New MEGA study website (30 November 2016)

[docsimsim]

I look forward to savouring your fury.

Seriously, I'd rather others with more energy, knowledge and equally strong views were chosen. We'll see.

@trishrhymes, the most important thing is to have the passion and commitment to obtain the best deal for ME patients. Any gaps in knowledge you might feel you have can be remedied by reading and researching issues, I'm
always so impressed how incredibly well informed my fellow sufferers (including your good self) are on the science of ME research. Some despite having no prior medical/scientific training are wise beyond belief

 

[charles shepherd]

Professor Stephen Holgate was with us for about an hour at the House of Lords yesterday afternoon - during which he gave a detailed overview of the MEGA Study and then answered a number of questions relating to the various concerns and uncertainties that are being expressed here and elsewhere about both the MEGA Study and the Patient Advisory Group

As Margaret says, we are aiming to produce the Minutes for this meeting as soon as possible

This will not be a word by word transcript of the session with Professor Holgate but it should provide a very comprehensive account of everything that was discussed and said

We normally pass the draft minutes to invited speakers to make sure that there are no inaccuracies present - so the turnaround is likely to take a week or so

I don't recall anything being said by Professor Holgate that was' not for minuting' - so there should not be any omissions

Please note that the group does not have any staff or money - so all the administrative work is done by members of the group on a voluntary basis

Forward ME Group website:
http://www.forward-me.org.uk

Dr Charles Shepherd

 

[BurnA]

Professor Stephen Holgate was with us for about an hour at the House of Lords yesterday afternoon - during which he gave a detailed overview of the MEGA Study and then answered a number of questions relating to the various concerns and uncertainties that are being expressed here and elsewhere about both the MEGA Study and the Patient Advisory Group

Thanks for the update.

Are you able to elaborate as to what concerns specifically were raised?

I would like to think the inclusion / selection criteria, and the name E Crawley were given priority. Can you confirm if this was the case or not?

 

[charles shepherd]

A list of wide ranging questions and answers covered:

- how the work has been funded so far (mainly from SH!)
- PACE and FITNET
- the information on the new MEGA website,
- how the planning group will be responding to questions,
- the researchers who are on the planning group,
- patient selection procedures,
- the use of the NHS clinics, including NICE diagnostic criteria for CFS, for people with ME/CFS,
- the use of other sources of ME/CFS patients,
-the need to recruit people with severe ME/CFS and the practical difficulties this will create,
- administration and selection of people for the Patient Advisory Group
- work of the PAG over the Xmas and New Year period
- how the information from the genomic, epigenetic, proteomic and metabolomic components of MEGA will be used to carry out cluster analysis under the ME/CFS umbrella

In fact, just about every concern and question that has been appearing on internet discussion forums and in correspondence to the various charities that belong to Forward ME Group

I think it would be fair to say that Professor Holgate tried to provide as much information as he could on the comments and questions that were raised - some of which were (not surprisingly) very critical of certain aspects of the MEGA study

 

[Esther12]

Would be good if Holgate showed any indication he was able to understand the problems with PACE and the work of Esther Crawley. Not holding out much hope on that, but without that it's very difficult to see how Holgate could rewspond meaningfully to patient concerns about Crawley's involvement.

 

[Valentijn]

Unless something changed in the past few days, the "answers" were mostly a flat denial that there's any problems. Eg, severe patients are not explicitly excluded from fatigue clinics, ergo there will supposedly be plenty of them there to recruit.

There's a rejection of reality there. Maybe he just doesn't get it, or he's deliberately playing dumb as an excuse to dismiss patient concerns. But either way, it means crappy trial design is going to stay crappy.

Kill MEGA, before it hurts ME patients with more substandard methodology and spun outcomes. And maybe then we can take down the CMRC and replace it with something fit for purpose.

