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Phoenix Rising presentation at IoM meeting Jan. 27th

Nielk

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Thank you for the invitation to speak on behalf of Phoenix Rising. We are a non-profit patient-led organization which hosts the largest online forum for ME/CFS patients.

We have enlisted our members to comment on the question posed by the IoM in their study to recommend clinical diagnostic criteria for ME/CFS: “What is the most important aspect or information that this committee should consider throughout the course of the study?”

Phoenix Rising members have identified several points of focus:

  1. ME is an organic, complex, seriously disabling disease
  2. · ME needs a definition at least as strict as the CCC or ICC
  3. · ME is not a psychogenic somatoform illness
  4. · Myalgic Encephalomyelitis (ME) should be the term used for the disease

1-ME is an organic, complex, seriously disabling disease

ME is a complex, severely disabling disease involving multiple systems in the body. It involves extreme muscle weakness, drastic loss of stamina, cognitive dysfunction and viral symptomatology along with neurological and endocrine dysfunction. Fatigue is only a small part and not necessarily the most prominent symptom.

ME renders half of the patients unable to work. A quarter of the patients are left bedbound, some unable to feed themselves. Others have died due to complications of ME. In the U.S. estimates show that there are 800,000 adults and children suffering from ME/CFS. This would mean that 200,000 patients might be listening to us from their beds. In addition, this large group of disabled patients is a great strain on the U.S economy. You might be surprised then to hear that in each of the past ten years the NIH has spent less on ME than on hay fever - a mere $3m to $6m.


2-ME needs a definition at least as tight as the CCC or ICC


Most of the experts treating and researching ME have endorsed and are currently using the Canadian Consensus Criteria (CCC). They have recognized that by using post exertional malaise (PEM) as a hallmark of the disease and mandating neurological and immune dysfunction, the CCC best captures the patients who are suffering from this particular disease.

Any new definition for ME must include PEM as a minimal prerequisite for the diagnosis of ME.

The CCC were created to distinguish ME patients previously diagnosed using broad CFS definitions such as the Oxford Criteria of 1991 and the Fukuda Criteria of 1994. These definitions selected many who suffered from vaguely defined idiopathic fatiguing illnesses. These broad definitions have impeded serious research into the complex disease and have held the disease hostage without a chance of effective recognition and advancement.

The time has come to move the understanding of ME forward and to stop being stuck in the past. Studies on the disease have shown that there are testable biomarkers, such as the two day cardio-pulmonary exercise testing (CPET), which show remarkable abnormalities in ME patients. The fact that PEM/PENE is a hallmark of the disease is no longer debatable. Immune dysfunction has been shown with multiple studies uncovering defects in natural killer cells in ME patients. Neurological/cognitive dysfunction has been shown by abnormalities in cerebrospinal fluid and structural MRIs.

We therefore ask the panel that the population of severely ill and disabled ME patients should be separated out from the broad fatigue-based definitions, using a definition at least as 'strict' as the CCC or ICC.


3-ME is not a psychogenic somatoform illness

Terms previously used to describe the syndrome CFS, such as “depressive mood”, “deconditioning”, “somatoform”, “personality disorder”, “childhood abuse”, “hypochondria”, “laziness”, “malingering” , or “unwellness” do not apply to the organic disease of ME.

Other illnesses such as Asthma,Stomach Ulcers, Multiple Sclerosis, and Inflammatory Bowel Disease have been thought as ‘psychosomatic’ until a known and identifiable physical element was discovered.

Any research into ME as a psychological, psychogenic or functional disorder should be disregarded. Attempts to give a psychiatric or somatization explanation for our illness have utterly failed to explain the realities of the disease, and are incompatible with the details of its progression.

4 Myalgic Encephalomyelitis (ME) should be the term used for the disease

The term “Chronic Fatigue Syndrome” (“CFS”) is not appropriate for this disease. No disease should be characterized by a symptom shared by many healthy people. Patients with different illnesses and different clinical needs are mixed together under a single ‘CFS’ label. CFS as defined by Fukuda may include people suffering from depression and idiopathic fatiguing illnesses. This leads to confusion in clinical settings often leading to chronic neglect.

ME, as described by the CCC, has a distinct and definable nature. It best describes our members’ complex and specific symptoms of muscular and neurological dysfunctions.


