How Drugs Work

From the New England Journal of Medicine. By Pieter A. Cohen, MD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective critically evaluates the Dietary Supplement Listing Act of 2022, arguing that the bill would create an appearance of regulatory reform while leaving the core problems of supplement oversight unresolved. The authors — Cohen, Avorn, and Kesselheim — contend that the Act's listing requirement would be largely symbolic, providing regu

From Health Affairs. By Aaron S. Kesselheim, MD, JD, MPH; Jonathan J. Darrow, SJD, JD, MBA; Martin Kulldorff; Beatrice L. Brown; Mayookha Mitra-Majumdar; ChangWon C. Lee; Osman Moneer; Jerry Avorn, MD. SUMMARY: This Health Affairs article provides a systematic overview of the processes by which vaccines are developed, evaluated, approved, and regulated in the United States, with explicit attention to how these processes would apply to COVID-19 vaccines being developed under e

From the New England Journal of Medicine. By Benjamin N. Rome, M.D. and Jerry Avorn, M.D. SUMMARY: This NEJM Perspective by Rome and Avorn examines how the COVID-19 pandemic stress-tested the US drug evaluation and approval infrastructure. Writing in April 2020 as the pandemic's first wave intensified, the authors argue that the pressure to act quickly in a public health crisis creates specific vulnerabilities in the normally rigorous process of evaluating whether drugs work

From the New England Journal of Medicine. By Chana A. Sacks, MD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective by Sacks, Avorn, and Kesselheim examines the case of solanezumab, a monoclonal antibody developed for Alzheimer's disease that failed to demonstrate meaningful clinical benefit in trials. The authors argue that the FDA's rejection of the drug — despite significant industry and patient-advocate pressure to approve it — served the pu

From HealthAffairs. By Aaron S. Kesselheim, Yongtian Tina Tan, and Jerry Avorn. Abstract Transformative drugs, defined as pharmaceuticals that are both innovative and have groundbreaking effects on patient care, are the “holy grail” of drug research and development. The sources of drug innovation are often debated, with pharmaceutical manufacturers arguing that high drug prices support innovative output from their sector. We studied the developmental histories of twenty-six d

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 (Vio

From Health Affairs. By Jerry Avorn, MD. SUMMARY: This Health Affairs article by Dr. Avorn uses the case of nesiritide (Natrecor) — a drug approved for acute decompensated heart failure that was rapidly adopted into widespread practice before post-market studies raised serious concerns about its safety and efficacy — to illuminate broader problems in the US drug approval and post-market surveillance system. The Natrecor story illustrates the risks of rapid clinical adoption o

From the New England Journal of Medicine. ByJerry Avorn, MD; Stephen B. Soumerai, MSPH; D. Everitt; D. Ross-Degnan; M.H. Beers; D. Sherman; et al. SUMMARY: This NEJM research article reports a randomized controlled trial in which an academic-detailing educational program was tested in nursing homes to reduce the inappropriate use of psychoactive (sedating) medications in elderly residents. Avorn, Soumerai, and colleagues randomized nursing homes and tracked prescribing outcom