- Email: [email protected]
Costly delivery of health services in Canada
on biotechnology products, and demand clinical data. Kessler said that the FDA is also exploring ways to reduce the uncertainty on how much surrogate marker evidence would be acceptable for drug approval, but that the real issue is still how much evidence is required to prove efficacy, not how much evidence is required for regulatory approval. To enhance scientific communication, the AIDSLINE database of the National Library of Medicine is putting abstracts of all AIDS research reports on-line. The panel also recommended that the Office of AIDS Research survey the HIV research targets for industry and academia
patents not to
regularly. Changes in FDA regulations were recommended to end the persistent exclusion of all women of childbearing age from clinical trials, and to initiate sanctions against companies whose drug trials continue to exclude women unnecessarily. The panel emphasised that this should not mean quotas for or requirements to include women. The panel also recommended elimination of the requirement for the consent of the father of the fetus for participation of a pregnant woman in any clinical trial, a regulation widely criticised because it excludes from trials many women who are separated from the father. Paul M Rowe
Gene therapy in vascular proliferation models
of health in Canada
Costly delivery
services
Canada could shave Can$7 billion per or about 15%, from its public health budget, without compromising care, by simply "shifting to less costly modes of
year,
delivery", according to a 3-year national study conducted by a Queen’s University and University of Ottawa Economic Projects team. Apart from the "more appropriate use of facilities and services" such as same-day surgery and home care, the report says that savings could also have come from provincial adoption of "better practices" that have proven
The study notes that Canada’s fee-forservice system, in which doctors are paid per individual task performed, has also driven up costs. Between 1979 and 1989, of the number Canadian patients increased 20%, whereas the number of services done by physicians rose 50%. Similarly, it notes that spiralling pharmaceutical costs are in part predicated on
multiple drug prescriptions issuing elderly patients.
to
"These extra services may be necessary, but we do not know. We do not know, for example, whether more doctors’ visiting were required because people had more health problems than they had in the 1970s, or because utilisation patterns themselves in other parts of the country. : changed", says the report. Hence it urges an extensive research As an example of how provincial bench: to assess the cost-effectiveness and frameprogramme marking improved regulatory works would also reduce system costs, the of alternative forms of intervention and study describes how British Columbia has to develop reliable measures of health constrained costs by controlling hospital outcomes, particularly those related admission rates and using alternative to the use of non-hospital services. It also health facilities but has allowed wage-rates urges an evaluation of the various regulafor health-care workers to rise above the tory systems in the provinces to assess Canadian average. Quebec, meanwhile, their respective "accountability, control, pays lower wages and has lower admission equity and efficiency". Notably, among rates for health facilities but offsets those measures defined as key to a successful gains with longer hospital stays. Ontario’s regulatory structure is "payment for proper caput costs are above the national fessional services on the basis of capitation or salary". average because of "more physician services and, to a lesser extent, higher fees for services".: Wayne Kondro balloon
angioplasty. Using the rat model, Mark Chang and co-workers injured the carotid artery by balloon angioplasty and exposed the arteries to AdARb or control. The migration of
Gene therapy has taken another step forward with a report of the effect of . medial smooth-muscle cells into the the insertion of constitutively active neointima was inhibited by nearly tworetinoblastoma-gene-product (Rb) via thirds. In the porcine femoral artery modlocal infection with an adenovirus vector el of restenosis, the neointima/medial area (AdARb) in rat and porcine models of ratio was decreased by nearly half 21 days arterial restenosis (Science 1995; 267: : after the local application of AdARb. 518-22). This vector codes a non-phosLocal use of AdARb did not induce phorylatable active form of human Rb. In inflammatory responses or other toxicities other cell models, unphosphorylated Rb in these models. Use of antisense oligoinactivates transcription factors to hold nucleotides or the herpes-simplex-virus the cell in the resting GO phase of the cell thymidine-kinase vector in association cycle. Phosphorylation of Rb releases the with ganciclovir are active in vivo in cell into Gl/S phase, and proliferation restenosis models but the use of AdARb results. The proliferation of vascular may be more specific and less toxic. smooth-muscle cells is implicated in human atherosclerosis and restenosis after David McNamee
Venomous caterpillars dangerous consequence of handling caterpillars of some moths from the family Saturnidae is hypofibrinogenaemia with
One
Fewer than 40 cases have been recorded-24 from Venezuela, 10 from Brazil, and, recently, two from French Guiana (Semaine des Hopitaux 1995; 71: 9-12), although there are likely to have been many more unrecognised and unrecorded cases. The effects of the venom on fibrinogen, fibrin, and factor VIII are known but its nature is not. Symptoms begin with immediate itching at skin-puncture points, followed by pain, malaise, and headache. Bleeding from the gums, nose, or into the skin may occur within 2 h to 3 days, and profound hypofibrinogenaemia can last for 2 weeks. Bleeding may be severe (gastric and intracerebral haemorrhages, and severe haematuria have occurred). Saturnid moths are found worldwide, and because many live communally on vegetation, there are ample opportunities for contact with human beings. Unexplained purpura
haemorrhage.
