Bad medicine: pain
BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.b5683 (Published 06 January 2010) Cite this as: BMJ 2010;340:b5683
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I read the letter by Dr Spence (i) with a mixture of
sympathy and concern. In his letter he rightly highlights
the apparent paucity of studies which support the use of
long term opioids in improving quality of life and suggest
there is increasing evidence that prescribed opioids are
contributing to the widespread addiction problem in the USA.
He goes on to state that we over diagnose pain and that GPs
who refuse to prescribe opiates are often stigmatised.
Do we over diagnose pain ? The answer is that is not the
right question. “Pain” is not a diagnosis, but a symptom. In
the Grampian Region of Scotland, one study put the incidence
of self reported pain as over 50% (ii). On the face of it,
other studies also support the very high incidence of self
reported musculoskeletal pain in the community, with a study
from Europe giving rates of up to 50% or so for various
pains particularly with rising age(iii). However a further
analysis in the same paper shows whilst the incidence of
general complaints of pain may be up to 40-50% depending on
age group studied, the prevalence of clinically significant
pain is much lower at about between 3-15%.
More importantly it is crucial to recognise that perceived
pain may be a symptom of another underlying diagnosis or
certainly exacerbated by it, in particular depression (iv).
Indeed some authorities believe many cases of fibromyalgia
are generally a manifestation of depression(v).
Failure to recognise that many factors may contribute to the
final common presentation of the symptom of pain is a
profound mistake. In my experience as a Pain Medicine
Consultant, the commonest error is to prescribe strong
opioids in the presence of severe depression, distress, and
complaints of pain, often on an unrecognised background of
past history of significant psychological problems including
abuse (vi)drug and alcohol problems, perhaps in the vain
hope that they will help generally.
As one author put it
“opioids are being used to treat this undifferentiated state
of mental and physical pain.” (vii).
The presence of depression or anxiety has to be recognised
and treated independently by pharmacological or other
techniques(viii).
The largest studies of opioid treatment of chronic pain
suggest that particularly in this distressed group of
patients, improvements in either pain scores or quality of
life are NOT achieved(ix). Though Spence suggests otherwise,
it is unlikely that opioids themselves generally cause a
significant general reduction in quality of life in these
long term patients.
Becker et al (in Denmark, with the world highest rates of
opioid prescription and consumption) suggest that those who
go on to opioids therapy were already had significant co-
morbidity and were already consuming FIVE times the health
care resources PRIOR to initiation of opioid therapy, and
indeed already are more likely to have had pre-exisiting
drug and alcohol problems(x). Interestingly Eriksen and his
co-authors reported that addiction rates in their study
patients (again in Denmark) were comparable to the general
population(xi).
Yet it is clear that subgroups (of correctly chosen)
patients can do well with opioids with on a number of
measures including addiction rates of less than 1% (xii xiii
xi vxv xvi) and doctors with a little training can
instinctively predict who are likely to do well(xvii).
Quite simply carefully chosen opioids prescriptions in
carefully chose patients per se are unlikely cause long term
morbidity and mortality(xviii). But we need to recognise
that currently the patients who end up on opioids may have
severe pre-existing risk factors such as anxiety,
depression, and addiction problems(xix), and quite simply,
these patients need to be recognised and treatments planned
more carefully for them(xx). These points have been high
lighted the Pain Society in their opioid prescribing and
other guidelines (xxi)and in this journal(xxii).
It is also becoming increasing clear that not all opioids
are the same, diversion of opioids from their intended
recipients is less likely to take place with sustained
release formulation particularly the newer opioid patch
medications such as Butrans and Transtec (Buprenorphine
patch) or Fentanyl patch (Durogesic patch) and that
problematic addiction problems and dose escalation is less
likely particularly with buprenorphine , which incidently,
is used to treat opioid addiction in some countries(xxiii
xxiv xxv). However it is clear further research is
required(xxvi).
Coincidently one of our local PCTs is trying to introduce a
guideline whereby GPs are not able to prescribe opioid patch
medication in chronic malignant pain without first referring
to a pain clinic. A potential disaster for a GP who hopes to
prescribe the safest forms of opioids when they are
necessary and these proposed guidelines
will be totally disempowering to GPs and quite frankly to
Pain Clinics who are generally under resourced and who would
be currently unable to cope with the huge surge in demand
such a retrograde change in prescribing powers would
produce.
It was pleasing to note that the Chief Medical Officer
recognised the valuable role all health professionals but
specifically the critical role pain clinics play treating
such patients but, we are quite frankly utterly under
resourced (xxvii).
In our pain clinic we recognise that the causes of pain
needs to be diagnosed , opioids are only one tool in our box
of tricks. Non pharmcological techniques including
diagnostic and therapeutic spinal radiofrequency injections
can produced long lasting improvement in pain scores and
quality of life – sadly these techniques have been rather
unfairly dismissed by NICE in their new early low back pain
guidelines despite strong evidence for a moderate a to good
outcome (xxviii).
Psychological approaches including Nurse run patient
seminars, counselling, CBT and indeed NLP, and pain
management programmes(xxix)and other more recent techniques
such as the Lightening Process (xxx) and the Expert Patient
Progamme may make a profound difference to patients life.
Unfortunately such psychological and related programmes are
intensive consumers of health care professional time
and and incur a significant cost in cash strapped
NHS but in the longterm the saving to the rest of the NHS
particularly in reduction in consumption of health care
resources, saving money and both GP and Consultant time and
reducing unnecessary investigations are likely to be
immense, not to mention the immense possible benefit to
society generally(xxxi xxxii xxxiii).
In our pain clinic we also recognise that pain is a symptom
that is has to be treated in partnership with GPs and our
Consultant colleagues. We are absolutely dedicated to
empowerment of our medical colleagues in general practice
and hospital by education which we do so vigorously at the
local levels by meetings and contributions through the
internet (xxxiv).
Dr Rajesh Munglani
References.
i Spence D. Bad Medicine: Pain. BMJ 2010;340:b5683
ii Elliot, Smith Penny, Smith and Chambers. The Epidemiology
of chronic pain in the community Lancet 1999;354:1248-1252.
iii Picavet and Schouten. Musculoskeletal pain in the
Netherlands: prevalences, consequences and
risk groups, the DMC3-studyPain 102 (2003) 167–178
iv Klauenberg Maier ,Assion et al Depression and changed
pain perception: Hints for a central disinhibition mechanism
Pain 140 (2008) 332–343
v Ahles Yunus and Masi Is chronic pain a variant of
depressive disease?
The case of primary fibromyalgia syndrome. Pain, 29 (1987)
105-111
vi Balousek, Plane and Fleming. Prevalence of Interpersonal
Abuse in Primary Care PatientsPrescribed Opioids for Chronic
Pain. 2007 Society of General Internal Medicine
2007;22:1268–1273
vii Sullivan, Edlund, Steffick and Unutzer. Regular use of
prescribed opioids: Association with common psychiatric
disorders. 2005 Pain 119 95–103
viii Gärtner · M. Schiltenwolf. Limited efficacy of opioids
in chronic musculoskeletal pain. Analysis of cause. Schmerz
2004 · 18:506–514
ix Ballantyne. Opioids for chronic pain: Taking stock Pain
125 (2006) 3–4
x Becker Thomsen, Olsen Sjøgren, Bech and Eriksen. Pain
epidemiology and health related quality of life in chronic
non-malignantpain patients referred to a Danish
multidisciplinary pain center. (1997) Pain 73 393–400
xi Eriksen, Sjøgren, Bruera, Ekholm and Rasmussen. Critical
issues on opioids in chronic non-cancer pain:An
epidemiological study. Pain 125 (2006) 172–179
xii Tassain, N. Attal, D. Fletcher, L. Brasseur. Long term
effects of oral sustained release morphine on
neuropsychological performance in patients with chronic non-
cancer pain. 2003 Pain 104: 389–400
xiii Ballantyne and Fleisher Ethical issues in opioid
prescribing for chronic pain PAIN_ 148 (2010) 365–367
xiv Noble, Tregear,Treadwell and Schoelle. Long-Term Opioid
Therapy for Chronic
Noncancer Pain: A Systematic Review and Meta-Analysis of
Efficacy and Safety. 2008 J Pain Symptom Manage;35:214-228.
xv Maier , Schaub, Will weber-Strumpf and ZenzLong-term
efficiency of opioid medication in patients with chronic
non-cancer-associated pain. Results of a suvey 5 years after
onset of medical treatment. 2005 Schmerz ;19:410–417
xvi Chou et al on behalf of FOR THE AMERICAN PAIN SOCIETY–
AMERICAN ACADEMY OF PAIN MEDICINE OPIOIDS GUIDELINES PANEL.
Clinical Guidelines for the Use of Chronic Opioid Therapy in
Chronic Noncancer Pain . 2009 The Journal of Pain:10;113-130
xvii Miles J. Belgrade,* Cassandra D. Schamber,† and Bruce
R. Lindgren. The DIRE Score: Predicting Outcomes of Opioid
Prescribing for
Chronic Pain. 2006: The Journal of Pain: 7; 671-681.
xviii Kalso,Edwardsb, Moore and McQuay. Opioids in chronic
non-cancer pain: systematic reviewof efficacy and safety.
