Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.
Kaiser Permanente Washington Health Research Institute, Seattle, WA.
Med Care. 2018 May;56(5):384-390. doi: 10.1097/MLR.0000000000000897.
Despite the good intentions of the Food and Drug Administration (FDA), many drug warnings are ineffective or have unintended consequences, particularly if the media exaggerates the messages and scares the public. The controversial 2003 to 2004 FDA warnings on youth suicidality associated with antidepressant use are a case in point. In a 10-year interrupted time series (ITS) analysis in 11 health plans, we found that the warnings and hyped media coverage led to substantial reductions in antidepressant use (declines in antidepressant use and overall care corroborated in several studies), and small, visible increases in emergency room and inpatient poisonings with psychotropic drugs. In a gross misunderstanding of the method, Dr Stone calls ITS, "an intuition based upon false analogies, fallacious assumptions and analytical error." We demonstrate visually using published studies that the ITS method is one of the oldest (hundreds of years) and strongest quasi-experimental study designs, and that the alternative data analyses proposed by Dr Stone do not have rates (denominators), nor baselines, so the measures of change are invalid.
尽管美国食品和药物管理局（FDA）的初衷良好，但许多药物警告要么无效，要么产生了意想不到的后果，尤其是如果媒体夸大了这些信息并吓到了公众。有争议的 2003 年至 2004 年 FDA 关于抗抑郁药使用与青少年自杀意念相关的警告就是一个很好的例子。在 11 项健康计划的 10 年间断时间序列（ITS）分析中，我们发现这些警告和媒体的大肆报道导致抗抑郁药的使用大幅减少（在几项研究中，抗抑郁药的使用和整体护理都得到了证实），而精神药物的急诊室和住院中毒事件则明显增加。斯通博士错误地将 ITS 理解为“一种基于错误类比、错误假设和分析错误的直觉”，这是对该方法的严重误解。我们使用已发表的研究进行了直观的演示，表明 ITS 方法是最古老的（数百年）和最强的准实验研究设计之一，而斯通博士提出的替代数据分析方法既没有比率（分母），也没有基线，因此变化的衡量是无效的。
