MEGA research for M.E./CFS: White & Crawley listed as involved

[AndyPR]

This would seem to indicate that it has changed over time

 

[Countrygirl]

 

[Stuart]

Any ME study needs to begin with the research criteria that is Most exclusive to the known disease. This should include outbreak patients as they are best defined as they originate the investigation of the disease. The ME-ICC is the closest definition for research purposes we have.

Clinically those who see many patients are able to 'know them when they see them,' as we patients often recognize each other. This is fine for care and treatment as most doctors begin to treat on a presumptive diagnosis, but not for a research study.

If we had say ME, MS, and Lupus patients all mixed in a study as a single cohort of a 'broad study' we may well find commonalities but they may be meaningless and confusing to investigating ME. Looking at other patient groups less well fitting the ME-ICC criteria could be done later once some clear findings show a recognizable pattern.

To include a 'broad cohort' confounds the findings and makes them meaningless. This was the whole point of the multiple 'chronic fatigue' wastebasket definitions. Some of the recent attempts to 'redefine' the disease looks at the history of muddled research of 'fatigue' and crafts a muddled definition exactly due to the inclusion of patient data who should have never been included. It is self-fulfilling, GIGO.

It is also a tactic to do overly broad studies with many variables as you can pick and choose any results as 'statistically relevant.' This was shown by the hoax study last year that led to widespread headlines of "Eating chocolate ... can even help you LOSE weight!" and findings such as "Not only does chocolate accelerate weight loss, the study found, but it leads to healthier cholesterol levels and overall increased well-being."

The authors explain how the study worked:
"Think of the measurements as lottery tickets. Each one has a small chance of paying off in the form of a “significant” result that we can spin a story around and sell to the media. The more tickets you buy, the more likely you are to win. We didn’t know exactly what would pan out—the headline could have been that chocolate improves sleep or lowers blood pressure—but we knew our chances of getting at least one “statistically significant” result were pretty good."

He also mentioned the problem with large legitimate studies:
"For example, the Women’s Health Initiative—one of the largest of its kind—yielded few clear insights about diet and health. “The results were just confusing,” says Attia. “They spent $1 billion and couldn’t even prove that a low-fat diet is better or worse.” Attia’s nonprofit is trying to raise $190 million to answer these fundamental questions. But it’s hard to focus attention on the science of obesity, he says. “There’s just so much noise.”

An overly broad cohort does exactly that, it introduces too much noise, it has too many variables, it allows cherry picking of results to spin a story around. And they are cleverly getting you to buy into it even before it begins. This has a two-fold result, once you have committed to approving it, you have difficulty in rejecting it in the future no matter what proof is offered. Second, no matter what evidence comes that the study is flawed, no matter the results promoted, no matter how many patients and advocates and groups decry it in the future, they have a 'get out of jail free card' in the 'patient petition' that 'approved' the study.

 

[AndyH]

Pariante is a he, btw.

Yes. a He. Not sure why I wrote Her.

 

[medfeb]

To include a 'broad cohort' confounds the findings and makes them meaningless. This was the whole point of the multiple 'chronic fatigue' wastebasket definitions. Some of the recent attempts to 'redefine' the disease looks at the history of muddled research of 'fatigue' and crafts a muddled definition exactly due to the inclusion of patient data who should have never been included. It is self-fulfilling, GIGO....

"For example, the Women’s Health Initiative—one of the largest of its kind—yielded few clear insights about diet and health. “The results were just confusing,” says Attia. “They spent $1 billion and couldn’t even prove that a low-fat diet is better or worse.” Attia’s nonprofit is trying to raise $190 million to answer these fundamental questions. But it’s hard to focus attention on the science of obesity, he says. “There’s just so much noise.”...

An overly broad cohort does exactly that, it introduces too much noise, it has too many variables, it allows cherry picking of results to spin a story around.

This is my biggest concern also - meaningless patient selection that makes the results uninterpretable or lead to nonsense or selective findings

Perhaps I have missed it so please point me to the information if so. But its not clear to me how broad this cohort will be. How are they going to select patients? medically unexplained chronic fatigue? To Stuart's point, that's even broader than obesity, lacking an identifiable sign to select patients. How are they going to characterize the patients symptom profiles to know which patients have the hallmark characteristics of ME. And are all the selected patients being labelled "CFS" patients?

I appreciate the power of the methods being used. But if this study does not characterize the ME patients well enough so that they can be identified as a group, what kinds of conclusions will it be able to draw about the biological pathology in those ME patients? And if they have some undefined collection of fatigued patients with unidentified ME patients mixed in, will they be able to pick out the kinds of observations that Naviaux, Davis, Hornig, and others have made? Or will they just say that in their study, such observations did not hold up.

 

[BurnA]

Perhaps I have missed it so please point me to the information if so.

I don't think you missed anything - fundamental details are lacking.

 

[eafw]

One thing to consider is to work out how to address the funding bodies with any objections. This is from the AfME site where they are trying to get support for the MEGA circus:

" For this to have a high chance of success when it applies for funding, MEGA needs evidence that patients support MEGA – which is why adding your name in support is so important."

OK, then we supply evidence - to the grants committee or whoever they are - that there are very good reasons why patients do NOT support MEGA in its current proposed form. This is something we have longer to work on rather than been done in a rush. In addition, wider publicity is needed aimed at anyone who might get caught up in this study without being fully informed, and possibly an appeal to some of the other researchers on that list (though I wouldn't hold out much hope as the instinct to close ranks with their fellow "professionals" will over-ride reason)

 

[AndyH]

A4ME has run with this with little or no input from the other CMRC memebers.
To call it biomedical research is deceptive and clearly seeks to get patient support even by deception.
Patient support can and I am sure will be used to claim patients wanted the research.
Gathering a bunch of data and hoping the needle in the haystack is going to pop out and stare them in the face can only lead to the psychosocial element claiming the trial for which they took part (or ran perhaps) showed no evidence of biomedical causation.
This is a potentially very dangerous proposition that could cause yet more years of obstruction in biomedical research.
Make no mistake.

 

[Esther12]

A4ME has run with this with little or no input from the other CMRC memebers.

Where did you get that from? If true, that would be extra worrying.

 

[AndyH]

Where did you get that from? If true, that would be extra worrying.

One only has to read their minutes at which they state they represent the CMRC etc. etc. and see the questions and statements CMRC members have made to realise that they couldn't have been involved in the decisions because they wouldn't be asking the question or taking the stance they have. Also, although not directly relevant but look at the branding. It's all branded A4ME. I thought it was fairly obvious but if you have doubt, asking the question of the other memebrs of the CMRC might be telling and perhaps wise? It's as if the other memberss have been pushed out out of the way in my opinion.

 

[Esther12]

One only has to read their minutes at which they state they represent the CMRC etc. etc. and see the questions and statements CMRC members have made to realise that they couldn't have been involved in the decisions because they wouldn't be asking the question or taking the stance they have. Also, although not directly relevant but look at the branding. It's all branded A4ME. I thought it was fairly obvious but if you have doubt, asking the question of the other memebrs of the CMRC might be telling and perhaps wise? It's as if the other memberss have been pushed out out of the way in my opinion.

I'm not sure if I read/cannot remember the details of that. Thanks for your view.

 

[AndyPR]

MEGA is Prof George Davey-Smith, University of Bristol; Prof Chris Ponting, University of Edinburgh; Prof Colin Smith, University of Brighton; Prof Caroline Relton, University of Bristol; Tony Bartlett, Somalogic; Dr Rick Dunn, University of Birmingham; Prof Julia Newton, University of Newcastle; Sonya Chowdhury, Action for M.E., representing the patient charity members of the UK CFS/M.E. Research Collaborative Board; Prof Andrew Morris, University of Edinburgh; Dr Simon Collin, University of Bristol; Prof David Ford, Swansea University; Prof Esther Crawley, University of Bristol; Prof Paul Moss, University of Birmingham; Prof Jim Horne, Loughborough University; Prof Maria Fitzgerald, University College London; and Prof Paul Little, University of Southampton.

