Proposed Structure and Organisation of ME Clinic
" What can we learn from those people who have recovered from ME and those who have improved significantly to resume work ? What can we learn from those dedicated, patient, considerate and highly professional doctors who treated them ? "
We can learn much from those doctors who have successfully treated ME. We can apply this knowledge in a Clinic specifically devoted to diagnosing and treating ME in Ireland.
Organisation, Structure and Financing of ME clinic
There are two basic options:
(i) a state financed clinic which would be financed by the Irish government
(ii) a private clinic (national or foreign based) which sets up in Ireland. And receives grants, investment or other financial assistance from the Irish government. This would be a system of private - state partnership, a joint financing arrangment.
This Clinic would use the diagnostic and treatment protocols used in the most successful ME Clinics where thousands of patients have recovered from ME. The building of this clinic and the provision of medical equipment would be financed by the Irish government or a private clinic or by both the Irish government and the private clinic, in a public-private partnership. The operation of the clinic and payment of personnel would be financed by by the Irish government or a private clinic or by both the Irish government and the private clinic. At the moment there is plenty of space and a number of excellent sites inside the grounds of Merlin Park Hospital in Galway city in the Republic of Ireland. This is an ideal location for the following reasons :
(i) there is plenty of space for development (ii) there are plenty of parking spaces (iii) it is on a national highway which is linked to the rest of the island of Ireland (iv) it is on a national bus route (v) the railway station is within three miles and is located beside the bus stop and taxi rank for the hospital. Several taxis are wheelchair accessible. (vi) the hospital is served by a regular city bus service which are wheelhair accessible (vii) Galway city has plenty of taxis and hackney cabs, many of which are wheelchair friendly (viii) Galway airport is within three miles of the hospital and is served by taxis. Those people coming into Galway from outside the county would find it very easy to get to the Clinic. Basing the clinic outside Dublin would save patients the hassle of having to commute through Dublin which is a highly congested city.
Private management and privately hired personnel working on subcontract to the state in a state clinic or state-private partnership clinic or privately for a private clinic would mean a high degree of autonomy for the clinic. We feel that private management would make better and more productive use of resources. The Clinic's private management team would establish the terms and conditions for all personnel. The hours of opening would have to be line with the demands of customers and the marketplace. There would also be greater flexibility in terms of costs and work schedules, and the clinic would be better able to adjust and adapt to changes in the marketplace. At the moment there is a massive pent-up demand for ME treatment both in Ireland and in Britain. To effectively meet and manage this demand, the Clinic would need to operate a 9 hour day schedule, six days a week. Furthermore, diagnosis requires significant patient-doctor time and significant amounts of time testing samples or sending them away for testing. Also, long opening hours will suit those patients who have to travel long distances. The clinic would be run as a private business delivering efficiency and value for customers (who are patients) and significant returns for stakeholders - the government and /or private investors. Private management would pay greater attention to targets, customer satisfaction ratings and be more motivated to implement timely measures to improve customer satisfaction ratings. Bonuses could be implemented to encourage management and doctors to meet targets, and prescribed customer satisfaction ratings and Clinic objectives. Incentives tend to work. Private management would help maximise the return to the state, and the benefits to the customer (the ME patient).
Cost-Benefit Analysis: the cost of building an ME Clinic would be 45 million euros, which would include a modern clinic with several rooms, and advanced diagnostic equipment. Running it would cost a few million euros per year. Yet the total cost of the ME illness at present to the Irish economy is estimated at 1.83 billion euros per year. This is a significant loss to the Irish economy. (See Why build a Clinic section).
Diffusion of Costs and Expanding the Return on Investment
The clinic will result in savings of tens of millions of euros per year, as more patients improve and recover. And would over time approach the figure of 1.83 billion euros per year in savings. The clinic will also pay for itself in many other ways. Initially, the clinic will involve considerable outlay of funds to acquire state of the art diagnostic equipment and treatment equipment, yet the investment itself will enable the clinic to differentiate itself from other clinics and hospitals in Europe in terms of quality, accuracy, precision and excellence. This will attract more customers (patients) to the clinic and build a reputation which will sustain high customer numbers over time.
