In 2004, Dinesh Thakur, a senior employee of Ranbaxy, then India’s largest pharma company, discovered a terrible secret. Ranbaxy had been fabricating the test results of their drugs, endangering millions of patients. Thakur resigned and became a whistleblower to the US Food and Drug Administration, one of the regulators Ranbaxy had been lying to, and ultimately brought the multibillion-dollar behemoth to its knees. This is the sensational account of the high-stakes chase to bring Ranbaxy to book and the fall from grace of one of corporate India’s biggest success stories. But the rot in Indian pharma isn’t confined to Ranbaxy alone. In this book, investigative journalist Katherine Eban relies on over 20,000 FDA documents and interviews with over 240 people to show how fraud and trickery are deeply entrenched in much of the industry in India, and raises troubling questions about some of its biggest names – Wockhardt, Dr Reddy’s, Glenmark and RPG Life Sciences. Filled with shocking and eye-opening details, this book lays bare the ugly truth of Indian pharma. It will make you view every pill you take with foreboding and suspicion.
Katherine Eban, a New York Times bestselling author and investigative journalist, is a Fortune magazine contributor and Andrew Carnegie fellow. Her narrative, deeply reported articles on pharmaceutical counterfeiting, gun trafficking, and coercive interrogations by the CIA, have won international attention and numerous awards. She lectures frequently on the topic of pharmaceutical integrity. Press and speaking event contacts can be found here: https://www.katherineeban.com/contact
Eban describes negligence and fraud in the generic drug industry and the FDA’s inability to keep unsafe drugs out of the American market. She focuses on the story of a large Indian company, Ranbaxy, which was cited time and again by the FDA for practices that produced drugs that were contaminated, ineffective, not the labelled dosage, erratically time released or failed to disintegrate properly. Ranbaxy falsified records and test results. The company destroyed legitimate ones that would have identified the true state of their drugs and operations. The company even ran tests on the name brand products they were copying and submitted those results to the FDA as their own. Despite the citations and evidence Ranbaxy was allowed to keep producing drugs for export to the U.S. Eban highlights examples of similar problems at other companies in India as well as China and similar levels of inaction by the FDA.
Eban details the inadequate FDA protocols for inspecting drug manufacturing plants in foreign countries that produce drugs for the American market. She shows how bureaucratic practices and political influence undermine the FDA’s efforts. In addition FDA employees leave for lucrative jobs in the drug industry making them reluctant to anger the drug companies while still at the FDA. The FDA does not have the number of inspectors needed to properly inspect foreign drug manufacturing plants. Years go by between inspections. Some foreign drug companies have offered FDA inspectors perks such as free vacation trips including spouses while in the country or just outright bribes. Foreign plants to be inspected are typically notified well in advance giving them time to clean up their act and hide unapproved practices. U.S. based plants always have to be ready for surprise inspections which are much more revealing. The rigor of FDA inspections in the U.S. compared to the laxity of FDA inspections in foreign countries has been one reason many drug companies have moved production overseas particularly to India and China. While much of the information Eban presents is not new, tying it all together paints an alarming picture.
Prior to 1984 generic drugs were held to the same standards as new drugs, meaning clinical trials had to be conducted to prove safety and efficacy. But then U.S. law was changed so that generics only had to show bioequivalence to the FDA approved drug. The goal was to lower the cost of drugs, important for most people in the U.S., but critical for people in poor and less developed countries. For example, generics were crucial to fighting the spread of AIDS in Africa. In developed countries, generics are essential to keep government drug programs affordable such as the Prescription D plans available with Medicare in the U.S. Sadly some companies that manufacture generics have done so with different standards for countries with less regulation. The profit motive prevails, so for countries that don’t inspect facilities or test drugs, generic manufacturers can cut corners or cut dosages. Some scientists believe that one of the reasons drug resistant bacteria are spreading is the proliferation of generic antibiotics with less than the labeled dosage which are found most often in less developed countries. This gives the bacteria time to develop resistance.
In America 90% of prescription drugs sold are generics. About 40% come from India and 80% of the raw ingredients used in all drugs come from India or China. The FDA requires exhaustive testing to approve a new drug. Yet the FDA’s program to ensure generics are bioequivalent to those well tested drugs is deficient. Eban references a number of medical professionals and organizations that have identified ineffective and unsafe generics approved for use in the U.S. She notes that some hospitals keep an emergency stash of name brand drugs just in case the generics don’t work. A couple of years ago I went to my primary care physician with welts that were not going away. She right away asked me to examine my prescriptions to see if the manufacturer had changed. I was surprised by her concern, but now I understand. The welts subsequently went away with no reason ever found. After reading Eban’s book I immediately went to my medicine cabinet to see the company that made the drugs and where they were made.
Eban makes a convincing case. She also makes the book an interesting read by using the Ranbaxy case as a focal point and digressing from there to examine the broader implications. Most of the book reads like a corporate detective story with a whistleblower trying to do the right thing, manipulative senior executives putting profit above all else, agents wanting to take action for wrongdoing and more politically minded FDA executives trying not to rock the boat or cause an international incident. I have avoided describing the details of the Ranbaxy case, because for readers not familiar with the Ranbaxy case (I wasn’t), the book reads with suspense keeping you turning pages. I had some sobering takeaways realizing that I cannot assume generics will work the same as the originally authorized drug, that the FDA does not inspect foreign based plants with the same frequency or rigor it does U.S. based plants and despite FDA statements to the contrary it cannot ensure that foreign based plants exporting to the U.S. operate to FDA standards or produce drugs to FDA standards.
One of these rare books when you spend couple days or a week and will get so much information about the subject you knew nothing before - sometimes even more than you asked for. I enjoyed it a lot and it make me think if any medicine me or my relatives takes are generic one (will try to use brand name only drugs from now on). Excellent journalism to show us different players related to this scandal and how people don't give a shit (excuse my French) about other people - best example is bad AIDS drug they send to Africa and manager says - "it's black people, who cares". It remind me Bad Blood: Secrets and Lies in a Silicon Valley Startup which I read recently and enjoyed a lot as well. Make yourself a favor: read this book and may be some day it'll save your life by not taking some generic which could harm you. This books shows clearly that it's not only problem with Indian companies that try to make big bucks by producing shit (some of the factories had bird nest and monkey shit in same room they produce a medicine), other countries such as China and even USA has the same problems - if not regulated and checked constantly these companies will do anything to cut cost to improve their bottom lines.
Before now, I had a pretty rosy view of generic drugs: I assumed they were chemically identical to the brand name drugs, minus the exorbitant fees of the big pharmaceutical companies. I also assumed there was an air-tight system of checks in place to ensure their safety and efficacy. In Katherine Eban's Bottle of Lies: The Inside Story of the Generic Drug Boom, I learned the picture is far more complicated than that. Eban tells the story of Ranbaxy, an Indian generic drug company, and how it lied and cheated for years to create competitively priced generic drugs at minimal cost while endangering patients the world over.
Eban describes the intricate trials and approvals a large pharmaceutical company goes through to create a drug. Once it has produced an effective treatment, it has two decades to corner the market and rake in record profits. After that, the patent expires, and generic companies fight to be the first to get approval from the FDA to produce their own version for an exclusive six-month period before the market is open to everyone else. To do this, they must first figure out how to reverse-engineer the drug (being careful to avoid certain procedural steps the original producer still holds patents on) and run tests for efficacy, ingredient release, time window, and so forth... within certain acceptable parameters. Then they present a credible proposal to the FDA showing they can ramp up production and make the drug available in sufficient and affordable qualities.
Ranbaxy was one of those generics companies, known for being particularly adept at reverse-engineering drugs. They would send their representatives to wait overnight in the FDA parking lot in an attempt to get their proposals in first (everyone did this until the FDA stopped enforcing a first-come, first-served rule). Their first big claim to fame was when they began producing AIDS drugs at cut-rate prices that could make life-saving treatments available to people in all countries; not just the rich ones. This won Ranbaxy face time with and praise from former president Bill Clinton and put them on the map as one of the top generics contenders. They secured the rights to dozens of other drugs as well.
Eban makes it clear that Ranbaxy had the technical know-how to create effective drugs: that wasn't the problem. The problem was that, in order to cut costs and maximize profits, they would systematically fake results, introduce impurities, change suppliers, hire illiterate and untrained workers, mix in cheaper or failed batches of ingredients, and generally flout all the FDA guidelines they'd agreed to. This required lying about failed tests, copying results from good batches and applying them to bad ones, aping results from the actual brand name drugs, altering or destroying records, running non-networked testing machines, misleading inspectors, and of course... threatening whistleblowers.
To complicate matters, Ranbaxy would vary its products based on markets so that countries with strict quality oversight (such as the US) got the best versions of a product while a poor country got a mixture so degraded as to be useless or even harmful. When confronted about the useless batches of AIDS drugs being sent to Africa, a top medical executive at Ranbaxy said, "Who cares? It's just blacks dying." Beyond being horribly unethical, this was obviously a practice that would be noticed at some point. Doctors began realizing that, when dealing with low-grade generics, they'd have to multiply dosages to get the same effects, or sometimes find their patients worse off. If they switched a patient to the far more expensive brand-name drugs, they would see an immediate turnaround and improvement: a testament to the quality of the drug that was termed "the Lazarus effect". At one point, inspectors found drug batches with visible black particles. In another instance, small shards of blue glass were found in Ranbaxy pills. While Ranbaxy is the primary target of this book, other companies did this, too. When Israeli company Teva began making a generic version of Wellbutrin XL, many patients found themselves sick, sleep-deprived, irritable and even suicidal.
These red flags would occasionally prompt the FDA to demand fresh reporting from Ranbaxy, which set off an immediate, panicked effort to throw them off and conjure faked results. Some employees, such as Raj Kumar and Dinesh Thakur, caught on to what was happening and demanded that the company start behaving ethically. Both were shocked to find out that the directors knew about this behavior. They both quit out of frustration, but Thakur began a silent, many-year campaign to feed the FDA what he knew. This whistleblowing effort, combined with the careful work and surprise inspections of star investigators like Peter Baker, led to the full story of Ranbaxy's mendacity coming to light and a massive $500 million judgment against the company.
