Vioxx and other pharmaceutical product withdrawals: ethical issues in ensuring the integrity of drug and medical device research, development and commercialization

Abstract

The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of products by commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems.