Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

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FDA approved concept. Rubber stamp with FDA and pills on craft paper. 3d illustration.

Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

By Matthew Chun

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust, oncologist Mikkael A. Sekeres tells a captivating story of how the U.S. Food and Drug Administration became the agency it is today and how it makes some of its toughest decisions regarding the regulation of potent drugs.

Sekeres centers his narrative on the controversial 2011 Avastin hearings, in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug. Having served on the Oncologic Drugs Advisory Committee (ODAC) tasked with making a recommendation to the FDA based on the hearings and clinical data, Sekeres provides a relatable personal account of the emotion-filled proceedings and the agonizing decision to withdraw approval of a beloved treatment option that never lived up to its promising initial results.

As he recounts his experience as an ODAC member, Sekeres skillfully weaves in historical references to various regulatory failures, including poisoned vaccines, opioid deaths, thalidomide-induced birth defects, and the woefully inadequate response to HIV/AIDS, which shaped the role of the FDA since its inception in 1930. Upon describing how the FDA developed its modern system of checks and balances to ensure drug safety, efficacy, and accessibility, Sekeres then illustrates how the Avastin hearings put all of these processes and values to the test. Among other things, Drugs and the FDA encourages readers to grapple with several important themes that pervade the agency’s decision-making process, including (1) the tension between drug safety and accessibility, (2) the relative weight of expert opinion versus patient autonomy, and (3) the role of democracy and transparency in drug regulation.

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A calculator, a stethoscope, and a stack of money rest on a table.

Why Our Health Care Is Incomplete: Review of “Exposed” (Part I)

By: Daniel Aaron

Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. This book review will offer an analytical discussion of “cost exposure,” the main subject of his book.

What is cost exposure in health care?

Cost exposure is payments people make related to their medical care. There are many ways patients pay – here are a few common ones.

  • Deductible – Patient is responsible for the first, say, $5,000 of their medical care; after this point, the health insurance kicks in. Resets each year.
  • Copay – Patient pays a specific amount, say $25, when having an episode of care.
  • Coinsurance – Patient pays a specified percentage, say 20%, of care.

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