White has disappeared from the list, Collin/Collins is still there. So both were said to be retiring from the group, the one staying in an advisory role is taken off the list, the one changing universities is still there. I have every faith in this....

 

[Yogi]

I am still a bit annoyed at the MEGA and the conduct of the CMRC and not surprisingly the patient group representative AFME over the disastrous launch of MEGA and a random petition.

A few months ago I realised that the CMRC annual conference was to be held on 27 and 28 October which was the following day after the Millions Missing on 26 October. I had a bad feeling about this given the demands of millions missing could be simply responded to and patients placated by showing the government/CMRC was doing some research for patients.

Millions Missing was obviously a great success but CMRC/ MEGA project the following day along with the petition took the shine off the week. Despite already being concerned about the CMRC I was still shocked at the petition and I feel it was very underhand and deceptive to launch the MEGA project petition the day after MillionsMissing when many people were campaigning for biomedical research as the main protest demand. Many people will have signed because of the campaign around MillionsMissing protests etc.

The two key and major issues of CMRC/ MEGA I believe the majority are concerned with:

1. ME Criteria
2. Role of BPS individuals involved with PACE scandal

I and i am sure numerous others and in fact the majority of people are genuinely interested from people who support the MEGA project (and advise others to do so as well) on the answers to the following questions.

1. Can somebody please explain what the purpose of MEGA is and why it is of any benefit? I agree it may be of use if there were clear criteria for ME such as CCC or ICC. I find it unacceptable and very disingenuous that the criteria has not been decided but people were duped into signing the petition. It appears that it will be a mix of fatiguing conditions and MEGA so large that nothing of real value can be deduced from it. AFME have now said they will use NHS criteria which is NICE criteria. How can we have any confidence that accurate sub grouping will be done given many in CMRC believe that ME is MUPS and just tiredness and refuse to validate or endorse CCC/ICC.

2. Why was a petition required? What other diseases have petitions organised by government agencies? It is claimed that support would allow it to go ahead. Many have supported past petitions which are ignored. I do not believe that the genuine reason is for patient support to see if the 12000 can be recruited. Many people signing are foreign and also family members. This needs to be explained.

3a. Peter White of the infamous PACE trial is included in MEGA. Many signed and felt deceived in doing so as they were not aware of White and Crawley as they were not mentioned in the documents. Why was it felt necessary to have him?

3.b White wrote a disgraceful article a day after the petition in the guardian with lies over concern of patients welfare and CBT/GET and smearing the PACE critics including senior statisticions of "tweaking" the data. What value is the petition given many feel duped into signing and do not now support it given his role and how will this be taken into account to measure support.

3.c. Now White has resigned ( 3rd Oct) what influence will he have as advisor? Bearing in mind the decade long scandal of PACE and his psychosocial beliefs of ME what skills will he be bringing into this.

4. In addition to White, Simon Collins had also resigned. The MEGA project within a few days has changed significantly.
Were these announcements linked to the negative reaction by the patient community to MEGA?

5. This leaves Crawley (the other main BPS proponent concern). Will she be remaining on the project now or also resigning?

6. Some believe that a counter petition should not be launched as it is counter productive. Can this MEGA petition be similarly terminated given the outstanding questions and concerns over validity of signatures and the significant lack of clarity of MEGA and validity of petition and changes to the MEGA project?

7. Some are now advising that their should be communication and open letters instead petitions. Nearly all open letters and communications from patients had failed with PACE and fallen on deaf ears for 10 years. There had been no two way communication from CMRC and MEGA. It appears disingenuous. Why will this time be different and what reassurance do we have that they will be communication and patients will be listened to?

8. If a (counter) petition is a bad idea why was/is the original petition a good idea?

9. a. MEGA will cost £5m for 12,000 patients. That is around £400 per individual. That would include all diagnosing costs and tests. This is an absurd amount and one simple blood test can cost that much. Does this appear reasonable or even MEGA for the individual participant?

