Summer 2010 - The British Pain Society

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Indeed, dissenters have become increasingly marginalized branded “opiophobes” a term that to me, smacks of intolerance, but also of ignorance. (When I choose to raise concerns many felt I merely needed to be better educated). Research and time, however, have cast doubt over the low addictive potential with some estimates as high as 50% in chronic users. [2] Likewise more recent research questions whether opioids actually improve patients functioning and quality of life. [1] "Pain is whatever the patients says it is" There is a prevailing mantra that "pain is whatever the patients says it is" and this has been widely accepted as part of patient centeredness. Although the concept of “pain is whatever the patients says it is" seems both reasonable and logical - this obviously cannot be the case. Self reporting is notorious fraught, for what people say, and what they do are two quite separate entities. Also in the field of pain there are numerous contraindications in respect to pain. A WHO report into the incidence of persistent pain in primary care pain generated extreme variation – women’s reporting of persistent pain in Chile is 40% while is only 3.9 % of Italian men [3] . How can this be so? These large differences have no robust pathological or physiological explanation. The only conclusion, as everyone knows, is that pain clearly has a strong cultural, gender and personal perspective - pain is not one entity. All doctors know that pain clearly has strong psychological components and is a manifestation of many different interactions of physical and non physical mechanisms. I doubt therefore, that anyone truly believes that “pain is whatever the patient says it is”. The unspoken truth is we promote complementary and alternative medicine because we understand its importance as placebo in pain management. How have we dealt with some of the risks of potent opiate prescription? It is argued that proper assessment with the use of validated tools can screen out patients with drug seeking behaviors, personality disorders and psychological issues. This patently is not the case. Why else is there such variation between pain clinic and doctors who administer these and again reflect the dangers of relying on self reporting. I believe these questionnaires are both crude and clumsy with a low specificity and large rates of false positives (especially when used out with a research environment) But worse still, questionnaires undermine that most important clinical tool – clinical judgment. This is even more of a risk with the newer government trend towards a protocol based generic chronic care model that will inevitably be delivered by the least expensive option possible. Opioids have both a physical and psychological effect therefore many patients with psychological issues do respond to medication. Applying "pain is whatever the patients says it is” has lead to an irrefutable over-diagnosis of pain. These potent forces have, in my opinion, conspired to produce a significant cohort of opiate dependent patients who are “stuck” and unable to engage in any meaningful functional activity or rehabilitation. Would they be better off if they had not been prescribed these medications? The Land of the Free But these arguments against the widespread use of opiates are not new. In the Victorian period opium was widely abused and lead to the controls over its use. Indeed the backlash against abuse likely limited its legitimate use in medicine. In 1873, an English physician noted: “...Amongst the three millions and three-quarters [people in London] there are to be found some persons here and there who take [opium] as a luxury… began under medical advice. The genuine opium-eating districts are the ague and fen districts of Norfolk and Lincolnshire. There it is not casual, accidental, or rare, but popular, habitual, and common…. You offer money, and get opium as a matter of course. This may show how familiar the custom is.... In these districts it is taken by people of all classes, but especially by the poor and miserable, and by those who in other districts would seek comfort from gin or beer.” Today, we do not need to look too far to see the potential harms associated with opioids - namely the USA. A potent cocktail of consumerism and free marketeering, "pain is whatever the patients says it is" , political lobbying, direct to consumer advertising , doctor shopping, private practice with wealth through health and a lack of integrated records has caused a prescription addiction to a wide range of prescription medicines and has coined new terms such as “hillbilly heroin” And we need to look beyond the high profile deaths of Michael Jackson, Heath Ledger and others celebrities . In Washington state there has been a 10 fold increase in death associated with opioids over a decade (450 in 2007) – a change that mirrors prescribing patterns. [4] The USA is now seeking to control this over prescription medication which might see draconian restrictions. Consider this statement from the U.S. Centers for Disease Control and Prevention (CDC) - “CDC said that while automobile crashes remain the top cause of accidental death nationally, drug-related incidents caused more deaths in 16 states -- double the number of states in 2003. In 2006, 45,000 Americans died from car crashes, while 39,000 died from drug-related causes” Most of the deaths were due to overdoses, especially of opioid analgesics like methadone, Vicodin, OxyContin, and Fentanyl.” But this of course could not happen in the UK! I have spent 15 years in general practice and encountered widespread drug seeking behaviour; commonly for benzodiazepines but more recently for opioids and opiates. The main abused medications are dihydrocodeine, cocodamol, codydramol and in recent years tramadol and oxycodone. In my practice we have had patients die from opioids overdoes, numerous examples of medication being diverted and even a patient who had fulminant liver failure from compound analgesics. But as these are prescription medication they receive little reporting. It is also very difficult to challenge patients about overuse of medication or dependence, as the medication has been legitimized through a diagnosis of pain. Medication is therefore often impossible to stop. This type of information is difficult to collect and collate but needs urgent research from a UK perspective. But rather than accept concerns over drug dependence there is a policy of medical denial. In a widespread cohort, explaining away addictive behavior as a “pseudo addiction” (as just a reflection of a patients need for pain relief) and not dependence or addictive behavior is a form of dangerous knight move thinking 36 PAI N N E W S S U M M E R 2010
