Cuba--innovation through synergy.
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Biomedical subjects
Publications and source records attributed to Abdallah S Daar.
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Genomics, the comprehensive examination of an organism's entire set of genes and their interactions, will have a major impact on the way disease is diagnosed, prevented and treated in the new millennium. Despite the tremendous potential it holds for improving global health, genomics challenges policy-makers to ensure that its benefits are harnessed equitably across populations and nations. The classification of genomics as a global public good and the inequity encountered in the development and application of genomics knowledge are outlined in this paper, We examine the effect of the current patent system on the distribution of costs and benefits relating to genomics knowledge between countries of different economic strength. The global public goods concept provides a normative economic rationale for the modification of certain aspects of the current patent system and for the creation of complementary mechanisms to respond to the health needs of low-income and middle-income countries.
The technology associated with the care of surgical patients and the level of sophistication of biomedical research accompanying it are evolving at a rapid pace. Both new and old bioethical issues are assuming increasing levels of prominence and importance, particularly in this age of molecular medicine. The authors explore bioethical issues pertinent and relevant to surgeons. Four specific areas that are exemplary by presenting both major scientific and ethical challenges are briefly addressed: privacy of information, stem cells, gene therapy, and conflict of interest in biomedical research. All of these can be generalized to all surgeons. As bioethical issues today play a greater role in surgical practice than they did even a decade ago, it is hoped that this brief review on ethical issues in molecular medicine will help stimulate present and future generations of surgeons in thinking about the ethical dimensions of their work.
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The system for protecting human research subjects is under increasing pressure. Under the currently dominant Regulatory Ethics Paradigm, clinical research protocols must be reviewed and approved by an institutional review board (IRB) or equivalent. Although the IRB was introduced into health care in part to protect patients and investigators from the inherent conflict between the best clinical interest of the individual patient and the interest of science and society in answering a clinical question, its rigorous standards and rigid framework discourage surgeons from seeking potentially valuable early IRB consultation. Most of the important advances in the history of medicine, such as anesthesia, appendectomy, antibiotics, intensive care, and immunization, were introduced through an informal, unregulated innovation process that has been enormously productive but can lead to ratification of ineffective or harmful treatment by credulous physicians and patients. We propose a surgical innovation ethics paradigm that is a more nimble, flexible source of institutional and public oversight and approval of innovations that are in the gray zone prior to their conversion to formal protocols that then require IRB approval. We also discuss the management of personal and institutional conflicts of interest.
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