Letters Section Editor: Robert M. Golub, MD, Senior Editor.
In Reply: We are in agreement with Drs Dervaux, Kanit, and Laqueille that all smoking cessation therapies, including varenicline, merit evaluation in population-based effectiveness trials following US Food and Drug Administration approval. These varenicline trials were phase 3 clinical trials designed to investigate safety and efficacy of an investigational drug prior to Food and Drug Administration approval. The exclusion criteria that were specified, including those for psychiatric conditions, were similar to those used in prior studies of investigational drugs for smoking cessation.1,2 They were chosen for several reasons.
Jorenby DE, Tonstad S, Gonzales D. Efficacy of Varenicline for Smoking Cessation—Reply. JAMA. 2006;296(21):2555-2556. doi:10.1001/jama.296.21.2555-b