthma (and other conditions), and the resulting effect of targeting different treatments far more effectively, then you do need very large numbers of ME/CFS (Canada, Fukuda, Ramsay, IoM, ICC, NICE criteria) patients taking part.

For me the fixation on NICE criteria is an issue in U.K. How much do the respected American scientists and ME & CFS drs e.g. aDavis, Peterson, Montoya and Jason recognise it or value it in relation to ME? Americans, when it comes to Oxford CFS seem to think it's irrelevant and should be scrapped as an impediment to proper ME & CFS research, how does NICE stand on the world CFS stage? Again if NICE CFS is a fatigue syndrome some would not really count or think will contribute directly, is MEGA going to put a massive tick falsely against the "doing our bit on the CFS/MEfront" box as many would argue uk CFS service and research so far has.

 

[Snowdrop]

Yes, that is certainly the reasoning that is being put forward by Professor Holgate and some of the -omic and 'big data' researchers who are on the MEGA planning group

They would argue that if you are going to obtain the sort of meaningful cluster analysis under the ME/CFS umbrella that has helped researchers to make progress in sub-grouping all the various types of asthma (and other conditions), and the resulting effect of targeting different treatments far more effectively, then you do need very large numbers of ME/CFS (Canada, Fukuda, Ramsay, IoM, ICC, NICE criteria) patients taking part.

If this is the case then why would the researchers not consider the need to include the severely ill. They are the ones most likely to represent a group with robust findings.

Also, if enough of the total cohort studied come to the study with chronic fatigue as defined by NICE, Fukuda, Oxford is it not possible that this dilution would yield more information regarding say depression or other illnesses rather than providing data on ME.

There is an extreme lack of trust between patients and this research community. Why the need for the inclusion of loose criteria. Even after the explanation it does not seem reasonable or necessary to include what is elsewhere acknowledged as crappy criteria for defining ME. It keeps coming back to this. Some researchers seem to be in an alternate reality as to what ME might be and throwing everything fatigue like in. If the severely ill are not include in a large enough number even with a large cohort will it be enough to find data useful to ME?

 

[charles shepherd]

For me the fixation on NICE criteria is an issue in U.K. How much do the respected American scientists and ME & CFS drs e.g. aDavis, Peterson, Montoya and Jason recognise it or value it in relation to ME? Americans, when it comes to Oxford CFS seem to think it's irrelevant and should be scrapped as an impediment to proper ME & CFS research, how does NICE stand on the world CFS stage? Again if NICE CFS is a fatigue syndrome some would not really count or think will contribute directly, is MEGA going to put a massive tick falsely against the "doing our bit on the CFS/MEfront" box as many would argue uk CFS service and research so far has.

There is quite a lot of misunderstanding about what is termed the NICE diagnostic criteria for ME/CFS

And I don't think this NICE criteria has any significant standing outside the UK

As I'm sure you are aware, the MEA has consistently been very critical of the 2007 NICE guideline and we do not regard it as being fit for purpose
And we do not believe that the NICE diagnostic criteria is a satisfactory way of diagnosing ME/CFS

HOWEVER, and this is where the misunderstanding occurs, the purpose of the NICE diagnostic criteria is to provide GUIDANCE to doctors as to when they should CONSIDER making a diagnosis of ME/CFS
And from that point of view it does have some merit

It is also worth noting that in addition to the patient having new onset and persisting fatigue that cannot be explained by another condition, and results in a substantial reduction in activity, the fatigue in the NICE criteria also has to be accompanied by:
POST EXERTIONAL MALAISE AND/OR FATIGUE (typically delayed, for example by at least 24 hours, with slow recovery over several days)

So, for the non expert doc, this is actually a fairly useful starting point when CONSIDERATION needs to be given to making a diagnosis of ME/CFS

But the NICE definition of fatigue + post exertional malaise + one other symptom from their list (eg cognitive dysfunction, pain) should not be used to make a diagnosis of ME/CFS

I also think that here in the UK, many docs are like myself when it comes to making a diagnosis of ME or CFS, and take a fairly pragmatic approach - rather than sticking dogmatically to one of the 20+ diagnostic criteria for ME, CFS, ME/CFS and SEID etc…..

 

[charles shepherd]

If this is the case then why would the researchers not consider the need to include the severely ill. They are the ones most likely to represent a group with robust findings.

Also, if enough of the total cohort studied come to the study with chronic fatigue as defined by NICE, Fukuda, Oxford is it not possible that this dilution would yield more information regarding say depression or other illnesses rather than providing data on ME.

There is an extreme lack of trust between patients and this research community. Why the need for the inclusion of loose criteria. Even after the explanation it does not seem reasonable or necessary to include what is elsewhere acknowledged as crappy criteria for defining ME. It keeps coming back to this. Some researchers seem to be in an alternate reality as to what ME might be and throwing everything fatigue like in. If the severely ill are not include in a large enough number even with a large cohort will it be enough to find data useful to ME?

My recall of the MEGA website information is that the MEGA planning group have made it clear that they want to include people with severe ME/CFS

Profesor Stephen Holgate also made it very clear when he came to the House of Lords meeting this week (see my notes) that he wants people with severe ME to be included

The way in which this will be done is clearly challenging and the subject of discussion