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

    PITTSBURGH, Feb. 22 /PRNewswire/ -- 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.
    GSK believes that quitting smoking is the only proven way to eliminate
completely the harm from tobacco use. Until there is scientific evidence that
harm reduction is a necessary alternative, nothing should be done to risk the
proven benefits of quitting or deter smokers from quit attempts.  All of GSK's
products and programs are focused on the ultimate goal of improving the public
health by helping smokers to become tobacco- and nicotine-free.


SOURCE GlaxoSmithKline




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CONTACT:
Leslie Ashburn of GlaxoSmithKline,
412-928-1636