The Book of Evidence
Welcome to the interactive, electronic version of our Book of evidence Weâ€™ve worked hard to include the most relevant information, statistics and exemplars in these 20 pages. However, if youâ€™re eager to investigate further then you can do so via the links provided. To access the cited papers, articles, etc. in full then just click on the references at the end of the document. If youâ€™d like to read more about the casestudies included or the patient testimonies, then you can also click on these sections to read more.
ExEcutivE summary Across Europe, millions of people of all ages struggle with brain, mind and pain disorders. Neurological and chronic pain conditions arise from illnesses or damage directly affecting the brain, spinal cord or nerves, or as pain from a musculoskeletal injury or of unknown origin. Collectively, brain disorders are the biggest economic challenge for European healthcare, costing around â‚Ź800 billion each year, ~6% of GDP. Chronic pain may cost an additional 3% of GDP. As life expectancy increases across Europe, the prevalence and cost of these conditions are growing. Neurological and pain disorders have a huge personal impact, causing enormous suffering and disability. Stigma and lack of public knowledge worsen the burden on patients and families by preventing people from seeking treatment and causing social exclusion. Public awareness campaigns are needed to reduce stigma, encourage people to seek early treatment and support, make lifestyle choices that can help prevent some of these disorders, and maintain quality of life in those who are already affected. Large health inequalities persist in the EU and many patients do not have access to effective treatment for neurological and pain disorders. Uncontrolled symptoms worsen the personal and economic impact of these disorders, and new and better treatments are urgently needed. Increases in both public funding and industry investment are necessary, and should be supported by a regulatory and legal environment which facilitates both innovation and access to affordable medicines. Cross-border disease registries represent a major opportunity to accelerate both basic research and clinical trials in these conditions. There is evidence that involving patients throughout the research process results in more relevant and effective research. Appropriate patient involvement should therefore be a routine part of publicly funded research as well as clinical trials. There are additional opportunities to better involve patients in regulatory and other decision-making processes, to make information about clinical trials and drug development more accessible and relevant to patients, and to improve support to researchers for engaging patients and the public in their work. For many patients, the biggest effect of their disorder is its impact on education and employment of themselves and their family members. There is considerable variation in the effect of these conditions on employment in different Member States. To maximise economic productivity and minimise the economic and social impact on patients and families, European social legislation must be consistently implemented and access to rapid diagnosis and treatment must be available to all patients.
TABLE OF CONTENTS Introduction to the Brain, Mind & Pain Programme
Background: What are neurological and pain disorders?
Focus area 1: Stigma â€“ Visible and invisible
Focus area 2: Improving Investment in Research
Focus area 3: Patient Involvement
Focus area 4: Quality of life â€“ Education & Employment
thE Brain, mind and Pain ProgrammE The aim of the Brain, Mind and Pain programme is to raise political awareness of the impact of neurological and chronic pain disorders in Europe and to encourage policy solutions aiming to prioritise these disorders, encourage research, increase access to innovative treatment, improve quality of life and decrease stigma. It is an initiative of the European Federation of Neurological Associations (EFNA) and Pain Alliance Europe (PAE) which are umbrella organisations representing national and European patient advocacy groups. The cross-party, cross-national MEP Interest Group on Brain, Mind and Pain is co-chaired by Marian Harkin (Ireland - ALDE), Jeroen Lenaers (Netherlands - EPP) and Daciana Octavia Sârbu (Romania - S&D). The Book of Evidence is a report commissioned by EFNA & PAE in order to inform and support the activities of the MEP Interest Group. It summarises evidence in each of the four focus areas, along with case studies of positive activities from around Europe, and recommendations for action. More information can be found on the website: www.brainmindpain.eu.
Background: What arE nEurological and Pain disordErs? Neurological disorders are conditions arising from illness or injury to the brain, spinal cord or nerves. Some, like cerebral palsy, are present from birth, while others such as Alzheimer’s diseases affect older people. Some disorders, like migraine, typically give intermittent symptoms, while others such as Parkinson’s disease involve a progressive deterioration and loss of independence. neurological disorders. It can arise directly from damage to the nervous system or as a result of musculoskeletal pain caused by the symptoms of a neurological disorder or an injury or it can be of unknown origin. These are long-term conditions that severely impact quality of life, often leading to considerable disability and sometimes to reduced life expectancy. As a result they have an enormous impact on European economies, as well as on patients and their families. Neurological and pain disorders are a huge problem: each year, approximately 1 in 3 Europeans are affected by a brain disorder1 and 1 in 5 by chronic pain2. This includes 153 million people suffering migraine or other disabling headaches, 200 million musculoskeletal disorders, 100 million people experiencing chronic pain, 8 million living with stroke, 6 million with dementia and 4 million with traumatic brain injury2-4. Many others suffer from one of a vast number of rare neurological conditions, each of which affects relatively few patients but which together have an enormous impact on families and society.
The economic impact of brain, mind and pain conditions
The World Health Organisation estimates that brain disorders cause one-third of the burden of all diseases5.
€295 billion a year is spent directly on healthcare for neurological and brain disorders3, making them “the number one economic challenge for European health care, now and in the future” 6.
Including the effect of non-medical costs such as nursing homes, and indirect costs such as lost work productivity, the total cost of brain disorders in Europe is estimated to be around €800 billion each year3, about 6% of GDP.
Musculoskeletal disorders are estimated to cost the EU €240 billion a year4 and chronic pain conditions overall around 1.5-3% of GDP7,8.
Focus arEa 1: stigma - visiBlE & invisiBlE the impact of stigma on individuals and society Compared with cancer or heart disease, neurological and pain conditions are not widely recognised and understood by the general population. Negative attitudes towards people with these conditions include ignorance and fear about the disorders, and their causes and impact. This results in behaviours ranging from blatant expressions of reluctant to disclose their condition, or avoid certain activities. Rare conditions such as Guillain-Barré syndrome and ataxia-telangiectasia are unfamiliar to even most healthcare professionals. More common disorders such as epilepsy are well-known but widely misunderstood by the general public. Where symptoms are invisible, for example in many chronic pain disorders, patients can be made to feel that the condition is not accepted as genuine and disabling. Stigma can prevent people from seeking help quickly, because of possible negative social consequences9. If a patient delays seeking help, they cannot receive the best treatment and support, which might stabilise symptoms and prevent comorbid conditions such as depression, pain, and fatigue. For many conditions, earlier diagnosis and treatment aids a quicker return to independence and less reliance on health and social care services. Even for degenerative conditions such as Alzheimer’s disease, early diagnosis is cost-effective because treatment can help people to maintain independence and delay expensive interventions such as admission to nursing homes10,11. Stigma also results in an under-estimation of the true prevalence of some conditions by healthcare systems, payers and research funders11. This contributes to relatively modest funding of charities and patient advocacy groups for these conditions and a massive under-funding of research by governments. Brain disorders cost Europe twice as much as cancer, but cancer research receives twice as much public funding13.
Almost a third of people with chronic pain report that even their friends and family do not know what chronic pain is, or do not talk to them about it14
More than half of people with epilepsy feel stigmatised and 18% highly stigmatised15. Thirty percent never reveal their diagnosis16, often for fear of losing their job17.
Personal testimonies “When you have a better day and people see you walking on the street they say “well, it appears she’s healthy enough to take a walk, but not to work…”. That hurts, even after 10 times, even after 100 times. What people can’t see is the condition you’re in at home, how you need to rest after every effort you make, how many pills you have to take to get there. The worst thing is that you can’t see pain from the outside”. (Belgian patient with chronic pain)
“It took several years for doctors to believe me. I live in constant pain. They treated me as a hypochondriac. Therefore, I wasn’t getting my condition properly managed at the earliest stage and I was denied access to therapies for pain management… I feel I was denied a right to be informed about all the pain management options available so I could not make the best decisions for my condition. I feel I was denied my right to live with the least amount of pain possible.” (Slovenian patient with chronic pain)
“I can clearly remember on my 21st birthday arriving home from work and going to bed with a migraine rather than heading out to celebrate with friends... One person I was living with commented that she had never had a headache in her life and didn’t believe in headaches, that they were just in someone’s head… From then I found myself playing down the extent of my headaches in my working and social life for fear that others would also misunderstand and think I was exaggerating, looking for attention or to try and get out of something.” (Irish patient with migraine)
“I informed my friends at a gathering, when there was some hinting on the issue that I maybe just need to exercise more, by showing them an article... This article explained Cervical Dystonia in a way that I feel relates a lot to how my (Norwegian patient with dystonia)
click here to read more patient stories
the invisible burden of ataxia Patients with ataxia report regularly receiving the following comments from the public:
That they appear drunk, due to movement or speech problems
That they are clumsy, and don’t look ill or like they have a real disease
Many patients with ataxia need to use a wheelchair. They report that:
People often ignore them and speak only to the person attending them
Some people speak them as if they were a child, or as if they must be deaf (Comments reported on the Facebook page of Euro-ATAXIA)
the need for awareness-raising campaigns Campaigns are needed to increase awareness and understanding of neurological and chronic pain conditions among the general public, employers, and healthcare professionals. Increasing awareness will help reduce stigma and encourage people to seek help for possible symptoms earlier. For disorders such as stroke, where early treatment is extremely important, increasing public awareness can be highly cost-effective. Among health and social care professionals, who most regularly work with people with these conditions, educational interventions can improve those contacts for both the professional and the patient and can also contribute to ongoing professional development. For example the patient group Parkinson’s UK run a range of online and face-to-face training courses for healthcare professionals, from 30-minute courses for people working in primary care to full day courses aimed at social workers and professionals involved in care assessments.
