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 antiinflammatory 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.T raditional non-steroidal anti-inflammatory drugs (NSAIDs) decrease the pain and swelling associated with inflammatory conditions, such as rheumatoid arthritis; however, their chronic use increases the risk of severe gastric side effects, including haemorrhage. The new class of anti-inflammatory drugs known as cyclooxygenase (COX)-2 inhibitors were developed with the aim of decreasing the pain and swelling of inflammation without the increased risk of adverse gastric events.

Animal studies of the functional consequences of suboptimal polyunsaturated fatty acid status during pregnancy, lactation and early post‐natal life

“…On the basis of animal studies and a consideration of basic, non‐EBM research in humans, many trials would be blatantly unethical or impossible to conduct in humans. An ethical sense has been broached as a guide for health practice (James & Cleland 2004).…”

The story of Vioxx—no pain and a lot of gain: ethical concerns regarding conduct of the pharmaceutical industry

“…), r using medical research and consequent publications to obfuscate rather than provide guidance. Second, it might be of interest that, in cases of conflicting medical data (as with Vioxx), each practitioner tries to apply a "research ethics committee" approach to their daily practice [9]. This "good clinical practice" may seem burdensome when applied to every medical act; however, informing patients about potential adverse side effects (which need not be exhaustive) does fall within the scope of duty of care.…”

Cyclooxygenase-2 inhibitors: what went wrong?

“…Based on analysis of the ethical issues, we have argued that, in a research environment, a Research Ethics Committee would have had no problem in dealing with the apparent controversy. The Committee would simply insist that the myocardial infarction results in the VIGOR study were included in the participant information sheet, thereby allowing research participants to balance the possibilities [40]. It was argued further that, in the therapeutic arena, there was at least in some jurisdictions a legal obligation to disclose information on cardiovascular risk with Vioxx use.…”

“…It was argued further that, in the therapeutic arena, there was at least in some jurisdictions a legal obligation to disclose information on cardiovascular risk with Vioxx use. Due to a precedent set by a judgement from the High Court of Australia in 1992 in a case involving duty of disclosure of information, it is highly likely that there was a legal obligation to convey the possibility of cardiovascular risk to patients being prescribed Vioxx [40]. In 2005 there are many legal actions in place against Merck & Co. in relation to Vioxx use.…”