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Thursday, 09.07.2020

Katherine Eban: Bottle of Lies. The Inside Story of the Generic Drug Boom

New York: Harper Collins; 2019,  p.482

Reviewed by Barry Blackwell

 

       The outrageous cost of brand name drugs in America continues to provoke press and public outrage (New York Times 2019), fueled by legislation that prohibits Medicare from bargaining with avaricious manufacturers. An appealing but precarious alternative are generic drugs, clouded by doubts about equivalency, concerns about diminished efficacy and increased side effects.

       A recently published volume Bottle of Lies, The Inside Story of the Generic Drug Boom, by Katherine Eban casts a long awaited and desperately needed floodlight on this predicament. As prescribers, our patients often complained but were seldom mollified when we alleged the FDA tested for and insisted on bio-equivalency.

       So read this recently published book (2019) to learn the startling and little-known truth about the drug industry and generic drugs. In the past two years the FDA has approved some 1,600 generic drugs that constitute 90% of those prescribed. This volume’s 482 pages and 28 chapters of scintillating prose are written by an investigative journalist and Andrew Carnegie Fellow, educated at Brown University and Oxford where she was a Rhodes Scholar.

       Over a four-year period Eban visited China, Ghana, India, Africa, Brazil, Mexico and Britain. End notes to each chapter document her sources, including 20,000 FDA documents, some the product of 16 Freedom of Information requests. She interviewed more than 240 informants including regulators, scientists, criminal investigators, doctors, patients, lawyers, whistleblowers, diplomats and politicians. She visited four pharmaceutical companies and 13 manufacturing plants, interviewing executives.

       Eban’s data yields a remarkable oeuvre, a saga global in scope and redolent with detail that tells a fabulous tale. It begins in 1935 when the first Indian pharmaceutical company was founded.  At the outbreak of the Second World War, when the European drug industry collapsed, Gandhi urged Cipla Corporation to begin manufacturing drugs for the British and America troops (quinine for malaria and vitamin B12 for anemia).

       The tale Eban tells continues today with still unresolved issues. The author’s prose paints a distinctive picture of the personalities, manufacturers, issues and conflicts in the evolving generic drug industry.

       The major scenario is between Ranbaxy, India’s largest generic manufacturer, its corrupt executives and the FDA’s often overwhelmed, sometimes inept investigative and legal staff. Corporate CEOs, whistleblowers, diplomats and politicians (including Bill Clinton and his Foundation) stir the mix.  Underlying the slugfest is an industry embedded in an Indian culture of bribery (baksheesh), bold faced fraud, corruption and threats of violence. Malfeasance on a massive scale often outwitting an understaffed, bewildered and ineffectual FDA, struggling to uphold its mandate to monitor manufacturing practices in an unhospitable foreign country with its own laws and customs.

       Bottle of Lies is an informative, entertaining and intriguing page turner telling a story far too long under wraps that every physician prescribing drugs and every patient taking them should read to know the truth the FDA never told the public.

 

Reference:

The Editorial Board. Sound, Fury and Prescription Drugs. Despite talk of reform, drug prices keep climbing. Here’s how to change that. New York Times, July 6, 2019.

 

December 12, 2019