Promoting lifestyle changes to reduce risk and self-manage symptoms For some neurological and pain conditions the opportunity in raising public awareness is not just to make life better for those living with the disorder, but also to prevent it, because risk for developing the condition is linked to lifestyle factors such as diet and exercise. For cardiovascular disease, the links with smoking, obesity and diet are widely accepted by the public and routinely managed by doctors. It is much less widely known that lifestyle interventions are just as important in preventing conditions such as stroke and dementia. For example, eating a Mediterraneanstyle diet reduces risk for disorders including dementia, Parkinson’s and stroke more than it reduces risk for cardiovascular disease18. Around half of a person’s risk for Alzheimer’s disease can explained by seven lifestylerelated factors: hypertension, obesity, diabetes, smoking, depression, cognitive activity/ education and physical activity19. Educating the public, including healthcare professionals and employers, about the preventability of some neurological and pain disorders, and lifestyle choices supporting healthy aging, has potential to greatly reduce the economic as well as personal burden of these disorders. Where prevention is not possible, patient-led self-management is an important piece of the sustainable economic future for European healthcare. In many long-term conditions, interventions such as peer-support services can be emergency room attendance, hospital admissions and shorter hospital stays; such interventions could reduce healthcare spend by 7%20.dy: the swedish national stroke campaign
case study: the swedish national stroke campaign This campaign run by the Swedish Association of Local Authorities and Regions aimed to teach the public to test for the four signs of stroke and then take immediate action by calling the emergency services. It ultimately reached 80% of the population with the stroke test message. Over three years the number of patients who received clotdissolving treatment increased 30%, saving an estimated SEK 85 million (â‚Ź9 million) in public costs, an excellent return on investment for a campaign cost of SEK 50 million (http://strokekampanjen.se/).
case study: hundred cities against Pain September 27th 2014 was the 4th Foundation (www.fondazioneisal.it), this aimed to raise funds and increase awareness about chronic pain and its treatment. Volunteers distributed the â€˜First Aid Kit for Painâ€™ guidebook, and media and the public contributed to the online campaign #zeropain. The campaign was linked to the recent passing of Italian law 38/2010, ground-breaking legislation guaranteeing free access to pain treatment.
case study: time to change This ambitious media and marketing campaign led by the UK charities Mind and Rethink Mental Illness aims to end stigma about mental illness in England (www.time-to-change.org.uk). Regions where there has been most campaign activity have shown the greatest improvements in attitudes and knowledge during the course of the campaign21. There has been a 3% increase in the number of people who say they face no discrimination, a 12% reduction in average levels of discrimination, and a 2% improvement in public attitudes.
click here to read extended case-studies
recommendations & call to action Public awareness campaigns led by patient groups should be funded by the EU and used to raise awareness of neurological and chronic pain disorders across Europe, in order to combat stigma and its negative consequences. diagnosis and treatment. This would improve the quality of life of patients suffering from neurological and pain disorders and ease the burden on caregivers. Particular emphasis should be given to educating the public about supporting healthy aging and reducing risk for some neurological disorders through lifestyle changes such as diet and exercise. This could considerably reduce the economic impact of these disorders by reducing the prevalence raise awareness of the devastating personal and social effects of these disorders and the need for more and better 22 .
We call on European Policy-Makers, via the Institutions and Members States, to support patient-led campaigns to educate, eradicate stigma and raise awareness of neurological and chronic pain disorders
Focus arEa 2: imProving invEstmEnt in rEsEarch investment in research into neurological and chronic pain disorders is decreasing On average, a new medicine takes ten years and US$1bn to come to market23. While 15% of candidates in other areas of medicine eventually become approved drugs, for central nervous system (CNS) drugs, only 8% do24. CNS drugs take longer to develop: late-stage clinical development takes one third longer than for other categories24. New treatments for these disorders are therefore less attractive to pharmaceutical companies, because of these reduced success rates and longer development cycles which result in a shorter period of market exclusivity in which to recoup costs. As a result the pharmaceutical industry overall is considerably reducing its investment in this area25.
