Risk communication: the Avandia case, a pilot study

Abstract

On 21 May 2007, the New England Journal of Medicine published Nissen and Wolski’s article entitled ‘Effect of rosiglitazone on the risk of myocardial infarcation and death from cardiovascular causes.’ The publication of the article had immediate ramifications. The producer of rosiglitazone (under the trademark Avandia^®); GlaxoSmithKline, saw its share price fall 8% on the day of the publication, and it led to front-page headlines in national newspapers in Europe and North America. This article evaluates the risk-communication strategies of the various actors involved in the Avandia case from the time of the Nissen and Wolski article to the present day. The evaluation is based on a content analysis of a number of USA and UK newspapers from the period January 2007 to May 2008, interviews with GlaxoSmithKline staff, drug regulators (EMEA, Medicines and Healthcare Products Regulatory Agency and US FDA), journalists at the Wall Street Journal and the Financial Times, and advisors to US politicians (Congressional staffers).

Keywords::

• Avandia^®
• drug safety
• risk communication
• US FDA

Financial & competing interests disclosure

In conducting this research materials, consultancy fees, assistance and travel grants were provided by Astra Zeneca, Biogen Idec, Dutch Medical Evaluation Board, Eli Lilly and Company, EMEA, US FDA, Medicines and Healthcare products Regulatory Agency, Pfizer Global Research and Development, and the Swedish Medical Products Agency. The research on which this article is based was partially funded by Eli Lilly. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.