www.phoenixrising.me

Monday January 27th, 2014

Phoenix Rising presentation to the Institute of Medicine

Thank you for the invitation to speak

� Thank you for the invitation to speak on behalf of Phoenix Rising.

� We are a non-profit patient-led organization which hosts the largest forum for ME/CFS patients.

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We have enlisted our members to comment

� 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:

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“What is the most important aspect or information that this committee should consider throughout the course of the study?”

Points of focus

Phoenix Rising members have identified several points of focus:

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ME is an organic, complex, seriously disabling disease1

ME needs a definition at least as strict as the CCC or ICC2

ME is NOT a psychogenic somatoform illness3

Myalgic Encephalomyelitis (ME) should be the term used for the disease4

www.phoenixrising.me

Points of focus

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.

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Fatigue is only a small partand not necessarily the most prominent symptom.

ME is an organic, complex, seriously disabling disease

� 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.

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ME is an organic, complex, seriously disabling disease

� 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.

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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.

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

� 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 truly suffering from this disease.

� Any new definition for ME must include post-exertional malaise (PEM) as a MINIMAL PREREQUISITE for the diagnosis of ME

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Most of the experts treating and researching MEhave endorsed and are currently using the

Canadian Consensus Criteria (CCC).

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

� The CCC was created to distinguish ME patients previously diagnosed using broad CFS definitions such as the Oxford Criteria of 1991 or the Fukuda Criteria of 1994.

� These definitions included many who suffered from vaguely defined idiopathic fatiguing illnesses.

� These broad definitions have impeded serious resear ch

into the complex disease and have held the disease hostage without a chance of effective recognition and advancement.

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These broad definitions have impeded serious resear ch

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

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The time has come to movethe understanding of ME forward and

to stop being stuck in the past.

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

� Studies on the disease have shown that there are testable biomarkers , such as:

− The two day cardio-pulmonary exercise testing (CPET) testing, 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 studies uncovering defects in natural killer cells in ME patients.

− Neurological/cognitive dysfunction has been shown by abnormalities in cerebrospinal fluid and structural MRIs.

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

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We therefore ask the panel thatthe 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.

do not apply to the organic disease of ME.

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”

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ME is NOT a psychogenic somatoform illness

� 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, psychogeni c 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.

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Any research into ME as a psychological, psychogeni c or functional disorder SHOULD BE DISREGARDED.

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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.

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This leads to confusion in clinical settingsoften leading to chronic neglect.

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

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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.

www.phoenixrising.me

In conclusion

In conclusion

� 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 CCC now .

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In conclusion

� 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.

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In conclusion

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Please keep in mind that the recommendationsthat this study will produce will directly affect t he LIVES OF MILLIONS OF PATIENTS WORLDWIDE.

In conclusion

� We hope that you will take the patients’ voice to h eart and that you will continue to invite us to be part of the process.

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www.phoenixrising.me

Thank you