Furthermore the clinic could share it's facilities and resources for those with other illnesses. Specifically, the equipment in the ME clinic could be made available to the hospital itself and to other nearby hospitals and clinics for those with other neurological illnesses, endocrine and glandular illnesses, autoimmune illnesses, head injuries, internal injuries, and cardiac illnesses subject to designated time usage and demand levels. This would ensure that the equipment is used regularly and there is adequate payback for the intitial capital investment in the equipment, facilities and personnel. The demand for this will grow as population continues to grow, and as a higher percentage of the population ages, and and more and more people become ill or have accidents.
All of the above factors would guarantee an excellent return on investment over the long-term.
Fact Finding Mission and Consultative processes for the establishment of the Clinic
Before setting up the Clinic we propose that there would be a series of meetings between top ME experts and doctors from around the world and (i) senior officials from the Department of Health in Ireland (ii) senior civil servants from the HSE and NHS (iii) the Ministers for Health from Ireland (iv) representatives from private ME clinics wishing to set up in Ireland, and representatives from our organisation and other ME support groups (v) representatives from the Irish Medical Council and the Irish Medicines Board. This would be a Fact Finding Mission and Consultative process whereby these parties would examine the diagnostic tests and treatments and medical drugs and supplements used in the most successful ME clinics around the world. This would include the following:
North America and South America
- The Cheney Clinic in the USA . Dr. Paul Cheney has been treating ME and CFS since 1985. He was one of the doctors involved in treating patients in the Lake Tahoe outbreak in the mid 1980's in the USA. He is a highly regarded medical doctor and researcher, and is one of the most knowledgable doctors on ME and CFS in the world.
- Dr. Daniel Peterson, is a well known ME and CFS doctor and researcher. He has been treating the illness since 1985, including treating victims of the Lake Tahoe outbreak in the 1980's. He has a very comprehensive knowledge of the illness. He currently works in Sierra Internal Medicine Associates 926 Incline Way, Incline Village NV 89452. Tel: (775) 832-0989
- Dr. Byron Hyde has been involved in ME treatment and research since the mid 1980's and is one of the most experienced ME / CFS doctors in the world. Address: Dr. Byron Hyde, Nightingale Research Foundation, 121 Iona Street, Ottawa, Ontario, Canada. Book an Interview with Dr Byron Hyde on Skype or iChat Video
- Dr. Lucinda Bateman's medical clinic in Utah, USA. Dr. Bateman is a highly respected and well experienced medical doctor who has been treating ME / CFS patients since the late 1990's. Her expertise in ME / CFS has been ackowledged by the US government authorities and national patient organistions in the USA, who have asked her to serve on their committees and bodies.
- Dr. Alison Bested, in Toronto, Ontario. She is a highly experienced doctor who has been treating ME and CFS since the late 1990's. She was one of the authors of the Canadian criteria (2003).
- ME Clinics in development
- Dr. Sarah Myhill's Clinic in Britain. Dr. Sarah Myhill is a distinguished and highly regarded medical doctor and researcher based in Wales. Dr. Myhill has been treating ME patients and researching the illness since the mid 1990's.
Australasia, Asia and Africa
- Dr. Chris O'Callaghan in Melbourne Australia has an excellent reputation for treating ME, CFS, POTS, EDS and Dysautonomia in Australia
- Dr Hugh Derham
Bicton - Healthquest - Point Walter Medical Centre
322-324 Canning Highway (Cnr Point Walter Rd) Bicton WA 6157. Phone: 08 9438 2299
Bicton - Bicton Medical Centre
- Ehlers-Danlos Syndrome (EDS), commonly found in ME and CFS patients
- The Royal Melbourne hospital familial cancer Centre, affiliated with Melbourne University has a genetics section dedicated to connective tissue diseases including EDS.