2004 Pain 112 372–380.
xix Jensen Thomsen, Højsted. 10-year follow-up of chronic
non-malignant pain patients: Opioid use, health related
quality of life and health care utilization. European
Journal of Pain 10 (2006) 423–433
xx Fields Should we be reluctant to prescribe opioids
for chronic non-malignant pain? 2007 Pain: 129; 233–234
xxi http://www.britishpainsociety.org/pub_professional.htm
xxii Hester BMJ 2010;340:c476
xxiii Jensen Thomsen, Højsted. 10-year follow-up of chronic
non-malignant pain patients: Opioid use, health related
quality of life and health care utilization. 2006 European
Journal of Pain 10 423–433
xxiv http://clinicaltrials.gov/ct2/show/NCT00750217
xxv http://www.drugabuse.gov/Bupupdate.html
xxvi Chou et al on behalf of FOR THE AMERICAN PAIN SOCIETY–
AMERICAN ACADEMY OF PAIN MEDICINE OPIOIDS GUIDELINES PANEL
Research Gaps on Use of Opioids for Chronic Noncancer Pain:
Findings From a Review of the Evidence for an American Pain
Society and American Academy of Pain Medicine Clinical
Practice Guideline. 2009 The Journal of Pain;10: 147-159
xxvii http://www.dh.gov.uk/en/News/Media/DH_096271
xxviii Manchikanti et al Comprehensive Evidence-Based
Guidelines for
Interventional techniques in the Management of Chronic
Spinal Pain. Pain Physician 2009; 12: 699-803
xxix Morley S, Williams A, Hussain S. Estimating the
clinical effectiveness of cognitive behavioural therapy in
the clinic: evaluation of a CBT informed pain management
programme Pain. 2008 Jul 31;137(3):670-80.
xxx http://www.lightningprocess.com/
xxxi Johnson Cost-effectiveness and Pain Medicine.
1998.Current Review of Pain, 2:254–266
xxxii
http://www.cochrane.org/reviews/en/topics/85_reviews.html.
xxxiii Chronic pain: introduction in McQuay and Moore An
evidence based resource for pain relief OUP 1998 pp195-200
xxxiv Personal communication Dr Marcia Schofield
http://courses.cardiff.ac.uk/postgraduate/course/detail/848.
html
Competing interests:
I have enjoyed meeting
and lecturing my GP and
consultant colleagues at
meetings funded by a
number of pharmaceutical
and Pain Clinic equipment
companies
Competing interests: No competing interests
I certainly agree that further debate is much needed with regard to
the issues raised by Dr Spence (1). It should be noted though that such a
debate, in various forms and at various levels, has been taking place for
over 150 years. Therefore, matters are unlikely to be resolved in a day or
so. The use of opioid therapy for chronic pain other than that caused by
cancer has for some time been described as controversial (2-15). Brena
and Sanders described the ongoing controversy in terms of a pendulum
swinging between different views on the acceptability of opioids (2).
However, the so-called 'Great Debate' began in 1842 following one of the
opium wars, in which Chinese resistance to the trade in opium grown in
India and shipped to China had been subdued by a British naval task force
and the Times subsequently published a critical leading article denouncing
Britain's instigation and perpetuation of the trade (16).
In addition to the moral aspects of the opium trade, the Great Debate
concerned general aspects of opioid acceptability in society, including
usage for chronic conditions (17). Thus, the metaphoric pendulum can be
seen to have started swinging at this time. During the Great Debate, the
central argument was the question of whether or not there was a class of
moderate, long-term, 'non-addicted' opium user (17). Any evidence of
regular yet moderate, therapeutic use for chronic illnesses would have
undermined the anti-opium movement's case for ending the opium trade in
China (17). Clearly, this issue remains unresolved and is central to the
ongoing controversy, this being a consequence of lack of understanding and
consensus around particular terminology (18, 19). Indeed, as Confucius
said: ‘The beginning of wisdom is to call things by their right names.’
As a part of Victorian progress, many phenomena were newly classified
as disease entities according to new 'scientific' theories (17). However,
the boundaries between studying physics, biology or sociology were not
fixed and it was not uncommon to refer to phenomena in terms of the 'moral
sciences' (20). It was in such a climate that medical professionals began
to study the newly specialised area of ‘addiction’ and viewed opium
consumption under the auspices of inebriety, which, in the trend to
medicalise social deviancy was classified as a disease (17). The anti-
opium movement, with the ‘scientific’ backing of the medical profession
who desired greater control over opium use, claimed that all regular use
of opium would, without exception, lead to addiction (17).
It is this shaky foundation upon which the concept of the ‘disease of
addiction’ was constructed which continues to trouble us. Reflective of
this, Professor Gossop of the UK National Addiction Centre (despite the
name of his organization), avoids use of the term ‘addiction’ indicating
that the words used to describe drug taking are confronting us with a
'terminological minefield' (21). This is further highlighted in the World
Health Organisation’s International Classification of Diseases which lacks
a definition for the disease of addiction, instead listing 'Dependence
Syndrome' (22).
