Two Centuries of Assessing Drug Risks

From the New England Journal of Medicine

By Jerry Avorn, MD

SUMMARY: In this NEJM Perspective, Dr. Avorn surveys two centuries of drug risk assessment in the United States, tracing how society's capacity to identify, measure, and respond to the harms caused by medications has evolved from the era of patent medicines to the sophisticated pharmacovigilance infrastructure of the modern FDA. The piece contextualizes contemporary drug safety challenges — including rofecoxib (Vioxx), aprotinin (Trasylol), and other widely used drugs found to cause serious harm — within this longer historical arc, examining what each era's failures reveal about the persistent challenges of post-market safety surveillance. (Note: Full text paywalled; summary based on publicly available title, description, and field context.)

BACKGROUND: The history of drug safety assessment in the United States spans over two centuries, from early patent medicine abuses through the progressive-era Pure Food and Drug Act and the modern FDA pharmacovigilance system.

KEY FINDINGS: Not fully retrievable from publicly available text; article is paywalled. The piece examines drug safety controversies including rofecoxib and aprotinin as case studies in the challenges of post-market safety detection.

IMPLICATIONS: Historical perspective on drug risk assessment reveals persistent structural challenges in detecting post-market harms and suggests lessons for improving pharmacovigilance systems.