What are the real lessons from Vioxx®?

The Vioxx® situation was not a failure of regulation itself, neither was it an issue of data collection, nor of the quality of studies performed. It was and is a complex decision-making/communication challenge in which some improvements are possible. Making wise drug safety decisions is not easy and is made worse by: • a lack of clear goals of acceptable benefit and risk for those who are affected; i.e. the patients; • decisions being driven by legal and bureaucratic concerns rather than the need to provide timely and well thought out communication; • regulatory structures being overly cumbersome already, overwhelmed by data from the pharmaceutical industry, not transparent and such that they do not include procedures for assessing impact of their actions; • the need for regulatory agencies to consult the pharmaceutical industry before decisions are made and information given, rather than consulting patients; • the pharmaceutical industry taking all the punishment (and therefore being defensive), when decisions are shared with regulators; • regulators lacking resources to perform studies quickly; • safety departments in the pharmaceutical industry being over-ruled due to marketing issues and concerns over litigation; • the pharmaceutical industry being one that is strongly driven by market forces, leading to small safety budgets. © 2005 Adis Data Information BV. All rights reserved.