 

[charles shepherd]

Professor Holgate told the meeting that the MEGA study would have to include people with severe ME/CFS and fully acknowledged that there were real practical difficulties in obtaining samples from this group of patients

We briefly discussed one of the options available - which would be to pay for home visits

This is how blood samples from people with severe ME/CFS are being collected for the ME Biobank

 

[JoanDublin]

A list of wide ranging questions and answers covered:

- how the work has been funded so far (mainly from SH!)
- PACE and FITNET
- the information on the new MEGA website,
- how the planning group will be responding to questions,
- the researchers who are on the planning group,
- patient selection procedures,
- the use of the NHS clinics, including NICE diagnostic criteria for CFS, for people with ME/CFS,
- the use of other sources of ME/CFS patients,
-the need to recruit people with severe ME/CFS and the practical difficulties this will create,
- administration and selection of people for the Patient Advisory Group
- work of the PAG over the Xmas and New Year period
- how the information from the genomic, epigenetic, proteomic and metabolomic components of MEGA will be used to carry out cluster analysis under the ME/CFS umbrella

In fact, just about every concern and question that has been appearing on internet discussion forums and in correspondence to the various charities that belong to Forward ME Group

I think it would be fair to say that Professor Holgate tried to provide as much information as he could on the comments and questions that were raised - some of which were (not surprisingly) very critical of certain aspects of the MEGA study

Was the issue of EC, and patient no confidence in her, discussed at all?

 

[charles shepherd]

Was the issue of EC, and patient no confidence in her, discussed at all?

Professor Holgate is very well aware of these concerns, criticisms and objections and the reasons why they are being made by the ME patient community

But membership of the MEGA planning group was not discussed in any detail at this meeting

 

[Cinders66]

It would be nice if MEGA /CMRC had further study & assistance of the severe as a key goal and just worked through the various ways to achieve that instead of presenting us a burdensome group wracked with problems. It Costs more to take a blood test from disabled people at home, it also costs the state currently millions to pay for social care and benefits for this group, it also inconveniences all the health professionals who have to routinely visit us at home because we can't travel. If we are talking of millions of pounds being asked for a study to include the NICE fatigued as well as FUKUDA CFS as well as ME then asking for some of that money to go towards those probably disabled by the NHS approach to their illness totally neglected to date by the state just seems like a given requirement rather than a problematic issue AFAIC. The Ron Davis Severe study just got on with doing what needed to be done.

 

[charles shepherd]

It would be nice if MEGA /CMRC had further study & assistance of the severe as a key goal and just worked through the various ways to achieve that instead of presenting us a burdensome group wracked with problems. It Costs more to take a blood test from disabled people at home, it also costs the state currently millions to pay for social care and benefits for this group. If we are talking of millions of pounds being asked for a study to include the NICE fatigued as well as FUKUDA CFS as well as ME then asking for some of that money to go towards those probably disabled by the NHS approach to their illness totally neglected to date by the state just seems like a given requirement rather than a problematic issue AFAIC. The Ron Davis Severe study just got on with doing what needed to be done.

You are making a very valid point

A meaningful number of people with severe ME/CFS must be included in this study

So the MEGA ream will have to accept that there will be additional costs involved if people are going to be clinically assessed, examined and blood and urine samples taken in their own homes

 

[Jo Best]

Professor Holgate told the meeting that the MEGA study would have to include people with severe ME/CFS and fully acknowledged that there were real practical difficulties in obtaining samples from this group of patients

We briefly discussed one of the options available - which would be to pay for home visits

This is how blood samples from people with severe ME/CFS are being collected for the ME Biobank

Home visits are also how samples from people with severe ME/CFS are being collected for the IiMER Centre of Excellence for ME translational biomedical research strategy. It's hard to see how else it may be done. However, I think the main point being made for the MEGA study is that severe ME/CFS should be proportionally represented (i.e. 25%) in the samples as the plan is to collect such a large number from 10,000 adults and 2,000 children.

 

[Valentijn]

We briefly discussed one of the options available - which would be to pay for home visits

Which still completely ignores the point that this would only (potentially) happen with the severe patients who are currently registered with a fatigue clinic. But severe patients are not going to clinics, and very very few are being seen as outpatients by those clinics.

Additionally, the vast majority of ME patients give up on fatigue clinics or are kicked out after a year when the CBT/GET fails to work and makes them sicker. Clinic-based recruitment is going to be heavily loaded in favor of mild and short-term patients, who might not meet even NICE criteria, since Crawley ignores the PEM requirement.

 

[BurnA]

But membership of the MEGA planning group was not discussed in any detail at this meeting

A list of wide ranging questions and answers covered:
the researchers who are on the planning group,

Charles,
There appears to be conflicting information in your two posts above, could you clarify?

