- The Lock and Key of Medicine: Monoclonal Antibodies and the Transformation of Healthcare by Lara V. Marks
The Lock and Key of Medicine starts with an affirmation that may sound surprising to people who are not familiar with the recent evolution of pharmaceutical markets: six of the ten best-selling drugs in 2015 are monoclonal antibodies (mabs): standardized and homogenous antibodies produced in the test tube. The book’s last chapter provides more details on the commercial success of these drugs. In her impeccably researched and innovative book, Lara Marks explains how it happened. It is a captivating story with ups and downs, unexpected failures, and surprising achievements of producers of monoclonal antibodies; by telling this story, the book traces the unfolding relationships between scientific entrepreneurship and the pharmaceutical industry.
Monoclonal antibodies have two main applications: diagnostic and therapeutic. The diagnostic uses are relatively unproblematic. Specific antibodies were employed for nearly a hundred years to diagnose infectious diseases, identify biological materials in forensic medicine, and study changes in the body, and the industrial production of standardized antibodies amplified their already existing uses. The transformation of mabs into therapeutic agents, at the center of Marks’s book, was less straightforward. It suffered several setbacks in the early 1990s, but from the mid-1990s on took off rapidly, thanks to parallel developments of mabs that treat selected cancers, such as transtuzumab (Herceptin) and bevacizumab (Avastin), those that treat autoimmune diseases, above all rheumatoid arthritis, like infliximab (Remicade), and those that are used to treat both malignancies and autoimmune conditions, like adalimumab (Humira).
Marks’s story of the success of mabs as drugs follows fruitful and less fruitful strategies of pharmaceutical firms. It shows how two key variables, regulatory constraints and profit-related consideration, shaped industrial strategies. In order to obtain a market permit a new drug needs to target a condition for which its use can display clear-cut clinical benefit; in order to achieve commercial success it needs to find a sufficiently large market niche and generate profits. The double pressure of “demonstrability” and profitability shapes the profile of a successful drug—successful, that is, from its manufacturer’s point of view, not necessarily from one of the drug’s potential users.
Marks’s book is grounded in extensive use of printed and archive materials, but above all in numerous interviews with the main actors (nearly all, it so happens, male). Marks was able to win their confidence and gained access to exclusive information, perhaps partly because in some cases at least she seems to accept their point of view. The most problematic aspect of the therapeutic use of mabs is their high cost. Not only are mabs expensive, but in many cases only a small proportion of their users respond well, while it is impossible to know ahead of time who these fortunate users will be. Desperate patients, especially those who face premature death, put pressure on health authorities to finance their access to expensive drugs, putting health administrators in a difficult position. Marks [End Page 573] discusses this complex issue in detail, but she seems to view it as a structural, probably insoluble problem, because the production and testing of mabs are costly, while it is necessary to inject patients with considerable amounts of mabs to achieve a therapeutic effect. There is, however, a counterexample. Cuban anticancer mabs, produced by a nonprofit biotechnology plant, are considerably cheaper than their Western counterparts.
Marks’s book tells the fascinating story of the transformation of mabs into pharmaceutical industry blockbusters. But mabs became blockbusters not because of their exceptional efficacy (as, for example, antibiotics did) but because they are very expensive drugs, employed mainly to treat chronic conditions. The term “blockbuster,” exactly as when it describes a movie, refers to a commercial success, not to the product’s usefulness, although some mabs constitute very efficient treatments (and some commercially successful movies are also artworks). Marks has written a rich and multilayered history of...