The following are comments and questions from members of the public posted on Prof Perry’s blog when it originally appeared on a previous MEGA website, and his reply.
Dr Nancy Klimas director of Institute for Neuro Immune Disorders has not needed a BPS disciple for patient involvement why should UK research differ from that of an internationally recognised expert
Possibly because the Institute for Neuro Immune Disorders is part of a college of osteopathic medicine? Osteopathic doctors are largely body oriented, being still manipulation trained. It appears that osteopathic psychiatrists would be closer to a UK neurologist. That being the case it seems unlikely that an institute in a college of osteopathic medicine would have anyone proposing a biopsychosocial model of anything on staff?
Neil, “That being the case it seems unlikely that an institute in a college of osteopathic medicine would have anyone proposing a biopsychosocial model of anything on staff” So with that view, you suggest that none of the biomedical scientists in MEGA should be involved with the pseudoscientists in MEGA. I’d not looked at it from the angle that perhaps the scientists should go. I’d prefer to see the pseudoscientists/psychosocial counterparts go from MEGA.
Andy, I suggest nothing of the sort because there are no pseudoscientists on the MEGA team. You may not agree with individuals but that doesn’t make them pseudoscientists.
Neil, Dr Nancy Klimas is an osteopath in which universe?
Harry, If you check my comment you will see that I was talking about the institute which is part of the Nova Southeastern University College Of Osteopathic Medicine.
…and how does MEGA hope to achieve even a proportion of this magnitude of sample size? Even with all those samples, you found no causation for Alzheimer.
One man, Alan MacDonald, with focused research, found nematode worms carrying Borrelia having caused damage to Alzheimer sufferer’s brains in all autopsy’s. His research has been replicated, has yours?. There are clearly plenty of funds in the study and time before the NICE review to the get a psychosocial view on the mental health questionnaires out which is very concerning. However, there’s far from enough funds to complete the biomedical side of the proposed study, especially of the size quoted or to include a representative proportion of the true severe; let alone enough funds to support a study of the size needed. A pseudoscientist driven study designed to fail to find biomedical causation IMHO.
Lots of marketing, no substance.
A little off topic – but where is this research on Alzheimers? A search on pubmed for ‘Alzheimer nematode Borrelia’ gives no results.
Neil, Alan MacDonald’s papers are here: http://alzheimerborreliosis.net/research/ (Google search with his name found them).
Rosalind, Still can’t find any peer reviewed publications about nematodes carrying borrelia causing damage to Alzheimer sufferer’s brains?
The problem is a complex multi systemic disease which studies on strictly defined patients with the neurological disease as defined by the CCC and ICC criteria are shedding light on the pathophysiology outside the Uk. Inside the UK only Invest in ME is doing quality work. PACE and FINE authors spent millions of pounds on a low tech study that set back rather than enhanced research. High tech studies are needed which comes with a high cost and hence it’s only feasible for relatively small study samples.
Studies on me/CFS should be on the disese not vague mental health disorders as per this proposal.
I don’t follow this. How is this study proposing to look at “vague mental health disorders”?
Neil, “I don’t follow this. How is this study proposing to look at “vague mental health disorders”?” You don’t follow it because you refuse to accept how weak diagnostic criteria such as the Oxford or NICE allow or promote their inclusion. I think it’s crystal clear from the comments on this petition, that patients and outside scientists need to be consulted for the design of MEGA because views such as yours demonstrate just how much ignorance of ME goes on in the world of ME research and medical practice.
Patient support was said to have been required for funding. With Hugh Perry involved, perhaps as an esteemed researcher for Wellcome, he could get this mess of a design study opened up for proper public consultation long before any application for funding is made.
It does appear to many that MEGA has been designed to fail in terms of biomedical findings and succeed in terms of pseudoscientific findings; certainly by the time the NICE review happens, which is a key date for pseudoscience.
The damning report on PACE has put much doubt over any efficacy for GET and of course, therefore the safety of the MAGENTA and FITNET trials on children, some of whom will purportedly be severely affected. The MAGENTA trial claims no harm, so with the reanalysis of PACE, there’s a real potential for successful legal claims should any of those children be harmed in that trial. Pseudoscientists will do whatever they can to protect their careers, their prestige and their family lives and given that different people have different objectives, perhaps even at the expense of sufferers. If pseudoscience can interpret questionnaires etc. from MEGA to support their previous assertions, they will surely try to do that consciously or otherwise. MEGA is pseudoscience’s opportunity to ignore what patients need, perpetuate the NICE guidance and it’s ideas about GET and CBT, which will prevent any progress for sufferers and further funding of biomedical study. We know from one study (which you can search for) that 40% of people diagnosed with ME don’t have ME. We know that many with ME are being given differential diagnoses because clinicians can give a different diagnosis to those if that might have MUS. We know that patients want pure biomedical science to include the full range of ME, not a range from general fatigue to moderate ME which seems to generally be the current state of play.
