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Protecting donor marrow from HIV
158
Noticeboard Safe motherhood The World Health Organisation’s Safe Motherhood Initiative has an ambitious target-to reduce maternal deaths by half by the year 2000. A more general aim is to improve the quality and safety of the lives of all women and girls by strengthening maternal health services, extending family planning facilities, and introducing effective measures for raising the status of women. Last month WHO launched a newsletter, Safe Motherhood,’ to provide a news service and a communication forum for all those working within the initiative. Safe Motherhood is to be published three times a year and will include a news review, a fact file, information on technology and on WHO’s US$3 million safe motherhood operational research programme, a diary of international, national, and regional events, and details of publications and resource materials. Among the topics discussed in the first issue is the successful use of home-based maternal records by tribal women in Indian villages. Dr Kusum Shah, who introduced the first cards to women in villages near Bombay in the 1970s, thinks that they can make an important contribution to the improvement of maternal health and the health of women in general. He says that women who use the cards become better informed about their health and are more likely to take advantage of available services. After a WHO meeting in Pune, India, last year, at which other countries also strongly supported the use of the cards, the Indian Government decided to distribute similar maternal record cards in several districts where maternal deaths were particularly high. In the United States, the US Agency for International Development (USAID) has decided to fund project MotherCare, which is aimed at enhancing the services and educational programme that have a significant impact on maternal and neonatal health and nutrition. The work is being carried out by John Snow Incorporated in Washington DC and will include five projects in different countries to demonstrate the efficacy of various interventions, such as improvements in the nutrition of newborn babies, as well as the prevention and treatment of disorders known to be important to maternal and neonatal mortality and morbidity. The MotherCare project will also introduce research and training initiatives in a number of countries. For those interested in researching a practical approach to reducing maternal mortality, the Safe Motherhood Operational Research programme is offering funding for government and non-governmental organisations in developing countries.2 1. Free copies of the newsletter are available from Safe Motherhood newsletter, Division of Family Health, WHO, 1211 Geneva 27, Switzerland.
2. Further information from the Division of Switzerland.
The post-graft weeks saw some evidence of immune restoration and falling titres of antibody to all HIV-1 antigens. The chemotherapy had eliminated the lymphoma apart from a 1 cm left axillary node. At necropsy there was a lymphoma in the left axilla measuring 5 x 4 x 4 cm, but no other gross tumour involvement; nor was there any evidence of infection. Yet death was ascribed to tumour relapse, and the heavy burden of treatment was exonerated. Holland et al wonder if BMT plus antiviral drugs might be helpful in HIV infection generally.
mortem.
Family Health, WHO, 1211 Geneva 27,
Protecting donor marrow from
HIV
A
41-year-old man in Baltimore, Maryland, was treated by chemotherapy for non-Hodgkin lymphoma, followed by bone marrow transplantation (BMT). When tumour recurrence was detected on day 39 he refused further treatment; the patient died in respiratory failure 8 days later. The interest in this case’ lies in the fact that the patient was infected with HIV-1. The lymphoma apart, he seems to have been well, having no history of opportunistic infection and a Kamofsky performance score of 100. However, the patient had a poor prognosis in respect of his malignant disease because of the retrovirus infection, and in such settings BMT is worth trying but the donor marrow has to "take" without itself being infected with HIV. Dr H. Kent Holland and colleagues gave prophylactic zidovudine, starting 14 days before BMT, at an initial dose of 5 mg/kg intravenously every four hours. Bone marrow ablation was with cyclophosphamide and total body irradiation. After the graft, which was successful, HIV-infected cells were detectable, but they were thought to be "nonproliferating recipient cells that were lethally damaged but had not yet been cleared from the body". By day 32, in a thorough search, HIV was no longer found in blood or bone marrow; and organs were free of virus post
HK, Saral R, Rosi JJ, et al. Allogeneic bone marrow transplantation, zidovudine, and human immunodeficiency virus type 1 (RIV-1) infection: studies in a patient with non-Hodgkin lymphoma. Ann Intern Med 1989; 111: 973-81.
