Counter-Point: Staying Honest When Policy Changes Backfire

Abstract

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.

Figure 1

U.S. newspaper and television coverage of stories on pediatric antidepressant use and suicidality 2000–2010 from LexisNexis. We used LexisNexis database to collect data from all U.S. newspapers and U.S. TV transcripts from four major news networks CNN, ABC, CBS, and NBC. The search terms used were: suicid! AND (antidepressant! OR anti-depressant! OR antidepressiv! OR SSRI!) AND (child! OR pediatric!) AND FDA!

Figure 2

Rates of antidepressant use and psychotropic drug poisoning per quarter before and after the warnings among adolescents enrolled in 11 health plans in nationwide Mental Health Research Network. Reproduced with permission from British Medical Journal.

Figure 3

No Effect of FDA Warning to Reduce Refills of Propoxyphene Reproduced with permission from American Journal of Public Health. Trend in Propoxyphene Refill Rates (top half) and Dose per Prescription (bottom half) Dispensed by Retail Pharmacies in the US by Quarter from July 1978 through March 1981 Data provided from US FDA, based on National Prescription Audit.^,

Figure 4

Puerperal fever monthly mortality rates at Vienna Maternity Institution 1841–1849. Rates drop when implementing handwashing. Available publicly. Semmelweis I (1861). Die Aetiologie, der Begriff und die Prophylaxis des Kindbettfiebers. [The etiology, concept, and prophylaxis of childbed fever]. Budapest and Vienna: Hartleben.

Figure 5

Time Series of Average Number of Constant-Size Prescriptions per Continuously Eligible Patient per Month among Noninstitutionalized Patients Receiving Multiple Drugs (N=860) and Other Outpatients (N=8002). Reproduced with permission from The New England Journal of Medicine.