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Invest in ME responds to the IOM report

Kati

Patient in training
Messages
5,497
it is dense and thorough, sometimes heavy handed and for the most part, heavy handed is needed in highlighting the governments' failures in recognizing and reacting appropriately to this disease.

This report should be used in our advocacy efforts.

Here it is.

Thank you Invest in ME.

Highlights for me:

This disease needs a medical specialty and needs it now and it will not be psychiatry.

The report is a major indictment of negligent MRC/NIH/CDC policy over a generation

What a waste of life has been allowed to occur by governments from their failure to monitor progress or listen to continuing and mounting patient concerns; how corrupt and immoral has been the attitude of those leading the organisations which use public funding of ME research, given mainly to researchers who consider ME/CFS a psychosomatic illness?
 
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Kati

Patient in training
Messages
5,497
Im quite impressed with Invest in ME's comments esp with the name as its exactly how I feel about it.

i may not personally agree with everything they wrote, however I am impressed at how responsive this organization has been in these 2 reports from the US, out of their turf so to speak. They understand how important it is to get it right and how these reports affects not only those in the US but also all the patients around the world.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
i may not personally agree with everything they wrote, however I am impressed at how responsive this organization has been in these 2 reports from the US, out of their turf so to speak. They understand how important it is to get it right and how these reports affects not only those in the US but also all the patients around the world.

nods, they are putting a lot of thought and work into it even if people don't agree with it. A genuine group who truly wants to help patients and aren't trying to belittle or cover anything up.
 

Dolphin

Senior Member
Messages
17,567
I think there are some good points to the Invest in ME review.

However, I don't agree with their argument on the name, that it's premature to change the name now:
IiME’s view has been a pragmatic one – that the name will eventually take care of itself once enough data has been
collected from proper research.

In a report which later continually confirms the paucity of research and the possibility that new research can change
things then it seems senseless to us to make a change to the name of this disease at this time, and somewhat
irresponsible.

It also seems a little odd to suggest a name change when the report also states –
“The committee was not asked to investigate the etiology, pathophysiology, pathogenesis, or treatment of
ME/CFS.”
Caution would be the best option in this instance and would advise against a short-term approach to change the
name.

So we wonder why there is a judgement to suggest a change of the name now as expected research findings will surely provide more clarity regarding nomenclature.

Maybe research will come up with the sort of evidence that will lead to a new name quickly. Or maybe it will take a long time (I think there is quite a good chance it will be the latter - given all the different aspects of the illness, research progress is quite slow). In the meantime, I don't think it is good to have "chronic fatigue syndrome" as the main name the medical profession uses for the condition.
 
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Dolphin

Senior Member
Messages
17,567
(Invest in ME do a summary. However it's quite long. Here it is in plain text (it didn't copy well) or people can go to pages 21-26 where it is easier to read)

IIME SUMMARY

The IOM concludes with what patients have been fighting to make known for a generation – to governments, research councils, health services, the media and the public


“Conclusion: It is clear from the evidence compiled by the committee that ME/CFS is a serious, chronic, complex, multisystem disease that frequently and dramatically limits the activities of affected patients.”


We summarise below the points from the report that we feel are worth noting 


- IOM is a respected and influential institute This means that the good points from this report can be quoted elsewhere to aid convincing other healthcare authorities that ME needs to be treated seriously as a systemic disease.


- IOM did an extensive literature review This means that the good points from this report can be quoted elsewhere to aid convincing other


- The proposed new diagnostic criteria are clinical criteria for the US healthcare system


- There was only one European and no UK reviewers involved so it remains to be seen whether the UK and other European health care authorities will adopt this report


- The criteria allow co-morbidities which seems sensible for clinical purposes as anyone can have more than one disease.


- Care should be taken to avoid misdiagnoses and this is why specialists are needed to oversee diagnosis


- Researchers use stricter criteria based on the requirements of their projects and they may sometimes choose cohorts with or without comorbidities. This would be no different from research into any other disease.


- PEM is obligatory not optional for diagnosis and this is the one defining symptom that patients say was missing from CDC Fukuda


- Both the IOM report and the P2P draft report call for more research and highlight the serious lack of research into this area of medicine compared to the numbers of patients involved “Literature on mortality associated with ME/CFS is sparse.”

Also subgrouping was a task to be analysed by the IOM committee but due to the sparcity of research that was not possible.


- The implicit result of the above commentary is a direct condemnation of the research and funding policies of the UK Medical Research Council and US National Institute for Health


- This report is essentially far better than the UK CFS/ME NICE guidelines which were heavily biased toward CBT and GET and did not encourage, for example, further investigation into the promising IVIG paediatric research (Rowe, 1997) which the IOM does


- It is good that the committee declares that ME/CFS is a physical illness, a disease


- The IOM definition and the name goes against treatments such as CBT and GET and contradicts the P2P report in that respect.


