From HealthAffairs. By Aaron S. Kesselheim and Jerry Avorn. At a time of rapidly developing new medications and growing public health challenges, there is now no official leadership in place at the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, and the Office of the Surgeon General. Marty Makary's legacy will be that he undercut many of the key principles that had made the agency one of the most important public health institutions in the

From The People’s Pharmacy. Abstract "Americans spend more on drugs and have less to show for it than people in other countries. The FDA used to be the envy of the world. Has it been captured by the pharmaceutical industry it's supposed to regulate?" In this wide-ranging episode of The People's Pharmacy — one of the most substantive and practically useful interviews in the archive — Dr. Jerry Avorn joins hosts Joe and Terry Graedon for a 70-minute conversation covering the er

From American Society for Pharmacy Law (ASPL). In this special edition premiere of Post Scrip, host Henry sits down with Dr. Jerry Avorn, MD, Harvard Medical School professor and author of the groundbreaking book Rethinking Medications: Truth, Power and the Drugs You Take. Dr. Avorn, a senior internist at Mass General Brigham and author of over 600 papers, takes us on a dive into the complex world of drug approval, pricing, and pharmaceutical policy. This episode explores how

From Causes or Cures Podcast with Dr. Eeks. In this episode of Causes or Cures, Dr. Eeks chats with Dr. Jerry Avorn, a Professor of Medicine at Harvard Medical School, drug safety watchdog, and author of Rethinking Medications: Truth, Power, and the Drugs You Take. If you’ve ever felt uneasy about the rising cost of prescription drugs, the process or speed by which new meds are approved, or why the side effects list is longer than your grocery receipt, this episode is for you

From Big Brains Podcast. Teaser/Abstract "When a patient gets a medication from their doctor or nurse practitioner, they assume that somebody has looked very carefully at this drug and determined that it is indeed effective for the purposes for which it's being given to you and that it's reasonably safe. I frankly think a lot of us doctors believe that that's all kind of taken care of as well." Source: Big Brains podcast, University of Chicago Podcast Network, Episode publish

From Science-Based Policy. By David Weinberg. Teaser/Abstract "Rethinking Medications: Truth, Power, and the Drugs You Take by Jerry Avorn presents a critical appraisal of the state of the prescription medications in the United States. It explores the complex relationships among drug companies, regulators, prescribers, academics, and patients. The book is part history of US drug regulation, part critique of the status quo, and finally, a roadmap for a better path forward." S

From NPR's On Point. By Paige Sutherland and Deborah Becker. Teaser/Abstract "With more than 60% of Americans taking a prescription drug, there are increasing questions about how these medicines are approved, how they're kept safe and how they're priced. In a new book, Harvard's Dr. Jerry Avorn argues the drugs we take have been compromised by profits." Source: On Point with Meghna Chakrabarti, WBUR Boston, April 21, 2025. Host: Deborah Becker. Duration: 45 minutes 32 seconds

From The Washington Post. By Jerry Avorn, MD. SUMMARY: In this Washington Post opinion piece, Dr. Avorn argues that the FDA's binary approve-or-reject framework is structurally ill-suited to drugs like Leqembi (lecanemab), which occupy a gray zone of modest benefit and meaningful risk. Leqembi offers only modest benefit for Alzheimer's disease, could pose worrisome safety risks, and stands to cost the nation $2 billion to $5 billion per year. Avorn contends that even when a d

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 Jerry Avorn, MD and Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM Perspective examines an unprecedented role reversal in the COVID-19 vaccine approval process. In September 2020, nine pharmaceutical company leaders took the unusual step of pledging not to apply for vaccine approval until adequate trial data were available — signaling caution — while the federal government was simultaneously pushing to accelerate emergency au

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 Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH; Ameet Sarpatwari, JD, PhD. SUMMARY: This NEJM Perspective by Avorn, Kesselheim, and Sarpatwari evaluates the FDA Amendments Act of 2007 (FDAAA) a decade after its enactment. The authors open by situating the FDAAA within the long history of US drug regulation, which has been shaped by crises: Progressive-era concerns about patent medicines led to the 1906 Pure Food and Drug Act; th

From the New England Journal of Medicine. By Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD; Jeremy A. Greene, MD, PhD. SUMMARY: This NEJM Perspective by Kesselheim, Avorn, and Greene examines the legal and regulatory framework governing generic drug safety, with particular focus on the question of who bears responsibility when a generic drug causes harm. The piece engages the then-contested legal question of whether generic manufacturers could be held liable for inadequat

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 the New England Journal of Medicine. By Jerry Avorn, MD and Sebastian Schneeweiss, MD, ScD. SUMMARY: This NEJM Perspective by Avorn and Schneeweiss addresses the challenge of managing the growing volume of drug-risk data emerging from pharmacovigilance systems, post-market studies, and meta-analyses. The authors examine how clinicians and patients should interpret and act on the constant stream of new numbers — relative risks, absolute risks, number-needed-to-harm — gene

From the New England Journal of Medicine. By Jerry Avorn, MD. SUMMARY: In this NEJM Perspective, Dr. Avorn defends the field of pharmacoepidemiology against critics who argue that observational data are inherently unreliable and that only randomized controlled trials can provide valid evidence about drug effects. Avorn argues for a both/and approach — the yin and yang of drug research — in which RCT and observational methods complement each other, each suited to answering dif

From the New England Journal of Medicine. By Jerry Avorn, MD. SUMMARY: This NEJM Perspective by Dr. Avorn examines the concealment of adverse drug effect evidence, using the Vioxx withdrawal and the FDA aprotinin (Trasylol) warning as central case studies. Avorn opens with the September 2004 Merck announcement that rofecoxib doubled the risk of myocardial infarction and stroke — leading to its withdrawal after five years of use in more than 20 million patients — and argues th

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