Healthy Skepticism Library item: 11441

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

Lehman HP, Chen J, Gould AL, Kassekert R, Beninger PR, Carney R, Goldberg M, Goss MA, Kidos K, Sharrar RG, Shields K, Sweet A, Wiholm BE, Honig PK.
An evaluation of computer-aided disproportionality analysis for post-marketing signal detection.
Clin Pharmacol Ther 2007 Aug; 82:(2):173-80
http://www.nature.com/clpt/journal/v82/n2/abs/6100233a.html

Abstract:

To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck’s post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck’s safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.

Keywords:
Publication Types: Evaluation Studies MeSH Terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data Computer-Aided Design/standards* Databases, Factual/statistics & numerical data Drug Industry/methods Drug Industry/statistics & numerical data Drug Industry/trends Drug Toxicity/chemically induced Drug Toxicity/prevention & control Pharmaceutical Preparations/adverse effects Product Surveillance, Postmarketing/methods* Product Surveillance, Postmarketing/statistics & numerical data Reproducibility of Results Retrospective Studies Time Factors Vaccines/adverse effects Substances: Pharmaceutical Preparations Vaccines