- Das Diphtherieserum: Ein neues Therapieprinzip, seine Entwicklung und Markteinführung
The introduction of diphtheria serum in 1894 marked the advent of a new pharmacological principle—passive immunization—and of new manufacturing methods relying heavily on biological processes rather than chemical syntheses. It is Carola Throm’s contention in this book that the measures taken by researchers, manufacturers, and state authorities in the course of the introduction of diphtheria serum were both novel and constitutive of the essential elements of modern pharmaceutical legislation. The latter includes the testing of the medicinal substance for toxicity and efficacy on animals and human patients; state approval of production facilities and personnel; and state supervision of production and distribution through inspectors, veterinary control of animal facilities, production documentation requirements, labeling regulations, price administration, and official batch testing. The result was a regime that could be and was extended to other pharmaceuticals.
Throm gives a meticulous reconstruction of the path of diphtheria serum—from Emil von Behring’s research in the 1880s and early 1890s, which resulted in recognition of the principle of passive immunization, through Behring’s relationship with the fine chemicals manufacturer Höchst beginning in 1892, to the myriad problems involved in production, marketing, and state regulation from the 1890s to the 1920s. Although Behring occupies the center of the research stage, Throm assigns an important part to Paul Ehrlich, who developed assessment methods crucial to quality assurance of serum preparations, and whose Institute for Experimental Therapy first emerged in response to the need for serum testing. Similarly, although Höchst initiated the connection with Behring and became a leading manufacturer of diphtheria serum, Throm does not neglect German competitors, including Schering, E. Merck, and Ruete-Enoch.
The great strength of this book is Throm’s largely realized ambition to go beyond existing fragmentary historical accounts of diphtheria serum by providing a comprehensive picture of research, testing, commercial development, and state regulation that displays the connections of these facets of the medicine’s life story. She makes extensive use of state and corporate archival collections in Germany, giving her study an admirable precision and richness of detail. One example is her account of the development of the production process, which, by including many specifics such as the cost of food for the horses used in producing the serum and its effect on production costs, conveys a vivid sense of the ingenuity and effort involved in moving from initial research to marketing and medical use. The book includes several informative appendices and an index.
As comprehensive as it is in certain directions, Throm’s study also has exclusions and limitations. As she concedes in the introduction, the book does not directly consider medical aspects such as clinical use, dosage, side effects, or case histories. Throm’s focus is almost entirely on diphtheria serum as a pharmaceutical [End Page 134] product. Although she alludes to its public health importance, she does not discuss its effect on public health, even within Germany. The confinement of her study to Germany allows her to consider one national setting in fine-grained detail, but misses an opportunity for cross-national comparisons of scientific, commercial, and regulatory patterns that will need to be taken up in future investigations.
Throm gives a good account of Behring’s research leading up to his development of diphtheria serum, but one based mainly on published sources. This approach stands out both in contrast to her treatment of other aspects of Behring’s career, and in relation to the work of historians of science who have documented important differences between published and unpublished records of research for other investigators.
Throm’s assertion that the development of diphtheria serum called forth the creation of essential elements of modern pharmaceutical legislation is important and plausible, but the present study provides only one piece of the larger picture that will have to be filled in to make this claim convincing. It is not sufficient to compare...