- Hardcover: 512 pages
- Publisher: Ecco Press (14 May 2019)
- Language: English
- ISBN-10: 0062338781
- ISBN-13: 978-0062338785
- Product Dimensions: 3.9 x 15.2 x 22.9 cm
- Boxed-product Weight: 739 g
- Customer Reviews: 273 customer ratings
- Amazon Bestsellers Rank: 53,697 in Books (See Top 100 in Books)
Bottle of Lies Hardcover – 14 May 2019
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"An extraordinary international corporate thriller...A compelling narrative...This book is good for your health."--Hindustan Times
"An urgent, alarming work of health reporting that will make you question every drug in your medicine cabinet."--Kirkus Reviews (starred review)
"Gripping...Riveting and increasingly foreboding...Eban's pacing, along with a structure that makes this astonishingly complex story easy to follow, gives the book a rough, unforced elegance...An invaluable exposé, a reportorial tour de force and a well-turned epic."--New York Times
"Bottle of Lies is a tour de force of dogged reporting. In her bracing, panoramic account, Katherine Eban expertly unspools a colossal fraud with momentous implications for public health...This book is so alarming in places that it reads like a dystopian medical thriller. But it's true."--Patrick Radden Keefe, author of Say Nothing and The Snakehead
"A shocking exposé of corporate greed, arrogance, and eagerness to exploit the weak for profit....Bottle of Lies is an important work of investigative journalism. Anyone who takes prescription drugs should read it."--Eric Schlosser, author of Command and Control and Fast Food Nation
"This book will save lives...What Rachel Carson did for our understanding of the perils facing the environment Katherine Eban has now done for our understanding of the threats to our health from the drugs we take every day. Bottle of Lies is Katherine Eban's masterwork of global investigative reporting."--James Risen, Pulitzer Prize winner and author of Pay Any Price and State of War
From the Back Cover
From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale--The Jungle for pharmaceuticals
Many have hailed the widespread use of generic drugs as one of the most important public health developments of the twenty- first century. Today, 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 overseas, and do they outweigh the savings? An investigation with international sweep, high-stakes brinkmanship, and big money at its core, Bottle of Lies reveals how the world's greatest public health innovation has become one of its most astonishing swindles.
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Top international reviews
Katherine Eban’s investigation, guided by a handful of intrepid and determined whistleblowers and inspectors, brings us to places where deception and fraud are the norm. Where unapproved materials and unregistered active ingredients are substituted for genuine ones as secret changes are made in formulation. Unfavourable test results are concealed. Data is manipulated. Everyone working for the company is a participant, enjoying gaming the regulations, or simply trying to earn a living under duress. The Indian drug firm, Rambaxy, after an investigation lasting for several years, pleaded guilty to criminal charges and, in May 2013, was fined $500 million by a court in the US.
The consequences of a market flooded with inferior drugs are worst for countries like those of Sub-Saharan Africa, where regulation is weakest, but can be found anywhere on Earth. Antibiotics not potent enough to destroy bacteria have resulted in the deaths of children. Vials of insulin, meant to be sterile, but contaminated with microbes have been released on to the market. Adulterated heparin from China, inadvertently given to patients on dialysis, caused around 100 deaths in the US. A generic antidepressant from Israel lacking the time release mechanism of its branded parent brought numerous complaints of severe side effects, including suicidal thoughts.
‘Bottle of Lies’ is about the drug companies, but it is also about the ineptitude of the American Food and Drug Administration. Conscientious and hard working employees, focussed on patient safety, found their efforts undermined by an organisation which gave priority to ensuring smooth trade with countries like India and China, and a smooth flow of drugs, however defective, to American patients.
Katherine Eban has written an outstanding and necessary book. Perhaps the next question that needs to be asked is ‘Why have we become so dependent on drugs, and thus so vulnerable to exploitation?’
Another important understanding of Ranbaxy ways of working under the leadership of Malwinder Singh & team is that, the behaviour was driven by Profits over and above Purpose, which was fueled by policies of US like F2F and exclusivity with bare minimum checks.
There could be few isolated issues of generics not matching bioequivalence of innovator drug but it may not be case that generic manufacturer has deliberately followed some shortcut. Even sometimes innovator drugs are pulled off shelves for not meeting desired results.
My doctor refuses to prescribe generic drugs to me or all his patients and he has had this policy for 30+years, well before this book came out.
This book illustrates why, and why I'm still living!. Granted, I'm in a financial position where I can easily afford brand-name drugs, but these bandits that run generic drug sweat shops in India and China do not care about patient safety - only profits, and the FDA is asleep at the switch approving these "drugs" bowing to political pressure. These gross violators should be jailed for life with no parole - They are the scum of the earth
Thank God for people like the FDA's Peter Baker and India's Dinesh Thakur who both had the moral fortitude to expose this scam threatening the lives of millions of people.
I'm just hoping governments listen and pay heed, but they won't.
It was, however, very disappointing (shocking, disturbing!), to learn about the negligence and outright fraud associated with the manufacture of many generic drugs and the lack of oversight and public protection provided by the federal agency that is supposed to regulate these products, the U.S. Food and Drug Administration (FDA). About 90% of medications consumed in the United States are generics and the vast majority of these are made in India and China. The FDA is responsible to inspect and regulate plants that make medicines for use in the U.S., including plants outside the U.S. While the book highlights some dedicated and highly competent FDA employees, they often failed to receive support from higher in the agency.
Key lessons from this book:
--Don’t assume that all generic drugs are equivalent to brand name products, especially those that are supposed to release the ingredients slowly over time (e.g. products ending with “LA”, “SR”, or “XL”).
--Political considerations sometimes trump public health and patient safety concerns at the FDA. Where is the accountability for the organization? House Energy and Commerce Committee members should read this book!
--Along with accountability, the FDA needs more resources and funding. Since 2005, the number of plants and medicines manufactured outside the U.S. has exceeded the number inside the U.S. The FDA needs to be like the State Department, with dedicated international employees who understand the language and culture and reside for longer terms in other countries.
I highly recommend this book to anyone who takes generic medicines, is considering taking generic medicines, or is involved in health policy. This should cover about 95% of Americans.
Additionally the quality of the sheets is also too thin and you can see how the next page text is visible. Very poor quality for the price that I've paid ...
I'm willing to read it and forget about these details.
Apart from Ranbaxy's story, the book explores the challenges of ensuring quality standards in generic drug making. Spread around the world, generic drug factories are physically far separated from FDA. It is not very difficult to hide unacceptable data from the reach of FDA. Lack of sophistication of the FDA makes the task of the devious manufacturers easy.
The book paints a vivid picture of the generic drug industry landscape and brings out the urgency of the challenge by highlighting instances loss of life. Patients face even larger danger in less developed countries with lighter monitoring. Unscrupulous drug makers dump subpar drugs in these markets with impunity.
At the core of the conundrum are economic realities, as much as lack of integrity. FDA lets off even egregious cases with a rap on the knuckles. The pressure to make affordable drugs available to patients is apparently restraining FDA's hands. Unfortunately, the book pays little attention to the underlying economic reasons for the dangerous state of affairs.
At places, the author attributes the lack of integrity of Indian generic makers to the country's 'culture'. This is unfair and clearly without basis. A few businesses trying to take advantage of the permissive regulatory framework cannot be considered the failure of a culture.