- Royal Childrens Hospital - Professor Ravi Savirayan and Mr Gary Nattrass - recommendation from EDS Australia group
- Monash Children's Hospital - Professor Sue Piper - recommendation from EDS Australia group
- POTS commonly found in ME and CFS patients.
The clinical pharmacology department at the Austin Hospital which is affiliated with Melbourne University includes Specialist POTS Diagnosis and treatment.
- Dr. Rosamund Vallings, New Zealand. A medical doctor with over 15 years experience treating ME/CFS patients and researching the illness, and one of the authors of the Canadian Criteria (2003) and International Consensus Criteria (2011)
The top ME clinics in the world above are focussed on diagnosing and treating the biomedical, biological and physical disease processes in ME. Their treatments often include multi-treatments or several treatments at the same time to treat diagnosed medical abnormalities and dysfunctions and infections.
The clinics above are international centres of excellence for treating ME, and their knowledge and insights would prove invaluable to this Irish clinic. The Irish team would analyse and discuss and debate the workings of those ME clinics which have successfully treated ME patients. From this consultative process, a detailed plan would be drawn up for a ME Clinic involving the following:
(i) how best to proceed with an ME clinic in Ireland, whether it is a state clinic, a private clinic or a state-private partnership clinic. The staffing, equipment and resource needs, and how to manage and operate such a clinic using best international practises.
(ii) the diagnostic methods to be used and the multi-treatments to be used in the clinic. How to implement the specific diagnostic and treatment protocols used in the most successful ME clinics.
(iii) the staff, skill-sets, and equipment necessary to deliver the services at the clinic
(iv) how to measure the effectiveness of an ME Clinic and how to improve and refine the working of the clinic over time.This would be a detailed process.
These techniques, methodologies and structures would be constantly updated and improved over time to take into account new developments in the diagnosis and treatment of ME. This would provide Irish ME patients with the best treatments available, treatments which have been medically proven to work, bringing about total recoveries in the majority of cases.
Necessary Resources, Personnel and Equipment for an ME Clinic
The following staff would be employed full-time or part-time OR subcontracted by the clinic OR their services hired on a case-by-case basis from a nearby hospital, clinic or medical practise.
- medical doctors who are knowledgeable about ME
- an Immunologist
- a Virologist
- an Endocrinologist
- a Neuroendocrine Immunologist or Neuroimmunologist
- an Infectious Disease Specialist
- a Neurologist
- a Haematologist
- a Gastroenterologist
- a Toxicologist
- a Cardiologist
- a Geneticist
- a Hepatologist
- a Clinical nutritionist
The support staff: 6 nurses, 1 receptionist, 1 administrator, 1 exercise technician, 2 radiologists to run scanners, 3 laboratory technicians to test samples. Nurses and / or doctors would take samples from ME patients. Clinic opening hours - 9 hours, 6 days per week.
Buildings & Equipment Resources
Necessary equipment would include
- special immune system diagnostic equipment. This would test for immune system dysfunctions, abnormalities and autoimmunity.
