Trial By Error, Continued: The CMRC Affirms Full Support for Libelous Crawley

[lilpink]

For me the fallibility of MEGA comes from people looking at the wrong part of the elephant. Whatever tests they run, metabolomics schmetabolomics, they will be studying rehabilitatatable fatigue and not PEM. They may study PEM as a facet of lifestyle fatigue, for example.

And the emphasis on 'fatigue' per se takes us far away from Ramsay's original diagnostic conditions. Whereas 'PEM' / 'PENE' call it what you want is intrinsic to the diagnosis I fear too many forget (including the MEGA team) the multitude of other symptoms that must be experienced in order to get a proper diagnosis of authentic Ramsay defined 'ME'. Just sayin'..... http://www.cfids-me.org/ramsay86.html

 

[Jonathan Edwards]

From Q. 9 in the MEGA Q & A http://www.megaresearch.me.uk/qanda/
"Patients with ME/CFS will be identified by clinicians in the NHS clinics which use NICE guidance to determine if patients have ME/CFS. This means patients with other causes of fatigue will not be recruited including, for example, those with thyroid disease, diabetes or depression that is sufficiently severe to explain their fatigue. Patients will have been examined, a full history taken and they will have had screening blood tests (to ensure other causes of fatigue have been excluded).We will collect sufficient information on each patient to be able to say whether they have ME/CFS using other research criteria, for example, the CDC [Fukuda 1994] diagnostic criteria, Canadian Consensus Criteria [2003], the International Consensus Criteria [2011] and so on. We will also consider other tools such as the De Paul Symptom Questionnaire for capturing data as well as samples. We will listen to our Patient Advisory Groups in terms of how much data we can collect on different diagnostic criteria. Our advisory groups may recommend collecting less data as patients are so ill."

@jodie100,
This is actually the reason I made a clear decision to warn people against MEGA. The plan seems to be to ask clinicians throughout the country to send in names of people they think have CFS. This is probably worse than self-diagnosis. The important thing is to think through the psychology of what will happen. Most clinicians will be too busy to bother to answer the request. So their patients will not be included. Those that do reply will have to have some incentive to help Dr Crawley with her project. (I won't elaborate on what such an incentive might be.) Once incentivised they will tend to collect together as many patients as they can squeeze into the category of 'those nutters with nothing much wrong with them that Dr Crawley cures', because I know from experience that most specialists in the UK dealing with ME/CFS think that way at heart.

It is well understood in medical research that you do not go about collecting cohorts this way. The proper way to do it is to define a population, usually based on living area, and devise ways of systematically trawling for every case within that area. The Norfolk Arthritis Register is the best example. The School of Hygiene Biobank has used this method, as best it can. It is expensive, which is why the cohort is quite small. But you cannot get a big cohort that is any use on the cheap. The proposal in MEGA is exactly the same bad methodology we saw in PACE. And one should not be surprised. People in science who say they have gathered together all the best experts in the field are usually phoneys, just like in politics. Good scientists are more modest and get on with the work. These 'best experts' turn out to be people who have been chums of Dr Crawley for years.

Dr Crawley used to work in our unit and was quite good at her job. However, what she has said in the last year makes me think that she is about as much a seeker after the truth as Donald Trump. I have been flabbergasted more than once by the insensitivity and self-centredness of her pronouncements. I have a reputation for being very tolerant about people's behaviour but there are times when even I have to call a spade a spade.

 

[lansbergen]

However, what she has said in the last year makes me think that she is about as much a seeker after the truth as Donald Trump.

 

[Valentijn]

What incentive do they have to differentiate between primary and secondary depression beyond 'good science' -- an abstract concept that hasn't seemed to matter to these selfsame researchers in the past?

And when Crawley has studied depression in CFS patients in the past, she has been very misleading by not using the appropriate cut-off points for a depression diagnosis, yet going on to refer to the CFS patients as being more depressed, and having higher rates of depression. Since the depression scales she prefers are the ones which conflate physical symptoms with mood disorders, she can guarantee that patients will score higher.

Don't add that she's the bitter pill we must swallow in order to earn good science. There is something deeply, intrinsically wrong there.

It's a justification of staying in an abusive relationship. She loves her patients, and she knows best, so it's supposed to be okay if she verbally and medically abuses us. We should be grateful for all the good things she says she does, and not focus on the little negatives, right? And gosh, did we have it coming for some of the naughty things we've said about her!

