1212
Health insurance, HIV testing, and
genetic
risk SiR,—The conflict of interest between public health and private insurance based on health risk has been highlighted by attempts to prevent insurance companies calculating risk on the basis of testing for HIV and genetic risk. The UK Minister for Health, Mrs Virginia Bottomley, and Sir Donald Acheson, former Chief Medical Officer, appealed to the Association of British Insurers to remember their duty to the public and to stop regarding an individual with a negative HIV test as being at increased risk.1 Faced with much the same difficulty with genetic risk, the Danish Parliament has banned the use of genetic information on insurance assessmentsBaroness Warnock has called for UK legislation to 3 prevent life insurance companies from requiring genetic screening,3 and the Dutch insurance industry, preferring self-regulation to legislation, has promised that insurance will not depend on readiness to submit to a genetic examination or on divulging genetic risks that are already known.4 The public health argument is that insurance company questions discourage people from coming forward for testing, contravene respect for privacy, and discriminate against individuals who are not in a position to reduce their risk (as compared with, for example, smokers, who are). Consent to inclusion on genetic and disease registers may also be affected. It is unrealistic to expect insurance companies to change their practice. They may agree to token concessions for the sake of public relations, but their duty to their shareholders is to make a profit, not to improve health, respect privacy, or protect the innocent. The present negotiations for making special exceptions will not resolve the wider issue. Where do you draw the line? Many individuals with increased health risk cannot obtain a mortgage, or life insurance to provide for their family’s future. The long-term structural solution can only be to decrease society’s dependence on health-based private insurance and increase our mutual insurance through taxation. The higher the standard of health care, education, and social security financed from taxation, the lower will be the financial disadvantage for individuals unable to obtain health-based private insurance. Wolfson Child Health Monitoring Unit, Division of Public Health, Institute of Child Health, London WC1N 1EH, UK
CAROLINE WOODROFFE
1. Anonymous. Insuring against AIDS. Lancet 1991; 338: 306. 2. Anonymous. Proposed ban on genetic testing m Denmark. Lancet 1991; 337: 1340. 3. Connor S. Legislation urged to control genetic screening by firms. Independent Aug 23,
1991, p 8. Question
no 566/90. 207/42. Aug 20, 1990.
4. Written
Official
Journal of the European Communities,
no
C
Regulation of assay kits SIR,-It is almost 15 years since the Nobel prize for medicine was awarded for the development of immunoassays for hormones. Now, diagnostic laboratories in virtually every district general hospital in the UK are using this technology to measure hormones and other substances of clinical importance. However, few laboratories use reagents and methods over which they have control; the market is dominated by commercial kits and, increasingly, by those that are linked to dedicated machines. The users, and clinicians and patients are thus dependent on the validity, ruggedness, and consistency of the kits and the integrity of the manufacturers. This is an inadequately regulated industry. There is a growing list of examples where a manufacturer alters a key component of the assay system (eg, an antiserum) or reformulates or recalibrates the kit, with a consequential effect on assay performance and the results obtained in the diagnostic laboratory. Unless such a change is carefully introduced an individual patient’s result may be interpreted against an inappropriate reference ("normal") range, with the risk of misdiagnosis and mismanagement. For example, "recalibration" of an a-fetoprotein kit produced a 10% change in estimates but this was not made known to users for almost 3 months despite the need for accurate measurement in the sensitive area
of prenatal diagnosis of neural tube defects and Down syndrome. For diagnostic kits, unlike pharmaceutical products, there is no formal system for product licensing or for inspection of premises, products, or data and no requirement for manufacturers to provide evidence on validation or to justify, or even inform on, variations in the method. The UK trade organization, the British Laboratory Ware Association, has recently taken a small step forward and produced, in conjunction with the Medical Devices Directorate of the Department of Health and the UK National External Quality Assessment Scheme, a code of practice for handling changes to diagnostic kits. Unfortunately this code is voluntary and may not be strong enough. Extra pressures come from the prospect of laboratory accreditation and the rigid standardisation beloved of certain European bodies, and, in the UK, from the continuing erosion of the disciplines of chemical pathology and clinical biochemistry and the laboratory/clinical interface. Something must be done, and soon, if the public health is to be protected. National Institute for Biological Standards and Control, South Mimms EN6 3QG, UK
S. L.
JEFFCOATE
Asylum seekers in British prisons SIR,-Newspaper coverage of the recent death of a Zairean asylum seeker held in Pentonville prison has drawn attention to protests by the Prison Officers Association about the routine detention of refugees, some of whom are psychologically disturbed, in what the association called wholly inappropriate conditions.’ The criminalisation of refugees in this way, which is in breach of guidelines of the United Nations High Commission for Refugees, was addressed by us in a letter to The Lancet (July 6, p 58). Such detention is at its most unjust and cruel when there is a history of We have received messages of support from the President of the Royal College of Psychiatrists, whose Special Committee on Unethical Psychiatric Practices discussed the issue, and by the Professional, Scientific, and International Affairs Division of the British Medical Association, and the medical section of Amnesty International. Government proposals to restrict further the rights of asylum seekers in the UK do not suggest that the use of prisons and detention centres, which is clearly intended to serve as a kind of deterrent, is to be reduced. In fact, we are concerned that the proposed fast-track procedures and restrictions on legal advice will compound the confusion and distress of these already traurnatised torture.
people and, furthermore, complicate psychiatric assessments. Issues relating to correct management, including medical treatment, of refugees who may be psychologically disturbed raise ethical questions for attending doctors and, as we now see, for prison officers
as
well.
Medical Foundation for the Care of Victims of Torture, 96-98 Grafton Road, London NW5 3EJ, UK 1.
CAROLINE GORST-UNSWORTH DEREK SUMMERFIELD
Guardian, Oct 12, 1991, p 2.
Community health care in Kenya SIR,-Malcolm Dean’s July 13 article from Nairobi provides a valuable perspective on the difficulties of health service delivery and health awareness education in the semi-arid and arid areas of Kenya. Additional perspective is needed, however. We know1,2 that in densely populated areas of Kenya (50-400 or more people per square km) the cost of fielding a community health worker (CHW) is measured in hundreds of pounds per year, and that the cost per contact between CHW and a neighbour household is jC2-3 per contact. These figures are based on tens of thousands of such visits. Typically, these costs are, in decreasing order of magnitude: salaries (of supervisory and training staff), transport (mainly of supervisory staff), and training. This compares with a cost of about 1 for a patient to visit a nurse at a clinic1,2 or for a mobile clinic contact between nurse and client. The best training programmes for CHWs achieve 200 classroom hours compared
Health insurance, HIV testing, and
genetic
risk SiR,—The conflict of interest between public health and private insurance based on health risk has been highlighted by attempts to prevent insurance companies calculating risk on the basis of testing for HIV and genetic risk. The UK Minister for Health, Mrs Virginia Bottomley, and Sir Donald Acheson, former Chief Medical Officer, appealed to the Association of British Insurers to remember their duty to the public and to stop regarding an individual with a negative HIV test as being at increased risk.1 Faced with much the same difficulty with genetic risk, the Danish Parliament has banned the use of genetic information on insurance assessmentsBaroness Warnock has called for UK legislation to 3 prevent life insurance companies from requiring genetic screening,3 and the Dutch insurance industry, preferring self-regulation to legislation, has promised that insurance will not depend on readiness to submit to a genetic examination or on divulging genetic risks that are already known.4 The public health argument is that insurance company questions discourage people from coming forward for testing, contravene respect for privacy, and discriminate against individuals who are not in a position to reduce their risk (as compared with, for example, smokers, who are). Consent to inclusion on genetic and disease registers may also be affected. It is unrealistic to expect insurance companies to change their practice. They may agree to token concessions for the sake of public relations, but their duty to their shareholders is to make a profit, not to improve health, respect privacy, or protect the innocent. The present negotiations for making special exceptions will not resolve the wider issue. Where do you draw the line? Many individuals with increased health risk cannot obtain a mortgage, or life insurance to provide for their family’s future. The long-term structural solution can only be to decrease society’s dependence on health-based private insurance and increase our mutual insurance through taxation. The higher the standard of health care, education, and social security financed from taxation, the lower will be the financial disadvantage for individuals unable to obtain health-based private insurance. Wolfson Child Health Monitoring Unit, Division of Public Health, Institute of Child Health, London WC1N 1EH, UK
CAROLINE WOODROFFE
1. Anonymous. Insuring against AIDS. Lancet 1991; 338: 306. 2. Anonymous. Proposed ban on genetic testing m Denmark. Lancet 1991; 337: 1340. 3. Connor S. Legislation urged to control genetic screening by firms. Independent Aug 23,
1991, p 8. Question
no 566/90. 207/42. Aug 20, 1990.