1. Holland
Guidelines for medical research Local ethics committees are, in the words of Prof
Margaret
Turner-Warwick, president of the Royal College of Physicians, "custodians of good practice in research". To help them in this role the College has updated its 1984 guidelines! on research involving human volunteers. The new guidelines2 take account of recent developments in medical research (including embryo research) and growing public concern about its regulation. Another document, which sets out the College’s recommendations for research involving patients,3complements earlier guidelines on the conduct of research in healthy volunteers.4 The guidelines for ethics committees dwell heavily on the legal aspects of medical research, for duty of care is an awesome responsibility for the committees (however well conducted) and the authorities that appoint them. The College emphasises the need for committee members to be indemnified for loss arising out of a claim for damages for negligence. Although most medical members will be protected by their health-authority employers and/or their defence societies, lay members are advised to ask for indemnity before accepting an appointment and to insist on an unequivocal
reply. Patients, though in some respects no different from other volunteers taking part in research projects, may not feel wholly free to refuse to collaborate with an enthusiastic research-worker. The fundamental safeguard for patients, as set out in Research Involving Patients,3 is that they should know that they are taking part in research; but there may be circumstances when consent is unnecessary-as, for instance, in the case of research based on anonymous specimens. As additional measures the College suggests that patients may need information sheets (to back up oral explanations), the help of an adviser, and time to reflect. Royal College of Physicians of London. Guidelines on the practice of ethics committees in medical research. London: Royal College of Physicians, 1984. 2. Guidelines on the practice of ethics committees in medical research involving human subjects. London: Royal College of Physicians, 1990. £8. 3. Research involving patients. London: Royal College of Physicians, 1990. £8. 4. Royal College of Physicians. Research on healthy volunteers. J R Coll Physicians Lond 1986; 20: 1-17. See Lancet 1986; ii: 900-01. 1.
Funding of UK medical
research
Medical charities in the UK fear that a new Government proposal for funding will greatly increase the cost of the research they support. Under the present arrangements, money for Government funded medical and scientific research carried out in highereducation institutions comes partly from grants to the research councils and partly from block funding to the institutions themselves. The universities provide for academic and support staff, some equipment and materials, and such things as research
laboratories, libraries, and computing facilities; the research councils pay for all additional costs of the projects they sponsor. The new proposal, set out in a consultative document released by the Department of Education and Science,l is to transfer to the research councils responsibility for all the costs of the projects they sponsor, except for the salaries of academic staff working on the projects and general accommodation costs. The Education Secretary, John MacGregor, claims that the change is necessary because confusion about who should pay for what has given rise to unproductive arguments, inadequate resourcing of some projects, and ill-
Noticeboard Safe motherhood The World Health Organisation’s Safe Motherhood Initiative has an ambitious target-to reduce maternal deaths by half by the year 2000. A more general aim is to improve the quality and safety of the lives of all women and girls by strengthening maternal health services, extending family planning facilities, and introducing effective measures for raising the status of women. Last month WHO launched a newsletter, Safe Motherhood,’ to provide a news service and a communication forum for all those working within the initiative. Safe Motherhood is to be published three times a year and will include a news review, a fact file, information on technology and on WHO’s US$3 million safe motherhood operational research programme, a diary of international, national, and regional events, and details of publications and resource materials. Among the topics discussed in the first issue is the successful use of home-based maternal records by tribal women in Indian villages. Dr Kusum Shah, who introduced the first cards to women in villages near Bombay in the 1970s, thinks that they can make an important contribution to the improvement of maternal health and the health of women in general. He says that women who use the cards become better informed about their health and are more likely to take advantage of available services. After a WHO meeting in Pune, India, last year, at which other countries also strongly supported the use of the cards, the Indian Government decided to distribute similar maternal record cards in several districts where maternal deaths were particularly high. In the United States, the US Agency for International Development (USAID) has decided to fund project MotherCare, which is aimed at enhancing the services and educational programme that have a significant impact on maternal and neonatal health and nutrition. The work is being carried out by John Snow Incorporated in Washington DC and will include five projects in different countries to demonstrate the efficacy of various interventions, such as improvements in the nutrition of newborn babies, as well as the prevention and treatment of disorders known to be important to maternal and neonatal mortality and morbidity. The MotherCare project will also introduce research and training initiatives in a number of countries. For those interested in researching a practical approach to reducing maternal mortality, the Safe Motherhood Operational Research programme is offering funding for government and non-governmental organisations in developing countries.2 1. Free copies of the newsletter are available from Safe Motherhood newsletter, Division of Family Health, WHO, 1211 Geneva 27, Switzerland.