"Patients with ME/CFS will be identified by clinicians in the NHS clinics which use NICE guidance to determine if patients have ME/CFS. This means patients with other causes of fatigue will not be recruited including, for example, those with thyroid disease, diabetes or depression that is sufficiently severe to explain their fatigue. Patients will have been examined, a full history taken and they will have had screening blood tests (to ensure other causes of fatigue have been excluded)."

This means they consider the diagnosis at the clinics to be satisfactory (it isn't) and won't be conducting any tests to ensure that a basic misdiagnosis hasn't been made. They talk of blood tests purely in the past tense, and there is a good chance many clinicians will have skipped even basic testing due to the supposed harm it does to presumed psychosomatic patients.

"We will listen to our Patient Advisory Groups in terms of how much data we can collect on different diagnostic criteria."

They can (and likely will) listen and ignore. The advisory group members are bound by a confidentiality agreement, so will not even be able to inform other patients of the specific ways in which they are being ignored. This is not a transparent process, yet it allows them to make vague statements like the one above, which suggest patient support without proving it, while forbidding public disagreement from the group.

Our advisory groups may recommend collecting less data as patients are so ill."

There are very very few patients who want less data collected. We're desperate for answers, so this sounds like a prepared cop-out for limiting data collection to psych questionnaires for Crawley to play with. I expect it will sound something like "Oh, we wanted to run biological tests, but we consulted with the patient advisory group and came to the decision that it would be too much for the participants." And again, the nondisclosure agreement will discourage members of the patient advisory group from clarifying the situation.

... so I just viewed it as discussing the scientific findings of one study and did not find it in any way offensive or view it as applicable to everyone with M.E.

It was a highly flawed study, just like the others. And the tweeted comments accompanying those slides indicate that the topic was CFS, not "Chronic Disabling Fatigue." It would suggest that Crawley did not differentiate between her fatigue findings and ME/CFS, and thereby misled her audience.

I think I am broadly aware of them, as I do read this forum quite often, I tend to view it as the problems mainly relate to her treatment recommendations rather than to her views on the causes of M.E., which is what MEGA would be studying. I find her epidemiological studies interesting.

No, the problem with her research is that it sucks. That has nothing to do with her treatment recommendations, though those do suck as well.

 

[lilpink]

No, the problem with her research is that it sucks. That has nothing to do with her treatment recommendations, though those do suck as well.

YES!

 

[Barry53]

It is well understood in medical research that you do not go about collecting cohorts this way. The proper way to do it is to define a population, usually based on living area, and devise ways of systematically trawling for every case within that area.

This I can understand. There must be all manner of selection-bias traps to fall into, and anything that hints of subjectivity by anyone in the selection chain, must surely risk a whole cascade of errors.

 

[Snow Leopard]

The proper way to do it is to define a population, usually based on living area, and devise ways of systematically trawling for every case within that area.

A population/community based study in the UK would be wonderful!

 

[A.B.]

If you do a population based study, I suspect it would bring to light great tragedy: many patients that have fallen through the cracks of the healthcare system, are seriously ill and without any help or treatment, and don't even show up in any registers or statistics.

The patients on social media that have at least a minimum of visibility are just the tip of the iceberg.

 

[Large Donner]

No, the problem with her research is that it sucks. That has nothing to do with her treatment recommendations, though those do suck as well.

I'm so tempted to graffiti this all over the walls of the town.

 

[user9876]

And when Crawley has studied depression in CFS patients in the past, she has been very misleading by not using the appropriate cut-off points for a depression diagnosis, yet going on to refer to the CFS patients as being more depressed, and having higher rates of depression. Since the depression scales she prefers are the ones which conflate physical symptoms with mood disorders, she can guarantee that patients will score higher.

I think some of her early work used the HADS scale which is unreliable and particularly when used with other illnesses. Coyne wrote a paper on the scale saying like Elvis it is dead but there are many sightings.

 

[Snowdrop]

I wonder why those defending MEGA keep skirting around the fact that they're making no effort to utilise best practises in the field, particularly with regards to diagnostic criteria, outcome measures, biobank collaboration etc. The lack of collaboration in general is a problem across the field, so many research groups around the world don't seem to share. It's really disappointing.

The answer is most probably that most people (myself included) do not have a solid grasp of what best practices look like in science. And even those who do, I would argue, need to maintain a critical attitude toward BP as they can (I presume) be flawed too. I suspect that there are even science literate people who don't have a solid grasp and/or critical view of Best Practices.

This is the type of discussion that would prove fruitful if laid out clearly and in basic terms so that the rest of us can have a better understanding of how science ought to work and be able to see more clearly why MEGA is not what it might first look like (apart from the non confidence in EC).
J Edwards has done this to an extent.

