Rationing, randomizing, and researching in health care provision.
In this paper the need for valid evidence of the cost-effectiveness of treatments that have not been properly evaluated, yet are already available, albeit in short supply, are examined. Such treatments cannot be withdrawn, pending proper evaluation, nor can they be made more widely available until they have been shown to be cost-effective. As a solution to this impasse the argument put forward recently by Toroyan et al is discussed. They say that randomised controlled trials of such resources could be done but only if resources are randomly allocated independently of a research context. Relevant outcome data could then be collected for research, given this opportunity. (There are already a few investigators who have turned limited resources, mostly health service provision, to their advantage in this way.) We agree. We disagree with Toroyan et al on a number of points. First, they claim that no ethical issue relating to equipoise arises. We disagree and this disagreement depends on our showing that equipoise should be maintained in a relationship that they do not consider. Secondly, they say that consent to data collection is always needed. Again we disagree. Thirdly, they claim that the previous two issues are the only possible ethical issues that could arise. We argue, instead, that there is a further conflict of interests that has ethical import.
Edwards
S J L
SJ
Centre for Ethics in Medicine, University of Bristol, UK . sarah.edwards@bristol.ac.uk
Kirchin
S
S
D035843:Biomedical Research; D003362:Cost-Benefit Analysis; D003625:Data Collection; D004992:Ethics, Medical; D015276:Health Care Rationing / Q000191:economics / Q000592:standards*; D006805:Human Experimentation; D006801:Humans; D009313:National Health Programs; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000592:standards*; D012107:Research Design; D006113:United Kingdom