238
more than medicine on a large scale") as for his famous Cellular Pathology. The presumption in Virchow’s analysis is that appreciation of social pathology is fundamental to understanding of disease prevalence. His report detailed the oppression of the Polish-speaking inhabitants by the Prussian landowners and bureaucracy, which he saw as the source of their poverty, starvation, and illness. Virchow did not record congenital defects or dermatological disorders or high concentrations of lead or cadmium in the blood: he made his case for social circumstances as the causal factors by pointing out that clergymen, doctors, and the landlords did not contract typhus to the extent that peasants did. Norska-Borówka’s account deals with the same geography. A current map shows Virchow’s Ratibor as Racibor, Gleiwitz as Gliwice. Norska-Borowska’s epidemiological analysis proposes "a declared ecological disaster", and blames air and soil pollution, the result of unregulated industrial development. She does not mention official neglect, but one cannot overlook the parallels. In 1879 Virchow noted that matters in Upper Silesia had hardly improved since his report thirty years earlier. Still, it came as a shock to find things so little changed in 1990. The governance is different (Upper Silesia is now Polish, not Prussian) but a century and a half of industrial development has apparently made little impact on the wretched life of that province-if anything it has created a new source of ills. Upper Silesia is hardly unique in this regard. We do not have to look far within the United States to find pockets of continuing or recurrent disadvantage. How are we to assess the source of the continuity--or the recurrence-of social pathology? Social medicine now centres on the environment. Are the ecoepidemiologists overlooking other crucial factors, even as the microbially focused epidemiologists overlooked the environmental factors for so many years? The story of Upper Silesia is another indication that we need to rethink "social" diagnosis and "social"
nothing
treatment. Yale University School of Medicine, 590 Ellsworth Avenue, New Haven, CT 06511, USA
George Silver
Medicine and the Law Haemophilic AIDS patient loses claim
in
Australia On Jan 4,1990, the plaintiffclaim in a case brought against Australian children’s hospital and others was dismissed by Mr Justice Badgery-Parker in the Supreme Court of New South Wales. The evidence focused on scientific knowledge and standards of practice in the early period of the spread of HIV. Awareness of the dangers of HIVcontaminated blood products led, too slowly some argue, to an
improvements
in the
testing
of donors and in the
manufacture of blood products. Any future litigation is likely to be concerned with the period during which contaminated products continued to be used when purer products were or should have been available. In August, 1980, a 7-year-old boy in Sydney was diagnosed as having mild haemophilia A (factor VIII level 10-50%). In April and June, 1981, he was treated at the
Royal Alexandra Hospital for Children with antihaemophilic factor (AHF) VIII, probably as powdered factor VIII concentrate rather than cryoprecipitate. In March, 1982, and in September, 1983, joint swellings necessitated further factor VIIItreatments. In early 1985 he was treated for what seemed to be an upper-respiratorytract infection but in June of that year HIV infection was diagnosed. This proceeded to AIDS, and in October, 1989, the boy’s life expectancy was put at 12 months. The boy sued the hospital; the Commonwealth Serum Laboratories, which manufactured concentrate given in 1982 and 1983; which manufactured the in and supplied all blood 1982 cryoprecipitate given The claim was based on the to the hospital. products alternative hypotheses that the patient had been infected in March, 1982, or September, 1983. and
the
blood
bank,
Case against manufacturers and blood bank The judge accepted that all three defendants owed a duty of care, and it was well-recognised that blood and blood products could transmit blood-borne viruses. The judge said that "The risk in March, 1982, could fairly be described as slight or remote though by no means far-fetched or fanciful. By September, 1983, the risk was rather more substantial". However, before March, 1982, there was no evidence that the exclusion of donors known to be at high risk for hepatitis B could have been seen as an effective method of screening out likely carriers of unrecognised viruses. Thus neither the blood bank, in failing to exclude homosexuals or other risk groups from the donor pool before March, 1982, or the manufacturer, in accepting plasma from such a donor pool, were negligent. The judge cited the 1988 US case of Jones v Miles Laboratories Inc in concluding that there was no reasonable prospect that questioning donors before March, 1982, would have eliminated donors from high-risk groups. People found to be or admitting to being intravenous drug users were ruled out but no other steps were taken. In Jones, a donor had disclosed to his doctor, just before he died of AIDS, that he was a homosexual. He had donated blood many times and from 1983 had been asked if he was a homosexual, but denied it every time, and when asked to sign a form to that effect he did so. The donation of blood in Australia is voluntary and the expert evidence was that it was that there should be no barriers to donation "unless there was a strong reason". The judge said that with hindsight exclusion of homosexuals would probably have eliminated from the donor pool most donors likely at that time to be carrying HIV-but that could not have been known before 1982. Screening began in some parts of the USA at the end of 1982 and was extended during 1983 but there did not seem to have been "a consensus as to what group should be excluded". From January to September, 1983, male homosexuals in Sydney were asked, via the media and in other ways, not to donate blood. Some homosexuals complained of unfair discrimination, and Sydney’s blood transfusion centres were picketed. Eventually guidelines for self-exclusion were agreed, and risk groups included people with signs and symptoms indicative of AIDS, sexually active homosexual men with multiple partners, intravenous drug abusers, and the sexual partners of such individuals. At a meeting in May, 1983, a working party of the Australian Red Cross Society confirmed this approach. The judge said that this policy was reasonable even though there were those in the USA who would have excluded all homosexuals. "... there was responsible opinion in support of the view that the risk increased with the number of sexual partners, and that the high risk group comprised the promiscuous homosexuals." The judge found that the plaintiff had not established that there was anything more that could and should have been done by the blood bank during January to September, 1983, and that it was reasonable for the manufacturer to have continued to accept plasma from blood banks without demanding more
stringent screening.