9.b. No-one had explained the rationale for 12,000 patients. Why are 12000 required and how reasonable is it to assume that they can be recruited without skewing the data with other non relevant illnesses. From university statistics classes I recall for a standard normal distribution rule of thumb was 30 data observations was reasonable. If we assume there are sub groups (recall around 7 sub groups). That is 210 patients. If we assume controls of the same. That means the study should have 410 patients. I will be generous here and increase it 50% for any errors in my back of the envelope calculations. That would mean at maximum 600 patients. MEGA is X20 times the necessary size. Why is this - no one heard of size doesn't matter it's what you do with it that counts!! Quality over size any day. It appears if there is no explanation to this then the whole purpose is to grand stand about the sheer scale of MEGA that no-one can argue against when the results are announced due to its dominance.

10. Finally AFME were the patient group to support PACE trial without which the PACE trial could not have been launched. Many if not the majority of ME patients are distrustful of AFME and have no faith in them because of this. Why are AFME the patient representative given there are a number of charities in CMRC and how was this decided?

In theory myself and many would have supported MEGA. However the conduct of CMRC/MEGA is a serious concern.

I don't think anyone wanted to strangle MEGA at birth. MEGA had not been transparent with the 2 major concerns to the community and obvious issues were not addressed before launching the petition. It appears MEGA is becoming a shambles and is at risk of strangling itself at birth if transparency and communication is not improved immediately.

I genuinely am interested in MEGA and any answers (especially from those who continue to support it) that can be provided to the above questions.

 

[AndyPR]

MEGA is Prof George Davey-Smith, University of Bristol; Prof Chris Ponting, University of Edinburgh; Prof Colin Smith, University of Brighton; Prof Caroline Relton, University of Bristol; Tony Bartlett, Somalogic; Dr Rick Dunn, University of Birmingham; Prof Julia Newton, University of Newcastle; Sonya Chowdhury, Action for M.E., representing the patient charity members of the UK CFS/M.E. Research Collaborative Board; Prof Andrew Morris, University of Edinburgh; Prof David Ford, Swansea University; Prof Esther Crawley, University of Bristol; Prof Paul Moss, University of Birmingham; Prof Jim Horne, Loughborough University; Prof Maria Fitzgerald, University College London; and Prof Paul Little, University of Southampton.

And Collin/Collins disappears.

 

[Chrisb]

This may not be the right place to ask this, but there are so many related threads that I get confused. (Nothing new there, you all shout.)

There is talk of the need to recruit 12,000 patients (10,000 adult, 2,000 children) yet there has also been mention of a control group. As the control would not be patients does this mean that substantially more than 12,000 samples will have to be tested, or do they already have data from a standard control, if that is ever considered acceptable practice?

The alternative would seem to be that the 12,000 contains patients and controls, which somewhat reduces its meganess.

 

[slysaint]

@Yogi with a bit of 'tweaking' what you have written here just about covers what is needed for the 'open letter' see separate thread.

 

[Yogi]

It appears that it is not only PR members who are suspicious of this MEGA.




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

Her is a very large comment!

SunnyOctober 3, 2016 at 7:39 pm
This sounds likes it’s written by Weesley – ‘scaring researchers away’ so, not only are you tied up with White and Crawley, the funder is Wellcome trust who for those who don’t know awarded the book prize this year to Suzzane O’Sullivan, author of ‘It’s all in your head, psychosomatic disorders explored’ which contains an entire chapter on ME. Here’s the thread on PR if you want to read more about that;
http://www.healthrising.org/forums/threads/th-countess-of-mars-letter-to-dr-suzanne-osullivan.2655/

So, you’re asking us to ignore the PACE trial, the FINE trial, all of the trials Crawley has been funded for and has provided no futher answers, the trials Wessely has been funded for, because we know he’s involved from Jane Colby’s report;

http://forums.phoenixrising.me/inde...arch-collaborative-uk-cmrc-tymes-trust.32302/

But we should trust Action for ME who cheated us, and has done for forty years?