Patients want the insistance by the few that GET and CBT are answers for ME to be extinguished. The inclusion of pseudoscience has to be removed from MEGA if people want clear answers from this study. The inclusion of pseudoscientists can only muddy the waters.
Andy, the N.I.C.E. criteria are a fairly robust set of diagnostics requiring the characteristic P.E.M. along with other symptoms alongside fatigue. As to your comments on experimental design; as you can confuse the basic scientific procedures proposed with a completely unrelated journal publishing group based on a similarity of name you’ll excuse me if I suggest that your knowledge of the area might be lacking.
Neil, incorrect. We’ve argued this before, so not going round in circles with you. You’re clearly determined to support the psychosocial’s involved, so wasting my beath with you. You refuse to see what’s in front of your eyes and choose to believe only what you want.
Given your comment, I guess you’ve deleted the post re extrapolation, so we’ll leave it there. However, that’s an example if you want one.
Neil, Peter White suggests the study of people with anxiety, depression, stress etc…. why? The first step is to characterise Me/CFS then once you have a biomarker move forward. The large scale studies of people with alzimers were on people with alzimers and not people with alzimers and some other people who don’t have the core diagnostic signs of alzimers.
Adrienne, Peter White may suggest that – but this study has said that they will be drawing people from the N.H.S. C.F.S./M.E. clinics so they will have a diagnosis of C.F.S./M.E. not anxiety depression or stress. The whole point of the study is to characterise the biomarkers in that population and move forward.
Andy, given that I’m going by the NICE written guidelines I’m going to have to say that you’re wrong. I’ve not supported the psychosocials because this isn’t a psychosocial study; I’ve supported MEGA because it’s a solid biological study. Perhaps if you had a little more grounding in the area (not confusing the perdatory journal publishers OMICS with the well established scientific research process of -omics would be a good start) you might understand what it is aiming to do.
Neil, you need to read what Peter White is as he says that it might be too onerous for the patients to use the CCC and ICC criteria- give us a break. PW.
To onerous to actually record a person’s symptoms?
What sort of a study is this?
It may be to onerous to have everyone do the 2 day CPET test but symptoms can be obtiwned from the patient or the carers.
If the severely ill are to be studies then it is important that the need to protect them from long winded onerous questionnaires is recognised and that the carers/family can provide as much of the history as possible and quantifying OI is nit carried out.
ME/CFS has clear easily mesuranle signs eg elevated heart rate after exertion – exertion may he just rolling over in bed.
NICE clinics only have the relatively well and offer CBT and GET which are ineffective and sometimes harmful for people with Me/CFS so it’s pretty hard to see how on earth that a study of such people will be representative.
The problem with PW and EC is the history of misleading publications.
The problem is not what they are studying which isn’t known as they want to spend millions of pounds collecting samples that they don’t have the money or time to test.
A bio bank of NICE samples is valueless whereas a biobank of CCC and ICC samples have validity and could be used to compare results with other countries.
Adrienne, where to start? MEGA are proposing to take details from patients so patients can have multiple diagnostic criteria. Any biological findings can be mapped back to patients to see if any of the criteria have any validity. As you’ve already posted, even CCC/ICC patients are heterogeneous so restricting yourself to them won’t give you any sort of “pure CFS/ME” group; it’s becoming increasingly apparent no such thing exists.
Everyone has an elevated heart rate after exertion. There’s no “raised heart rate after exertion” criteria for CFS/ME so how could you possibly use it as a marker? Even if you could it certainly wouldn’t be any sort of definitive marker as those with heart conditions PoTS or even just the very unfit would show similar profiles.
NHS clinics by no means “only have the relatively well” as I’ve told you multiple times now I’ve been at times severe, I’ve had long periods where I’ve been completely bedbound and unable to move or do anything. All that time I’ve been under a NHS clinic. Repeating a false claim does not make it any more true.
