Bottle of Lies The Inside Story of the Generic Drug Boom

Bottle of Lies The Inside Story of the Generic Drug Boom 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 uality of generic drugs exported to African countries is extremely poor to say the least Instead of the stipulated 25mg 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 uantity of active ingredients compromise on sterility cut down on clinical trials fabricate raw data Bottle of Lies opened as an expose on the poor uality 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 uality slip ups that endanger lives Bottle of Lies is a shocking read and an eye opener It has made me careful about the drugs I prescribe and consume This was scary And it should be reuired reading for all adults 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 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 overEban 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 ualitiesRanbaxy 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 wellEban 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 reuired 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 whistleblowersTo complicate matters Ranbaxy would vary its products based on markets so that countries with strict uality 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 expensive brand name drugs they would see an immediate turnaround and improvement a testament to the uality 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 suicidalThese 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 uit 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 companyThe 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 originalFollowing 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 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 wellThe 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 uestion 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 subseuently brazenly Dinesh Thakur the Indian origin American citizen who uit Bristol Myers Suibb to return and help create a global RD 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 conseuenceWhile 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 uite 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 figureMulti 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 uality 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 reuirement of obtaining visas which necessitates informing the companies much in advance and allowing them all the time reuired for a cover up in the US the FDA conducts inspections without notice and with higher freuency On the other when enterprising inspectors uality approach and integrity of inspectors can be uite 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 fakeIndian 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 uiet 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 to do with concern for the bottom line uality 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 Katherine Eban’s Bottle of Lies exposes the deceit behind generic drug manufacturing—and the attendant risks for global health Drawing on exclusive accounts from whistleblowers and regulators as well as thousands of pages of confidential FDA documents Eban reveals an industry where fraud is rampant companies routinely falsify data and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit confident in their ability to fool inspectors Meanwhile patients unwittingly consume medicine with unpredictable and dangerous effectsThe story of generic drugs is truly global It connects middle America to China India sub Saharan Africa and Brazil and represents the ultimate litmus test of globalization what are the risks of moving drug manufacturing offshore and are they worth the savings A decade long investigation with international sweep high stakes brinkmanship and big money at its core Bottle of Lies reveals how the world’s greatest public health innovation has become one of its most astonishing swindles  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 uestionable practices high pressure lobbying by the US govt in cahoots with the drug industry and corrupt officials walking its corridorsThis book brings out the fact that poor inferior uality drugs are pushed to African Eastern European and South American countries where the drug controls are lax and corruption is widespread Kudos to the author this book definitely is an eye opener and a mindblowing read 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 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 any but its factories were bought by Sun Pharma which is using them and sells pills in the US We need good regulation We need 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 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 euivalent of the name brand drugs It seems to me that it should be without uestion that no one has an inherent right to sell drugs in the US 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 US needed to meet top bioeuivilancy 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 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 conseuences of short cuts and ethical problem solving The term “ethical drug” traditionally means a pharmaceutical reuiring 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 euals 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 bookThe general reader might not benefit as much as the 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 reuired 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

About the Author: Katherine Eban

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 freuently on the topic of pharmaceutical integrity Press

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