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Bottle of Lies: The Inside Story of the Generic Drug Boom

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A NEW YORK TIMES BESTSELLER 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, almost 90 A NEW YORK TIMES BESTSELLER 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, 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?  A decade-long 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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A NEW YORK TIMES BESTSELLER 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, almost 90 A NEW YORK TIMES BESTSELLER 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, 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?  A decade-long 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.  

30 review for Bottle of Lies: The Inside Story of the Generic Drug Boom

  1. 4 out of 5

    Renée

    We all need to thank Katherine Eban for her phenomenal book "Bottle of Lies." This is a must-read book, especially if you're taking generic drugs. (I spent a lot of time after reading Eban's book researching the companies who make the generic drugs I take. I am definitely switching away from certain generics based on my reading of "Bottle of Lies.") Eban's "Bottle of Lies" is a blockbuster and needs to be on every 2019 "Best Of--" list. My gratitude for the courage of people who spoke up and who We all need to thank Katherine Eban for her phenomenal book "Bottle of Lies." This is a must-read book, especially if you're taking generic drugs. (I spent a lot of time after reading Eban's book researching the companies who make the generic drugs I take. I am definitely switching away from certain generics based on my reading of "Bottle of Lies.") Eban's "Bottle of Lies" is a blockbuster and needs to be on every 2019 "Best Of--" list. My gratitude for the courage of people who spoke up and who were whistle blowers. Eban covers their stories expertly. Just, wow. 📕💊

  2. 4 out of 5

    Marian

    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-sol 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.

  3. 4 out of 5

    E. Kahn

    In a world where pharmaceutical companies charge thousands of dollars for life-saving medicines that cost under a dollar to make and whose development was paid for by the taxpayer, inexpensive generics threaten to undercut prices and eliminate outrageous return on investment. Only one woman stood up to defend billionaire CEO's and rent-seeking shareholders. That hero... wrote this book.

  4. 5 out of 5

    Ankit Agrawal

    I have been studying the pharma industry for the last couple of months from the ground up and this book couldn't have come at a better time. Needless to say, I bought a copy the day it was released. The recent media reports over the generics price-fixing scandal gave it good publicity as well. The book is a stunning expose of the dark underbelly of the global generics industry, of which India and China are the powerhouses. These two countries are also the most notorious in terms of non-compliance I have been studying the pharma industry for the last couple of months from the ground up and this book couldn't have come at a better time. Needless to say, I bought a copy the day it was released. The recent media reports over the generics price-fixing scandal gave it good publicity as well. The book is a stunning expose of the dark underbelly of the global generics industry, of which India and China are the powerhouses. These two countries are also the most notorious in terms of non-compliance to regulations if the author is to be believed. One may question if generics makers at other places outside of the US fare any better but that's not the point. What is of foremost importance is whether the medicine we are ingesting is actually helping us get better. Worse, is it actually harming us instead? The author devotes a considerable portion of the book to exposing Ranbaxy's systemic fraud that was perpetrated right from the top and continued for years- first covertly and subsequently, brazenly. Dinesh Thakur, the Indian origin American citizen who quit Bristol-Myers Squibb to return and help create a global R&D behemoth out of his homeland, acts as the whistleblower who sought to do the right thing. His years-long crusade came at a great cost, professionally, financially and personally. In a country like India, it takes nerves of steel to fight a corporate behemoth with shady promoters. Add to that a government and bureaucracy that prioritises India's reputation and jobs over public health. In face of such hostility and threats to life, most would take the easy way out and give up. A case in point being Mr. Nitin Mangal who merely wrote an adverse research report on an Indian real estate major and had his life nearly destroyed as a consequence. While Ranbaxy hogs most of the author's attention, a number of Indian pharma majors are named and shamed by describing specific shocking instances of non-compliance at manufacturing plants and in some cases, outright threat to the US FDA inspectors. While one might want to put the blame on culture of non-compliance at the lowest levels of employees and give the benefit of doubt to promoters, some of whom adorn the glossy pages of business and lifestyle magazines day in and day out, a statement by the chairman of a drug major on an investor call in response to the FDA's adverse report on his plant is quite telling. The gentleman claims that due to a goof-up on his employees' part, the FDA ended up inspecting the wrong plant within the premises. According to him, the section inspected doesn't make medicines for the US market and hence wasn't built to the FDA's standards. If one chooses to believe this, what this means is that it makes drugs for India and markets like Africa, Latin America, South East Asia etc. where regulators don't give a damn. Having read what this inspection exactly revealed, I would never spend a penny on his company's medicine. But then from what I understand, most Indian companies use their non-FDA compliant plants to make drugs for the Indian market. Go figure. Multi-tier manufacturing systems in the industry are not even a secret. I have interacted with a pharma company that stated this as a matter-of-fact and at the time I didn't know enough of the industry to be horrified. You manufacture the worst quality a market will tolerate, plain and simple. The world markets are a tiered system in the minds of pharma companies. The absolute rejects and trashworthy stuff ends up in poor African countries where there are practically no checks and balances (one reason why there are much lesser rejects in Indian pharma plants as against globally) and the best one can produce goes to the US and EU. The FDA doesn't come out looking good either. On the one hand, it faces practical challenges in conducting inspections overseas at faraway and remotely located plants with hardly any inspectors keen on going. There is the additional requirement of obtaining visas which necessitates informing the companies much in advance and allowing them all the time required for a cover-up (in the US, the FDA conducts inspections without notice and with higher frequency) On the other, when enterprising inspectors (quality, approach and integrity of inspectors can be quite variable) uncover blatant fraud and manipulation at these facilities, it seeks to kill the messenger instead. Political pressure to approve generics faster in order to reduce healthcare costs and the agency's own budget being made contingent on success in granting approvals has set up the system to fail. Add to that the slow moving nature of a bureaucracy and what you get is a paper tiger and a convenient scapegoat on which to pin blame for public health disasters from sub-standard medicine. In the Ranbaxy case, while one arm of the FDA was investigating outright fraud the other kept granting approvals to new medicines by the company despite being confident that the underlying data was most certainly fake. Indian companies have taken full advantage of this and ended up getting caught despite. Nevertheless, with Indian political and regulatory backing, the pharma lobby has managed to use the US desire to have access to cheap drugs to water down the process. The FDA conducted surprise inspections for a while but it was given a quiet burial with no explanation offered. In return, the industry has merely promised to reform itself and claimed that it takes time to institute a culture of compliance in a country used to the "chalta-hai" attitude. While this may be true in part, I believe it has more to do with concern for the bottom-line. Quality comes at a cost and that lowers margins. With the product by nature supposed to be cheap and currently facing stiff price competition in the US, I doubt things are going to change for the better anytime soon. As for the Indian market, we were always second-class citizens anyways. I doubt it can get any worse. The only loser in the whole game is the patient who doesn't know whether he is ingesting elixir or poison- much the worse if for a chronic condition.

