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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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Very Good Research Work

It's very good piece of work but seems to be highly biased against Generic players in general. USFDA is shown as slow and bureaucratic organisation and all Asian and specifically Indian companies are being shown in bad light. All things equal author should appreciate the fact that getting lower quality is much more important than not getting any medicine (on account of high costs of branded players specially in case of African countries).

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Shocking and definitely should be read

Bottle of Lies, a book about the quality problems plaguing generic drugs. In May 2013, Ranbaxy Laboratories admitted in an American court to selling adulterated drugs. It begins with Dinesh Thakur, the whistle-blower who exposed Ranbaxy’s misdeeds. In 2003, Thakur left his job at Bristol Myers Squibb’s New Jersey office to join the Gurgaon office of Ranbaxy — then a rising star of the Indian generics industry. There, he encountered a shocking web of chicanery. Wockhardt’s manufacturing plants too are now blocked from exporting drugs to the U.S.
China and Ghana is no better as far as quality control is concerned.

Quite shocking and worth a read.

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Brilliant

This is incredibly well researched, written, and read. It should be made into a movie.

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if you are ever planning to take any medicine

An absolutely brilliant account of the fraud being conducted by the generic drug industry. It pains me personally more since I am an Indian, a doctor and also someone who at one time used to vouch for generic drugs. If you sometimes feel, why the medicines you take don't work... Or cause you more harm.... Read this book.👍👍

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Nice book

Nice book with good explanation of facts. .. it reveals the dark site of pharmaceutical industries, special generic medicines.

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  • Byzantine Dixie
  • 19-05-19

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).

28 people found this helpful

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  • Marian
  • 16-05-19

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.

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  • Becky B
  • 24-08-19

Shocking!!!

As a nurse I assured people - and myself, that generics were the same as brand name drugs. What a shock that some are not even close!! I sort of had a hint 20 years ago when my husband's cardiologist told me that generic heart drugs were not the same as brand name drugs. He said he had patients that had taken a brand name for years or decades. Their condition was totally under control. Then they switched to a generic and they went bad. I thought maybe some were just a little different. Now I know it can be a lot different and also contaminated. I assumed the patent covered the process of how to make the drug, not just the chemical. If the government wants people to take the drug, then the process should be part of the patent and made known in order for them to be the same. Add laws and politics that encourage greed, corruption, denial, and cover-ups and you have a toxic and sometimes deadly mix. There is an old scripture that we seldom hear anymore - "The love of money is the root of ALL evil." That really shows in how the public has been dealt this sometimes deadly hand. And the patients in third world countries are getting hammered worse than us. How very, very sad!!

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  • Danny Metzcalf
  • 17-05-19

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.

9 people found this helpful

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  • VB
  • 13-01-20

overbearing self-righteous indignation

I wanted to like this book and while I agree with the findings, I was majorly disappointed at how it was presented. Born and brought up in India and now in the US working in Big Pharma, the subject matter is close to me both personally and professionally. I remember reading about the Ranbaxy case and was glad they got the stick (would've been great if someone had gone to jail as well). But overall the book was disappointing. Here are the problems I have with this book:

1. While it was great to read something that doesn't bash Big Pharma ;) the whole premise of Genrics-Bad, Branded-Good is a gross oversimplification of reality. Yes, its true that branded drugs for the most part are of higher quality than some generics, its not because of the goodness of the hearts of C-suites or any drive towards achieving highest quality. It's because they are under direct FDA control and face the dangers of class action lawsuits. Overseas generics are not and can therefore skimp on quality. Since quality is directly proportional to costs, one way to maximize profits is cutting down on quality. Hence to say West is more about quality and SE Asia in not, is incorrect. Author misses/overlooks the nuance.

2. The most vexing aspect of this book was the "corruption is in the Indian culture" narrative. To malign an entire population is wrong. I lived long enough in India to see corruption in action so I'm not naive about it. The book mentions a couple of employees who were caught redhanded making statements to the effect "doing-such-and-such-is-in-our-culture". If anyone believes in these dog ate my homework excuses, thats because they want to believe it. The author heaps well deserved scorn on Indians/Chinese who were implicated, but expresses mere disappointment at Americans' missteps (unless they were of Indian/Chinese origin). The fact is, every race, every nationality has good and bad people. The book mentions of several Indian employees working for tainted companies who did not want to participate in the nefarious schemes and put the blame squarely on higher management. Would anyone be surprised to find out about C-suites and boardrooms directly involved in crimes and coverups? Corporate greed is everywhere not just in India or China.

3. There were instances where the author makes emphatic accusations without proof. For example, when FDA agents were investigating plants in India they felt sick because the Indian employees spiked their food/water -- something that remains unproven and could well be unrelated. The plants were cheating with data fabrication etc and the evidence against that was ironclad, so why make petty accusations without evidence? Especially since, in hindsight, nothing happened to the health and safety of the inspectors.

4. Having heard a number of narrators absolutely butcher Indian (Hindi/Urdu) words, I thought nothing can shock me. Katherine Eban, take a bow. With her comically terrible pronunciations, she took it to a level I didn't know existed.

Drug product quality is an extremely important issue facing our societies. Relentless India/China bashing is not going to solve it. Fear mongering is not going to solve it.

8 people found this helpful

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  • Whitney
  • 09-11-19

Beware generic drugs

Outstanding investigative reporting on the problems with foreign manufactured generic drugs and lack of effective FDA oversight.

When you consider Pharmacy Benefit Managers’ (PBMs) push to have consumers use mail order pharmacies in states where state law requires generic substitution, and PBMs are driven by cost over effectiveness or safety, you should be very worried about the source of your generic drugs. Consider also that generics that perform dissimilarly to brand drugs may result in more visits to the provider or more tests to figure out the lack of response to a generic drug, costs the SYSTEM more but not affecting the PBM’s bottom line.

WHAT YOU CAN DO: Take your prescription bottles with you to every provider visit/exam. Highlight the manufacturer’s name on your pill bottle. Do not mix different bottles of the same medication because they may be manufactured by different companies. If you feel a medication is not working as intended, call your provider or ask the pharmacist if there has been a warning issued or a recall on that drug. Be a smart consumer and also write your legislators and demand more transparency and oversight of generic drug manufacturers.

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  • Eugene Young
  • 04-09-19

Must read if take prescription drug

Never assume generic drugs are safe or performs equivalent to the name brand drug. Do your research, it may make sense to pay for name brand.
It’s your LIFE.
Although the FDA approves the generic drugs as safe and effective, there are far too many situations that these same drugs are recalled.

7 people found this helpful

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  • Tais Helena Schmitt
  • 03-09-19

Excellent, eye opening work!

Every person should read this book to become aware of the risks that generic drugs are imposing to our health, even if we are not taking them ourselves. Katherine Eban masterfully reports the frauds in the over the seas manufacturing companies of generic drugs and brings into question the role of the FDA as a serious, trustworthy regulatory agency.

5 people found this helpful

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  • John Nolan
  • 16-06-19

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.

8 people found this helpful

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  • John
  • 11-08-19

Never take a generic drug again

Investigative reporting at its finest. If you’re taking a generic drug, be sure to google it. If it’s made in India or China, beware.

7 people found this helpful