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

With Mirko von Hein and The Pharma Perspective. Harvard professor Jerry Avorn and I discuss drug regulation, FDA approval standards, surrogate endpoints, pharmaceutical pricing, public research funding, medical misinformation, and what all of this means for patients, innovation, and health policy.

From STAT First Opinion. By Jerry Avorn. Abstract "Around 1990, a bright, young Harvard academic became interested in the possibility that a relatively unknown peptide might slow gastric emptying and reduce hunger — a potential boon to the treatment of diabetes. Although he was employed as a full-time faculty researcher and clinician at a major teaching hospital and his lab was funded by the National Institutes of Health, he chose to pursue this particular line of research pr

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 Changing Minds Podcast. Teaser/Abstract "How do we stay the course and stay rooted in facts amidst a major disruption impacting the healthcare landscape? 'Godfather' and originator of academic detailing Jerry Avorn joins the show to share his reflections on the current state of healthcare; the history of treatment and medications prior to rigorous study; his new book, Rethinking Medications; the critical importance of treating evidence, facts, and science as our collecti

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 American Journal of Epidemiology. By Jerry Avorn, MD. SUMMARY: This invited commentary in the American Journal of Epidemiology addresses the origins, current status, and future possibilities of interventional pharmacoepidemiology — a field that uses epidemiological methods not merely to study drug use and outcomes but to actively intervene to improve prescribing. Avorn, one of the founders of this approach through his landmark 1983 academic-detailing trial, reflects

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 Jonathan J. Darrow, SJD, JD, MBA; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH. SUMMARY: This NEJM review evaluates the FDA breakthrough-therapy designation program, created by Congress in 2012 to accelerate testing and approval of drugs with potential for substantial improvement over existing treatments. Darrow, Avorn, and Kesselheim systematically examine the first four years of the program's operation, assessing which drugs

From the New England Journal of Medicine. By Jerry Avorn, MD. SUMMARY: In this NEJM Perspective, Dr. Avorn critically examines a widely cited claim by an industry-supported research center that it costs pharmaceutical companies $2.6 billion to develop a new drug. Avorn identifies significant methodological concerns with this estimate, including its reliance on industry-provided data, its inclusion of the opportunity cost of capital as an actual cost, and its failure to accoun

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 Health Affairs. By Michael Fischer, MD and Jerry Avorn, MD. SUMMARY: This Health Affairs article by Fischer and Avorn argues that academic detailing — the practice of providing clinicians with personalized, evidence-based educational outreach — is well positioned to help translate comparative effectiveness research (CER) findings into improved prescribing. As the national emphasis on CER generates growing volumes of head-to-head comparisons of drugs and other interventio

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 and Michael Fischer, MD. SUMMARY: This Health Affairs article by Avorn and Fischer addresses the challenge of translating comparative effectiveness research (CER) findings from the bench into actual improvements in clinical practice. The authors argue that the national investment in CER — stimulated in part by the American Recovery and Reinvestment Act — will generate an unprecedented volume of new head-to-head comparisons of drugs and

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