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Smoking cessation product long-term outcome and use data necessary, cmte. members say.

This article was originally published in The Tan Sheet

Executive Summary

SMOKING CESSATION LONG-TERM STUDY HAS "INHERENT VALUE," Carol Falkowski, Minnesota Department of Human Services' Chemical Dependency Division, said at a June 9 meeting of FDA's Drug Abuse Advisory Committee in Bethesda, Md. The committee met to discuss smoking cessation product labeling inclusion of "secondary outcome measures" such as quit success despite relapse, reduction in cigarettes smoked, or diminished withdrawal symptoms. Studies of other drugs that treat addictions examine six-month and one-year outcomes "in spite of limitations" on the data available, she said. "Even if the treatment group is only two weeks or six weeks or eight weeks," there is "inherent value in knowing what the outcome is six months down the road and a year down the road," Falkowski commented.
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