Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Comprehensive Approach to Low Back Pain
- Deepa Krishnaswami (11 June 2009)
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Official Statement from the British Pain Society
- Joan B Hester (12 June 2009)
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Withdraw or modify
- Bernard J nawarski (13 June 2009)
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When is Low Back Pain Non-specific?
- Dr Sanjeeva Gupta, Dr Jonathan Richardson, Consultant Pain Specialist, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ. (15 June 2009)
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NICE Back pain guidelines: A step too far in wrong direction
- Manohar Sharma (16 June 2009)
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NICE guidline on backpain is misleading
- Christian Egeler (18 June 2009)
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NICE guidance: acupuncture
- mark c aley (18 June 2009)
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If you want something done ask a busy man
- Simon J Thomson (18 June 2009)
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Response to the NICE guidelines for back care
- Charlotte Woolley (18 June 2009)
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This massive investment in additional acupuncture does not appear to be justified.
- John R Lethbridge (19 June 2009)
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Acupuncture in Low Back Pain?
- Rudi Stilz (21 June 2009)
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Sham acupuncture
- Richard Bartley (22 June 2009)
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NICE but not nice
- Gnanie Panch (23 June 2009)
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Response to the NICE guidelnes for low back pain
- Timothy Charles Barling (23 June 2009)
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Improved Radiofrequency Technique and Outcome – It Does Matter.
- Sanjeeva Gupta, Dr Jonathan Richardson, Consultant Pain specialist, Bradford Teaching Hospitals NHS Foundation Trust, Duckworth Lane, Bradford, BD9 6RJ. (26 June 2009)
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Catch-22
- Phillip Taylor (7 July 2009)
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NICE work
- ANDREW D LAWSON (8 July 2009)
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NICE outraged by ousting of BPS President
- Michael Rawlins, Peter Littlejohns (23 July 2009)
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NICE Strategy
- J. David Leopold (24 July 2009)
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A riposte to Prof Rawlins & Littlejohns
- Sandeep Kapur, DY1 2HQ (25 July 2009)
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Ejection of Pain Society President is deeply disturbing
- Peter R Croft (25 July 2009)
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Please do not shoot the messenger
- Martin R Underwood, Elaine Buchanan, Paul Coffey, Peter Dixon, Christine Drummond, Margaret Flanagan, Mark Griffiths, Dries Hettinger, Gill Ritchie, Pauline Savigny, Steven Vogel, and David Walsh (26 July 2009)
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Clarification of recent BPS actions
- Dr. Liz Garthwaite, Dr. D.F. Jones (27 July 2009)
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NICE guidelines back pain
- ASHISH GULVE (27 July 2009)
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Re: NICE outraged by ousting of BPS President, but the real outrage is the planned reduction in Pain Clinic services
- Christopher J Wells (27 July 2009)
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British Pain Society response to NICE. The lion has roared: the mouse responds
- John Goddard (28 July 2009)
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Re: NICE outraged by ousting of BPS President
- Jonathan Richardson (28 July 2009)
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Re: Please do not shoot the messenger
- ANDREW D LAWSON (28 July 2009)
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Members shocked and saddened
- Cathy M Price, Charles Pither, Cathy Stannard, Beverly Collett, Chris Main, Dee Burrows, George Harrison, Nick Allcock, Mick Serpell, Ann Taylor, Martin Johnson, Mike Bailey, Amelia Williamson, Maggie Keeling, Roger Knaggs, Chris Barker, Brona Fullen & 71 others (28 July 2009)
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The hidden cost of endorsing voodoo
- David Colquhoun (28 July 2009)
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Re: The hidden cost of endorsing voodoo
- Mark Struthers (30 July 2009)
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Judging the NICE early low back pain guideline
- Rajesh Munglani (31 July 2009)
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Comparison with controversy surrounding NICE Guidelines on CFS/ME
- Tom P Kindlon (31 July 2009)
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Re: Correction on Low Back Pain Guidelines, earlier letter
- Dr Chris J Wells (10 August 2009)
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Deepa Krishnaswami, Consultant Phisician Chennai 600018, INDIA
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I am writing in response to the article published in the The BMJ, 30th May 2009,"Nice Recommends Early Management of Persistent Low Back Pain” – BMJ2009;338:b2115. Having worked for the NHS for 6 1/2 years, I am well aware of the waiting list for advanced radiological investigations including MRI’s for the spine. Back pain especially low back pain in women is very subjective as the pain threshold varies from person to person. Although this article is abridged, if back pain persists for more than 4 to 6 weeks after a thorough clinical and neurological examinations and basic laboratory and radiological investigations, it is very important for the patient to undergo MRI scan of the affected region and any other region (referred pain), as one may miss crucial conditions like nerve root compression, Radiculopathy, Foraminal Canal Stenosis, Pott's spine, seronegative / reactive arthritis Retroperitoneal Fibrosis, Chronic Urinary Track Infections, PMT, Osteopenia / Osteoporosis and more importantly tumours of the spine. These are just a few of the many conditions that can cause Low back pain. In India where obesity and diabetes is on the rise, and where size 0!! has become a fad among youngsters (teenagers both Male & Female) erratic dieting including completely cutting off Carbohydrates from ones diet is being followed due to peer pressure and a desire to emulate their favorite film stars. There are numerous gyms cropping up for weight reduction and these have positive & negative effect in one’s life. Many women and men present with upper, mid & low back pain as they use the treadmill, Stationery cycle and cross trainer(elliptical), without doing proper knee, back strengthening exercises (quadriceps, pelvic bridging, stretches etc) to improve core muscle and bone integrity. Let us also not forget that doing Dexa Scan is also important as osteopenia and osteoporosis is on the rise due to improper dietary, hormonal changes. An early morning walk using a sun screen and not a sun block in a park1 is a very important message to convey to people, age no bar for obvious reasons (effect on bone integrity and lowering LDL cholesterol) & physiotherapy after consulting a General Practitioner / Rheumatologist / orthopaedician is vital in the road to recovery for the distressed patient with back pain. Dietary counseling should also be made mandatory. Yes, alternate therapy (acupuncture, homeopathy, herbal / ayurvedic massages, Physiotherapy) done by qualified people can reduce the pain but the root (!) problem needs to be dealt with first. Pulsed Electro Magnetic Field Energy (PEMFE) therapy to the specific tender spot in the back pain is the latest addition to the therapeutic armamentarium offering rapid and significant pain relief2,3. Thanks & Regards,
References: 1. “Sunlight can cut your risk of death to half”, Archives of Internal Medicine, 2008;168(12):1340 – 1349. 2. B.M.Hegde. “A Bonus of pure healing outcomes” TheJSHO;2009-Vol1,No2,3:3 3. Glen Gordon. “The false dogma of drugs and the natural balance of things”, TheJSHO,2009;Vol2,3:47-49 Competing interests: NONE |
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Joan B Hester, Consultant in Pain Medicine London
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The British Pain Society, which represents the views of over 1,500 healthcare professionals from a variety of disciplines involved in the active management of chronic pain, has serious reservations about the NICE low back pain guidelines published May 2009. We acknowledge the high cost of low back pain, both in terms of suffering, loss of individuals to the workforce and the financial burden of treatment. We also recognise the complex nature of low back pain as a biopsychosocial disorder, and do not believe that it can be adequately assessed by using evidence from randomised controlled trials within a limited scope. Professor Sir Michael Rawlins (October 2008) advises that decision makers should incorporate judgements in reaching their conclusions1. We do not believe that judgement has been applied fairly or appropriately in these guidelines. The guidelines specifically target those suffering pain between 6 weeks and 12 months. They are not applicable to all other types of low back or radicular leg pain. We are concerned that this is not made absolutely clear and that commissioners and purchasers of services will apply the guidance to all back pain patients. We applaud the recommendation for people with low back pain to exercise and remain physically active, and to undergo an exercise programme. However, the inclusion of acupuncture and manual therapy as first line treatments has received a great deal more publicity and will have to be carefully controlled if the suggested modest costs of these treatments are to be realised. We welcome the recommendation that patients who may require strong opioid medication should be referred to a pain specialist2. Long term use of opioids is not to be encouraged3. We also welcome the prominence given to the early provision of combined physical and psychological (CPP) programmes (similar to Pain Management Programmes) for patients who are distressed by their pain. The guidelines recommend that CPP programmes should be intensive; 100 hours over a maximum of 8 weeks. The BPS has published guidance on how pain management programmes might be delivered and the skill mix required for effective delivery4. It remains to be seen if the proposed CPP programmes will prove effective, and indeed, cost effective. They will require considerable investment in terms of time, training of staff, and resources. We recommend clarification of the exact nature of these programmes. We cannot agree with the exclusion of all injections for back pain. The BPS provided evidence to support the clinical effectiveness of such procedures. The Guideline Development Group (GDG) did not consider evidence presented from cohort studies and clinical case series in its deliberations on these, or any other, treatments. We think this was misguided. Although NICE has recommended further research into these procedures, we are most concerned that a significant number of patients will be denied this choice of treatment in the interim. The recommendation for early consideration of spinal surgery causes us great concern. No alternative is provided for those who do not wish to have an operation or who are unsuitable for surgery. It is anticipated that surgery will only be appropriate for a very small number who fulfil specific indications. Surgery is an irreversible step with an acknowledged failure rate. We feel strongly that the opinion of a Pain Management Specialist should be offered to all patients before consideration of surgery. The treatment of back pain is complex and has to be individualised; one size does not fit all. Application of these guidelines to all those with persistent low back pain will result in a major change in clinical practice, which in the opinion of the Council of the BPS, will not represent good or appropriate patient care. The Council of the British Pain Society recommends withdrawal of these guidelines. 1. Sir Michael Rawlins. Statistics can help, but doctors must also use their judgement. 2008; Independent News and Media. 2. Recommendations for the appropriate use of opioids for persistent non-cancer pain. British Pain Society, 2005, revision in press, expected September 2009. http://www.britishpainsociety.org/pub_professional.htm#opioids 3. Jensen MK. 10-year follow-up of chronic non malignant pain patients: opioids, health related quality of life and health care utilisation. Eur J Pain 2006;10(5):423-33 4. Recommended guidelines for pain management programmes for adults. The British Pain Society 2007 http://www.britishpainsociety.org/pub_professional.htm#pmplts This is a consensus statement from the Council of the British Pain Society June 10th 2009 Competing interests: Members of the BPS Council are clinicians and academics from medicine, nursing and physiotherapy who are actively involved in pain managment services in the NHS and some also in independent practice. |
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Bernard J nawarski, Consultant in Pain Medicine Frimley Park NHS FT
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In your guidelines summary you state "NICE recommendations are based on systematic reviews of the best evidence available. When minimal evidence is available, recommendations are based on the Guidelines Development Group's experience and opinion of what constitutes best practice." As the evidence for injections is stronger than the evidence for the therapies you have recommended, and that there was not a Pain Physician who performs injections on your group to give a balanced view (despite our requests to be represented), it is clear to me that your "experience and opinion" fall far short of "evidence based medicine" and that you were wrong to deny patients this effective treatment. The Guidelines should be withdrawn or modified before patients are irreparably damaged by unnecessary lumbar fusions. Competing interests: None declared |
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Dr Sanjeeva Gupta, Consultant Pain Specialist Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary, Beadford, BD9 6RJ, Dr Jonathan Richardson, Consultant Pain Specialist, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ.
