Using the NICE Guidelines on M.E. in Northern Ireland.
Brief to the C.M.O. (N.I.)
from the Northern Ireland M.E. Association.
Monday 12th November 2007.
Summary.
The NICE guidelines of August 2007 are the gold standard for treatment of ME within the UK. New clinics in England are in a position to begin implementing the guidelines. But Northern Ireland is poorly equipped to follow suit.
The debate on ME is one of the most rancorous in modern medicine. Disputes on the aetiology and management of ME are longstanding, and show no signs of resolution. That explains much of the NHS paralysis respecting this condition, but does not justify it.
The D.O.H. (N.I.) correctly takes the view that there is no cure for ME, and no effective treatment. NICE has declined to endorse any of the doctrinaire theories held by patients and practitioners; in Northern Ireland the Department should do the same. There is no cure for ME, unfortunately. But by putting in place basic diagnostic, advice, and support services, the D.O.H. (N.I.) would greatly ameliorate the condition of many ME patients.
In developing new services, the Department should take cognizance of deep-seated aversion among patients to the psychiatric hypothesis on M.E, and the attendant clinical, political, ethical and legal ramifications.
Treatments recommended by NICE have limited efficacy and known adverse effects, and face inevitable patient resistance. Clinicians in Northern Ireland should adopt a pragmatic approach, in the awareness that more acceptable treatments will hopefully evolve.
NICE Recommendations for M.E.
The NICE guidelines on CFS/ME for England and Wales, issued on 22nd August 2007, are the first comprehensive instructions for N.H.S. personnel respecting the diagnosis and treatment of M.E.
The principal recommendations are:
Establishing specialist treatment centres are the best way to develop M.E. services.
50% of patients can be managed by GPs; the rest will need specialist referral.
All paediatric cases should be referred to a paediatrician.
Severely ill adult patients should be referred to a specialist immediately; the lesser affected within 3-6 months.
Housebound patients need adequate N.H.S., Social Services & D.W.P. support for effective home management.
For mild and moderate cases, the recommended management strategies are CBT (Cognitive Behavioural Therapy) and GET (Graded Exercise Therapy), as specifically defined by NICE. These approaches are palliative, not curative.
Obstacles to implementation in Northern Ireland.
In Northern Ireland:
The D.O.H (N.I.) has no strategy for M.E. services.
The budget for M.E. services is derisory.
The sole specialist centre can no longer accept referrals from outside Belfast.
In 8 years, no attempt has been made to set up satellite services for those who cannot travel long distances.
Clinical expertise in M.E. has not been developed, and specialists are scarce.
Paediatric and adolescent services are inadequate.
Domiciliary support for the severely affected is practically non-existent.
Since 2003 England has had a national strategy to develop M.E. services, and many parts of the country now have the clinical resources necessary to begin implementing the new NICE guidelines. However the same cannot be said for Scotland, Wales, and Northern Ireland.
According to NICE statistics, there are 6,700 M.E. patients in Northern Ireland. The sole funded specialist provision to handle this workload is one single Occupational Therapist, working part-time at Belfast City Hospital. Due to a limited budget and excess demand, the Belfast clinic has been unable to accept outside referrals since May 2007.
Strategy to develop M.E. services in Northern Ireland.
The D.O.H. should plan a comprehensive service covering all parts of the province.
The starting point is an adequate budget.
Medical expertise in M.E. should be developed locally.
The Belfast clinic should be expanded to include permanent medical staff, a social worker, and additional OTs.
Satellite clinics should be developed at strategic locations such as Craigavon, Omagh and Altnagelvin.
Services must be developed for (a) children and adolescents, and (b) the severely affected housebound.
The starting point for the expansion of ME services is to provide an adequate budget. So far, few doctors in Ulster have shown an interest in this field of medicine. But (as one leading London ME clinician put it), if a ring-fenced budget is provided, practitioners will soon reach out. Existing treatments for ME involve no expensive drugs or procedures. But they are manpower intensive, and do not come cheap.
The kind of clinicians who are required hardly exist, either here or indeed in G.B. The only local solution is to recruit and train a new cadre specifically for the purpose. In theory CBT should be delivered by psychologists or psychotherapists. However there is a national shortage of psychotherapists. In practice, such management of ME patients is handled by Occupational Therapists, both in England and Northern Ireland.
Leading ME clinics in England are staffed by all grades of doctors, from professor to staff physician, by social workers, physios, OTs, and benefit advisors. If the Belfast clinic is to follow NICE recommendations, then a much larger number of patients will be seen, for longer periods of treatment, with greater frequency. Obviously this will entail a larger complement of staff. Currently the sole doctor works in a voluntary capacity. This is laudable but unsustainable, given the expected workload.