  5. 4 out of 5

    Elizabeth

    This is a must read book for anyone who has been prescribed a generic medication....... which is pretty much everyone. The book is long and may look intimidating, but it reads like an action thriller. There are heroes and villains, conspiracies involving presidents (of companies), and chases (although they probably weren't high speed as they usually involved bench analytical chemists who mostly sit in front of a computer all day). The amount of research and number of interviews that were necessar This is a must read book for anyone who has been prescribed a generic medication....... which is pretty much everyone. The book is long and may look intimidating, but it reads like an action thriller. There are heroes and villains, conspiracies involving presidents (of companies), and chases (although they probably weren't high speed as they usually involved bench analytical chemists who mostly sit in front of a computer all day). The amount of research and number of interviews that were necessary to put together this excellent example of investigative reporting is impressive. My only gripe (and it is really more of a pet peeve since I work on them for a living) is that the author refers to HPLCs as "machines." They are not machines, they are instruments, because they make measurements and are used for scientific work.

  6. 5 out of 5

    Gaurav Andhansare

    What is worse than a drug with a lot of side effects? A drug with only a lot of side effects. A scintillating read into the evolution of global generic drug industry and its transgressions. The author doesn't pull any punches intended for the astoundingly criminal lack of integrity and regulatory oversight in the generic pharmaceutical industry. From an author's point of view, what could have been a simple, boring collection of news articles, she did a commendable job in describing the quality and i What is worse than a drug with a lot of side effects? A drug with only a lot of side effects. A scintillating read into the evolution of global generic drug industry and its transgressions. The author doesn't pull any punches intended for the astoundingly criminal lack of integrity and regulatory oversight in the generic pharmaceutical industry. From an author's point of view, what could have been a simple, boring collection of news articles, she did a commendable job in describing the quality and integrity (or the lack of it) in the Indian pharmaceutical companies through the prism of the Ranbaxy debacle. She also underscores the intricacies of congressional pressure to keep drug costs down by approving more generics along with the lack of authority the FDA possesses once outside its country's borders. Although it upsells the use of branded drugs instead of generic substitutes (which have their own demons: read Deadly Medicine by Peter Gotzch), it highlights the imminent need of empowering regulators across the globe to ensure public health safety.

  7. 4 out of 5

    Patwm

    I urge everyone I know to read this account of generic drug manufacturing in India and China. When you do you will run to your medicine cabinet and check every bottle. This is sobering and sad as it is another illustration of humankind’s love of profit and lack of love for everyone else. It will also give you hope because there remain whistleblowers with courage and conviction whose affection and concern for their fellow man trumps greed, not to mention the dedication of this journalist for shin I urge everyone I know to read this account of generic drug manufacturing in India and China. When you do you will run to your medicine cabinet and check every bottle. This is sobering and sad as it is another illustration of humankind’s love of profit and lack of love for everyone else. It will also give you hope because there remain whistleblowers with courage and conviction whose affection and concern for their fellow man trumps greed, not to mention the dedication of this journalist for shining light on the issue.

  8. 4 out of 5

    Saket Saurabh

    Amazing storytelling, at par with books like Den of thieves or Enron story. May seem a biased against generic pharma but enough lessons for those willing to take a constructive viewpoint. Lots of respect Mr Thakur, what a person. May the forces with you.

