Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/9621
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Type: | Journal article |
Title: | Applying a research ethics committee approach to a medical practice controversy: the case of the selective COX-2 inhibitor rofecoxib |
Author: | James, M. Cleland, L. |
Citation: | Journal of Medical Ethics, 2004; 30(2):182-184 |
Publisher: | British Med Journal Publ Group |
Issue Date: | 2004 |
ISSN: | 0306-6800 1473-4257 |
Statement of Responsibility: | M J James and L G Cleland |
Abstract: | The new class of anti-inflammatory drugs, the COX-2 inhibitors, have been commercially successful to the point of market dominance within a short time of their launch. They attract a price premium on the basis that they are associated with fewer adverse gastric events than traditional anti-inflammatory drugs. This marketing continues even though a pivotal safety study with one of the COX-2 inhibitors, rofecoxib, showed a significant increase in myocardial infarction with rofecoxib use compared with a traditional anti-inflammatory drug. This finding has led to a series of publications containing pooled analyses of existing data that both support and refute the possibility of increased cardiovascular risk with COX-2 inhibitors. These medical journal publications have served to obfuscate rather than provide guidance for medical practitioners. Consideration of a research ethics committee approach to this issue suggests that it would deal with the controversy in a straightforward manner—namely, it would simply inform research participants of the trial results with rofecoxib. The certainty of this research ethics committee approach raises the issue of whether it should be applied in normal medical practice outside of the research environment. A consideration of the legal tests for disclosure of information suggests that therapeutic medical practice should mirror that within the research environment, in this case. |
Keywords: | COX-2 research ethics committee rofecoxib duty to inform |
Description: | © 2004 BMJ Publishing Group Ltd & Institute of Medical Ethics |
DOI: | 10.1136/jme.2003.004515 |
Published version: | http://jme.bmj.com/cgi/content/abstract/30/2/182 |
Appears in Collections: | Aurora harvest Medicine publications |
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