- The report states that ME/CFS is a diagnosis to be made and provides good suggestions for asking questions and eliciting medical history as well as assessing supportive symptoms such as sleep disturbance and pain.


There needs to be extensive medical education to make more doctors confident in making the diagnosis but we need centres of excellence and experienced consultants to oversee the education. Diagnosing patients according to them fitting in the diagnostic criteria rather than by exclusion of other illnesses is good.


One of the committee’s most important conclusions is that a thorough history, physical examination, and targeted work-up are necessary and often sufficient for diagnosis of ME/CFS.


This point has often been emphasized by clinicians speaking at IiME conferences too. It is also all the more important to invest in fundamental research that can come up with objective and easily implemented tools for aiding diagnostic accuracy. “First and foremost, listening to patients and taking a careful history are key diagnostic tools.”


- Good to see it mentioned that even if patients do not meet the criteria for this disease, clinicians should address their symptoms and concerns. Patients who have not yet been symptomatic for 6 months should be followed over time to see whether they meet criteria for ME/CFS at a later time.


- The report mentions objective tests such as CPET or tilt test being useful for gaining social security but not necessary for diagnosis due to risk for worsening the patient's condition


- The report calls for research into biomarkers and acknowledged there being sufficient evidence for immune dysfunction despite there not being reliable markers for clinical use yet


- Recognises that most patients never regain their pre-illness levels of health or functioning


- Recognises inappropriate removal of children from their families in some extreme cases – though perhaps more common in the backward UK environment


- Rejects childhood trauma and somatisation as being part of paediatric cases  The IOM recognise the impact on education from this disease for children. The isolation for children affected by this disease in school years is a major factor which society needs to address and schools need to be criticised for their lack of knowledge of the disease and their apathy in attempting to keep children linked in some way to their school class.


- Recognises impact on employment and education


- There was no public consultation as happened in the P2P or UK NICE guidelines


- The report stated that CFS is not appropriate. This aligns with the P2P report The committee determined that the name “chronic fatigue syndrome” has done a disservice to many patients


- It was not totally clear if the recommendation for a name change was to replace CFS or ME or both. The report rejected the long established name myalgic encephalomyelitis (ME) stating there not being enough evidence to justify the correctness of the name and that the name “myalgic encephalomyelitis” does not accurately describe the major features of the disease. Yet, even if one believed that to be correct, it seems to ignore the fact that there are other diseases with incorrect names such as malaria and hay fever and they have not been changed. The UK MRC states that there is now evidence of neuroinflammation in some severe cases of ME. This is no different from for example of poliomyelitis where the mild cases may appear unremarkable and go even unnoticed.


- In place of ME the committee proposes SEID “systemic exertion intolerance disease” as a name that more fully captures the full scope of this disorder. We feel this is not a progressive decision and provides a name not so dissimilar from the ineffectual and inappropriate CFS Both the P2P report and the IOM report fail to move away from the association of ME with fatigue as the main symptom. That ought to have been addressed. They should have recommended dropping CFS and used ME until more is known as ME is well established in the name and even US researchers and clinicians have started to use ME instead of CFS in recent years.


- SEID is a clumsy acronym and many people seem to type SIED already but it is better than CFS. Although better than CFS, and confirming this is a systemic disease, the use of a potentially misunderstood fatigue-associated word means that this will be bound to retain the implication of ME/CFS being a fatigue illness


- Systemic and Disease are easy to accept but Exertion Intolerance will not be well understood by the general public and will be confused with exercise (physical) intolerance only.


- US WHO ICD10CM does not control what the central WHO decide and the central WHO have so far said there is no plan to change the classification of ME away from G93.3


- SEID is said to replace CFS (US WHO ICD10CM code R53.82 which includes CFS not otherwise specified ( CFS NOS) but excludes post viral fatigue syndrome (PVFS) which has the same code as benign myalgic encephalomyelitis G93.3 so ME and PVFS would presumably stay as they are even in the US WHO CM codes


- The criteria are more specific than the CDC Fukuda but wider than CCC or ICC. This may lead to an influx of patients for the few US specialists. Is that the intent? Or is there a plan to train more specialists?


- Is there sufficient infrastructure in place to deal with the large percentage of undiagnosed patients that this report refers to?


Who takes responsibility for the follow up work or will this expensive report end up like the UK CMO, 2003 report whose recommendations were not acted upon  Does anyone currently diagnose ME in the US? If so, which criteria do they use?


