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The dilemma between efficacy as defined by regulatory bodies and effectiveness in clinical practice.

In order to be launched on the market, drugs must be considered to meet the safety, efficacy, and pharmaceutical quality criteria established in the German Medicines Act. Drugs are evaluated within the framework of a risk/benefit analysis, as it is called in the Act, performed by the licensing authorities on the basis of clinical trial results submitted by the manufacturer. If the risk/benefit analysis is unfavorable, approval may be refused. 
 
From a physician’s perspective, however, the availability of data or the best available evidence when a drug is licensed is rather unsatisfactory. This is because the Phase II or III clinical trials conducted before approval are of little use in drawing conclusions on the therapeutic effectiveness of new drugs in ordinary conditions. 
 
This was evidently the reason that led Mariam Ujeyl and her colleagues to evaluate the features of 81 licensing studies of 39 drugs that had been presented to the European drug approval body, the EMA (European Medicines Agency), in 2009 and 2010, in a striking piece of scientific research (1). The results were sobering and should give pause for thought to those who still equate approval with proof of benefit: information on a patient-relevant endpoint was provided for only 46% of approvals, and for only 28% of approvals was it possible to determine whether the new drug was superior to an active control.