ME, CFS support and research

Proposed Structure and Organisation of National ME / CFS Clinic

" What can we learn from those people who have recovered from ME / CFS ? 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 / CFS ? We can apply this knowledge in a Clinic specifically devoted to diagnosing and treating ME / CFS in Ireland ? Before setting up the Clinic we propose that there would be a series of meetings between top CFS experts and doctors from around the world, senior officials from the HSE and Department of Health, the Minister for Health and representatives from the Coalition for a National ME / CFS Clinic. This would be a Consultative process whereby the top CFS experts would advise the Irish government on:
(i) how best to proceed with an ME / CFS clinic. The staffing, equipment and resource needs, and how to manage and operate such a clinic using best international practises.
(ii) how to implement the specific diagnostic and treatment protocols used in the most successful ME / CFS clinics.
(iii) how to measure the effectiveness of an ME / CFS Clinic and how to improve and refine the working of the clinic over time.

This would be a detailed consultative process. Senior officials from the Department of Health and HSE and a representative of our organisation would visit the most successful ME / CFS Clinics on a fact-finding tour. This would include the following:
- the Cheney Clinic in the USA
- the Hunter Hopkins Center in the USA
- the De Meirleir Clinic in Belgium
- the Cologne clinic run by Dr. Gorter in Germany
- Dr. Basant Puri's clinic in Hammersmith Hospital in England
- Breakspear Hospital in England
- Professor Jose Montoya's clinic in Stanford University, California
- Dr. CL Jadin and Dr Peter Tarbleton in South Africa
- The diagnostic and treatment regimes used by doctors in the book ' Chronic Fatigue, Fibromyalgia and Lyme disease ' (2nd Edition) by Burton Goldberg and Larry Trivieri.

They would analyse and discuss the workings of those ME / CFS clinics which have successfully treated ME / CFS patients. From this consultative process, a detailed plan would be drawn up for a National ME / CFS Clinic and accompanying diagnostic and treatment protocols.

Organisation and Structure
A properly organised and structured Clinic will be vitally important as it will enable us to apply this knowledge and methodologies in a controlled medical environment.

Firstly the Strategic objectives of this clinic would be three-fold:
(a) provide a diagnosis of ME / CFS
(b) provide treatment for ME / CFS
(c) do research into the root causes of ME / CFS and collaborate with other such research projects worldwide

This clinic would combine highly successful programmes from the following clinics:
- the Cheney Clinic in the USA
- the Hunter Hopkins Center in the USA
- the De Meirleir Clinic in Belgium
- the Cologne clinic run by Dr. Gorter in Germany
- Dr. Basant Puri's clinic in Hammersmith Hospital in England
- Breakspear Hospital in England
- Professor Jose Montoya's clinic in Stanford University, California
- Dr. CL Jadin and Dr Peter Tarbleton in South Africa
- The diagnostic and treatment regimes used by doctors in the book ' Chronic Fatigue, Fibromyalgia and Lyme disease ' (2nd Edition) by Burton Goldberg and Larry Trivieri.

These are international centres of excellence for treating ME / CFS, and their knowledge and insights would prove invaluable. 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 / CFS. This would provide Irish ME / CFS patients with the best treatments available, treatments which have been medically proven to work, bringing about total recoveries in the majority of cases.

Financing
The building of this clinic and the provision of medical equipment would be financed by the Department of Health. The operation of the clinic and payment of personnel would be financed by the Health Service Executive. At the moment there are a number of excellent sites inside the grounds of Merlin Park Hospital in Galway city. 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 dual carraige-way (iv) it is served by a regular city bus service (v) it is on a national bus route (vi) the railway station is within three miles and is located beside the bus stop for the hospital (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 a highly congested city.

We believe that the clinic itself should be financed by the state, but privately run and cater for both public and private patients. Private management would mean a degree of autonomy for the clinic. We feel that private management would make better and more productive use of resources. 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. For example, waiting lists could be counter-acted by taking on additional staff on a sub-contractual or temporary basis ; additional demand from abroad could be met by combining the latter with increases in capacity. Private management would pay greater attention to 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 prescribed customer satisfaction ratings and Clinic objectives. Private management would help maximise the return to the state, and the benefits to the customer (the ME / CFS patient).

We also believe that in the future, this ME / CFS clinic could take the form of a Health Service Trust Clinic, enabling it to avail of both state funding and private investor funding. In Britain the British government has set up NHS Trusts to run the hospitals. This allows hospitals to avail of both state money and money from private investors and private foundations. This is creating more financial resources for hospitals, enabling them to invest in new technologies, extensions, new personnel and new skill-sets. Investors in this Clinic would be able to avail of the generous tax breaks offered to private investors who invest in new hospitals and clinics. Private investment would facilitate continued future expansion of the clinic and greater autonomy.

Both private and public patients would be charged the same fees and treated the same. There would be no discrimination against public patients. The state would cover the costs of public patients, including consultation and tests. Private health insurance companies would cover private patients, including consultation and tests.

This clinic could be affiliated to a regional hospital and a University or cluster of Universities. This clinic could form part of the innovation programme in medical services and pharmaceutical drug development which is being undertaken by Irish Universities. It could also help provide a more comprehensive medical training programme for student doctors and qualified doctors.

Personnel
Personnel would be hired by the Clinic's private management team not by the Health Service Executive or the Department of Health. 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. At the moment there is a massive pent-up demand for ME / CFS treatment both in Ireland and in Britain. To effectively meet and manage this demand, the Clinic would need to operate a 16 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 private investors.