incentivising investment in and access to new treatments is hampered by issues such as the relative inaccessibility of brain tissue and the fact that for many disorders, symptoms (particularly pain) and disease progress cannot be directly measured but must be assessed using questionnaires or interviews with patients. attractiveness of investing in these disorders versus other areas of medicine. Over the past decade, the removal of market access barriers has greatly increased the competition for generic products and therefore the affordability of medicines to patients26.. Most treatments for neurological conditions are small molecules which are relatively simple to imitate, so competitor drugs, including generics, can be rapidly developed. Unfortunately there are few economic incentives for pharmaceutical companies to invest in repurposing old treatments for new diseases, or to investigate new treatment combinations which combine both old and new drugs; both approaches which are likely to be particularly important in producing better treatments for brain disorders12,27 a balance between minimising treatment costs to patients (e.g. through generics) and continuing to incentivise There is considerable potential to make European trial design and regulation work more in the interests of patients and more attractive to pharmaceutical companies and medical device manufacturers. In particular, initiatives such as those recently developed by France and Belgium for adaptive licensing and early temporary authorisations for new medicines should be encouraged by the Commission’s Expert Group on Safe and Timely Access to Medicines and the European Medicines Agency’s adaptive pathways approach, both of which aim to expedite access to new treatment in disorders with high unmet need. There is also greater scope to incorporate patients’ views in the review and ethical approval processes, encourage patient participation in clinical trials, and ensure patients can access high quality information before and after clinical trials. Patient organisations should be consulted about providing participating, and what the results of trials mean for them. For many disorders, regulators now require evidence that a drug changes the patient’s real-world functioning as well as improving symptoms. In neurological and chronic pain conditions, where external markers of disease progress are often absent, this is a positive step which re-orientates drug development towards the most patient-relevant outcomes. Many Member States are investing in the development of health technology assessment (HTA) procedures to make the decisions about access to and reimbursement of drugs and there is increasing EU-wide co-ordination of HTAs through the European Network for HTA (EUnetHTA)26. However there is considerable variation between disorders and across Member States as to the extent to which cost, supply, or other considerations dictate access to both new and established treatments. For some conditions, notably chronic pain, patients in many Member States may be unable to access even well-established and cost-effective treatments28.
Recommendations to speed up the rate of new drug development The Collegium Internationale Neuro-Psychopharmacologicum (CINP) acts as a conduit between academic researchers and the pharmaceutical industry. To increase the rate of development of new innovative treatments in Europe their recommendations include12:
Reviewing and evaluating new clinical scales such as those used to measure pain or psychiatric symptoms for acceptance by regulatory bodies for inclusion in pivotal studies.
Making available regulatory science training to all publicly-funded neuroscientists and other researchers.
New biomarkers are needed to identify people at risk, improve rapid diagnosis, and speed up the rate at which the effectiveness of potential treatments can be determined.
supporting basic research European bodies must work to increase the perceived importance of neurological and pain research to governments, regulators and society and drive investment to a level commensurate with its importance as an area of unmet supported by public funders. Analysis of research funding from 200513 revealed that the total spent on brain research in Europe was approximately €4.1 billion, of which 21% was public funding (government and charitable foundations). For comparison, the US spent €12.5 billion on brain research, 42% of which was publicly funded. European public funding was equivalent to just 0.2% of the cost of brain diseases per year (and industry funding a further 0.8%). together to develop and align national strategies22. Co-ordinating research into neurological conditions is a central tenet of many such strategies including the French National Plan for neurodegenerative diseases and many of the national dementia plans now in place or in development29 at a September 2014 meeting of the Council of European health ministers, agreement was reached on the need to create a European network for professional training and to exchange research data.
supporting disease registries One major opportunity for progressing research and accelerating clinical trials is the development of large pan-European disease registries. Such registries provide a highly valuable and cumulative resource in which to investigate research hypotheses regarding causal factors, biomarkers, and genetics. They represent a unique opportunity to understand what are the safest, most effective and cost-effective treatment regimens since they are more representative of real patient populations than clinical trials, including patients with multiple comorbidities taking complex combinations of medications over longer periods than a typical clinical trial. They may also include patient-reported outcomes which are potentially more relevant to patients, governments and payers. Finally, disease registries may provide a ready pool of well-characterised participants for new clinical trials. Current initiatives exist to combine regional and national registries in cross-border platform such as EUReMS, the PARENT initiative and IMI programmes. Pan-European registries are particularly important in rare disorders where local registries would be limited in size and where the effort required to recruit large groups of patients is one barrier to developing new treatments. TREAT-NMD (www.treat-nmd.eu disorders, is one group bringing together registries of patients with rare disorders in order to encourage and facilitate clinical trials. TREAT-NMD lists available national databases, and for Duchenne muscular dystrophy and spinal muscular atrophy, has created global registries. The experience of such projects, alongside technical recommendations such as those proposed by the Healthcare Coalition on Data Protection30 and the European Data in Health Research Alliance (www.datasaveslives.eu) should be leveraged to assist the development of registries in other neurological and chronic pain conditions. The results of pan-European disease registries are of considerable interest to many different stakeholders, including patients, clinicians, pharmaceutical and medical technology companies, researchers, regulators and payers. Patient advocacy groups are likely to be best placed to manage the requirements and interests of these disparate groups, and should be supported to do so. 7
case study: the European register for multiple sclerosis (Eurems) EUReMS (www.eurems.eu) was initiated by the European Multiple Sclerosis Platform (EMSP) and launched in 2011 to address the lack of data on treatment and care for people with multiple sclerosis (MS) at a Europe-wide to a common protocol. A core dataset of items was established and four test studies were launched. Its highly successful process involved collaboration and methodology development steps which have informed subsequent initiatives including PARENT. They could now be directly replicated in other neurological and pain conditions.
