Healthy Skepticism Library item: 6230

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kesselheim AS, Fischer MA, Avorn J.
The rise and fall of Natrecor for congestive heart failure: implications for drug policy.
Health Aff (Millwood) 2006 Jul-Aug 01; 25:(4):1095-102
http://content.healthaffairs.org/cgi/content/full/25/4/1095

Abstract:

Recent revelations of unexpected side effects of widely prescribed medications have raised questions about several aspects of U.S. drug policy, from initial Food and Drug Administration (FDA) approval to promotion by manufacturers and prescribing by physicians. One prominent example is nesiritide (Natrecor), a treatment for congestive heart failure. We use it as a case study to assess how FDA standards for drug approval, marketing practices by drug manufacturers, and physicians’ prescribing choices can shape the risk-benefit relationship of new drugs. Based on the nesiritide experience, we suggest several ways to improve policies for drug approval, postmarketing surveillance, and drug utilization.

Keywords:
Advertising Drug Approval/legislation & jurisprudence* Drug Industry/legislation & jurisprudence* Drug Utilization Heart Failure, Congestive/drug therapy* Humans Natriuretic Agents/adverse effects* Natriuretic Peptide, Brain/adverse effects* Product Surveillance, Postmarketing United States United States Food and Drug Administration