The bulk of the book expands on how the take-down happened: the evasions, intimidations, disgusting conditions, legal standoffs, delays, and sometimes stupefying laziness and complacency involved on both sides. Some of it is jawdropping, and some of it is exhausting and repetitive. I guarantee you'll never find a book that uses the word "Ranbaxy" this much. Still, it's an important story, and I'm glad this exposé will serve as an example of why it doesn't pay to cheat. At the same time, Eban reminds us that the cat-and-mouse game never stops, and that our faith in the products should only be as good as the oversight structure we have in place. There couldn't be a better example of why regulation is so important. In the meantime, be ready to study up a bit before you assume a generic drug is identical to the original.
Following up with a helpful link I learned about in our book club meeting: Katherine Eban shares a helpful guide on how to research the safety of generic drugs on her site.
Rattled by revelations! After giving birth by cesarean section, new mothers in Uganda, succumb to bacterial infections despite taking a full course of antibiotics because the quality of generic drugs exported to African countries is extremely poor, to say the least. Instead of the stipulated 2.5mg Olanzapine, a Ghanaian psychiatrist gave 10mg of the same drug to one of his patients with psychosis and saw no results. It's shocking that doctors throughout Africa have to adjust their medical treatment sometimes doubling or tripling recommended doses to produce a therapeutic effect.
Katherine Eban explains that while the goal of a branded drug company is to make the best possible drugs to be sold at highest possible price, that of generic drug companies is to make the best cures affordable and available to all. To make profit, many generic drug companies mess with the quantity of active ingredients, compromise on sterility, cut down on clinical trials, fabricate raw data...
Bottle of Lies opened as an expose on the poor quality of some genric drugs imported to the USA, loosely based on Dinesh Thakur's experience in Ranbaxy, went on to reveal the dark side of pharmaceutical companies like Pliva, Dr. Reddy's, Glenmark, Ethex, Zydnus and Sandoz. Consumers from developing and underdeveloped countries who're being sold bottles with bigger lies printed on them are continuing victims of quality slip ups that endanger lives.Bottle of Lies is a shocking read and an eye opener. It has made me more careful about the drugs I prescribe and consume.
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.
4.5 * Puikus tyriamosios žurnalistikos pavyzdys apie vieną iš tų atvejų, kai gera ideja realybėje virsta į nebesuvaldomą monstrą. Knyga - apie generinius vaistus (Generic Drug). Už juos (ne)dėkingi turime būti, ir kas galėjo pagalvoti, Mahatma Gandhi'ui. Būtent jis ragino chemiką Khwaja Abdul Hamied'ą kuo greičiau pradėti kopijuoti vakarietiškus vaistus ir padaryti juos prieinamus Indijos nepasiturintiems. Iš pradžių viskas ėjosi puikiai ir ne viena gyvybė buvo išgelbetos ne tik Indijoje, bet visame pasaulyje. Tačiau metams einant augo kompanijų godumas, atsakomybės stoka, nesąžiningumas.... Viso to pasekoje radosi faktai liūdijantys apie šių vaistų nesaugumą (rimti sveikatos sutrikimai ir pasitaikančios mirtys). Tai ir paskatino autorę imtis šio mums visiems svarbaus tiriamojo darbo. Kaip jau aišku iš knygos pavadinimo (Melų indelis), autorė, kuriai prireikė ne vienerių metų šiam tyrimui, bando įspėti mus apie pavojus tykantčius šiuose vaistuose. Pagrinde buvo tiriama Indijos (didžiausios pasaulyje) ir šiek tiek Kinijos generinių vaistų gamybos kompanijos. Autorę šokiravo higienos sąlygos laboratorijose, netikslus dozavimas, vaistų balinimas chemikalais, kad būtų vizualiai prilygta originalam, laikymo sąlygos, per greitas gamybos procesas (sutrumpinant būtiną kai kurių komponentų ''brendimą'', nepakankamas jų testavimas...Beje, istatymai originaliems ir generiniams vaistams yra skirtingi. Originalių vaistų testavimas yra ilga procedūra, reikalaujanti daug didesnio bandomųjų pacientų skaičiaus, taip pat teigiamų rezultatų skaičius turi buti ženkliai didesnis už generic... Beje, knygos herojai (autorės šaltiniai) aptiko daugybę suklastotų dokumentų, o apie trukdymus tyrimams net kalbėti neverta. Žodžiu- gera knyga, būtina. Verta vertimo į lietuvių ir kt. kalbas. Rekomenduoju!
I wish I could rate this higher because the content is super-important but the writing is not great. The book is about 200 pages too long and filled with clunky sentences like "On the cold, clear night of December 23, 2002, with Christmas just two days away, the FDA parking lot was crowded."