Crawley Research;

https://frownatsmile.wordpress.com/tag/dr-esther-crawley/

http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-415

http://bmjopen.bmj.com/content/1/2/e000252.short

http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-217

http://adc.bmj.com/content/98/6/425.full

http://adc.bmj.com/content/93/5/419.short

http://pediatrics.aappublications.org/content/130/1/e71.short

http://link.springer.com/article/10.1007/s00787-009-0029-4

http://adc.bmj.com/content/95/4/245.short

http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-308

http://adc.bmj.com/content/early/2010/07/24/adc.2009.173161.extract

http://adc.bmj.com/content/92/12/1058.short

http://adc.bmj.com/content/99/2/171.abstract

http://ccp.sagepub.com/content/early/2012/10/19/1359104512460862.abstract

http://ccp.sagepub.com/content/16/2/215.short

http://www.magonlinelibrary.com/doi/abs/10.12968/hmed.2006.67.9.21994

http://journals.cambridge.org/actio...e=online&aid=9202412&fileId=S1463423613000121

http://ep.bmj.com/content/90/4/ep92.

http://bmjopen.bmj.com/content/2/4/e001417.full

http://onlinelibrary.wiley.com/doi/...nticated=false&deniedAccessCustomisedMessage=

http://adc.bmj.com/content/98/7/561.full

http://pediatrics.aappublications.org/content/137/2/1.51.abstract

http://www.bris.ac.uk/social-community-medicine/people/esther-m-crawley/pub/292703

http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-16-S2-P71

http://download-redirector.springer.com/redirect?ddsId=art:10.1186/1745-6215-14-444&originUrl=

http://trialsjournal.biomedcentral.com/article/10.1186/1745-6215-14-444&contentType=pdf

http://ep.bmj.com/content/early/2012/09/04/archdischild-2012-302484.short

http://www.bmj.com/content/342/bmj.d3956?tab=response-form#bmj_el_266989

http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-217

http://adc.bmj.com/content/94/10/752.short

http://adc.bmj.com/content/94/10/757.short

https://adc.bmj.com/content/98/6/425.full

And finally, you’re asking us to accept the Oxford criteria for patient selection?

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[Yogi]

Remember that Crawley and AFME got together for child prevalence study last year and many members expressed concern on AFME s Facebook page. AFME deleted all comments and said they were ALL DEFAMATORY!!! Not some but all.

It is AFME we are going to write to with our open letter and who will be representing us patients and we are expecting to have open communication with us.

Can someone who is on Facebook copy all the comments re MEGA over here in case they are deleted from all our patient representative Facebook's pages for asking reasonable questions.


Crawleys prevalence of CFS is 1.8%

Therefore 1 in 56 have ME At school

Prevalence at Age 16

In a study[21] published in 2016 using data from almost 6000 children in the Children of the 90s Project[22], Crawley and her team concluded that the prevalence of CFS at age 16 was 1.8%. However, the children were included as having CFS on the basis of questionnaires, no doctors were involved in the diagnosis, and there was no attempt to exclude other fatigue-related conditions except depression. If children reporting depressive thoughts were excluded, the prevalence was reduced to 0.6%, but the 1.8% figure was highlighted in the media. BBC Radio 4 coverage[23]described the condition studied as ‘ME also known as chronic fatigue syndrome’. Dr Charles Shepherd of the ME Association wrote to express concerns about the methodology used but the journal did not publish his letter[24]


.

 

[Chrisb]

I have a suspicious mind and sometimes I wonder about the use of diversionary tactics. Someone has set a hare running and we are all dutifully following it. It has taken our minds right off PACE.

There seems to have been little good reason for the production of this petition at this time, especially as it was so badly underprepared. The public face of AFME does not seem capable of such deception, but who knows what the non public face is. I would not be at all surprised to find that this was standard operating procedure.

 

[Countrygirl]

I have a suspicious mind and sometimes I wonder about the use of diversionary tactics. Someone has set a hare running and we are all dutifully following it. It has taken our minds right off PACE.

There seems to have been little good reason for the production of this petition at this time, especially as it was so badly underprepared. The public face of AFME does not seem capable of such deception, but who knows what the non public face is. I would not be at all surprised to find that this was standard operating procedure.

@Chrisb Very good point. I think we do need to bear this in mind and not let it distract us from the scandal of PACE. It certainly has diverted our attention .................beware of diversionary tactics.