Whittemore - Institute of Medicine

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Introduction and Overview

 Although it has been over 25 years since the CDC investigated an outbreak of this disease in northern Nevada, Chronic fatigue syndrome is still lacking an appropriate name, a concise biological definition and an agreed upon medical category.

1988: How Can Anyone Mistaken this illness for Depression or Fatigue?

Strep throat and non-EBV mono in the same week. She had a fever, lymphadenopathy, severe pain and muscle weakness.

Doesn’t recover but returns to school

First physical diagnosis: Adrenal insufficiency.

Our 26 year Long Battle isn’t Over

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Number of years to diagnosis: 2 Number of major medical institutions visited: 4 Doctors and specialists consulted over 26 years includes: pediatricians, gastroenterologists,(gastro-paresis) cardiologists,(tachycardia) endocrinologists, psychiatrists, psychologists, internists, infectious disease specialists,(infections) hematologist oncologist,(severe anemia) surgeons,(gall bladder disease) family medicine, complementary

This is what patients want; You can them get here!

Living healthy, happy and full of energy

This is where we are today: people are still asking

“What is fatigue?” “Are you sick or tired?” Simple: “Can you exercise the next day?”

ME is:

Characterized by: inflammation, abnormal immune function, multiple infections, mitochondrial dysfunction, rapid disability and exercise intolerance

Complex and chronic

Relapsing and remitting and/or progressive

ME is not:

Psychological depression

A benign disorder (one which resolves completely with therapy or does not impact lifespan)

A Somatization disorder (one in which there is no physical cause of disease)

A matter of will-power

Caused by too little sleep/tiredness

Caused by working too hard

Caused by childhood abuse

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Medical Challenges

How does one explain an illness called, Fatigue?

Inappropriate name for one common symptom Symptomatic Definition/diagnosis of exclusion Lack of medical knowledge/not adequately explained Physician shortage/those willing to treat patients Diagnostics Treatments/great variation depending upon physician Lack of coordinated medical care with other medical specialists Medical subspecialty (disease experts) Public information is misleading, causing confusion and lack of support of those who are ill

A Disease with Many Names or are there Many Diseases?

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Myalgic Encephalomyelitis, ME Post Infectious Fatigue or Chronic Fatigue Syndrome, Fatigue, CFS, CFS/ME

Other similar diseases or subgroups :

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Gulf War Illness: Multi-symptom illness resulting in loss of physical and mental stamina Mycotoxin Illness: Multi-symptom illness due to mitochondrial and immunological damage from mold infections and their mycotoxins along with other pathogens found in water damaged buildings Chronic /Post-Lyme Disease Autism

The name “Chronic Fatigue Syndrome” has got to go!

Fatigue has been reduced to “tiredness”

Fatigue is only one of many symptoms

Fatigue is not the most severe symptom

Fatigue is difficult to quantify and often confused with depression

Before “Chronic Fatigue Syndrome” it was called Myalgic Encephalomyelitis (ME)

A neurological disease Abnormal

response of the patient to the

organism.

immunological Circulatory

disorder

Abnormal cerebral activity

Any excessive physical or mental stress is likely to precipitate a

relapse

.

Tends to be

chronic

Dr. Ramsey described ME in 1956

Compare Symptoms/Not Definitions

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ME Acute onset follows respiratory or gastrointestinal illness/low grade fever Circulatory abnormalities/cold extremities/ashen pale Cerebral symptoms/memory, concentration, emotional liability Abnormal immunological response Fluctuating symptoms Chronic

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CFS Follows infectious illness/environmental toxins Chronic infectious symptoms Muscle pain/weakness Neurological symptoms/memory, concentration/ ataxia, seizures, Dysautonomia Post exercise malaise Relapsing/remitting symptoms Chronic

2011: Myalgic Encephalomyelitis International Consensus Criteria

Myalgic Encephalomyelitis is an acquired neurological disease with complex global dysfunction.

Pathological dysregulation of nervous, immune and endocrine systems with impaired cellular energy metabolism, and ion transport are prominent features.

Other Biological Disease Definitions

Lupus is a chronic, autoimmune disease that can damage any part of

the body (skin, joints, and/or organs inside the body) LFA

Multiple sclerosis (MS) is …. A disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. (MS society)

ICD-10 Chapter VI Diseases of the nervous system (G00-G99)

G93.3

Post viral fatigue syndrome

Benign myalgic encephalomyelitis

They are joined

Challenges: Yesterday and Today

Doctors

Patients

Families of those with ME

Researchers

Challenges for Physicians

No approved biological diagnostic tests

No FDA approved pharmaceutical treatments

Insurance coverage denied for testing and treatments

Need guidelines for emergency room, anesthesia or surgery

Challenges for ME/ CFS Patients

Name of illness trivializes impact and ignores reality of infectious and immunological aspects of disease

Lack of understanding of complexity and severity of disease

Difficulty finding doctors who are knowledgeable about ME

Lack of means to pay for appropriate medical care

Challenges for Families

Lack of centralized accurate information

Lack of emotional support for entire family

Lack of medical support

Lack of financial support for medical care

Loss of income and/or functioning family member

Lack of educational support/guidelines

Challenges for Researchers

Too little research funding

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Groups of patients often dependent upon physician’s practice

No national repository of patient samples

Research definition lacks specificity Patients are all grouped together No clinical centers of excellence

Obstacles to Progress

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Disagreement by most physicians and researchers Definition: needs to add biological information to be more concise Most significant underlying feature should be stressed ME has an ICD10 medical category (neurological) but it is not listed in the NIH research home: NINDS, why not?

