Research by Dr. Orla O'Donovan and Dr. Joel Lexchin on conflicts of interest policies and procedures in drug regulation agencies
18 Nov 2009
In light of debates about the relationship between interests and scientific expert judgments, and the potential for declarations of conflict of interest to minimize corporate bias, Orla O’Donovan from the School of Applied Social Studies and Joel Lexchin from York University, Canada (who was a visiting scholar in the School of Applied Social Studies in 2007) reviewed the approach to conflict of interest in three European drug regulatory bodies. These bodies were the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency in Britain and the European Medicines Agency. Their research, published recently in Social Science & Medicine, shows that official statements about conflict of interest laws and codes of practice in the three contexts suggest that conflicts of interest are prohibited. However, in practice, the approaches to conflict of interest in the three drug regulatory agencies presuppose and promote the ideas that conflicts of interest cannot and need not be eliminated as the risk of bias can be managed. Because the evidence about if and how conflict of interest affects micro-level decision-making in drug regulatory authorities is neither complete nor comprehensive, they advocate a precautionary principle model. Under this model conflict of interest would be prohibited on the grounds that it might influence the outcome of regulatory decisions. They conclude that the threats of serious damage to people’s health are too high to continue in the current direction.
For media coverage of this research see http://www.timesonline.co.uk/tol/news/world/ireland/article6907930.ece
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