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As defined by NICE in the Low Back Pain Guidelines published “Non- specific low back pain is tension, soreness and/or stiffness in the lower back region for which it is not possible to identify a specific cause of the pain. Several structures in the back, including the joints, discs and connective tissues, may contribute to symptoms”. So the authors agree that in addition to malignancy, infection, fracture, ankylosing spondylities and other inflammatory disorders as mentioned in the guidelines there are several other structures in the back, including the joints, discs and connective tissues that may contribute to low back pain. So pain arising from these structures cannot be labelled as non specific unless specific causes have been excluded. In the past we did not have the capability of diagnosing low back pain and patients with low back pain were conveniently dumped into a group called “mechanical low back pain” or “non specific low back pain”. In recent years there have been publications describing the neuroanatomy of the spine which has improved our understanding of the innervation of the different structures in the lower back which could be the source of pain (1,2). Simultaneously various techniques have been validated to precisely identify which structure in the lower back could be the source of patients pain thus providing the patient with an objective diagnosis and the possibility of logical, specific treatment. With the information we gather from clinical consultation, imaging studies and precision diagnostic techniques we can diagnose approximately 70% of low back pain (3 – 6). In our opinion our patients deserve to be given an opportunity of a diagnosis and treatment where possible rather than just acupuncture and manipulation which have weak evidence and (by guideline definition) must be applied to non-diagnosed patients. We feel it is ethically and morally wrong to not give the patient an opportunity to identify the cause of their pain until one year and keep trying one treatment after the other by which time the chances of the patient recovering are likely to be significantly reduced. In order to make a diagnosis patients need an MRI scan and specific nerve blocking or structure stimulating techniques, all of which have very high quality evidence and yet are specifically banned under the new guidelines. Low back pain is a complex problem and the treatment has to be tailored to patient’s needs and prescriptive guidelines promoting “one size fits all” is not acceptable. The NICE guideline on low back pain does a great disservice to our patients and represents several steps backwards in the management of low back pain. This is also emphasised by the fact that the two major pain organisations, The British Pain Society which is a multidisciplinary organisation and the Faculty of Pain Medicine of the Royal College of Anaesthetist, London have asked for withdrawal of the guidelines. Ref: 1.Groen GJ, Baljet B, Drukker J. Nerves and nerve plexuses of the human vertebral column. Am J Anat 1990; 188: 282-296. 2.Bogduk N. The inneravtion of the lumbar spine. Spine 1983; 8: 286- 293. 3.Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine 1995; 20: 31-37. 4.Dreyfuss P, Michaelsen M, Pauza K, McLarty J, Bogduk N. The value of history and physical examination in diagnosing sacroiliac joint pain. Spine 1006; 21: 2594-2602. 5.Schwarzer AC, Wang S, Bogduk N, et al. Prevalence and clinical features of lumbar zygapophysial joint pain: a study in an Australian population with chronic low back pain. Ann Rheum Dis 1995; 54: 100-106. 6.An algorithm for the investigation of low back pain. In: Practice Guidelines- Spinal Diagnostic and Treatment Procedures. Ed: Bogduk N. International Spinal Intervention Society, California, USA, 2004, pp 87- 94. Competing interests: Dr Sanjeeva Gupta and Dr Jonathan Richardson are both Consultant Pain Specialists |
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Manohar Sharma, Consultant in Anaesthesia and pain management The Walton centre for Neurlogy and Neurosurgery NHS Trust, Lower Lane, Liverpool, UK, L9 7LJ
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I am very surprised by the non specific nature of these guideline for low back pain. I spend significant time doing cancer pain and very often come across patients whose tumor/spinal malignancy has been missed, often with poor outcome. These patient have been treated on the similar pathway for non specific low back pain, as these guidelines tend to suggest. I think it is not very easy to rule out all specific causes for low back pain, although this can be debated. Do we have the resources (financial,skiled staff and patient enthusiasm/motivation) to implement and deliver, 100 hours of intensive pain management programme as suggested for a sigificant number of patients? Is there high quality randomised controlled trial data showing long term efficacy of pain management programme? From acupuncture to spinal fusion, all with in one year for non specific low back pain, seems a step too far in the wrong direction and may well be even more expensive and combersome, than thought by NICE. No pain physician with a special interest in interventional pain management was on the guideline development group and these guidelines are the personal opinions of the guideline development group of NICE, rather than a synthesis of published high quality (though limited)evidence for management of low back pain. For the time being I will still use my clinical acumen to manage these patients (within the context of multi-disciplinary teams) and hope these non specific guidelines are either modified or withdrawn as recommended by the British Pain Society and Faculty of Pain Medicine of the Royal College of Anaesthetists, London. Competing interests: Consultant in pain medicine |
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Christian Egeler, Consultant Anaesthetist and Pain Specialist Swansea SA6 6L
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Sir, is it pure coincidence that the guidelines on early management of persistent non specific back pain include as recommended treatment options every modality represented by the panel members but, as no interventionalist has been accepted onto the panel, no injection treatment? What horrifying thought to even consider spinal fusions for these patients. I only take comfort in the fact that non specific back pain by definition means exclusion of specific contributing factors and as such targeted injections for diagnostic and therapeutic purposes remain an important part of pain practice. It is unfortunate that the guidelines don't make this clear and as such they are misinformed, misleading and should be withdrawn. Competing interests: pain specialist as part of a multidisciplinary team that includes injection therapy |
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mark c aley, GP so53 2lh
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It is interesting that shortly after the NICE guidlines, which suggests acupuncture as a (rather costly in terms of time and resources) intervention, Arch int med published data on acupuncture in back pain, suggesting actual point specific, non-point specific and simulated acupuncture all had about the same success rate. Actual or simulated acupuncture therapy appears to be more effective than usual care for chronic low back pain,(RCT 600+ patients. individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care, 10 sessions in the accu groups in 7/52). At 8 weeks, improvements in mean dysfunction scores were 2.1 points for those receiving usual care, 4.4 points for individualized acupuncture, 4.5 points for standardized acupuncture, and 4.4 points for simulated acupuncture. To me this seems that the type of acupuncture (even real vs not real) makes no difference: is the main benefit ? clinician interaction… seems a poor set of data to base a national programme on… Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and even penetration of the skin appear to be unimportant in eliciting therapeutic benefits [Arch Intern Med. 2009;169:858-866] Competing interests: None declared |
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Simon J Thomson, Consultant in pain medicine and anaesthesia Basildon and Thurrock University Hospitals SS16 5NL
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It is with sadness that I have read NICE's guideline development group submission on low back pain. I was serving on council of the British Pain Society (BPS) when volunteers for names to go forward to this particular guideline group were being solicited for. I was told that it would involve meetings of up 10 days during the year. I felt unable to committ to that amount of time whilst working in my full time NHS pain practice with little support and serving on 2 medical education societies and contributing to a NICE technology assessment on spinal cord stimulation. Now I am rather wishing I had found the time as judging by the biased output I might have better represented interventional pain medicine as others seem to have represented their own crafts. Already there is evidence of commissioners using this guideline to withdraw funding of treatment outside the scope of this guideline. It is not right to prevent patients from receiving an accurate pain diagnosis in those that don't respond to education, pain relief and exercise for a year. Please withdraw these guidelines. Competing interests: Consultant within a multidisciplinary pain management service |
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Charlotte Woolley, Osteopath Basuto Medical Centre. SW6 4BJ
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As an osteopath, I have found the recent NICE guidelines for back pain, advising against the use of facet joint injections, very concerning and am left bemused as to the rationale. NICE appears to have recommended options that in practical terms will be more expensive and less effective for pain control. There are two main issues arising from these guidelines. Firstly, NICE have found insufficient evidence for facet joint injections. The studies are fundamentally flawed as they do not assess injection therapy in combination with any form of manual therapy. This seems to me rather like having a hip replacement with no mobilisation or physiotherapy post operatively, then wondering why the hip still feels a bit stiff and sore. It is easy to be distracted by the esoteric of the exact sensory pathways that arise from facet joint capsules; the kind of thing some osteopaths get very excited about. However, as I understand it, the clue here is very much in the name and a facet joint is just that, a joint whose function is to move. Thus while a steroid injection may well temporarily decrease the pain from a facet joint, unless you get it moving with appropriate mobilisation, it will continue to hurt, just as it did before once the steroid has worn off. The blessed relief that injections can elicit should be considered a crucial part of the whole that is spinal pain management, where the whole is very much more than the sum of its parts. The second and possibly more fundamental issue that arises from these guidelines is the apparent attempt to bypass consultant medical specialists, trained in spinal pain management. These are the specialists whom, I feel should play an integral part in our management of back pain rather than be a last resort referral for ‘chronic pain’ cases after all else has failed. By then, they are pretty much doomed to failure by definition. Currently a patient with back pain sees their GP, then a physiotherapist and if neither of these sort things out, a surgical opinion is sought. Whilst not against spinal surgery, far from it, I have yet to meet a spinal surgeon who thinks spinal surgery should be entered into lightly. It is on occasion, the only course of action open, when severe structural instability is present. Thank goodness for these individuals who are available when you do need them but are they really the best people to manage the vast majority of back pain patients who don’t require their technical skills? Surely this is the role of a doctor who can first offer the less expensive, less invasive options such as the aforementioned injections. The consultant specialist has extensive expertise in medical management and furthermore has an extensive understanding of the whole concept of pain and its control. It is they who the patients should be referred to after initial primary care assessment and treatment. Conservative pain management is what these doctors are trained to do and they should be allowed to do it at the appropriate time. As a manual therapist, I treat patients who sometimes reach the end of the road in terms of what I can offer them acting alone. These patients may not want, nor necessarily need surgery. I am fortunate in that I practise largely privately and so can easily advise my patients of what I feel would be the best next step for them; I am just glad that I am not one of the GPs having to try to manage these complex pain patients, who come back from their surgical appointment feeling like there is nowhere else to go. Competing interests: None declared |
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John R Lethbridge, Consultant in Anaesthetics and Pain Management East Sussex Hospitals NHS Trust
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The Costing Report published alongside the NICE document on low back pain calculates that the additional cost of providing a course of acupuncture comprising up to a maximum of 10 sessions over 12 weeks will be £24 Million per year. This is based on an estimated increased uptake for acupuncture from 5% to 35% of the relevant low back pain population covered by the NICE report, with courses of acupuncture required for an estimated 125,000 patients every year for this group. It is expected that much of the funding will come from a 95% reduction in injections, and a reduced volume of spinal surgery (Even though the perverse effect of this report could be an increase in the volume of spinal surgery). What is most surprising is that such a major recommendation to be implemented accross the country at massive expense to the NHS, can be based on evidence that appears to have such a central flaw: The NICE report notes a statistical difference between groups receiving acupunture and no acupuncture. But it also notes evidence that shows no difference between acupuncture and sham acupuncture. Surely many experienced pain management physicians will see this as highlighting that patients in this group, where psychosocial problems are often a major component, are frequently capable of responding positively to any labour intensive intervention involving multiple treatments by a sympathetic and unhurried therapist, with the time to take an interest in the patient and his problems. I find it extra-ordinary that this evidence concerning acupuncture and sham acupuncture can be so easily dismissed , while at the same instant rolling out a national acupuncture program at an estimated annual cost of £24 Million. Competing interests: None declared |
