Status
Publication
Description
"Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban's Bottle of Lies exposes the deceit behind generic-drug manufacturing--and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings?" -- Dust jacket.… (more)
User reviews
One little overlooked consequence of globalization and the generics boom is the move to overseas production of pharmaceuticals--in particular, India (though China is also a problem, but getting information is difficult). The FDA has historically been regarded as one of
Indian pharmaceutical manufacturers jumped on the opportunity to reverse engineer popular drugs and sell them in the US. Problem was, some of them faked their safety data and hid it from the FDA. Eventually, a whistleblower spilled the beans.
Eban traces the story of the generics boom, the laws and regulations that govern it, and in particular the story of Ranbaxy, which faked its data and went to great lengths to cover it up. The consequences were not just confined to the US, but to other countries. Ranbaxy had a hierarchy of liability: the US and Canada first, Africa last. When a scientist expressed concern over the quality of AIDS drugs Ranbaxy was supplying for the PEPFAR initiative, a top executive replied, "Who cares? It's just blacks dying."
I looked askance at my bottles of generic medicine after finishing.