- If CFS and ME have traditionally had different criteria as stated in the report and the IOM report used ME/CFS as in the CCC then it was somewhat unclear whether this report meant to combine the two definitions into one


- The P2P draft report calls for agreement on one set of criteria but the IOM report has created criteria for SEID to replace CFS and recommends classification away from fatigue codes ( we assume they refer to R53.82 CFS NOS and not ME and PVFS which are already in the neurological code of G93.3)


- Most ME, CFS or ME/CFS research has been performed using the CDC criteria and more recently the CCC or the combination of CDC and CCC and hardly any research has been performed using the ICC or the Ramsay Criteria. The ICC is based on research that has used CCC or CDC criteria. This just goes on to show that researchers use various criteria and then it is used as evidence for any of the acronyms of CFS, ME/CFS or ME depending on the users and it would be sensible to use criteria that are inclusive for diagnosis but allows for specific phenotypes to be selected for research.


- The IOM panel included ICC signatories Drs Lucinda Bateman and Nancy Klimas. The ICC 2011 states that the panel recommended the use of myalgic encephalomyelitis for patients who meet the ICC criteria because a distinctive disease entity should have one name. So does this mean that the ICC should be used for ME and the IOM report for SEID?


- Less than one-third of medical schools include ME/CFS-specific information in the curriculum


- For years ME and CFS patients have been let down by the disbelieving medical profession and hopefully this report benefits patients rather than cause yet more problems


- The few doctors/researchers that have believed in patients have been let down by their colleagues and research funding bodies and we hope that the HHS and NIH now take ME and SEID seriously and allocate funding based on them being physical diseases


- Acknowledges high societal costs and recommends that the guidelines are revisited in no more than five years to allow new research findings to be taken into account


“Ideally, experienced individuals without significant conflicts of interest should conduct a systematic literature review to address the key questions.”


“Members of this group should clearly disclose their potential conflicts of interest, and the conveners of the group should try to limit the number of members with significant conflicts, who should in no case represent a majority of the group’s membership.”


“There is no adequate evidence to enable comment on the manifestations of ME/CFS across the life course.”


This is an acknowledgement which NICE and the MRC have never made in the UK where vested interests continue to affect what is funded or reported. In



Conclusion - Going Forward


As the report admits “Patients, advocates, researchers, and clinicians expressed strong opposition to the study, arguing that the IOM lacks the expertise to develop clinical case definitions”


Yet as the IOM insisted on continuing this exercise then they set up a unique opportunity to make things better.


Will this report promote the prompt diagnosis of patients with this complex, multisystem, and often devastating disorder; enhance public understanding; and provide a firm foundation for future improvements in diagnosis and treatment?


After so long a period where governments, medical research councils, health departments and some of those supporting organisations have completely abrogated their responsibilities to patients with this disease then it might be too optimistic to expect one report to overturn all that has been allowed to be wrong with the research into, perception and treatment of ME.


But a start has to be made.


In the absence of anything else one must take what one can and build upon it. And there are many good points in the report.


If the intent to improve the situation for people with ME and their families is honest then elements from this and the P2P report can change the way healthcare professionals treat the disease.


The good points from this report ought to force and demand a radical rethink of Health Institutes’ and Research Councils’ policies – something long overdue.


To exact a greater morality amongst research funders might be one benefit from this.


Name


Unfortunately, however many good points there may be in this report the name will be something which many will interpret and then relate to their perception of the disease. We believe the suggested name is ill thought-out needs to be rethought. Whilst it is obviously logical and correct to remove the term CFS and Chronic Fatigue we feel it is not a sensible strategy to change the name to the suggested SEID at this point. Even if the intent was honourable the name will still influence how this disease is treated. Just as with food the contents in the tin may be completely ignored due to poor labelling. By deciding to tinker with the name of this disease one is also obliged to examine the history and politics behind it and understand why such a name change could offend, discriminate, confound, disappoint or just enrage some patients. Playing with the name and using exertion – however the correctness in medicine may be different from lay perception – will still invoke an initial response of this is being a fatigue illness rather than a systemic disease. So we suggest retaining Myalgic Encephalomyelitis (ME) until enough current data is found to support or otherwise. ME (itis) is already in the WHO, it does not stop research, it removes the rather useless CFS denigration and still allows a correct view to be presented.


Criteria


Whilst it may be good that a set of simplified criteria are produced there is the concern that the criteria listed by the IOM report may be too broad. The criteria also need to be validated first to see if they really capture the right kind of patients. At the Invest in ME conferences there have been calls for the need for simple diagnostic criteria.


However, the committee also added a table with many more symptoms which could be used to support the diagnosis.


It will require education of doctors to make them able to identify the disease and avoid incorporating misdiagnoses into the assessment. The multiple comments within the IOM report relating to lack of belief from healthcare staff are evidence that this education is important.


