Bottle of Lies: The Inside Story of the Generic Drug Boom

Peter Baker was an investigator for the FDA. Eban describes him as meticulous, detail-oriented, and relentless in his pursuit of uncovering fraud and ensuring patient safety.

Baker often saw through the facade that the heads of generic drug plants wanted to present. Executives would try to lead FDA investigators on a pre-planned tour through their plants, strategically guiding them through areas that were clean and compliant while hiding the true extent of the manufacturing issues. They would try to waste time by giving long presentations to the investigators. However, Baker remained focused and determined, knowing that time was of the essence in uncovering dangerous practices. He would cut through the executives’ tactics and demand access to areas they were trying to keep hidden.

He started investigating companies’ digital data, rather than just physical evidence. He recognized the importance of analyzing digital data to uncover patterns and inconsistencies in manufacturing practices. He would locate non-networked computers and identify files and documents that revealed discrepancies between what the company claimed and the actual manufacturing processes.

Baker’s methods started a trend within the agency, and other agents began to follow Baker’s lead in utilizing digital data analysis in their investigations. Baker went on to inspect Ranbaxy plants as well as other sites across India and China.

Dinesh Thakur was a whistleblower who became central to the case against Ranbaxy. Originally from India, Thakur immigrated to the United States to receive his education. He worked for BMS until his mentor convinced him to work for Ranbaxy. While at Ranbaxy, Dinesh Thakur discovered widespread fraud and deception in the company’s operations.

Eban describes Thakur as meticulous, dedicated, and relentless. Thakur tirelessly collected evidence of data manipulation and regulatory violations at Ranbaxy, eventually submitting his findings to the FDA. Thakur’s actions led to a massive investigation into Ranbaxy and its practices, ultimately resulting in the company being fined $500 million. The process to get there was fraught with challenges, as Thakur faced resistance and retaliation from within the company. Even though he was afraid of the potential repercussions, Thakur knew that it was crucial to bring the misconduct at Ranbaxy to light to protect public health and ensure the integrity of the pharmaceutical industry.

While Thakur was relentless in his pursuit of justice, his marriage suffered as a result. He chose not to share his investigations and the challenges he faced at Ranbaxy with his wife, instead keeping his stress to himself. Thakur felt more at ease with other whistleblowers who understood the risks and complexities involved in exposing corporate misconduct, and felt that others couldn’t fully comprehend the weight of his burden.

Ranbaxy was a company based in India that was involved in the production and marketing of generic drugs. Founded and run by the Singh family, Ranbaxy grew to become one of the largest generic drug manufacturers in the world.

Eban describes the culture of Ranbaxy as focused on profit above all else, with an emphasis on speed over quality. The company eventually gained a reputation for cutting corners and engaging in unethical practices, such as fabricating data, falsifying test results, and selling substandard drugs. Fraud was embedded as part of the company culture: “Not only is the culture of fraud and deceit still alive and well at Ranbaxy—it exists all the way to the top” (278). Eban describes this as a systemic issue within Ranbaxy, with top executives encouraging and covering up these unethical practices. Malvinder Singh, the CEO of Ranbaxy at the time, was portrayed as a key figure in perpetuating this culture of dishonesty and lack of accountability.

Ranbaxy’s unethical practices and lack of quality control came to light through investigations by the US FDA and whistleblowers. These investigations revealed a pattern of misconduct and regulatory violations across multiple Ranbaxy facilities. Ranbaxy eventually ceased to exist, and its assets were acquired by Japanese pharmaceutical company Daiichi Sankyo. Daiichi Sankyo eventually won a case against the Singh brothers for deceiving investors and hiding the extent of regulatory issues at Ranbaxy.

Rajiv Malik was a process chemist at Ranbaxy. Eban describes him as “canny and ebullient” (28). He was “viewed by his colleagues as a Houdini of the generic drug world” (28). At Ranbaxy, executives called on him to fix issues quickly. When executives tried to get him to quickly fix formulation problems with the Ranbaxy drug Sotret, Malik warned that the process would take time. The executives chose to release the drug without fixing it, which Malik viewed as irrational.

Malik eventually left Ranbaxy to help head another generic drug company, which was later acquired by Mylan, a name-brand drug company. There, he brought over practices that were commonplace at Ranbaxy. Data manipulation became commonplace under his leadership, leading to several quality and safety issues with the drugs produced by the company.

The US FDA is a regulatory agency within the United States government that is responsible for protecting public health.

In the book, the FDA is described in a multifaceted way. Eban presents the organization as the gold standard for drug approval and regulation, highlighting its role in ensuring the safety and efficacy of medications. At the same time, she depicts the organization as plodding and overwhelmed, struggling to keep up with global outsourcing. She also describes moments in history when FDA agents took bribes and accepted gifts from pharmaceutical companies, raising questions about the agency’s integrity and independence. However, Eban spotlights ethical and determined FDA employees like Peter Baker, who were frustrated with their agency’s inability to effectively regulate and monitor the pharmaceutical industry to ensure the safety of the general public.

Overall, Eban depicts the FDA as the best regulatory body of its kind globally, but one that has its flaws and imperfections, despite being staffed with many individuals who care deeply about their work