A cardiology professor–turned–academic consultant and clinical investigator for a pharmaceutical company reveals the way prescription drugs are developed.
In Mills’ (Practical Approaches to the Treatment of Heart Failure, 2001, etc.) part memoir, part scientific account of the way the Food and Drug Administration approves new medications—in this case, a treatment for heart failure called Nesiritide distributed by the “small biotech company” Scios—readers learn how medications are tested and sold. Mills tracks the rise of Scios and its eventual demise. The goal of this cautionary tale, or as Mills terms it, “tragic drama,” is to “instill fear in the audience, the fear of making the same mistake” that his company did. During his time at Scios, Mills engaged “deeply with questions of drug safety and efficacy.” Here, he concisely outlines how Scios went wrong in testing and marketing their now defunct product, from how they worked with the FDA to the press coverage of Scios that was “instrumental in shaping much of the company’s fall” to the Scios management that repeatedly stumbled along the way. Those who work in the pharmaceutical industry or have either an educational or professional interest in understanding how big pharma operates from the inside will glean the most from Mills’ book. He weaves a compelling narrative: he introduces dynamic players like his patient Eddy Buczynski, who suffered from heart failure and was one of the first people to get Mills interested in curing the disease, and later Kim Hillis, the national sales manager at Scios—a “compact blonde dynamo,” who could have been “the star shortstop on a championship softball team.” These descriptions and characters keep what could have been a dry narrative fresh and engaging.
A lively, well-told, thoroughly researched look at how drugs are brought to market.