For most, CFS is still a diagnosis of exclusion Most biological research has been ignored in government definition

Doctors Who Misunderstand

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Internist: “If I don’t know what it (abnormal viral titers) means it can’t be important.” Neurologist: “I didn’t read her medical reports because the facts might get in the way of my theory.” Neurologist: “I couldn’t read her MRI: it probably wasn’t important anyway.” Surgeon: “I won’t do her gallbladder surgery because she has CFS.” Cardiologist: “I can’t treat her tachycardia because she has CFS.” ER doctor: “I could give her fluids if she had an immune deficiency.”

CDC Definition Lacks Scientific Information for CFS

  Chronic fatigue syndrome (CFS) is a debilitating and complex disorder characterized by intense fatigue that is not improved by bed rest and that may be worsened by physical activity or mental exertion.

Systemic Lupus Erythematosus is an autoimmune disease in which the immune system produces antibodies to cells within the body leading to widespread inflammation and tissue damage.

A New Beginning

Possible Solutions: A Fresh Start because ME has become CFS

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Rename the disease: perhaps after the person who first described ME: Dr. Ramsey; Ramsey’s Use the CCC criteria for clinical definition and add a biological one sentence definition.

Seek international input to create suggested diagnostic and treatment protocols based on biological science not on psycho-social theories Select a medical specialty to focus on this disease: Neurology and/or infectious disease?

Why is

a Name so Important?

Disease name and definition determines research emphasis and funding

Research identifies biomarkers of disease

Industry develops and sells diagnostic tests

Diagnostic tests lead to pharmaceutical treatments

Mandatory insurance coverage of testing and treatment

Knowledge equals better physician education

Keys to Defining Disease

Concise description: one sentence that categorizes the disease: neurological,autoimmune, infectious, toxic, inflammatory, mitochondrial, etc.

Identifies the effect of the disease on various parts of the body

Identifies the risks or complications associated with the disease

Biological Abnormalities Associated with ME/CFS

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Immunological low NK cell function and number Gut pDCs produce HERV proteins (auto antibodies) Inflammatory cytokines

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Cardiovascular Gastrointestinal Musculoskeletal Endocrine

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Neurological abnormal brain scans EEG results abnormal Dysautonomia Disordered sleep Seizures

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Systemic Infections low glutathione, low blood volume and abnormal VO2 max.

Energy deficits

Major Symptoms

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Cognitive Impairment Dysautonomia Pain; nerves, joints, muscles Lymphadenopathy, sore throat, severe headaches, low grade fevers Disordered and unrefreshing sleep Gastrointestinal distress/gastro paresis/nausea, vomiting, hypoglycemia Tachycardia, chest pain, dehydration, fainting, Profound loss of energy: post exercise fatigue

How important are mitochondria to those with ME/CFS?

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Mitochondrial disease: Symptoms may include loss of motor control, muscle weakness and pain, gastrointestinal disorders and swallowing difficulties, poor growth, cardiac disease, liver disease, diabetes, respiratory complications, seizures, visual or hearing problems, lactic acidosis, developmental delays and susceptibility to infection.

Adult onset is becoming more prevalent

#1:Change the Name: Drop Fatigue and ME

Name for first person to describe ME after UK outbreak: Dr. Ramsey

Knowledge of disease changes over time without having to change the name

Subgroups can be identified such as Ramsey 1, Ramsey 2, etc.

New name will end old stigmas and misinformation

#2 Improve the Biological Definition

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…….. is a complex (neuro-inflammatory) disease. It is triggered by infection and toxic environmental exposures which result in…..

Symptoms include mild cognitive impairment….

This disease may follow a relapsing and remitting course or become progressively worse over time. It is associated with an abnormal immune response to various pathogens most notably borrelia, herpes viruses, entero-viruses and mycoplasma in addition to fungi and their mycotoxins. It is chronic and can be severely debilitating

#3 Identify a Medical Specialty as Needed

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Disease affects the nervous system and is immune and pathogen driven Disease is debilitating Disease is difficult to manage because of changing nature and complexity Evaluation should be comprehensive Diagnosis and treatment may be complicated Treatment may require intravenous drugs or drug mixtures/knowledge of long term treatment protocols

#4 Educate the Medical

Profession and the Public

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Information should be kept up to date Based on biological science Consistent from one entity to another Continue to change and add new information as it becomes available Seek input from physicians, researchers and patients

Future Action Items for ME Experts

Create science based medical education text and online seminars

Identify lead NIH research institutes

Improve funding and focus of research

Help to develop medical standards, for emergency room visits, anesthesia and surgery

Can We Learn from Responders?

Ampligen

Antivirals

Anti-retrovirals

Immune Support

Anti-fungals

Anti-bacterials Clinical Studies Backed by Research Can Tell Us What we Need to Know!

Create a Research Road Map

Innate immunity

Chronic infections

Mitochondria

Autoimmunity

Genetic Susceptibility

Environmental Toxins

Create National Research Resources

Bio bank

Patient Registry

Cell lines

Animal model

What One Patient Wished the Doctors Knew

I have very bad days when I am too sick to see you

I have many other medical problems that you might be able to treat

My disease has many other symptoms that are much worse than fatigue.

Don’t blame all of my symptoms on my illness: you may miss something important

I try everyday to help myself through diet, limited exercise, supplements and prayer

I want to get well more than anything!

Follow progress of other disease groups to improve the lives of those with this disease!

MS:

Lupus:

Cancer:

Mitochondrial disease: Thank you!