- genetic sequencing devices to rapidly identify the genetic signatures of viruses, bacteria and other pathogens in blood, spinal fluids, intestinal tissue and muscle tissue, nerve tissue and myelin sheaths
- MRI, SPECT, PET, MRS and CAT scanners for the brain and nervous system
- Nuclear magnetic resonance imaging (NMRI)
- equipment for carrying out EEG spectral coherence tests
- special thyroid gland, adrenal gland, hypothalmus gland and pituitary gland diagnostic equipment
- Doppler Ultrasound technology for testing Flow reversal in the liver and the brain, Chronic Cerbral Spinal Venous Insufficiency (CCSVI), Chronic Hepatic Venous Insufficiency (CHVI) and related cardiac dysfunction
- ultra violet irradiation therapy equipment
- heart monitoring equipment to carry out Impedance cardiography, abnormal holter monitoring oscillating T-wave flattening and inversions, tachycardia at rest, left ventricular (LV) dilatation, and other tests listed in the diagnostic section of our web site
- equipment for monitoring artery and vein blockages
- equipment for mitochondria and krebs cycle testing
- exercise equipment and an exercise facility for assessing VO2 Max and Post Exertional Malaise
- allergy, mold and mycotoxin testing facilities
- Diabetes test equipment
- spinal tap equipment,
- diagnostic equipment for blood volume tests, orthostatic intolerance and POTS
- facility for cognitive dysfunction tests
- chiari malformation and / or cervical spinal stenosis test equipment
While samples could be taken from patients and sent to specialist private laboratories for:
- genetic tests
- tests for specific viruses, mycoplasmas, lyme, bacteria, candida and parasites, which cannot be identified with the equipment in the clinic
- tests for abnormal spinal fluid proteins and oligoclonal bands
- Cancer risk tests
- tests for EDS, Behcets syndrome.
- methylation cycle testing
- apoptic serum DNA testing
- stool tests
- urine tests
- toxicology and heavy metal / chemical poisoning tests
- urine mycotoxin tests
- liver tests
- Ciguatera testing
- live blood tests
- red blood cell structure and blood composition tests
- oxidative stress tests
- Lymph drainage tests
While the following diagnostic services could be contracted out to nearby hospitals:
- sleep analysis : a sleep clinic to assess sleep abnormalities or research sleep clinics affiliated to hospitals / Universities / pharmaceutical company research programs
- colonoscopy and endoscopy : a major hospital
Inpatient facilities for severely disabled
The location of an ME clinic within the grounds of Merlin Park hospital in Galway city would be strategically important. Merlin Park Hospital typically has 15 - 20 beds free per week. These free beds could be made available to severely ill ME patients. Up to 20% of ME patients are bedridden and are very disabled. Another 20% have moderate to severe mobility impairments. There is abundant space in Merlin Park Hospital grounds for expansion, and it should be possible to build an inpatient facility for the ME clinic to accommodate 60 patients. This inpatient facility could be attached to both the ME clinic and Merlin Park Hospital and avail of hospital personnel and resources. Inpatient stays could be limited to 4 days so as to avail of thorough diagnostic services and accompanying treatment assessments. This 4 day time limit would enable more patients to be admitted over the course of a month, a year, thus ensuring a high throughput over time.
Operation of Proposed ME Clinic
A properly organised and structured Clinic will be vitally important as it will enable us to apply biological-based knowledge and methodologies in a controlled medical environment.
Firstly the Strategic objectives of this clinic would be five-fold:
(a) provide a diagnosis of ME and constantly improve and refine this over time in line with best international practises
(b) provide multi-treatments for ME patients based on diagnosed medical abnormalities and dysfunctions and infections. These treatments would be constantly improved and refined over time in line with best international practises, new scientific research findings and new developments in these top 20 ME clinics.
(c) get the Irish government and the Irish Medicines Board to legalise and designate the following medical drugs for ME treatment - Click here for Listing of medical drugs
(d) track and record objective data and changes to biomarkers and improvement or regression of each patient, and input this into research reports and scientific papers. This would be for the benefit of the larger scientific and medical communities.
(e) do research into the root causes of ME and collaborate with other research projects worldwide
Methodology to be used by ME Clinic
ME Diagnosis :
(1) Self referral or family referral or GP referral to the ME Clinic would be accepted.
(2) Exclusionary Tests. After referal to the clinic, the GP's and hospital consultants of ME patients would supply the clinic with the full medical files of each ME patient. This ideally would be done electronically or through the Internet. ME patients would be screened for illnesses which are very similar to ME - Illnesses very similar to ME & Co-existing and co-mormid Illnesses with ME
All of this would help separate those who have ME from those who have other illnesses with similar symptoms to ME.