This situation, described as ‘conceptual chaos’ (19) urgently needs
to be addressed through debate around the use of appropriate terminology
within relevant contexts. Indeed, it is not uncommon for terms such as
abuse and addiction to be used interchangeably or for confusion to arise
over the meanings of physical dependence, psychological dependence and
therapeutic dependence (18, 19). Also, while some patients clearly exhibit
problematic behaviour when prescribed opioids, such problems are often
overlooked when other drugs are involved and indeed many other types of
drug are also ‘abused’. In a survey of pain clinic patients it was found
that similar small numbers were abusing non-opioid analgesics as were
abusing opioids (23). Furthermore, patients may ‘abuse’ drugs such as
laxatives through compulsive over use or they may ‘abuse’ anti-biotics by
not completing a course of treatment, leading to the presence of resistant
organisms. According to the manufacturers, a ‘common’ side-effect of SSRI
anti-depressants is attempted suicide and anyone who has knowledge or
experience of too rapid a withdrawal from these drugs may testify to the
hallucinations, anxiety attacks and other unpleasant physiological and
psychological withdrawal symptoms. So, why is it that these forms of
problematic drug use rarely seem to receive the same attention as those
associated with opioids?
Not least, we need more research-generated evidence to underpin and
inform any further debate. For example, we need more studies to build upon
previous work that examined the physiological and psychological status of
so-called ‘addicted’ pain patients when abstaining from their opioids
under controlled conditions, who, it transpired did not appear to be
addicted after all (24).
We also urgently need studies such as that described in the DOMINO
proposal alluded to by Dr Allan, whereby we can collect important data on
the relative efficacy, effectiveness, safety and toxicity of opioids and
NSAIDs in ‘head to head’ fashion in significant numbers of patients.
Furthermore, we need more research in the important area of
pharmacogenetics and better dissemination of the findings. For example, if
a patient does not appear to respond as expected to large doses of
codeine, do we assume that the patient’s pain is not responsive to
opioids, or that the patient is a drug-tolerant, drug abuser who is trying
to extract ever more codeine from their GP, or do we consider the
possibility that the patient may be one of 7% of the population who, for
genetic reasons, cannot metabolise codeine? (25)
I could go on, but will save the rest in anticipation of continuation
of the Great Debate. In the meantime, sadly, some patients with chronic
non-cancer pain who are maintained on opioids are labelled by GPs and
others as 'junkies’ ‘addicts’ or abusers’, sometimes based merely upon the
time period of opioid use (26-29).
References:
1. Spence D. Bad medicine: pain. BMJ 2010; 340: b5683.
2. Brena SF, Sanders SH: Controversy corner: Opioids in non-malignant
pain: Questions in search of answers. Clinical Journal of Pain 1991; 7:
342-345.
3. Fishbain DA, Rosomoff HL, Rosomoff RS: Drug abuse, dependence, and
addiction in chronic pain patients. The Clinical Journal of Pain 1992; 8:
77-85.
4. Butler SH: Opiates for chronic pain: Present American controversy.
Proceedings of the 24th Interational Narcotics Research Conference, Sweden
1993. Regulatory Peptides 1994; Supp s295-296.
5. Savage SR. Pain medicine and addiction medicine: Controversies and
collaboration. Journal of Pain and Symptom Management 1993; 8: 254-256.
6. Turk DC: Clinicians attitudes about prolonged use of opioids and the
issue of patient heterogeneity. Journal of Pain and Symptom Management
1996; 11; 218-28.
7. Collett BJ: Opioid tolerance: the clinical perspective. British Journal
of Anaesthesia 1998; 81: 58-68.
8. Harden RN, Fox CD (ed): Chronic opioid therapy: another reappraisal.
American Pain Society Bulletin 2002; 12: 1.
9. Mikta M: Experts debate widening use of opioid drugs for chronic
nonmalignant pain. Journal of the American Medical Association 2003; 289:
2347-2348.
10. Gallagher R: Editorial 2005 Pain Medicine 6; 2, 103-104
11. Zenz M, Strumpf M, Tryba M: Long-term oral opioid therapy in patients
with chronic non-malignant pain. Journal of Pain and Symptom Management
1992; 7: 69-77.
12. Melzack R: Landmark article on management of chronic non-malignant
pain. Canadian Family Physician 1995; 41: 9-12.
13. Portenoy RK: Opioid therapy for chronic non-malignant pain: A review
of the critical issues. Journal of Pain and Symptom Management 1996; 11:
203-17.
14. A consensus statement from the American Academy of Pain Medicine and
the American Pain Society: The Use of Opioids for the Treatment of Chronic
Pain. Pain Forum 1997; 6: 77-79.
15. McQuay HJ. Opioids in pain management. Lancet 1999; 353: 2229-2232.
16. Scott JM. 1969. The White Poppy, The Great Debate. Heinemann. London.
83-108.
17. Berridge V: 1999.Opium and the people. Free Association Books. London.
18. Cowan DT, Problematic Terminology for Problematic Drug Use. Journal of
Opioid Management 2006; 2: (1) 23-30.
19. Shaffer HJ: The Most Important Unresolved Issue in the Addictions:
Conceptual Chaos. Substance Use & Misuse 1997; 32: 1573-1580.
20. Smith M. 1999. Social Science in Question. Open University. London.
21. Gossop M: 2000.Living with drugs Ashgate, UK.
22. International statistical classification of diseases and related
health problems. 10th Revision, 2007 Version. (WHO-ICD-10) Geneva, World
Health Organisation.
23. Kouyanou K, Pither CE, Wessely S: Medication misuse, abuse and
dependence in chronic pain patients. Journal of Psychosomatic Research
1997; 43: 497-504.
24. Cowan DT, Wilson-Barnett J, Griffiths P, Vaughan DJA, Gondhia A, Allan
LG: A Randomised, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study
to Assess the Effects of Long-Term Opioid Drug Consumption and Subsequent
Abstinence in Chronic Non-Cancer Pain Patients Receiving Controlled-
Release Morphine. Pain Medicine 2005; 6: 113-121.
25. De Leon J, Susce MT, Murray-Carmichael E. The AmpliChip CYP450
genotyping test: Integrating a new clinical tool. Mol Diagn Ther
2006;10(3):135-51.
26. Cowan DT, Allan LG, Griffiths P, Libretto SE: Opioid Drugs: A
Comparative Survey of Therapeutic and 'Street' Use. Pain Medicine 2001; 2:
193-203.
27. Cowan DT, Allan LG, Griffiths P: A Pilot Study into the Problematic
Use of Opioid Analgesics in Chronic Non-Cancer Pain Patients.
International Journal of Nursing Studies 2002; 39: 59-69.
28. Cowan DT, Wright D, Wilson-Barnett J, Griffiths P: Cessation of Long-
Term Morphine Analgesia – A Case Study. British Journal of Anaesthetic and
Recovery Nursing 2003; 4: 20-23.
29. Pain Relief Network http://www.painreliefnetwork.org/ 2007.
Competing interests:
Has undertaken research funded by Janssen-Cilag Ltd and received free plasma sample analysis from Napp Pharmaceuticals
Competing interests: No competing interests
I try to be consistent but appreciate that much of what we
do as doctors is conflicted. I am no opiaphobe. I have
prescribed widely and freely in palliative care and
methadone to a large group of patients for nearly 15 years.
I also have a post graduate qualification in addiction.
I am a captive of my own experiences during the eighties
and nineties I witnessed drug overdose deaths, amputations
and complications of infection in many, many IV drug
users. I choose to believe Methadone research and coloured
by my own experience that it works in the short
term . The end points of methadone are hard - reduced street
drug use, less criminality and reduced medical
complications. Methadone is no cure and many patients have
not moved on for two decades - struggling to work and
function . But I just can't see an alternative currently and
whether decades of methadone is good medicine , I don’t
think so. Indeed , I promise to write on this in the next
six months. Finally it is also important to highlight that
the doctor patient relationship within a methadone
programme is doctor centred , controlled and often
sceptical. Confrontation is common.
I see a fundamental difference when prescribing opioids in
many chronic pain syndromes, for we are initiating
potential dependence, not responding to established
addiction as in methadone substitution . We run the real
risk of iatrogenic addiction . Lastly unlike in a
methadone programme the relationship is different, patient
centred and based on trust. Confrontation is rare and
controlling medication difficult.
I do try to be consistent, but it is not easy.
Competing interests:
None declared
Competing interests: No competing interests
I normally applaud Dr Des Spence as a paradigm of common sense.
Indeed I frequently tell students that they will not find anywhere else
such a concise and well-written distillation of the responsibilities of
the GP at the coalface as opposed to the ivory tower. I do recognise that
prescribing addictive analgesia is on the increase. I am also aware of the
dictum of Margo McCaffrey that “Pain is whatever the patient says it is,
and exists whenever the patient says it does” which has guided both GPs
& hospital Drs in pain management over the last few decades. The
balance between empathetic prescribing to relieve pain and creating a
further iatrogenic problem of addiction is not easily struck- particularly
for those complex pain syndromes and conditions with little physical
evidence of disability.
I suspect that much of the liberal prescribing may not emanate from
pressure from big pharma but from the gradual loss of the will of GPs to
question and probe difficult questions about pain and collate this with
examination findings and psychosocial cues. This may reflect the time
pressures on GPs - or the opprobrium that may arise if a patient feels
that the GP has not listened to their request and utilises one of the many
avenues of complaint open to them in the latter-day NHS.
But my main issue is the disparity of the author between the caution
he advocates for opioids in pain and the liberalism he appeared to
advocate for opiate substitution in his article “Junk reporting” in Nov
07. In my inner-city practice, I treat many iatrogenic analgesic-abusing
patients. We would be fooling ourselves if we thought that many of the
scripts we issue do not end up back on the streets and indeed, I am
informed that co-codamol 30/500 costs only 50p per tab on the streets. The
sad thing is that frequently the buyers are those on opiate substitution.
It is compounding a tragedy that treatment for heroin addiction can be
further complicated by liberal prescribing of opioids –even with the best
of intentions.
Competing interests:
None declared
Competing interests: No competing interests
I endorse the importance of recognising the benefit and potential
harm of opioid therapy in primary care.Spence,the GP raising this matter
called for a debate and responses agree this would be useful.However, the
setting is vital, the problem is in primary care and that is where the
debate must be as indeed should any research.
Jaleel has noted the matter is in danger of being hijacked by pain
industry moguls. This includes the debate on offer from members of the
Pain Society, who have made industry conflicts statements as required by
the BMJ, but are not published openly by the Pain Society in its own
publications.This information is only provided to individual enquirers!Can
we know from the Pain Society what sponsorship has been or will be on
offer in relation to the planned debate? We should remember the recent
forced resignation of their President for apparently expressing personal
views on a NICE guideline committee.If their had been greater transparency
within the Society in these matters, this embarassing public issue may
have been avoided.There are clear statements from the Institute of
Medicine on these issues and in particular for those Societies setting
guidelines for practice. Would the Society be able to find someone, not
sponsored by Grunenthal or anyone else to update the 2004 opioid guidance,
as the Institute requires?
Competing interests:
LA has been Principle Investigator for pan European sponsored clinical trials by Janssen-Cilag Ltd. She has participated in a number of clinical trials sponsored by other pharmaceutical companies, and has also authored Expert Reports for regulatory purposes, lectured internationally and participated in Expert panels. She continues to provide paid consultancy services to the pharmaceutical industry.
LA is a shareholder in hd-clinical, an IT company providing internet solutions recognised by Connecting for Health by contract status and currently providing services in 110 Trusts.
Competing interests: No competing interests
I am ever so pleased that this debate has been ignited by a General
Medical Practitioner (1) but sadly , it now appears to have been hijacked
by the Moguls of Pain Industry : all you have to do is to read some of the
contributions here to recall the rigid attitudes of yesteryear.
More importantly, why is there no contribution from patients or
their carers. Perhaps this reflects the unthinking attitude, bordering
on arrogance, of our profession. George Bernard Shaw aptly exposed
this approach as " conspiracies of all professions against the laiety
".(2)
let me be the first to apologise to all those who suffer from badly-
treated or untreated pain and to those who are disbelieved by their
physicians and hope that this omission will be remedied .
References :1.Spence,D:Bad medicine :pain BMJ 2010;340:b5683
2.Shaw, B,The doctor's Dilemma ;Penguin books, London (1946 ),ISBN 0-
14-045027-0
Competing interests:
None declared
Competing interests: No competing interests
Des,
The debate is already happening that you ask for.
British Pain Society Annual Scientific meeting Manchester Central.
Wednesday 14th April 2010 16.00-17.30 Room B2:
Long term opioid use: Chair Dr Cathy Stannard.
See you there?
Competing interests:
C Price is an ex British Pain
Society Council member &
accepted sponsorship from
Grunenthal to attend the
European Federation of IASP
chapters meeting in September
2009
Competing interests: No competing interests
Dear Dr. Spence,
I am writing in response to what I find a very interesting
subject which I am glad to see has initiated discussion.
As mentioned in your letter, pain is indeed a highly
subjective phenomenon, highlighted by the IASP definition:
"An unpleasant sensory and/or emotional experience,
associated with actual or potential tissue damage, or
described in terms of such damage."
The complex nature of pain is only now beginning to be
revealed, a far cry from the out-dated Descartes model,
where pain pathways are "hardwired" with no cognitive
influence. When treating these difficult pain states
(whether it be cancer related, or chronic pain syndromes),
clinicians should bear in mind the late Dame Cicely Saunders
and her description of "Total Pain", which describes the
importance of non-pharmacological intervention in pain
management - a subject I feel would have been appropriate to
mention in your letter.
Regarding your description of pain rating scores, I agree
that they are less than perfect, however much research is
currently underway in improving the validity of these.
Evidence against your description of the non-scientific
nature of these scores is provided by Holdgate (2003) who
showed that Visual-Numerical Rating scores and Visual-
Analogue Scores correlate well. Fainsinger (2002) also
showed that a high pain intensity recorded using VNRS had
predictive value in picking up patients early on who
wouldn't respond well to opioids.
Tracey (2008) has recently identified pain centres within
the brain using fMRI. This study I hope also goes some way
to arguing the case of chronic pain sufferers in the
community - by examining fMRI of chronic pain sufferers, who
often suffer from "psychological pain" ie the experience of
pain without obvious clinical nociceptive input, pain
centres in their brain show activity. This demonstrates the
importance of appreciating how very real their pain is.
Your letter highlights the increase in opoid use in
community pain management, and suggests the vested interests
of the pain industry and over-diagnosis of pain is
contributing to this. I would like to highlight the dangers
of cautioning clinicians against "over-diagnosing" pain.
Until recently (and studies such as those done by Tracey
have contributed massively to this) many clinicians believed
chronic pain was drug/attention seeking, and it is important
to remember this new evidence that these patients are
experiencing very real pain.
I would like to suggest an alternative cause contributing
to this increased opioid consumption. You rightly inform
readers that pain management has improved in recent years,
however in my view when chronic/difficult pain is concerned
, lack of evidence in the field has hampered both
clinicians/tutors in the use of alternatives to ovoids in
pain management.
Using the WHO ladder to exemplify this: clinicians seeking
guidance for difficult pain syndromes are faced with the
decision to use either Step 3 opioids, or prescribe
"adjuvant analgesia". Improved guidance for the use of
adjuvant analgesia and furthering awareness of the latest
discoveries in the science of pain, I feel would be a step
towards not only reducing opoid use in the community, but
actually improving the pain control of these patients.
An excellent example of non-pharmacological management of
these pain states is the use of TENS. Forst (2004) showed
the use of TENS improved pain control in diabetic
neuropathy, a pain notoriously resistant to opioids.
To conclude, the diagnosis and treatment of pain is
difficult and complex. However until diagnosis methods
improve, it is important to keep an open mind when a patient
presents with a complaint of chronic pain. Further research
is required to produce evidence-based guidance of the use of
non-opioid analgesia in the treatment of these pain
syndromes, and non-pharmacological approaches must always be
considered by clinicians.
Competing interests:
None declared
Competing interests: No competing interests
Here in Australia, the same debate continues. We will be having The
National Pain Summit on March 11, 2010 at Parliament House in Canberra. A
Draft National Pain Strategy has been already been circulated:
http://www.painsummit.org.au/strategy/Strategy-NPS.pdf .
Leading participants consist of professional, consumer and other
organizations all with varying potential conflicts of interest standing to
benefit from increased pain therapies. These groups include industry
advocates and industry representative bodies.
While there was a solitary addiction medicine doctor contributing to the
Draft Strategy, the promotion of surveillance for opiate misuse and any
advice on pain management in those with a past or present history of
Substance Use Disorders, were all but missing.
The role of addiction medicine physicians was confined to hospital care to
minimize suffering and the duration of stay (Goal 4). The only concern
noted in the Draft Strategy about long term opiate prescribing concerned
“people with predominantly psychological factors contributing to the
pain.”
The pharmaceutical industry has been very successful in increasing the
indications for prescribing opiates outside cancer and decreasing concerns
by prescribers in doing so (van Zee, A. 2009). While doctors would prefer
to see themselves as managing pain, we may well be gathering together a
very different population. Recent US findings show half of patients with
past opiate disorder in 2001 were on long term prescription opiates by
2005 (Weisner, C. M. et al.2009).
We should not risk the improvement of pain management due to a cavalier
approach towards the risks involved.
Van Zee, A. (2009). "The Promotion and Marketing of Oxycontin:
Commercial Triumph, Public Health Tragedy." Am J Public Health 99(2): 221-
227.
Weisner, C. M., C. I. Campbell, et al. (2009). "Trends in prescribed
opioid therapy for non-cancer pain for individuals with prior substance
use disorders." Pain 145(3): 287-293.
Competing interests:
I am a member of Working Groups looking at pharmaceuticals misuse for both the Alcohol and Drugs Council of Australia and the Royal Australasian College of Physicians.
Competing interests: No competing interests
Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine
In his response "Failure to appreciate pain is a symptom not a
diagnosis is what leads to bad medicine", Dr Munglani, Consultant in Pain
Medicine, West Suffolk Hospital, recommends the Lightning Process [1].
The Lightning Process is a three-day course said to be based on neuro
-linguistic programming (NLP) and life coaching. It is marketed not as a
therapy or a treatment but as a "training program". It is unregulated and
its practitioners are trained and "licensed" by the Phil Parker
organisation. Many of those who train to become Lightning Process
instructors are former "trainees", themselves.
I note that Dr Munglani has a provided a number of personal
testimonials for the pages of the website of a Suffolk Lightning Process
Centre [2].
The website states that there are now NHS and private consultants,
GPs and occupational therapists referring patients to the centre, and that
NHS clinicians have attended as observers of the work carried out there.
Visitors to the site are encouraged to contact an OT at the James Paget
University Hospital pain clinic or OTs at the Norfolk and Suffolk ME/CFS
service, for which contact details are given.
On one of its web pages is the following:
"What does the Lightning Process work for?
"People using the Lightning Processâ„¢ have recovered from, or
experienced significant improvement with the following issues and
conditions
"ME, chronic fatigue syndrome, PVFS, adrenal fatigue, acute and
chronic pain, back pain, fibromyalgia, rheumatoid arthritis, migraine,
injury, PMT, perimenopausal symptoms and menopause, clinical depression,
bipolar disorder, anxiety and panic attacks, OCD and PTSD, low self-
esteem, confidence issues, hay fever, asthma and allergies, candida,
interstitial cystitis, urinary infections, bladder and bowel problems,
IBS, coeliac disease, crohns disease, food intolerances and allergies,
blood pressure, cardiac arrhythmia, type 2 diabetes, restless leg
syndrome, hyper/hypo thyroidism, insomnia and sleep disorders, autistic
spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever,
epstein barr virus, weight and food issues, anorexia and eating disorders,
multiple sclerosis, cerebral palsy, parkinsonian tremor, motor neurone
disease"
On 16 June, the Advertising Standards Authority (ASA) published an
adjudication against a Bournemouth company following its upholding of a
complaint about a Lightning Process advertisement [3].
