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  • Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development
  • Louis Galambos
Takuji Hara . Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development. Cheltenham, U.K.: Edward Elgar, 2003. ix + 271 pp. Ill. $95.00 (1-84376-050-9).

Two complex historical phenomena have brought innovation to center stage in a number of academic disciplines and in policy circles during the past few decades: one is the third industrial revolution, the information-age revolution driven by the transistor, the integrated circuit, the computer, and lately, the Internet; the other is globalization and the intense competition generated by the rise of new competitors, the breakdown of national barriers to trade, and the shift away from public toward private enterprise. To many observers it is apparent that innovation plays a central role in both of these developments. The ability of various national systems, regional entities, industries, and firms to achieve leadership positions by producing important innovations has excited those who would emulate the leaders, as well as those who would merely achieve a better understanding of entrepreneurship.

One of the industries most studied today is pharmaceuticals—in part because it has a good long-run track record for innovation, in part because its products can be matters of life or death for all of us, and in part because the business has whipped up an international sandstorm of controversy in recent years. Takuji Hara has made a decisive move into this field of scholarship with his Ph.D. dissertation (University of Edinburgh) and subsequent book Innovation in the Pharmaceutical Industry. The book is both less and more than the title indicates: It is, in fact, a comparative study of British and Japanese pharmaceutical innovation, with detailed studies of four classes of drugs (cardiovascular and antiasthmatic drugs, histamine H2 antagonists, and LHRH analogues) and three case studies of Japanese innovations. The "more" is the great technical depth that the author achieves in his explanation of the process of drug discovery. In writing the histories of modern high-tech industries and firms, most scholars have been limited by their unfamiliarity with the basic sciences at the heart of the innovations. [End Page 378] Not so in this case. Hara's command of medicinal chemistry, biochemistry, and enzymology serves him and his readers well.

The author provides us with an interesting history and analysis of Japan's accomplishments and its problems in pharmaceuticals. In particular, he notes the conservatism of the leading Japanese firms. This, Hara says, left them engaged primarily in "modification-based innovation," which involved less risk than "paradigmatic innovation" of the sort conducted at ICI by Sir James Black, who guided to market the first receptor antagonist against hypertension (pp. 165–66). While most of the British innovations have already been covered in previous studies (see, for instance, Ralph Landau, Basil Achilladelis, and Alexander Scriabine, Pharmaceutical Innovation, 1999), the Japanese efforts have been less well documented and analyzed. In each of his case studies of R&D in Japan, Hara includes material from the interviews he conducted, as well as personal communications and reports in the medical journals and in business publications. His research is thorough, although not entirely exhaustive, and medical historians interested in Japan will find much here of interest.

I wish I could say that the analysis is as strong as the research. It is not. The author's training is in the social shaping of technology, and to his credit, he acknowledges that the physical universe—in this case, the molecules and patients on whom they are used—are involved in an important sense in the process of drug discovery and, by implication, in the practice of medicine. But alas, he wants to include everything else that is involved, and this leaves him with long lists of causal factors: "In the shaping of the credible compound," he explains, "actors including the project leader, chemists, biologists and research management played a significant role. Nonhuman entities such as bioassay systems also contributed to the process. Institutional and structural factors were also involved," as were markets and regulatory bodies (p. 103). And so on. And so on. Hara gets our noses so close...

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