27 March 2002
Towards concerted efforts for treating and curing spinal cord injury
Social, Health and Family Affairs Committee
Rapporteur: Mr Miroslav Ouzký, Czech Republic, European Democratic Group
There are estimated to be at least 330 000 people living with spinal cord injury (paraplegia and tetraplegia) in the member states of the Council of Europe, with about 11 000 new cases every year. About half of these injuries are the result of road accidents and occur at a young age. Advances in health maintenance and emergency healthcare have resulted in increasing numbers of people with spinal cord injury surviving and living relatively successfully in the community with their disability, often in a wheelchair and for a near normal lifespan. The economic costs to the individuals involved and to the community are considerable.
Recent years have seen remarkable developments in scientific research relating to spinal cord injury, and the report stresses that, as part of a comprehensive policy for people with disabilities, more intensive efforts must be made to achieve further progress in research designed to bring about a cure, that is to say, neurological restoration leading to functional recovery.
The report recommends among other things that a world centre for the co-ordination of research and development concerning spinal cord injuries should be established with the World Health Organisation, financed with all available resources, both public and private, together with a research database that would pool all existing and future medical and scientific material on spinal cord injuries and ensure effective co-operation between doctors and researchers from all over the world. Moreover, prevention campaigns should be stepped up.
I. Draft recommendation
1. The Parliamentary Assembly notes with concern that there are estimated to be at least 330 000 people living with spinal cord injury (paraplegia and tetraplegia) in the member states of the Council of Europe, with about 11 000 new cases every year. Some 40% to 50% of these injuries are the result of road accidents and most occur at a young age.
2. The Assembly emphasises that policies in regard to people with disabilities should be consistent with human rights principles as reflected in the relevant Council of Europe instruments and seek to promote dignity, independence, equality of opportunity, active participation, full citizenship and quality of life. These objectives can be served among other things by progress in the search for a cure for spinal cord injury.
3. The Assembly underlines that advances made in health maintenance and emergency healthcare have resulted in increasing numbers of people with spinal cord injury surviving and living relatively successfully in the community with their disability, often in a wheelchair and for a near normal lifespan.
4. For lack of a cure, that is, neurological restoration leading to functional recovery, priority so far has been given to rehabilitation aimed at increasing function and alleviating the symptoms of people with spinal cord injury . Despite high hopes that current research will lead to a cure, the present reality is that interdisciplinary rehabilitation is the only effective treatment that can be provided .
5. Nevertheless, the last ten years have seen remarkable developments in scientific research relating to spinal cord injury. For example, the regeneration of the central nervous system is no longer considered impossible. The transplantation of embryonic neurons below a complete spinal transection in adult rats has permitted total restoration of reflex locomotion in these paraplegic animals. This is, up to now, the most convincing evidence of significant progress in this field.
6. The Assembly believes that, as part of a comprehensive policy for people with disabilities, more intensive efforts must be made to achieve further progress in research designed to bring about a cure for spinal cord injury, while at the same time increasing the possibilities for rehabilitation with a view to maximising the active life of those with spinal cord injuries. Services aimed at rehabilitation should not be neglected and should be provided effectively and fairly, it being particularly important to provide care and access to treatment for the most disadvantaged, including in developing countries.
7. The Assembly is aware of the great direct and indirect economic costs generated by spinal cord injuries. In the United States , the aggregate costs of spinal cord injury have been estimated at 9.73 billion US dollars a year, and the life-time costs for an individual with tetraplegia at one million dollars. These figures, which are certainly higher in the wider Europe, highlight the importance of promoting prevention and financial support for spinal cord research. Council of Europe member states should make greater concerted efforts with a view to supporting and financing research in this area. In this way there could be considerable cost savings .
8. The Assembly therefore recommends that the Committee of Ministers:
i. urge the member states to:
a. step up funding at national level for research into treating and finding a cure for spinal cord injury induced paralysis, and explore the possibility of raising additional funding from road traffic violation fines, revenue on alcoholic beverages and taxes on health insurance premiums;
b. join together in promoting the establishment of a World Health Organisation (WHO) collaborating centre for the co-ordination of research and development concerning spinal cord injuries, financed with all available resources, both public and private, with a view to making cost savings through joint efforts;
c. promote, with WHO and in a concerted manner, the setting up of a research database aimed at the treatment and cure of spinal cord injuries. This database would pool all existing and future medical and scientific material on spinal cord injuries and ensure effective co-operation between doctors and researchers from all over the world leading among other things to the development of international spinal cord injury care models;
d. promote, with WHO, the systematic collection and comparison of statistics and the harmonisation of medical terminology relating to spinal cord injury;
e. initiate or step up advertising campaigns designed to reduce road traffic accidents, falls, violence, consumption of drugs and alcohol, seasonally targeted where appropriate to coincide with periods of increased incidence of spinal cord injury such as summer or winter holidays;
f. establish specialist spinal cord injury departments where necessary within accident and emergency centres with a view to making them more accessible even in low population density areas to those in need of treatment or rehabilitation;
g. expand co-operation between doctors and scientists from developed and developing countries so that appropriate healthcare for all people with spinal injuries is available to them;
h. in this context, observe the principles governing data protection and patients’ rights set out in the relevant Council of Europe instruments (Convention No. 108, Recommendations R (86) 1, R (97) 5, R (97) 18, and R (2000) 5);
ii. instruct the appropriate intergovernmental committees to develop measures and strategies to promote spinal cord injury research and prevention as a specific contribution to the European Year of Persons with Disabilities 2003.
9. Lastly, the Assembly requests that this recommendation be forwarded to the relevant authorities in every member state, and also to the World Health Organisation and the institutions of the European Union.
II. Explanatory memorandum by Mr Ouzký
1. There are few reliable statistics on the incidence or prevalence of spinal cord injury. However, based on a conservative average annual incidence of 14 people injured per million population, it may be estimated that there are some 11 000 new cases each year in the Council of Europe member States (2001 population estimate 785 million). Assuming, again conservatively, an average post-injury lifespan of 30 years, that means that some 330 000 people in the Council of Europe area are living with spinal cord injury (paraplegia, i.e.paralysis of the lower part of the body, and tetraplegia, i.e. paralysis of both arms and both legs). In 40-50% of cases, road accidents were the cause of injury, with sporting accidents making up another 10% of the total. The average age at which such injuries occur is 33 years, but most occur around the age of twenty.1
2. Spinal cord injuries (SCI's) can be divided into three types: complete, incomplete, and “discomplete”. Complete means that the spinal cord has been completely severed or so badly damaged that there is little hope of recovery or repair. Incomplete means that the spinal cord is still partly functional, giving hope that there may be some recovery of function. “Discomplete” means that although the spinal cord has been completely severed neurologically, there are some surviving uncut fibres. Hence any technique to improve conduction in the surviving fibres might be useful. Cervical SCI's usually cause loss of function in the arms and legs, resulting in tetraplegia , while injuries to the thoracic region usually affect the chest and legs. Thoracic, lumbar and sacral vertebra injuries result in paraplegia.
3. Until recently, for lack of a cure, that is neurological regeneration and restoration leading to functional recovery, priority has been given to rehabilitation aimed at increasing function and improving the skills of people with spinal cord injury through training and technology and alleviating the symptoms . Despite high hopes that current research will lead to a cure, the present reality is that interdisciplinary rehabilitation is the only effective treatment that can currently be provided to people with spinal cord injuries. Its goal is to maximise quality of life and social integration.2
2. Developments in treatment and research
4. Advances in treatment (particularly health maintenance and emergency healthcare) have resulted in increasing numbers of people with spinal cord injuries surviving and living successfully in the community with their disability. According to the International Campaign for Cures of Spinal Cord Injury Paralysis (ICCP), around 92,000 additional people worldwide survive a traumatic spinal cord injury each year and prepare to spend perhaps forty years or more in a wheelchair. If this trend continues, it is estimated that over 2.5 million people worldwide will be living with spinal cord injury induced paralysis by 2005.3 Early medical and surgical therapies (within two hours for medical, eight hours for surgical) can improve the outcome significantly, by permitting the prognosis to remain as an incomplete lesion and not to evolve into a complete one.4
5. It has been possible to improve the walking capabilities of a small number of people with incomplete spinal cord injury by means of intensive training consisting of walking upright on a treadmill. However, people with neurologically complete SCI are still unable to walk despite the development of sophisticated techniques for ambulation, such as Functional Electrical Stimulation (FES). FES involves the implantation of electrodes on and under the skin in order to stimulate the underlying muscles, but there are many difficulties in controlling movement. Even so, those with complete SCI may well derive overall benefit from the physical exercise and stimulation involved in treadmill and FES therapy.
6. Restoring the upright mobility of persons with paraplegia through Functional Electrical Stimulation was the main objective of the now discontinued European project "Stand Up and Walk" , co-financed by the European Commission, , Denmark, Germany Italy, the Netherlands and the United Kingdom, and with the co-operation of private companies such as IBM and Thomson. This project has led to treatment of two complete paraplegic patients, without, however, convincing evidence of benefit to them. Moreover, this clinical project has not given rise to any publication in any peer-reviewed journal. Nor was it preceded by any serious pre-clinical evaluation in experimental animals, and, as such, should not have obtained the approval of local ethical committees.
7. The last ten years have seen remarkable developments in scientific research relating to SCI. For example, the regeneration of the central nervous system is no longer considered impossible. Only recently have scientists begun to truly appreciate the diverse number of biochemical pathways that can cause a cell to die after the onset of damage. Although there is little evidence yet that the amount of regeneration required to restore functions such as the ability to walk independently at different speeds in humans can be achieved, tests on animals with complete spinal cord injuries have shown that the potential exists.
8. Certain avenues were explored at a Conference sponsored by the Icelandic Government and the World Health Organisation on Human spinal cord injury: new and emerging approaches to treatment, held in Reykjavik on 1-2 June 2001. These included transplantation into the spinal cord of embryonic stem cells which, it is hoped, can develop into motor neurons capable of integrating into the spinal cord neurological network,5 and the role of laser energy in promoting functional recovery after such transplant operations in rats. Some promise has been shown with techniques to graft new tissue to the injured spinal cord, thus promoting regeneration. Significant functional recovery has been achieved by attaching peripheral nerves coming from the spinal cord above the injury to spinal cord nerve roots below it. The transplantation of embryonic neurons below a complete spinal transection in adult rats has permitted total restoration of reflex locomotion in these paraplegic animals.6 This is, up to now, the most convincing evidence of significant progress in this field.
9. It is difficult to imagine that an eventual cure for SCI could be instant and complete, the more likely result for the patient being a slow improvement with partial recovery of his or her neurological functions. A single therapy is unlikely to be able to address all the complexities of spinal cord injuries, multiple therapies being considered more likely to provide the most promising results for patients.
10. While vigorously pursuing further progress in research, it is essential to intensify at the same time the development of rehabilitation with a view to maximising the active life of those with spinal cord injuries, however difficult. Services aimed at rehabilitation should not be neglected and should continue to be effectively provided, especially since the benefits of techniques such as FES are limited to those with incomplete spinal cord injuries. Significant provision must be made for the present management of those who are suffering so that they can have access to available treatment that is denied to many, including in developing countries.
3. Economic costs
11. In the United States alone, aggregate annual SCI-related costs have been estimated at 9.73 billion US dollars per year.7 These represent both direct costs such as medical care in the first and subsequent years, expenditure on personal assistance, and the cost of home modifications, wheelchairs and vehicle modifications, as well as indirect costs such as loss of productive capacity. Over a lifetime, costs for an individual with tetraplegia have been estimated at one million US dollars.8 Some observers give much higher individual cost estimates.9 Thus the significant economic cost of spinal cord injuries should encourage Council of Europe member states to increase their concerted efforts towards supporting and financing research aimed at finding a cure for paralysis. In this way there could be significant cost savings .
4. International action
12. Intergovernmental organisations such as the Council of Europe, but in the first instance the World Health Organisation (WHO), can help doctors and researchers working on the injured spinal cord by contributing to the support and coordination of their work and ensuring that national authorities encourage public and private funding and give attention and support to such initiatives as the International Campaign for Cures of Spinal Cord Injury Paralysis.10
13. Adequately funded joint action by governments and organisations must be encouraged to ensure that research findings are available to doctors, patients, researchers, and all those seeking a cure for spinal cord injury. The successful public-private cooperation achieved on the "Stand Up and Walk" project as well as the network of European rehabilitation centres set up in 1992 to prepare it, should serve as examples of the level of cooperation that can be achieved. Such cooperation could constitute a model for other areas of treatment.
14. The current COST B 10 action “brain damage repair” launched by the European Union in 1998, promotes co-operation between research institutes from Austria, Belgium, Croatia, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and Switzerland. This represents a solid basis for European networking in this area. However, it is not a source of funding for international research projects.
15. In order to ensure that research findings are available, a basic and urgent need is the establishment of a global database of SCI research that would include not only current research projects (of which there may be some 2000) but also the research scientists conducting them. Such a database should be available on the Internet and could be set up and managed, it is suggested, under the auspices of WHO. It has been estimated that, taking account of planning and consultation, personnel, promotional, design, programming and overhead costs, this might require an initial annual budget of some 150 000-250 000 US dollars over five years.11 Such a database should be closely co-ordinated with that already started under the European Union COST B 10 action on “brain damage repair”, accessible to any scientist, as well as other sources such as Medline or the International Campaign for Cures of Spinal Cord Injury (ICCP).
16. The evidence of effective nerve tissue regeneration that is being demonstrated in research laboratories (at the animal testing stages) must be acknowledged so as to enable these discoveries to be developed into effective therapies. In this context, a world panel of experts should be set up to evaluate and promote the most promising research projects. Then, following extensive laboratory research into the restoration of neurological function, there must be clinical trials, for which large numbers of SCI patients must be recruited and prepared and for which an internationally accepted protocol must be devised to judge the results. Again, a fund should be established to promote this development. The British charity Spinal Research, which is beginning this work, estimates the cost at between Ł20 million-Ł30 million over eight years.
17. Securing adequate funding, both public and private, is of course a key prerequisite to intensifying the search for the cure and improved treatment of SCI. As has been said, this should result from an international collaborative effort. It has also been said above that some 40-50% of spinal cord injuries result from road accidents. It would therefore seem entirely fitting that a proportion of a surcharge on all fines levied for moving traffic violations should be earmarked for the SCI research effort, as was introduced into law in New York State in 1998.12 A further appropriate source would be a proportion of tax on alcohol, a major cause of road accidents. Moreover, to the extent that curing spinal cord injury could result in huge savings to the health insurance industry, a minimal tax could be levied on health insurance premiums.
5. Conclusions and recommendations
18. Spinal cord injury results in some of the most severe forms of disability. As a human rights organisation, the Council of Europe aims among other things to fight exclusion and discrimination and to promote the dignity, rehabilitation, quality of life and social reintegration of persons with disabilities. Helping to promote and intensify the research effort with a view to achieving a cure and improving treatment for spinal cord injury is entirely consistent with these aims.
19. What is needed is an international collaborative effort, together with the World Health Organisation, to increase funding not only for research and eventual clinical trials, but also for international co-operation and exchange in the research field, not least through the establishment of a global research database.
20. In conclusion, the Parliamentary Assembly should recommend, among other things, that the Committee of Ministers should call on the member states:
i. to step up funding for research that is aimed at finding a cure for spinal cord injury induced paralysis, and explore the possibility of raising additional funds derived from road traffic violation fines, revenue on alcoholic beverages and taxes on health insurance premiums;
ii. to promote the setting up, within WHO, of a world centre for the coordination of research and development into spinal cord injury, including the collection and comparative analysis of statistics, financed through all available resources, public and private, with a view to making cost savings through joint efforts;
iii. to promote, within WHO, the creation of a research database aimed at the treatment and cure of spinal cord injury. This database would centralise all existing and future medical and scientific material on spinal injury and ensure cooperation between doctors and researchers from all over the world leading, among other things, to the development of international spinal cord injury care models;
iv. to promote, within WHO, the harmonisation of medical terminology relating to spinal cord injury;
v. to initiate or step up advertising campaigns designed to reduce road traffic accidents, falls, violence, consumption of drugs and alcohol, seasonally targeted where appropriate to coincide with periods of increased incidence of spinal cord injury such as summer or winter holidays;
vi. to establish specialist spinal cord injury departments where necessary within accident and emergency centres with a view to making them more accessible even in low population density areas to those in need of treatment or rehabilitation;
vii. to encourage the member states to work towards promoting cooperation between doctors and scientists from developed and developing countries, so that appropriate healthcare for persons with spinal injury is not limited to the wealthy.