As regards treatments, NHS staff in Northern Ireland will feel bound by NICE recommendations on CBT & GET. Doctrinal disputes on treatments are inevitable, unfortunately. But - for the immediate term only - these arguments can wait. The most pressing need is to set up basic diagnostic, advice and support services.
One of the greatest challenges will be to establish support services for severely affected bedbound patients. One approach would be to base a specialist domiciliary visiting service in Belfast, going on frequent circuit round the province.
Addressing Treatment Controversies.
There is no cure for ME, and no effective treatment.
Patients, practitioners, the education sector, and employers should not be misled into expecting quick-fix cures for ME.
Treatments recommended by NICE have limited efficacy, and known adverse effects, and will face patient resistance.
NICE stress that ME patients should not be denied treatment if they exercise their rights to choice and free consent.
Clinicians should take a pragmatic approach to treatments. Research is still in its early stages, and new strategies may well evolve.
Regardless of treatment controversies, the simple act of introducing adequate services for diagnosis, advice, information and support, will be a great improvement.
The view of the D.O.H. (N.I.) is that there is no cure for M.E. and no effective treatment. That is an accurate statement of medical fact, recently confirmed by NICE.
However, there is still much that can be done for M.E. patients. (1) Prompt diagnosis removes uncertainty; (2) Expert prognosis reduces anxiety; (3) Informed management advice improves quality of life; (4) Objective expert medical assessments are vital for employers, the education sector, and the Benefits Agency.
In recommending CBT and GET for mild and moderately affected M.E. patients, NICE make no greater claim for these approaches than that they moderate symptoms and improve quality of life: “The GDG did not regard CBT or other behavioural therapies as curative or directed at the underlying disease process, which remains unknown”, they say; "such interventions can help some patients cope with the condition".
The leading British research advocate for these treatments concurs. "They are not remotely curative", he says; "They are not the answer for M.E." (Professor Simon Wessely, JAMA, Vol. 286, 11 Sept. 19, 2001). Some of his associates are known to make exaggerated promises on treatment efficacy, however. NICE have emphatically rejected such claims.
Patient opinion on the new NICE guidelines has been mixed. Some aspects have been welcomed. But NICE recommendations on CBT & GET have been rejected by all UK ME charities, representing the full spectrum of patient opinion.
Patients’ objections to these forms of management are well grounded. The authors of the Canadian and Australian national guidelines on ME pointed out that the evidence base for the effectiveness of CBT & GET in ME is flimsy; and that there are many reports of adverse effects with GET. The NICE 2007 guidelines warn practitioners about such adverse events, and do not recommend these treatments for the severely affected.
Additionally, NICE anticipate widespread patient objections to current treatments, and proposed a strategy to deal with them. Patients should not be simply discharged if they refuse recommended treatments. Instead they should be offered alternatives, and allowed to continue with elements of the treatment programme they find acceptable. NICE emphasised that, as in all other medical conditions, ME patients have an absolute right to choice and consent.
In rolling out new ME services in Northern Ireland, the D.O.H. (N.I.) should not adopt any doctrinaire stance in the long-running controversy about particular forms of treatment. Current NICE recommendations are subject to revision at two years, and may change. MRC research studies into GET & CBT - and alternatives - are under way, but will not report until 2009. Subsequently, more acceptable treatment strategies may emerge.
Northern Ireland need not wait for the outcome of these investigations, however. It will be a significant advance simply to put in place basic services, diagnostic, advisory and supportive.
Psychiatric Oversight of the Belfast CFS Clinic: Implications.
The Belfast CFS clinic is headed by a liaison psychiatrist.
The clinic's O.T. has a high patient satisfaction rating.
A large percentage of patients strongly object to the siting of this ME clinic within a psychiatric unit.
These objections will ultimately inhibit the growth of this unit.
Only a minority of English ME specialist centres are psychiatrist-led.
Patients should be offered a choice of treatment approach. Proposed new units in N.I. should be located outwith psychiatric medicine.
The Belfast CFS clinic is based at Windsor House, the psychiatric department of Belfast City Hospital, and is supervised by a liaison psychiatrist. This clinic is well-established. The current Occupational Therapist has accumulated valuable expertise in the condition, and is well-liked by those patients who choose, and are chosen, to be treated by her.
That said, this clinic will not achieve its full potential while it remains solely within the psychiatric specialty. Patients surveys indicate a high level of satisfaction among those who attend. But approval is not universal. Its location in Windsor House produces strong hostility within a large remaining section of the patient population in Northern Ireland. Their grounds for objection are that a medical condition, the psychiatric status of which remains undetermined, should not automatically be managed by a psychiatrist.
The strength of this groundswell should not be underestimated, and its causes must be addressed, not ignored. In August 2005 a Belfast journalist, and ME patient, published a full-page feature in a Belfast morning newspaper, detailing her objections to the psychiatric classification of this condition, and her unjustified psychiatric referral.
