Healthy Skepticism Library item: 10824

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

Garrison LP Jr, Towse A, Bresnahan BW.
Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysis.
Health Aff (Millwood) 2007 May-Jun; 26:(3):684-95
http://content.healthaffairs.org/cgi/pmidlookup?view=long&pmid=17485745

Abstract:

Regulatory authorities make difficult risk-benefit decisions when approving new drugs. Food and Drug Administration (FDA) advisory committees and reviewers must consider a complex body of evidence, including efficacy and safety results of trials, disease epidemiology, potential side effects, and patients’ needs. However, this menu of information is not usually presented in a consistent and integrated framework. The members of an FDA review panel vote with some unobserved, implicit weighting of the evidence. This paper argues that outcomes research tools for modeling long-term health outcomes, measuring health preferences, and establishing the value of additional information could provide a more structured, transparent, and quantitative process of assessing risk-benefit balance.

Keywords:
Drug Labeling/legislation & jurisprudence Drug Labeling/methods* Drug Labeling/standards Educational Status Government Regulation Health Knowledge, Attitudes, Practice Humans Pamphlets Patient Education/methods* Physician-Patient Relations United States United States Food and Drug Administration