The evidence did not suggest that withdrawal
or
recall of factor
239
before donor screening was introduced was a measure. Nor were the defendants and reasonable practicable negligent in failing to use surrogate tests to exclude HIV-infected blood. By March, 1982, the defendants knew that hepatitis and other infections could be transmitted by factor VIIII (and soon after 1983 they knew that HIV might also be transmitted) but any warnings on products would be for doctors, not patients, and the doctors responsible for the boy’s care were well aware of those risks. The manufacturer’s products did carry a warning about hepatitis but not about AIDS risk. Although by 1983 such a failure indicated lack of reasonable care such a warning would not have altered the attitude of the doctors who gave the products for the treatment of joint bleeds.
VIII
preparations
Case against hospital The judge was satisfied that the administration of AHF was appropriate. The no-treatment option claimed by the plaintiff was not realistic. Desmopressin had been shown to be ineffective in this case and its further use would have been inappropriate. It would not have been practicable for the hospital to insist that it be supplied with AHF manufactured solely from plasma derived from a more completely screened pool. There was reason, in the USA at least, to assume that the risk of infection from concentrate was greater than the risk from cryoprecipitate. Australian haematologists felt that both locally produced products were safer than those in the USA, and that, clinically, the concentrate was superior. It was not reasonable to expect doctors to warn patients of the remote risk of infection by an unknown virus. It was probable that in 1980 the boy’s parents had been told in general terms of the slight risk of infection from blood products; and the doctor’s duty of care did not oblige him to repeat warnings subsequently. However, by September, 1983, the position had changed. There was a material risk of which the parents had not been previously warned. They should have been told about the AIDS risk but were not-and the absence of such a warning amounted to negligence. However, the judge decided, in the light of the parents’ previous experience and their confidence in the haematologist, that the plaintiff had failed to establish that treatment with AHF would not have been consented to even if such a warning had been given in September, 1983.
composition was patented. A biotechnology company bought the cell line for$3 million, and when the patient found out what had become of his body tissue (he had not given permission for the spleen to be used for research) he claimed damages.2 Both parties see the High Court findings as a victory. Although the ruling is binding only within California, it has set a precedent. The case (which began in 1984) has been closely followed by biotechnology firms. It has also prompterd debate on whether doctors should disclose a financial interest in the treatment of patients. Some doctors think that if this were required, some Americans might be tempted to try to sell thier body parts. One British university student I know was given a week’s free lodging by an old lady last summer in return for a pint of blood. The sale of organs or body tissue, unless prohibited, could emerge in a free-market economy. In the UK the sale of kidneys by impoverished Turks led to the hasty criminalisation of such activities and the disciplining of the clinicians involved. Until the Californian decision there were no legal guidelines on the responsibility and rights of firms engaged in research on human cells. The patient did win the right to sue his doctor for breach of trust because he had not been told about the research despite being recalled for blood tests several times after the operation. The Californian court has ruled that doctors must tell their patients in advance of an operation if they intend to use cells for research and must list the potential uses to which the material is to be put; in this way the patient would have the opportunity to negotiate a fee with a
drug company. In the UK the General Medical Council cautions on the need for
prior disclosure to the patient if a doctor has a financial interests in institutions where he plans to refer a patient, and deals with a doctor’s relationships with the pharmaceutical and allied industries. The GMC may now wish to add some guidance on the use of body tissue for research, perhaps on an analogy with its advice about the use
of fetal tissue.