they could equally apply to the financing of other EU agencies. Trade The London-based European Medicines Commissioner Martin Bangemann placatEvaluation Agency might finally be able to ed the parliament meeting in Strasbourg ’, start work next month. The political spat on January 18 largely by promising that or ecchymoses might provoke questions over the agency’s fees was not overcome in fresh legislation overhauling the agency’s about such contact. Should the possibility time for the formal inauguration on Jan statutes would be tabled in 1996, with a be considered, treatment with aprotinin or 26. The main obstacle had been a dispute view to implementation in 1997. The agency, which came into being on between the European Commission and fibrinogen is effective, but not with blood or fresh-frozen plasma which, in several the European Parliament, with the latter Jan 1, is not accepting applications for drug cases, has provoked disseminated intravastrying to secure rights to control theauthorisations until the dispute is settled. it is contacts". cular coagulation. EMEA Meanwhile, such time as until "making agency’s budget becomes "self sufficient". For the parliaJohn Bignall ment, the issues are of a wide importance Arthur Rogers
EMEA’s
248
delayed start
since
patents not to
regularly. Changes in FDA regulations were recommended to end the persistent exclusion of all women of childbearing age from clinical trials, and to initiate sanctions against companies whose drug trials continue to exclude women unnecessarily. The panel emphasised that this should not mean quotas for or requirements to include women. The panel also recommended elimination of the requirement for the consent of the father of the fetus for participation of a pregnant woman in any clinical trial, a regulation widely criticised because it excludes from trials many women who are separated from the father. Paul M Rowe
Gene therapy in vascular proliferation models
of health in Canada
Costly delivery
services
Canada could shave Can$7 billion per or about 15%, from its public health budget, without compromising care, by simply "shifting to less costly modes of
year,
delivery", according to a 3-year national study conducted by a Queen’s University and University of Ottawa Economic Projects team. Apart from the "more appropriate use of facilities and services" such as same-day surgery and home care, the report says that savings could also have come from provincial adoption of "better practices" that have proven
The study notes that Canada’s fee-forservice system, in which doctors are paid per individual task performed, has also driven up costs. Between 1979 and 1989, of the number Canadian patients increased 20%, whereas the number of services done by physicians rose 50%. Similarly, it notes that spiralling pharmaceutical costs are in part predicated on
multiple drug prescriptions issuing elderly patients.
