Editor’s Commentary: Assessing Worst-Case Scenarios in Regulatory Science

Abstract

Last year we introduced several new categories of submissions, including Letters to the Editor. The first two letters were published in the September 2011 issue of the Journal, one from Dr Norman Stockbridge (FDA) and the other from Dr Larry Satin (Cardiocore). Both letters addressed an Expert Commentary on ambulatory blood pressure measurement (ABPM) by Professor Eoin O’Brien entitled ‘‘Why ABPM Should Be Mandatory in All Trials of Blood Pressure–Lowering Drugs.’’ Of note is that one comment contained in Dr Stockbridge’s letter has already been highlighted by speakers at several international conferences, and has therefore generated ongoing discussion. This issue of the Journal contains two Commentary pieces, one from Associate Editor Peter Pitts (president, Center for Medicine in the Public Interest, New York) and the other from Dr Michael Weber (professor of medicine at SUNY Downstate College of Medicine and chairman of the Center for Medicine in the Public Interest). They discuss issues of central importance to the practice of medicine in the United States, and Letters to the Editor from readers in response to these issues are encouraged.