Author Affiliations: Department of Epidemiology, Leiden University Medical Center, Leiden, the Netherlands (Dr Vandenbroucke); and the Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington and Center for Health Studies, Group Health, Seattle (Dr Psaty).
The central theme of the Institute of Medicine report on the US drug safety system was the need for a life cycle approach to drug evaluation: both the benefits and the risks need to be evaluated and integrated during the entire market life of a drug.1 The Food and Drug Administration Amendments Act of 2007 also called on the agency to improve its methods of communicating risks and benefits to patients and physicians. The Institute of Medicine recommendation to “develop and continually improve a systematic approach to risk-benefit analysis for use throughout the [Food and Drug Administration] in the preapproval and postapproval settings” specifically acknowledges the need for and the challenges of the development of new methods of combining evidence about risks and benefits.1
Vandenbroucke JP, Psaty BM. Benefits and Risks of Drug TreatmentsHow to Combine the Best Evidence on Benefits With the Best Data About Adverse Effects. JAMA. 2008;300(20):2417-2419. doi:10.1001/jama.2008.723