PHARMOCRACY: VALUE, POLITICS, AND KNOWLEDGE IN GLOBAL BIOMEDICINE

By Kaushik Sunder Rajan,
Duke, $99.95

The book, Pharmocracy, by Professor Kaushik Sunder Rajan, throws light on the popular topic of clinical trials, and on attempts made by the pharmaceutical companies to overcome the pecuniary crises in the course of drug development so as to get maximum value from the market. The term 'pharmocracy' has been coined by the author to describe the dominance of drug makers in the biomedical industry, and to show how they try to influence the drug regulatory framework.

Pharmocracy not only gives an overview of the drug development processes in the global pharmaceutical industry, but also highlights how, in the past, global clinical trials discounted the rights of the patients in order to meet the international regulatory requirements. It is clear that the author has done his research - gone through several publications, including books and news articles on drug marketing and development - while writing this book. Rajan talks of the struggles of the pharmaceutical industry to endure the financial hardships experienced during the development of a new drug. He also outlines the measures taken by the industry to overcome such crises, for instance, by splitting the investment in different products instead of the whole company. At present, the pharmaceutical industry sees more mergers and acquisitions than research and development; the causes behind this being the extensive and laborious drug discovery processes and associated regulations which dry up the finances and the patience of investors.

The author also discusses the few Indian clinical trials that exposed the inadequacies of the regulatory system in the country and in which trial subjects were exploited and ethics ridiculed. The most infamous of these being the study on a cervical cancer vaccine. It raised serious concerns, including irregularities in the process of taking informed consent and the way it was concluded that deaths were not related to the vaccine. The other study is on the much debated trials conducted on the family members of the victims of the Bhopal gas tragedy at the same hospital that was built to serve them. The book also takes a look at the petition filed by Novartis in early 2000s, regarding the patent rights for their blockbuster drug, Gleevec. The case became highly publicized when the Supreme Court of India delivered a landmark ruling against Novartis's application. Pharmocracy also briefly describes the drug patency laws in India, which have been put to good use by some of the drug manufacturers in the country to beat prominent pharmaceutical giants.

An earlier book, also titled Pharmocracy, by William Faloon in 2011 had revealed how regulatory bodies in the United States of America either over-regulate, so that lifesaving medicines do not reach the suffering patient on time, or are utterly inept at controlling the corrupt practices undertaken by various drug manufacturers in their race for profits. Faloon's book had warned about the rising costs of healthcare in the affluent economy of US owing to such practices. Rajan's book, too, highlights how the system works to the disadvantage of patients across the globe.

Overall, this is an enjoyable read for people interested in laws related to drug development. It will also encourage the uninitiated to learn more about 'pharmocracy'. But the writing is detailed and complex, and a basic knowledge of the drug development process is required to understand the book fully.