case study: ParEnt cross-border initiative The Cross Border PAtient REgistries iNiTiative (http://patientregistries.eu) is a Joint Action under the EU’s Health Programme 2008-2013. It supports Member States to develop comparable and interoperable patient registries, enabling analyses of secondary data for cross-border public health research from electronic health records. Practical steps involve harmonising methodologies of patient registries and producing policy and governance guidance to enable cross-border usage of data. In October 2013 a web-based ‘Registry of registries’ was launched which lists nearly 200 local or national databases, and provides information about the data collection and usage policies.
case study: the innovative medicines initiative (imi) & EPad IMI (www.imi.europa.eu/), the world’s biggest public-private life sciences partnership, aims to speed up development of innovative medicines. A partnership between the EU and the pharmaceutical industry, its second phase (2014-2024) has a €3.3 billion budget, half of which comes from Horizon 2020, the EU’s framework programme for research and innovation. The European Prevention of Alzheimer’s Dementia Consortium (EPAD) project will be a registry drawing on cohorts from across Europe involving more than 200,000 people. The aim of the project is to develop a sustainable, pan-European platform for running adaptive trials for the secondary prevention of Alzheimer’s dementia.
click here to read extended case-studies
recommendations & call to action The EU must continue to invest in basic research, and encourage national funders of research to align their national strategies to increase the pan-European impact of research in tackling these enormous health challenges. European innovative drug development and making treatments affordable and accessible to all patients. In particular, the on the learnings from projects such as EUReMS and continuing to invest in projects such as PARENT and the IMI EPAD.
We call on European Policy-Makers, via the Institutions and Members States, to support research into the development of innovative prevention and treatment options within a regulatory framework which facilitates equitable access to affordable therapies.
Focus arEa 3: PatiEnt involvEmEnt the role for patient involvement in research activities It is right that patients should be involved in helping to shape priorities for research that is publicly funded and improves the relevance, quality and/or speed of that research31–33 . However, it is important to consider what the most appropriate form is for patient and public involvement (PPI) for different types of activities (e.g. basic science versus clinical research) and for different patient groups (e.g. young adults with MS versus people with dementia). Including patients in top level priority-setting in order to close the gap between what researchers want to research, the condition are more likely to work. For clinical trials in neurological and pain conditions, patient participation is which drugs can be assessed, helping pharmaceutical and medical technology companies and payers to understand the true value of a treatment12. EU-wide research programmes such as the Seventh Framework Programme (FP7), and Horizon 2020 encourage but do not mandate PPI. In the UK, a requirement for PPI has become universal for funding applications for translational research and sometimes even for basic research. For example the UK Alzheimer’s Society runs a research network comprising 250 people with dementia and carers who are consulted on all funding proposals, including those for lab-based science, as part of the grant review. At the stage of top-level research prioritisation, the James Lind Alliance facilitates priority setting partnerships that bring together patients, carers and clinicians to prioritise the most important treatment gaps for research. While these and many other examples of good practice exist, there remains considerable variability across Europe as to the extent to which national and charitable funding of research expects or requires PPI.
Benefits and Challenges of Patient and Public Involvement in Research Involving patients and the public can help research in neurological and pain conditions by:
Helping identify and prioritize the most patient-relevant topics
Identifying cultural issues that should be taken into account
Suggesting the best way to get informed consent from patients and/or carers
Ensuring that information sheets, questionnaires and interview schedules are patient-friendly; helping adapt academic language to make it clearer and culturally-sensitive
Speeding recruitment by providing researchers with better access to the patient community
» them in a more user-friendly way Involving these patients in research can also bring challenges, including:
A need to ensure that the full diversity of patients is represented, and not limited by issues such as physical access to venues,
» including a placebo arm in a clinical trial »
How to appropriately compensate patients without affecting welfare or disability payments
The challenges of involving neurological and pain patients in research must be tackled by educating both scientists
how to go about engaging with patients in this way. Patient organisations play a key role in both processes since researchers and funders keen to engage with the patient community.