to
"These extra services may be necessary, but we do not know. We do not know, for example, whether more doctors’ visiting were required because people had more health problems than they had in the 1970s, or because utilisation patterns themselves in other parts of the country. : changed", says the report. Hence it urges an extensive research As an example of how provincial bench: to assess the cost-effectiveness and frameprogramme marking improved regulatory works would also reduce system costs, the of alternative forms of intervention and study describes how British Columbia has to develop reliable measures of health constrained costs by controlling hospital outcomes, particularly those related admission rates and using alternative to the use of non-hospital services. It also health facilities but has allowed wage-rates urges an evaluation of the various regulafor health-care workers to rise above the tory systems in the provinces to assess Canadian average. Quebec, meanwhile, their respective "accountability, control, pays lower wages and has lower admission equity and efficiency". Notably, among rates for health facilities but offsets those measures defined as key to a successful gains with longer hospital stays. Ontario’s regulatory structure is "payment for proper caput costs are above the national fessional services on the basis of capitation or salary". average because of "more physician services and, to a lesser extent, higher fees for services".: Wayne Kondro balloon
angioplasty. Using the rat model, Mark Chang and co-workers injured the carotid artery by balloon angioplasty and exposed the arteries to AdARb or control. The migration of
Gene therapy has taken another step forward with a report of the effect of . medial smooth-muscle cells into the the insertion of constitutively active neointima was inhibited by nearly tworetinoblastoma-gene-product (Rb) via thirds. In the porcine femoral artery modlocal infection with an adenovirus vector el of restenosis, the neointima/medial area (AdARb) in rat and porcine models of ratio was decreased by nearly half 21 days arterial restenosis (Science 1995; 267: : after the local application of AdARb. 518-22). This vector codes a non-phosLocal use of AdARb did not induce phorylatable active form of human Rb. In inflammatory responses or other toxicities other cell models, unphosphorylated Rb in these models. Use of antisense oligoinactivates transcription factors to hold nucleotides or the herpes-simplex-virus the cell in the resting GO phase of the cell thymidine-kinase vector in association cycle. Phosphorylation of Rb releases the with ganciclovir are active in vivo in cell into Gl/S phase, and proliferation restenosis models but the use of AdARb results. The proliferation of vascular may be more specific and less toxic. smooth-muscle cells is implicated in human atherosclerosis and restenosis after David McNamee
Venomous caterpillars dangerous consequence of handling caterpillars of some moths from the family Saturnidae is hypofibrinogenaemia with
One
Fewer than 40 cases have been recorded-24 from Venezuela, 10 from Brazil, and, recently, two from French Guiana (Semaine des Hopitaux 1995; 71: 9-12), although there are likely to have been many more unrecognised and unrecorded cases. The effects of the venom on fibrinogen, fibrin, and factor VIII are known but its nature is not. Symptoms begin with immediate itching at skin-puncture points, followed by pain, malaise, and headache. Bleeding from the gums, nose, or into the skin may occur within 2 h to 3 days, and profound hypofibrinogenaemia can last for 2 weeks. Bleeding may be severe (gastric and intracerebral haemorrhages, and severe haematuria have occurred). Saturnid moths are found worldwide, and because many live communally on vegetation, there are ample opportunities for contact with human beings. Unexplained purpura
haemorrhage.
they could equally apply to the financing of other EU agencies. Trade The London-based European Medicines Commissioner Martin Bangemann placatEvaluation Agency might finally be able to ed the parliament meeting in Strasbourg ’, start work next month. The political spat on January 18 largely by promising that or ecchymoses might provoke questions over the agency’s fees was not overcome in fresh legislation overhauling the agency’s about such contact. Should the possibility time for the formal inauguration on Jan statutes would be tabled in 1996, with a be considered, treatment with aprotinin or 26. The main obstacle had been a dispute view to implementation in 1997. The agency, which came into being on between the European Commission and fibrinogen is effective, but not with blood or fresh-frozen plasma which, in several the European Parliament, with the latter Jan 1, is not accepting applications for drug cases, has provoked disseminated intravastrying to secure rights to control theauthorisations until the dispute is settled. it is contacts". cular coagulation. EMEA Meanwhile, such time as until "making agency’s budget becomes "self sufficient". For the parliaJohn Bignall ment, the issues are of a wide importance Arthur Rogers
EMEA’s
248
delayed start
since