Diana Brahams 1. Ellicott S. US court rules on removed body tissue. Times July 2. Brahams D. A disputed spleen. Lancet 1988; ii: 1151.
11, 1990.
Date of infection no contemporaneous serological tests were done in on the likely incubation period, the fact that the evidence 1982, had had patient symptoms consistent with a seroconversion in April, 1982, and the probability against the 1982 batches of concentrate having been contaminated suggested infection via cryoprecipitate in March, 1982.
Although
Comment In Britain, a group action is being brought by haemophiliac patients and their dependants, partners, and others infected with HIV through contaminated blood products. This Australian case, though not binding, will clearly be persuasive in respect of the period covered. H v Royal Alexandra Hospital for Children, Commonwealth Serum Laboratories Commission and the Australian Red Cross (NSW Division) (1990)1 MLR 297.
Diana Brahams
Ownership of a spleen Earlier this month, a High Court in California ruled that a patient did not hold the rights to body tissue removed in an
operation and later used to develop new treatments.1 The patient, with hairy cell leukaemia, had had his grossly enlarged spleen removed in 1976. His doctor, David Golde, and colleagues had found the cells to be unique and their
Obituary Derek Hobson
lately reader in medical microbiology at Liverpool University, and honorary consultant microbiologist at the Royal Liverpool Hospital, died on June 3, aged 66. He was in Seattle, USA, on a visit with his wife to one of their daughters and her family. Dr Derek Hobson,
Derek Hobson, a graduate of Sheffield University, started his research career at St Mary’s Hospital, London, and was awarded an MD with distinction in 1956 for work on experimental typhoid in the mouse. He returned to Sheffield in 1958 to join the virologists in Charles Stuart-Harris’s department who contributed so much to our knowledge of respiratory tract virus infections. Derek concentrated on influenza and brought this interest to Liverpool when appointed senior lecturer in 1964. He was particularly interested in the role of antibody to different viral components in influenza immunity and in the virulence of influenza virus. He was a member of the MRC Committee that organised and evaluated important trials of various influenza vaccines. In the early 1970s he turned his attention to chlamydia. The methods he developed for detecting human chlamydia in cell cultures and for assay of their antibiotic sensitivity helped clinical colleagues to establish the importance of chlamydia as causes of ophthalmia neonatorum and non-specific urethritis and to lay down guidelines for rational therapy.
D. Baxby
more than medicine on a large scale") as for his famous Cellular Pathology. The presumption in Virchow’s analysis is that appreciation of social pathology is fundamental to understanding of disease prevalence. His report detailed the oppression of the Polish-speaking inhabitants by the Prussian landowners and bureaucracy, which he saw as the source of their poverty, starvation, and illness. Virchow did not record congenital defects or dermatological disorders or high concentrations of lead or cadmium in the blood: he made his case for social circumstances as the causal factors by pointing out that clergymen, doctors, and the landlords did not contract typhus to the extent that peasants did. Norska-Borówka’s account deals with the same geography. A current map shows Virchow’s Ratibor as Racibor, Gleiwitz as Gliwice. Norska-Borowska’s epidemiological analysis proposes "a declared ecological disaster", and blames air and soil pollution, the result of unregulated industrial development. She does not mention official neglect, but one cannot overlook the parallels. In 1879 Virchow noted that matters in Upper Silesia had hardly improved since his report thirty years earlier. Still, it came as a shock to find things so little changed in 1990. The governance is different (Upper Silesia is now Polish, not Prussian) but a century and a half of industrial development has apparently made little impact on the wretched life of that province-if anything it has created a new source of ills. Upper Silesia is hardly unique in this regard. We do not have to look far within the United States to find pockets of continuing or recurrent disadvantage. How are we to assess the source of the continuity--or the recurrence-of social pathology? Social medicine now centres on the environment. Are the ecoepidemiologists overlooking other crucial factors, even as the microbially focused epidemiologists overlooked the environmental factors for so many years? The story of Upper Silesia is another indication that we need to rethink "social" diagnosis and "social"
nothing
treatment. Yale University School of Medicine, 590 Ellsworth Avenue, New Haven, CT 06511, USA
George Silver
Medicine and the Law Haemophilic AIDS patient loses claim
in
Australia On Jan 4,1990, the plaintiffclaim in a case brought against Australian children’s hospital and others was dismissed by Mr Justice Badgery-Parker in the Supreme Court of New South Wales. The evidence focused on scientific knowledge and standards of practice in the early period of the spread of HIV. Awareness of the dangers of HIVcontaminated blood products led, too slowly some argue, to an
