Counterpoint: Staying Honest When Policy Changes Backfire

摘要

Despite the good intentions of FDA, many drug warnings are ineffective or have unintended consequences, particularly if the media exaggerates the messages and scares the public. The controversial 2003–04 FDA warnings on youth suicidal ideation associated with antidepressant use are a case in point. In a 10-year interrupted time series analysis (ITS) 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 ER 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 in landmark studies that ITS is one of the oldest (hundreds of years) and strongest quasi-experimental study designs, and that his alternative data analyses do not even have rates (denominators), nor baselines, so the measures of change are invalid.