A Critical Appraisal of the State of the Prescription Medications in the US

From David Weinberg | Science-Based Policy

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."

Source: Science-Based Medicine, May 28, 2025. Reviewer: David Weinberg, MD (emeritus Professor of Ophthalmology and Visual Science, Medical College of Wisconsin). Note: This is a third-party review of Dr. Avorn's book, not a primary source authored by Dr. Avorn.

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SUMMARY

Reviewer David Weinberg offers a comprehensive, highly favorable assessment of Rethinking Medications, describing it as "a critical appraisal of a highly flawed health care system" that is simultaneously engaging, informative, and appropriately alarming. He characterizes the book as part history of US drug regulation, part critique of the status quo, and part roadmap for reform — structured, unusually, around a series of "morbidity and mortality" case studies drawn from the history of pharmaceutical approval, safety surveillance, pricing, and communications. He recommends it for medical professionals, policymakers, pharmaceutical professionals, and healthcare consumers alike.

BACKGROUND

Weinberg provides useful context on Dr. Avorn's background and the institutional setting in which his work developed. Following his internship and residency at Harvard's teaching hospitals, Dr. Avorn assembled a multidisciplinary team — physicians, epidemiologists, policy experts, statisticians, lawyers, and ethicists — focused on everything that needs to go right, but sometimes goes wrong, after a new molecule is discovered and before it enters routine clinical use. This team grew to become the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham and Women's Hospital. All DoPE faculty are prohibited from receiving personal remuneration from the pharmaceutical industry. Despite what Weinberg describes as less-than-universal embrace by colleagues and leaders in the Harvard community, DoPE has been highly productive and influential, and Dr. Avorn is among the most cited researchers in the US.

Weinberg notes that Dr. Avorn explicitly structures the book as a series of morbidity and mortality (M&M) conference presentations — the case-review sessions in which physicians analyze bad outcomes to understand what went wrong and prevent recurrence. Applied to pharmaceutical policy, this structure focuses each section on a documented failure in drug approval, safety surveillance, pricing, or communication, placed in historical context and followed by reform recommendations.

KEY FINDINGS

The review summarizes the book's six parts, providing a useful structural map of its contents.

Part One: Does It Work? Addresses FDA approval standards and the erosion of evidentiary rigor under industry pressure. The central case study is Aduhelm, the Alzheimer's drug approved despite a failed clinical trial and a unanimous negative vote from the FDA's expert advisory panel. The drug was eventually pulled from the market when payors refused to cover it. Other regrettable FDA decisions are also discussed.

Part Two: Is It Safe? Focuses on drug safety and examples of missed, downplayed, or suppressed safety signals. The primary case study is Vioxx, Merck's anti-inflammatory blockbuster with peak sales exceeding $2 billion per year. Data from multiple sources, including Dr. Avorn's pharmacoepidemiology unit, demonstrated increased cardiovascular risk. Safety signals were present in the earliest large clinical trials. Merck obfuscated, distracted, and denied the findings until the evidence was irrefutable. The drug was withdrawn from the market, and Merck paid billions in lawsuits. Weinberg quotes the book directly: "Merck's blockbuster product Vioxx, an anti-inflammatory drug that was the best-selling medicine in the world before it turned into one of the biggest drug safety problems ever, taught us a lot about how to rethink the risks of medications, why we sometimes get that wrong, and what we can do to manage things better."

Part Three: What Should It Cost? Examines US drug pricing. Patients and payors in the US pay more for drugs than in any other country. Current laws prohibit the government from meaningful price negotiation. Middlemen in the supply chain — particularly pharmacy benefit managers — impose additional charges in service to their own profits. Drug companies manipulate the patent system by extending exclusivity well past standard patent protection through "evergreening" strategies. American taxpayers fund substantial drug development through the NIH yet continue to pay premium prices, receiving no financial benefit as early-stage investors when a drug becomes a blockbuster.

Part Four: Spreading the Word. Analyzes how physicians and patients are informed about medications. Pharmaceutical companies control the message through discretion over what is published about their products, large advertising budgets targeting both physicians and patients directly, payments to physician "opinion leaders," and polished sales detailing forces that visit physicians regularly. In response, Dr. Avorn founded academic detailing — the practice of providing working physicians with spin-free, evidence-based drug assessments using the same interpersonal communication techniques as pharmaceutical sales representatives, but without commercial motivation.

Part Five: Mind-Altering Examples. Two chapters address specific drug categories. The first examines the challenges of investigating hallucinogens and other mind-altering drugs as potential therapeutic agents. The second is a post-mortem of the opioid crisis.

Part Six: Empowering the Patient. A critique of the US healthcare system in which lifesaving drugs are inaccessible or unaffordable to many. Dr. Avorn recounts his own activism, including a year-2000 ballot initiative in Massachusetts — which he organized with similarly motivated allies — designed to ensure universal healthcare access. The initiative failed, pitted against an opposition heavily funded by the commercial healthcare industry. Weinberg notes that the effort may nonetheless have been a catalyst for "Romneycare," Massachusetts Governor Mitt Romney's subsequent universal healthcare program, which in turn became a model for the Affordable Care Act.

IMPLICATIONS

Weinberg's assessment is that "Big Pharma" invective is common but that this book rises above it: "It is a thoughtful dissection of a complex system; with careful consideration of each of the component parts: drug companies, lawmakers, regulators, insurance companies, and physicians." He notes that Dr. Avorn names members of his own Harvard community when warranted, and that the book is extraordinarily up to date, including discussion of the implications of the 2024 election and the appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services. Weinberg's final verdict: "Dr. Avorn builds his case skillfully and litigates his recommendations for reform persuasively. It is appropriate reading for medical professionals, policy makers, pharmaceutical professionals, and healthcare consumers. Highly recommended."