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Bottle of Lies

The Inside Story of the Generic Drug Boom
Narrated by: Katherine Eban
Length: 14 hrs and 26 mins
5 out of 5 stars (80 ratings)

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Publisher's Summary

From an award-winning Fortune reporter, an explosive narrative investigation of the generic drug boom that reveals the life-threatening dangers posed by globalization - The Jungle for pharmaceuticals.

The widespread use of generic drugs has been hailed as one of the most important public-health developments of the 20th 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 pharmacists, our doctors, and our regulators that the generic and brand-name drugs are identical, generics just cheaper. But is this really true? 

Katherine Eban’s Bottle of Lies exposes the widespread deceit behind generic-drug manufacturing - creating terrifying risks for global health. Drawing on exclusive accounts from whistle-blowers, inspectors, and regulators, as well as thousands of pages of confidential internal FDA documents, Eban reveals an industry where fraud is rampant, companies falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit. Meanwhile, patients unwittingly consume adulterated medicine with unpredictable and even life-threatening effects. 

The story of generic drugs is truly global: It connects middle America to sub-Saharan Africa, China, India, and Brazil and encompasses every market banking on the promise of a low-cost cure. Given that tens of millions of patients take drugs of dubious quality approved with fake data, the generics industry is the ultimate litmus test of globalization: What is the risk of moving drug manufacturing offshore, and is it worth the savings? 

An investigation with international sweep, exotic settings, molecular mayhem, 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.

©2019 Katherine Eban (P)2019 HarperCollins Publishers

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A Call to Action - Citizens Awake!

Here is an important, easily read, current book with essential information we collectively need to prioritize rethinking of pharmaceutical ethics, manufacturing, delivery, politics, guidelines, and economics worldwide. I strongly encourage those interested in public health, policy-making, regulatory affairs, and global vision to hear Eban’s story. I also encourage all involved in pharmaceutical manufacturing to learn about integrity, the health consequences of short-cuts, and ethical problem-solving. The term, “ethical drug,” traditionally means a pharmaceutical requiring a prescription. The people who make medicines must have accountability and ethics, yet this is not the default case. Many ethical drugs are not ethically made at all. Money, greed, societal pressures, and ignorance all contribute. Some generic medicines may be very weak, may contain contaminants, may be bogus, may be toxic, may have undergone dangerous processing errors. The lack of consistent, uniform regulations worldwide results in potentially dramatic variations between a trademarked medicine and any given batch of a generic substitute. What's in a name! Not all items with the same small print name are equals. Eban emphasizes the generics, but we have big problems with Big Pharma trademarked medicines, too, including affordability. Many of the problems detailed in this book are about dirty factories, unscrupulous manufacturing, unconscionable pursuits of profits, system failures, regulatory goofs, untrained help, and the resistance of politicians to protect the public. One whistleblower is particularly featured with his tale interwoven in the story. With Eban’s highlighted tales from primarily Indian manufacturing, we can clearly see how the potential benefits of generic drugs can work against health promotion goals. Our needs for a global vision of integrity, incentives, responsibility, liability, and affordability is past due. Bottle of Lies is a call for action, not a history book.

The general reader might not benefit as much as the more involved stakeholder from the reading, and this book does not read like a cliff-hanger. I worry that all generic substitutes might be tarred and feathered in the minds of some readers. There are conscientiously manufactured generics. And then there are products that India has made that could not legally be sold in India or the United States but were sent to Africa. Shameful!

My interest was easily maintained. I listened on Audible. Two measures I use to assess a book: how many times I stop to take notes, and how many times I find myself doing extra internet research on new on new concepts. I took notes on all sections, but the content never required me look up strange technical words or to do extra Google work. If read by Kindle or paper, the density is light enough for speed reading.

7 of 7 people found this review helpful

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Accurate, Authentic and Genuinely Scary

I worked my entire career (I am recently retired) in the pharmaceutical industry and specifically in Quality so this is an industry I know inside and out. This book is incredibly well researched. I found it to be an accurate representation of what goes on and the real risks we face. The language used is spot on. Her easy use of certain terms made me believe she might have worked in pharma for a while. I have either known about (by reputation) or have worked directly with some of the folks mentioned. I was captivated and couldn't stop listening until the book had ended. Apart from the out and out fraud covered, this book makes it clear why no pharmaceutical company should be satisfied with simply "meeting regulations". Sure, meeting regulations is a given, it must be done...but the ultimate quality culture is one where the needs of the patient are of utmost importance, regardless of market (US, Europe, LATAM or ROW). it is absolutely unconscionable that the health of people in countries with little regulation or low risk for inspection of the manufacturer is jeopardized by substandard meds. Yet, this is what is happening today. One of the best books I have read (listened to) - on par with Bad Blood (the Theranos story).

