title: Applying a research ethics committee approach to a medical practice controversy: the case of the selective COX-2 inhibitor rofecoxib.
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.
authors.affiliation: Rheumatology Unit, Royal Adelaide Hospital, Adelaide, SA, Australia. michael.james@adelaide.edu.au
authors.forename: M J
authors.initials: MJ
authors.lastname: James
authors.forename: L G
authors.initials: LG
authors.lastname: Cleland
mesh_terms: D002318:Cardiovascular Diseases / Q000139:chemically induced; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D004345:Drug Industry / Q000941:ethics*; D028744:Ethics Committees, Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007783:Lactones / Q000009:adverse effects*; D040541:Marketing / Q000941:ethics*; D011364:Professional Practice / Q000941:ethics*; D011643:Publishing / Q000941:ethics; D013450:Sulfones
chemical_list: D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib