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(Circulation. 2005;111:1459-1461.)
© 2005 American Heart Association, Inc.

Editorial

Nesiritide and Worsening of Renal Function

The Emperor’s New Clothes?

From the Section of Cardiology, San Francisco Veterans Affairs Medical Center, and the School of Medicine, University of California-San Francisco, San Francisco, Calif.

Correspondence to Barry M. Massie, MD, San Francisco VAMC, Cardiology, 111C, 4150 Clement St, San Francisco, CA 94121-1545. E-mail Barry.Massie@med.va.gov

Key Words: Editorials • heart failure • kidney • natriuretic peptides • drug approval

An extract of the first 250 words of the full text is provided, because this article has no abstract.

When we walk the streets at night in safety, it does not strike us that this might be otherwise. This habit of feeling safe has become second nature, and we do not reflect on just how this is due solely to the working of special institutions.

— —Georg W.F. Hegel (1770–1831), The Philosophy of Right (1821, trans. 1942)

Concern about the safety of commonly used and heavily promoted medications has grown in recent years, culminating with the recent events surrounding the cyclooxygenase-2 (COX-2) inhibitors. Patients, physicians, politicians, and government bodies are asking how newly approved medicines can be belatedly found unsafe and at the same time be prescribed widely on the basis of what is perceived as misinformation about their efficacy relative to older agents with which there is far greater experience. Is the approval process flawed, are medical practitioners so uninformed or unconcerned, or is essential information systematically withheld or misrepresented?

See p 1487

The article by Sackner-Bernstein and colleagues¹ in this issue of Circulation provides useful insight into the processes of drug approval, marketing, and physicians’ acceptance of new therapies. These authors used data from clinical trials of nesiritide (human B-type natriuretic peptide; BNP) to examine the effect of this agent on renal function. The unique feature of their analysis is that it is based neither on a direct review of the study data nor on data from peer-reviewed publications but rather primarily on data contained in US Food and Drug Administration (FDA) reviews and the sponsor’s briefing . . . [Full Text of this Article]

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