That High Design of Purest Gold

Reviewed by: That High Design of Purest Gold: A Critical History of the Pharmaceutical Industry, 1880–2020 by Graham Dutfield Toine Pieters (bio) That High Design of Purest Gold: A Critical History of the Pharmaceutical Industry, 1880–2020 By Graham Dutfield. Singapore: World Scientific Publishing, 2020. Pp. 510. This book is all about the long twentieth century of drug making, patenting, and regulating. It offers a fascinating journey into the evolution of one of the major global industries today: the pharmaceutical industry. The large-scale preparation of alkaloids by pharmacist-industrialists alongside the expanding chemical-pharmaceuticals markets laid the foundation for the international pharmaceutical industry in the second half of the nineteenth century. An early success of the burgeoning industry was the international launch of the new drug Aspirin (acetylsalicylic acid) in 1899. German drug maker Bayer and its marketers positioned Aspirin as a specialty drug and a profit-making, revolutionary pain medicine. Thus, the first global drug brand was born. As a major representative of the German pharmaceutical industry, Bayer led the way in its sophisticated use of intellectual property, including trademarks, as well as in its scientific, research-based approach. For the innovative, ethical, and international pharmaceutical industry, Aspirin's success clearly showed that branded drugs or specialty products were much more profitable than chemical or pharmaceutical bulk products. The high profit margins justified continued investments in drug discovery and development and also allowed for the emergence of corporate in-house research and development. Graham Dutfield convincingly shows a historical continuity in terms of profit-seeking business behavior and R&D priorities, but also in terms of the leading countries—Germany, Switzerland, Britain, and the United States—involved in what has become a truly global enterprise. He also points out the post–World War II Atlantic and, more recently, the transoceanic shift in the geography of biomedical innovation, as well as the global distribution of pharmaceutical companies. The book's major focus and contribution, however, are on the co-development of intellectual property rights and pharmaceuticals. Dutfield's in-depth knowledge of this rather complicated subject matter is amazing, and his ability to explain the workings of patent law and trademark law by means of compelling historical case studies is laudable. In particular, the Myriad Genetics BRCA1 and BRCA2 human DNA patenting case is well documented. Dutfield gives a crystal-clear explanation of drug lifecycle management and the ever-increasingly aggressive practice of evergreening and extending the market power of a given medicine far beyond the lifetime of the first patent. The author thus provides ample ammunition for criticizing the sustainability of the current drug patent protection and regulatory system. I agree with Dutfield that current concerns about pricing, access, and [End Page 593] competition should go further than a focus on patents. A systemic approach is needed that acknowledges the historically grown interdependencies between the different stakeholders—including scientific institutions, governments, pharmaceutical companies, regulatory bodies, medical associations, patient organizations, and hospitals—as part of the medical-industrial complex. However, the book's strength is at the same time its weakness. More often than needed, the reader gets lost in details presenting a critical co-evolutionary history of the pharmaceutical industry, not necessarily serving the purpose of the book. What I dearly miss in the book is a systematic analysis of how the aforementioned interdependencies between stakeholders became strengthened to the point that no stakeholder seems willing to support a much-needed radical reform of the medical-industrial complex. Exemplary of this effect is the post-1960s exponential growth of the clinical trial industry, which serves the interests of regulators, pharmaceutical companies, hospitals, and doctors alike, but also serves patients in desperate need of a cure. In providing prescriptions for a healthier pharmaceutical industry, Dutfield argues persuasively that regulatory and market reforms are needed to achieve a better balance between the pursuit of profit and global public health needs. I wholeheartedly support his plea for closing regulatory loopholes to prevent system-gaming in the form of evergreening and the abuse of orphan drug incentivization programs. The challenge was, is, and will be, of course, how to strike a balance between rewarding investments in innovation, achieving reasonable drug pricing

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