Bottle of Lies The Inside Story of the Generic Drug Boom

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

Book Report

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

Book Report

Bottle of Lies: The Inside Story of the Generic Drug Boom is a book by Katherine Eban, was published by Ecco, 2019, and covers 512 pages of investigative work on the Pharmaceutical industry. A lot of people have considered the use of generic drugs a crucial public health revolution in the twenty-first century. Today, the United States pharmaceutical market is made up of generics amounting to almost 90 percent most of which are manufactured overseas. Doctors have been reassuring patients that these generic drugs are identical to their brand alternatives, just less costly.

Katherine Eban in her book Bottle of Lies: The Inside Story of the Generic Drug Boom exposes the sham behind the manufacturing of generic drugs- and the consequent threat to global health. The author draws from select versions from whistleblowers and regulators, as well as numerous pages of confidential FDA paperwork, to expose an industry characterized by fraud, falsified data from manufacturers and executives finding loopholes in every principle of safe manufacturing to generate more profit and to cut costs, assertive in their facility to fool inspectors. Meanwhile, patients have prescribed drugs with unpredictable and hazardous effects.

The generic drug narrative is truly global, connecting middle America to India, Sub-Saharan Africa, China, and Brazil, and is a complete representation of the litmus test of globalization. The book creates the dilemma of whether the risks of moving drug manufacturing of shore are worth the savings.

Katherine embarks on a decade long investigation across the globe, with high-stakes risk-taking and a huge investment to disclose how the world’s greatest public-health revolution is now one of the most shocking deceptions.

Katherine is a New York’s bestselling author, an investigative journalist who writes articles for Fortune Magazine and a fellow at Andre Carnegie. She has also contributed content for Vanity fair, the New York Observer, the New York Times, Self, The Nation, and other publications. She has written several books including Dangerous Doses: A True Story of Cops, the Contamination of America’s Drug Supply. and Counterfeiters. She also does lectures from time to time on pharmaceutical integrity. Her narrative that is based on investigative work including an article on pharmaceutical counterfeiting, unlawful questionings by the Central Intelligence Agency and gun trafficking, has drawn international attention and won her numerous awards.

It is no doubt that Bottle of Lies: The Inside Story of the Generic Drug Boom a comprehensive investigation if callous, indictment of a number of major Indian Pharmaceutical companies who operate a huge chunk of generics made and used in the United States and various parts of the Globe. The author does not downplay the unpleasant aspects of generic drugs manufacturing in her narrative and calls out companies indulging in Fraud. She also casts doubt on the story of India as the world’s pharmacy. The book does not shy from attacking the United States Food and Drugs Administration, which has had its measure of rule-bound administrators, reluctant to act with the necessary enthusiasm.

Katherine discusses the evasive, dubious and dishonest practices of various manufacturers including Ranbaxy, GVK Biosciences, Mylan, Wockhardt, and the CRO Vitma Labs. She also mentions the smaller roles of Zydus and Dr. Reddy’s in producing, documenting and shipping medical supplies to the United States. A number of these companies are or were huge industry players. The USFDA’s strict standards are somewhat just implied.

The book discusses the violation of the regulatory requirements of importing countries. It narrates that the manufacturing companies falsified documentation from their manufacturing sites, They did not conduct dissolution and stability as well as Chromatograms test and used those from the reference drug and recorded that they actually did them. There were blue glass particles in the drug atorvastatin but this problem was pursued to concealed and tablets containing such faulty bulk drug was shipped. The workers were also found to be unhygienic and unsafe practices were routine. Even after the companies were afforded the opportunity to rectify these mistakes, they did not. Medicine consignments that did not meet GMP and quality requirements, were sent to Africa instead of being destroyed. Indian executives’ perspective on the regulatory system was one of an obstacle to be maneuvered. All of these even by capitalist principles of maximizing gain is irresponsible.

By reading the book as a concerned individual who has come across this revelation with this much depth almost for the first time, you cannot help and wonder what happens with our own manufacturers. If this huge Indian companies raking in billions of dollars in sales can play hard and fast with the safety and quality practices for products sold to a country with apparently the most sophisticated drug regulatory agency in the entire globe, what is the local pharmaceutical manufacturing industry doing with their products considering the regulation is decidedly less effective.