This is a devastating muckraking report, not just about Indian generic drug manufacturing (which is bad enough) but about the ENTIRE PHARMACEUTICAL INDUSTRY AND THE FDA. Part of me wants to say that every single person should know this information, but that's wrong. That's the problem. It shouldn't be up to every individual citizen to look at the pills that come from the pharmacy and then investigate what company manufactures them in what country in what factory, and then try to find out somehow if that facility is reliable. THAT'S THE FDA'S JOB! And anyway, it's not just medicines clearly produced by a company from India that are the problem. American (and European and Israeli...) GENERIC AND NAME-BRAND drug companies manufacture their pills in substandard Indian plants or get their raw ingredient chemicals from substandard Chinese factories. The book's subtitle is hard to understand, because it obscures the magnitude of the problem described.
The ultra-fraudulent company focused on in the book (Ranbaxy) does not exist as a name anymore but its factories were bought by Sun Pharma, which is using them and sells pills in the US.
We need good regulation. We need more honest inspectors and we need to prevent and to punish corruption. This is not trivial. This is killing people. And of course, unfortunately, this issue with the medicines is just one symptom of a broader culture of corruption and incompetence. We can do better. A few greedy CEOs shouldn't be able to wreck the world.
After a long time I read a book that was captivating and enthralling right till the end. Katherine Eban has done full justice to her years of painstaking research on the pharma industry. This book has brought to light the various malpractices the pharma industry indulges in to pass the muster in FDA books and the key to US markets. The book highlights the lax drug controls in developing countries like India and China to manufacture generic versions of branded expensive drugs. It has detailed how Ranbaxy flouted good manufacturing practices and permeated a system of corruption and record manipulation in their company. It took a whistleblower like Dinesh Thakur to bring out the malpractices to the attention of FDA. To compound his problems, including living in constant fear for his family, the FDA also took its own time (around eight years) to finally take action against Ranbaxy. This was only because of a few officials' dogged persistence to pursue justice. The FDA is also not spared with questionable practices, high pressure lobbying by the US govt in cahoots with the drug industry and corrupt officials walking its corridors.
This book brings out the fact that poor, inferior quality drugs are pushed to African, Eastern European and South American countries where the drug controls are lax and corruption is more widespread. Kudos to the author, this book definitely is an eye-opener and a mindblowing read.
Uma excelente exposição dos problemas com a nova indústria de genéricos que se formou na Ásia, principalmente na Índia e na China. Katherine Eban é uma jornalista investigativa que conta neste livro como se formou a indústria de genéricos no mundo (começando pelo Brasil), como essa indústria cada vez mais fornece a maior parte dos insumos para o mundo todo. E como cortaram muitos caminhos para fazer produtos mais baratos e mais competitivos.
Ela descreve em especial como o FDA (a Anvisa americana) acabou descobrindo fraudes no sistema de aplicação e vigilância e como uma série de medicamentos nos EUA não tinham princípio ativo por usar esses insumos fraudados. O fim do livro é especialmente preocupante, pois ela discute como essa descoberta acabou gerando "categorias" de qualidade de algumas farmacêuticas que mandam insumos mais bem feitos para países com mais vigilância, enquanto países mais pobres ficam com insumos bem piores.
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. 📕💊
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.
Read this on a whim. Highly impressed with the research that must have gone into this, and deeply troubled by the findings and implications.
In a nutshell, it reveals the real story behind the Indian generic drug industry, and how it managed to fool regulators across the world, while having rampant corruption, shady manufacturing practices , outright fraud, and very little consequences.
Some of the undrawn parallels with the Indian software boom are interesting to ponder about: Our BPO and IT boom happened for very similar reasons: cheap labour, little oversight by regulators, and a government that protects corporate interests above everything else. However, the drug industry has a few facets that make it stand differently:
1. The blast radius for, say a IT consultancy screwing up is much lower. It will be limited to a few companies at most. Lives are rarely at stake, with very few exceptions. 2. It is easy for a small-sized change in drug quality to have a large impact down the road. This is hard to understand at first, but makes complete sense once you understand the importance of quality in the drug industry.
Drugs are the cornerstone of modern healthcare. In order for us to be able to trust the healthcare system, we need to be able to trust our drugs, and that means a high quality reliable drug manufacturing pipeline. Doctors need to be able to trust that their prescriptions will work. Even if one out of every hundred batches of a medicine is faulty, the whole system breaks down. If your clinic gets a bad batch - all your patients are screwed.
What Ranbaxy (and other indian manufacturers) did resulted in patient deaths across the globe, and doctors losing trust in the drugs themselves, such was the shoddy quality of the same. In the race to the bottom for profits, Indian Pharma puts its morals on fire and sells everything.
Another aspect that the book covers is how tied up the FDA itself is, and how badly underfunded and under prepared it was throughout the crisis. Despite having evidence going back to 2005, it took them more than half a decade to take any action at all. The Indian regulators are still on the side of the pharma companies.
By the end, I was hoping for a lifeboat of sorts, against all odds, to see some changes. Sadly, that's not the case.
The book reads like a thriller, and reminds me the most of Bad Blood in a way. Except that the impact here was so much higher, and yet there ends up being no criminal action against any of the executives. The only minor nitpick I had was regarding superfluous callbacks to people who were already well introduced.
Highly recommended, and I'm gonna go read news reports from the time, that I somehow completely missed back then.
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.