Broadening the impact of patient involvement including regulatory processes. The ‘Healthy Brain Healthy Europe’ conference led by the Irish Presidency in 2013 recommended the promotion of “the role of patients in all stages of research and evidence-based healthcare… Patients need to be actively involved in the planning of research approaches, the execution of services and the maintenance of standards of healthcare practice”22. Research, health service delivery and healthcare policy are intertwined and patient involvement in all three can become a virtuous circle. Involving neurological and pain patients in improvements to local services can result in those improvements being taken up at national level, eventually becoming standard and supported by policy. Similarly, patients’ experience of healthcare services can help research be more relevant and credible, and The European Medicines Agency involves patient representatives in a number of steps in the regulatory process. Building a capacity of well-informed patients and patient organisations to act as effective advocates in regulatory and other decision-making processes is supported through activities including the IMI project EUPATI (www.patientsacademy.eu) and courses run by EFNA on pharmaceutical access, pricing and reimbursement (http://efna.net/european-patient-training-and-research-network-get-involved/). Measuring the impact of patient involvement in service delivery and policy-making is at an early stage. However empowering patients to take part in these activities, as well as in research, will bring new insights that may be applicable across all these activities. Empowering patients to get involved in such activities is a challenge that will organisations.
Empowering patients through better information Patients with neurological and chronic pain conditions need clear and reliable information to enable them to make decisions about their own health, and about whether to take part in research and other forms of engagement. approved medicines or as part of a clinical trial.
Improving information transparency in EU clinical trials One of the purposes of the new European Clinical Trial Regulation (EU 536/20140) is to increase the transparency of clinical trial results to scientists, clinicians and patients. It will require that:
All drug trials must be registered on the publicly accessible EU clinical trials register.
All trials used in support of an application to run a new clinical trial must also be registered, or have published their results.
A summary of the results from a trial must be published on the register within a year of the trial’s end, and a summary must be published in language understandable to a lay person.
Complex treatment decisions involve co-operative relationships between patients and their doctors, while doctors learn about new discoveries and best practice through interactions with a range of stakeholders in the medical community. These include clinical and professional bodies, local and global key opinion leaders, academic researchers, payers, and the pharmaceutical industry. There are opportunities for all these stakeholders to engage with patients directly to provide unbiased information so that patients are better equipped to understand their treatment options. This can improve the ability of patients and doctors to work together, for example by ensuring that they have a shared terminology for discussing the disease, treatments and symptoms. One example of this occurred at the 2014 ACTRIMS-ECTRIMS multiple sclerosis conference, where the pharmaceutical company Novartis ran a session in which clinicians and representatives from patient organisations discussed the extent to which the new clinical concept of ‘no evidence of disease activity’ is understood by, and would be useful to, patients with MS. At the same conference an international survey, commissioned by Biogen Idec, highlighted a consistent gap between patients’ and neurologists’ opinions about the quality of communication between them. While both were generally positive, patients rated neurologists 15 or more percentage points lower than neurologists rated themselves for statements such as ‘does everything he/she can to manage my multiple sclerosis’, ‘ makes sure I know everything I need and want to know’ and ‘ ensures I have a clear understanding of my options for therapy’34. Results like this suggest there remains a clear need to provide patients with more information to empower them in their treatment decisions.
case study: involvE INVOLVE (www.invo.org.uk) is a UK government-funded national advisory group supporting public involvement in medical and social care research. INVOLVE brings together experts to advocate, motivate, support and innovate in order to make public involvement an essential part of the research process. Their activities include producing guidelines and educational material, such as payment guidelines, guidelines for the reporting of patient and public
Genetic Alliance UK undertook a project to explore how patients with rare or serious conditions perceive the risks Citizen’s Jury made recommendations, which were subsequently tested with patients and carers across Europe35. They concluded that patients with rare conditions often have few effective treatments available, and so may be willing to take greater risks than the system currently allows; that they want to decide which treatment to take, but where the stakes are high and few treatment options are available.
recommendations & call to action Appropriate patient involvement should be a routine and universal feature of both publicly funded research and the drug development process. For EU-funded grants, there should be a requirement that due consideration is given to the appropriate involvement of patients in designing research goals and protocols, and in how results will be disseminated. Regulators should increase the involvement of patient representatives at all stages of the drug for conditions where few treatments are currently available. National funders of research should provide guidance on the appropriate engagement of patients in different types of research, and support the development of national support services to assist researchers in this engagement. Pharmaceutical companies and regulators should work together with patient advocacy groups to make information about clinical trials and the drug development process more visible and relevant to patients.
