American Scientist

In Quest of Tomorrow's Medicines. Jürgen Drews. David Kramer, trans. 280 pp. Springer-Verlag, 1999. $29.95.

The pharmaceutical industry has achieved prominence over the past 130 years through innovation and unfettered development. The system now faces crises of purpose and means, according to author Jürgen Drews, former president of global research and development at Roche and Sandoz. Challenged by the consolidation of health care and the increasing cost of research and development, the unwritten 19th-century social pact of providing medicines for all ills is ending. Today's products are directed at the most prevalent diseases in the largest markets. Innovation in the discovery of new medicines is also on the wane as business concerns dominate company activity.

Most people have no idea where new medicines come from, or how they are discovered and produced, nor do they appreciate the criteria by which the medicines' safety and efficacy are judged. Drews describes the prominence of pharmaceuticals in Western medicine and traces the role of industry in bringing this about. He provides a history of pharmaceuticals, beginning with natural products extracted from plants, such as morphine from opium, emetine from ipecac root and digitalis from foxglove. Apothecaries prepared these medicaments for physicians through the 19th century, eventually establishing a fledgling pharmaceutical industry. With the rise of the German chemical industry, coal-tar derivatives were investigated for new molecules. Medicine eventually adopted the concepts of cellular physiology pioneered by François Magendie and Claude Bernard. Pharmacological principles introduced by Rudolph Buchheim and Oswald Schmiedeberg experimentally established the clinical effectiveness of medicines. Finally, Paul Erhlich's concepts of selective binding of dyes and chemotherapy led to Salvarsan, the first antisyphilitic agent.

Drews considers the 1860s' synthetic chemistry a turning point for the discovery of new medicines. Nearly a century later genetic technologies are now having a similar impact. He discusses genes and molecular-biology concepts, concentrating on gene therapy and applications of information from the Human Genome Project. He explains drug discovery and the multistage drug-approval process. Legislation imposing safety and efficacy requirements was spurred by the catastrophic thalidomide birth defects that transformed society's former acceptance of new medicines into deep suspicion, resulting in the current regulatory environment.

Drews foresees substantial change in the pharmaceutical industry. The divergent cultures of discovery research and drug development are increasingly out of balance. He believes that market forces and high-tech volume testing inordinately influence which medical needs will be addressed and how discovery will be done. He shares his concept for the appropriate management to encourage research innovation while staying within a budget. In the final chapter, the author prognosticates separation of research and development, with semi-autonomous institutes, academic centers or biotechnology companies providing the innovative research. Pharmaceutical companies would then provide development, clinical testing and marketing. These changes are of concern for scientists contemplating a research career in the pharmaceutical industry.

The book has messages for two groups of readers: for generalists a succinct description of how medicines are discovered and developed, and for those in the pharmaceutical industry advice on the management of innovation in research.—Harry Levine III, Parke-Davis Pharmaceutical Research Division, Warner-Lambert Company