How do you know they won’t have the money to study the samples? High throughput screening costs have been dropping precitously. You can now get an metabolomics screen from the NIH metabolomics center starting from $69.00. You can get a pretty comprehensive genetic analysis done commercially from the likes of 23 and me for about $100.00. These are commercial rates and take no account of the economies of scale you would get from a population study the size of M.E.G.A. and ignore the fact that the people nvolved have the facilities to do these tests in house dropping the cost to personel and consumables.Even full sequencing of an entire human genome is now in the order of $1k and take about a day to do.
Whatever their history M.E.G.A. is not PW and EC and to try and resolve it back to two members and assume that because of their particular history (which your reading of other people may not agree with) M.E.G.A. is dubious / biopsychosocial / whatever with no regard to the reality of what the study holds no water.
M.E.G.A. is not proposing a biobank of anything, they are a study not a storage facility. As pointed out above they are planning on taking details so that those patients that also fullfill the ICC/CCC criteria can be identified then their data can be compared with other countries. Ditto Fukida etc.
Peter White actually states that it might be too onerous for the patients to categorise them against CCC and ICC criteria?
All that is being requested is that people with ME/CFS are studied, the fact that this is a big issue is quite gob smacking.
One abnormality in people with ME/CFS is an elevated heart rate at rest after exertion. My suggestion was that if you are serious about identifying and characterising the disease you start looking at the known abnormalities found in people with the disease and identifying known sub groups eg various forms of orthostatic intolerance, multiple chemical sensitivities …..
If the patients are sourced from NHS they will presumably already have been identified as having ME.
Why therefore is it a problem to screen them for ME/CFS – CCC and or ICC so that any results can be compared with the USA and other countries results.
At this stage from what I’ve read the initial request is for around. 9 million pounds for a biobank of samples from 12,000 people.
Directly from the people who took 6 years and 5 million pounds to study 641 people 12-15 times over a year. At a cost of around 8,000 pound sterling per person.
Just imagine what Invest in ME could do with that money and how far further ahead we’d be now ???
Neil, I completely disagree NICE are robust criteria. They are not world recognized ; they are old and were designed basically to be a catch all and encompass all those with anything above idiopathic fatigue, which isnt the CFS or ME used elsewhere; unlike the IOM and ICC Criteria they were not AFAIK created by world renowned experts and based on careful review of the latest science and they dont require PEM but a vaguer PEF .At the recent IACFSME Conference which sounded really vibrant and cutting edge Lily Chu presented on PEM, she defined it something as multi symptom and prolongued , not doing extra tired after exrrtion. Requiring one symptom on top of fatigue doesn’t fit the emerging evidence and changing narrative of this as a multi system disease
Kathryn, The NICE criteria doesn’t require fatigue plus one symptom; it requires fatigue plus the key post exertional malaise (and yes they do specify post exertional malaise not post exertional fatigue) plus at least one other symptom.
I think the problem is the study will miss many if not most of those who have true ME. All severe sufferers and many moderate will never get as far as NHS clinics. Most longterm sufferers won’t be NHS outpatients because they will have long ago given up on the type of treatments (CBT/GET) that are routinely offered. The older and sicker people are the less likely they are to have companions to accompany them to appointments. They simply give up. And these are the people whose disease has proved the most devasting and intransigent. So the study may be interesting and it may tell you small amounts about people with mild fatigue and other types of fatigue but I don’t think it will tell you much about people with ME. Really it’s like doing a study on homelessness by visiting people who live in houses. Pointless.
I fall into the moderate / severe group (depending on how I am that day / week / month) and I’ve been under an NHS clinic for many years now. I’ve also always refused CBT and GET and still found them very supportive and helpful. When I’ve not been able to attend I’ve had phone appointments. I’m certainly not the only person in this situation.
As to true M.E.; no-one knows what true M.E. is or even if there is such a thing or a collection of sympromatically very similar conditions. Without this sort of widescale research we’ll never know. If you can I would heartilly recomend watching the video posted by Rosalind Smith above which gives an excellent overview of the research proposed.
Neil, the ICC and the CCC define ME/CFS and ME strictly and it’s pretty clear that this neurological disease is characterised by highly abnormal post exertional exacerbation of symptoms on exertion.
This is not fatigue and it is accompanied by abnormal physiological signs eg elevated heart rate in response to exertion.
ME/CFS is being identified by a number of researchers and they are finding the disease extremely heterogeneous even within the IcC and CCC criteria.
Why if the study is on people with ME/CFS wouldn’t they be the people in the study to start with.
