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Ladataan... Bottle of lies : the inside story of the generic drug boom (vuoden 2018 painos)Tekijä: Katherine Eban
TeostiedotBottle of Lies: The Inside Story of the Generic Drug Boom (tekijä: Katherine Eban)
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Kirjaudu LibraryThingiin nähdäksesi, pidätkö tästä kirjasta vai et. Ei tämänhetkisiä Keskustelu-viestiketjuja tästä kirjasta. Sobering look at the generic drug industry and the FDA that is supposed to be protecting us ( ) This book is fairly limited in its scope, but it points out important issues that affect pretty much everyone because pretty much everyone, at one time or another, uses prescription medication. The main focus here is on a company in India and the government regulation of that company, but the issues raised go well beyond the "star attraction" of this book. There are "bad" people and bad companies and bad regulators and bad oversight of those regulators...and bad understanding by the average prescription drug buyer of how bad everything is. Many of us badly need to read this. This book actually scared me. 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 the strongest, if not the strongest, pharma regulators in the world, and manufacturers take it seriously. In the US, they have the power to conduct inspections without notice and with full access. For overseas facilities, they don't: notice is given. Pharma companies in the US, Canada, and Western Europe take safety and quality seriously. A growing number of our generics are manufactured outside the US and Western Europe, including injectable medications that are incredibly sensitive to contamination, and an even larger supply of raw ingredients comes from overseas. 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. ei arvosteluja | lisää arvostelu
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"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. Kirjastojen kuvailuja ei löytynyt. |
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