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Rudi Stilz, SpR Occupational Medicine St Thomas Hospital, SE1 7EH
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With some surprise I noted NICE's recommendation for acupuncture in this setting. The European Guidelines for Management of Low Back Pain in 2006 could not recommend acupuncture based on available evidence. Since then further data has become available and, again, the new evidence which is also presented in the full NICE guidance shows no significant difference between sham and real acupuncture. Unfortunately, there was only a small trial with economic figures relevant to the UK but it did not have a sham acupuncture arm. One could argue this means that there wasn't an appropriate control. It appears that this trial (and this trial only) forms the basis of the current NICE recommendations to offer acupuncture on the NHS as one of the first three interventions for persistent non-specific low back pain. I am not convinced that these recommendations are justified, scientifically or economically. Competing interests: None declared |
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Richard Bartley, Physiotherapist Wales
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There seems to be some confusion over the term ‘sham’ acupuncture. It is often confused with simulated acupuncture (i.e. the needle does not puncture the skin even if the patient perceives it has). ‘Sham’ is often used inappropriately to describe the practice of sticking needles into places that do not fit with traditional Chinese acupuncture points. Western Medical Acupuncture (a better nomenclature) involves non- meridian needling based on the theories of pain gating and endorphin stimulation. Whether Western Medical Acupuncture actually does what it says in the tin is of course open to debate. However ‘sham’ refers more appropriately to simulated acupuncture. Competing interests: None declared |
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Gnanie Panch, Consultant in pain management and anaesthesia N19 5NF
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NICE, but not nice Re: NICE CG88 Guidelines for early management of chronic non-specific low back pain and the application of more evidence based care to promote prevention of long term disability were long overdue. The focus on interventions that may reduce pain and improve physical and emotional functioning is also a logical goal. The seal of “NICE” on the recommendations would mean that the guidelines are likely to be read by those who suffer or treat back pains. The readers however, must examine the guidelines with the knowledge of the following four factors. Firstly, the need to prioritise resources will continue to be an uncomfortable but the needed task for those providing NHS care. It is the responsibility of everyone who pays the price of futile interventions. Getting it right the first time and early is the priority. Secondly, for the prevalent condition, chronic non specific back pain, that is treated by medical, para medical and non medical providers of care, robust guidelines are essential. The inherent bias of individuals favoring treatments they know and practice must be minimised during guideline development. The top-heavy nature of contributors to the GDC makes uncomfortable reading. Thirdly, an international consensus recommendation for the measurement of chronic pain has been published and the web based information is universally accessible to all interested parties. www.immpact.org. Finally, a few good quality RCTs in chronic pain or back pain are available to guide treatments and author of almost every review article emphasise the lack of robustness in the evidence. Re-organisation or expansion of parts of the service as proposed, based on the NICE CG88 when robust evidence is lacking, will also have a massive cost implication. Comments must be made on the recommended interventions. Exercise program- Encouraging activity is acknowledged as an important goal. But exactly how it must be done however has not been proven. Every study investigating physiotherapy or group exercise therapy has shown opposing results. Acupuncture- involves treatment by traditional Chinese and modified western techniques. The uniformity, clarity of content or the nature of improvement has never been proven. Although clinicians may assume that a treatment that has stood the test of time in china must be effective, the treatment offered at present is a mixture that varies from practitioners offering treatment with a weeks’ training or traditional Chinese techniques. Manual therapy- The studies quoted does not only provide no evidence of effectiveness of treatments but highlights the risk of manipulation that can go terribly wrong for patients. Pain Management program (PMP)- While reviewers of Health Technology Assessment in 1998 have indicated the effectiveness of psychology based treatment programs, later reviewers have questioned the validity of short programs. To quote their conclusion, “The reviewed studies provide evidence that intensive (>100 hours of therapy) multidisciplinary biopsychosocial rehabilitation with functional restoration produces greater improvements in pain and function for patients with disabling chronic low back pain than less intensive multidisciplinary or non-multidisciplinary rehabilitation or usual care. Whether the improvements are worth the expense of these intensive programmes is open for discussion. The final judgment will depend on societal resources, available alternatives, and the value attached to the observed decreases in human suffering from back pain.” The GDC appears to have concluded this statement as adequate support for recommending intensive PMPs. A high quality randomised controlled study from Oxford compared the effect of spinal fusion and multidisciplinary pain management program using “immpact” recommended tools. The conclusion was that the quality of life scores, measured by SF36 did not improve as a result of either intervention each costing more than £4000.00 per patient. Evidence for recommending spinal fusion surgery as the 3rd or 4th line treatment for non-specific low back pain is unfounded. Lord Darzi proposes an NHS fit for the purpose for the 21st century with measurement of quality outcomes as the central theme. A slogan, “We can only be sure to improve what we can actually measure” has been quoted. A clinician reading the guidelines, with the knowledge of the four comments on the second paragraph, can only conclude that the guidelines are a disservice to patients we serve and to the NHS in general. The project commissioned by NICE was a golden opportunity to have made a difference. But the NICE CG88 unfortunately has turned out to be nothing “but not nice” for promoting evaluation of treatments, providing better outcomes or a sensible use of finite resources. It is not too late to prevent harm that would ensue if guidelines were adhered to. Finally what has not been mentioned in CG88 must be emphasised. No mention was made of outcome evaluations during the pathway a patient takes, in succession through the exercise, acupuncture, manual therapy or PMPs. Lord Darzi would not be pleased or approve it as guidelines fit for the purpose. Ref: 1 Guzman J, Esmail R, Karjalainen K, MalmivaaraA et al. Multidisciplinary rehabilitation for chronic low back pain: A systemic review. BMJ 2001;322: 1511-1516 2 Fairbank J, Frost H, Wilson MJ, Yu LM et al. Randomised controlled trial to compare surgical stabilization of the lumbar spine with an intensive rehabilitation program for patients with low back pain: The MRC spine stabilization trial BMJ 2005; 330: 1233-1239 Competing interests: None declared |
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Timothy Charles Barling, GP and Musculoskeletal Physicia Moorfield House Surgery, 35 Edgar St, Hereford, HR4 9JP
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Early management of persistent non-specific low back pain: summary of NICE guidance – a response. I am a General Practitioner with a Special Interest (GPwSI ) running a musculoskeletal (MSk) clinic in Hereford. In my training in MSk medicine I learnt to differentiate between different types of mechanical low back pain (LBP) – simple dysfunction, through instability to degenerative-type pain, affecting different areas from upper lumbar through to the sacroiliac region. The NICE guidelines differentiate specific LBP (malignancy, infection, fracture and inflammatory) from non-specific LBP, a category into which they appear to lump together all these potentially very different types of LBP. The NICE guidelines state that “injection of therapeutic substances into the back” is not a “recommended treatment for non-specific LBP”. I agree entirely with this but for specific mechanical LBP targeted injection treatment is effective and safe. The evidence for most specific interventions in LBP is limited, not only for facet joint injection with steroid, radio-frequency denervation ,facet joint medial branch block and prolotherapy but also for acupuncture and manipulation. Certainly the case for spinal fusion is unimpressive. Where minimal evidence is available, according the article, recommendations are based on the Guideline Development Group’s “experience and opinion”. Since this group contains no MSk experts or interventional pain specialists whatsoever it is my opinion that the balance of this lesser evidence is flawed. It is based on mechanical LBP being a single diagnostic entity which will respond to nine sessions of manipulation or ten sessions of acupuncture over a 12-week period. NICE do not even differentiate between where each these two modalities should be preferred, for instance acupuncture for myofascial pain or manipulation for pain due to simple dysfunction. I have been taught that diagnosis is an essential prerequisite in medicine and here we have a broad and diverse area being “dumbed down” by an organisation seeking to set the highest standards for medical care. I use a number of injection techniques including c/arm guided facet joint injection and prolotherapy. I am aware that the evidence for each intervention is ambiguous and with flawed methodology. I carry out regular audit of pain and function which is the best I can do. These are patients for whom physical therapies have generally been ineffective and my results in terms of reduced pain and improved function are good. Certainly the procedures have minimal risk compared to spinal fusion which NICE promotes for non-specific pain unresponsive to acupuncture, manipulation or a combined psycho-physical approach. Rather than issue a blanket statement about not injecting therapeutic substances into the back NICE should perhaps be more specific about their message; for instance: “The targeted injection by properly trained doctors of therapeutic substances into the back should be considered for certain specific conditions causing mechanical LBP. Further research in this area is a matter of priority”. Perhaps ‘non-specific ‘as a term is in itself something of an indictment of our attitude towards mechanical LBP in general. The message seems to be that we do not need to be any more specific in our diagnosis. In order to make back pain management work properly GP’s and Nurse Practitioners need to attempt to filter not only malignant disease etc from mechanical LBP but also recognise different types of mechanical pain, just as they would differentiate anterior knee pain from a medial collateral ligament sprain of the knee. In the same way they should not prescribe a specific treatment (manipulation or acupuncture) without a clear idea of what they are trying to treat. Rather than advising GP’s to throw specific treatment modalities at LBP in a non-specific way, NICE should be promoting the old-fashioned standards of good clinical medicine, such a history-taking and examination in order to establish a more specific diagnosis such as lumbar facet joint pain or sacroiliac instability. NICE should also refrain from issuing blanket statements such as “do not offer injections of therapeutic substances into the back” without consulting pain management specialists or musculoskeletal doctors at all, particularly when there is some evidence for benefit in the case for instance of prolotherapy (injections to strengthen ligaments) when allied to other modalities of treatment. I suspect that much of the NICE document is driven by cost factors and the fact that manipulation and acupuncture are mainly found in the private sector may be significant. I also notice that NICE claims that savings of £33 million could be made by stopping the use of injections without commenting on the cost of increasing spinal fusions that would result, not to mention the lack of choice for patients and lack of evidence for fusion. As doctors we will always quite rightly be suspicious of directives from on high which appear inflexible and prescriptive particularly when treating a condition so multifaceted and incompletely understood as low back pain. Correspondence to Dr Tim Barling on timothy.barling@btinternet.om Competing interests: None declared |
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Sanjeeva Gupta, Consultant Pain Specialist Bradford Teaching Hospitals NHS Foundation Trust, Duckworth Lane,Bradford, BD9 6RJ, Dr Jonathan Richardson, Consultant Pain specialist, Bradford Teaching Hospitals NHS Foundation Trust, Duckworth Lane, Bradford, BD9 6RJ.
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We read with interest the NICE publication on Low Back Pain. The guideline categorically mentions “do not refer for radiofrequency facet joint denervation” (1). In our opinion radiofrequency (RF) neurotomy when performed correctly in appropriately selected patients is a minimally invasive procedure with good outcome and no significant complications (2) compared with spinal fusion which is invasive, irreversible, expensive and associated with complications, yet which the guideline recommends. Our understanding of the physics of radiofrequency (RF) and the RF technique for facet joint denervation which determines the outcome of the procedure has evolved in the last 35 years since it was first described by Shealy in 1974 (3). In 1997, Bogduk et al (4) described the appropriate technique of diagnosing facet joint pain. Subsequently descriptive studies have been published which concluded that long lasting pain relief can be obtained if patients are selected after appropriate diagnostic medial branch block and if multiple RF lesions are performed by placing the RF needle parallel to the medial branch in order to lesion a longer length of the nerve that supplies the facet joint in question (5-7). Randomised controlled studies have also shown good outcome following RF when the procedure is performed appropriately as recommended by the International Spinal Intervention Society (8-11). We feel the guideline panel members have not been guided appropriately as there was no interventional pain specialist in the panel. The study by Leclaire et al described in the NICE guideline did not use appropriate diagnostic criteria to diagnose facet joint pain and the technique of RF was not described and not surprisingly the results were not favourable (12). The study by van Wijk et al, although it used diagnostic methods to recruit patients for RF, used a technique that was inaccurate, and hence the conclusions are not valid (13). With the advancement of science we now understand the physics of RF technique better and also have a better understanding of the neuroanatomy of the spine. We feel it is inappropriate to include studies which are flawed in patient selection and technique to produce a guideline. In the UK the guidelines published by NICE are prescriptive and it is very important that studies with such major flaws are not included. This should not only apply to the low back pain guidelines but also to any future plans to develop guidelines or indeed when systematic review or meta-analysis are published in any peer reviewed journals which are often referenced. We feel that the guidelines on non specific low back pain should be withdrawn and the process restarted after inclusion of appropriate members on the guideline development committee. References: 1. Savigney P, Watson P, Underwood M. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ 13 June 2009; 338: 1441-42. 2. Kornick C, Kramarich SS, Lamer TJ, Sitzman TB. Complications of lumbar facet radiofrequency denervation. Spine 2004; 29:1352-1354. 3. Shealy CN. Facets in back and sciatic pain. Minn Med 1974; 57:199- 203. 4. Bogduk N. International Spinal Injection Society guidelines for the performance of spinal injection procedures. Part 1: Zygopophysial joint blocks. Clin J Pain 1997; 13: 285 – 302. 5. Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine 2000; 25:1270-1277. 6. Gofeld M, Jitendra J, Faclier G. Radiofrequency denervation of the lumbar zygapophysial joints: 10-year prospective audit. Pain Physician 2007; 10:291-300. 7. Burnham RS, Hollistski S, Dimnu I. A prospective outcome study on the effects of facet joint radiofrequency denervation on pain, analgesic intake, disability, satisfaction, cost, and employment. Arch Phys Med Rehabil 2009; 90:201-205. 8. International Spine Intervention Society. Lumbar medial neurotomy. In: Bogduk N (ed). Practice Guidelines for Spinal Diagnostic and Treatment Procedures. International Spinal Intervention Society, San Francisco, 2004 pp 188-218. 9. Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain. A randomized double-blind trial. Spine 2008; 33:1291-1297. 10. Tekin I, Mirzai H, Ok G, Erbuyun, Vatansever D. A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain. Clin J Pain 2007; 23:524-529. 11. van Kleef M, Barendse GA, Kessels A, et al. Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine 1999; 24: 1937-1942. 12. Leclaire R, Fortin L, Lamber R, et al. Radiofrequency facet joint denervation in the treatment of low back pain: a placebo controlled clinical trial to assess efficacy. Spine 26;1411- 1417, 2001. 13. Van Wijk RMA, Geurts JWM, Wynne HJ, Hammink E, Buskens E, Lousberg R, Knape JTA, Groen GJ. Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain. A randomized, double-blind sham lesion-controlled trial. Clin J Pain 2004; 21:335-344. Competing interests: Dr Sanjeeva Gupta and Dr Jonathan Richardson are both Consultant Pain Specialists |
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Phillip Taylor, Consultant in Anaesthesia & Pain Management Bradford Teaching Hospitals BD9 6RJ
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I note the NICE guidelines specifically exclude the management of malignancy, infection, fracture and inflammatory disease. I also note that the guidelines specifically prohibit the use of imaging in non- specific Low Back Pain of 6 weeks - 1 year in duration. I fear that the guideline committee did not consider the contradiction inherent in those two statements - if imaging isn't allowed, how are those specific conditions to be diagnosed or excluded? There are certainly conditions whose onset can easily be confused with benign, musculoskeletal low back pain (for instance myeloma, tuberculosis). It is of deep concern to me that adherence to these guidelines will result in prolonged treatments by non-medical professionals without proper assessment of the patient. This will inevitably lead to delayed diagnosis of serious conditions, which in turn is likely to lead to worse outcomes in these patients. Though the numbers involved are likely to be small in comparison to the number of patients with "nonspecific" low back pain, the consequences for the individuals involved are potentially devastating. I am astonished that his contradiction was not addressed by the NICE committee, nor its consequences considered, and it is my belief that this is symptomatic of the inconsistent and illogical processes which the committee has followed. Joseph Heller would, I am sure, have been proud of this particular NICE committee. Competing interests: Consultant in Pain Management |
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ANDREW D LAWSON, HON SEN LEC , MEDICAL ETHICS , IMPERIAL COLLEGE . POST GRAD STUDENT OXFORD UNIVERSITY OX107DA
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Sir- I have watched with some incredulity over the past 6-8 months whilst members of a recognised sub-speciality of pain medicine with a faculty in a royal college have tried in vain it seems to get NICE , to listen to what were, and are, reasoned opinions as to what may be appropriate treatments for patients with disabling pain. Clearly we need evidence in medicine to ethically justify our actions as without evidence a bad outcome would always necessarily be bad practice. It is true that over the past 30-40 years the evidence based movement has transformed medicine, from a situation where clinicians’ decisions were based on “ high quality evidence “ in only 20% of cases 1, to one where the evidence base for what we do seems much more robust. However to some at least this desire for better evidence has undergone a transformation from an appeal for good and better science to the establishment of a new aristocracy in medicine, one which brooks no criticism of its methodology. “The randomised clinical trial has become supreme. “ This may be warranted but what is not is the idea that evidence that is not in the form of a RCT is, in the absence of a relevant RCT, of no value. A paper published in the BMJ a few years ago came to the, tongue in cheek, conclusion that “ parachutes reduce the risk of injury after gravitational challenge, but their effectiveness has not been proven with randomised clinical trials 2 ”, a self evident proposition . The emphasis on only one kind of evidence can hamper innovation, leading to belief in only one kind of truth. Truth may be difficult to find though. Criticism of EBM does not only come from the fringes. “ By the rules of EBM itself, no definitive evidence whatsoever has accumulated over 15 years of research and debate on EBM to show that ‘medicine by EBM “ is superior to ‘medicine as usual 3 ’ NICE in it’s considerations seems to be hidebound by a dogma that considers that if a RCT has demonstrated benefit a treatment will work and if it has not there is some ethical justification for ignoring other available evidence. This is simply not true for a given patient, nor justifiable in philosophical or statistical terms. As Charlton said; “The basic error of EBM is quite simple. It is that the epidemiological data do not provide the information necessary to treat individual patients. The error is intractable and intrinsic to the methodological nature of epidemiology , and no amount of statistical jiggery-pokery with huge data sets can make any difference.” It may of course be a guide for overall healthcare planning, but only if all available evidence has been gathered. To exclude other types of evidence prior to decision making is both intellectually wrong but also potentially harmful to our patients. To ignore submissions of evidence that might have produced a more nuanced report , enhancing patient choice and individualising care in the process , seems incomprehensible. It seems to be a given , accepted as though it were an undisputed fact, that the hierarchies of evidence from Level 1++ to level 4 are somehow founded upon a bedrock of absolute truth. When the ex-president of NICE, Sir Michael Rawlings, said in his Harveian Oration of 2008 that “ the notion that evidence can reliably placed in hierarchies is illusory 5 “ perhaps it is time for some members of NICE to listen. The argument over the data for injections will continue but I have seen nothing in the BMJ or elsewhere that has convinced me of the absolute rightness of one early treatment over another, which I suspect is what most doctors would agree with. Firm, conclusive, irrefutable data is lacking for all modalities of treatment for this complex problem; should we be surprised by this? However as has been mentioned elsewhere the lack of data does not mean it does not exist. Doctors are ethically obliged to provide or refer for the appropriate treatment in their patients’ best interests, but where uncertainty exists as it does here clinical judgement needs to be used. Sir Michael, rightly in my mind, called for people to use their judgement in combination with the best scientific evidence when making decisions as to how to treat patients. These guidelines show something of a lack of that, unless the aim is to drive early back pain management out of the NHS entirely. This would be, of course , highly cost effective! References: 1. US Office of Technology Assessment 1978 2. Hazardous journey. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials Smith G, Pell J BMJ 2003; 327:1459-1461 (20 December) 3. Editorial, Journal of Evaluation in Clinical Practice May 2003 4. Charlton B Journo Evil Clint Practice 1997 3 169-172 5. www.rcplondon.ac.uk/pubs/brochure.aspx?e=262 Competing interests: Ex Chairman of Pain Interventional Interest Group |
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Michael Rawlins, Chairman, NICE MidCity Place, 71 High Holborn, London WC1V 6NA, Peter Littlejohns
