Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma is a superb account of fraudulent business practices conducted by pharma companies manufacturing generic versions of branded drugs. For numerous reasons, it is a highly recommended book.
Katherine Eban has brought out a book that reads in part like a detective novel, and in part like a compassionate prose anthem extolling the benefits of ethical and quality manufacturing.
Eban is a New York-based investigative journalist and writer, and an award-winning one. She has written for publications such as The New York Times and Vanity Fair, among others. For Bottle of Lies, her latest book, Eban investigated for about four years, from January 2014 to November 2018, with “on-the-ground reporting trips to India, China, Ghana, England, Ireland, and Mexico and travel throughout the United States.” By any standards, this is a massively thorough act of journalism. Eban must have waded through tides of pages flowing out of litigations and government reports around the Ranbaxy case and other cases; clearly, she has conducted interviews of scores of people if not more.
In Bottle, she brings the watchdog spirit to bear upon the generics manufacturing sector out of her concern for American citizens primarily. But she has ensured that her investigation also has points to ponder for the consumers in developing nations such as India.
Indian readers will in particular benefit from the critique of the chalta hai attitude when applied to the field of pharma, which has life and death implications for the citizenry. And Indian pharma watchers will hopefully get a sobering look at the deeply unethical underbelly of much of the country’s generic drugs manufacture.
Here is an excerpt from Bottle: “To minimize costs and maximize profit, 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 the required safeguards and then selling them into regulated and more costly Western markets, claiming that they had followed all the necessary regulations, companies could reap enormous profits.” These practices, as Eban’s sources told her, resulted in the sales of “generic drugs that either didn’t work or caused devastating side effects” in users.
Scenes and conversations reconstructed
One result of her comprehensive investigation is that she manages to reconstruct scenes and conversations, often damning ones. Sample this one from a meeting at Ranbaxy: “In a conference call with a dozen company executives, Spreen (an employee who smelled fraud) expressed her fears about the quality of the AIDS medicine that Ranbaxy was supplying for Africa. One of the company’s top medical executives responded, ‘Who cares? It’s just blacks dying.’”
Whether scenes or dialogues, all of it is superbly structured, in a complex yet accessible narrative that always flows smoothly. Woven into this narrative is the history of the Indian pharma sector and the laws that let it soar; the permissive Indian drugs regulator who seems keen to defend companies rather than consumers; the history of the global generic drugs paradigm and India’s position in it; the brief history of Cipla (with Cipla being held up as an example of good manufacturing practices and the company that inaugurated the revolution centred around cheap generic drugs); the corporate journey of Ranbaxy; the history of the US FDA. All these strands are seamlessly integrated into the narrative.
Bottle shows how the US FDA proved to be less than competent in policing its domestic drug industry; for it, regulating generics manufacturers located outside US borders was a herculean challenge. The book makes it clear that the US FDA’s quest to help in making cheap drugs available to American patients led to its eagerness in approving generic drug applications such as those from Ranbaxy.
Eban also writes about a few US FDA employees who played a heroic role in uncovering the generics racket. In good detail are the real-life adventures of Peter Baker, a US FDA employee sent to India, a man who did his job despite external and intra-FDA pressure. He inspected Ranbaxy (and other companies’) plants and found clinching proof of shoddy manufacturing practices. Through accounts of Baker and other inspectors, the book shines a bright light on the horrifying slip-ups and cover-ups by manufacturers, which led to medicines turning out substandard.
We are told that offending Indian companies were “… aiming to make the lowest-quality drugs they could get away with, to make the biggest profits.” In all detected cases they knew they were committing crimes, and continued nonetheless. We are further told, “Without a doubt, the companies could have made perfect medicine. There was no knowledge gap. Their equipment was first-rate. The difference was simply cost. Exacting controls cost about 25 percent more, according to some industry estimates.” In brief, they told lies and committed crimes for a few rupees more.
Devastating effects of ineffective medicines
The writer goes over and beyond her call of duty, so to say, by highlighting quality failings in non-Indian generics manufacturers as well as Indian, though briefly. The devastating and often fatal effects of ineffective medicines on African patients are shown in passing, but in a moving and compassionate manner. This is clearly shown to be the result of ‘dual-track’ manufacturing: producing relatively high-quality drugs for markets with strict regulators, and inferior drugs for markets with lax regulations.
Eban does not, however, investigate the plight of Indian patients -- a rather curious omission.
Her book has the subtext: what is quality work and what gives rise to it? What is substandard and fraudulent work and what causes it to ensue?
For one, she emphasises that moral lapses lie at the root of the fraud; a series of systemic crimes such as those that happened at Ranbaxy can be traced to weak moral values; these values apparently came from the top and passed down the corporate ladder.
Ultimately this is a story of people, what makes them tick, and what leads them astray. In a few expert brush strokes, the psychology of Ranbaxy chief Malvinder Singh is dealt with. His flamboyant lifestyle and concern to be among India’s richest people is mentioned. Also, we are told, “Unlike his father-- a visionary who built institutions and legacies -- Singh saw his primary role as creating value for shareholders.” The book is scathing in its indictment of Singh’s role in the fall of Ranbaxy. It bases its conclusions on legal cases which Singh eventually lost.
The narrative becomes particularly exciting with the entry of Dinesh Thakur, a man hired by Ranbaxy to organise information at the company. With a bird’s eye view of rampant fraud, Thakur eventually exposed Ranbaxy’s crimes to the US FDA through a series of emails and face-to-face depositions. Briefly but convincingly, Eban details how the whistleblower Thakur’s upbringing, particularly his morally upright father, moulded his strong sense of right and wrong, which probably shaped his conscience as that of a whistleblower. Thakur’s surprise at the fraud in his company, his ensuing confusion and finally his outrage and resolution to act even at risk to his career, are all shown in pleasing detail. The book evokes our compassion for Thakur by sensitively showing the results of his whistleblowing work, that is, the emotional and family troubles he went through, and how his exposéled to his bittersweet victory.
The book is more than muck-raking into the unscrupulous workings of ruthless pharma makers. Eban also reveals to us the conscientious people who helped expose the Ranbaxy racket. The book thus is also “… a true account of a group of characters struggling to protect global public health, among them Indian heroes; some Indian companies who strove to aid the world’s most vulnerable patients, and others who sought to profit at their expense; and patients, Indians among them, who were both helped and harmed by a generic drug industry claiming to have only their welfare in mind.”
Sometimes it takes an outsider, like Eban, to point to our dark places and the heroes there with their flickering torches, trying to dispel the darkness for us all. Bottle of Lies deserves pride of place on the bookshelf of every Indian CEO and indeed every Indian who is concerned about the ethics of quality production.Suhit Kelkar is a freelance Journalist. He is the author of the poetry chapbook named The Centaur Chronicles.