I read about half fiction, half nonfiction every year. And almost every year there is one nonfiction book that just blows me away. In the past: 5 Days at Memorial, The Blood Telegram, Blood in the Water (there seems to be a theme). This year, that book is Bottle of Lies. It is a devastating, revelatory expose of the generic drug industry around the world, specifically in India (though we do hear about China - another huge source of generic meds - too). The upshot: we should all be very worried about the drugs we're taking. With the globalization of the pharmaceutical industry, not only are a majority of our generic drugs made far from the oversight of the FDA (which is far from perfect anyhow) but a majority of the active ingredients in all drugs - generic or brand name - are also made outside of the United States. Now that's not inherently a problem except that the industry as a whole is motivated by money. And if you make things quicker and cheaper and skirt and cheat standards, you can make more money. And that's exactly what's happening. Meanwhile the West is stuck with generics that are less effective than brand names and sometimes even with impurities in drugs, and the rest of the world is doing even worse, as companies make even more substandard meds for countries that have less strict standards. And the FDA announces its inspections so far in advance that companies can prepare and seem compliant even if they're not. And the FDA is so tied to needing to approve cheaper drugs for consumers that desperately need them, that they let a lot of these companies off the hook. Thank goodness for the whistleblowers who let us know about this, but how is it going to be fixed? I recommend you check your medicine labels and inform yourself.
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.
The other day I was chatting with my doctor and I mentioned to him that he should consider reading Katherine Eban’s recent book, BOTTLE OF LIES: THE INSIDE STORY OF THE GENERIC DRUG BOOM. He was not familiar with the title but as we chatted about the role of India and China in reverse engineering American brand name medications his eyes lit up. My physician is of Indian descent and he described to me what he witnessed when visiting India and the practices pursued by Indian generic drug manufacturers, particularly Ranbaxy. He described disingenuous practices, fraud, corruption, the lack of government oversight and a myriad of illegal practices pursued by companies that went against the FDA’s best practices protocols. Since 40% of all generic drugs are produced in India and 80% of the active ingredients in all drugs are produced in India and China his comments were eye opening and affirmed what Eban lays out in her investigative narrative of the generic drug industry and raised in my mind whether the new medication I was about to ingest was based on correct data and honest productive practices. According to Eban, Americans should think twice when taking medications which puts people in a quandary – you need the medication, but can they be trusted?
The narrative that Eban has produced can best be described as “mind blowing.” As one Dutch pharmaceutical executive described the generic industry as being similar to the meatpacking productive processes described by Upton Sinclair in his book, THE JUNGLE at the turn of the 20th century. Eban delineates the gulf that exists between what regulations require of generic drug companies and how those companies operated. Their goal is to minimize costs and maximize profits. To achieve this companies circumvented regulations and resorted to fraud: “manipulating tests to achieve positive results and concealing or altering data to cover their tracks. By making the drugs cheaply without regard to safeguards and then selling them into regulated and more costly Western markets, claiming that they had followed all necessary regulations, companies could reap enormous profits.”
The key figure in the first half of the narrative was Dinesh S. Thakur, who was employed by Bristol-Myers, Squibb in Hopewell, NJ where he ran a department that built robots and other automated products designed to make drug testing more efficient and reliable. Thakur’s problems began when he decided to leave his position in the United States and took one at Ranbaxy Laboratories located in India. Almost immediately Thakur witnessed extensive fraud and a lack of transparency at the company. Within two years Thakur’s friend, Rashmi Barbhaiya who convinced him to accept a position at Ranbaxy left the company leaving Thakur to fend for himself. The first issue was HIV medications for South Africa which had a number of defects and the company refused to recall them. As time went on Thakur would soon learn that Ranbaxy faked over 50% of its dossiers to the Food and Drug Administration (FDA); 100% for India; and 50% for Europe. Thakur ordered a breakdown of every product, year by year of each dossier. Ranbaxy used data as a fungible marketing tool without consideration for the impact its drugs had on patients. “The company manipulated almost every aspect of the manufacturing process to quickly produce impressive looking data that would bolster its bottom line.” Ranbaxy’s approach was to do whatever it could get away with the patients be damned.
Eban unravels the crimes and conspiracies involved in Ranbaxy’s approach to developing and producing generic drugs, layer by layer. The company had no written protocols for investigating physician and patient complaints and viewed FDA regulations as an obstacle to be gamed. When Dr. Kathy Spreen, Ranbaxy’s American Executive Director of Clinical Medicine uncovered the fraud dealing with Aids drugs she expressed her concerns to a company executive who responded, “Who Cares…It’s only blacks dying.” When another friend of Thakur, Rajinder Kumar resigned because of company practices, Thakur was targeted by executives because of his complaints and when executives threatened him and his family, he also left the company. Eban’s focus on Thakur’s experiences reads like a crime novel. He smuggled out damning evidence against the company and became a whistleblower for the FDA. His life was a mess and his experience were chilling as he feared he would be outed, and his family would pay the price.
The theme that dominates Eban’s narrative is that Ranbaxy’s approach to its manufacturing process, covering up its misbehavior, its dealings with the FDA, and the callousness of its executives was a recurring problem throughout the generic drug industry for decades. A number of cases highlight this process. First, executives would smuggle out brand named drugs from the United States in their luggage to be reverse engineered in India and then made up data to apply for the first time right of a generic to the FDA – executives became “drug mules!” Second, plant inspections in India by the FDA were a game of cat and mouse. There were no surprise visits by FDA personnel as part of the process, so Indian companies had weeks to prepare for visits, falsifying data, shredding negative data, and putting on a dog and pony show for investigators. Eban describes numerous examples of this process at a series of Ranbaxy plants in India. Third, and possibly the most egregious was the sale of a controlling interest in Ranbaxy to a Japanese company, Daiichi Sankyo. The sale would provide $2 billion for Malvinder Singh, the company CEO and his brother. However, as soon as the deal was completed Daiichi Sankyo learned that Ranbaxy was in trouble with the US Justice Department and the FDA as their products would no longer be approved for sale in the US until they could prove their products were not fraudulent. Fourth, the sale of tainted heparin used for dialysis in the United States killing 31 Americans. What emerged is that chemists were bribed, further data was falsified, the Ranbaxy pattern continued. The last example, among many is Eban’s dive into FDA dealings with Ranbaxy over its attempt to gain approval of its version of Lipitor, atorvastatin. Ranbaxy faked atorvastatin records before FDA investigators visited Paonta Sahib, the manufacturing site. Eban presents company emails and FDA documentation proving that Ranbaxy was not to be trusted and in the end because of pressure by Congress which needed the lower price as the drug was considered an integral part of the new Affordable Care Act they gamed the system once again and gained approval.
Thakur is not the only one to experience the deceit of the Indian generic industry. Eban describes how Dr. Harry Lever, a Cleveland Clinic cardiologist discovered that when his patients switched from brand name drugs to generics their health greatly deteriorated. Dr. Randall Starling, a member of the Cleveland Clinic Heart Failure and Cardiac Transplant Medicine team uncovered that the generic version of tacrolimus, made by Dr. Reddy’s Laboratories, an Indian company caused major issues with his transplant patients. Eban’s discussion of Joe and Jerry Graedon who for over thirty years had a syndicated newspaper column and a patient advocate NPR program realized through their own research that FDA standards in approving generic medication were extremely flawed and eye opening. All of these examples lead one to believe that the generic industry produces one horror show after another and the under funded and understaffed FDA with little access to the truth in India can not protect American patients, or for that matter foreign markets that Indian companies supply with medications.
Aside from Thakur there are a number of important personages in Eban’s expose and the one that stands out the most is Peter Baker. In 2008 Baker joined the FDA and soon became its most important foreign investigator. A no nonsense individual who thought nothing of jumping into a dumpster to find evidence of fraud and god knows what else as he became the bane of Ranbaxy and other companies’ existence. His work in India and China, the threats he dealt with from foreign companies, and even opposition within the FDA who at times saw him as a “cowboy” probably resulted in saving countless lives. Baker’s discoveries boggle the mind and provide unbelievable insights into the minds of foreign generic executives and their approach to the manufacturing process and the frauds they engaged in.
The further one reads Eban’s expose the more distressing the information becomes. It seemed it was standard practice for the generic companies to make different versions of the same product, high quality drugs for the Western markets, and low-quality ones for lower income countries which was highlighted by Eban’s reportage of the drug Lipitor. Eban’s work is very important and I found myself checking the labels on my own medication and where they were manufactured as I became immersed in the book producing a great deal of anxiety on my part. It seems that what started in Mahatma Gandhi’s ashram as a campaign of Indian self-reliance had morphed into a pharmaceutical rescue mission for the world’s most unfortunate patients. It is obvious that Eban’s work is extremely one sided which can be seen as a criticism, but in reality, how could it be anything different based on her findings especially since her research is impeccable. The book should have a label for patients on the cover because it will create extreme angst in anyone who reads it.
Bottle of lies- Ranbaxy and the dark side of Indian pharma is book written by Katheeine Eban. Author claimed at starting of book itself that funding for this book has came from independent, impartial sources so fund provider has no stake in outcome of this book. But at every page author forced us to think that “is this book is sponsored by US pharma giants to kill Indian generic pharma industry?”
First and foremost reason to say above statement is that author seldom mentions malpractices in US pharma giants. There are famous litigants in US courts to pay billions of dollars of fine to US pharma companies. One such example is famous Johnson and Johnson child products and there are numerous such cases if anyone does a simple Google search. But it seems that Eban is unaware of all these things.
Second reason is that author mostly targets Indian firms only, when there is giant generic pharma industry in China also. Most important point here is Eban conveniently forget that India imports most of its Active Pharmaceutical Ingredients (AIP) from China. And AIP is most important part in any medicine.
Eban also fails to provide solution to high cost original drugs. Is Eban wants to suggest that millions of poor should die because of lack of drugs? Eban should have mentioned how US companies can reduce cost of their medicine. There are certain instances in which US Drug Company’s increased price of medicines 100 times overnight such recent case is Turing Pharmaceuticals increased its drug ‘Daraprim’ or 'Pyrimethamine' overnight from $13.50 per tablet to $750 per tablet- whopping 5000 percent jumps.
Eban never mentions contribution of Indian pharma in reduced mortality in different disease. Positive side of this book is that author heavily depends upon Indian Whistleblower DInesh Thakur. Thakur seems to have provided useful and true information of Ranbaxy which later proved to pivotal in Ranbaxy’s 500 million fine by FDA.
If you want to read journalism at its finest, you can't do better than Katherine Eban.
I keep trying to search for discrepancies in her work, and I'm not finding much online. I'm sure she made mistakes somewhere. Every journalist does make mistakes at some points. Perhaps she should have spent more time talking about what good generic drug manufacturers have done. That said, it's truly bewildering what she reports in this exposé and how much of it seems to check out.
When I was living in a Latin American country, I was put on some generic medications by my doctor. They were inexpensive and accessible to all people. However, their side effects were irregular. Sometimes the meds did nothing. Sometimes they flooded you. Other times, you'd have extremely strange side effects.
When I moved back to the USA, I was put on a different generic. It was still inexpensive, but it was made in a different country. Overnight, all the strange side effects disappeared. I felt much better every day.
That experience left me curious as to how two different generics could have such wildly different effects on people. So, I picked up this book.
What you read here will answer exactly why poor generics enter the international and American markets. When you read about the ineptitude, corruption, and cowardice of some people in the FDA your blood will boil. When you hear people go on the record about how generic drug manufacturers actually save ineffective batches for Africa your jaw will drop. The stories from the frontlines of African aid hospitals are horrifying.
It's difficult to describe how disgusting this book is to read. It's not meant to be entertaining. Katherine Eban clearly knew she was lobbing a bomb at this industry, so she took her time to discuss in excruciating detail how data fraud was committed, how fake factories were created for inspection, etc. What happens when you're reading is you'll go through a sickeningly slow burn as the facts and figures mount up.
The worst part is you find out all these companies only have to pay fines to stay in the American market. They literally kill people in third world countries with ineffective medication we subsidized, and they get fined.
Actually, the worst part is realizing everybody is complicit. Many generic drug companies do try to get a good product to consumers, but they're incentivized to be first (and cheapest) to market. Some companies are, of course, reprehensible, but for the most part, we encourage these companies to cut corners because we're always looking for the cheapest quickest med. It's like if you went to a mechanic and said, "I need you to fix this quickly and I don't want to pay you much of anything." You know the work is not going to be great. Congress hobbles the FDA because they're fighting for constituents who need cheaper meds now. The FDA has many great people, but they don't want to be the group who force Americans back on expensive name-brand drugs again for years. I'm making a caricature of this whole process, but Katherine Eban does an excellent job of describing all the nuances that created this defective industry. It will keep you shaking your head.
If you or a family member uses generic medications at all you should read this book to learn how the industry came to be and where it's headed now.
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.
Is your generic drug on the "clean list"? If you don't know, you should probably investigate. Thanks to whistleblowers and the people who helped ensure our drugs are better regulated and of better quality, there still exists corruption in drug manufacturing. If you, like the vast majority of human beings, depend on drugs to remain healthy, you should probably be aware of just what goes into the manufacturing of the drugs your doctor prescribes.
My husband saw Eban give a talk at Rutgers University and came home to tell me how shocking it was. After his summary of her talk, I immediately bought this book and was really happy I did so. Eban recounted a really shocking and interesting look into the fraudulent actions people all over the world will engage in if there are not enough resources allocated to forcing standards or policing the work done by drug makers. Most of the book focused on the now defunct Ranbaxy drug company that was supposed to specialize in making affordable generic drugs but ended up making what was more akin to snake oil.
One of the best things about this book is that it quietly, but definitively combatted the potential racism this book could engender -- since most of the fraud committed was done so in foreign countries such as India and China-- by highlighting how many scientists all over the world have important skills and insights to contribute. It helped set up the reader to understand that not everyone in a specific culture or country is interested in committing fraudulent acts. In fact, we owe our good health to the passion and sheer will of people from other countries who fought hard to discover and take down those committing drug fraud.
Sadly, in some countries, there are little to no actual regulations placed on them to produce the drugs that people all over the world rely on to remain alive. Since there are no stringent regulations, those who spend extra money to produce a better product are actually punished because their business cannot compete with fraudulent businesses that cut corners to save money. The corners cut resulted in the illness and deaths of many people all over the world, including the United States.
One of the biggest take home messages from this book was that the FDA is not nearly well funded enough to carry out adequate inspections or provide adequate oversight when it comes to the drugs manufactured over seas or even in our own back yard.
The lack of oversight coupled with the greedy nature of some-- so greedy, their actions literally cost lives -- far too many generic drugs were manufactured that did not have the right dose. Sometimes doctors had to give more than 4 x the regular dose to effectively treat a condition. This meant that it was far too easy to be under dosed, and have the drug not do the job it was produced to do, or be overdosed, causing complications. Even if the drug had the right dose, if that dose was tied to a time release mechanism, the full dose of the drug could be released ineffectively, overdosing patients during part of the day and under dosing them during the other part of the day. Worse than that, drugs often had contaminants such as glass and lead.