  9. 5 out of 5

    Elizabeth Stolar

    I'm pretty numb at this point to seeing instances of egregious and even obvious wrongdoing being ignored by any bodies that are capable of righting and punishing that wrongdoing. But this book still dismayed and shocked cynical me. I want to say that I just can't believe what is going on, but I believe it. This book was referred to somewhere as "The Jungle" of generic drugs, and that characterization is spot-on. But, whereas The Jungle spurred the creation of the FDA and food regulations in gene I'm pretty numb at this point to seeing instances of egregious and even obvious wrongdoing being ignored by any bodies that are capable of righting and punishing that wrongdoing. But this book still dismayed and shocked cynical me. I want to say that I just can't believe what is going on, but I believe it. This book was referred to somewhere as "The Jungle" of generic drugs, and that characterization is spot-on. But, whereas The Jungle spurred the creation of the FDA and food regulations in general, this book highlights how the FDA utterly fails us, with high level bureaucrats overturning decisions to shut down or restrict imports of contaminated and ineffective drugs due to political considerations, the desire for low cost drugs, or to remedy shortages of certain drugs. But what good is it to have a drug available if it may kill you, or be utterly ineffective? I'm just dismayed that this is allowed to continue. This certainly makes me want to do everything I can to avoid taking any generic drugs and to not allow my family to do so. I had always believed they were the equivalent of the name-brand drugs. It seems to me that it should be without question that no one has an inherent right to sell drugs in the U.S. There is no reason that the FDA must grant approval for a particular company to sell drugs (or food, for that matter) in our market. Our government's priority should be to keep its citizens safe. So, just because it is difficult to inspect a foreign manufacturing plant is no reason that we should essentially forego inspections or do them in such a way that they are useless, or even worse, ignore wrongdoing and outright fraud when we find it. We could make the companies bear those costs. We should set up offices that allow for proper inspections. And we should not allow companies that sell ineffective and tainted drugs in our market. That should be a given. The fact that it is not is just outrageous and astounding. One important point that the book makes, but is not a main focus is that it is ultimately in everyone's self interest to make sure that ineffective drugs are not widely manufactured and used. Even if we took the position that the only people who mattered were Americans, and we created and maintained a system that every drug exported for sale within the U.S. needed to meet top bioequivilancy, sterility and purity standards, but ignore and allow inferior drugs to go to other countries, that adds to the problem of the emergence of drug resistant strains of various pathogens, and once those show up, they don't care where you live or how much money you have. They can infect anyone. This is a book everyone could read, because if everyone knew about this issue, there would be real outrage and it could force our government to at least take some action.

  10. 5 out of 5

    Dona

    I finished reading that book BOTTLES OF LIES. It doesn't give the companies who manufacturer generic drugs a good rap -- esp. those from India & China, The FDA does not really have much clot in foreign counties about safety standard, cleanliness, testing procedures, correct mixtures. even thou there is tons of evidence to their fudging data not much can to do without causing an international incident. The book does not give an hope or way to safety guard ourselves from bad med's. Really eye o I finished reading that book BOTTLES OF LIES. It doesn't give the companies who manufacturer generic drugs a good rap -- esp. those from India & China, The FDA does not really have much clot in foreign counties about safety standard, cleanliness, testing procedures, correct mixtures. even thou there is tons of evidence to their fudging data not much can to do without causing an international incident. The book does not give an hope or way to safety guard ourselves from bad med's. Really eye opening book.

  11. 5 out of 5

    John Hopkins

    Never again will I swallow a new pill without finding out where the thing was manufactured. Katherine Eban's devastating account of fraud in the generic drug industry is equally damning to the compromises that our regulators make in response to political demands for low-cost medication. Please do whatever you can to make sure your physician, your pharmacist, and your members of Congress read this book. I am not greatly surprised that deception is widely practiced in the Indian drug industry, but Never again will I swallow a new pill without finding out where the thing was manufactured. Katherine Eban's devastating account of fraud in the generic drug industry is equally damning to the compromises that our regulators make in response to political demands for low-cost medication. Please do whatever you can to make sure your physician, your pharmacist, and your members of Congress read this book. I am not greatly surprised that deception is widely practiced in the Indian drug industry, but I am shocked and greatly disappointed that our own Food and Drug Administration has relaxed its vigilance over the standards under which generic medicines are made -- even in our own country. This needs to be corrected, ASAP. Eban deserves congratulation not only for her important research but also her skill as a narrator. Once you begin, you'll find that "Bottle of Lies" keeps you turning the pages. Well done! Thanks to the Graedons and their "People's Pharmacy" show on National Public Radio for bringing this important book to my attention.

  12. 5 out of 5

    Shivakumar Srinivasan

    A fantastic read . Written with a investigative narrative, it digs deep into the rise of the generic drugs industry , and in particular exposes the recents scandals uncovered in the US on these bulk drug manufacturers, many of them out of India. While the bulk of the story is focussed on Ranbaxy, it also covers companies such as Mylan . The discovery of the fraud and deception of many of these firms will make you think twice before popping in any of these generic drugs . A must read in the curre A fantastic read . Written with a investigative narrative, it digs deep into the rise of the generic drugs industry , and in particular exposes the recents scandals uncovered in the US on these bulk drug manufacturers, many of them out of India. While the bulk of the story is focussed on Ranbaxy, it also covers companies such as Mylan . The discovery of the fraud and deception of many of these firms will make you think twice before popping in any of these generic drugs . A must read in the current state of heathcare and drug manufacturing.

  13. 5 out of 5

    Harriet

    Reading this book will give you nightmares. But not reading it might make you sick in a different way. This is the utterly harrowing story of what's wrong with our generic medications and why. Obsessively reported, painstakingly laid out, this account shows us what's wrong with not just manufacturers outside the U.S. who are used to doing things a certain way but with the FDA itself. You can't help but come to the conclusion after reading this that there is simply no way the FDA could effectivel Reading this book will give you nightmares. But not reading it might make you sick in a different way. This is the utterly harrowing story of what's wrong with our generic medications and why. Obsessively reported, painstakingly laid out, this account shows us what's wrong with not just manufacturers outside the U.S. who are used to doing things a certain way but with the FDA itself. You can't help but come to the conclusion after reading this that there is simply no way the FDA could effectively regulate manufacturers, even if it wanted to--and from this account it seems the FDA doesn't always want to. In this world, a cheap supply of tainted or ineffective medication is better than a short supply of an effective drug, or--horrors!--a costlier supply of a drug that works. This book puts the lie to the fantasy of cheap and effective medication and will make you think a hundred times before taking any drugs yourself.

