Friday 1 July 2022

Nonfiction Review: Bottle of Lies

Forget Stephen King. The Bottle of Lies. In The Inside Story of the Generic Drug Boom , writer and investigative journalist Kathryn Eban writes about real-life horrors more terrifying than any King novel. As sometimes happens, my reading group picked up this book that I had no interest in reading, and as is almost always the case, I ended up glad I read it. This engaging and exciting non-fiction book opens the door to the dirty secrets of the generic drug industry.

Eban begins by taking a closer look at Ranbaxy, one of the worst players in the generics industry, an Indian company that has thankfully gone out of business. He describes the founding of the family business and talks about the personal and professional lives of some of the key players. This society has been terribly, scandalously deceived from above. Management willfully and knowingly manufactured drugs without quality control, collected extensive data to get their drugs approved by the FDA, and provided fraudulent data in their rare FDA reviews. One of the reasons he spends so much time on Ranbaxy is that what they have done is not uncommon in the generic drug industry. Many other companies, particularly in India and China, run similar scams by falsifying their data for approval, hiding test data showing contamination or low potency, sourcing their active ingredients from dubious companies not listed on their official records, and much more. . keep doing it. One of the main characters in the book is Dinesh Thakur, an Indian-American citizen scientist who worked at Bristol-Myers Squibb in New Jersey, where he saw what carefully regulated and conscientious pharmaceutical research and manufacturing looked like. His friend, also Indian, convinced him to move to Ranbaxy, where he and his new wife could be closer to their families in India and become part of the burgeoning Indian pharmaceutical industry. Thakur was a good man with a strong moral character and he could not be a part of what he finally realized was going on in Ranbachi. So he became a whistleblower, which killed you many times in India, and eventually found someone at the FDA who would listen to him. Amazingly, despite all the hard evidence Thakur presented, it took ten years for the FDA to finally get money for Ranbaxy, and even then, it had far less impact than it deserved. From there, the author moves on to other examples and other companies and American doctors and patients who have found that their generic drugs don't work as well as brand-name drugs, but not once does anyone listen to them. He delves into the inner workings of the FDA and explains why politicians often make drug approval decisions. Unfortunately, the book does not end on a hopeful note. many of the described problems remain unsolved.

I was very disappointed and shocked by this book. First, I rely on 15 different generic medications to help me manage my chronic condition. After I finished this book, my husband and I ran to our laptops to find out where our medicine was being made (not easy to find out) and if any of the more nefarious companies were involved in book laundering. I have also conducted such audits as FDA inspectors, but not in the pharmaceutical industry. I have worked in Quality Management Systems (QMS) and FDA Good Manufacturing Practices (which many of these companies scoff at) is a version of QMS. The idea that the company I tested would completely redact their data and records is unimaginable. It's certainly a fascinating book, but somehow it's "impossible to take your eyes off the car accident." I kept interrupting my husband's reading to tell him the horrible facts. As terrifying as this information is, I had no problem reading the entire book (and quite quickly). The book is very well written. because the author focuses on the people involved and tells a moving, exciting story that sometimes reads like a real thriller. Unfortunately, it's a thriller where most villains get away with their crimes. I will never look for a generic bottle again.

461 pages (although the text ends on page 410, the rest is a reference work), Ekko

reading problems.

B in the alphabet soup challenge

Nonfiction Readers Challenge (January 2nd is a record for me) - belongs to the Popular Science category.

diversity challenge

India in Books Around the World competition

Maryland in the Literary Escape Contest

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