The clinic would consist of the following:

Six international medical experts in the field of ME / CFS. Three for each 8 hour shift. They would meet with ME / CFS patients.
The following staff would be affiliated to the clinic on a sub-contract basis : an immunologist, a virologist, an endocrinologist, a neurologist, a gastroenterologist, a toxicologist, a cardiologist, a hepatologist and a clinical nutritionist. Since they would not be employed full-time or part-time, this would save the clinic money, allowing it to access only those resources which it needs at a given time.
The support staff: four nurses and two receptionists who would be involved in administration. Two nurses and one receptionist for each 8 hour shift. The clinic would operate a 16 hour day schedule.
One general manager and one assistant manager. They would have a proven track record in management in private industry. The management team would consist of the general manager, the assistant manager and a senior Health Service Executive official.
The tests for ME / CFS patients are very specialised and cannot be carried out in Ireland at present. All laboratory tests would be sub-contracted out to special private laboratories, preferably laboratories with an international reputation for excellence. They would have the high-tech equipment and highly skilled personnel to undertake the specialised tests required for ME / CFS patients. Patients would provide samples at the ME / CFS Clinic and these would be specially stored and sent to these laboratories. This would save the clinic having to invest in very expensive laboratories, high-tech equipment and highly skilled personnel.
Opening hours - 16 hours per day, 6 days per week.

Methodology to be used by National ME / CFS Clinic

CFS Diagnosis :

(a) Before entry into the clinic CFS patients would be screened for illnesses which are very similar to ME / CFS - click here for a listing of such illnesses . This screening would be undertaken by the patient's own doctor. Foreign patients visiting the clinic would require evidence or proof of similar screening in their own countries. All of this would help separate those who have ME / CFS from those who have other illnesses with similar symptoms to ME / CFS.

(b) Once all other illnesses have been ruled out, the patients' doctor or GP would forward all of the medical files and test results of the patient to the ME / CFS clinic two weeks before each appointment. These files would be examined and analysed prior to interview so as to build up a profile of each patient.

(c) At the first interview patients would receive an intensive consultation with a doctor who is a CFS 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 CFS specialist would use the following medical protocols:
- Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols (2003) (Canadian Protocols)
- The CDC (USA) Definition of Chronic Fatigue Syndrome (1994)
and special medical tests (listed below) to determine whether or not the patient has CFS. These are internationally recognised diagnostic protocols for ME / CFS. The following medical tests would be undertaken to establish the following :

- A medical diagnosis of ME / CFS

- The infections, abnormalities and dysfunctions present in each ME / CFS patient

- Research shows that the immune dysfunction is triggered by an environmental factor. Determine if the illness been induced by a virus or a mycoplasma or a chlamydia or by toxins and determine which sub-group the patient belongs to.

All samples - blood, spinal fluids, tissue samples, saliva, etc. would be taken that day and throughout the next day if necessary. This would be done with the assistance of the CFS 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 muscle tissue samples and appointments for MRI / CAT scans of the brain. These appointments could be set up in a hospital near to where the patient lives and expedited within 6 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 6-8 weeks.

(d) Assessing the tests to form a Diagnosis
The test results would be analysed and assessed by the CFS specialist with the help of another specialist(s) eg. virologist, immunologist. They would consult the Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols (2003)
and The CDC (USA) Definition of Chronic Fatigue Syndrome (1994) to further assess the test results. The patient's symptoms as told by the patient himself would be further analysed to see how they relate to the test results and medical protocols. From this they would draw a conclusion:
(i) the patient has ME / CFS. The CFS medical expert would meet with the patient to discuss the test results and the conclusions of the CFS medical expert and other specialists. Having diagnosed ME / CFS, the CFS expert would progress to the treatment protocol mentioned below.
OR
(ii) the patient does not have ME / CFS. The CFS medical expert would meet with the patient to discuss the test results and the conclusions of the CFS medical expert and other specialists. Any abnormalities and dysfunctions found in the tests would be communicated to the patient and he would be referred on to a specialist in a general hospital who could help treat these abnormalities and dysfunctions.

(e) Identifying abnormalities and dysfunctions present in each CFS patient:
The above tests will identify the root causes, and all of the abnormalities and dysfunctions involved in the illness. This will then give the specialist a complete profile of the patient's illness and various medications can be used to improve the condition, alleviate symptoms and / or bring about recovery.

CFS Treatment

From diagnostic tests, determine the root causes, and all secondary infections, abnormalities and dysfunctions in each CFS patient. Implement treatment plan for each factor involved in the illness.
Treatment options for the following:

Further Treatment Measures

Establish best international practises in the treatment of CFS. Constantly upgrade and improve these practises over time as new information becomes avialable.
Keep up to date with the latest CFS research findings from around the world. Use the research to refine and improve the diagnostic process and treatment process for CFS patients.
Regular monitoring of patients so as to scientifically assess the effectiveness of medications, diet and supplements.

Research into the root causes of ME / CFS

Research Prioritisation process: The cost of CFS is much greater than most other illnesses yet CFS research funding is very small when compared to these other illnesses (this is investigated in some detail below). While funding for CFS research remains low or non existent, CFS 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 CFS research in Ireland. The Clinic could be allocated a CFS research grant every year and the Clinic's CFS experts would decide which research projects they wish to finance in Ireland and Britain. All CFS 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 CFS research from around the world
(b) all leading CFS experts and their research works
(c) all past and present clinical trials of drugs / medicines for CFS worldwide
(d) all those people who have fully recovered from CFS 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 CFS, 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 CFS 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 CFS 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 / CFS 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: