- Email: [email protected]
ETHICS OF SCREENING FOR HEPATITIS C VIRUS
1221 have
expected conventionally. Let
survive if
to
had been attacked
Japan
more
forget, members of IPPNW or not, the massive barbarism perpetrated by the Japanese and how that barbarism (see, for example, the Daily Telegraph of Oct 31, 1989) and the further slaughter of those still fighting was spectacularly and almost instantly stopped by the dropping of two brilliantly conceived bombs. I recall nothing but uninhibitedjoy at what in 1945 was such unexpected cause for huge celebrations. Let us not forget, either, that, had it not been for Pearl Harbor and subsequent other unprovoked attacks, the Japanese might never have been visited with the retributions that they and some others seem so to deplore. us never
Crawley Hospital,
H. G. PENMAN
West Sussex RH1 7PH
ASSESSING WORKLOAD IN NEONATAL MEDICINE
SiR,—The UK Government proposes that all medical units be financed on the basis of workload, and an American system, linking reimbursement with diagnostic related groups (DRGs)l is being evaluated. The seven categories allocated to neonatal medicine are: DRG Definitzon 385 386 387 388 389 390 391
Died or transferred to acute care Extreme immaturity/respiratory distress syndrome Prematurity with major problem Prematurity with no major problem Full term with major problem Neonate with other significant problems Normal newborn
We
compared the number of babies in the major workload groups (DRGs 386, 387, and 389) with the number of intensive-care days per annum2 in special-care and neonatal intensive-care units, this information having been collected as part of a larger study of neonatal services in the Trent region. The relation between the two variables is shown in the accompanying figure.
ETHICS OF SCREENING FOR HEPATITIS C VIRUS
SiR,—There have been several reports in The Lancet (Aug 5, pp 294, 297; Sept 30, pp 796-98; Oct 21, p 987) on the seroprevalence of hepatitis C virus (HCV) in various groups of individuals-not only in those at high risk but also in those at low risk, healthy subjects such as pregnant women, hospital staff, and those with previous hepatitis A. I fmd the flurry of enthusiasm for this new test understandable but at the same time ethically disturbing. It is likely that a significantly high proportion of those infected with HCV will not only be infectious to others but also may go on to have chronic, potentially fatal liver disease. The anti-HCV test does not distinguish past infection from carriage, and gives no information on infectivity; thus the interpretation of a positive result will be difficult, with major consequences to the individuals concerned. Have we not learnt from our past and not untroubled experience of testing for blood-borne and sexually transmitted infections such as hepatitis B and HIV? We should be applying the same ethical criteria when testing for HCV as we recommend for these other infections. For example, have the subjects tested so far been informed that they were to be tested, or has any effort been made to inform them of the result and its implications? Are positive patients to be told that they will be regarded as high risk individuals and need to take precautions against the possibility of infecting others, while at the same time never being sure if they truly are infective? A positive test would also compromise life insurance and mortgage cover if insurers apply the same criteria as are undertaken with hepatitis B. Surely pre-test counselling should be considered in the light of these applications? The screening of low-risk populations for evidence of anti-HCV without the availability of confirmatory tests will also result in a high proportion of false-positive to true-positive reactions. It may be that many of these questions will be resolved with the advent of specific assays to detect antigen and identify those who remain infected. Nevertheless, the uncertainties point to the need for a more careful and considered approach to widespread antibody testing, especially in low-risk groups, and I hope this is taken into account before more people jump onto the HCV testing bandwagon. Infectious Diseases Unit,
City Hospital, Edinburgh EH10 5SB
PETER J. FLEGG
HEPATITIS C VIRUS INFECTION AND LIVER TRANSPLANTATION
SIR,-Reports of the detection of antibodies directed against a recombinant polypeptide of hepatitis C virus (HCV) in human serum have shown that HCV is the most frequent transfusionhepatitis-associated viral agent.1,2 In the United States, over 90% of transfusion-hepatitis cases have been attributed to HCV infection.
