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Journal of Long-Term Effects of Medical Implants
Abstract of "Translating Evidence from the Technical to the Social for Regulatory Approval"
Bioethics Faculty of Medicine, Dalhousie University, Halifax, NS, B3H 3J5 Canada
Social, technical, and moral issues surround the construction and interpretation of research data and how scientific evidence is used to arrive at regulatory and policy decisions. When a new pharmaceutical or biological agent receives its federal market approval in Canada, i.e., a Notice of Compliance, the public assumes that the product is safe, effective, and of consistent quality. When provincial committees refuse to fund these same products, citizens are understandably confused. Our newspapers regularly feature stories about patients seeking treatments outside of their own jurisdictions, and of inequities and access issues associated with different formulary decisions. Using longitudinal ethnographic data and techniques and analytical tools from anthropology, science and technology studies, and epidemiological critical appraisal, this paper compares scientific evidence to policy decisions at various sites of the pharmaceuticals life cycle and regulatory process. Structural constraints at each level of the therapeutic product life cycle, many of which are neither transparent nor subject to accountability, lead to different weights given to evidence. Conclusion: This succeeds in altering the essential balance of risks and harms used in working out the details of a decision. Variability in negotiation, in assessing the science, and in public pressure result in differences of opinion regarding what new therapies will be accessible. Issues of public involvement, corporate drivers, clinical judgment, political will, and scientific evidence are involved. The scientific and policy nuances of premarket product approval along with the wider implications to understanding the current shift toward emphasizing postmarket regulatory follow-up are addressed.
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