that is completely counter intuitive to most non medical outsiders. Ultimately intractable pain, from whatever cause, many being non malignant, should never been seen as an absolute birthright to potent narcotics. Big Pharma and the real cost Pharma companies have been very active in promoting their medications. This has taken the familiar form of promotion masquerading as medical education. When was the last meeting that you attended that wasn’t sponsored? Many leading specialist have been paid to speak and to advise companies with the amounts paid undisclosed. International conferences, flights, and accommodation have been gifted widely to the medical community, including pain physicians and GPs. None of this over steps common professional boundaries but has lead to a dominance of therapeutics in the mind set of the pain community and undoubtedly increased the uptake of new medications. I could quote corporate billions but this is difficult to conceptualize. So in table 1, I have set at the cost to the NHS for commonly prescribed opioids to illustrate the personal implications of our prescribing patterns. This explains why the industry is so benevolent with its money for education. Chronic medical conditions are industries golden geese. The more pain, the more medication and the more profit – this a simple and hugely effective business model – a monster goose. This is no anti pharma conspiracy but merely a statement of fact. The industry is active in all areas of public lobbying. But most insidiously with patient groups. Emotions drives health care, not science, and the emotion of suffering patients is marketing dynamite. The American Pain Society suggests no one should suffer pain and has a campaign “Dream no Small Dreams “. This same society has received $ 500,000 from a single pharmaceutical company. I wonder who is doing the dreaming? Always promoting the simplistic message on pain – that is it is both under diagnosed and under treated. Pharma money pollutes many patient charities and suffers to reinforce the medical model of care and the use of therapeutics. Harms But even if we assume that current practice does good, do we know if it does harm? Most pharma research is short by design for both efficacy and harms. Also study populations are carefully chosen to be the groups most likely to benefit and are often very different from general practice populations. This research is then applied inappropriately to different and unrepresentative populations e.g. research in a group of 300 attending a pain clinic is quite different from a general practice population. Lastly, because pain has such a wide cultural variation, research should be country specific. Good critical appraisal skills are essential- don’t always believe the research at face value. Opioids are associated with tolerance and significant withdrawal when stopped. Once started opioids are difficult to stop and seem to be taken for decades. Opioids cause both a physical and psychological addiction. But what is the long effect on social functioning, like work, relationships and the rest? Key systematic and literature reviews highlight the “scarcity of evidence” [5] and huge variation in reported incidence of addiction of 0-50%. [2]. There is also little evidence to support better social functional and new evidence comments “it is remarkable that a opioids treatment of long-term/ chronic non-cancer pain does not fulfill any of the key outcomes of opioids treatment goals: pain relief, improved quality of life and improved functional capacity” [1] But other hard end point data is beyond refute - opioids are associated with abuse, unintentional overdose and deaths. The numbers dying in the UK are not known, but if we look to the USA, the increase in mortality mirrors increasing prescribing. So the doubling in prescriptions has likely doubled iatrogenic death. [4]. We need urgent UK research, not anecdote, to inform the issue of balance versus harm for the rapid and widespread use of opioids. The Future The pain community has been a great advocate for improved pain relief ( a problem often ignored) and they should be rightly proud of the improvements in care. The problem is those pain clinics are detached from the community and lack continuity. In recent times many GPs complain that pain clinics purse a policy of inconsistent polypharmacy, new medicines and rapid dose escalation. There are new regional pain syndromes that many are skeptical of. And despite the assertion of pain clinic are multidisciplinary with a broad view of pain - intervention seems dominated by therapeutics. The pain community needs to acknowledge these concerns for they are the key opinion leaders. Table 1 Medication* Monthly Cost * Real 10 year Cost Butrans 10 Patch £32 £3,840 Patch Oxycontin 40mg £101 £12,120 Durogesic 100 £163 £19,560 *as per BNF GPs need better guidance and monitoring of prescribing activity. There also needs to be serious consideration from both pain clinicians and GPs as to whether they need to distance themselves from the Pharma industry due to the huge financial conflicts of interest. At the very least the amounts paid to leading specialists needs full disclosure and a move away from the traditional sponsored educational events. How we do this is a thorny issue but transparency is key. We must monitor the prescribing trends and halt the rate of rise. Lastly, we need to redefine the notion that “pain is what the patient says it is” for this is clearly not the case and rebalance the doctor patient relationship. I maintain that the rapid increase in opioids prescribing in non malignant pain is generating significant iatrogenic harm, is bad for patients and is bad medicine. References [1] Eriksen J et al. Critical issues on opioids in chronic non-cancer pain: an epidemiological study. Pain 2006;125:172-179 [2] Hǿjsted J, Sjǿgren P. Addiction to opioids in chronic pain patients: A literature review European Journal of Pain 2007;11:490-518 [3] Oye Gureje, MBBS, PhD, FWACP; Michael Von Korff, ScD; Gregory E. Simon, MD, MPH; Richard Gater, MRCPsych Persistent Pain and Well-being A World Health Organization Study in Primary Care JAMA. 1998;280:147-151. [4] http://www. agencymeddirectors.wa.gov/ Files/AGReportFinal.pdf [5] Ballantyne J and LaForge KS. Opioid dependence and addiction during opioid treatment of chronic pain. Pain 2007;129:235-25 PAI N N E W S S U M M E R 2010 37
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Summer 2010 - The British Pain Society

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