(3) At the first interview patients would receive an intensive consultation with a doctor who is a ME specialist. The patient's condition, medical history and medical files would be discussed and analysed in some depth during the interview. At this interview the ME specialist would use all of the following 5 medical diagnostic protocols:
Overview charts of chronic state of ME / CFS would also be used to help identify and track the constituent parts and dynamics of this complex illness. Click on the following link for diagrams depicting the chronic state of ME / CFS
Chronic Immune Dysfunction and Inflammatory State, Infection(s), Neurological, Endocrine, Mitochondria, and Oxidative Stress Cycles
Diagnostic Tests for ME
Identifying Biomarkers for the Biological Abnormalities, Dysfunctions and Infections in ME Subgroups
The following factors will affect the biological markers and subgroup designation - does the patient have a co-morbid or co-existing illness with ME ? inherited genetic weaknesses and vulnerabilities ? virus, mycoplasma, bacteria or other infection(s) ? reactivated latent infection(s) ? microbiota of bacteria which include L-form, biofilm, and intracellular bacterial forms ? immune system status and autoimmunity factors ? RnaseL status ? VDR status ? heavy metals, chemicals and environmental toxins and their effects on genes and immune system status ? methylation cycle defects ? total damage to the nervous system and HPA axis ? total damage to the cardiac and vascular system ? total damage to the mitochondria ? total damage to tissues, muscles, organs and joints ? gradual onset or sudden onset ? what phase is the patient in, how long does he/she have the illness ? is the patient severely ill, moderately ill or mildly ill ?
Factors which have high probability of being the root cause
- Viral, Lyme, Mycoplasma, Bacteria, Parasite and other Pathogen Infections of the nervous system, brain, muscles, intestines, blood, joints, heart and blood vessels
- Pregnant women who have ME or CFS should read the following document by Dr. John Richardson concerning risks to the unborn child. Myalgic Encephalomyelitis: Guidelines for Doctors John Richardson. Journal: J of Chronic Fatigue Syndrome, Vol. 10(1)
2002, pp. 65-80.
- Test for Vitamin D deficiency, Folic acid and B-12 deficiency. These deficiencies co-exist with ME in many cases
Mitochondria and Energy systems of the Body
Brain & Neurological
Vascular & Lymphatics
- Blood and Urinary markers
Factors which have high probability of being symptoms
All samples - blood, spinal fluids, nerve tissue, muscle tissue and intestinal tissue samples, urine, saliva, etc. would be taken in one day and then stored. This would be done with the assistance of the ME specialist and the nurse. These samples would be either sent to the laboratory in the clinic or to the local hospital or sent to national or international laboratories for tests. Some appointments may have to be made in a general hospital, for example, MRI / CAT / PET scans of the brain and special neurological tests. These appointments could be set up in a hospital near to where the patient lives and expedited within 4 weeks of the patient visiting the Clinic. This systematic scheduling of tests and scans would save the patient's time and the doctor's time enabling them to make a diagnosis and establish which infections, abnormalities and dysfunctions are present inside 4-5 weeks.
(4) Assessment of Diagnostic tests
(a) Determine if the person actually has ME through identifying the exact number of infections, biological dysfunctions and abnormalities present in the patient, and correlation of these with International Diagnostic criteria mentioned above.
(b) The phase of the illness. Tests on 285 ME patients and 200 controls in 2013 by Hornig et al. in New York show that there are significant differences in biomarkers between patients who have the illness for 3 years or less, and those who have it for more than 3 years. This explains the slight differences between patient groups which consistently appear in scientific studies. (Preliminary findings of Hornig et al., September 2013). This ties in to the findings of Dr. Paul Cheney who has stated there are 3 phases of the illness - phase 1, 2, 3. This is important as ME progresses over time, and the patient usually develops multiple biological dysfunctions and abnormalities and can become very disabled.