  14. 5 out of 5

    Ivana

    What a terrifying book. Really, I have no words. You couldn’t make up something like this. We’re all just simply a collateral to the greedy corporate overlords. And it’s not like we have any recourse. What the fuck.

  15. 5 out of 5

    AprilNancy

    recommended by Ron's colleagues at Nerd Night

  16. 4 out of 5

    Louis

    Katherine Eban’s Bottle of Lies: The Inside Story of the Generic Drug Boom is the story of the rise and fall of Ranbaxy, a generic drug manufacturer, as well as the larger issues surrounding generic drugs. In Theranos-esque fashion, Ranbaxy substituted brand name drugs for its own, in order to produce more favorable testing results, and knew there were issues with their drugs. Among the more brazen efforts was a document with a label instructing whoever read it not to give it to the FDA. On top o Katherine Eban’s Bottle of Lies: The Inside Story of the Generic Drug Boom is the story of the rise and fall of Ranbaxy, a generic drug manufacturer, as well as the larger issues surrounding generic drugs. In Theranos-esque fashion, Ranbaxy substituted brand name drugs for its own, in order to produce more favorable testing results, and knew there were issues with their drugs. Among the more brazen efforts was a document with a label instructing whoever read it not to give it to the FDA. On top of that, Ranbaxy had layers of forged documents that were designed to fool FDA inspectors. These problems were exacerbated by the fact that the Ranbaxy was notified, long in advance, of any inspection, providing time to fool FDA inspectors. As corrupt as Ranbaxy was, they are not the only player in the generic drug debacle. The FDA also shares a substantial amount of responsibility in choosing political expedience over safety, especially when a whistleblower from within Ranbaxy provided more than enough evidence to show what was really going on. Bottle of Liesgives the reader an appreciation for how difficult it can be to produce generic drugs that are as safe and effective as their brand name counterparts, even when manufacturers have good intentions. When manufacturers have less than honorable intentions, as was the case with Ranbaxy, the result is a horror show. After the failure of the FDA to prevent Ranbaxy’s products from entering the United States, despite having plenty of evidence of numerous problems, one may question whether generics can be trusted.

  17. 4 out of 5

    Michael Silverman

    3.75 Stars Well researched. Incredibly disturbing. For those who believe that generic drugs are identical to brand names, Eban provides a very rude awakening. This part of the story is the most riveting, surprising and important (as a consumer) to understand. What Eban details in regards to the deceptive scientific, manufacturing and distribution processes are completely plausible. The hardest part to accept is that according to Eban, a considerable number of people place financial gain over the 3.75 Stars Well researched. Incredibly disturbing. For those who believe that generic drugs are identical to brand names, Eban provides a very rude awakening. This part of the story is the most riveting, surprising and important (as a consumer) to understand. What Eban details in regards to the deceptive scientific, manufacturing and distribution processes are completely plausible. The hardest part to accept is that according to Eban, a considerable number of people place financial gain over the responsibility of fulfilling the promise of helping someone in life or death (read, medical) need. The vast majority of “Bottles of Lies" focuses on one pharmaceutical company in particular with briefer mentions about the generic drug industry as a whole. In its entirety, it is a very harsh critique/assessment of the Federal Drug Administration (FDA) and its policies. Indeed, the generic pharmaceutical industry merely acts as a backdrop to her criticisms. Eban paints her story as one of a public health crisis primarily due to an administrative system that does not allow for proper oversight. However, her industry-wide argument about the incompetence of a US governmental regulatory system with limited resources, vested interest, and political influence, are frightening. There are strong overtones towards incompetence and even a vast conspiracy, but as an academic journalist, Eban is careful to avoid explicitly stating this and instead leads the reader to arrive at that conclusion independently though her observational reporting style. Maybe this was a result of lawyering. But in the end, I am left to ponder why this book was marketed as a story about the generic drug industry when it is clearly more about the FDA and the infrastructure it created in order to provide the American public with cheap but not entirely safe medications. Maybe, in the end, the lawyers and/or the editors felt that selling a cognitive split between brand pharmaceuticals (as good) and generic (as evil) is a safer sell than one directed at deceptive governmental “bureaucrats” who are often named in the book. Unfortunately, it’s a shame, because I feel what could have been a 5-star book ultimately suffers as a result of repetitive writing likely associated with attempting to manage a mixed focus. Eban argues that the quality, safety and effectiveness of medicinal drugs in the United States and around the world could be controlled and monitored effectively, but for political reasons, the FDA chooses not to. More than anything else, Eban paints a very strong warning - While it is the U.S. that sets the world standard on the safeguards protecting us from poorly manufactured pharmaceuticals, the scaffolding that supports this effort globally is shaky at best. Further, should the FDA continue to falter in its responsibility to keep medicine safe and effective, we will find ourselves in an increasingly dangerous situation in our times of greatest need.

  18. 5 out of 5

    Jessica Capelle

    This book is some fantastic journalism. But warning- it will make you so very angry. The level of corruption and fraud and complete lack of concern for patient safety is appalling.