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We write to express our outrage at the British Pain Society’s vote to force their President, Professor Paul Watson, out of office because some members disagreed with a recommendation in NICE’s recent guideline on low back pain which he helped develop. The BPS’s sustained campaign against this highly respected pain management and rehabilitation expert is professional victimisation of the very worst kind. That it has now culminated in the BPS forcing an exemplary expert out of office, is shameful. All NICE guidelines are developed by independent clinical and patient experts who give up their time and expertise, over a two year period, to produce robust, evidence-based guidance. It is totally unacceptable for guideline developers to be singled out in this way and have their professional integrity called into question, simply because some groups don’t like a robust, evidence-based recommendation that has been developed by a group of independent experts. The guideline developers’ only aim is to help improve the care and treatment of people with specific conditions by highlighting gold standard approaches based on the available evidence. The BPS is clearly admitting that they do not accept evidence-based medicine. Moreover, the Society’s actions fly in the face of the comment made in a recent High Court judgement. At a judicial review of NICE’s chronic fatigue syndrome guideline in March this year, at which the judge dismissed the claims in their entirety, he particularly highlighted the importance of health experts to be able to express their opinions without fear of retribution. The BPS has acted dishonourably in making their own President a scapegoat for the fact that some of its members refuse to accept that there is not the scientific evidence to support their interventions. It is a sad day for freedom of experts to express views, for evidence-based medicine, and for the ideals of the medical profession. Yours faithfully, Sir Michael Rawlins, Professor Peter Littlejohns Competing interests: None declared |
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J. David Leopold, Consultant Physician Cwnrhydycwrw Cottage Hospital, Swansea
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Sir. Once more we observe the laboriously produced and disseminated guidelines from NICE frankly rubbished in print and in everyday gossip among doctors. There have been too many examples where NICE has gone too far, or accepted polemic as fact. Its credibility is low and getting lower. Time to stop and take stock, before we lose the benefits from wider dissemination of the many extant well-established bodies of knowledge. NICE is charging in where angels fear to tread, and destroying its brand. Contrast this with the standing of such as the D+TB, and the Cochrane Collaboration. kind regards David Competing interests: None declared |
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Sandeep Kapur, Consultant (Pain management & Anaesthesia) Dudley NHS Trust, DY1 2HQ
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Sir, I think Professors Rawlins & Littlejohns rather miss the point in their recent rapid response, wherein they express their 'outrage' at the ousting from office of British Pain Society (BPS) president Prof Watson: BPS members did not object to Prof Watson's involvement with the NICE Back Pain Guideline development group; what they did take exception to was Prof Watson's attempt to run with the hares and hunt with the hounds. It was his fatal conflict of interest in helping NICE formulate the guidelines and then opposing them as President of BPS that placed him in an invidious position and made his BPS presidency untenable. Sandeep Kapur Consultant (Pain Medicine & Anaesthesia) Dudley NHS Trust Competing interests: None declared |
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Peter R Croft, Professor of Primary Care Epidemiology Arthritis Research Campaign National Primary Care Centre, Keele University, ST5 5BG
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In our Centre’s response to the draft NICE guidelines on back pain, we articulated a number of points of criticism and support. This was part of a transparent process involved in the development of the guidelines even if, as is inevitable, some opinions and views did not get included in the final version. Continuing robust and detailed debate, discussion and criticism of the published guidelines is entirely justified. However, the notion that a respected organisation such as the British Pain Society would throw out an officer of the Society who had engaged in NICE guideline development because Society members disagree with the NICE recommendations is deeply disturbing. From the viewpoint of intellectual and academic freedom, it is distressing that the Society regards this as an acceptable way to oppose the guidelines. Ejection of the BPS President on these grounds is entirely at odds with the aims and spirit of a professional society, which previously had a respected track record and reputation as an organisation supporting critical scientific approaches to its clinical discipline. Competing interests: I have in the past been a collaborating author with the President of the British Pain Society and with other members of the BPS |
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Martin R Underwood, Professor of primary care research, chair of the back pain guideline development group Warwick Medical School, CV4 7AL, Elaine Buchanan, Paul Coffey, Peter Dixon, Christine Drummond, Margaret Flanagan, Mark Griffiths, Dries Hettinger, Gill Ritchie, Pauline Savigny, Steven Vogel, and David Walsh
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We are all members of the group that developed the NICE guidelines for the early management of persistent non-specific low back pain. We note with some dismay that an extraordinary general meeting of the British Pain Society has forced the resignation of Professor Paul Watson as president of the Society because of his involvement with and continued endorsement of these NICE guidelines. This is a most surprising course of action by members of the British Pain Society when Professor Watson has contributed to the development of the guidelines in an exemplary manner. The NICE guideline development procedure is fundamentally a group rather than an individual responsibility, and it was made clear at the outset that individuals on the guideline development group were not there to represent particular professional groups. Where there was a conflict of interest, individuals were required to absent themselves from the room for particular discussions and decisions. The resignation of Professor Watson was forced by the votes of 186 of the Society’s 1,550 members. Although another 179 members voted against the motion at its extraordinary general meeting, the outcome appears to send a message that the Society rejects evidence-based medicine when they do not like the outcome, and wishes to restrict the academic freedom of any of its officers that may choose to participate in the development of evidence-based guidelines in the future. We understand fully that not everyone will agree with all parts the guideline. As developers of it, we are very happy to engage in academic debate about its content, including the advice against injecting therapeutic substances into the back for non- specific low back pain of 6 weeks to 12 months duration which appears to have caused greatest concern from some members of the British Pain Society. However, we are very unhappy with personalisation of the debate. It is most disappointing that a respected senior academic like Professor Watson can have his personal and professional integrity called into question in this manner. There are potential wide reaching consequences if this action results in decisions made by developers of future guidelines being driven by sectional interests, and the fear of retribution, rather than evidence and the greater good. This decision to shoot the messenger has the potential to do serious harm, for many years, to the cause of improving the quality of care for patients with back pain; a cause that we are interested in promoting. Such a response also leads to a danger that professionals who might have relevant expertise to offer to future guideline development groups, not putting themselves forward for fear of personalised attacks following their contribution. This presents a danger for clinical guidance development and a threat to best practice. Competing interests: The competing interests of the members of the guideline development group are published on the NICE website |
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Dr. Liz Garthwaite, Specialist in Pain Management Scarborough Hospital YO12 6QL, Dr. D.F. Jones
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With due respect to Sir Michael Rawlins, Prof. Littlejohns, Prof. Croft and Dr. Underwood et al; the public statement they made in the rapid response, regarding Prof. Watson, (quoting Sir Michael Rawlins): " some members disagreed with a recommendation in NICE’s recent guideline on low back pain which he helped develop" is simply not correct. If they would like to go back to the rapid response statement made by the the Council of the British Pain Society on 12th June 2009 where it states in the first sentence: "The British Pain Society, which represents the views of over 1,500 healthcare professionals from a variety of disciplines involved in the active management of chronic pain, has serious reservations about the NICE low back pain guidelines published May 2009" and ends with "The Council of the British Pain Society recommends withdrawal of these guidelines." I do not think this constitutes 'some members'. This statement, of course, left the President in an untenable position. In a statement he himself made as newly appointed President: "The President is the Chief Executive of the Society rather than an honorary title and this will help me to further the aims of the society to promote best clinical practice, improve education in pain and further research into the causes and treatment of pain. " This is, indeed, laudable. The problem was, how could he, as President of the BPS and an officer on the Council, lead the Society to try to get the NICE guidelines withdrawn, (as the BPS rapid response recommended), when he had been the Clinical Advisor to NICE, setting up the guidelines. Unfortunately, he was in the wrong place, in the wrong position and at the wrong time. It was indeed regrettable that a vote had to be made. All members of the BPS were entitled to vote, whether they attended the Extraordinary Meeting or not. Numbers of voters are thus irrelevant. The vote was not against Prof. Watson personally or professionally but had to be made so that the BPS could move forward in recommending the withdrawal of the NICE guidelines. Competing interests: None declared |
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ASHISH GULVE, Consultant in Pain Management & Anaesthesia The James Cook University Hospital, Middlesbrough
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Dear Professor Croft, Underwood & Rawlins, No one has made Professor Watson a scapegoat. I had a huge respect for him and all his work. As a British Pain Society President, he failed to Co-opt a Pain Physician on this NICE back pain committee. It is him who along with himself has brought the British Pain Society to disrepute. Please stop blaming BPS members who voted to oust him. Tomorrow as an Anaesthetist can I formulate or should I be formulating Guidelines on Intracranial Aneurysm Clippings? The evidence for spinal fusion and acupuncture is no better than Pain Interventions. I think by recommending spinal fusion (if conservative management has failed) NICE has put patients at risk. Surgery is irreversible. What about the incidence and long term costs of treating failed back surgery? At international meetings every one is laughing at NICE for its current recommendations. This not only includes Pain Physicians but also Neurologists, Neurosurgeons, Spinal Surgeons and every one else involved in caring for back pain patients. NICE has started on the path of self destruction. Competing interests: None declared |
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Christopher J Wells, Pain medicine 25, Rodney Street, Liverpool, L1 9EH
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Sir Michael Rawlins and Dr Littlejohns have expressed their outrage at the consequences of the British Pain Society’s refusal to accept the NICE guidelines on low back pain. They say they are evidence-based, but they are not. They feel that the BPS members, some of whom have spent their lifetime dealing with people who have chronic pain, should meekly accept their clinics being closed down, the treatments that they have helped patients with over the years simply ceasing. Looking at the guidelines, whilst some of the recommendations are evidence-based, others (over a third) are based upon the personal opinions of the Guidelines Development Group (GDG). This requires that we look closely at the composition of the GDG, and that follows later. However, whenever the British Pain Society put a viewpoint to the guidelines committee, it was told that only RCTs were acceptable as evidence (but see Sir Michael Rawlins, 2008, http://www.independent.co.uk/opinion/commentators/michael-rawlins- statistics-can-help-but-doctors-must-also-use-their-judgement-962607.html “ …the notion that evidence can be reliably placed in hierarchies is illusory. Judgements are an essential part of the decision-making process. As Bradford Hill, the architect of the RCT, stated so cogently: 'Any belief that the controlled trial is the only way would mean not that the pendulum had swung too far but that it had come right off the hook…... It is scientific judgement – conditioned by the totality of the evidence – that lies at the heart of making decisions about the benefits and harms of therapeutic interventions'"). And yet this large group, the BPS, was completely ignored in the formulation of the guidelines. If we look at the Guidelines Development Group (GDG), NICE tell us they advertised for a Chair, and they appointed Professor Underwood, who is an honourable man and who is the co-ordinator of the BEAM trial. The results showed that "manipulation, followed by exercise, achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months." Brought into the GDG then was one of his close colleagues, Vogel, an Osteopath with whom he has published extensively, Dixon, a Chiropractor, to make sure there was plenty of knowledge about manipulation and then three Physiotherapists. One of the Physiotherapists, Hettinga, is listed as a patient representative; she is a laudable person who has helped patients immensely. She works for Back Care, but she is after all a Physiotherapist, and has published on manipulation. The next person to be recruited was a Spinal Surgeon with a well-known dislike of interventions. NICE tell us that they advertised for an interventionist to join their panel. They were given a recommendation from the British Pain Society. They ignored that suggestion. Instead they appointed a person who is not an interventionist. Does no-one look at the CVs of anyone who is appointed? This suggests either incompetence or design. NICE can choose which. One would have expected a balanced GDG to have noticed this discrepancy and call for someone to give evidence on pain medicine. When it came to acupuncture, they clearly felt that they did not have enough knowledge concerning this and they called upon an Acupuncturist to come and discuss things with them. However, the whole of the GDG, including Professor Watson (by that time President-Elect of the BPS), did not think it appropriate to bring in a pain physician, and NICE did not manage to appoint such a person to the GDG. So, any fair person would agree that the GDG, whilst comprising honourable and scientific people, was actually a very biased group with pre-existing, strong beliefs in manipulation and exercise. Perhaps another GDG could be set up with 6 pain physicians and no specialist in manipulation, to see if they came to exactly the same conclusions. I doubt it. We know that the evidence on back pain is weak at best. Machado and colleagues (Rheumatology 2009 48:520-527) pointed out that there is only strong evidence for two treatments for chronic low back pain, anti- inflammatories and analgesics. Cohen (BMJ 2008:337;a2718) pointed out that there is weak evidence for many things, including interventions. There are many factors involved in the production and maintenance of LBP, which all recognise as the ultimate bio-psycho-social disorder. How sad then, that the NICE guidelines do not cover the proper assessment of the patient, but move straight on to treatment, with the assumption that all LBP is non-specific (although they also say it can come from the discs and joints, muscles and ligaments). Although the guidelines exhort the treater to review the diagnosis, they preclude hospital assessment in multidisciplinary Pain Clinics by experienced Clinicians and Psychologists. Assessment and management is left in the community, in the hands of GP’s, Physiotherapists, Acupuncturists and Chiropractors, rather than hospital teams. Some will be well-versed in assessment, many will not. The guidelines are based on evidence that shows the treatments offered will produce a small to no effect at the end of 12 months. At the end of their treatment, patients are simply cast adrift. Very little chronicity will be prevented, and they will then have nowhere to turn. It is important to consider that these are unlike any other guidelines anywhere in the world. These guidelines are now Government policy, to be implemented (See NICE website, slideshow notes - "Implementation of this guidance is the responsibility of local commissioners and/or providers" ). They come with costings, both national and for communities of 100,000 people, so that local commissioners can fund some new treatments and stop funding present treatments. See www.nice.org.uk/nicemedia/pdf/CG88CostReport.pdf. Funding to Pain Clinics will be stopped, to provide acupuncture and chiropractic and also the more useful, but less well-funded options, of exercise and CPP (Combined Physiotherapy and Psychology - no need for doctors and nurses). A fortunate 2600 patients, out of four million seeing their GP’s will be offered this. Transcutaneous Electrical Stimulation Therapy (TENS) will be stopped. Individual psychotherapy will be stopped. Pain Management Programmes (PMP) will be stopped. Injections into the base of the spine will be stopped. Is this what we think is appropriate for our patients? It concerns us greatly is that Service Commissioners (PCTs) are encouraged by the costings to remove funding from established Pain Clinics for all patients with LBP at ANY time (not just up to 12 months). The reassurances that have been offered in this respect so far are wholly inadequate. Removal of funding for Pain Clinics which have been slowly and carefully built up to serve local communities and into which we have put our great efforts and careers is nothing short of vandalism. To suggest that this will be done in the name of "science" is the real outrage. Multidisciplinary Pain Clinics were developed to help patients with back pain. Staff within them use evidence and clinical judgements to fully assess and manage chronic pain patients. They know that the main reasons for chronicity are psychosocial problems, with a significant minority of patients having physical problems. None of these factors are addressed by acupuncture or manipulation, which show only minor long-term benefit in some patients. All of these factors are daily addressed within a multidisciplinary Pain Clinic. Accurate assessment and targeted treatments are applied. Does it not seem reasonable to Sir Michael Rawlins and Dr Littlejohns that those of us who are aware of all this are annoyed about proposals to close down our clinics? Do they think we will just sit by whilst patients are disadvantaged in this way? The President of any society has to believe in what the organisation does. Professor Watson only believes in a small part of what his organisation does. He is actively promoting guidelines with which the British Pain Society disagrees. Any organisation that believes in itself, faced with swingeing closures that are supported by its own President, would do as we have done. We take no pleasure in our action to ask him to step down. NICE suggests that the guidelines are evidence-based, many believe they are flawed. The GDG demonstrated a strong professional selection bias and that has resulted in an unscientific, almost predictable Guideline. There are many calls for NICE to withdraw the guidelines and reconsiders the wider consequences. I would urge that the Guideline is suspended before real and irreparable damage is done to the Country, our services, our future patients and NICE itself. Competing interests: Specialist in Pain Medicine |
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John Goddard, Consultant in Paediatric Anaesthesia & Pain Management Sheffield Childrens Hospital
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The Council of The British Pain Society would like to clarify its position, in response to the letter from Sir Michael Rawlins and Professor Peter Littlejohns and their outrage at the democratic proceedings of The British Pain Society. Council of The British Pain Society deeply regrets the resignation of the President, Professor Paul Watson. We continue to hold Paul Watson in high regard and believe he has acted honourably. He has contributed immensely to the Society over many years and retains the respect not only of Council, but of the vast majority of the membership. We are a multidisciplinary organisation committed to the promotion of best practice in the management of those experiencing pain. We are also a limited company, bound by company law and our Memorandum and Articles. It needs to be recognised that the Officers of the Society acted in accordance with the Memorandum and Articles in holding an Extraordinary General Meeting in response to a request by twenty four members. We are disappointed that an alternative way of dealing with this issue was not possible and that the resolution suggesting a conflict of interest and calling for Professor Watson to resign was carried by just seven votes; the total votes cast representing only a quarter of the Society’s membership. We would emphasise that Professor Watson’s professional integrity was never questioned at the meeting. We share some of the sentiment expressed by Rawlins and Littlejohns. The meeting, the resolution and the outcome now represent an uncomfortable chapter in the Society’s history. These events reflect the sincere concerns of some within the Society’s membership; they were of the view that the NICE low back pain guideline represented a serious conflict of interest for their President. While only a minority of the Society’s membership adopted this stance, there should be no doubt that that this group are not alone in their concerns about the guideline. Although the guideline contains many important elements we would wish to wholeheartedly endorse, we have concerns with some aspects of the NICE process that has resulted in this guideline. We are particularly concerned that access to a pain specialist does not form part of the care pathway. We are also concerned with regard to the omission of an expert in non-surgical interventions from the guideline development group and the costing report, which includes injections performed outside the specified window of the guideline. We believe that the British Pain Society does respect the academic freedom of its members and officers. We wish to reassure Rawlins and Littlejohns that we do embrace the principles of evidence based medicine, but also recognise its limitations and that it must be applied with judgement (Rawlins, Harveian Oration 2008). We believe that this guideline, in the latter part of the pathway, is not in the best interests of many patients and would welcome the opportunity to engage in a constructive debate with NICE with regard to the guideline, and more importantly, its implementation and future revision. As a Society, we need to reflect on recent events and examine our procedures. We also need to retain our multidisciplinary membership and move forward, continuing to champion the importance of pain management in the interests of patients. We maintain a strong commitment to high quality interdisciplinary pain management, based on the application of evidence, with judgement, for individual patients. Signed the Executive Officers on behalf of the Council of the British Pain Society. Competing interests: Chair of the EGM, and Executive Officer of The British Pain Society |
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Jonathan Richardson, Consultant Pain Specialist Bradford Hopsitals NHS Trust