We would like you to know that our members have expressed many concerns about this study, including and especially the fact that many members of the panel, as currently constituted, lack appropriate expertise in the treatment or diagnosis of this disease. In addition, there is a large group of stakeholders, experts, advocates and patients who are calling for a cancellation of this study and the adoption of the CCC now. Their concerns are due to the fact that they believe that a new definition can come only from a panel of knowledgeable experts. Some have questioned the legality of the contract as well as the lack of transparency in the actions of HHS. These feelings have resulted in them boycotting these proceedings and choosing not to take part.

Please keep in mind that the recommendations that this study will produce will directly affect the lives of millions of patients worldwide. We hope that you will take the patients’ voice to heart and that you will continue to invite us to be part of the process.
 

SOC

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Excellent work, team! Many thanks for your very hard work under a difficult time constraint.

While I wasn't able to hear Gaby's presentation of this document, I hear it was strong and clear. Kudos to Gaby, as well!
 

Nielk

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See this post for link to the PowerPoint presentation and the supporting document that were distributed to the panel members.
 

alex3619

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That surprises me, I had thought only a tiny percentage of sufferers manage to carry on working.
In the FDA presentation, based on their report, given to the panel, only 25% of CFS or ME patients work full time. Many do continue to work part time or study for some years though, or occasional part time work, or contract work from home, or even run small home businesses. Alas, many have to eventually stop doing even that.

Having said that I was surprised at the figure too. Is there a reference for this figure that can be looked at?
 

Nielk

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In the FDA presentation, based on their report, given to the panel, only 25% of CFS or ME patients work full time. Many do continue to work part time or study for some years though, or occasional part time work, or contract work from home, or even run small home businesses. Alas, many have to eventually stop doing even that.

Having said that I was surprised at the figure too. Is there a reference for this figure that can be looked at?
Don't forget that this study's cohorts are all expert clinician's patients. How many patients have never seen an ME/CFS expert? In many parts of the country these experts are non-existent. Dr. Unger also mentioned that many of these patients have been sick for a long time. This might also skew the statistics.
 

alex3619

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Don't forget that this study's cohorts are all expert clinician's patients. How many patients have never seen an ME/CFS expert? In many parts of the country these experts are non-existent. Dr. Unger also mentioned that many of these patients have been sick for a long time. This might also skew the statistics.
It is indeed very likely that it is skewed toward those who work, are wealthy, or can afford good insurance. Was it 75% college educated? How representative is that of the whole population?
 

Firestormm

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I don't think any of this addresses @Artstu 's point. Where did the 50% able to work, come from in our presentation? It's probably not too far short in terms of a guess based on being able to perform some form of work. There were those cost to the economy studies - certainly one from the UK I recall - but I'm not sure if a figure was attached or what it was. I suppose there must have been some estimate made in order to calculate the cost...
 

Nielk

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I don't think any of this addresses @Artstu 's point. Where did the 50% able to work, come from in our presentation? It's probably not too far short in terms of a guess based on being able to perform some form of work. There were those cost to the economy studies - certainly one from the UK I recall - but I'm not sure if a figure was attached or what it was. I suppose there must have been some estimate made in order to calculate the cost...
There have been many studies on this subject over the years. The results vary widely due to many variables. the figure of 50% is an average.

Please see:

http://archinte.jamanetwork.com/article.aspx?articleid=217015
 

Nielk

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Table 3 also summarizes the highly variable employment information available in the accepted studies. The total number of employed patients with CFS was reported in 35 studies (2652 patients; 42% employed). The number of unemployed patients was reported in 37 studies (2720 patients; 54% unemployed). The number of studies reporting the percentage of patients unemployed exceeds the number of studies reporting the percentage of patients employed because 2 studies reported16or implied17 the number unemployed but not the number employed. Nine of these studies also reported the total number of controls who were employed and unemployed (340 controls; 90% employed and 9% unemployed). These results do not sum to 100% due to incomplete reporting in some studies.
 

WillowJ

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I guess the people working, especially full (or even half?) time are not, by and large, hanging out on message boards (though some do, of course). So we would know fewer working PWME.

Jason's papers also mention a subset of less ill people who are able to carry out work (though they obviously can't do all the things they used to be able to do or that a normal healthy person could do).
 

alex3619

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I continued working for some years as my ME progressed from mild to less mild. However everything else disappeared from my life. I only had energy to get to work, and get home, and I started taking lots of time off when I had no energy to get to work, resting all weekend, using my annual leave for sick time etc. In the end it was unsustainable, though that is a complicated story for another time.
 

Little Bluestem

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I guess the people working, especially full (or even half?) time are not, by and large, hanging out on message boards (though some do, of course). So we would know fewer working PWME.
The severely ill don't spend time on message boards either. It is difficult to know how many PWME are still working.