❰Reading❯ ➿ Bottle of Lies Author Katherine Eban – Dolove.info
Never again will I swallow a new pill without finding out where the thing was manufactured Katherine Eban s devastating account of fraud in the generic drug industry is equally damning to the compromises that our regulators make in response to political demands for low cost medication Please do whatever you can to make sure your physician, your pharmacist, and your members of Congress read this book I am not greatly surprised that deception is widely practiced in the Indian drug industry, but I am shocked and greatly disappointed that our own Food and Drug Administration has relaxed its vigilance over the standards under which generic medicines are made even in our own country This needs to be corrected, ASAP.Eban deserves congratulation not only for her important research but also her skill as a narrator Once you begin, you ll find that Bottle of Lies keeps you turning the pages Well done Thanks to the Graedons and their People s Pharmacy show on National Public Radio for bringing this important book to my attention. 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 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, often than not, were company salesmen.The investigators also couldn t read street signs, which made them vulnerable to wild manipulations Companies steered them to phony show plants, where everything looked compliant, but the companies weren t manufacturing there Sometimes a group of companies pooled their resources and invested in the same show factory, so that different FDA inspectors returned to the same plant at different times, each one thinking they were inspecting a different facility.Companies routinely adjusted their manufacturing quality depending on the country buying their drugs They sent their highest quality drugs to markets with the most vigilant regulators and their worst drugs to countries with the weakest review.Racism undoubtedly played a role, as it had at Ranbaxy when the medical director said of the poor quality AIDS drugs bound for Africa, Who cares It s just blacks dying But at root, a cold calculation drove the disparate standards companies could make their cheapest drugs for markets where they would be least likely to get caught.Dinesh Thakur who was the whistle blower about Ranbaxy was legally protected under USA s The Whistleblower Protection Act, but India didn t have any Whistle Blowers Protection Act until 2014 Even now the right to freedom of speech and expression in India is not absolute In India, filing a defamation suit against someone is a sure way to tie the person up with legal fees and court proceedings, potentially for years Powerful Indian corporations do not hesitate to sue authors, journalists, or activists for defamation, backed up with claims for damages no author, publishing house, newspaper, or non profit group can afford to pay Reliance Industries Ltd., run by Mukesh Ambani, sought 1 billion Indian Rupees in damages from journalists for a book on Reliance.With increasing number of drugs manufactured in developing countries, FDA cannot control the quality of the drugs without the help of the government and ethical culture in those countries, but that is not going to happen anytime soon.Some articles written by Katherine Eban Bottle of Lies is about the problems in generic industry, Phake The Deadly World of Falsified and Substandard Medicines by Roger Bate is about counterfeit medicine These two books will take the reader through the problems in the drug industry. A NEW YORK TIMES BESTSELLER From An Award Winning Journalist, An Explosive Narrative Investigation Of The Generic Drug Boom That Reveals Fraud And Life Threatening Dangers On A Global Scale The Jungle For PharmaceuticalsMany Have Hailed The Widespread Use Of Generic Drugs As One Of The Most Important Public Health Developments Of The Twenty First Century Today, Almost Percent Of Our Pharmaceutical Market Is Comprised Of Generics, The Majority Of Which Are Manufactured Overseas We Have Been Reassured By Our Doctors, Our Pharmacists And Our Regulators That Generic Drugs Are Identical To Their Brand Name Counterparts, Just Less Expensive But Is This Really True 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 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. 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 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 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. Amazing storytelling, at par with books like Den of thieves or Enron story May seem a biased against generic pharma but enough lessons for those willing to take a constructive viewpoint Lots of respect Mr Thakur, what a person May the forces with you. This is a must read book for anyone who has been prescribed a generic medication which is pretty much everyone The book is long and may look intimidating, but it reads like an action thriller There are heroes and villains, conspiracies involving presidents of companies , and chases although they probably weren t high speed as they usually involved bench analytical chemists who mostly sit in front of a computer all day.The amount of research and number of interviews that were necessary to put together this excellent example of investigative reporting is impressive My only gripe and it is really of a pet peeve since I work on them for a living is that the author refers to HPLCs as machines They are not machines, they are instruments, because they make measurements and are used for scientific work. 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 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 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 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. 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 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.