The ASA records their concerns that "the company did not hold robust
evidence to support their claims that the lightning process was an
effective treatment for CFS or ME. We therefore reminded them of their
obligations under the CAP Code to hold appropriate evidence to
substantiate claims prior to publication. Because we had not seen any
evidence to demonstrate the efficacy of the lightning process for treating
the advertised conditions, we concluded that the claims had not been
proven and were therefore misleading."
The company was advised to ensure "they held substantiation before
making similar efficacy claims for the lightning process".
The Advertising Standards Authority's remit does not extend to
website content. But I hope that Dr Munglani, who provides personal
testimonials for the Suffolk centre, has satisfied himself that this
centre is able to provide robust evidence to substantiate its claims that
people using the Lightning Process, said to be based on neuro-linguistic
programming (NLP) and life coaching, have "recovered from, or experienced
significant improvement" from diseases and conditions which, in addition
to ME and chronic fatigue syndrome, include urinary infections, coeliac
disease, crohns disease, blood pressure, cardiac arrhythmia, type 2
diabetes, hyper/hypo thyroidism, autistic spectrum disorder, dyspraxia,
ADHD, lymes disease, glandular fever, epstein barr virus, multiple
sclerosis, cerebral palsy, parkinsonian tremor and motor neurone disease.
This is a very topical issue because in March, the Royal National
Hospital for Rheumatic Diseases NHS Foundation Trust, also known as the
Min, and the University of Bristol announced a pilot study looking into
interventions and treatment options for Chronic Fatigue Syndrome [4].
Funding of £164,000 from the Linbury Trust and the Ashden Trust has
been awarded to a research team led by Dr Esther Crawley, Consultant
Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, CFS
Clinical Lead for Bath NHS FT and a Senior Lecturer, University of
Bristol.
The pilot study, scheduled to start in September, will look at the
feasibility of recruiting children aged 8 to 18 with CFS and ME into a
randomised controlled trial (RCT) comparing the Lightning Process and
specialist medical care. The study has the involvement of Phil Parker and
colleagues.
"The study will involve in depth interviews with the patients and
their parents, and the primary outcome measure will be school attendance
after six-months. It is hoped that over 90 children aged between eight and
18 and their families will be involved in the study. They will be
recruited after assessment by the specialist team at the Min."
The Medical Research Council (MRC) produces specific guidelines for
research involving vulnerable patient groups. The document "MRC Medical
Research Involving Children" is clear:
"4.1 Does the research need to be carried out with children? Research
involving children should only be carried out if it cannot feasibly be
carried out on adults." [5]
No rigorous RCTs into the application of the Lightning Process in
adults with CFS and ME have been undertaken.
Data from two large patient surveys carried out by Action for
M.E./AYME (published 2008) and by the ME Association (published May 2010)
show similar levels of worsening of symptoms in CFS and ME patients
following the three day "training program", or of no improvement at all
(AfME/AYME: Worse:16%, No change: 31%; MEA: Slightly worse 7.9%; Much
worse 12.9%: No change: 34.7%) [6].
With no robust data from the application of Lightning Process in
adults, how can the research team determine that overall the likely
benefits of the research outweigh any risks to child participants and that
undergoing the training program would not be detrimental to a child’s
current health status and psychological well-being, as a patient diagnosed
with CFS or ME?
There are considerable concerns that an NHS paediatric CFS unit
should be planning a study involving children as young as eight when no
rigorous trials have first been undertaken into the safety, acceptability,
long and short-term effects of the application of this controversial and
unregulated "process".
Not only is it feasible to carry out research into the application of
the Lightning Process using adults with ME and CFS, many feel it unethical
not to do so first.
References
[1] Failure to appreciate pain is a symptom not a diagnosis is what
leads to bad medicine: Rajesh Munglani, 8 March 2010:
http://www.bmj.com/cgi/eletters/340/jan06_2/b5683#232414
[2] The Rowan Centre, Suffolk:
http://www.simpsonandfawdry.com/about-simpson-and-fawdry.htm
[3] Advertising Standards Authority Adjudication, 16 June 2010:
http://www.asa.org.uk/Complaints-and-ASA-
action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx
[4] Media Release, University of Bristol, 2 March 2010:
http://www.bristol.ac.uk/news/2010/6866.html
[5] MRC Medical Research Involving Children (Nov 2004, revised Aug
2007):
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
[6] Patient Survey 2008, Action for M.E. and AYME:
http://www.afme.org.uk/res/img/resources/Survey%20Summary%20Report%20200...
Patient Survey May 2010, ME Association:
http://www.meassociation.org.uk/images/stories/2010_survey_report_lo-
res.pdf
Competing interests:
None declared
Competing interests: No competing interests