The Case for Transparency – AVANDIA?

In December, I argued for more transparency in relation to clinical trials, and hoped that the Commission would take up this issue in the forthcoming revision of the Clinical Trials Directive. I thought it might be useful to look at particular cases where more or earlier transparency might have saved lives or reduced harm.

Take the Glaxo diabetes medicine, Avandia (rosiglitazone), withdrawn from the European market in 2010 and subject to severe restrictions in the US. Did the company have information from research that might have led to an earlier withdrawal if it had been made publicly available sooner?

Well, yes, according to the US Senate Finance Committee which accused the company in July 2010 of failing to publish in good time a number of studies that showed problems with Avandia, and of using “ghost-writers”, professional writers paid by the company, to present the results of their clinical trials...