This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Scopus Google Scholar Articles by Will, C. M. Social Bookmarking                         What's this?

Identifying Effectiveness in ‘‘The Old Old’’

Principles and Values in the Age of Clinical Trials

University of Sussex, c.will{at}sussex.ac.uk

This article explores some implications of the increasing reliance on clinical trials in contemporary health care, particularly health care payers’ efforts to use them in the so-called fourth hurdle decisions. How do these agencies manage medical uncertainty given the desire to produce clear guidelines for clinicians? Their solutions take account of trials in at least two ways, reflecting broader debates about the meaning of these medical experiments. Trials can be read as either ‘‘proofs of protocol’’—straightforward guides to action with individual drugs in specific populations—or ‘‘proofs of principle’’— where extrapolation is made possible through an appeal to underlying biological mechanisms. These contrasting readings of trials are illustrated with reference to guidelines on heart disease prevention/cholesterol reduction using statins among the elderly in North America and the United Kingdom. Uncertainty in these cases does not lead to inertia but solutions use different fixed points to aid navigation, including both physiological principles and moral values.

Key Words: pharmaceuticals • age • extrapolation • medical evidence

Science, Technology & Human Values, Vol. 34, No. 5, 607-628 (2009)
DOI: 10.1177/0162243909340261


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?