improvements
in the
testing
of donors and in the
manufacture of blood products. Any future litigation is likely to be concerned with the period during which contaminated products continued to be used when purer products were or should have been available. In August, 1980, a 7-year-old boy in Sydney was diagnosed as having mild haemophilia A (factor VIII level 10-50%). In April and June, 1981, he was treated at the
Royal Alexandra Hospital for Children with antihaemophilic factor (AHF) VIII, probably as powdered factor VIII concentrate rather than cryoprecipitate. In March, 1982, and in September, 1983, joint swellings necessitated further factor VIIItreatments. In early 1985 he was treated for what seemed to be an upper-respiratorytract infection but in June of that year HIV infection was diagnosed. This proceeded to AIDS, and in October, 1989, the boy’s life expectancy was put at 12 months. The boy sued the hospital; the Commonwealth Serum Laboratories, which manufactured concentrate given in 1982 and 1983; which manufactured the in and supplied all blood 1982 cryoprecipitate given The claim was based on the to the hospital. products alternative hypotheses that the patient had been infected in March, 1982, or September, 1983. and
the
blood
bank,
Case against manufacturers and blood bank The judge accepted that all three defendants owed a duty of care, and it was well-recognised that blood and blood products could transmit blood-borne viruses. The judge said that "The risk in March, 1982, could fairly be described as slight or remote though by no means far-fetched or fanciful. By September, 1983, the risk was rather more substantial". However, before March, 1982, there was no evidence that the exclusion of donors known to be at high risk for hepatitis B could have been seen as an effective method of screening out likely carriers of unrecognised viruses. Thus neither the blood bank, in failing to exclude homosexuals or other risk groups from the donor pool before March, 1982, or the manufacturer, in accepting plasma from such a donor pool, were negligent. The judge cited the 1988 US case of Jones v Miles Laboratories Inc in concluding that there was no reasonable prospect that questioning donors before March, 1982, would have eliminated donors from high-risk groups. People found to be or admitting to being intravenous drug users were ruled out but no other steps were taken. In Jones, a donor had disclosed to his doctor, just before he died of AIDS, that he was a homosexual. He had donated blood many times and from 1983 had been asked if he was a homosexual, but denied it every time, and when asked to sign a form to that effect he did so. The donation of blood in Australia is voluntary and the expert evidence was that it was that there should be no barriers to donation "unless there was a strong reason". The judge said that with hindsight exclusion of homosexuals would probably have eliminated from the donor pool most donors likely at that time to be carrying HIV-but that could not have been known before 1982. Screening began in some parts of the USA at the end of 1982 and was extended during 1983 but there did not seem to have been "a consensus as to what group should be excluded". From January to September, 1983, male homosexuals in Sydney were asked, via the media and in other ways, not to donate blood. Some homosexuals complained of unfair discrimination, and Sydney’s blood transfusion centres were picketed. Eventually guidelines for self-exclusion were agreed, and risk groups included people with signs and symptoms indicative of AIDS, sexually active homosexual men with multiple partners, intravenous drug abusers, and the sexual partners of such individuals. At a meeting in May, 1983, a working party of the Australian Red Cross Society confirmed this approach. The judge said that this policy was reasonable even though there were those in the USA who would have excluded all homosexuals. "... there was responsible opinion in support of the view that the risk increased with the number of sexual partners, and that the high risk group comprised the promiscuous homosexuals." The judge found that the plaintiff had not established that there was anything more that could and should have been done by the blood bank during January to September, 1983, and that it was reasonable for the manufacturer to have continued to accept plasma from blood banks without demanding more
stringent screening.
The evidence did not suggest that withdrawal
or
recall of factor
239
before donor screening was introduced was a measure. Nor were the defendants and reasonable practicable negligent in failing to use surrogate tests to exclude HIV-infected blood. By March, 1982, the defendants knew that hepatitis and other infections could be transmitted by factor VIIII (and soon after 1983 they knew that HIV might also be transmitted) but any warnings on products would be for doctors, not patients, and the doctors responsible for the boy’s care were well aware of those risks. The manufacturer’s products did carry a warning about hepatitis but not about AIDS risk. Although by 1983 such a failure indicated lack of reasonable care such a warning would not have altered the attitude of the doctors who gave the products for the treatment of joint bleeds.
