A physician’s insight into drug development
Looking at the conflicts between medical and regulatory teams and marketing departments in the world of drug development.
This book recounts the experiences of a physician who spent more than 35 years in the pharmaceutical and biotechnology industries. It offers an interesting insight into drug development and, in particular, illustrates the conflict between the ethical stance of medical and regulatory teams and the often cavalier attitudes of their colleagues (“opponents” might sometimes be a better description) in marketing departments.
Of particular interest is the author’s account of his involvement, after retirement, in the fall-out from “the clinical trial that went wrong” – a 2006 study of a humanised monoclonal antibody that left healthy volunteers with multi-organ inflammation and failure. Because of his own experience of monoclonal antibodies his expert opinion was widely sought in the aftermath of the disaster. He explains why, in his view, the study should never have been allowed to taken place.
Pharmacists should find the book interesting and even though it is mainly written in an easy style, I would not recommend it for general consumption as it assumes that readers already have a fair knowledge of medical matters and drug development. For example, it refers to, but makes no effort to explain, concepts such as first-pass metabolism and placebo-controlled double blind comparisons.
The lack of an index is a disappointment, but the book does at least have a comprehensive, three-page contents list.
The book includes nearly 100 photographs, most of which add nothing of value. They include a number of images of press releases, journal articles and other documents that are printed too small to be readable. Two dozen photographs show dodgy products sold in the 1950s and 1960s by a precursor of one of the firms the author worked for. He deviates from his autobiographical narrative to devote a dozen pages to describing these long-discarded products, one of which, an alleged aphrodisiac, gave the book its title, ‘Vie d’or’, meaning ‘Life of gold’.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200351
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