Distribution


An obvious point – but one which needs reaffirming for any diagnostic criteria used -


“The criteria proposed here will not improve the diagnosis and care of patients unless health care providers use them”


Apart from the name the distribution of the other sensible points from the IOM report needs to be managed, monitored and followed-up in order that uptake of ME being a real systemic disease in ensured.


In the UK the CMO report of 2002 [10] produced seven recommendations.

It would be a disaster if the IOM report ended up like the CMO report in the UK where none of the recommendations were implemented and the psychiatric lobby who refused to sign the report went on take charge of the fatigue clinics and obtained all of the public research funding. At that time the participating psychiatrists should have been left out. But what has transpired is that they have still been allowed to control the debate in the UK. We would urge the US authorities to avoid a repeat of that.


The report makes a major point -


“Key to this effort will be the continued positioning of ME/CFS as a legitimate disease that occurs in both children and adults and should be properly diagnosed and treated.”


What can be very helpful is if the information emphasises ME/CFS as a serious physical illness and that in itself leads to health care providers taking a correct attitude toward these patients despite there being no cure or effective treatment being available yet. Just informing patients to avoid overexertion in the early stages of the disease can make a huge difference in the outcome of the disease.


It is good that the committee recommends continuing surveillance of the evidence and revisiting the criteria in no more than five years.

But if “The committee recognizes that new and accumulating evidence will likely enable refinement of the diagnostic criteria proposed in this report and possibly define subtypes of the disease or even distinct entities” then this would also mean that the name SEID would have to be revisited and almost certainly changed.


The toolkit for screening and diagnosis is an important part of the process. If this is not done properly then it is no good of having all of these recommendations. Again, there is a need for centres of excellence such as IiME have proposed [11] and experienced clinicians that can oversee this work.


Research


The report has underlined a core message from the earlier P2P report – namely how mediocre has been the research to date on such a serious disease; The report is a major indictment of negligent MRC/NIH/CDC policy over a generation


The way that research and treatment and information about ME have been totally misrepresented over the last generation by false funding policies, flawed research and vested interests It is, above all, another indictment on the appalling policies toward ME research that have been carried out by organisations responsible for this disease – such as UK MRC and USA NIH.


What a waste of life has been allowed to occur by governments from their failure to monitor progress or listen to continuing and mounting patient concerns; how corrupt and immoral has been the attitude of those leading the organisations which use public funding of ME research, given mainly to researchers who consider ME/CFS a psychosomatic illness?


Our overriding feeling is that the report highlights the complete lack of any strategy to research this disease properly by those entrusted with the responsibility to do just that.


The aim now should be to find a speciality that owns ME/CFS or make ME/CFS a speciality in its own right – and this will not be psychiatry.


The onus is on the IOM and P2P to honour those good points from these reports – and to translate these into action.


Clearly a dramatic and immediate increase in funding for biomedical research needs to be made.


IiME suggested $250 million dollars for the next five years. This problem needs to be fixed so the clear message from IiME to NIH and IOM is – FIX IT!


This will be a long haul. Those in NIH and CDC – as well as those in UK MRC - and the respective government health ministers who have been responsible for ME research and funding and guidelines over the last generation have been incompetent, or worse. So lessons have to be learned from these past failures to ensure the same fatal mistakes are not made again.


As we ended our P2P report evaluation - Words are fine and Progress is a fine word – but change is its motivator – and it is action that delivers change


These organisations and those leading them will be judged by their actions.


The task now is to implement the good points of this new acceptance of ME as being the real disease that patients already know it is.


To restate the opening remarks in the IOM report,

- “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe
 

usedtobeperkytina

Senior Member
Messages
1,479
Location
Clay, Alabama
I think there are some good points to the Invest in ME review.

However, I don't agree with their argument on the name, that it's premature to change the name now:






Maybe research will come up with the sort of evidence that will lead to a new name quickly. Or maybe it will take a long time (I think there is quite a good chance it will be the latter - given all the different aspects of the illness, research progress is quite slow). In the meantime, I don't think it is good to have "chronic fatigue syndrome" as the main name the medical profession uses for the condition.
Absolutely. researchers, individually, say, "I'm just about to publish something that will change everything." They do, and it doesn't change the bad name. The studies come out with biological findings and say, "This could be a diagnostic biomarker." And it doesn't go any further.

Why? The studies are small and comparing healthy to CFS patients instead of CFS patients to those with similar illnesses.

Meanwhile, clinical care is absent and terrible. Another issue is that there is no widely respected and well-known medical professional organization of trained and certified experts to bless a name or criteria and do the educating of doctors, or do these studies of validating a proposed criteria. So we go to the government. Getting this into a specialty, in my opinion, will be the biggest help.