Dr. Paul Cheney has successfully treated hundreds of ME patients in the USA since the early 1990's has identified 3 phases of the illness in the following lectures
Lecture by Dr. Paul Cheney who has successfully treated hundreds of ME patients in the USA
Summary of the above lecture by Dr. Paul Cheney
(c) Subgrouping: based on infections and biological abnormalities and dysfunctions found. And other relevant factors such as: - what phase is the patient in, how long does he/she have the illness ? is the patient in remission or having a relapse ? does the patient have a co-morbid or co-existing illness with ME ? what infections does the patient have and where are they located ? is the patient severely ill, moderately ill or mildly ill. Was it gradual onset ME or rapid onset ?
5. ME Treatment
Elimination of any infections and toxins should be the first treatment option, followed by or combined with immune system normalisation, resolving of sleep problems and HPA axis and Neurological treatments, and other treatment options depending on the results of the diagnostic tests. Combining treatments such as treatment for immune sytem abnormalities with ani-viral or anti-mycoplasma or anti-pathogen treatment may achieve better results for some patients.
Treating factors which have high probability of being the root cause
Brain and Nervous system, Allergies, HPA axis
Treating factors which have high probability of being symptoms
Further Treatment Measures
Assess progress after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months. Revise or update treatment if necessary. The objective data and changes to bio-markers and improvement or regression of the patient would be input into research reports and scientific papers. This would be standard procedure in the clinic.
Regular monitoring of patients so as to scientifically assess the effectiveness of medications, diet and supplements.
Establish best international practises in the treatment of ME. Constantly upgrade and improve these practises over time as new information becomes avialable.
Keep up to date with the latest ME research findings from around the world. Use the research to refine and improve the diagnostic process and treatment process for ME patients. This includes updating treatment protocols for patients undergoing treatment and also updating diagnostic protocols.
(6) Follow-up Diagnosis. After 6 months a patient would return to the clinic for another diagnosis to assess how he / she is progressing in their treatment. This may involve amending the treatment protocol or maintaining it for another 6 months. The objective data and changes to bio-markers and improvement or regression of the patient would be input into research reports and scientific papers. This would be standard procedure in the clinic.
(6) Research into the root causes of ME
Research Prioritisation process: The cost of ME is much greater than most other illnesses yet ME research funding is very small when compared to these other illnesses (this is investigated in some detail below). While funding for ME research remains low or non existent, ME will continue to inflict higher and higher economic costs on individual European countries, the European economy and the US economy. The Clinic could serve as a focal point for ME research in Ireland. The Clinic could be allocated a ME research grant every year and the Clinic's ME experts would decide which research projects they wish to finance in Ireland and Britain. All ME research funding would be prioritised - see Research Prioritisation process . This prioritisation process would focus exclusively on the root causes of the illness and not the secondary symptoms.
Research Collaboration: It would be necessary to set up and maintain a Computer Database of:
(a) all ME research from around the world
(b) all leading ME experts and their research works
(c) all past and present clinical trials of drugs / medicines for ME worldwide
(d) all those people who have fully recovered from ME around the world and the doctors who treated them.
To facilitate national and international research efforts the clinic would set up a complex computerised model of all of the cellular and sub-cellular dysfunctions and abnormalities involved in ME, and how they are related to each other. This model would simulate a biological complex adaptive system. As more and more knowledge becomes available this would be built into the model. The Clinic would make this computerised model available to international ME researchers and doctors over the Internet. This would enable greater international collaboration. This adaptive model would be used to identify the root causes of the illness and the dynamics and progression of the illness over time.
International collaboration would include the establishment of computer links, network links (Intranet, Extranet, VPN) and video-conferencing capabilities with the following:
(i) similar clinics in other countries eg. USA, Canada, Australia, European countries, Japan, South Korea, Asian countries
(ii) leading researchers worldwide
(iii) top ME research laboratories around the world
(iv) successful alternative medicine clinics worldwide
(v) international pharmaceutical companies
(vi) Clusters of Universities and Medical / Pharmaceutical Innovation centres involved in ME research worldwide
These computer links could be used to collaborate on diagnosis, scientific trials, treatment and research. This would serve to further refine diagnostic and treatment protocols.
Other services would include: