625
slowly on treatment. Many patients have advanced disease, with massive splenomegaly and a haemoglobin of less than 6 g/dl. A body-weight of only 30 kg is common. Treatment requires a month of daily injections with pentavalent antimony. Under the current field conditions a mortality rate of 10% is a considerable achievement.
The difficulties of managing such an epidemic are vastly magnified when a government thinks that it has no responsibility for the affected people because they live in a war zone. In Sudan, the tribes people live in an area partly controlled by the rebel army, and the Government is unable and unwilling to provide medical supplies to the rebel area. Medical staff cannot reach the affected area, and the local infrastructure has collapsed. The absence of transport and presence of an army means that antimony has to be flown into this remote region at considerable personal risk. Visceral leishmaniasis is spread by the biting female sandfly. Potential preventive interventions include killing sandflies and any vertebrate parasite reservoirs and protecting man from sandfly bites. No animal host has been definitely identified in the Sudan, and there is now such a high level of infection in the human population that control of the epidemic is contingent upon reducing the burden of human infection. Vaccination is not feasible. The sandfly lives in the acacia bushes and trees that cover the land, but denuding the land of its vegetation is not a sensible proposition. Spraying the bushes to kill sandflies is not possible: there are no planes, and if there were, flying would not be permitted. Protection against sandfly bites might be possible by provision of clothes or use of permethrinimpregnated bed nets. Impregnated nets have a dual function: they protect against bites and kill any sandflies that come into contact with the net. Even just leaving permethrin-impregnated rags in sleeping areas may be sufficient to reduce sandfly bites. Why has this epidemic occurred? The last major Sudanese epidemic was in 1958. In the early 1980s severe flooding killed most of the acacia trees that support the sandflies. The growth of new trees coincided with largescale army movements on the Sudan-Ethiopia border in 1984-85. Probably the parasite was reintroduced by the troops into the area at a time when, dislocated and malnourished, the local population was vulnerable. The consequences of failing to control this epidemic are frightening. Already there has been a rapid increase in the level of symptomatic disease. Initially the outbreak was confined to a relatively small area but is now spreading to adjoining areas. A recent survey found no HIV positivity in these tribes people, but in adjacent areas there is considerable HIV positivity, which is associated with an increased risk of visceral leishmaniasis. This provides ideal conditions for accelerating the epidemic. The people of southern Sudan are ill served by their Government’s refusal to acknowledge this epidemic. Improvement and extension of current facilities are needed for treatment of newly presenting cases and optimising treatment to effect a reduction in the mortality rate. An active surveillance programme is needed to identify people with early disease and to monitor the development of the
epidemic. Diana N. J. Lockwood 1. De Beer P, El Harith A, van Grootheest, et al. Outbreak of kala-azar in the Sudan. Lancet 1990; 335: 224. 2.Perea WA, Ancell T, Moren, et al.Visceral leishmaniasis in southern Sudan. Trans RSoc Trop MedHyg1991;85:48-53. 3.Lockwood DNJ, Weber JN. Parasite infections in AIDS. Parasitol Today 1989; 5: 310-16.
Medicine and the Law Group litigation on the horizon In the UK there are some 250 000 insulin-dependent diabetics, of whom over 80% now use synthetic "human" insulins. The transfer from insulin of porcine or bovine origin has not met with universal satisfaction, and there have been allegations of paralysis, memory impairment, and even death as a consequence of the loss of awareness of the warning symptoms of hypoglycaemia. Some 500 diabetics have now consulted solicitors, with the numbers growing so quickly that the Law Society has opened up its disaster coordination service to supply information to the public and solicitors. On Aug 29 representatives from twenty-five firms (about half of those contacted by potential insulin litigants) met at the Law Society in London to appoint a steering group, of which there are five member firms, with Mr Peter Stott of Stevensons (Leigh, Greater Manchester) as chairman. The steering group held its first meeting on Sept 6 in Manchester to plan strategy and to appoint experts to advise on the medical and legal merits of this potential group action. The concerns of the diabetics and their legal advisers at the heart of this embryo group litigation were supported by studies suggesting that over one-third of patients lost awareness of warning symptoms after transfer to human insulin.1 As a critical review at that time noted, an apparent increase in unexpected deaths among insulin-treated patients in 1988-89 had been "attributed to hypoglycaemia associated with the use of human insulin".2 Some consultants put patients back on animal insulin, with beneficial effects for some according to Mr Stott, chairman of the Insulin Steering Group. However, as the statistics show most have persevered with the change. A paper published in The Lancet of Aug 28 casts doubt on the view that human insulin deprives patients of early warning signs, though its authors concede that "It is still not known whether human insulin genuinely impairs the perception of hypoglycaemia. Of 302 randomly selected patients who had lately changed from animal to human insulins, 6% reported diminished awareness ... whereas 3% reported enhanced awareness". This new study will be carefully considered by the steering group and its medical advisers, when appointed. The insulin litigation could be wide-ranging, with potential defendants ranging from the manufacturers (Novo Nordisk, Eli Lilly, and CP Pharmaceuticals) to the prescribing doctors and the Committee on Safety of Medicines in its role as watchdog and "learned intermediary". However, matters are at a very early stage: applications are being processed for the grant of legal aid in individual cases and for a study of medical and legal issues raised.
Other multiple medical negligence/product claims under consideration are claims for side-effects caused by human growth hormone implanted into children with dwarfism and for hepatitis C resulting from contaminated blood used in transfusions. Lawyers who acted for 1200 patients with haemophilia infected with HIV (whose claims were settled out of court by the government for an estimated C82 million) are investigating these new claims. The virus is carried in the blood by 1-2 per 2000 blood donors, the proportion rising tenfold among immigrant populations and inner city residents. Tests for hepatitis C antibody became available from 1989 and most European Community countries and the USA began screening at once. In the UK the National Blood Transfusion Service (NBTS), which handles 2 million donations annually, did not immediately follow suit because it had concerns about the reliability of the test. How far this approach was justified may become the nub of any
626
legal action. The NETS denies that it has been negligent or that it was more concerned about not upsetting the donors than the recipients. "A false positive is just as bad from our point of view as a false negative", said Dr Roger Moore, the NETS deputy national director.3 The Department of Health’s expert committee had in mind the pros and cons of testing with an earlier method when it decided when to start testing for hepatitis C in blood. Potential litigants who have not yet consulted a solicitor but who wish to join a third multiple action-the tranquilliser litigation now under way-will need to hurry. Applications for legal aid must be in by Sept 20, and Mr Justice Ian Kennedy, the High court judge in charge of the litigation, has directed that all proceedings must be served by April 15, 1992.
Diana Brahams 1. Teuscher A. Berger WG. Hypolgycaemia unawareness in diabetics transferred from beef/porcine to human insulin. Lancet 1987; ii: 382-85; Berger W, et al. Warning symptoms of hypoglycaemia during treatment with human and porcine insulin in diabetes mellitus. Lancet 1989; i: 1041-44. 2. Gale EAM. Hypoglycaemia and human insulin. Lancet 1989, ii: 1264-66. 3. Denison S. Patients may sue over hepatitis-C in blood. Independent Aug
7, 1991.
Noticeboard Unplanned pregnancies Sex education must become the principal means for reducing numbers of unwanted pregnancies, according to a new report from the Royal College of Obstetricians and Gynaecologists (RCOG).l Society needs to view abortion not as evidence of sexual promiscuity, says the report, but as proof that a woman wishes to have only planned children. The fear of an unwanted pregnancy among the young and sexually active is real: a recent survey of sexual attitudes among 16-19 years olds identified this concern as the deciding factor in their choice of contraceptive (see Lancet Aug 17, p 440). In response to the rising number of legal abortions, the RCOG established a working party in 1988 to review education about and services available for contraception. The College was especially concerned because the recommendations it gave in 1972 had had little impact. Rates of legal abortion continued to rise slowly, reaching a peak of 181 000 in 1989 and falling slightly in 1990 to 173 000. The increased abortion rate arises mainly from growing numbers of unwanted pregnancies among single women not having a supportive partner, especially those aged under 20. The emphasis on sex education stems from the belief that communication failures between partners lead to inadequate discussion of issues about contraception. Sex education tends to be conducted on an ad-hoc basis, and the College now recommends that it should be made a compulsory part of all teacher training. The implementation of national guidelines on sex education should be reviewed in each school so that parents and education authorities can ensure that schools provide effective tuition. The report also points to the importance of community contraceptive services and postgraduate training as essential parts of the infrastructure that is necessary to reduce the numbers of unwanted pregnancies. The importance of this subject might be reinforced by establishing a new subspecialty of community gynaecology. The pressure on services for termination of pregnancy in the National Health Service is highlighted in the annual report of the Department of Obstetrics and Gynaecology at St George’s Hospital, London.2 923 suction terminations were completed in 1990; 31 patients underwent termination at 12-16 weeks of gestation; and 81 women required late termination at up to 20 weeks. Chamberlain and Barker note their hope that the UK drug regulatory authority will soon license mifepristone for early termination of pregnancy. Requirements for both surgery and
anaesthetic facilities could theoretically be reduced by 90%, and total financial savings to the NHS could amount to 16 million
annually. 1.
Report of the RCOG working party on unplanned pregnancy. London: Royal College of Obstetricians and Gynaecologists, 1991. Pp 64. ISBN 090233154X. Copies obtainable from the RCOG, 27 Sussex Place, Regent’s Park, London NW1 4RG,
UK. 2. Chamberlain
G, Barker G. Annual report of the Department of Obstetrics and Gynaecology, St George’s Hospital, London, 1990.
Medical research in
Europe
BIOMED 1, the European Community biomedical research programme for 1990-94, is expected to receive final approval from the Council of Research Ministers in the next few weeks. This programme follows on from the 4th Medical and Health Research Programme (MHR 4), which ran from 1987-91, and it falls within the EC’s 3rd Framework Programme, which defines the broad priority areas and total budget for all EC scientific research for 1990-94. The budget for BIOMED 1 is 133 million ECUs (approx 87 million), to be allocated over 4 years. A fundamental principle in the implementation of EC programmes is "subsidiarity", by which any research that can be done satisfactorily at national level should not be carried out at European level. Thus applicants seeking funding from BIOMED 1 will have to explain what "added" value is to be obtained from a European project. The main method of support will be by Concerted Actions; here no funding is given for the research itself, but up to 100% support may be granted for exchange of information (eg, through meetings or newsletters) about nationally funded work. Shared-costs contracts are likely to be restricted to the human genome analysis area. The first two of the four areas of BIOMED 1 roll on from MHR 4. Area 1 covers the harmonisation of methodologies and protocols in epidemiological, clinical, and technological research. Particular attention will be paid to study of risk factors and screening, especially in occupational medicine. Area 2, which is the main focus of the programme, will be on novel approaches to tackling health problems of great socioeconomic impact; emphasis will be put om AIDS, cancer, cardiovascular disease, mental illness and neurological disease, and the ageing process and age-related handicaps. Area 3, the Human Genome Analysis Programme, will come under the BIOMED 1 umbrella in June, 1992. Area 4 covers research on biomedical ethics. Final approval of BIOMED 1 will be followed by the production of a detailed work programme indicating the objectives, the range of topics that applications can cover, and types of funding, and by calls for new research proposals. The first call will be for areas 1, 2, and 4 (with closing date likely to be in February, 1992), and the second call will be for area 3. In the mean time the Human Genome Analysis Programme has called for proposals for studies on the ethical, social, and legal aspects of human genome analysis. The studies should focus on the European rather than the national dimension, and proposals should reach the European Commission by Nov 14. Further information on this call or on BIOMED 1 is available from the Commission of the European Communities, DG XI 1/F6,200 rue de la Loi, B-1049 Brussels or from national contact points in EC-member states. In the UK the contact point is the International Section, Medical Research Council, 20 Park Crescent, London WIN 4AL.
Soviet psychiatry The
appointed by the World Psychiatric Association monitor changes in psychiatry in the Soviet Union returned from its 3-week visit to the USSR in June with disappointing news. Although no new cases of political abuse of psychiatry were uncovered, the team notes in its report1 that "large numbers of individuals are still suffering the consequences of erroneous and damaging psychiatric intervention". According to the report, the All Union Society of Psychiatrists and Narcologists, which resigned from the WPA in 1983 rather than be expelled, "bears a major responsibility for remedying this situation and, as yet, has not taken sufficient steps". Dr Jorge Alberto Costa e Silva, chairman of the WPA’s executive committee, concludes that there are "many continuing problems that require monitoring and follow-up". (WPA)
team
to
slowly on treatment. Many patients have advanced disease, with massive splenomegaly and a haemoglobin of less than 6 g/dl. A body-weight of only 30 kg is common. Treatment requires a month of daily injections with pentavalent antimony. Under the current field conditions a mortality rate of 10% is a considerable achievement.
The difficulties of managing such an epidemic are vastly magnified when a government thinks that it has no responsibility for the affected people because they live in a war zone. In Sudan, the tribes people live in an area partly controlled by the rebel army, and the Government is unable and unwilling to provide medical supplies to the rebel area. Medical staff cannot reach the affected area, and the local infrastructure has collapsed. The absence of transport and presence of an army means that antimony has to be flown into this remote region at considerable personal risk. Visceral leishmaniasis is spread by the biting female sandfly. Potential preventive interventions include killing sandflies and any vertebrate parasite reservoirs and protecting man from sandfly bites. No animal host has been definitely identified in the Sudan, and there is now such a high level of infection in the human population that control of the epidemic is contingent upon reducing the burden of human infection. Vaccination is not feasible. The sandfly lives in the acacia bushes and trees that cover the land, but denuding the land of its vegetation is not a sensible proposition. Spraying the bushes to kill sandflies is not possible: there are no planes, and if there were, flying would not be permitted. Protection against sandfly bites might be possible by provision of clothes or use of permethrinimpregnated bed nets. Impregnated nets have a dual function: they protect against bites and kill any sandflies that come into contact with the net. Even just leaving permethrin-impregnated rags in sleeping areas may be sufficient to reduce sandfly bites. Why has this epidemic occurred? The last major Sudanese epidemic was in 1958. In the early 1980s severe flooding killed most of the acacia trees that support the sandflies. The growth of new trees coincided with largescale army movements on the Sudan-Ethiopia border in 1984-85. Probably the parasite was reintroduced by the troops into the area at a time when, dislocated and malnourished, the local population was vulnerable. The consequences of failing to control this epidemic are frightening. Already there has been a rapid increase in the level of symptomatic disease. Initially the outbreak was confined to a relatively small area but is now spreading to adjoining areas. A recent survey found no HIV positivity in these tribes people, but in adjacent areas there is considerable HIV positivity, which is associated with an increased risk of visceral leishmaniasis. This provides ideal conditions for accelerating the epidemic. The people of southern Sudan are ill served by their Government’s refusal to acknowledge this epidemic. Improvement and extension of current facilities are needed for treatment of newly presenting cases and optimising treatment to effect a reduction in the mortality rate. An active surveillance programme is needed to identify people with early disease and to monitor the development of the
epidemic. Diana N. J. Lockwood 1. De Beer P, El Harith A, van Grootheest, et al. Outbreak of kala-azar in the Sudan. Lancet 1990; 335: 224. 2.Perea WA, Ancell T, Moren, et al.Visceral leishmaniasis in southern Sudan. Trans RSoc Trop MedHyg1991;85:48-53. 3.Lockwood DNJ, Weber JN. Parasite infections in AIDS. Parasitol Today 1989; 5: 310-16.
Medicine and the Law Group litigation on the horizon In the UK there are some 250 000 insulin-dependent diabetics, of whom over 80% now use synthetic "human" insulins. The transfer from insulin of porcine or bovine origin has not met with universal satisfaction, and there have been allegations of paralysis, memory impairment, and even death as a consequence of the loss of awareness of the warning symptoms of hypoglycaemia. Some 500 diabetics have now consulted solicitors, with the numbers growing so quickly that the Law Society has opened up its disaster coordination service to supply information to the public and solicitors. On Aug 29 representatives from twenty-five firms (about half of those contacted by potential insulin litigants) met at the Law Society in London to appoint a steering group, of which there are five member firms, with Mr Peter Stott of Stevensons (Leigh, Greater Manchester) as chairman. The steering group held its first meeting on Sept 6 in Manchester to plan strategy and to appoint experts to advise on the medical and legal merits of this potential group action. The concerns of the diabetics and their legal advisers at the heart of this embryo group litigation were supported by studies suggesting that over one-third of patients lost awareness of warning symptoms after transfer to human insulin.1 As a critical review at that time noted, an apparent increase in unexpected deaths among insulin-treated patients in 1988-89 had been "attributed to hypoglycaemia associated with the use of human insulin".2 Some consultants put patients back on animal insulin, with beneficial effects for some according to Mr Stott, chairman of the Insulin Steering Group. However, as the statistics show most have persevered with the change. A paper published in The Lancet of Aug 28 casts doubt on the view that human insulin deprives patients of early warning signs, though its authors concede that "It is still not known whether human insulin genuinely impairs the perception of hypoglycaemia. Of 302 randomly selected patients who had lately changed from animal to human insulins, 6% reported diminished awareness ... whereas 3% reported enhanced awareness". This new study will be carefully considered by the steering group and its medical advisers, when appointed. The insulin litigation could be wide-ranging, with potential defendants ranging from the manufacturers (Novo Nordisk, Eli Lilly, and CP Pharmaceuticals) to the prescribing doctors and the Committee on Safety of Medicines in its role as watchdog and "learned intermediary". However, matters are at a very early stage: applications are being processed for the grant of legal aid in individual cases and for a study of medical and legal issues raised.
