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

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

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 pharmaceuticalsMany 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 pharmaceutica...

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Title:Bottle of Lies: The Inside Story of the Generic Drug Boom
Author:Katherine Eban
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Bottle of Lies: The Inside Story of the Generic Drug Boom Reviews

  • 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.

  • 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.

  • 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.

  • 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. 📕💊

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • AprilNancy

    recommended by Ron's colleagues at Nerd Night

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