I also wouldn't mind having someone sharing an informed opinion on whether the confidentiality agreement could be enforced should someone wish to 'spill the beans' after the PAG dissolves. Perhaps @Valerie Eliot Smith ?

 

[jimells]

Don't add that she's the bitter pill we must swallow in order to earn good science. There is something deeply, intrinsically wrong there.

It's interesting to compare the situation in the UK with the situation in the US. On both sides of the Atlantic the important official agencies (CDC, NIH, NHS, MRC, etc) have adopted a policy of non-research - a policy that *still* has not changed. That policy has been implemented with the same strategies of patient blaming and various excuses as to why there is no biomedical research money going to competent researchers.

And without failure, each and every project that has the appearance of helping patients includes a giant poison pill that does eventually get swallowed. Here is an example from the reference @A.B. gave above:

AFME PACE Q&A

11. But why do it at all? Surely enough has been spent on CBT and GET?

The researchers were going to put in for a trial of GET and CBT without pacing, with every chance their bid could be successful.

We at Action for M.E. also think that too much funding has gone into CBT and GET research... If it was only those two we wouldn't have given our support.

However, the researchers wanted to compare CBT and GET with pacing... Since there have been no published trials of pacing, we believe this justified our support.

The threat was very clear: if patients want research into pacing, they must support PACE and research into GET and CBT. (AFME dismisses the fact that patients actually want research leading to effective prevention and treatment in another part of the same document.)

One can see the same approach in the US. For example, there were arbitrary constraints imposed on which research papers the IOM committee was allowed to consider. The P2P report (remember that million-dollar fiasco?) committee was not allowed to be composed of actual illness experts. The current in-house NIH study was forced to include researchers known to be unacceptable to most knowledgeable patients. CDC is still publishing rubbish "CFS" studies, while dragging their feet on the Multi-Site Study.

To get MEGA, patients must accept Crawley.

This is a great strategy, because it causes so much division among patient advocates, and there's really no way for us to defend against it. Over the decades, I have seen the same tactics used successfully many times.

NIH Director Collins is right about one thing: the UK BPS brigade doesn't have the right skill set to pull this off (the strategy of divide-and-conquer), while in the US one can see that the NIH has apparently hired a competent public relations consultant to blow enough smoke to calm the angry bees. That's not surprising, considering that the public relations industry was invented in the US in order to sell The Great War.

Patient advocates are currently focusing their efforts on the UK BPS Brigade because they have made themselves such an easy target. We are fortunate that not only is the UK BPS Brigade weak and crumbling, it is also the keystone to the whole rotten edifice.

 

[Jo Best]

I think I am broadly aware of them, as I do read this forum quite often, I tend to view it as the problems mainly relate to her treatment recommendations rather than to her views on the causes of M.E., which is what MEGA would be studying.

@jodie100,
Dr Crawley used to work in our unit and was quite good at her job. However, what she has said in the last year makes me think that she is about as much a seeker after the truth as Donald Trump. I have been flabbergasted more than once by the insensitivity and self-centredness of her pronouncements. I have a reputation for being very tolerant about people's behaviour but there are times when even I have to call a spade a spade.

My introduction to Esther Crawley was upon finding out about the SMILE trial on social media in 2010.

I assumed she was nice-but-dim, as it didn't occur to me that any paediatrician, let alone one specialising in a neurological disorder, would wittingly conduct unethical research; put children at risk of psychological or physical harm; deny them and their parents/guardians of informed assent or consent; and mislead the ethics service.

I was shocked by her behaviour, but more so by public-funded bodies closing ranks around her when they are supposed to be safeguarding the health and wellbeing of patients participating in research, such as the regional and National Research Ethics Service, National Patient Safety Agency, and General Medical Council.

The message to critics of the SMILE trial was essentially that the views, opinions, thoughts and feelings of Esther Crawley override the rights and safety of sick children and all official UK research guidelines.

This was followed up with full support and spin of the UK Science Media Centre.

Now Esther Crawley proudly displays on her conference slides a list of various recipients of queries, concerns, or complaints against her work, casts her critics as anti-science and libelous, presumably with full confidence that she can get away with doing and saying as she pleases, in the comfort of the protection of the establishment.

I suspect this is why several people have asked David Tuller to sue Esther Crawley for her accusations of libel (I accept his decision and his reasons) because legal action has been the only course of action as yet to succeed in getting at least some of the truth out to the wider medical research community.

Esther Crawley should have been prohibited from conducting further research back in 2010 imo, whereas on the contrary, she has been granted £millions more, and her career progresses. I hope that this course of action takes effect in the interests of science, ethics, the public purse, and most importantly, patient safety.

