Muraglitazar and the FDA: What Constitutes Drug Safety?

Selling safety--lessons from muraglitazar.

PEROXISOME PROLIFERATOR–ACTIVATED RECEPTORS (PPARs) are nuclear cell transcription factors with isoform agonists that exhibit clinical benefit. The PPARagonists increase insulin sensitivity, explaining the antidiabetic action of the thiazolidinediones rosiglitazone and pioglitazone. PPARagonists, including the fibrates, increase fatty acid oxidation, leading to a decrease in plasma triglyceride...

A difficult balance--pain management, drug safety, and the FDA.

n engl j med 361;22 nejm.org november 26, 2009 2105 conditions, pain is most common­ ly treated with analgesics. Over the past decade, there have been growing concerns about the harm — abuse and addiction, as well as serious injury and death — caused by the use of prescription and over­the­counter analgesics. These concerns have emerged in parallel with the evolving under­ standing of the impor...

What constitutes patient safety culture in Chinese hospitals?

OBJECTIVE To develop a patient safety culture instrument for use in Chinese hospitals, we assessed the appropriateness of existing safety culture questionnaires used in the USA and Japan for Chinese respondents and identified new items and domains suitable to Chinese hospitals. DESIGN Focus group study. SETTING AND PARTICIPANTS Twenty-four physicians, nurses and other health-care workers fr...

What Constitutes a Contract?

What Constitutes an Effective Representation?

This paper presents a taxonomy of 19 cognitive criteria for judging what constitutes effective representational systems, particularly for knowledge rich topics. Two classes of cognitive criteria are discussed. The first concerns access to concepts by reading and making inferences from external representations. The second class addresses the generation and manipulation of external representation...