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

The Ranbaxy case strained the lives of those who worked on it, including Debbie Robertson, Andrew Beato, and Thakur. In 2011, Robertson decided to retire.

In 2013, a judge approved the Ranbaxy settlement. The company settled for $500 million and none of Ranbaxy’s executives were held criminally responsible.

Some questioned whether the outcome would be an effective deterrent for fraud, since no individuals were held accountable. Moreover, during the process of this investigation, Ranbaxy executives had become experts in fraud and were now leaving the company to work throughout the industry, taking their practices with them. Investigators thought it would be worthwhile to trace the trajectories of former Ranbaxy employees and see which companies for whom they went on to work.

While at Mylan Laboratories, Rajiv Malik seemed to bring Ranbaxy’s practices with him. He prioritized speed and profit above all else.

Meanwhile, Mylan, which had formerly been known for quality and attention to process, suffered a blow to its reputation when it became notorious for raising the price of its EpiPen to $600. A year prior, a whistleblower had come forward, alleging that under Malik’s leadership, Mylan had engaged in widespread data fraud.

In 2016, the FDA made an unannounced inspection of one of Mylan’s India-based plants. There, they found that a phenomenon—”crashing files”—had become so common that it was likely the company was intentionally manipulating data. Rather than hiding data in non-networked computers or intentionally mislabeled files, it seemed that employees were regularly unplugging computers in order to corrupt data.

Eban describes doctors in Africa who struggled to treat patients with ineffective generics. They found that generic drugs often did not provide a strong enough dose to be effective, and grew used to either raising the dose of the drug or avoiding generics when possible. The doctors only had limited access to name-brand drugs, and triaged them in order to use them most effectively.

African scientist Alexandra Graham found that drug makers sent their least- effective, lowest-quality, and sometimes counterfeit, generic drugs to Africa, knowing that regulatory oversight was weak and patients had few alternatives.

International researchers have started to worry that these ineffective drugs lead to drug resistance, a problem that arises when pathogens become resistant to medicines that were previously effective. Drugs whose active ingredients are subpar or present only in low doses kill off only the weakest pathogens, leaving the stronger ones alive and leading to the development of drug-resistant strains.