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GlaxoSmithKline Response to Institute of Medicine Report 'Clearing the Smoke, Assessing the Science Base for Tobacco Harm Reduction' 

GlaxoSmithKline (GSK) supports the Institute of Medicine (IOM) of the National Academy of Sciences for investigating how to reduce the harm caused by tobacco use. We concur with the IOM's recommendation that more research on the wide variety of possible harm reduction approaches is needed.

However, nicotine replacement therapies, including GSK's Nicorette(R) nicotine polacrilex gum and NicoDerm(R) CQ(R) transdermal patch, are currently approved by the Food and Drug Administration as safe and effective first line therapies to help smokers quit. In fact, in recent clinical practice guidelines for treating tobacco dependence released to physicians and the most recent Surgeon General's report, physicians were strongly encouraged to recommend that their smoking patients use FDA approved products such as Nicorette and NicoDerm CQ to quit smoking. It is also important to note that some of the press coverage quoting the IOM report mistakenly point out that nicotine replacement therapy contains tobacco. Nicotine patches and gum approved by the FDA do not contain tobacco.

Although these products have already helped millions of Americans quit, nicotine replacement therapies are not indicated for harm reduction nor marketed for this purpose. If scientific evidence supports nicotine replacement therapy for use in harm reduction, GSK would consider pursuing this indication by obtaining FDA approval.

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