The USA and other researchers are finding plenty of abnormalities and biomarkers what hasn’t happened is validation of these biomarkers and comparison of the biomarkers to other similar disease groups such as Parkinson’s, multiple scelerois, diabetes…..these diseases also have a post exertional exacerbation of symptoms on exertion component.
I’ve seen the same grey face in a person with severe diabetes the day after too much exertion as a person with ME/CFS.
The problem is Peter Whites inclusion of depression/stress/anxiety patients etc…in the initial hunt for the disease and without strict criteria the worry test this cohort of patients may nit have ME/CFS and might cloud the picture.
Adrienne, Exactly. They are finding the condition extremely heterogeneous even in the ICC / CCC criteria. This shows that it’s most likely a number of conditions that fill the space we call CFS/ME rather than it being a single homogeneous condition. That being the case how can you say there is a true M.E.?
There is no inclusion of patienst with depression/stress/anxiety etc. The patients involved will be from CFS/ME clinics so will have a CFS/ME diagnosis which excludes depression/stress/anxiety as causes for their symptoms.
Neil – my post went in the wrong place please see above.
As GET was raised, for all those that live in Sheffield, it’s interesting to note that Shefield has the most votes to stop GET trials, after Bristol. I think that says quite a lot about how people regard the medical ‘care’ in Sheffield.
Actually it says precisely nothing about how people regard medical care in Sheffield. I’m under the ME clinic here, I’ve never had GET, I think the service is excellent, I signed that petition. You’re trying to conflate two unrelated things.
Neil, it seems simple all we actually want is for research into ME/CFS to be restricted to CCC and ICC defined groups UNTIL biomarkers are found.
People who have published misleading, poor and what appears to be fraudulent research barred from participation.
People with links to the insurance industries barred from participation.
Objective measures of disease severity where patient well enough- eg heart rate elevation on exertion, othoststic intolerance…..
Patients with comorbid mental health issues to be excluded from research as is done with research into the causes/treatments for other chronic illnesses.
These are pretty basic fundamental scientific principles – the fact that MEGA struggles with them appears indicative of so,etching fishy.
Adrienne, You have yourself posted how parients with a CCC/ICC diagnosis still show a a heterogeneous condition. So what your suggesting is that you take a heterogeneous subsample from a heterogeneous population. That will achieve nothing apart from making it difficult to generalise your findings to the rest of the population.
Claiming fraud is a very serious charge. Do you have evidence?
What you are suggesting as objective measurements don’t apply to the entire CFS/ME population. Not everyone with elevated heart rate has CFS/ME. (In fact the CCC document suggests that under exertion heart rate in CFS/ME may be reduced compared to the control population.) If there were objective measurements then they would be used in diagnosis.
Mood problems (e.g. labile mood, depression and anxiety) are all fairly symtpomatic of CFS/ME because of the cognitive involvement of the condition. How do you suggest that symptomatic depression and comorbid depression (for example) are differentiated and why would it even matter?
Exclusion of patients with co-morbid mental health issues from studies and clinical trials on other chronic disorders is certainly not the norm. It may be done if it would would cause problems with the specific protocol used but is by no means the rule.
Neil, what I suggest is that the patient group defined by the CCC-ME/CFS and or ME-ICC is used.
The fact that this group is heterogeneous in itself may make the task harder the sample should be as broad as possible within the diagnostic criteria or targeted where the first break though may be found.
Eg. Ron Davis targeting the severely ill.
The NIH targeting acute onset.
What I am saying is to look for and measure objective physiological signs a step is done in other diseases.
The work of Peter White appears fraudulent or extremely misleading at best, in my opionion.
Adrienne, Ron Davis targetted the severely ill and then said what needs to happen now is the same approach needs to be applied to the wider CFS/ME population which is exactly what this project aims to do.
Using a tight protocol for heterogeneous group within a larger heterogeneous group only means that you are artificially restricting your potential sample size and that you’re data may not be applicable to the population. A heterogeneous disease space means that all symptomatic criteria are to a greater or lesser degree arbitary and it may be that none have any validity when the underlying biochemistry is examined.
You’re entitled to your opinion of course but why should a group blacklist people that you don’t aprove of. If there was hard evidence of fraud then fine but blacklisting based on opinions seems not particularly sensible.
Neil, you are ignoring the fact that ME-ICC and ME/CFS-CCC define peole with a neurological disease that has physiological abnormalities and the core diagnostic feature of post exertional exacerbation of symptoms on exertion.