In America, the FDA carries out surprise inspections. This is a necessary way to conduct inspections so that companies run the risk of inspection at any time, compelling them to comply with guidelines in case they should be subject to a random inspection. Inspections for other countries had to be scheduled because it was difficult to get a travel visa, book the stay in a foreign country, and deal with the logistics. So, foreign companies always had a heads up. On one occasion, an inspector showed up a mere day early and found the company shredding tons of documents that detailed just how fraudulent their practices were.
If you think this was only a problem for other countries and not the USA, you are wrong. These drugs, which were not actually tested because the tests and trials were all faked, made their way under a reputable name and to reputable countries. The countries with the least power were sent the worst drugs. In fact, manufacturers purposely manufactured very poor quality drugs (if you could even call them that) for the poorest countries and put a little more quality and effort into the drugs that went to richer, more powerful countries. But, even then, they were able to package poor quality drugs by faking data, and send those drugs to more powerful countries.
Lest you think this book was all about the evil that exists in the world, Eban spent a lot of time and effort telling the stories of heroic activists, who demanded affordable drugs so that even poor people could have the chance to live, and whistleblowers, who risked their own livelihood, relationships with their families, and their own safety to bring corrupt manufacturers to justice.
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.
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.
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.
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.
Hi it’s your friendly neighborhood pharmacy technician. Long time, no talk. Just had to get my two cents in about this book. Saw it on sale on Audible. I cannot speak for every single generic drug out there; however let’s take protonix. Protonix’s generic is pantoprazole. It truly is the exact same pill. You open a bottle of pantoprazole and pour it out…yeah the tabs are coated and read in brown PROTONIX. The bottles go down a conveyor belt and then split apart to two different packing areas. Next we can talk about warfarin. Maybe you know this as Coumadin. It’s a blood thinner. Either way-you’re getting hit with the same ingredient that is used in rat poison. The big thing with warfarin is the dyes that are used to signify each strength. We also have this greatly important drug called cardizem, otherwise named diltiazem or about three other names at least depending upon manufacturer and its formulation: ER, CD , XT, and so on. It really depends on what the wholesalers are currently stocking and what your corporate will approve in that week’s order fulfillment anymore. Generic colace? Exact same soft gel at 100 mg dosing goes by docusate sodium. Senna is a plant-based constipation stimulant. It’s been used for ages as a natural remedy sooo yeah same thing. I’m going to have to buy this book because it sounds like the author is stirring a big ole black pot. If the author came out and maybe said binding agents or color dyes or “fillers” used in the making of the generic drugs, then I would say could be if like she is saying that all of them are being made in china now, which again, I’ve seen no evidence of that because all you have to do is look at the bottle it’s shipped in.
* 10/10 would watch a tv series following FDA inspectors going to plants and uncovering fraud, because oh my god
* high speed chases and intimidation and diving in dumpsters looking for evidence? what the fuck 😃
* anyway, the thing that this book has taught me is that as a patient, either you cough up THE MONEY for brand drugs and be fairly convinced they'll be effective and not kill you, or go for the generic option, which is loads cheaper, and pray to whatever gods are out there that it works and doesn't have impurities or lack of an active substance
* in conclusion, we're fucked no matter what, and Pharma gets all that sweet sweet cash 😃
* this was a legitimately fascinating look into the world of generic drugs and how deep the fraud and irregularities go when it comes to this, up to the point where it's literally known that the shittest drugs go to the poorest, most unregulated countries
* which ... fun
* yet again i stay firm in my belief that man's religion is greed and we should just get rid of money forever, because when all this cash comes at the expense of people's lives... bro... no
* and literally no one cares, except a bunch of whistleblowers afterwards caught in YEARS of legal proceedings that end with zero consequences for any companies
3.5 stars. I'm underrating this book but I can't justify 4 stars.
The first 2/3 of the book (the Ranbaxy scandal) is a potboiler. I was appalled by the depth of the fraud, horrified by its implications and impressed by the author's ability to tell the saga. If that was the whole book I'd be debating between a 4 or 5 star rating.
It felt to me that the author was too ambitious in the last third of the book. I was tired of reading about Thakur's marital problems; the safety violations at other generic manufacturers, while deeply troubling, felt thrown in and were a bad fit with the earlier narrative; the stories of the tensions within the FDA and between the Indian equivalent were tiresome and overly long; and the time shifting between story lines was a distraction. I couldn't wait to be done with the book. It's too bad I felt that way because it has an important message and it's thought provoking but it became too much of a jumble.
I don't think you can read this book and ignore the question of the safety and efficacy of prescription drugs of all kinds. Maybe even over-the-counter medications. If you've never thought about the FDA (why would you?) you might begin to wonder about its ability to not only monitor drug safety but America's food supplies. In an era of covid-19 are we better off with bigger government?
Reading this book may make the reader consider lifestyle changes to ward off or eliminate the need for prescription medications where possible. "Overdiagnosed" by H. Gilbert Welch, a counterpoint to excessive medical screening, is an interesting book that may also change the way you think about the medical industry.