Nonfiction Review: Bottle of Lies

Forget Stephen King. In Bottle of Lies: The Inside Story of the Generic Drug Boom, author and investigative journalist Katherine Eban writes about real-life horror scarier than any of King's novels! As sometimes happens, my book group chose this book that I wasn't interested in reading, and as almost always happens, I ended up being glad I'd read it! This engrossing, terrifying nonfiction book opens the door to the generic drug industry's dirty secrets.

Eban begins by taking an up-close look at one of the worst actors in the generic drug industry, Ranbaxy, an Indian company that is, thankfully, no longer in business. She details how the family-run company started and zeroes in on the personal and professional lives of some of the key players. This company was crooked in horrifying, shocking ways, from the top down. Top management willfully and knowingly manufactured medicines with no quality control, completely making up the data to get their drugs approved by the FDA and providing fraudulent data during their rare FDA inspections. One reason she spends so much time focusing on Ranbaxy is because what they did is not unusual in the generic drug industry. Many other companies, especially in India and China, commit similar frauds--making up their data to get approved, hiding test data that shows contaminants or lesser effectiveness, getting their active ingredients from shady companies not in their official records, and more--and they continue to do so. One of the main characters in the book is Dinesh Thakur, an Indian scientist who became an American citizen and worked at Bristol-Myers Squibb in New Jersey, where he witnessed what highly-regulated, conscientious pharmaceutical research and manufacturing looks like. A friend of his, also from India, convinced him to transfer to Ranbaxy, where he and his new wife could be near their families in India and be part of the up-and-coming Indian pharmaceutical industry. Thakur was a good man with a strong moral character, and he could not be a part of what he eventually realized was going on at Ranbaxy. So, he became a whistleblower, which in India often gets you killed, and finally found someone at the FDA who would listen to him. Stunningly, despite all the hard evidence Thakur provided, it took the FDA ten years to finally make Ranbaxy pay--and even then, it was far less consequences than they deserved. From there, the author moves onto other examples and other companies, as well as American doctors and patients discovering their generic drugs didn't work as well as the brand name drugs, though again, no one would listen to them at first. She delves into the inner workings of the FDA and why politics often guides their decisions on approving drugs. Unfortunately, the book does not end on a hopeful note--many of the issues described are still going on.

This book was so disturbing and shocking to me. First, I rely on about 15 different generic medications to help manage my chronic illness. When I finished this book, my husband and I both raced to our laptops to try to figure out where our meds are manufactured (not an easy thing to find out) and whether any of the sketchier companies in the book were involved. Also, I used to do audits similar to those that the FDA inspectors do, though not in the pharmaceutical business. I worked in Quality Management Systems (QMS), and the FDA's Good Manufacturing Practices (which many of these companies are making a joke of) are a type of QMS. The thought of a company I was auditing just completely making up their data and records is unthinkable. It is certainly a fascinating book, but in a "can't look away from the car crash" kind of way. I kept interrupting my husband's reading to tell him horrifying facts. As much as the information terrified me, I had no trouble at all reading the whole book (and fairly quickly). The book is very well-written. because the author focuses on the people involved and tells an immersive, engrossing story that sometimes reads like a legal thriller. Unfortunately, this is a thriller where most of the bad guys got away with their crimes. I will never look at a bottle of generic medication the same again. 

461 pages (though the text ends on page 410; the rest is reference material), Ecco

Reading Challenges:

B in the Alphabet Soup Challenge

Nonfiction Reader Challenge (2 in January - a record for me!) - fit into the category of popular science

Diversity Challenge

India in the Travel the World in Books Challenge

Maryland for the Literary Escapes Challenge

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