If the issue of researchers on the planning group was not discussed in any detail then it seems one of the biggest objections to MEGA has been sidestepped.
The problem won't go away just because you don't want to talk about it.

There needs to be a discussion about the inclusion of EC and it needs to be documented. Do the MEGA team support her statements that PACE was a great trial. Do they support the methodology of her previous and ongoing work. If no statement is made on this, the assumption must be that they do, and that is not acceptable.
You are deluding yourself if you don't think this is an issue. It needs to be addressed.
Tks.

 

[charles shepherd]

Home visits are also how samples from people with severe ME/CFS are being collected for the IiMER Centre of Excellence for ME translational biomedical research strategy. It's hard to see how else it may be done. However, I think the main point being made for the MEGA study is that severe ME/CFS should be proportionally represented (i.e. 25%) in the samples as the plan is to collect such a large number from 10,000 adults and 2,000 children.

One other option, which I think is worth considering in relation to recruitment of people with severe ME/CFS, would be to make use of the NIHR Primary Care Networks:

http://www.nihr.ac.uk/nihr-in-your-area/primary-care/

 

[charles shepherd]

Charles,
There appears to be conflicting information in your two posts above, could you clarify?

If the issue of researchers on the planning group was not discussed in any detail then it seems one of the biggest objections to MEGA has been sidestepped.
The problem won't go away just because you don't want to talk about it.

There needs to be a discussion about the inclusion of EC and it needs to be documented. Do the MEGA team support her statements that PACE was a great trial. Do they support the methodology of her previous and ongoing work. If no statement is made on this, the assumption must be that they do, and that is not acceptable.
You are deluding yourself if you don't think this is an issue. It needs to be addressed.
Tks.

I am well aware that this is a key issue in relation to the patient community

The planning group are also well aware that this is a key concern in the patient community

As I have said the membership of the planning group formed part of the discussion but there was not a detailed discussion on this

Could I suggest that you wait for the Minutes to be published to see what was actually said

 

[charles shepherd]

Which still completely ignores the point that this would only (potentially) happen with the severe patients who are currently registered with a fatigue clinic. But severe patients are not going to clinics, and very very few are being seen as outpatients by those clinics.

Additionally, the vast majority of ME patients give up on fatigue clinics or are kicked out after a year when the CBT/GET fails to work and makes them sicker. Clinic-based recruitment is going to be heavily loaded in favor of mild and short-term patients, who might not meet even NICE criteria, since Crawley ignores the PEM requirement.

Yes, and as I have just said in another reply, my personal view is that the MEGA study planning group are going to have to look at a range of options when it comes to recruiting people with severe ME/CFS - and this should include the use of people who are not registered with an NHS hospital based referral service, or who have left an NHS referral service

 

[A.B.]

That Holgate is aware of Crawley being a problem is not enough. She needs to be removed. Holgate cannot hope to remain neutral because by having Crawley on the team he has already taken sides. The side of a system that continues to exploit and harm patients, and continues to produce the misleading information that results in the illness not being taken seriously. Claiming that internet CBT in comparison to a control treatment will make the recovery rate shoot up from 10% to 60% has exactly this effect.

 

[Jo Best]

I look forward to reading the minutes to see what was said, but how can we be expected to take seriously anything said by Stephen Holgate when: he is such an avid supporter of Esther Crawley's work; he treated the Chairman and trustees of the leading independent UK ME research charity with disregard by contacting their 'Scientific Advisory Board' directly, without including them, yet on a matter relating directly to the charity's stated views about MEGA; and knowing how he treated a junior researcher and member of the CMRC, Keith Geraghty? Stephen Holgate is central to the problem that people have with MEGA and the CMRC, along with CMRC Deputy Chair, Esther Crawley.

 

[Chrisb]

Let us for the moment try to depersonalise the issue and ignore any historical reasons for objecting to EC's involvement in the study with all the appearances of lead researcher.

EC is a paediatrician who is understood to claim that CFS/ME presents differently in children to adults. The proposed study is supposed to be divided 5/6 adult to 1/6 child/adolescent. Who is intended to have overall responsibility for the adult section of the trial? Presumably it was intended that White would fulfill this role. Is somebody else now undertaking this responsibility, and, if the duties have merely devolved upon EC, what is her claimed expertise in the subject?