Bottle of Lies - for folks interested in the Pharma industry.
Pasting my Goodreads review below and attaching my notes.
Notes:
BottleOfLies.pdf (82.4 KB)
Goodreads review:
This book exposes the sub-standard manufacturing practices adopted by Indian and Chinese pharmaceutical plants; the side-effects which come with it to the patients; and why sub-standard manufacturing is still being followed.
The book kept me so engaging that it is the longest book I have read in 2020, but probably took me shortest period of days to complete it!
Below are some topics which are covered in the book.
Spoiler Alert.
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Ranbaxy’s work culture; Promoter’s (Singh brothers) family background; their story of deceiving the US FDA; sale of the company to Japan’s Daiichi Sankyo by hiding critical information; family fueds between the brothers and how the Singhs finally ending up in jail (well-deserved) in 2019
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Life of Ranbaxy’s brave whistleblower, Dinesh Thakur; his taxing journey through the FDA’s case of eight years against Ranbaxy; how it took a toll on his personal life; his fight against India’s regulators after winning the case against Ranbaxy
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History on how FDA evolved over the last century; political implications on Congress of FDA being strict which could lead to drug shortages; internal politics within FDA; stark difference in investigation processes in domestic vs. overseas plants; how behind / laggard FDA is in comparison to company plant executive’s “smart-ness” in hiding their faults, while FDA is considered as the “Gold-Standard”; comparison of FDA to CDSCO
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Special appreciation for Dr. Yusuf Khwaja Hamied’s education and accomplishments; his role in building Cipla Ltd as one of most ethical pharmaceutical company in India; his revolutionary approach in supplying drugs to African and Indian consumers at fraction of market price while maintaining quality
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Mylan’s work and quality culture during the early 2000s; it’s growth and acquisitions in India; quality deterioration after Rajiv Malik (current President of Mylan) joined the company as he brought in ex-Ranbaxy employees; Epilepsy scandal; it’s journey from top quality pharmaceutical company to a situation where its head manufacturing plant was issued warnings even after political influence
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Technical aspects like how FDA relied on company’s test data than testing the drugs themselves; why bio-equivalence tests conducted by FDA are sub-standard; Experiences faced by patients (including death experiences) due to their in-take of substandard drugs manufactured even by top companies like Dr. Reddy’s
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Investigative stories in various Indian and Chinese manufacturing plants. Examples include FDA investigators getting life-threatened; their hotel rooms getting bugged; their DHL delivery executive getting impersonated by company’s sales guy; being shown falsified / tampered test and quality data; offered bribes…
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Africa’s fate of being supplied with sub-standard drugs; how companies supply the best drugs to developed countries as the regulators are “strict” and simply divert the sub-standard drugs to Africa’s poor countries instead of discarding them
All in all, my biggest take-away is to keep a track of how pharmaceutical companies are being run in India by tracking their FDA investigations and ensure that me and my family take drugs manufactured only by legitimate companies!
Discl: I may be invested in some of the companies mentioned. Please build your own conviction.