In light of the difficulties experienced by the pharmaceutical industry in developing important new drugs, the rapid design and introduction of the targeted chemotherapeutic agent, crizotinib, is a significant achievement. Understanding the roles of the patient, the physician, the regulator (FDA), health insurance companies, and the manufacturer (Pfizer) in the development of this drug can shed light on the prospects for future drugs and on the workings of the complicated health-care ecosystem. Patients were eager for an effective drug against lung cancer with minimal toxicity but were reluctant to enroll in clinical trials. Oncologists were enthusiastic about the new drug but have a financial incentive favoring intravenous medicines over oral agents. The FDA was under pressure to approve new drugs quickly. The drug manufacturer modified its corporate structure and developed collaborations with academics and international partners, but was pressured by stockholders to maximize short-term profitability. Insurance companies balked at the price of the drug and used tiered pricing to limit their costs. The successful design, development, and diffusion of crizotinib may signal a new departure for the pharmaceutical industry, but whether such successes are replicated in the future will depend on the delicately balanced ecosystem that constitutes American health care.


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pp. 268-284
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