We call on European Policy-Makers, via the Institutions and Members States, to strengthen patient involvement in research, and in policy-setting and decision-making. 11
Focus arEa 4: Quality oF liFE - Education & EmPloymEnt the impact of neurological and chronic pain conditions on employment in Europe People living with neurological and pain conditions report wide-ranging effects on their quality of life. A recent multi-country survey reported that health-related quality of life in patients with some chronic pain disorders was as bad as in those with lung and liver cancer, and worse than many other chronic conditions such as rheumatoid arthritis, chronic obstructive pulmonary disease and prostate cancer36. Others have reported relatively good quality of life: for example people with neuromuscular disorders report similar quality of life to nondisabled individuals, and better than that assumed by the public or healthcare workers37. Employment is an important determinant of quality of life. People with neurological and pain conditions may limitations that are symptoms of the disease or side-effects of treatment. Unemployment, under-employment, and leaving education early can worsen the situation for patients by impacting self-esteem, mental health and social interactions and increasing isolation. Conditions which affect young people can have a lifelong impact on their education and employment options. For many patients, work is both a positive contribution to their life and a 38 .
Impact of neurological conditions on employment in Europe » hardships in their job, and 28% were forced to retire early39. »
In a UK study, half of people employed at the time they were diagnosed with Multiple Sclerosis gave up their job, and 37% reported that their standard of living declined40.
People with epilepsy are more than twice as likely to be unemployed as the general population41,42 but this varies considerably between countries: in Poland, 49% of people with epilepsy are employed43 compared with 77% in Germany44.
Much of the economic cost associated with these conditions comes from reduced employment of caregivers. Informal caregiving affects economic productivity considerably through lost opportunity for the caregiver to undertake paid work and a lack of tax revenues from the unpaid work. For example, the total cost of dementia in the EU in 2008 was estimated at €160 billion, of which 56% (€90 billion) were costs associated with informal care45. Across Europe, caregivers of people with chronic pain provided an average of 27.5 hours of care per week. This ranged from 9.9 hours per week in France to 48.7 hours per week in Italy36.
The effect of chronic pain on employment »
Chronic pain results in more than 500 million sick days in Europe, costing the European economy >€34 billion46.
1 in 4 people with chronic pain say it has impacted their employment and they lose, on average, more than 3 weeks of work each year due to their pain2.
» of 2.2 workdays during the past 4 weeks47. » »
Among people with neuropathic pain, employment was affected in 43% of patients; those employed missed an average of 5.5 workdays during the past month48. 14
Ensuring access to employment support across Europe Brain disorders and pain due to musculoskeletal disorders are two of the biggest causes of long-term sick leave in Europe49. Over 40 million EU workers have musculoskeletal disorders caused by their work; representing almost 50% of all absences from work of three days or more and 60% of permanent work incapacity4. At current rates, half the European workforce will be diagnosed with a musculoskeletal disorder by 20304. Variations between Member States in the effect of neurological and chronic pain conditions on employment are considerable. For example, nearly twice the number of people in the Netherlands reported that they had lost their job as a result of their chronic pain (29%) as in Ireland or Belgium (15%)2 Employer’s liability generally drops the longer an employee is sick49, so assisting patients to return to work becomes less important for employers in long-term conditions than in acute ones. EU social and disability legislation is central to employment and educational opportunities for people with neurological and pain conditions. The 2000 Employment Equality Directive obliges Member States to eliminate discrimination on grounds of disability in employment and vocational training. The European Disability Strategy 2010-2020 states that people with disabilities have the right to participate fully and equally in society and the and the Open Method of Coordination for Social Protection and Social Inclusion (Social OMC) are important policy frameworks in this area, and most Member States use European Social Fund money to translate disability employment policy into action, for example through work experience schemes, wage subsidies and temporary sheltered employment. Examples of good practices could be applied more widely in Europe; for example, Finland offers all employees with long-term illnesses the opportunity to work part-time.
Ensuring access to treatment across Europe A major driver of a person’s ability to remain employed is access to diagnosis and then treatment that adequately controls their symptoms. Big health inequalities persist in the EU, and the existence of neurology resources and differs considerably between Member States. Many patients with neurological and chronic pain conditions cannot access effective treatment. Access to modern multiple sclerosis treatment ranges from 13% in Poland and 21% in the UK to 69% in Germany50. Across Europe, two thirds of people with brain disorders receive no treatment1 and 40% of people with chronic pain report that it is not adequately controlled2. Uncontrolled symptoms worsen the impact of these disorders: up to 70% of people with epilepsy could lead normal lives if properly treated, but for a majority this is not the case9. Improving Europewide access to existing treatments and supporting the development of innovative medicines to better treat these conditions is an important part of supporting employment and economic productivity among the large number of European patients and their caregivers.