2. Further information from the Division of Switzerland.
The post-graft weeks saw some evidence of immune restoration and falling titres of antibody to all HIV-1 antigens. The chemotherapy had eliminated the lymphoma apart from a 1 cm left axillary node. At necropsy there was a lymphoma in the left axilla measuring 5 x 4 x 4 cm, but no other gross tumour involvement; nor was there any evidence of infection. Yet death was ascribed to tumour relapse, and the heavy burden of treatment was exonerated. Holland et al wonder if BMT plus antiviral drugs might be helpful in HIV infection generally.
mortem.
Family Health, WHO, 1211 Geneva 27,
Protecting donor marrow from
HIV
A
41-year-old man in Baltimore, Maryland, was treated by chemotherapy for non-Hodgkin lymphoma, followed by bone marrow transplantation (BMT). When tumour recurrence was detected on day 39 he refused further treatment; the patient died in respiratory failure 8 days later. The interest in this case’ lies in the fact that the patient was infected with HIV-1. The lymphoma apart, he seems to have been well, having no history of opportunistic infection and a Kamofsky performance score of 100. However, the patient had a poor prognosis in respect of his malignant disease because of the retrovirus infection, and in such settings BMT is worth trying but the donor marrow has to "take" without itself being infected with HIV. Dr H. Kent Holland and colleagues gave prophylactic zidovudine, starting 14 days before BMT, at an initial dose of 5 mg/kg intravenously every four hours. Bone marrow ablation was with cyclophosphamide and total body irradiation. After the graft, which was successful, HIV-infected cells were detectable, but they were thought to be "nonproliferating recipient cells that were lethally damaged but had not yet been cleared from the body". By day 32, in a thorough search, HIV was no longer found in blood or bone marrow; and organs were free of virus post
HK, Saral R, Rosi JJ, et al. Allogeneic bone marrow transplantation, zidovudine, and human immunodeficiency virus type 1 (RIV-1) infection: studies in a patient with non-Hodgkin lymphoma. Ann Intern Med 1989; 111: 973-81.
1. Holland
Guidelines for medical research Local ethics committees are, in the words of Prof
Margaret
Turner-Warwick, president of the Royal College of Physicians, "custodians of good practice in research". To help them in this role the College has updated its 1984 guidelines! on research involving human volunteers. The new guidelines2 take account of recent developments in medical research (including embryo research) and growing public concern about its regulation. Another document, which sets out the College’s recommendations for research involving patients,3complements earlier guidelines on the conduct of research in healthy volunteers.4 The guidelines for ethics committees dwell heavily on the legal aspects of medical research, for duty of care is an awesome responsibility for the committees (however well conducted) and the authorities that appoint them. The College emphasises the need for committee members to be indemnified for loss arising out of a claim for damages for negligence. Although most medical members will be protected by their health-authority employers and/or their defence societies, lay members are advised to ask for indemnity before accepting an appointment and to insist on an unequivocal
reply. Patients, though in some respects no different from other volunteers taking part in research projects, may not feel wholly free to refuse to collaborate with an enthusiastic research-worker. The fundamental safeguard for patients, as set out in Research Involving Patients,3 is that they should know that they are taking part in research; but there may be circumstances when consent is unnecessary-as, for instance, in the case of research based on anonymous specimens. As additional measures the College suggests that patients may need information sheets (to back up oral explanations), the help of an adviser, and time to reflect. Royal College of Physicians of London. Guidelines on the practice of ethics committees in medical research. London: Royal College of Physicians, 1984. 2. Guidelines on the practice of ethics committees in medical research involving human subjects. London: Royal College of Physicians, 1990. £8. 3. Research involving patients. London: Royal College of Physicians, 1990. £8. 4. Royal College of Physicians. Research on healthy volunteers. J R Coll Physicians Lond 1986; 20: 1-17. See Lancet 1986; ii: 900-01. 1.
Funding of UK medical
research
Medical charities in the UK fear that a new Government proposal for funding will greatly increase the cost of the research they support. Under the present arrangements, money for Government funded medical and scientific research carried out in highereducation institutions comes partly from grants to the research councils and partly from block funding to the institutions themselves. The universities provide for academic and support staff, some equipment and materials, and such things as research
laboratories, libraries, and computing facilities; the research councils pay for all additional costs of the projects they sponsor. The new proposal, set out in a consultative document released by the Department of Education and Science,l is to transfer to the research councils responsibility for all the costs of the projects they sponsor, except for the salaries of academic staff working on the projects and general accommodation costs. The Education Secretary, John MacGregor, claims that the change is necessary because confusion about who should pay for what has given rise to unproductive arguments, inadequate resourcing of some projects, and ill-