6 of 6 people found this review helpful

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Gripping and enlightening ! A must read !

I could not put this one down, no matter how hard I tried. A really thorough analysis of the dark underbelly of generic drug industry in India.

The only issues I have with the author are -

1) 85% of the book is about fraud by Indian Generic Manufacturers. Similar issues in China are buried in the Epilogue. Issues with Generic Manufacturers in rest of the world are ommitted (e.g. Isreal, South America, Asia). I wonder if there is a hidden hand guiding this book.

2) There is literally one sentence about a controlled clinical trial comparing efficacy of Generics vs Brand Name drugs. This trial did not show any difference in efficacy or safety. Rest is lots and lots of anecdotes. Of course, you will have some people who will not respond when you have millions taking the Generics. Why would the author not cover adverse event rates in more detail?. Hidden hand ?

The biggest losers are the American people - They are screwed both ways - Go bankrupt if you buy Name Brands or Cross your fingers with Generics.

1 of 1 people found this review helpful

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holy sh*t this is an eyeopener

extremely detailed reporting tells the story from the other side of the low cost generic Market. People have told me that the reason drugs are so cheap in Africa is that they are cheap to manufacture and in the United States we are suckers paying drug companies. Mow I know that those drugs sold in Africa may be made in somebody's house and maybe fully fraudulent due to lack of regulation.

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Great reporting

The reporting in this novel is amazing. I would have given 5 stars except at the end the author gave special thanks to hee editors and publishers individually. She thanked the individuals who directly contributed with a short sentence.

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FDA bought and paid for

If you were ever under the impression that the FDA had the best interest of the citizens of the USA, you would be sadly mistaken. This book will enlighten you and make you think twice about ever taking a generic medication again. I’m a physician in Tulsa, Oklahoma and wonder how some drug manufacturers and FDA regulators sleep at night.

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very informative and amazing narrative style

an eye opener to new aspects I thought previously irrelevant. The book is well written with fiction like thrill style. very good and useful book

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A must read for anyone touched by generic medication

As a physician I found this book informative, engaging, but most importantly... terrifying. It makes me wonder what we in the medical community may have been unwittingly doing to our patience since the introduction of foreign made generics. This is a must read for anyone who prescribes or consumes generic medication or cares for anyone that does.

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Thank you to Katherine Eban

This book is a must read for anyone that struggles with medication reactions. It explains exactly why we are suffering from bizarre, often devastating side effects when taking generics that are not present with the brand name. I take Neurontin, a brand name for gabapentin, for epilepsy. I have been made to try many generic forms over the years and every one allows breakthrough seizures after about three weeks. Now I understand why, generics routinely reduce the amount of active ingredients or fail to take the time to ensure the active ingredient dissipates through the body in an even way.
I am always deeply concerned about whether the insurance will cover the brand name or how much of the 2,200 dollars a month they will require from me. In 2012 I was switched without my knowledge from brand name singular for asthma to a generic made by Dr Reddy’s Pharmaceuticals that they had recently started producing. This so called medicine damaged the nerves of the intestines and for years I was in terrible pain and still have a severe dysfunction in the intestines for which I must now take a medication.
This book is a remarkably well written history of generics and the profit minded corrupt companies that make them. The author never tells you what to think but presents the facts and realities with simple clarity. Allowing it to be a cathartic and heartbreaking book for me.
In the end it is our own Food and Drug Administration that is the searing failure to the people it should protect. They are the demonstrated exemplar of corruption and self-interest and may the sorrow and pain that myself and others have endured be returned to them a hundred fold.
Thank you so much Katherine Eban and those few heroic people that fought to protect people all over the globe from the sham medicines, generics.

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If you take medication or know someone that does.

Although not discussed in the book Puerto Rico has suffered the most, because drug makers would rather produce in countries with less regulation. The really sad part is that the FDA and our elected officials have worked hard to send jobs out of the country while putting consumers at risk.