For one, by taking legal action off the table, I occupy the moral high ground. That allows me to slam Dr. Crawley and the CMRC for their awful behavior as much as I want.
Source:http://www.virology.ws/2017/05/15/t...mrc-affirms-full-support-for-libelous-esther/

SUMMARY OF CONCERNS RAISED BY ‘frown at SMILE’ in 2010

Failure to –
• process SMILE as a clinical trial
• meet official guidelines for research in children
• take account of existing (and new) research on children with ME/CFS
• justify why the research should be done
• disclose risks (psychological and physical) of the LP intervention
• protect the safety of trial participants
• informed consent in breach of the Declaration of Helsinki
• declare financial incentive for trial participants
• declare conflicts of interest of key investigators/collaborators in the study
• ensure impartiality of ‘Independent Advisory Group’

Source: https://frownatsmile.wordpress.com/2016/02/14/smile-trial-summary-of-concerns/

 

[slysaint]

Esther Crawley should have been prohibited from conducting further research back in 2010

https://www.youtube.com/watch?gl=SN&feature=plcp&hl=fr&v=FGtChQPNUQw

eta: music at beginning is loud but watch the screen...........

 

[Snowdrop]

Couldn't listen. The music overlay is way too loud.

 

[Dx Revision Watch]

Couldn't listen. The music overlay is way too loud.

@Snowdrop If you can cope with a transcript, there is an unofficial transcript of the entire, original presentation archived on ME agenda site here:

Dr Esther Crawley: Transcript of Presentation: The Future of Research in CFS/ME

Dorset CFS/ME Society
Annual Medical Lecture

27th March 2010

http://wp.me/p5foE-3ay

 

[Snowdrop]

@Dx Revision Watch

Thank you. Will have a look.

 

[trishrhymes]

@Snowdrop If you can cope with a transcript, there is an unofficial transcript of the entire, original presentation archived on ME agenda site here:

Dr Esther Crawley: Transcript of Presentation: The Future of Research in CFS/ME

Dorset CFS/ME Society
Annual Medical Lecture

27th March 2010

http://wp.me/p5foE-3ay

I've just read quickly through the transcript. I knew Crawley seemed to have a very wide view of what CFS is. I hadn't realised quite how wide.

She seemed to be saying any child missing at least 1 day a week of school with fatigue over the last 6 weeks has CFS.

It was noticeable that she kept saying just chronic fatigue, not chronic fatigue syndrome.

The people who renamed ME as CFS have a lot to answer for.

I was shocked that she seemed to be including kids with migraines and recurrent sore throats as 'subgroups' of chronic fatigue. So she really does use a very wide definition. Ridiculous.

And not a single mention of post exertional malaise.

And even back then she was gearing up for a big gemome study - clearly MEGA has been a long time in gestation, and has been her baby from the start.

Thanks for alerting us to this. Having only started exploring the murky world of ME research recently, I'm still catching up with the back story.

 

[Dx Revision Watch]

Write up which ties in with the video and Suzy C's transcript.

http://www.maartensz.org/meinadam/2010ME/NL100822a.htm

To clarify, the link in Maarten's blog post above:

https://meagenda.wordpress.com/2010/08/18/dr-esther-crawley-discusses-xmrv-and-wpi-march-2010/

is for a partial transcript, posted on ME agenda on August 18, 2010.

The full transcript is at the link I have given in Post #136, which was a later post, posted on October 19, 2010:

https://meagenda.wordpress.com/2010...presentation-the-future-of-research-in-cfsme/

or

http://wp.me/p5foE-3ay

 

[jimells]

The full transcript is at the link I have given in Post #136, which was a later post, posted on October 19, 2010:

https://meagenda.wordpress.com/2010...presentation-the-future-of-research-in-cfsme/

This is a terrific resource. Thanks so much for posting it.

So, next time you go and see one of your clinicians, if we’re lucky with our funding, and we hope we will be, you may be asked to spit in a pot and, if you are asked to spit in a pot, please do, because this is how we’re going to tackle this problem.

The UK is the only place where the clinicians and researchers are working together and we are. We’ve put a grant into the MRC. It has all of the people working in research and genetic research, [they] have all got their names on the application to the MRC. “Please give us £2½ million so we can do this study.”

Please note that this is from SEVEN YEARS AGO - obviously the MRC rejected their application. Now I understand why MEGA applied to Wellcome instead of starting with an MRC grant.

It is astounding to think that Crawley believes the puzzle of ME can be solved by having tired people spit into a cup and fill out questionnaires.