bottle of lies, by katherine eban

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

• The initial acceptance of Indian generics came during the African AIDS epidemic when the U.S. government agreed to buy millions of drugs as part of their aid package. Part of this involved the FDA green-lighting Indian manufacturers, a milestone moment for the country and the first step in allowing Indian generics to be sold in the US
• In the 20th century, the FDA was considered to be the gold standard when it came to auditing companies. They pioneered the model of checking the process and not just the final product. The logic behind this was that processes are repeatable, whereas only a small sample of final products can be tested

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:

• In the U.S., the FDA can show up at the manufacturer's plant for inspections at any time, and they can stay for however long they want to. In foreign countries, this process is significantly more complicated. Ultimately, this meant that companies would know of FDA inspections weeks in advance, allowing them to conceal their fraudulent practices
• The FDA did not have resources to send people to India. This resulted in certain plants going unchecked for years at a time

This culminated in:

• Ranbaxy submitting fake data. According to some reports, 60% of the data they submitted to the FDA was fake. In India, this percentage was closer to 100, because no data was needed, it was just about political connections. Even when these findings were blatantly laid out to executives, they chose to conceal the data rather than recall the drugs, in an effort to protect their pockets and preserve the bottom line
• Different countries receiving different quality drugs. The poorest nations would receive counterfeit products because Ranbaxy knew that these governments had little to no capacity to test the products. Other countries would receive substandard drugs, which may have been even more dangerous than counterfeits, because they would only kill the weakest microbes, allowing the stronger ones to reproduce

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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.
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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.