the European academy of neurology suggests the following steps should be carried out across Europe in order to improve access to neurological services: » »
Develop a plan to implement acceptable standards of neurological services and care
» Europe »
Find ways to attract and retain the best young European clinicians and scientists
case study: Early intervention for patients with musculoskeletal pain The Fit for Work Europe Coalition has highlighted a highly cost-effective programme carried out at the Hospital Clínico San Carlos in Madrid51. Patients with musculoskeletal disorders were provided with both conventional treatments and educational interventions encouraging behaviours to aid recovery and prevent re-occurrence. A study of 13,000 cases treated by the clinic over two years found the intervention cut the number of days off work by 39%, and halved the number never returning to work. Patient satisfaction was high and for every €1 of expenditure, € case study: the national learning network of ireland This organisation (www.nln.ie) provides a range of training courses and employment support in 50 centres across Ireland. Many of the programmes are designed for people with mental health problems, learning disabilities, or people recovering from other disabling conditions. Over 3,000 employers provide work experience, training, and and support of NLN staff, are consulted in the design and provision of vocational training courses, and experience
case study: the European multiple sclerosis Platform’s Believe and achieve programme Across Europe, only around one third of people with MS are working, and more than one third take early retirement because of the disease52. The ‘Believe and Achieve’ programme (http://www.emsp.org/projects/believe-andachieve) arose from a workshop on employment issues for young people with MS. It works with major European businesses to provide paid traineeships for young people with MS, offering employers advice and a practical toolkit on how to best support employees, and a match-making service to recruit the best candidates.
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Personal testimonies “The greatest loss in my life is work since it has always been an important part of my life. I work in a men’s world and I am good at whatever I do. Due to pain I lost the possibility to work normally and therefore I have lost part of my he also doesn’t understand my situation as a pain patient. He gives me less work and the money I bring home is almost nothing”. (Finnish patient with chronic pain)
a cold look and said to me, “If you turn your left side of your body towards the desk you can write on the computer”. feels like not being able to control your movements the way you want, I thought. There is nothing else I would like than being able to hold my head straight and go to work.” (Swedish patient with cervical dystonia)
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recommendations & call to action EU social legislation must be reliably and consistently applied across Member States, to support patients to live possible for themselves and their caregivers. Quality of life and employment should also be supported by ensuring universal and timely access to appropriate diagnostic services and the best currently-available treatments.
We call on European Policy-Makers, via the Institutions and Members States, to implement relevant European social legislation to ensure appropriate support for people living with neurological and chronic pain disorders. conclusions Across Europe, millions of people with neurological and chronic pain disorders struggle to get the treatment and support they need. The MEP Interest Group on Brain, Mind and Pain calls on European policy-makers – via the Institutions and Members States – to:
1. Support patient-led campaigns to educate, eradicate stigma and raise awareness of neurological and chronic pain disorders 2. Support research into the development of innovative prevention and treatment options within a regulatory framework which facilitates equitable access to affordable therapies 3. Strengthen patient involvement in research, policy-setting and decision-making 4. Implement relevant European social legislation to ensure appropriate support for people living with neurological and chronic pain disorders
“Chronic pain and neurological disorders affect millions of people in Europe and involve huge personal and economic cost. The Brain, Mind and Pain interest group will raise awareness about these conditions and their prevention and treatment. As with other health issues, many cases can be avoided by reducing exposure to risk factors and making healthcare policy, reducing the number and severity of cases in a cost-effective way.” Daciana Sârbu (Romania - S&D)
“This book is a unique opportunity for us to share our experiences, thoughts and ideas on how we can make neurological and pain disorder therapy more effective and accessible to all European Citizens. Ultimately, it is only through better education and understanding that we can increase the awareness, reduce the stigma and ensure appropriate treatment for brain, mind and pain disorders.” Marian Harkin (Ireland – ALDE)
“Chronic pain and neurological disorder patients and employment is a complex subject-matter, judging from the
important to work on the employment aspect and the health aspect at the same time, thereby combining two very and neurological disorders are not discriminated against anymore.” Jeroen Lenaers (The Netherlands – EPP) 15
acknoWlEdgEmEnts EFNA & PAE would like to thank the following for their valuable contributions to this report: Maggie Alexander, European Multiple Sclerosis Platform; Monika Benson, Dystonia Europe; G端nther Deuschl, European Academy of Neurology; Cathalijne van Doorne, Euro-ATAXIA; David Hughes, University of Chester; Konrad Labuschagne, Grunenthal GMBH; Jean-Pierre Malkowski, Novartis Pharma AG; Wolfgang Oertel, European Academy of Neurology; Sophie Petit-Zeman, Oxford Biomedical Research Centre; Danuta Rydlewska, Biogen Idec; Christoph Thalheim, European Multiple This report was developed by Dr Jenny Barnett on behalf of Punch Consulting (www.punchconsulting.co.uk)
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