Catherine Eban is an American journalist known for her ‘Investigative firepower’. Bottle of Lies: The Inside Story of the Generic Drug Boom is her second book on the pharmaceutical industry. Eban’s first work Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America’s Drug Supply, which dealt with the distribution of illicit pharmaceutical products, did not get much attention. In Bottle of Lies, Eban performs the surgical skewering of the ‘dark underbelly’ of the generic drug industry. Sensationalism and scare-mongering are the warp and woof of the book. The cover design itself attests to this fact. Indian generic drug company Ranbaxy is targeted in the cover itself.
The book, divided into seven parts, reflects Eban’s versatile reportorial techniques. She discusses the quality issues of the generic drugs by delving into the nitty-gritties of unethical practices involved in the drug development and drug approval. For the preparation of this book Eban claims to have interviewed about two hundred and forty people and also gone through more than 20000 internal documents of USFDA, Ranbaxy and other generic companies. Thus, Eban has paid keen attention to detail. The book is not just about Ranbaxy alone, the attack is also centred on non-Asian generic companies like Teva and Mylan. The book which has all the ingredients of a medical thriller is captivating, and at the same time disturbing. And, of course, there are heroes and demons. The obvious heroic one is Dinesh Thakur, the whistle-blower who intimated the U.S. Food and Drug Administration (USFDA) about Ranbaxy’s mistakes, oversights, poorly executed investigations, procedural lapses, audacious lies and blatant disregard for truth.
Eban with her fluency, felicity and flamboyance in language demonstrates that anything that is of Indian origin—research, active pharmaceutical ingredients (APIs), formulations, generic drugs, technology, scientists, corporate leaders, and even FDA investigators—is substandard and an outcome of the unethical—chalta hai type—jugaad culture. The essence of the book is that if it is Indian, ‘something had to be not right’. At times, Eban’s writing sounds too polemical and hectoring. Hence this book will not appeal to desh-bhakts.
One of the consistent themes running throughout the book is about the validity of bioequivalence study. Eban tries to argue that bioequivalence studies for approving generic drugs are neither valid nor feasible. By presenting egregious examples one after another Eban tries to argue that generics should not be allowed on the basis of bioequivalent studies. Eban uses the voices of Cleveland Clinic’s Dr. Harry Lever and a few other brand evangelist doctors to make her case. In this venture, she primarily chooses and targets generic drug companies from India and China. Only CIPLA is spared. Ranbaxy is targetted because in its race for profit it lied to regulators, falsified data, and endangered patient safety in almost every country. Ranbaxy has/had more than two hundred products in more than forty countries. With these egregious examples of use of unapproved materials, the secret changes in the formulations, use of unregistered API, plagiarism, copying chromatograms from brand name drugs, Eban tries to convince us that fraud in the generic industry is widespread and intentional. She consistently maintains that both the bioequivalence data and stability data are grossly manipulated systematically by generic companies. Thus, she points fingers at flawed system drug regulation and pharmaco-vigillance in countries like India.