Abstract
How can a drug that is associated with higher rates of both renal dysfunction and death than placebo — and that costs 50 times as much as standard therapies and for which there are no meaningful data on relevant clinical end points — be given to more than 600,000 patients and be promoted throughout the United States for serial outpatient use, an indication not listed on the label?1-5 The answer to this question can be discerned, at least in part, from a review of the clinical development and marketing of nesiritide: recombinant human brain natriuretic peptide.