New MEGA study website (30 November 2016)

[trishrhymes]

This is getting very confusing. There is a parallel discussion of this going on on the Opposing Mega thread.

 

[slysaint]

This is getting very confusing. There is a parallel discussion of this going on on the Opposing Mega thread.

It's to reflect the clarity of the MEGA project and things to come..........get in training now.

 

[Dx Revision Watch]

I don't know why Dr Shepherd felt he needed to start a new thread, he could have posted the URL for the new MEGA site on the existing MEGA thread (not the OMEGA one but the one already started for MEGA).

Anyway, he is now back on PR and active so I look forward to his apology for his "real world" and "real life" comments.

And perhaps he will also comment on the revised schedule published, today, in response to complaints sent to AfME and Prof Holgate about the Patient Advisory Panel application process and whether he considers the MEGA Steering/Planning/Whatever Group have allowed themselves (and the Patient Advisory Panel) sufficient time in which to prepare a submission for funding in early January 2017.

 

[Jo Best]

Absolutely, and I put this to Chris Ponting, via Twitter. Better no funding application until 2018 than a rushed and shambolic application and a hastily cobbled together Patient Advisory Panel given insufficient time for the task for which they have been recruited.

Thanks Suzy.

 

[Barry53]

Those schedule dates don't account for any input or changes do they.

Maybe it wouldn't be a bad thing if the early January date was missed? There is no way that everything wrong with MEGA can be sorted in one or two meetings.

Like. Like. Like.

 

[Barry53]

It is a dog's breakfast.

Starting how they mean to finish?

 

[lilpink]

Interesting mailing from AYME today. (Obliquely related to this thread..mods might wish to relocate info to another thread?)

"
Children in Need funding gone – we urgently need your help!

At some point during the last three years, your family has been supported by AYME and we hope even in some small way this reduced the suffering your family has, or is experiencing.

The support may have been provided following contact with our help and information line and email service, or perhaps in some extreme cases via our emergency crisis line which operates 24 hours a day, seven days a week. Many of the families receiving support were and remain under threat of safeguarding proceedings and rely entirely on this support to empower them to challenge those taking proceedings against them.

These services have been funded by Children in Need since 2013, but funding will cease at the end of 2016. With severely limited general funds, AYME cannot continue to provide this level of support.

For some time, we have been desperately trying to identify other sources of funding but to no avail. Lack of awareness and understanding faced by many families we work with also poses a significant challenge when seeking financial support openly available for other more well-known causes. If you have appreciated the support you have received, no matter how little, I am begging you to ensure our services continue for those children with M.E./CFS and their families who are in crisis right now. If this is you and your loved ones we will continue to do our utmost for you.

If you are truly unable to help, then please ignore this email. However if you can spare even £1, believe me every penny will help keep AYME operating these support services.

You can help by:

· Donating regularly via AYME website or make a one off donation www.ayme.org.uk/donate

· Introduce AYME to potential corporate supporters (e.g. your employer)

· Hold a fundraising event no matter how small – see AYME’s website www.ayme.org.uk/fundraise for ideas or email Jo (Jo@ayme.org.uk)

· Do all of your online shopping via the AYME website www.giveasyoulive.com/join/ayme especially during the build up to Christmas! Every penny you spend will result in a donation to AYME, at no additional cost to yourself – don’t forget to tell friends and family friends and family. An important note is to go to the bottom of the page and under ‘Ways to Raise’ click ‘Donation Reminder’ and every time you shop online this will remind you by providing a short cut!


Your Charity really, really needs you right now. Thousands of children are still relying on AYME, so please help ensure we are there for them in 2017.

Thank you for taking the time to read this. Thinking of you all and especially those still dreaming of improved health.

Mary-Jane and team.

 

[Solstice]

Did they lose members and thereby funding?

 

[Dx Revision Watch]

I note that Dr Shepherd returned to PR, briefly, yesterday, and started a new thread for the MEA's Website Poll for December.

I don't know what purpose these informal "Polls" serve and question their methodology and the validity of their "results."

However, given that the MEA posts a monthly poll, a more pertinent and timely question for December might have been:

Timing of the MEGA application for funding

This month's MEA website poll is asking for your views on the timing of a funding application by MEGA.

On 1 December, a revised schedule was posted on the MEGA Blog for the timetable for recruiting the MEGA Patient Advisory Group and holding its initial meeting.