  19. 4 out of 5

    Stephen

    This is an important book not just about generic drugs that are its subject, but globalization in general. The story is painful to read as fraud, low standards, and corporate malfeasance in any country affects people in other countries in our global age. All that is frightening and Eban lays out the story of how generic drugs manufactured mostly in India harm people elsewhere in painful detail. She also exposes the US government’s role in creating the problem as pressure mounted to “just get gen This is an important book not just about generic drugs that are its subject, but globalization in general. The story is painful to read as fraud, low standards, and corporate malfeasance in any country affects people in other countries in our global age. All that is frightening and Eban lays out the story of how generic drugs manufactured mostly in India harm people elsewhere in painful detail. She also exposes the US government’s role in creating the problem as pressure mounted to “just get genetics to market ASAP” overrode lax investigators from the FDA. The flip side of the hard-to-read stuff is the possibility of fixing not only the drug manufacturing in those counties but the underlying problems that make such dishonesty attractive. It’s clear that India (China and other places) can manufacture clean and effective drugs. The challenge is and will be for some time achieving consistency. The book on that is not this one, and remains to be written in full, but it’s in progress.

  20. 4 out of 5

    Manzoor Elahi

    Katherine Eban is an investigative reporter focusing on the pharmaceutical industry for many years. In 2008, Joe Graedon, a host of the NPR program The People’s Pharmacy, contacted Katherine Eban. Patients had been calling and writing in to his program with serious complaints about generic drugs that either didn’t work or caused devastating side effects. Patients who had previously been stabilized on brand-name drugs relapsed when switched to certain generics. He wanted to know whether generics w Katherine Eban is an investigative reporter focusing on the pharmaceutical industry for many years. In 2008, Joe Graedon, a host of the NPR program The People’s Pharmacy, contacted Katherine Eban. Patients had been calling and writing in to his program with serious complaints about generic drugs that either didn’t work or caused devastating side effects. Patients who had previously been stabilized on brand-name drugs relapsed when switched to certain generics. He wanted to know whether generics were equivalent to the brand. This book is the result of that question. Prior to 1984, generic companies of the world had no way to challenge the brand name drugs. There was no clear pathway for a generic drug to be approved in the United States. Under FDA rules, even if a drug’s patent had expired, generic drug companies were required to repeat extensive and costly clinical trials, even though the brand companies had already proven the safety and effectiveness of their drugs. That changed with the Hatch-Waxman Act. According to the act generic companies can do the clinical studies on fewer patients, because safety and efficacy of the molecule has already been proven. They just have to prove bio-equivalency. By the year 2000, manufacturing began to move offshore. By 2005, for the first time, foreign manufacturing sites regulated by the FDA exceeded those in the United States. The goal in the brand-name world was to make the best possible drugs for the highest possible price. In the generic world, the goal was different: to make the best cures affordable and available to all. Generic drugs are essential to the health care system, and their quality is critical to us all. While CIPLA with its ‘One Dollar a Day’ AIDS medicines, at a time when the disease was ravaging the poor in Africa and elsewhere and such drugs were prohibitively expensive for most, became the poster child for the good part of the generic industry—affordable excellence, Ranbaxy became the dark side of it—getting less from less. Most part of the book is about how Ranbaxy swindled the FDA. With increasing number of overseas manufacturng, the FDA has become overwhelmed and underresourced. The best way to keep drug plants compliant was for investigators to show up unannounced. So long as a drug plant remained fearful of a surprise visit, it would be more likely to follow good manufacturing practices. But the dynamic of the inspections in the international realm was completely different. No longer could an investigator walk in, show his badge, and conduct an inspection. Instead, the FDA notified foreign plants of upcoming inspections months in advance. The plants then issued a formal invitation, which the FDA’s investigators used to secure travel visas. This system of advance notice was not legally required, but as the FDA scrambled to deal with a growing backlog of foreign inspections, advance notice became the jury-rigged solution to a host of challenges. It served as a diplomatic gesture to foreign governments. Under this system, the foreign inspections became a staged event. The hotel rooms of investigators were bugged, they showed them falsified reports, while the inspections were done one a dummy plant, the actual manufactirng was done at a different plant. Around 50 percentage of the dossiers submitted to FDA contained data that did not match what Ranbaxy had on file. Most of the data is faked. Ranbaxy executives smuggled the branded drugs from USA to India and showed them as their own generic drugs for testing. Some tests were done on drugs manufactured under good controlled environment but the bulk manufactured drugs were not as good as them. If you think 50 percent is a large number, Ranbaxy faked 100 percent of its dossiers to Indian regulators. Testing the drugs for India was just a waste of time, according to an employee of Ranbaxy, because no regulators ever looked at the data. So the regional representatives just invented the dossiers on their own and sent them to the Drug Controller General of India (DCGI). What was needed for the DCGI was not real data but good connections, which they had. On one occasion, an FDA investigator fell ill while invstigating Wockhardt. The investigators suspected that the company had slipped tap water into his food. The FDA’s investigators had been trained for a different era, when the data printed out on paper was the only data that existed. The agency had not significantly rethought or overhauled its training program in decades. As one FDA consultant put it, “People are using brains from 1990 to do their thinking” today. FDA investigators who went to investigate Changzhou SPL, which was located about 150 miles west of Shanghai, instead, inspected and approved a plant with a similar-sounding name. Most of the FDA’s investigators who were sent to China did not speak the language. They couldn’t read the manufacturing records. The FDA did not provide independent translators. Instead, the companies provided the translators who, more often than not, were company salesmen. The investigators also couldn’t read street signs, which made them vulnerable to wild manipulations. Companies steered them to phony “show” plants, where everything looked compliant, but the companies weren’t manufacturing there. Sometimes a group of companies pooled their resources and invested in the same “show” factory, so that different FDA inspectors returned to the same plant at different times, each one thinking they were inspecting a different facility. Companies routinely adjusted their manufacturing quality depending on the country buying their drugs. They sent their highest-quality drugs to markets with the most vigilant regulators and their worst drugs to countries with the weakest review. Racism undoubtedly played a role, as it had at Ranbaxy when the medical director said of the poor-quality AIDS drugs bound for Africa, “Who cares? It’s just blacks dying.” But at root, a cold calculation drove the disparate standards: companies could make their cheapest drugs for markets where they would be least likely to get caught. Dinesh Thakur who was the whistle blower about Ranbaxy was legally protected under USA's The Whistleblower Protection Act, but India didn't have any Whistle Blowers Protection Act until 2014. Even now the right to freedom of speech and expression in India is not absolute. In India, filing a defamation suit against someone is a sure way to tie the person up with legal fees and court proceedings, potentially for years. Powerful Indian corporations do not hesitate to sue authors, journalists, or activists for defamation, backed up with claims for damages no author, publishing house, newspaper, or non-profit group can afford to pay. Reliance Industries Ltd., run by Mukesh Ambani, sought 1 billion Indian Rupees in damages from journalists for a book on Reliance. With increasing number of drugs manufactured in developing countries, FDA cannot control the quality of the drugs without the help of the government and ethical culture in those countries, but that is not going to happen anytime soon. Some articles written by Katherine Eban: https://fortune.com/2013/01/10/are-ge... https://fortune.com/2013/05/13/maker-... https://www.self.com/story/dangers-of... https://fortune.com/2013/05/15/dirty-... While Bottle of Lies is about the problems in generic industry, Phake: The Deadly World of Falsified and Substandard Medicines by Roger Bate is about counterfeit medicine. These two books will take the reader through the problems in the drug industry.

  21. 5 out of 5

    Ali

    MOST TERRIFYING BOOK I'VE EVER READ: Do you or loved ones take generic drugs? Are they manufactured in India or China? If so, THROW THEM AWAY and get the brand-name stuff instead. I'm 100% serious. Why? Because in order to save money and make more profit, generic drug manufacturers in India and China operate on the "what can we get away with" principle, vs the rigorous current Good Manufacturing Practices (cGMP). FDA inspectors found birds and snakes nesting in supposedly sterile facilities, gla MOST TERRIFYING BOOK I'VE EVER READ: Do you or loved ones take generic drugs? Are they manufactured in India or China? If so, THROW THEM AWAY and get the brand-name stuff instead. I'm 100% serious. Why? Because in order to save money and make more profit, generic drug manufacturers in India and China operate on the "what can we get away with" principle, vs the rigorous current Good Manufacturing Practices (cGMP). FDA inspectors found birds and snakes nesting in supposedly sterile facilities, glass shards in pills, doctored data, falsified data, bad batches of drugs hidden from view, contaminants found but sent off for sale anyway. That's when the plants had *4 weeks* advance notice that an FDA inspection was coming. And that's for the drugs bound to the US, EU and other highly regulated markets. For Africa, South America, Asia and Eastern Europe, there are *entire 2nd tier facilities* that adhere to no standards at all. These companies absolutely do not give a damn about the livelihoods of the recipients of these drugs. The quotes from the Indian executives are shocking, e.g. "Who cares if a few black people die?" The FDA has seriously dropped the ball by being lenient about these violations found *by their own field agents* instead of shutting down the offending plants. Why? High demand, duh. We need the cheap drugs, yo! Political expediency takes priority over patient's lives. Which of course makes NO SENSE AT ALL. Most people don't know that 40% of all drugs consumed in the US are manufactured in India and China. And yet, there is a high probability that those drugs are contaminated, ineffective, or improperly formulated. So, some guidelines: 1) Check your pills. If they're made in India or China (or by Teva in Israel), toss 'em. Get brand name instead, or something from a US/EU manufacturer. You health is worth it. 2) Don't buy cheap drugs when traveling abroad, eg in Mexico or Ukraine. You'll get what you pay for, which is ineffective or contaminated product. 3) When traveling to faraway places without access to first-rate medical care, take a stash of reliable antibiotics with you. It could be the difference between life and death. There is so much more in this book that everyone needs to know about. This is fraud on the level of Theranos, only 100x bigger and affecting the whole planet. If you care about your health and that of your loved ones, please take this seriously. Any reaction less than "you've gotta be fuckin' kidding me" is inadequate. Required reading for all healthcare providers and users.

  22. 4 out of 5

    Ita Marquess

    ‘Bottle of Lies’ takes us into a world where generic drugs are designed and manufactured. Generics, through reverse-engineering, are produced to act like the parent, brand drugs from which they are derived. They are not identical to these, but are meant to be bio-equivalent. 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 ingr ‘Bottle of Lies’ takes us into a world where generic drugs are designed and manufactured. Generics, through reverse-engineering, are produced to act like the parent, brand drugs from which they are derived. They are not identical to these, but are meant to be bio-equivalent. 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?’

  23. 4 out of 5

    Bryan

    Truly startling and distressing to read. We put faith in our regulatory bodies, in this case the FDA, and trust that what is available to us on the market is safe, effective, and reliable. This book not only exposes this charade but places serious doubt into the integrity of anything that is up against the all powerful god of the dollar. It makes you wonder if the reason you have to take an extended course of antibiotics is indeed because of the quality of the product is just poor. And the reper Truly startling and distressing to read. We put faith in our regulatory bodies, in this case the FDA, and trust that what is available to us on the market is safe, effective, and reliable. This book not only exposes this charade but places serious doubt into the integrity of anything that is up against the all powerful god of the dollar. It makes you wonder if the reason you have to take an extended course of antibiotics is indeed because of the quality of the product is just poor. And the repercussions of undertreating and breeding resistant bacteria is harrowing. The idea of spending hundreds of thousands or even millions of dollars for transplants, and then have people die because the post transplant drug is ineffective is simply enraging. Katherine Eban does an excellent job of reminding you who the key players are throughout the book, using clear language to help you understand, and presenting a carefully laid out, well researched case against the drug industry and the FDA. And the ones who suffer the worst are the countries without the ability to defend themselves. This book is most alarming not because companies attempt subterfuge (that is almost axiomatic), but because our regulatory bodies which are our last lines of defense, allow it to happen and then make a public statement which is misleading at best and intentionally and criminally lying at worst. And it is still happening. And for me it raises red flags about the machinations in other industries (Boeing) and how much safeguarding there actually is (FAA the last to ground Boeing planes). Stunning read.

  24. 4 out of 5

    skip thurnauer

    If you think all generics are the same as the brand name drug, you are wrong. Bottle of Lies says you could be dead wrong. The FDA is responsible for the quality control of drugs sold in America. They are not equipped to monitor the global generic business where fraud is rampant and quality is sacrificed for low costs and maximum profits. Katheran Eban follows the trail of whistleblower accounts and FDA documents to reveal the peril facing Americans in their quest for cheaper prescription drugs. If you think all generics are the same as the brand name drug, you are wrong. Bottle of Lies says you could be dead wrong. The FDA is responsible for the quality control of drugs sold in America. They are not equipped to monitor the global generic business where fraud is rampant and quality is sacrificed for low costs and maximum profits. Katheran Eban follows the trail of whistleblower accounts and FDA documents to reveal the peril facing Americans in their quest for cheaper prescription drugs. In India, the model of aggressive shortcuts, rule dodging, and workarounds is known as Jugaad. When Jugaad is applied to drug manufacturing, patients receive drugs with unpredictable and dangerous outcomes. After 40 years in pharmaceuticals, I still found the revelations in Bottle of Lies shocking, but not surprising. There are plenty of heroes in Bottle of Lies - the whistleblowers, FDA investigators, scientists and others who endeavor to ensure the quality of the drugs we consume. But, sadly, there are many more villains and few are held to account. What is most disconcerting is that there is no simple cure for the problems that are deeply engrained in the generic drug industry. One of the saddest aspects of this story is that America and the West receive the best generics. Africa and the Third World get the bilge scum.

  25. 5 out of 5

    Tammam Aloudat

    This account of the problems and deficiencies of generic medicine production is scary, the fact that there are medicines that are sold and distributed and then used by unsuspecting patients around the world that might fall short of any acceptable standard is terrifying. The book focuses mostly on the story of Ranbaxy but also addresses other issues and places both in India, the US, and other places where generics are produced. This is important to know about and mitigate. However, I struggle with This account of the problems and deficiencies of generic medicine production is scary, the fact that there are medicines that are sold and distributed and then used by unsuspecting patients around the world that might fall short of any acceptable standard is terrifying. The book focuses mostly on the story of Ranbaxy but also addresses other issues and places both in India, the US, and other places where generics are produced. This is important to know about and mitigate. However, I struggle with the fact that the book was presented as a story, a journalistic one, and while the author has done a lot of effort to "break" the story, she suggests no ideas almost at all to address the resulting problems: what is to be done, how generics which are the only affordable form of drugs for tens of millions of people around the world to be rehabilitated and guaranteed. On the other hand, how does that compare to brand name companies? This is a thrilling tale but it is partial and difficult to make use of other than individually saying that I won't buy indian made generics for myself and my family, which is not useful and throws the responsibility on consumers and patients rather than the state. The book is very readable and Kathrine Eban certainly knows what she is talking about.

  26. 4 out of 5

    Liz

    Well-written investigative account of the criminal fraud at Ranbaxy pharmaceuticals. It tries a little too hard in places to sound like a Tom-Clancy-type thriller, and some of the chapters work well on their own but don't flow together well for the sake of the overall book. Eban's frustration with the FDA is clear -- in her account they are hamstrung by conflicting objectives: on one hand, protect the American consumer from dangerous drugs that don't meet GMP standards, but on the other hand, kee Well-written investigative account of the criminal fraud at Ranbaxy pharmaceuticals. It tries a little too hard in places to sound like a Tom-Clancy-type thriller, and some of the chapters work well on their own but don't flow together well for the sake of the overall book. Eban's frustration with the FDA is clear -- in her account they are hamstrung by conflicting objectives: on one hand, protect the American consumer from dangerous drugs that don't meet GMP standards, but on the other hand, keep approving new drug applications so they can get the funding that the agency desperately needs. The book unfortunately does not propose any possible solutions or even improvements for the current situation and ends on rather a discouraging note. The book also leaves the reader with the alarming sense that all generic drugs are manufactured overseas in unsafe conditions, entirely overlooking generic drug manufacturing in the US (of which, admittedly, there isn't as much as there once was). Moral of the story: talk to your doctor/pharmacist, check the labels on your prescriptions, and call your representatives to encourage them to fund the FDA so they have what they need for rigorous inspections.