VIII
preparations
Case against hospital The judge was satisfied that the administration of AHF was appropriate. The no-treatment option claimed by the plaintiff was not realistic. Desmopressin had been shown to be ineffective in this case and its further use would have been inappropriate. It would not have been practicable for the hospital to insist that it be supplied with AHF manufactured solely from plasma derived from a more completely screened pool. There was reason, in the USA at least, to assume that the risk of infection from concentrate was greater than the risk from cryoprecipitate. Australian haematologists felt that both locally produced products were safer than those in the USA, and that, clinically, the concentrate was superior. It was not reasonable to expect doctors to warn patients of the remote risk of infection by an unknown virus. It was probable that in 1980 the boy’s parents had been told in general terms of the slight risk of infection from blood products; and the doctor’s duty of care did not oblige him to repeat warnings subsequently. However, by September, 1983, the position had changed. There was a material risk of which the parents had not been previously warned. They should have been told about the AIDS risk but were not-and the absence of such a warning amounted to negligence. However, the judge decided, in the light of the parents’ previous experience and their confidence in the haematologist, that the plaintiff had failed to establish that treatment with AHF would not have been consented to even if such a warning had been given in September, 1983.
composition was patented. A biotechnology company bought the cell line for$3 million, and when the patient found out what had become of his body tissue (he had not given permission for the spleen to be used for research) he claimed damages.2 Both parties see the High Court findings as a victory. Although the ruling is binding only within California, it has set a precedent. The case (which began in 1984) has been closely followed by biotechnology firms. It has also prompterd debate on whether doctors should disclose a financial interest in the treatment of patients. Some doctors think that if this were required, some Americans might be tempted to try to sell thier body parts. One British university student I know was given a week’s free lodging by an old lady last summer in return for a pint of blood. The sale of organs or body tissue, unless prohibited, could emerge in a free-market economy. In the UK the sale of kidneys by impoverished Turks led to the hasty criminalisation of such activities and the disciplining of the clinicians involved. Until the Californian decision there were no legal guidelines on the responsibility and rights of firms engaged in research on human cells. The patient did win the right to sue his doctor for breach of trust because he had not been told about the research despite being recalled for blood tests several times after the operation. The Californian court has ruled that doctors must tell their patients in advance of an operation if they intend to use cells for research and must list the potential uses to which the material is to be put; in this way the patient would have the opportunity to negotiate a fee with a
drug company. In the UK the General Medical Council cautions on the need for
prior disclosure to the patient if a doctor has a financial interests in institutions where he plans to refer a patient, and deals with a doctor’s relationships with the pharmaceutical and allied industries. The GMC may now wish to add some guidance on the use of body tissue for research, perhaps on an analogy with its advice about the use
of fetal tissue.
Diana Brahams 1. Ellicott S. US court rules on removed body tissue. Times July 2. Brahams D. A disputed spleen. Lancet 1988; ii: 1151.
11, 1990.
Date of infection no contemporaneous serological tests were done in on the likely incubation period, the fact that the evidence 1982, had had patient symptoms consistent with a seroconversion in April, 1982, and the probability against the 1982 batches of concentrate having been contaminated suggested infection via cryoprecipitate in March, 1982.
Although
Comment In Britain, a group action is being brought by haemophiliac patients and their dependants, partners, and others infected with HIV through contaminated blood products. This Australian case, though not binding, will clearly be persuasive in respect of the period covered. H v Royal Alexandra Hospital for Children, Commonwealth Serum Laboratories Commission and the Australian Red Cross (NSW Division) (1990)1 MLR 297.
Diana Brahams
Ownership of a spleen Earlier this month, a High Court in California ruled that a patient did not hold the rights to body tissue removed in an
operation and later used to develop new treatments.1 The patient, with hairy cell leukaemia, had had his grossly enlarged spleen removed in 1976. His doctor, David Golde, and colleagues had found the cells to be unique and their
Obituary Derek Hobson
lately reader in medical microbiology at Liverpool University, and honorary consultant microbiologist at the Royal Liverpool Hospital, died on June 3, aged 66. He was in Seattle, USA, on a visit with his wife to one of their daughters and her family. Dr Derek Hobson,
Derek Hobson, a graduate of Sheffield University, started his research career at St Mary’s Hospital, London, and was awarded an MD with distinction in 1956 for work on experimental typhoid in the mouse. He returned to Sheffield in 1958 to join the virologists in Charles Stuart-Harris’s department who contributed so much to our knowledge of respiratory tract virus infections. Derek concentrated on influenza and brought this interest to Liverpool when appointed senior lecturer in 1964. He was particularly interested in the role of antibody to different viral components in influenza immunity and in the virulence of influenza virus. He was a member of the MRC Committee that organised and evaluated important trials of various influenza vaccines. In the early 1970s he turned his attention to chlamydia. The methods he developed for detecting human chlamydia in cell cultures and for assay of their antibiotic sensitivity helped clinical colleagues to establish the importance of chlamydia as causes of ophthalmia neonatorum and non-specific urethritis and to lay down guidelines for rational therapy.
D. Baxby