Fatigue is the most disabling symptom of Parkinson’s, multiple scelerosi and many other diseases – if you think it’s a good idea to include all fatigue causing diseases in the study why not include them as well?
The focus on one symptom is bizzare- look at all the amazing work and studies at the International Association for ME/CFS conferemce ….. progress is being made by peole focusing on the neurological disese.
Meanwhile in the Uk….. FITNET is proposed a technique the Dutch found showed no improvement at follow up….
Adrienne, and you are ignoring the fact that ICC and CCC are still only based on symptoms. There is no guarentee that they give you an any more homogeneous population than the NICE criteria. I don’t think it’s a good idea to include all fatigue causing conditions and have never said anything remotely like that. What is wanted is information for those people who have been diagnosed with CFS/ME (i.e. based on the NICE critera – fatigue + the key P.E.M. + other symptoms and excluding all known diseases of that symptom profile) so we should look at them all.
Reply from Prof Hugh Perry:
Thank you for you comments. Perhaps I should have made clear that it is not necessary to have many tens of thousands of individuals involved in a GWAS study but very large studies do identify even genes with very small effects. As Chris Ponting described in his blog (20 Oct) GWAS studies involving a few thousands of people can generate important and novel insights. The first evidence of innate immune genes being involved in Alzheimers’ disease was found with a GWAS of 4,000 cases and reproduced in a study of about 2,000 cases and 2,000 controls (Harold et al 2009).
The point of referring to Alzheimers’ disease as an illustration of the power of GWAS is that the involvement of the immune system in a degenerative disease of the brain was really unexpected, but opens new avenues for investigation, diagnosis and treatment. The genes uncovered in a disease are not dictated by the discipline of the investigators – they are revealed in an unbiased fashion by the biology and that is the excitement and power associated with this approach. The MEGA study may find genes associated with specific pathways of the immune system, it may reveal genes associated with particular metaboic pathways. Whatever the findings, it offers new and unbiased routes into understanding this very complex condition.”
I urge the MRC to ring fence guaranteed funding for CFS and ME to encourage researchers in to the field as they did with HIV for 7 years from the 80s. If you compare the progress our field has made with HIV it is tragic. NICE top Officials, who currently have CFS on their static list as the field is so stagnant, said it’s tragic more research and more progress hasn’t been made for severely disabled sufferers. Action for ME CEO in 2012 called for more ring fencing, MRC refused. Therefore whatever the merits and flaws of the MEGA trial as presented so far, & not due to complete for years with unknown direct application in terms and treatment , the overwhelming sense from patients is that UK establishment is failing to act sufficiently for CFS and ME.
Andy D commented:
Hi Hugh, just wondered if you can give your opinion on why it is worth spending all this money on MEGA when apparently all that is needed is CBT according to your future colleague Esther Crawley. http://www.bbc.co.uk/news/health-37822068. I’m particularly curious as the Dutch study that this is based on shows null results at long term follow up https://www.ncbi.nlm.nih.gov/pubmed/23669515
I should have thought the answer to that was blatantly obvious! Even if you take the results of the first trial, there are still the (nearly) 40% that don’t ‘recover’. Do you seriously think that Esther Crawley is unaware of this? You are talking about a Paediatrician who is having huge numbers of patients dumped on her by doctors and parents all over the country who don’t know what else to do with them. Some she finds she can help towards recovery – principally through helping them to manage their activity levels a bit more effectively. However, a significant number don’t recover even with that help.
Can you step outside your own concerns for just a moment and imagine what that does to a doctor? EC tries to do what she can – which is actually a good deal more than many doctors. (She’s not washing her hands of these patients or trying to pretend they don’t exist). However, she is quite well aware that there are many patients who won’t recover as a result of these treatments – FITNET or no FITNET. And then there are those patients who never even make to her clinic – of which she is also going to be aware. So it’s absolutely no surprise to me that she would be behind MEGA because it may well open the door to new treatments that are likely to be so much more effective than what she can presently offer – treatments that will target the biochemical and physiological dysfunctions in her patients. Do you seriously think that, as a Paediatrician, she wouldn’t want this?
Rosalind, brilliant comment! People go into medicine and medical research because they want to help and they want to make people better. They may get things wrong, thay may make mistakes but claims of widespread fraud, malevolence or agenda pushing conspiracies are barely rational.
