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

Dr. Harry Lever was a cardiologist who started to notice that his patients weren’t reacting well to generic drugs. This spurred him to research generic drugs and help his hospital compile a list of generic drugs to avoid.

Generic drugs were especially ineffective, or even dangerous, in the case of “narrow therapeutic index drugs,” where small differences in dose or concentration can have a significant impact on a patient’s response (241).

However, in the FDA’s tests of generic drugs, they continued to find generics to be bioequivalent with their name-brand counterparts.

FDA agents experienced tension with Justice Department lawyers while working on the Ranbaxy case. Each side blamed the other for stalling the investigation. One incident involved a document that FDA agents compiled outlining their case against Ranbaxy. The agents had the Justice Department prosecutors agree not to share this document with Ranbaxy, but one of the lawyers shared it with them anyway.

As the two sides fought, President Obama signed the ACA, the Affordable Care Act, into law, which put pressure on the FDA to approve generic drugs faster and increase competition in the market. The agents wanted a settlement with Ranbaxy to start at $1.6 billion but by 2011, Ranbaxy’s lawyers eventually reduced the sum to $260 million.

In the meantime, Thakur started a new company called Sciformix that focused on providing pharmacovigilance and risk management services to pharmaceutical companies. He also spent much of his time helping Beato’s firm with the case. Thakur and Sonal’s marriage continued to experience strain as he lived and worked in the United States and spent so much of his time and energy on the Ranbaxy case.

Joe and Terry Graedon were hosts of the NPR program The People’s Pharmacy. The Graedons were advocates of generic drugs and initially believed that the FDA was a “competent regulator whose claims could be believed” (259). However, over the years, they started hearing from listeners that their generic drugs weren’t working as expected—they were ineffective or even caused dangerous side effects.

Joe Graedon studied the FDA’s definition of bioequivalence. He noted that the curve used by the FDA to determine bioequivalence of generic drugs was too lenient, allowing for a wider range of variability in drug absorption compared to brand-name drugs.

Patients taking the generic version of the name-brand drug Wellbutrin XL, a drug used to treat depression, started writing in to the Graedons complaining of negative side effects, including sudden suicidal tendencies. The Gradeons alerted the FDA, but their claims were brushed off. It took five years before the FDA acted and recalled the product.

Eban describes other instances of customers finding generic drugs to be suspicious: Patients described rotten smells and bottles with eyelashes and bugs inside them. One woman even found a live centipede in one of her capsules.

Karen Takahashi, a compliance officer at the FDA, was tasked with evaluating Ranbaxy’s application to create a generic version of Lipitor, or atorvastatin.

The FDA eventually decided to impose an AIP on Poanta Sahib, which shut down atorvastatin and other applications, but this left Ranbaxy free to move manufacturing to other plants.

The FDA debated with prosecutors over how to proceed against Ranbaxy. Some worried that if the FDA did not approve the atorvastatin application, then Ranbaxy wouldn’t make enough money to pay the government a huge settlement. Meanwhile, US Senators were pressuring the FDA to approve the drug quickly.

Eventually, the FDA approved the application for atorvastatin from Ranbaxy, despite the concerns surrounding the company. Ranbaxy made a significant amount of revenue: $100 million in the first 2 hours, and $600 million during the six-month exclusivity period.