The reason that the timescale is so short is because the mainstream funder to whom MEGA Team want to apply for funding has an application deadline in early January 2017.​

• 9am 13 December 2016 – Deadline for applications to join the MEGA Patient Advisory Group
• 13-14 December – Applicants contacted and group members confirmed
• w/c 19 December – Papers and key information sent out to Patient Advisory Group members
• 29 or 30 December – Patient Advisory Group teleconference and/or e-group meeting held
• 4 January 2017 – Back-up call for Patient Advisory Group if needed, to address outstanding issues from December meeting.

Do you consider:

a) An application for funding should be postponed until at least 2018 to allow increased time for Patient Advisory Group recruitment and consultation and to allow time for the many unresolved concerns about the project to be addressed?

b) An application for funding should be postponed until at least 2018 to allow increased time for Patient Advisory Group recruitment and consultation and to allow time for the many unresolved concerns about the project to be addressed?

c) An application for funding should be postponed until at least 2018 to allow increased time for Patient Advisory Group recruitment and consultation and to allow time for the many unresolved concerns about the project to be addressed?

d) Don't ask me, the project has no credibility while Holgate and Crawley are involved.​

 

[snowathlete]

The timetable for recruiting the MEGA Patient Advisory Group and holding its initial meeting is now as follows:

• 
  
  
  • 9am 13 December 2016 – Deadline for applications to join the MEGA Patient Advisory Group
  • 13-14 December – Applicants contacted and group members confirmed
  • w/c 19 December – Papers and key information sent out to Patient Advisory Group members
  • 29 or 30 December – Patient Advisory Group teleconference and/or e-group meeting held
  • 4 January 2017 – Back-up call for Patient Advisory Group if needed, to address outstanding issues from December meeting.

2 days in which applications are to be reviewed and selection process carried out.

"29 or 30 December – Patient Advisory Group teleconference and/or e-group meeting held"

Between Christmas and New Year - when some applicants may be away or have increased family commitments or may be recuperating following holiday induced PEM and crashes.

This is a football (soccer) schedule. Only the English Premier League play football over the Christmas period while the rest of the world stops because of Christmas and New Year. It is a great spectacle, but there is a reason why no one else does it.

The fact the MEGA project is squeezing in patient advisory work into this period just goes to show yet again how inappropriate and unprofessional the project is. No other research project would think this a good idea. You can't do it like this if you are serious about patients having proper scrutiny, input and having their concerns addressed correctly.

The only way you can work to this schedule is if you actually only are looking to tick a box - you just want to be able to say you had a patient advisory group look it over so that the study sounds more legitimate and credible to funders.

This study is a continuous farce.

 

[Dx Revision Watch]

The only way you can work to this schedule is if you actually only are looking to tick a box - you just want to be able to say you had a patient advisory group look it over so that the study sounds more legitimate and credible to funders.

This study is a continuous farce.

What snowathlete said.

 

[Dx Revision Watch]

And the MEA should pull out now, if they can't persuade the MEGA Team that this isn't acceptable.

 

[snowathlete]

I've seen some concerns raised that MEGA is too closely associated with the MRC and that it looks like this study already has funding agreed unofficially with them or someone else. This striving to meet the early Jan deadline when clearly there is not time to do so with proper process, would seem to back that up.

 

[trishrhymes]

MEGA is not 'the first of its kind' - because it does not yet exist. We are not even told what it is going to study.

Apologies that this is rather a long post. It is probably going over old ground.

I am becoming more and more puzzled about the question of what the MEGA study is actually intending to study. Apart from a list of distinguished scientists in various biomedical fields, we have very little clarity.

There are two bits of evidence I'm going on so far

1. The title of the project: MEGA stands for ME/CFS Epidemiology and Genomics Alliance. So no mention there of other -omics, just genomics.

According to a WHO definition:

Epidemiology is the study of the distribution and determinants of health-related states or events (including disease), and the application of this study to the control of diseases and other health problems.

This could, I suggest, mean trawling through masses of questionnaire data to look for associations between such things as socio-economic and psychological factors to look for associations with duration and severity of illness. Given Crawley's propensity for p-hacking her way through data to look for spurious associations that happen to pop up by chance, and attributing cause and effect to support her model of ME, this rings huge alarm bells for me.

All this with not a test tube being shaken, so to speak.

The other part, genomics, seems to be the driving factor in demanding a huge data set, justified on the grounds that it has been useful in other illnesses such as asthma and diabetes in determining subsets which can respond differently to different treatments.

However these illnesses already had a great deal of scientific knowledge and effective treatments available, so refining these treatments with genetic knowledge could potentially be useful. For ME/CFS this is very different, I would argue, and at this stage, with no effective treatments anyway, refining who should get what treatment seems to me to be pointless.