I find myself wondering what exactly the NHS clinics are able to help you with? I am not against a wide scale study but I think it has to include the same proportion of severe patients as exist within the patient population. How else can the disease be understood? How can patients newly presenting with it be protected or offered appropriate treatments if scientists fail to study those who have the most severe form? Anyway I think severe sufferers are owed decent research that includes them. When I referred to true ME I meant according to the CCC or ICC criteria. I find myself very interested in Navaiux’s research which seems to point to multiple triggers but the same disease.
In a heterogeneous disease space there is no “true CFS/ME” and thinking of the condition as a single disease is unhelpful. When all you have to go on is a set of symptoms it’s even more unhelpful.
Ideally yes the studied population would include the severely ill at the appropriate level, but that’s hard to know when this number is places between 10 and 25%. That’s quite a range so how do you know you have the right number? Realistically the only way around this is either to do a full epidemiological study (a small one is being done in Newcastle but then you get into is Newcastle representative?) or to go with what you have access to.
There has already been some -omics work done on the severely ill by the OMF so that may help to mitigate any percieved or real holes in the M.E.G.A. data.
The work by Naviaux was interesting but he said in the paper that the data he got looked a lot like other hypometabolic diseases. While it may be the case that CFS/ME does have some hypometabolic features those found may not be unique enough to identify between different hypometabolic conditions on their own. Naviaux looked at a subset of metabolic pathways, MEGA is planning to look at them all which would give a much clearer picture of what is going on and is more likely to give a unique diagnostic key.
As to what the NHS clinics have helped with, I’ve found they help with day to day dealing with the disases (pacing), provided essential doccumentation for things like the W.C.A., answer questions and give me support when I I want something from my G.P. and am having difficulty getting it.
Neil, I understand that the OMF study and Navaiux studies would need further research. My understanding is that this is planned and will include severe sufferers and other illness group’s.Whether the number for severe ME is10% or 25% it’s still a very large population to exclude. Whilst at the same time probably including people with all kinds of miscellaneous fatigue that is considerably less problematic. If you’re going to include the one then you definitely need to include the other. It remains my belief that it is reasonable to refer to true ME if you fit the criteria I mentioned. And it is these people who suffer from severe PEM who are going to be excluded.
I understand that clinics and GPs can be helpful in dealing with the DWP. I am rather surprised that you still need help with pacing after all this time!! I am afraid that does sound a bit like a justification for the not especially helpful NHS clinics.
Penny, As I’ve pointed out numerous times they are not excluded. The claim that the NHS clinics exclude the seriously ill is simply false.
You may consider that there is some true ME however you would be out of step with pretty much every researcher and the idea that there is one condition to find is likely dmaging to the research effort. As an asside, quite what would you expect the NHS clinics to offer?
Neil, no – the claim that NHS clinics preclude the severe is true. One only has to hear how Crawley publicly defines the severe on the BBC in the past and one only has to listen to how children with ME have their diagnosis changed and pushed into other NHS areas only to relapse badly, including psychiatric and one only has to hear of those being ignored when they don’t improve or those given a new diagnosis of pervasive refusal syndrome when parents challenge the harm being caused. As I said before, you lead a sheltered life; or perhaps you’re best buddies with the psychopaths, erm.. I mean psychosocialists..
Neil, Andy is right. There is no way that the majority of severely ill could attend a clinic. I think I said originally, that if any are able to be moved then they will inevitably be mainly young people. They are the most likely to have the support to leave the house. They are also the most likely to still be exploring avenues for treatment. I have contact with hundreds of long-term severe, some very severe, and moderately affected sufferers. Almost none of them attend a clinic. If they ever have they don’t now because these clinics are not able to help them.
My point that the large section of the patient population especially the long term sufferers will be excluded is entirely valid.
I am not “out of step” I am not arguing that the causes of ME are the same or that ME is the same thing in everyone. But I am arguing that nonetheless it produce a recognisable set of symptoms as in the ICC. This may also be the case with MS. Different triggers similar though not always the same symptoms. Obviously a lot more research is needed. My concern with this trial is that severe and moderately severe patients will be excluded. That it will not be proportionate. These people deserve research and treatment. And I don’t believe that including large numbers of people with miscellaneous fatigue who CAN get to clinics and excluding those with severe neurological ME who CANT, will help the people who I want to see get help. Basically I am saying the money could be better spent.
I don’t intend to continue this conversation with you any further. I sense an ignorance and lack understanding of severe ME which is unusual in a fellow patient and frankly rather odd.