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 oing on but I believe it This book was referred to somewhere as The Jungle of Djevojka bez mature generic drugs and that characterization is spot on But whereas The Jungle spurred the creation of the FDA and food regulations ineneral 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 Night Music 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 anyeneric 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 Zecca: The Mint of Venice in the Middle Ages grant approval for a particular company to sell drugs or food for that matter in our market Ourovernment 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 Irreverent Photo Tools for Digital Photographers 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 too 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 Red Metal government to at least take some action 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 manufactureeneric versions of branded expensive drugs It has detailed how Ranbaxy flouted Saphyre 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 USovt 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 is an eye opener and a mindblowing Before now I had a pretty rosy view
of eneric drugs I assumed they were chemically identical to the brand name drugs minus the exorbitant fees of the big generic drugs I assumed they were chemically identical to the brand name drugs minus the exorbitant fees of the big 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 eneric drug company and how it lied and cheated for years to create competitively priced Knight Esquire generic drugs at minimal cost while endangering patients the world overEban describes the intricate trials and approvals a large pharmaceutical companyoes 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 eneric companies fight to be the first to et 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 Shadow Work: A New Guide to Spiritual and Psychological Growth 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 toet 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 Metabolic Repair Manual 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 andenerally flout all the FDA Law and Society: A Sociological Approach guidelines they d agreed to This reuired lying about failed tests copying results fromood 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 Just an Illusion - Side A got the best versions of a product while a poor countryot 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. Katherine Eban’s Bottle of Lies exposes the deceit behind Cybersecurity: Protecting Critical Infrastructures from Cyber Attack and Cyber Warfare (Zones of Religion) generic drug manufacturing and the attendant risks forlobal 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 circu. .
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 lobally and the best one can produce oes to the US and EU The FDA doesn t come out looking Freedom Is a Constant Struggle: Ferguson, Palestine, and the Foundations of a Movement 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 onoing 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 enerics faster in order to reduce healthcare costs and the agency s own budget being made contingent on success in ranting approvals has set up the system to fail Add to that the slow moving nature of a bureaucracy and what you et 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 ranting 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 The Craving 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 wasiven 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 oing to change for the better anytime soon As for the Indian market we were always second class citizens anyways I doubt it can et any worse The only loser in the whole Love in Catalina Cove (Catalina Cove game is the patient who doesn t know whether he is ingesting elixir or poison much the worse if for a chronic condition One of these rare books when you spend couple days or a week and willet so much information about the subject you knew nothing before sometimes even than you asked for I enjoyed it a lot and it make me think if any medicine me or my relatives takes are The Million Dollar Goal 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 tive 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 Securing Caite 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 I wish I could rate this higher because the content is super important but the writing is notreat The book is about 200 pages too
long and filled with clunky sentences like On the cold clear night ofand filled with clunky sentences like On the cold clear night of 23 2002 with Christmas just two days away the FDA parking lot was crowded This is a devastating muckraking report not just about Indian Trudy 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 oret 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 "The ultra fraudulent company focused on in the book Ranbaxy 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 ood 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 reedy CEOs shouldn t be able to wreck the world This was scary And it should be reuired reading for all adults Rattled by revelations After The Unlikeliest Hero: The Story of Desmond T. Doss giving birth by cesarean section new mothers in Uganda succumb to bacterial infections despite taking a full course of antibiotics because the uality ofeneric drugs exported to African countries is extremely poor to say the least Instead of the stipulated 25mg Olanzapine a Ghanaian psychiatrist ave 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 oal of a branded drug company is to make the best possible drugs to be sold at highest possible price that of eneric drug companies is to make the best cures affordable and available to all To make profit many eneric 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 Prisoner of Midnight 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. Ultimate litmus test oflobalization 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 reatest public health innovation has become one of its most astonishing swindles?.
Summary Ó PDF, DOC, TXT or eBook ´ Katherine EbanGrade enerics they d have to multiply dosages to Confessions of an Air Ambulance Doctor 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 bluelass 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 eneric 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 inves Here is an important easily read current book with essential information we collectively need to prioritize rethinking of pharmaceutical ethics manufacturing delivery politics uidelines and economics worldwide I strongly encourage those interested in public health policy making regulatory affairs and lobal 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 reed societal pressures and ignorance all contribute Some Gökyüzü Mavi Kaldı 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 anyiven batch of a Corps Values: Everything You Need to Know I Learned In the Marines generic substitute What s in a name Not all items with the same small print name are euals Eban emphasizes theenerics 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 The Sun Shines Over the Sanggan River 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 ofeneric drugs can work against health promotion THIEME Atlas of Anatomy: Head and Neuroanatomy goals Our needs for alobal vision of integrity incentives responsibility liability and affordability is past due Bottle of Lies is a call for action not a history bookThe eneral 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 eneric substitutes might be tarred and feathered in the minds of some readers There are conscientiously manufactured enerics 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 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 Genericmust read book especially if you re taking eneric I spent a lot of time after reading Eban s book researching the companies who make the Dept. of Reproductive Management generic drugs I take I am definitely switching away from certainenerics based on my "reading of Bottle of Lies Eban s Bottle of Lies is a blockbuster and needs to be on every "of Bottle of Lies Eban s Bottle of Lies is a blockbuster and needs to be on every Best Of list My Beneath This Ink gratitude for the courage of people who spoke up and who were whistle blowers Eban covers their stories expertly Just wow I have been studying the pharma industry for the last couple of months from theround 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 The Psychology of Work generics price fixing scandalave it ood publicity as wellThe book is a stunning expose of the dark underbelly of the lobal The Woman You Want to Be: Margery Wilson's Complete Book of Charm 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 ifenerics 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 Laiden's Daughter get better Worse is it actually harming us insteadThe 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 alobal RD behemoth out of his homeland acts as the whistleblower who sought to do the right thing His years long crusade came at a How To Pass The New Police Selection System 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 aovernment 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 ive 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 ive the benefit of doubt to promoters some of whom adorn the Strategic Procurement 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 Theentleman claims that due to a oof 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 s standards If one chooses to believe this what this means is that it makes drugs for India and markets Africa Latin America South East Asia etc where regulators don t ive 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. Mvent 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 The Inclusion Imperative: How Real Inclusion Creates Better Business and Builds Better Societies generic drugs is trulylobal It connects middle America to China India sub Saharan Africa and Brazil and represents the.