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I am grateful for the opportunity provided by the BMJ to allow my response to the letter written a few days ago by Sir Michael Rawlins and Professor Peter Littlejohns criticising the ousting of the British Pain Society (BPS) President following the recent NICE publication of Guidelines for Low Back Pain (LBP). It is sad that these authors have chosen to ignore the true basis for this action and instead have attempted to trivialise it into a personal attack upon this individual and a general rejection by the BPS (or a section of it) of evidenced based medicine. Upon both accounts they are wrong. The facts of the case are that the ex-President advised the Guideline Development Group (GDG) of NICE and then strongly criticised the Guideline on behalf of his Society, and indeed called for its withdrawal. His criticism of the Guideline is appropriate because its enactment will see the wholesale removal of science from the highly disparate group of patients who present with pain expressed in the low lumbar area. The Guideline focuses upon treatments when what is fundamental is a diagnosis. As a Pain Specialist working in cities experiencing immigration, usually of non-English speaking people from parts of the world where infectious diseases of the spine are much more common than within traditional English populations, disallowing these patients imaging within the first 12 months of their symptoms, unless they can manage to express through an interpreter that they have clear red flags, worries me enormously. Getting a clear history through interpreters in patients who are then sometimes very unwilling undress to allow a full physical examination is difficult: it is something only clinicians daily working in this field can understand. The legal implications of missing serious pathology of the pelvis, urinary tract, bowel or bone presenting as "non-specific LPB" will become a time bomb waiting to explode. Will NICE rush to aid the defence in cases where this disallowance of investigation has lead to tragic results? There is no personal angle in the vote against the President of the BPS. His actions have spoken for him. He presided over a Society dedicated to the promotion of improved pain management within the UK. The NICE Guidelines will threaten the survival of many pain clinics by removing funding for vital activities such as minimally invasive diagnostic and therapeutic procedures, Pain Management Programmes, individual psychotherapy and Transcutaneous Electrical Stimulation Therapy (TENS) to name but a few. For any president to oversee the ruination of decades of construction of Pain Clinics by dedicated individuals who look to the BPS for leadership is unthinkable. Sir Michael Rawlins and Professor Peter Littlejohns suggest that the BPS or a section of it rejects evidenced based medicine. This is wrong. I and many colleagues of mine do not believe the evidence has been appropriately scrutinised. The GDG chose to ignore almost all evidence that was not derived through randomised controlled trials, but then admitted opinion from the Members of the GDG when it suited their agenda. NICE has erred. Unless the Guideline is withdrawn the consequences for the UK will be very serious. Let us not allow a diversion of attention to the gravity of this by suggestions of personalised bickering. Dr Jonathan Richardson MD, FRCP, FFPMRCA, FIPP Specialist in Pain Competing interests: None declared |
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ANDREW D LAWSON, Hon Sen Lec , Medical Ethics , Imperial College ;Post Graduate Student, Oxford University OX107DA
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Prof Underwood et al seem concerned about the shooting of the messenger. They say that " Such a response also leads to a danger that professionals who might have relevant expertise to offer to future guideline development groups, not putting themselves forward for fear of personalized attacks following their contribution " , well the key point is relevant expertise. The CDG did not have someone with relevant expertise in interventional pain medicine, a point that still seems to elude, or is simply being ignored by some people at NICE . I recently checked that I am still on the list of advisors from the BPS on the NICE website . I do have the relevant expertise and would have been happy to help; but the first I heard of the guidelines was when the drafts were published last autumn! As president of the BPS and chair of the CDG Prof Watson should have ensured that there was a relevant expert to advise and sit on the group. The fact that he then ends up being president of an organization that calls for the guidelines that he has overseen to be withdrawn is his fault and nobody else's . Sadly any criticism of his position is personal but that goes with the territory, as they say. If you give expert evidence in court, you are accountable in law. If you are going to make " expert judgments " or put your name to guidelines then you should expect to deal with the consequences and that includes dealing with criticism . I am sure that Prof Underwood and his colleagues are not suggesting that be being part of NICE they are immune from criticism or even censure by their professional bodies if they get it wrong, as seems to be the case here. Nobody , to my understanding , is impugning the integrity of Prof Watson, but as president of the BPS he seems to have failed to ensure that the members of the professional society of which he is president were given a fair hearing of their views in a forum in which he was the clinical adviser! Had he ensured that such an expert was on the group then this would not have happened. As president of the BPS he surely would be expected to know who to ask for expert guidance, as clinical adviser to NICE one would have thought that he had an obligation to ensure that that advice was sought. The numbers issue is irrelevant, the statutes of the BPS allow for an EGM and those interested could have turned up and voted or sent their proxy votes. A speaker from NICE was invited to present to the meeting, hardly a show trial ! If you do not like your MP you have not a leg to stand on if you did not vote! Competing interests: EX CHAIRMAN OF PIIG |
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Cathy M Price, Consultant in Pain Medicine Southampton University Hospitals Trust, Charles Pither, Cathy Stannard, Beverly Collett, Chris Main, Dee Burrows, George Harrison, Nick Allcock, Mick Serpell, Ann Taylor, Martin Johnson, Mike Bailey, Amelia Williamson, Maggie Keeling, Roger Knaggs, Chris Barker, Brona Fullen & 71 others
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Sir, We write in response to the forced resignation of Professor Paul Watson from the Presidency of the British Pain Society. We come from a range of backgrounds that has made the British Pain Society (BPS) an effective alliance of clinical and academic professionals working with patients to improve the understanding and treatment of pain in the UK. It has shocked and saddened us that a minority of individuals has been able to force the resignation of our respected President through a vote of no confidence at an Extraordinary General Meeting without sufficient time for reflection and debate amongst the whole Society. We remain firmly convinced that the majority of the British Pain Society saw no conflict of interest in Professor Watson’s previous role on the guideline development group of the NICE recommendations for the management of low back pain. Furthermore we respect Professor Watson’s scientific credentials, his impartiality, his freedom to serve on national bodies and committees, and also acknowledge his substantial contribution to the BPS over many years from both the scientific and organisational perspective. The proper place for a debate on NICE Guidance remains through scientific meetings, journals, with commissioners and with our patients. It is vital that Pain Management continues to take an evidence-based approach. The treatment of pain is necessarily a multidisciplinary endeavour. As a Society we have been proud of the breadth of our stance and the effective integration of the disparate specialties involved in pain management. We will strive to see inclusivity prevail and re-establish the reputation of the Society as a professional and impartial organisation motivated primarily by those who needlessly suffer pain. Yours sincerely, Competing interests: ChP is a director of the Real Health Institute specialising in pain management programmes, BC is chair of the Chronic Pain Policy Coalition (CPPC) Treasurer of IASP and a Past President of the BPS. NA, MS are current members of BPS council. BC,RK are co-opted BPS council members, CP, GH, CS, are recent BPS council members. CP/MJ/CS are members of the CPPC. All are health care professionals and academics specialising in pain management both in and outside the NHS. |
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David Colquhoun, Research professor UCL
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I am very surprised indeed to hear Professor Rawlins say that NICE's low back pain guidance is "robust and evidence-based". As far as I am aware, on the contrary, there isn't the slightest reason to think that one sort of manipulation is better than another. The guidance doesn't even pretend seriously that there is. That being the case, why on earth has NICE, for the first time ever, recommended alternative therapies? Not only has is the costing produced by the guidance group based on very dubious assumptions, but they have also neglected the serious cultural costs of endorsing alternative medicine, and the costs of having a new generation of students (mis)-educated in anti-scientific forms of medicine. These points are well illustrated by an examination paper for acupuncture students that recently came my way. Here are a couple of questions from the paper. 021. Jing/body essence is vital to the maintenance of life. In 100 words, explain the role of Jing plays in the cycle of human life. (10 marks) Or try this
This is the sort of thing that will be thrust down the throats of a new generation of students if NICE's recommendation to expand acupuncture is allowed to stand. It is deeply ironic that this should happen at a time when universities (including the one that set the exam) are closing down their antiscientific courses in alternative medicine. The guidance group does not seem to have noticed yet that the good times are over for quacks. They've been rumbled. And the endorsement of chiropractic, in the absence of any real evidence that it is better than manipulation by physiotherapist, could hardly have come at a worse time. The suing of Simon Singh by the British Chiropractic Association has led not only to a huge outcry (over 15,000 signatures and rising) about the iniquity of UK defamation law, but it has also led to a very detailed examination of the claims made by chiropractors, As a result, almost 600 formal complaints have been lodged with the General Chiropractic Council. There seems to be a problem of vested interests. No doubt it will be said that the widespread condemnation of the guidance stems, in part, from the fact that it might reduce the income of people giving ineffective injections in Harley Street. That could well be a contributory factor. One of many problems with the guidance was sheer arrogance. It didn't start out by saying honestly that, in many if not most cases of non-specific low back pain, there is little that can be done, pharmacologically, surgically or by voodoo medicine. As a result, the report resorted to clutching at straws (as it happens, those particular straws that happen to provide the livelihoods of the group members). If Professor Rawlins cares to mount a robust evidence-based defence of NICE's endorsement of acupuncture and chiropractic, I should very much like to see it. It was most certainly not to be found in the guidance documents. Competing interests: None declared |
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Mark Struthers, GP and prison medical officer Bedfordshire mark.struthers@which.net
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While Britain is gripped by fear of pandemic flu, Professor Colquhoun is indignant at the hidden costs of endorsing “anti-scientific forms of medicine” in tackling non-specific low back pain. If only the professor would turn his ire, fire and indignation on the cost of vaccine endorsements made on the back of precious little scientific evidence of benefit to anyone, man, woman, child or elderly person. A recent report from the ‘Institute of Science in Society’ (ISIS), written by Dr Mae-Wan Ho and Professor Joe Cummins, suggests that vaccines will be far more deadly than the swine flu and that mass vaccination could be a recipe for disaster. [1] The authors reiterate that influenza vaccines in general “give little or no protection against infection and illness, and there is no reason to believe that swine flu vaccines will be different.” In fact the evidence base suggests that flu-vaccinated children are more unwell and spend more time in hospital than the unvaccinated. As yet there are no plans for mass vaccination in the UK but the government has made advance orders for 195 million doses with GlaxoSmithKline (GSK). Of course, there may be a problem of vested interest to rival even the most pecuniary of chiropractitioners, homoeopathists and acupuncturists combined. And I wonder what sort of medicine Professor Colquhoun really thinks is being endorsed by the corporate swine flu- vaccineers. [1] Fast-tracked Swine Flu Vaccine under Fire. 27 July 2009. Dr. Mae- Wan Ho and Prof. Joe Cummins. http://www.i-sis.org.uk/fastTrackSwineFluVaccineUnderFire.php Competing interests: None declared |
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Rajesh Munglani, Consultant in Pain Medicine West Suffolk Hospital , Bury St Edmunds. IP33 2QZ
