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

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

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 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...

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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.

  • 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. 📕💊

  • 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:

    While Bottle of Lies is about the problems in generic industry,

    by

    is about counterfeit medicine. These two books will take the reader through the problems in the drug industry.

  • 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.

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