  27. 4 out of 5

    Dramatika

    A very important book on the safety of generics. The price of the brand name drugs supposed to reflect the costs of lengthy and expensive R&D that pharma companies spent. Unfortunately, as far as I know, the high prices of modern drugs has more to do with the high costs of marketing and advertising. For anyone who is forced to take drugs for chronic condition the high costs can be too high to bear. Here is where generics supposed to help. And they do if manufactured correctly. This book expl A very important book on the safety of generics. The price of the brand name drugs supposed to reflect the costs of lengthy and expensive R&D that pharma companies spent. Unfortunately, as far as I know, the high prices of modern drugs has more to do with the high costs of marketing and advertising. For anyone who is forced to take drugs for chronic condition the high costs can be too high to bear. Here is where generics supposed to help. And they do if manufactured correctly. This book explain how the manufacturing process in far away countries such as India (which where most of the book narrative takes place) or China can be so many mistakes and even disregard to quality that it compromises the safety of the drugs. What I especially liked is the meticulous explanation on how generics are reproduced (which was a completely new information to me) and how much the way drug works depends very much on the delivery process inside the body as well as the active component and inactive components. I love that book, even though some of the details can be too technical, but his was very helpful to me as I lack almost any knowledge of chemistry aside from long forgotten basic school course. This is also a very good story on the people who exposed the problems with the Indian pharma companies who manufactured the faulty medicines for years. These whistle blowers are a true heroes of this book, who risk everything in the search for truth. In out time as ever (or always?) the morality question is alive and well and no amount on ethics courses in business school can help the avarice of some of the industry bosses. One of the best books based on research done by the investigative journalist I've read this year. I would like to thank the author for this excellent book!

  28. 4 out of 5

    Ingrid98684

    I've never read The Jungle, but I believe based on descriptions that Bottle of Lies is along the same lines. Eban pulls back the curtain on the generic drug industry, and to say her findings are horrifying would be a gross understatement. The FDA comes out looking pretty culpable too. I finished the book last night, and discussed what I learned with my husband. We've made the decision, going forward, that we will be avoiding generics, and asking more questions about any prescription medicine tha I've never read The Jungle, but I believe based on descriptions that Bottle of Lies is along the same lines. Eban pulls back the curtain on the generic drug industry, and to say her findings are horrifying would be a gross understatement. The FDA comes out looking pretty culpable too. I finished the book last night, and discussed what I learned with my husband. We've made the decision, going forward, that we will be avoiding generics, and asking more questions about any prescription medicine that's recommended. We're also in the process of going through our medicine cabinet, to determine what we have, and where it was made. Anything made in India or China, or containing ingredients make in those countries, is being eliminated. Evan's work is eye-opening and ground shaking, but reads like a thriller. I found myself sucked in immediately, caught up in her story telling and the horror of what she was revealing. She does a good job of making the information accessible to a layperson like me. This is a book I'll be recommending to anyone and everyone I know.

  29. 4 out of 5

    Chaitalee Ghosalkar

    More often than not, news of FDA giving warning letters to pharmaceutical companies ends up tanking the companies' shares and as an alert to not invest in them. Katherine Eban makes you look past the superficial attention we pay to such news items and takes you though the murky ride fraught with corruption, tampering, dishonesty, and more importantly, gross neglect towards the value of human life The book builds itself around the dismantling of Ranbaxy, a company that became notorious for its ind More often than not, news of FDA giving warning letters to pharmaceutical companies ends up tanking the companies' shares and as an alert to not invest in them. Katherine Eban makes you look past the superficial attention we pay to such news items and takes you though the murky ride fraught with corruption, tampering, dishonesty, and more importantly, gross neglect towards the value of human life The book builds itself around the dismantling of Ranbaxy, a company that became notorious for its indiscretions, and focuses on the inefficiencies of Indian companies, but nowhere does it feel that Indian companies are being singled out. In a country where there isn't sufficient water and electric supply at places where manufacturing plants are built, or where 'jugaad' is the way of working, this book quite bluntly brings factors to the fore which we are known to shrug and forget Let this book serve as a wake-up call for patients, and make companies realize that no one has given them the right to toy with human lives

  30. 5 out of 5

    Kundan

    After you read this book, it'd be difficult for you to buy generic drugs - the cheaper yet almost equally effective alternatives of the highly expensive branded drugs. The extent to which offshore drug manufacturers, particularly in India (the worst offender being Ranbaxy) and China go to falsify data to produce generic drugs at scale is not just greed for money, it's inhumane, it's criminal. The meticulously detailed investigative piece traces the meteoric rise of the generic drug industry ( ho After you read this book, it'd be difficult for you to buy generic drugs - the cheaper yet almost equally effective alternatives of the highly expensive branded drugs. The extent to which offshore drug manufacturers, particularly in India (the worst offender being Ranbaxy) and China go to falsify data to produce generic drugs at scale is not just greed for money, it's inhumane, it's criminal. The meticulously detailed investigative piece traces the meteoric rise of the generic drug industry ( how the global demand for cheaper meds and laxed patent laws, led to the opening of a massive opportunity in the generic drug market). The extent of corruption and audacity of the Ranbaxy management to fool the US FDA officials is mind-boggling. The struggle of the whistle-blower to fight till the end and fix the system leaves you with nothing but deep respect and sympathy for him. This book gives a deep, insightful analysis of all that needs to be fixed in the global pharmaceutical industry.

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