How can a drug that is associated with higher rates of bothrenal dysfunction and death than placebo and that costs50 times as much as standard therapies and for which there areno meaningful data on relevant clinical end points begiven to more than 600,000 patients and be promoted throughoutthe United States for serial outpatient use, an indication notlisted on the label?1,2,3,4,5 The answer to this question canbe discerned, at least in part, from a review of the clinicaldevelopment and marketing of nesiritide: recombinant human brainnatriuretic peptide.
Dr. Topol is provost of Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and chair of the Department of Cardiovascular Medicine at the Cleveland Clinic, Cleveland.
An interview with Dr. Topol can be heard at www.nejm.org.
Related Letters:
Nesiritide Not Verified
Sackner-Bernstein J., Aaronson K. D., Schreiner G., April P. A., Topol E. J.
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N Engl J Med 2005;
353:1525-1527, Oct 6, 2005.
Correspondence
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