Number of Babies
Intensive
ITU
=
care
(DRGs 386, 387, 389)
days plotted against number of babies. special-care baby unit.
intensive-care unit; SCBU
=
The results show an alarming disparity. If reimbursement was based on this system, the major centres would receive about twice as much as the smaller units but would be responsible for five to ten times more work. These findings have major implications for neonatal care and, possibly, other branches of medicine. We recommend careful
prospective pilot
studies
the use of reimbursement days per annum per
assessing
DRGs in all specialties. For neonatal medicine system based on the number of intensive unit would be better.
care
a
Department of Child Health, University of Leicester, Clinical Sciences Building, Leicester Royal Infirmary, Leicester LE2 7LX 1. DRGs:
P. CHETCUTI DAVID J. FIELD
Diagnosis related groups, 5th revision (definitions manual). Connecticut: Health Systems International, 1988 2.British Paediatric Association/British Association for Perinatal Paediatrics. Categories of babies requiring neonatal care. London: BPA/BAPP, 1984.
Polytransfused patients, haemophiliacs, patients having haemodialysis and operations, and drug addicts are the groups most exposed to transfusion hepatitis. Patients having organ transplantation,3particularly liver transplantation, are at high risk of transfusion hepatitis because of the large amount of blood used. We have retrospectively measured antibodies to HCV (Ortho HCV antibody ELISA) in serum before liver transplantation in 62 (90%) out of 69 liver transplanted patients; 13 (21 %) patients proved to be anti-HCV positive, 2 of whom had cryptogenic cirrhosis, 4 liver cancer (3 with cirrhosis), 3 post-hepatitis-B cirrhosis, 2 biliary atresia, 1 primary biliary cirrhosis, 1 fulminant hepatitis. In 37 (60%) patients with a post-transplantation followmonths, anti-HCV titre was measured at various times before, during, and after the presumed incubation period of HCV after transplantation. In this group 6 (16%) were positive before transplantation, 2 of whom remained positive afterwards, and 4 of whom became negative from four to ten months after transplantation. In 3 (8%) patients who were anti-HCV-negative before transplantation, anti-HCV was detected in serum at four, six, and seven months after operation. 2 of these patients had increases in liver necrosis enzymes at the time of their positive anti-HCV test, and 1 had liver biopsy results suggestive of non-A, non-B hepatitis. Blood and blood-derivates use did not differ between patients who seroconverted and those who did not after transplantation. up of at least six
expected conventionally. Let
survive if
to
had been attacked
Japan
more
forget, members of IPPNW or not, the massive barbarism perpetrated by the Japanese and how that barbarism (see, for example, the Daily Telegraph of Oct 31, 1989) and the further slaughter of those still fighting was spectacularly and almost instantly stopped by the dropping of two brilliantly conceived bombs. I recall nothing but uninhibitedjoy at what in 1945 was such unexpected cause for huge celebrations. Let us not forget, either, that, had it not been for Pearl Harbor and subsequent other unprovoked attacks, the Japanese might never have been visited with the retributions that they and some others seem so to deplore. us never
Crawley Hospital,
H. G. PENMAN
West Sussex RH1 7PH
ASSESSING WORKLOAD IN NEONATAL MEDICINE
SiR,—The UK Government proposes that all medical units be financed on the basis of workload, and an American system, linking reimbursement with diagnostic related groups (DRGs)l is being evaluated. The seven categories allocated to neonatal medicine are: DRG Definitzon 385 386 387 388 389 390 391
Died or transferred to acute care Extreme immaturity/respiratory distress syndrome Prematurity with major problem Prematurity with no major problem Full term with major problem Neonate with other significant problems Normal newborn
We
compared the number of babies in the major workload groups (DRGs 386, 387, and 389) with the number of intensive-care days per annum2 in special-care and neonatal intensive-care units, this information having been collected as part of a larger study of neonatal services in the Trent region. The relation between the two variables is shown in the accompanying figure.
ETHICS OF SCREENING FOR HEPATITIS C VIRUS
SiR,—There have been several reports in The Lancet (Aug 5, pp 294, 297; Sept 30, pp 796-98; Oct 21, p 987) on the seroprevalence of hepatitis C virus (HCV) in various groups of individuals-not only in those at high risk but also in those at low risk, healthy subjects such as pregnant women, hospital staff, and those with previous hepatitis A. I fmd the flurry of enthusiasm for this new test understandable but at the same time ethically disturbing. It is likely that a significantly high proportion of those infected with HCV will not only be infectious to others but also may go on to have chronic, potentially fatal liver disease. The anti-HCV test does not distinguish past infection from carriage, and gives no information on infectivity; thus the interpretation of a positive result will be difficult, with major consequences to the individuals concerned. Have we not learnt from our past and not untroubled experience of testing for blood-borne and sexually transmitted infections such as hepatitis B and HIV? We should be applying the same ethical criteria when testing for HCV as we recommend for these other infections. For example, have the subjects tested so far been informed that they were to be tested, or has any effort been made to inform them of the result and its implications? Are positive patients to be told that they will be regarded as high risk individuals and need to take precautions against the possibility of infecting others, while at the same time never being sure if they truly are infective? A positive test would also compromise life insurance and mortgage cover if insurers apply the same criteria as are undertaken with hepatitis B. Surely pre-test counselling should be considered in the light of these applications? The screening of low-risk populations for evidence of anti-HCV without the availability of confirmatory tests will also result in a high proportion of false-positive to true-positive reactions. It may be that many of these questions will be resolved with the advent of specific assays to detect antigen and identify those who remain infected. Nevertheless, the uncertainties point to the need for a more careful and considered approach to widespread antibody testing, especially in low-risk groups, and I hope this is taken into account before more people jump onto the HCV testing bandwagon. Infectious Diseases Unit,
City Hospital, Edinburgh EH10 5SB
PETER J. FLEGG
HEPATITIS C VIRUS INFECTION AND LIVER TRANSPLANTATION
SIR,-Reports of the detection of antibodies directed against a recombinant polypeptide of hepatitis C virus (HCV) in human serum have shown that HCV is the most frequent transfusionhepatitis-associated viral agent.1,2 In the United States, over 90% of transfusion-hepatitis cases have been attributed to HCV infection.
Number of Babies
Intensive
ITU
=
care
(DRGs 386, 387, 389)
days plotted against number of babies. special-care baby unit.
intensive-care unit; SCBU
=
The results show an alarming disparity. If reimbursement was based on this system, the major centres would receive about twice as much as the smaller units but would be responsible for five to ten times more work. These findings have major implications for neonatal care and, possibly, other branches of medicine. We recommend careful
prospective pilot
studies
the use of reimbursement days per annum per
assessing
DRGs in all specialties. For neonatal medicine system based on the number of intensive unit would be better.
care
a
Department of Child Health, University of Leicester, Clinical Sciences Building, Leicester Royal Infirmary, Leicester LE2 7LX 1. DRGs:
P. CHETCUTI DAVID J. FIELD
Diagnosis related groups, 5th revision (definitions manual). Connecticut: Health Systems International, 1988 2.British Paediatric Association/British Association for Perinatal Paediatrics. Categories of babies requiring neonatal care. London: BPA/BAPP, 1984.
Polytransfused patients, haemophiliacs, patients having haemodialysis and operations, and drug addicts are the groups most exposed to transfusion hepatitis. Patients having organ transplantation,3particularly liver transplantation, are at high risk of transfusion hepatitis because of the large amount of blood used. We have retrospectively measured antibodies to HCV (Ortho HCV antibody ELISA) in serum before liver transplantation in 62 (90%) out of 69 liver transplanted patients; 13 (21 %) patients proved to be anti-HCV positive, 2 of whom had cryptogenic cirrhosis, 4 liver cancer (3 with cirrhosis), 3 post-hepatitis-B cirrhosis, 2 biliary atresia, 1 primary biliary cirrhosis, 1 fulminant hepatitis. In 37 (60%) patients with a post-transplantation followmonths, anti-HCV titre was measured at various times before, during, and after the presumed incubation period of HCV after transplantation. In this group 6 (16%) were positive before transplantation, 2 of whom remained positive afterwards, and 4 of whom became negative from four to ten months after transplantation. In 3 (8%) patients who were anti-HCV-negative before transplantation, anti-HCV was detected in serum at four, six, and seven months after operation. 2 of these patients had increases in liver necrosis enzymes at the time of their positive anti-HCV test, and 1 had liver biopsy results suggestive of non-A, non-B hepatitis. Blood and blood-derivates use did not differ between patients who seroconverted and those who did not after transplantation. up of at least six