- Email: [email protected]
DMPA, zalcitabine, and the FDA
45
department, rather than an issue for the organisation as a whole. Drawing up a policy on how to retain staff who became disabled was another. The district opted to consider such individuals for re-employment when a suitable vacancy arose, but it suggests that some of the existing retainer schemes (eg, that for retention of nurses) could be extended to cover disabled staff. Authority. A review of Parkside’s role as the NHS pilot on employing disabled people. 1992. Pp 12.
1. Parkside Health
RICHE project The second annual conference of the RICHE
Special
Interest
Group was held on June 15 and 16 in Brussels and representatives from western European countries were, for the first time, joined by colleagues from Hungary, Czechoslovakia, and Bulgaria. The aims of the meeting were to acquaint the participants with the scope of the RICHE project and what had been achieved in its first phase, to review its applicability in the different European national health systems, and to highlight potential areas of future collaboration. RICHE (Roseau d’Information et de Communication Hospitalier Europeen [Health Care Information and Communication Network for Europe]) is a non-profit-making foundation that was developed partly by the CEC-ESPRIT (Commission of the European Communities and its Strategic Programme for Research in Information Technology), and partly by a consortium of European hospitals, health-care authorities, and
information-systems companies. The project started in January, 1989, and the first phase ended last month; 10 million ecu has been invested (40% in France), and 300 hospitals in five countries have joined the scheme. The major result of the RICHE project has been the development of a framework architecture whereby units of a hospital’s system that have developed separately can be integrated. Unfortunately, much of the health-information systems on the European market are still characterised by fragmentation, high unit costs, and dissatisfaction of users. Only 5% of European hospitals use integrated patientbased systems. The key characteristics of the RICHE architecture are openness, modularity, portability, integration, innovation, and a European standard. In France the Plan Directeur project has applied the RICHE system to 62 hospitals so far and will be introducing it to 45 more. In Italy, the pilot trials of the nursing care part of RICHE are already operating in some hospitals. Discussions at the conference were directed to the intelligent act management system, customisation, platform strategies for open systems, and the opportunity for suppliers and users of information technology in health care to be included in the RICHE project. As the deputy project manager Prof Dr A. van der Werff said, "the mission of RICHE is to construct a framework for overall open information and communication systems for health care in
Europe". Chemical weapons draft treaty completed
Negotiators from the 39 countries of the Geneva disarmament conference have returned to their capitals taking with them the completed 188-page draft treaty prohibiting chemical weapons (see Lancet June 20, p 1530). They will reassemble on July 20, some no doubt bringing their Governments’ proposed amendments. These amendments are likely to be minor. The intention is that countries that have major reservations, such as China and Pakistan, and decline to sign the treaty will simply be left to reflect on the advisability of not associating themselves with an instrument of international legislation. The Hague was chosen as the site of the monitoring body of the treaty, which will come into force on ratification by 65 countries-a process expected to take perhaps 2 years, even with 50 or so initial signatories. The verification procedures, including challenge inspection, that are set out in the completed text are far more exigent than those administered by the International Atomic Energy Agency at nuclear energy installations. Negotiators describe the result of their labours as a unique endeavour and the first treaty ever achieved on abolishing an entire category of weapons.
DMPA, zalcitabine, and the FDA The US Food and Drug Administration’s (FDA) Fertility and Maternal Health Drugs Advisory Committee voted unanimously on June 19 to recommend approval of the use of depot
medroxyprogesterone acetate (DMPA, Depo Provera, Upjohn) as a contraceptive. The drug is approved in the US for use in endometrial and renal carcinoma.! The committee evaluated data from New Zealand showing a possible increased risk of osteoporosis associated with long-term use of DMPA .2 New data from Thailand also indicate that there may be a higher risk of low-birth-weight babies born to women exposed to DMPA during pregnancy. The committee suggested that the informed consent document discuss the possibility of osteoporosis and that post-marketing studies be conducted to address this problem. They further recommend that the label should warn against prescribing the drug to pregnant women. FDA had denied Upjohn’s application for approval of DMPA for contraception in 1978 because of safety questions (development of mammary tumours in dogs given the product), and the decision was upheld in 1984 by a board of inquiry set up in
Upjohn’s appeal. Cindy Pearson of the US National Women’s Health Network (NWHN) drew attention to the three case-control studies suggesting increasing risk of breast cancer with use of DMPA.3--5 Dr David Thomas, coordinator of the multinational study funded by the World Health Organisation,5 explained that the additional breast cancer risk applied to women aged under 35 years rather than to all users. He also pointed out that DMPA protects women against response to
endometrial cancer. On June 22, the FDA approved zalcitabine (dideoxycytidine) for use in combination with zidovudine as a treatment option for adults with advanced HIV infection (see Lancet April 25, p 1047). It is the first drug to be approved under the agency’s accelerated drug approval process (see Lancet April 18, p 982). 1.
Physicians’ Desk Reference. 46th ed. Montvale, NJ: Medical Economics Data; 1992: 2336-37.
2.
Cundy T, Evans M, Roberts H, et al. Bone density in women receiving depot medroxyprogesterone acetate for contraception. BMJ 1991; 303: 13-16. 3. Lee NC, Rosero-Bixby L, Oberle W, et al. A case-control study of breast cancer and hormonal contraception in Costa Rica. J Natl Cancer Institute 1987; 79: 1247-54. 4. Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo Provera) and risk of breast cancer. BMJ 1989; 299: 759-62. 5. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depot-medroxyprogesterone acetate: a multinational study. Lancet 1991; 338: 833-38.
Public funding and private genes The patenting of human genome DNA sequences is ethically unacceptable and all those working in this area of research ought to resist commercial pressures to patent, says a BMA working party set up to consider the implications of genetic technology on the community and to bring these matters to the attention of the public. They add that more public funds should be found for pure research to reduce the influence of private companies wishing, for financial reasons, to promote developments in a particular area. The results of human genome work should be as freely available as the results of other research projects and the work should concentrate on maximising therapeutic benefits. The report is equally firm in its recommendations on the use of genetic information. Genetic screening in the workplace, for example, should be used only as a means of promoting or maintaining an individual’s health, not to select "suitable" people for employment. The potential contribution of susceptibility to genetic disease to the overall risk of morbidity through accident or industrial disease should be taken into account in workplace screening. The working party believes that insurance companies are not justified in screening clients and that it is better for everyone to pay higher premiums than to force some to undergo tests against their wishes. DNA profiles should be kept on police records only if the person is found guilty, and profiles obtained for medical or civil purposes should not be transferable to other databases. The report outlines the history and science of genetics before discussing the scope and ethics of the various ways that genetic technology can be applied. Clinicians form part of the readership at
department, rather than an issue for the organisation as a whole. Drawing up a policy on how to retain staff who became disabled was another. The district opted to consider such individuals for re-employment when a suitable vacancy arose, but it suggests that some of the existing retainer schemes (eg, that for retention of nurses) could be extended to cover disabled staff. Authority. A review of Parkside’s role as the NHS pilot on employing disabled people. 1992. Pp 12.
1. Parkside Health
RICHE project The second annual conference of the RICHE
Special
Interest
Group was held on June 15 and 16 in Brussels and representatives from western European countries were, for the first time, joined by colleagues from Hungary, Czechoslovakia, and Bulgaria. The aims of the meeting were to acquaint the participants with the scope of the RICHE project and what had been achieved in its first phase, to review its applicability in the different European national health systems, and to highlight potential areas of future collaboration. RICHE (Roseau d’Information et de Communication Hospitalier Europeen [Health Care Information and Communication Network for Europe]) is a non-profit-making foundation that was developed partly by the CEC-ESPRIT (Commission of the European Communities and its Strategic Programme for Research in Information Technology), and partly by a consortium of European hospitals, health-care authorities, and
information-systems companies. The project started in January, 1989, and the first phase ended last month; 10 million ecu has been invested (40% in France), and 300 hospitals in five countries have joined the scheme. The major result of the RICHE project has been the development of a framework architecture whereby units of a hospital’s system that have developed separately can be integrated. Unfortunately, much of the health-information systems on the European market are still characterised by fragmentation, high unit costs, and dissatisfaction of users. Only 5% of European hospitals use integrated patientbased systems. The key characteristics of the RICHE architecture are openness, modularity, portability, integration, innovation, and a European standard. In France the Plan Directeur project has applied the RICHE system to 62 hospitals so far and will be introducing it to 45 more. In Italy, the pilot trials of the nursing care part of RICHE are already operating in some hospitals. Discussions at the conference were directed to the intelligent act management system, customisation, platform strategies for open systems, and the opportunity for suppliers and users of information technology in health care to be included in the RICHE project. As the deputy project manager Prof Dr A. van der Werff said, "the mission of RICHE is to construct a framework for overall open information and communication systems for health care in
Europe". Chemical weapons draft treaty completed
Negotiators from the 39 countries of the Geneva disarmament conference have returned to their capitals taking with them the completed 188-page draft treaty prohibiting chemical weapons (see Lancet June 20, p 1530). They will reassemble on July 20, some no doubt bringing their Governments’ proposed amendments. These amendments are likely to be minor. The intention is that countries that have major reservations, such as China and Pakistan, and decline to sign the treaty will simply be left to reflect on the advisability of not associating themselves with an instrument of international legislation. The Hague was chosen as the site of the monitoring body of the treaty, which will come into force on ratification by 65 countries-a process expected to take perhaps 2 years, even with 50 or so initial signatories. The verification procedures, including challenge inspection, that are set out in the completed text are far more exigent than those administered by the International Atomic Energy Agency at nuclear energy installations. Negotiators describe the result of their labours as a unique endeavour and the first treaty ever achieved on abolishing an entire category of weapons.