Other multiple medical negligence/product claims under consideration are claims for side-effects caused by human growth hormone implanted into children with dwarfism and for hepatitis C resulting from contaminated blood used in transfusions. Lawyers who acted for 1200 patients with haemophilia infected with HIV (whose claims were settled out of court by the government for an estimated C82 million) are investigating these new claims. The virus is carried in the blood by 1-2 per 2000 blood donors, the proportion rising tenfold among immigrant populations and inner city residents. Tests for hepatitis C antibody became available from 1989 and most European Community countries and the USA began screening at once. In the UK the National Blood Transfusion Service (NBTS), which handles 2 million donations annually, did not immediately follow suit because it had concerns about the reliability of the test. How far this approach was justified may become the nub of any
626
legal action. The NETS denies that it has been negligent or that it was more concerned about not upsetting the donors than the recipients. "A false positive is just as bad from our point of view as a false negative", said Dr Roger Moore, the NETS deputy national director.3 The Department of Health’s expert committee had in mind the pros and cons of testing with an earlier method when it decided when to start testing for hepatitis C in blood. Potential litigants who have not yet consulted a solicitor but who wish to join a third multiple action-the tranquilliser litigation now under way-will need to hurry. Applications for legal aid must be in by Sept 20, and Mr Justice Ian Kennedy, the High court judge in charge of the litigation, has directed that all proceedings must be served by April 15, 1992.
Diana Brahams 1. Teuscher A. Berger WG. Hypolgycaemia unawareness in diabetics transferred from beef/porcine to human insulin. Lancet 1987; ii: 382-85; Berger W, et al. Warning symptoms of hypoglycaemia during treatment with human and porcine insulin in diabetes mellitus. Lancet 1989; i: 1041-44. 2. Gale EAM. Hypoglycaemia and human insulin. Lancet 1989, ii: 1264-66. 3. Denison S. Patients may sue over hepatitis-C in blood. Independent Aug
7, 1991.
Noticeboard Unplanned pregnancies Sex education must become the principal means for reducing numbers of unwanted pregnancies, according to a new report from the Royal College of Obstetricians and Gynaecologists (RCOG).l Society needs to view abortion not as evidence of sexual promiscuity, says the report, but as proof that a woman wishes to have only planned children. The fear of an unwanted pregnancy among the young and sexually active is real: a recent survey of sexual attitudes among 16-19 years olds identified this concern as the deciding factor in their choice of contraceptive (see Lancet Aug 17, p 440). In response to the rising number of legal abortions, the RCOG established a working party in 1988 to review education about and services available for contraception. The College was especially concerned because the recommendations it gave in 1972 had had little impact. Rates of legal abortion continued to rise slowly, reaching a peak of 181 000 in 1989 and falling slightly in 1990 to 173 000. The increased abortion rate arises mainly from growing numbers of unwanted pregnancies among single women not having a supportive partner, especially those aged under 20. The emphasis on sex education stems from the belief that communication failures between partners lead to inadequate discussion of issues about contraception. Sex education tends to be conducted on an ad-hoc basis, and the College now recommends that it should be made a compulsory part of all teacher training. The implementation of national guidelines on sex education should be reviewed in each school so that parents and education authorities can ensure that schools provide effective tuition. The report also points to the importance of community contraceptive services and postgraduate training as essential parts of the infrastructure that is necessary to reduce the numbers of unwanted pregnancies. The importance of this subject might be reinforced by establishing a new subspecialty of community gynaecology. The pressure on services for termination of pregnancy in the National Health Service is highlighted in the annual report of the Department of Obstetrics and Gynaecology at St George’s Hospital, London.2 923 suction terminations were completed in 1990; 31 patients underwent termination at 12-16 weeks of gestation; and 81 women required late termination at up to 20 weeks. Chamberlain and Barker note their hope that the UK drug regulatory authority will soon license mifepristone for early termination of pregnancy. Requirements for both surgery and
anaesthetic facilities could theoretically be reduced by 90%, and total financial savings to the NHS could amount to 16 million
annually. 1.
Report of the RCOG working party on unplanned pregnancy. London: Royal College of Obstetricians and Gynaecologists, 1991. Pp 64. ISBN 090233154X. Copies obtainable from the RCOG, 27 Sussex Place, Regent’s Park, London NW1 4RG,
UK. 2. Chamberlain
G, Barker G. Annual report of the Department of Obstetrics and Gynaecology, St George’s Hospital, London, 1990.
Medical research in
Europe
BIOMED 1, the European Community biomedical research programme for 1990-94, is expected to receive final approval from the Council of Research Ministers in the next few weeks. This programme follows on from the 4th Medical and Health Research Programme (MHR 4), which ran from 1987-91, and it falls within the EC’s 3rd Framework Programme, which defines the broad priority areas and total budget for all EC scientific research for 1990-94. The budget for BIOMED 1 is 133 million ECUs (approx 87 million), to be allocated over 4 years. A fundamental principle in the implementation of EC programmes is "subsidiarity", by which any research that can be done satisfactorily at national level should not be carried out at European level. Thus applicants seeking funding from BIOMED 1 will have to explain what "added" value is to be obtained from a European project. The main method of support will be by Concerted Actions; here no funding is given for the research itself, but up to 100% support may be granted for exchange of information (eg, through meetings or newsletters) about nationally funded work. Shared-costs contracts are likely to be restricted to the human genome analysis area. The first two of the four areas of BIOMED 1 roll on from MHR 4. Area 1 covers the harmonisation of methodologies and protocols in epidemiological, clinical, and technological research. Particular attention will be paid to study of risk factors and screening, especially in occupational medicine. Area 2, which is the main focus of the programme, will be on novel approaches to tackling health problems of great socioeconomic impact; emphasis will be put om AIDS, cancer, cardiovascular disease, mental illness and neurological disease, and the ageing process and age-related handicaps. Area 3, the Human Genome Analysis Programme, will come under the BIOMED 1 umbrella in June, 1992. Area 4 covers research on biomedical ethics. Final approval of BIOMED 1 will be followed by the production of a detailed work programme indicating the objectives, the range of topics that applications can cover, and types of funding, and by calls for new research proposals. The first call will be for areas 1, 2, and 4 (with closing date likely to be in February, 1992), and the second call will be for area 3. In the mean time the Human Genome Analysis Programme has called for proposals for studies on the ethical, social, and legal aspects of human genome analysis. The studies should focus on the European rather than the national dimension, and proposals should reach the European Commission by Nov 14. Further information on this call or on BIOMED 1 is available from the Commission of the European Communities, DG XI 1/F6,200 rue de la Loi, B-1049 Brussels or from national contact points in EC-member states. In the UK the contact point is the International Section, Medical Research Council, 20 Park Crescent, London WIN 4AL.
Soviet psychiatry The
appointed by the World Psychiatric Association monitor changes in psychiatry in the Soviet Union returned from its 3-week visit to the USSR in June with disappointing news. Although no new cases of political abuse of psychiatry were uncovered, the team notes in its report1 that "large numbers of individuals are still suffering the consequences of erroneous and damaging psychiatric intervention". According to the report, the All Union Society of Psychiatrists and Narcologists, which resigned from the WPA in 1983 rather than be expelled, "bears a major responsibility for remedying this situation and, as yet, has not taken sufficient steps". Dr Jorge Alberto Costa e Silva, chairman of the WPA’s executive committee, concludes that there are "many continuing problems that require monitoring and follow-up". (WPA)
team
to