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Dear Sir, I write in response to the recent letter by Rawlins and Littlejohns (BMJ 339: b3028-b3028) in which they express outrage over the decision of the British Pain Society, which, after a open and democratic debate, called and voted for the resignation of the President of the BPS, Professor Watson. This position has been recently reported again in the BMJ (Kmietowicz BMJ 2009;339:b3049) Watson served as a member of the clinical development group (CDG) for the NICE guideline on early low back pain (LBP) and continued to support the NICE guideline (BMJ 2009;338:b1805) whilst the BPS council, on behalf of its 1500 or so members criticised those same guidelines. The BPS , the Faculty of Pain Medicine within the Royal College of Anaesthetists and many others have also roundly condemned the guideline but in addition (as has been highlighted particularly by Wells ,BMJ 2009;338:b1805) have expressed from a very early stage and continue to express, deep concern about the original make up of CDG, in particular not including a Consultant in Pain Medicine. All parties were concerned about the seemingly arbitrary treatments recommended by NICE (and certainly not based on any substantial or significant body of evidence –see responses by Wells above and Colquhoun “the Hidden cost of endorsing voodoo BMJ 2009;338:b1805). Wells notes that about a third of the decisions of the CDG were based not on evidence but on ‘consensus’ within the group. The growing opinion amongst many respected professionals is that the bizarre preferential choice of treatments proposed by NICE seems to reflect the chosen interests of the CDG and the excluded treatments with the known dislikes of CDG members. Rawlins and Littlejohns state in their letter that all the members chosen are experts and independent. In support, Rawlins and Underwood quote from a judicial review of NICE’s chronic fatigue syndrome (CFS) guideline handed down earlier this year. In this judgment the importance of health experts to be able to express their opinions without fear of retribution was highlighted. Rawlins and Littlejohns also added that Mr Justice Simons, the Judge in the NICE CFS guideline case dismissed the legal challenge to it in its entirety. The parallel conclusion Rawlins and Littlejohns are trying to draw is that NICE’s conduct in the current debate about early LBP is beyond reproach. I agree that the judgment by Mr. Justice Simon in the CFS case merits careful analysis and its implications for the current debate particularly in the makeup of and the responsibilities of the CDG and the way the CDG used submitted evidence. (For clarity references made to specific paragraphs from his approved judgment are given thus so [ ]. Justice Simon notes that NICE guidelines help health professionals in their work and do not replace or over ride knowledge, skills or clinical judgment of health professionals and do not detract from patient involvement in their treatment [14]. He notes that it is not for a court to over ride the decision making process of a public body but except “in a case where it is obvious that the public body, consciously or unconsciously, are acting perversely” [47 ii]. He notes members (of a CDG) will have prior views but they must approach the issue fairly and on the merits and specifically warns against “the appearance of predetermination , in the sense of a mind closed in the decision-making itself” [49 v]. Members with significant conflicts of interest should be excluded [51]. Notably a person with a specific pecuniary interest should (in general) take no part in the proceedings [54]. He notes in dismissing the legal challenge to the CFS guideline, that there was no contemporaneous significant objection to the membership of the CDG in that case prior to the guideline being produced [71]. This is a very different scenario from the current problems seen with the CDG in the NICE early LBP where there was widespread early concern about the makeup of the CDG in excluding a Pain Medicine Consultant (despite one being nominated by the BPS) who would have knowledge of interventional procedures which was not available from within the CDG. Furthermore concerns about strong prior opinions and conflicts of pecuniary interests of CDG prior to the publishing of the final guidelines were raised by many. Turning now to the subject of admission of evidence. Justice Simons notes the grades and weighting of evidence and notes that the CDG Consultation Draft states that “RCT base is not an adequate foundation of definitive guidelines, which is why the GDG also considers the experiences of both patients and clinicians ”[56]. The different types of RCT, high and low grade are acknowledged, and at the lowest level of evidence was that of expert opinion and general consensus. The Judge accepted that the CDG ultimately has to decide what evidence to examine [64]. Turning now to the current early LBP debate, why then, when there is generally so little evidence around (see Wells and Colquhoun BMJ 2009;338:b1805 ) was the expert opinion and consensus of the CDG given more weight than the evidence as regards spinal facet denervation submitted by stakeholders within the BPS? In fact it was not even examined and yet perversely the CDG after excluding such evidence specifically makes recommendations that patients should not undergo such treatment! Was the collective mind of the CDG already closed to such treatment? It is the suspicion of many observers. In contrast the outline for such treatment is made succinctly by Gupta and Richardson (BMJ 2009;338:b1805. This fact alone highlights the ludicrous decision of NICE not to include a Pain Medicine Consultant expert on the CDG who could have easily advised the group about the evidence for and clinical practice of injections in spinal pain The real possibility now exists that a Judge examining the current debate on the current early Low Back Pain guidelines might come to a very different opinion in this case compared to the CFS case; namely that the makeup of CDG in this case was unbalanced and the decision making process and outcome more or less pre determined by prior strong opinions and conflicts of interests. The outcome of the guideline being perverse both for patients and clinicians working in the area of LBP. The current NICE early LBP guidelines are questionable, scientifically unjustified, perverse clinically and should be withdrawn. ref 1 http://www.meassociation.org.uk/content/view/791/161/ Competing interests: Consultant in Pain Medicine |
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Tom P Kindlon, Information Officer, Irish ME/CFS Association (voluntary position) Dublin, Ireland
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I am following the debate on the NICE guidelines on persistent non- specific low back pain (LBP) with interest as there are many similarities to the controversy surrounding the guidelines for Chronic Fatigue Sydnrome/Myalgic Encephalomyelitis (CFS/ME). Rajesh Munglani draws attention to the judgement by Justice Simon on Chronic Fatigue Syndrome (CFS)[2]. In particular, that he noted in dismissing the legal challenge to the CFS guideline, "that there was no contemporaneous significant objection to the membership of the CDG in that case prior to the guideline being produced." I thought I would point out I think the main reason for this was that very very few people active in the ME community knew about the membership of the Guideline Development Group (GDG) for "CFS/ME". I was a member of three UK-based discussion groups for group leaders at the time (IMEGA-e (now defunct), Independentme and LocalME). I have done searches of the archives and can find no reference to the membership of the GDG till around the time the draft guidelines came out, by which time of course it was far too late. I am also a member of various other discussion forums such as MEActionUK and Co-Cure and I could not find the membership being given there or elsewhere either. Discussion of the membership of committees in the ME/CFS area has previously been discussed in detail in the past. For example, with regard to the membership of the Chief Medical Officer's Working Group (that published its report in 2002) and the membership of the group set up in 2002 by the Medical Research Council (MRC) to draw up a research strategy. Information spreads fast in the ME community as many people can attest to. I believe there would have been contemporaneous objections from many people to the membership of the GDG for CFS/ME if people had known about the membership at the time, in the same way some people have voiced their dissatisfaction with the group for LBP. There are basically two schools of thought with regard to CFS/ME: that all patients can be rehabilitated with strategies such as Graded Exercise Therapy (GET) and Cognitive Behaviour Therapy (CBT) based on GET, or that a more nuanced approach is required and that CBT/GET may not be appropriate for many. It is unclear if there were many if any professionals with the latter view point on the GDG for CFS/ME which is why I think many people would have raised objections if they had known about the membership. References: [1] Munglani Rajesh. Judging the NICE early low back pain guideline. http://www.bmj.com/cgi/eletters/338/jun04_3/b1805#217942 [2] http://www.meassociation.org.uk/content/view/791/161/ Competing interests: None declared |
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Dr Chris J Wells, Consultant in PainMedicine 25, Rodney St, Liverpool, L19EH
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Dr Hettinga has written to me, correctly taking me to task for my errors regarding him in my Rapid Response letter, BMJ 2009; 338: b 1805 . I apologise for these and am happy to set the record straight. He is male, and studied Health Sciences with a specialisation in human movement science. He has a PhD and Msc. I have previously read several of the papers he has written, and found them very useful. My error concerning his occupation was because one paper in "Physiotherapy" recorded him as being in research and development, Chartered Society of Physiotherapy.(Physiotherapy, June 08, Vol 94, Issue2, 97-104) I rang him to apologise and to make it clear that I was in no way casting any aspersion on his qualifications or work; we had a very useful conversation, during which he assured me that BackCare, the Charity for Healthy Backs, is committed to patients having access to Pain Clinics and pain treatments not covered by the guidelines.ie, after 6 weeks to 12 months, and those with conditions not covered by the Guidelines. I also made it clear that I had the utmost respect for Physiotherapists and indeed those practising in Health Science. All appropriately trained therapists who see patients with back pain are important. I set up the first Pain Management Programme for people with chronic pain and most importantly, back pain, at The Walton Centre in 1983. I set this up with Dr Ghadiali, Clinical Psychologist, and with the help of the excellent Physiotherapy and Occupational Therapy Departments at The Walton Centre. This Programme has been running ever since. I work with Physiotherapists every day in the management of low back pain and respect their opinions and expertise, and indeed am happy to say that they respect mine. I appreciate that they help some low back pain sufferers through excercise, acupuncture and manipulation, and they accept that some, where the pain continues, need to see me. Management of patients with back pain is truly multidisciplinary. This is one of the reasons why I am so sad that the guidelines as developed, and particularly as costed, appear to marginalise multidisciplinary Pain Clinics. Patients who have not improved at the end of their care pathway are discharged, with little provision for pain management, and only 2,600 extra of the millions of back pain patients would ever receive any psychological assessment or management through Combined Physiotherapy and Psychology Programmes (CPP). I am sure that this was not what some members of the GDG intended. The best way to prevent one hundred thousand or so patients developing chronicity every year is proper bio-psycho-social assessment and targeted treatments. Some of these will be to adress the physical aspects of their problem, many will be those adressing the psycho-social aspects. Many of us still believe that the best way to do this is in multi-disciplinary Pain Clinics, through Pain Management Programmes. Whilst some problems can be addressed by CPP, the Pain Management Programme remains the ultimate best management for patients with major psychological and social problems. Competing interests: None declared |
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