A maladaptive pathway to drug approval

The European Medicines Agency (EMA) has embraced a new model of drug testing and marketing called “adaptive pathways”, allowing new drugs for “unmet medical needs” to be launched on the market faster, on the basis of fewer data. While industry claims this is necessary, an analysis on thebmj.com looks at the assumptions underlying the new pathway, and raises concerns about the negative impact on patient safety and the cost of healthcare. To discuss, we're joined by Courtney Davis, senior lecturer at King’s College London, Peter Gøtzsche, director of the Nordic Cochrane Centre and Joel Lexchin, a professor at York University in Toronto. Read the full analysis: http://www.bmj.com/content/354/bmj.i4437