21. The Committee of Ministers should also instruct the appropriate intergovernmental committees to develop measures and strategies to promote spinal cord injury research and prevention as a specific contribution to the European Year of Persons with Disabilities 2003.
Reporting committee: Social, Health and Family Affairs Committee
Reference to committee: Doc 9154 and reference n° 2628 of 29 June 2001
Draft recommendation unanimously adopted by the committee on 22 March 2002
Members of the committee: Mrs Ragnarsdóttir (Présidente), Mr Hegyi, Mrs Gatterer, Mr Christodoulides (Vice-Présidents), , MM. Alís Font, Arnau, Mrs Belohorská (remplaçant Mr Tkáč), Mr Berzins, Mrs Biga-Friganovic, Mr Bilovol, Mrs Björnemalm, Mrs Bolognesi, MM. Brînzan, Brunhart, Cerrahoğlu, Cesário, Cox, Dees, Dhaille, Evin, Floros, Flynn, Mrs Gamzatova, MM. Giertych, Glesener, Goldberg, Gönül, Gregory, Gusenbauer, Gustafsson, Haack, Herrera, Hřie, Hörster, Mrs Jäger, Mrs Jirousová, Baroness Knight, MM Kontogiannopoulos, Liiv, Lomakin-Rumiantsev, Mrs Lotz, Mrs Luhtanen, MM. Makhachev, Malachowski, Manukyan, Mrs Markovska, MM. Marmazov, Marty (remplaçant: Schmied), Mattei, Mrs Milotinova, MM. Mladenov, Monfils (remplaçant: Timmermans), Mrs Nowiak, Olekas, Ouzký, Padilla, Podobnik, Popa, Poroshenko, Poty, Provera, Rigoni, Rizzi, Seyidov, Mrs Shakhtakhtinskaya, MM. Slutsky, Surján, Telek, Mrs Tevdoradze, Mrs Troncho, MM. Tudor, Vella, Mrs Vermot-Mangold, MM. Vesselbo, Vis, Vos, Mme Zafferani, Mr Zidu
NB : The names of those members present at the meeting are printed in italics
Secretaries to the committee: Mr. Newman, Ms Meunier and Ms Karanjac
1 International Campaign for Cures of Spinal Cord Injury Paralysis, Global summary of spinal cord injury, incidence and economic impact, http://www.campaignforcure.org/globalsum.htm, and rapporteur’s calculations.
2 The Rapporteur recalls that Mr Surján is currently preparing a report on the Social inclusion of persons with disabilities on behalf of the Social, Health and Family Affairs Committee.
3 See footnote 1.
4 Tadié, M. et al, Acute spinal cord injury : early care and treatment in a multicenter study with gacyclidine, 1999, Soc. Neurosci. Abstract No. 444.2, 25 part 1, 1090.
5 As a result of the positive decision taken by the House of Lords Select Committee on stem cell research on 27 February 2002, research into stem cells derived from cloned human embryos can now go ahead in. the United Kingdom.
6 Giménez y Ribotta., M., et al, Activation of locomotion in adult chronic spinal rats is achieved by transplantation of embryonic raphe cells reinnervating a precise lumbar level, 2000, J. Neurosci., 20, (13): 5144-5152.
7 M. Berkowitz, P.K. O’Leary, D.L. Kruse, C. Harvey, Spinal cord injury: an analysis of medical and social costs, Demos, New York, 1999.
9 P. Banyard, Director of Development, Spinal Research, a charity based in Guildford, United Kingdom, puts the figure at closer to $3 million for the United Kingdom, with lifetime care costs alone of about $1.2 million. Total annual cost of SCI to the United Kingdom economy is estimated at a minimum of $533 million.
11 D. Prast, International Campaign for Cures of Spinal Cord Injury (ICCP)
12 Christopher Reeve, Still me, Arrow Books, London, 1999, pp. 285-6.