The deceit and corruption exposed in this narrative non-fiction piece should earn Katherine Eban recognition as a world-class detective-cum-true crime author. Bottle of Lies provides a stunning revelation of the labyrinth of fraud and data corruption that transpires at all levels of generic drug production.
What are Generics?
Firstly, let's define generic drugs. Generics are bioequivalents of brand name drugs, produced and sold at much lower costs. They can be legally sold when patents on the brand name drugs expire. The wide-scale manufacturing of generics outside the U.S. has largely been pioneered by India, and is the focus of this book.
A Brief History
Case Study: Ranbaxy
Ranbaxy was one of the most prolific exporters of generics from India to the U.S. As a low-cost provider of life-saving drugs, the company was celebrated by the U.S. government and its people. However, Ranbaxy was built on a culture of fabricating results, disposing of data and was fraught with corrupt executives. They were able to get away with this shady behavior due to a few reasons:
This culminated in:
Today, Ranbaxy no longer stands in its current form. Dinesh Thakur, a Ranbaxy employee turned whistleblower was instrumental in orchestrating its downfall. After resigning, he fed the FDA compelling evidence about Ranbaxy's data manipulation techniques. He did this for many years, at great personal cost.
Current State of the Union
Ranbaxy's downfall was a landmark moment but unfortunately, corrupt behavior has permeated the generics industry worldwide. Prevailing issues include slow, bureaucratic procedures at the FDA, advance warnings given to manufacturer's outside the US, and worst of all, the culture of profit-seeking that is so prevalent amongst executives at many large generics producers.
Ultimately, deep structural change is required. The findings in this book were so shocking that I immediately checked all the medicines taken by my loved ones to make sure there were no generics amongst the mix. I know for a fact that it is going to be a very long time before I trust a generic drug again.