Some genetics, including family studies, are already happening elsewhere, and if there were a clear single allele site, we would know about it already. Maybe genomics is not the highest priority at the moment for a new biomedical study.

2. The particular fund being applied to at this stage. I have only now found out, by linking the dates given in the detail about the patient advisory group appointments and meetings, to information on the Wellcome website, that the deadline for preliminary application is in January, that it is probably this one:

'Biomedical Resource and Technology Development Grants
These grants are for researchers who want to establish or maintain resources or technology for the benefit of the wider scientific community.'

https://wellcome.ac.uk/funding/biomedical-resource-and-technology-development-grants

I'm guessing this means they are applying purely at this stage for a grant to set up a biobank. This would involve collecting the blood etc samples and questionnaires from thousands of patients and storing them. Storing the questionnaires would probably also involve collating the data from them into a data base.

As far as I can see, this doesn't involve any biomedical research being done, possibly for years. Further applications for money would be needed to enable the genomics etc to happen, and there is no guarantee that any funding will be available.

So what I conclude from both these points is that at the end of this process there will be a huge database of questionnaire data and a biobank full of samples waiting for people to make research grants for funding to do biomedical studies.

Since there is already an ME biobank which can be expanded as funding allows, I can't see how we will be any further forward.

They may claim that the new version of a biobank is needed because to do epidemiological studies, they need a sample representative of the whole population. However, they scupper that from the start by opting to use the skewed subset attending fatigue clinics.

I think I'm going over old ground here, but needed to clarify my understanding of what the project is supposed to be about. Given that whoever is chosen to be on the patient panel will only have, at best, a few days to examine the proposed grant application details, it is indeed odd that, as Jonathan Edwards says, 'We are not even told what it is going to study'.

 

[Dx Revision Watch]

I've seen some concerns raised that MEGA is too closely associated with the MRC and that it looks like this study already has funding agreed unofficially with them or someone else. This striving to meet the early Jan deadline when clearly there is not time to do so with proper process, would seem to back that up.

On the MEA's site, in a post about MEGA, it said Wellcome have already expressed an interest. I'll try and find link.

 

[Dx Revision Watch]

From 3 October 2016:

http://www.meassociation.org.uk/201...irth-says-dr-charles-shepherd-3-october-2016/

Give this MEGA project a chance to fly – don’t try to strangle it at birth, says Dr Charles Shepherd | 3 October 2016

...The MEGA study has also attracted the very positive attention of the Wellcome Trust _ the largest provider of non governmental funding for biomedical research here in the UK and the largest research funding charity in the world

Wellcome Trust: >https://wellcome.ac.uk​

 

[A.B.]

This striving to meet the early Jan deadline when clearly there is not time to do so with proper process, would seem to back that up.

I wonder if the urgency here is due to the NICE guidelines being reviewed in 2017. Some important events happened in the last few years. The IOM report, AHRQ downgrading CBT/GET, the Oxford case definition being declared as flawed by multiple US agencies, PACE exposed as fraud.

I can think of two reasons why they might want to get MEGA protocol approval before the NICE review:

There is the possibility of NICE case definition being changed because it's almost as bad the Oxford defition. This would likely result in fewer mildly affected patients being recruited and fewer misdiagnoses. Mildly affected patients and misdiagnoses are convenient, perhaps even necessary, for their goals.

One of the stated goals of MEGA was to enhance existing treatments. Now CBT and GET are at risk of being declared ineffective. If they get their study plan approved before that happens they would have an excuse to continue to publish on the subject for a while still.

 

[worldbackwards]

The support may have been provided following contact with our help and information line and email service, or perhaps in some extreme cases via our emergency crisis line which operates 24 hours a day, seven days a week. Many of the families receiving support were and remain under threat of safeguarding proceedings and rely entirely on this support to empower them to challenge those taking proceedings against them.

These services have been funded by Children in Need since 2013, but funding will cease at the end of 2016. With severely limited general funds, AYME cannot continue to provide this level of support.

AYME have got some nerve to ask for funds on this basis, when they actively support doctors putting parents and children under exactly that kind of pressure.

 

[Dx Revision Watch]

https://twitter.com/i/web/status/804693130406744068

 

[Jo Best]

On 1 November, a revised schedule was posted on the MEGA Blog for the timetable for recruiting the MEGA Patient Advisory Group and holding its initial meeting.

Suzy, I think you mean 1 December?