4. Written
Official
Journal of the European Communities,
no
C
Regulation of assay kits SIR,-It is almost 15 years since the Nobel prize for medicine was awarded for the development of immunoassays for hormones. Now, diagnostic laboratories in virtually every district general hospital in the UK are using this technology to measure hormones and other substances of clinical importance. However, few laboratories use reagents and methods over which they have control; the market is dominated by commercial kits and, increasingly, by those that are linked to dedicated machines. The users, and clinicians and patients are thus dependent on the validity, ruggedness, and consistency of the kits and the integrity of the manufacturers. This is an inadequately regulated industry. There is a growing list of examples where a manufacturer alters a key component of the assay system (eg, an antiserum) or reformulates or recalibrates the kit, with a consequential effect on assay performance and the results obtained in the diagnostic laboratory. Unless such a change is carefully introduced an individual patient’s result may be interpreted against an inappropriate reference ("normal") range, with the risk of misdiagnosis and mismanagement. For example, "recalibration" of an a-fetoprotein kit produced a 10% change in estimates but this was not made known to users for almost 3 months despite the need for accurate measurement in the sensitive area
of prenatal diagnosis of neural tube defects and Down syndrome. For diagnostic kits, unlike pharmaceutical products, there is no formal system for product licensing or for inspection of premises, products, or data and no requirement for manufacturers to provide evidence on validation or to justify, or even inform on, variations in the method. The UK trade organization, the British Laboratory Ware Association, has recently taken a small step forward and produced, in conjunction with the Medical Devices Directorate of the Department of Health and the UK National External Quality Assessment Scheme, a code of practice for handling changes to diagnostic kits. Unfortunately this code is voluntary and may not be strong enough. Extra pressures come from the prospect of laboratory accreditation and the rigid standardisation beloved of certain European bodies, and, in the UK, from the continuing erosion of the disciplines of chemical pathology and clinical biochemistry and the laboratory/clinical interface. Something must be done, and soon, if the public health is to be protected. National Institute for Biological Standards and Control, South Mimms EN6 3QG, UK
S. L.
JEFFCOATE
Asylum seekers in British prisons SIR,-Newspaper coverage of the recent death of a Zairean asylum seeker held in Pentonville prison has drawn attention to protests by the Prison Officers Association about the routine detention of refugees, some of whom are psychologically disturbed, in what the association called wholly inappropriate conditions.’ The criminalisation of refugees in this way, which is in breach of guidelines of the United Nations High Commission for Refugees, was addressed by us in a letter to The Lancet (July 6, p 58). Such detention is at its most unjust and cruel when there is a history of We have received messages of support from the President of the Royal College of Psychiatrists, whose Special Committee on Unethical Psychiatric Practices discussed the issue, and by the Professional, Scientific, and International Affairs Division of the British Medical Association, and the medical section of Amnesty International. Government proposals to restrict further the rights of asylum seekers in the UK do not suggest that the use of prisons and detention centres, which is clearly intended to serve as a kind of deterrent, is to be reduced. In fact, we are concerned that the proposed fast-track procedures and restrictions on legal advice will compound the confusion and distress of these already traurnatised torture.
people and, furthermore, complicate psychiatric assessments. Issues relating to correct management, including medical treatment, of refugees who may be psychologically disturbed raise ethical questions for attending doctors and, as we now see, for prison officers
as
well.
Medical Foundation for the Care of Victims of Torture, 96-98 Grafton Road, London NW5 3EJ, UK 1.
CAROLINE GORST-UNSWORTH DEREK SUMMERFIELD
Guardian, Oct 12, 1991, p 2.
Community health care in Kenya SIR,-Malcolm Dean’s July 13 article from Nairobi provides a valuable perspective on the difficulties of health service delivery and health awareness education in the semi-arid and arid areas of Kenya. Additional perspective is needed, however. We know1,2 that in densely populated areas of Kenya (50-400 or more people per square km) the cost of fielding a community health worker (CHW) is measured in hundreds of pounds per year, and that the cost per contact between CHW and a neighbour household is jC2-3 per contact. These figures are based on tens of thousands of such visits. Typically, these costs are, in decreasing order of magnitude: salaries (of supervisory and training staff), transport (mainly of supervisory staff), and training. This compares with a cost of about 1 for a patient to visit a nurse at a clinic1,2 or for a mobile clinic contact between nurse and client. The best training programmes for CHWs achieve 200 classroom hours compared
