Rational therapeutics in the biotechnology era

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This dissertation probes the rhetoric and reality of rational drug design in the United States biopharmaceutical industry at the close of the Therapeutic Revolution and the dawn of the Biotechnology Era. Starting in the mid-1970s, molecular biologists, genetic engineers, and biotechnology entrepreneurs imagined a new class of biopharmaceuticals for the twenty-first century. Biomedical scientists boasted that they were learning so much about the body's processes at the molecular level that traditional trial-and-error methods of drug discovery soon would be obsolete. They pursued a reductionist molecular etiology of disease and envisioned molecular manipulation of genetic material as the cure. These claims promised nothing less than a radical shift in biopharmaceutical research, from a pharmacology based in chemistry to one based in biology, and from the laborious, random, compound-screening method of drug discovery to rational, efficient drug design.

Three case studies demonstrate that even if therapeutic compounds could be produced successfully under conditions of rational design in the industrial laboratory, it did not necessarily follow that they could be evaluated under rational conditions in the hospital clinic, executive boardroom, regulatory arena, or pharmaceutical marketplace. Case studies include Immunetech's anti-allergy pentapeptide, Pentyde; Immunex's recombinant DNA granulocyte-macrophage colony-stimulating factor, Leukine; and Centocor's antisepsis monoclonal antibody, Centoxin. The cases cast biopharmaceutical endeavors as a triangular enterprise space bounded by entrepreneurship, technoscientific change, and regulation. Within this conceptual triangle, the cases explore the factors that stymied linear progress and introduced cul-de-sacs or hairpin turns into drug development pathways. And they delve into the technoscientific, sociopolitical, regulatory, and competitive factors that affected the safety, efficacy, and market viability of rationally designed drugs in the last third of the twentieth century.

The contributions of molecular biology to disease understanding, molecular pharmacology to drug discovery, statistical methodologies to clinical drug evaluation, and biotechnologies to drug production processes largely have failed to produce the miracle drugs promised by rational drug design. This dissertation reveals the range of scientific and extra-scientific hurdles to achieving a pharmacopoeia of rationally designed drugs and balances the biotechnology industry's success stories with analyses of some of its failures.