Locally and internationally, ME patients who are forced into a psychiatric construct become alienated from orthodox medicine. NICE found that 44% of ME patients in a UK sample had resorted to "alternative" practitioners. The Australian national ME guidelines proposed an obvious solution to this familiar difficulty: patients should be offered a range of treatment options, within psychiatric medicine and outside of it.
Most ME specialist centres in England are not run by a psychiatrist. At a leading ME clinic in London, Barts, oversight is by a physician/psychiatrist combination. When it was set up in the 1990s, the Belfast clinic initially had such an arrangement.
Psychiatric Classification Is Counterproductive.
Psychiatric hypotheses on ME are unproven, and are not accepted by NICE.
Nonetheless, the psychiatric hypothesis is the dominant UK treatment model.
Consequently, thousands of ME patients are levered into a psychiatric construct, on inadequate clinical grounds.
This is the principal source of the enduring, sterile, controversy on ME.
Many patients and some clinicians in Northern Ireland are active proponents in this controversy.
Chronic Fatigue Syndrome was recently described by a member of the NICE GDG as the most controversial illness ever. The reason for controversy is simple: there is a common though unfounded assumption that ME is a psychiatric disorder.
All other elements of the dispute flow from this misconception. There is widespread psychiatric misdiagnosis of large numbers of ME patients, who are then subjected to inappropriate treatments. Naturally this situation is resented and resisted by M.E. patients throughout the English-speaking world.
The theory that ME is a psychiatric condition has never been more than an hypothesis, itself under challenge by mental health professionals who specialise in this area. Warnings from the Royal College of Psychiatrists, (that ME cannot be equated with mental illness, and that M.E. patients should not be "blamed for being ill"), are routinely ignored in practice.
Some psychiatrists put forward the theory that ME patients are somatising, because of mental trauma, such as childhood sex abuse. Their principal mode of treatment is to persuade patients to ignore their own symptoms. Other psychiatrists suggest that ME patients are motivated by a desire for secondary financial gain. The lazy-minded and unscrupulous quickly translate these unproven hypotheses into a conviction that (a) the illness is "all in the mind"; (b) that ME patients are to blame for their own illness; and (c) that they are professional malingerers.
Ethical and legal implications of psychiatric misdiagnosis.
There is no consensus, nationally or internationally, within psychiatry or outside it, on the psychiatric hypothesis for ME.
Psychiatric misdiagnosis of ME patients, and inappropriate treatments, are widespread.
The lack of medical expertise in, and the depth of medical prejudice against the diagnosis of ME, are fertile breeding grounds for future litigation.
Practitioners in Northern Ireland should be aware that patient litigation against malpractice in ME has begun, and Parliamentary unease is growing.
Psychiatric theories on somatising and secondary gain are treated with horror by leading clinicians internationally. They are explicitly rejected in the Canadian and Australian national ME treatment guidelines. The position of the NICE GDG is that all theories on the aetiology of ME are unproven. In particular, NICE explicitly declined to endorse any of the psychogenic hypotheses.
Notwithstanding scientific doubt, the somatic hypothesis is dominant; it has now achieved a status akin to scientific fact. The English psychiatric ME lobby receives the lion's share of D.O.H. and MRC research funding. Its members are leading advisors on government policy within the DWP and NHS. The treatments they advocate have been adopted by NICE.
ME patients find this situation extremely threatening. Although the clinical debate is unresolved, and the aetiology of ME is still unknown, nevertheless thousands of ME patients are being levered into psychiatric management, in the absence of sound clinical indications. Patients' fears are now translating into political unease in Parliamentary circles.
The ethical and legal implications of mass misdiagnosis and mismanagement are obvious, and will be a fertile breeding ground for future litigation. Recently numbers of adult patients with ME have successfully challenged compulsory psychiatric detention; one young adult died soon after, from the trauma of her experience. One adolescent obtained financial compensation for unjustified detention, after a major inquiry. One paediatric case reached the GMC and the High Court, inconclusively; others are pending.
Political Disquiet.
A committee of senior Parliamentarians recently confirmed and condemned the psychiatric monopoly of ME treatment and research in the UK.
In 2006 Dr. Ian Gibson convened a cross-party committee to examine ME research funding. Membership included senior back-benchers and peers, a former Minister of Health, a consultant surgeon, and a former President of the Royal College of Physicians.
This committee regretted the dominance of the psychiatric analysis of ME. “While CFS/ME remains only in the psychological section of medical discourse, there can be little chance of progress”, they concluded.
They also objected to the psychiatric monopoly on research funding. This echoes sentiment among patients. At best, psychiatric research is aimed at palliation. The patient community would prefer biomedical research, aimed at cure.
Northern Ireland Myalgic Encephalomyelitis (M.E.) Association.
