Katherine Eban’s Bottle of Lies: The Inside Story of the Generic Drug Boom is a chilling recount of real-life events surrounding the rise of the generic drug industry. Split into seven multi-chapter parts, complete with a prologue and epilogue, the book follows Dinesh S. Thakur, an ex-Ranbaxy employee who became an infamous whistleblower uncovering the unsatisfactory manufacturing and operating standards of Indian generic drug companies. What started out as a great public health endeavor to increase equity for patients through affordable generic versions of brand name drugs quickly devolved into an opportunity for companies to maximize profits by providing lower quality drugs to the poorest patients.
During his employment at Ranbaxy, an Indian generic drug company, Dinesh Thakur witnessed pervasive deception and fraud; drugs went untested, data were falsified, and products that did not meet the quality standards of one country were shipped to less rigorous markets. Not only were resulting generics less efficacious than their brand name counterparts, but there were also differences between generics themselves. Furthermore, the FDA’s bioequivalence standard only considers the comparisons of peak drug concentrations and does not take into consideration the differences in release rates over time. In the US, physicians and patients were noticing that when patients who had previously been stable switched from brand name to certain generic drugs, their symptoms reappeared or worsened.
After leaving Ranbaxy, Thakur took it upon himself to reveal what he had become privy to during his time in India. The resulting litigation case spanned several years and faced countless hurdles. The FDA was under pressure to approve more generic drug applications and the Justice Department simply did not seem to prioritize the case. In the midst of this, Ranbaxy was approved to launch the highly sought-after atorvastatin, the first generic version of the cholesterol lowering drug Lipitor. As the best-selling prescription drug in world history, any delays in generic production would have been costly to the US government. Eventually, the Ranbaxy case concluded with a $500 million settlement, the largest settlement to date with a generic drug manufacturer. However, even today, there remains significant difficulty in regulating the quality of international drug markets.
This book is a thoroughly captivating tale suitable for lay and professionals audiences alike. It addresses issues that may not be widely known, even among healthcare professionals, and serves as an important impetus for readers to be critical of the medications they take and brings awareness to the inequities faced by patients in countries with less regulatory power.