The author paints although subconsciously, the stereotypical Indian storyline: dilapidated, developing county, with poor ethics, developing country, and poor hygiene. “Employees did not wash their hands after using the toilet” (Eban, 2019). This is damage resulting from the dishonest behavior and careless manufacturing practices.

The book then discusses the issue of Bioequivalence of generics and the innovator product but chooses to underemphasize the nuances of this debate. A generic is bioequivalent if it serves the same purpose and acts by all intents as the innovator drug. It is always a requirement by many regulators for first-time manufacturers to prove bioequivalence to an existing drug.

The book as mentioned earlier relied also on accounts given by whistleblowers narrates the story of one Dinesh Thakur, an Indian America who gave up his desirable job in Bristol-Myers Squibb in the United States and moved to India to work for Ranbaxy where he encountered Unimaginable manufacturing and data integrity practices. His moral decency could not allow him to watch what was going on and remain silent, he went on to expose Ranbaxy. Many people In Thakur’s position would have resigned and searched for better jobs or disappeared but he decided to do a huge service to the Indian pharmaceutical industry. The book also mentions the relentlessness of some personalities in the FDA who took the initiative to flush out fraudulent practices, in India’s pharmaceutical industry and at very huge personal risk.

Dr. Harsh Vardhan the Indian health minister at the time dismissed the suggestions of Thakur or did not give them the rightful attention. A little investigation after reading the book confirms that Dr Vardhan is back in that position, even after he called out the country’s drug regulatory agency the CDSCO by terming it “a snake pit of vested interests (Pulla, 2014), and terming his own position a “poisoned chalice “ may be a sign that he may be willing to listen to whistleblowers (Thakur, 2016).

Summary

Eban’s riveting work opens up what was Gandhi’s well intention initiative for his country that has turned into a hellish globalized sham. What was once a tale of tragic heroism and an expansive but succinctly written epic, portrays a picture of how and industry created with the intention of counteracting being pharmaceutical companies has effortlessly merged with it resulting in a two-headed monster whose tentacles grab both the unlucky consumer and would-be regulators.

The author provides a general idea of Ranbaxy’s malpractices through the eyes of their former employee and whistleblower, Dinesh Thakur. She takes the reader through “Jugaad” a mindset used in the production of generics in India. She also delves into the adequacy of the settlement between the United States and Ranbaxy back in 2013, the role played by a stakeholder from Japan Daiichi Sankyo and the ability of the FDA to effectively inspect generic manufactures from various parts of the world. She continues to discuss the recent and upcoming congressional action on this issue, and how inadequate production practices obscure dealing with the problem of drug shortage and the precautions patients should adopt before they can use generic drugs.

The book is centered on a David and Goliath whistle-blower narrative with the likes of Dinesh Thakur and Ranbaxy which is a giant in the drug manufacturing industry. It emphasizes the key to safe manufacturing of drugs being close observing and hands-on control of each aspect of the production with everything recorded to create a guarantee that each vial, pill or capsule perfectly mirrors the formula.

The contents of the book have gone through intensive research before being written like a crime thriller. The opening chapter with a real audit experience of the FDA at a factory in Aurangabad gives the reader the chills and sets the heart racing. It might be a good read for a professional with an interest in audits of the medical industry. Also, the doctors that enthusiastically recommend generic drugs to patients should grab a copy. A reader can only hope that this is a wake-up call for action to make India and the rest of the world healthier and more honorable.

This book is a good read even for non-professionals in this field because there is so much on how the regulatory infrastructure works they can learn. It may be an oversight that explores options or alternatives to this issue, where readers can reason and come up with the resolution to avoid medicine coming from India (which to be honest is near impossible).

References

Eban, K. (2019). Bottle of lies: the inside story of the generic drug boom. Ecco, 512 pages; ISBN: 978-0062338785

Pulla Priyanka. (2014). Medical Council of India is corrupt, says health minister BMJ; 349: g4762

Thakur, D. S. (2016, March 12). A sincere attempt to improve the quality of medicine for people around the world. Retrieved from https://www.governancenow.com/views/columns/a-re-tempt-improve-the-quality-medicine-people-the-world