DMPA, zalcitabine, and the FDA The US Food and Drug Administration’s (FDA) Fertility and Maternal Health Drugs Advisory Committee voted unanimously on June 19 to recommend approval of the use of depot
medroxyprogesterone acetate (DMPA, Depo Provera, Upjohn) as a contraceptive. The drug is approved in the US for use in endometrial and renal carcinoma.! The committee evaluated data from New Zealand showing a possible increased risk of osteoporosis associated with long-term use of DMPA .2 New data from Thailand also indicate that there may be a higher risk of low-birth-weight babies born to women exposed to DMPA during pregnancy. The committee suggested that the informed consent document discuss the possibility of osteoporosis and that post-marketing studies be conducted to address this problem. They further recommend that the label should warn against prescribing the drug to pregnant women. FDA had denied Upjohn’s application for approval of DMPA for contraception in 1978 because of safety questions (development of mammary tumours in dogs given the product), and the decision was upheld in 1984 by a board of inquiry set up in
Upjohn’s appeal. Cindy Pearson of the US National Women’s Health Network (NWHN) drew attention to the three case-control studies suggesting increasing risk of breast cancer with use of DMPA.3--5 Dr David Thomas, coordinator of the multinational study funded by the World Health Organisation,5 explained that the additional breast cancer risk applied to women aged under 35 years rather than to all users. He also pointed out that DMPA protects women against response to
endometrial cancer. On June 22, the FDA approved zalcitabine (dideoxycytidine) for use in combination with zidovudine as a treatment option for adults with advanced HIV infection (see Lancet April 25, p 1047). It is the first drug to be approved under the agency’s accelerated drug approval process (see Lancet April 18, p 982). 1.
Physicians’ Desk Reference. 46th ed. Montvale, NJ: Medical Economics Data; 1992: 2336-37.
2.
Cundy T, Evans M, Roberts H, et al. Bone density in women receiving depot medroxyprogesterone acetate for contraception. BMJ 1991; 303: 13-16. 3. Lee NC, Rosero-Bixby L, Oberle W, et al. A case-control study of breast cancer and hormonal contraception in Costa Rica. J Natl Cancer Institute 1987; 79: 1247-54. 4. Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo Provera) and risk of breast cancer. BMJ 1989; 299: 759-62. 5. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depot-medroxyprogesterone acetate: a multinational study. Lancet 1991; 338: 833-38.
Public funding and private genes The patenting of human genome DNA sequences is ethically unacceptable and all those working in this area of research ought to resist commercial pressures to patent, says a BMA working party set up to consider the implications of genetic technology on the community and to bring these matters to the attention of the public. They add that more public funds should be found for pure research to reduce the influence of private companies wishing, for financial reasons, to promote developments in a particular area. The results of human genome work should be as freely available as the results of other research projects and the work should concentrate on maximising therapeutic benefits. The report is equally firm in its recommendations on the use of genetic information. Genetic screening in the workplace, for example, should be used only as a means of promoting or maintaining an individual’s health, not to select "suitable" people for employment. The potential contribution of susceptibility to genetic disease to the overall risk of morbidity through accident or industrial disease should be taken into account in workplace screening. The working party believes that insurance companies are not justified in screening clients and that it is better for everyone to pay higher premiums than to force some to undergo tests against their wishes. DNA profiles should be kept on police records only if the person is found guilty, and profiles obtained for medical or civil purposes should not be transferable to other databases. The report outlines the history and science of genetics before discussing the scope and ethics of the various ways that genetic technology can be applied. Clinicians form part of the readership at