, Volume 34, Issue 2, pp 93-96
Date: 21 Nov 2012

Pharmacovigilance and the Null Hypothesis

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access
This is an excerpt from the content

1. An Introduction

Over the past few years, the media has been replete with criticism of the failure of pharmacovigilance (PV) systems to prevent harm to people. In both the US and Europe this has resulted in calls for more effective PV. Indeed, on both sides of the Atlantic there is a flurry of funded activity to find better data sources, to use better analysis tools and to be more proactive in risk management.

It was arguably rofecoxib (Vioxx®) that instigated the activity because of the increased incidence of myocardial infarction. Because heart attack is serious and common, and the drug was very widely used, the public health impact was great and the public outcry loud; the regulators had been much too slow in taking action. Much of the above is summarized beautifully in a review by Greener.[1] Just after the Vioxx® issue became public, Edwards[2] wrote “The Vioxx® situation was not a failure of regulation itself, neither was it an issue of data collection, nor of the quality of stud ...