The result: Within each two-year survey time frame, about one-third of the quitters had begun to smoke again. Nicotine replacement therapy appeared to have no impact on the relapse rate, meaning that those who used the therapy for six weeks or longer were as likely to relapse as those who hadn't.
The study authors concluded that the findings raise "serious questions" about the effectiveness of nicotine replacement therapy as experienced by most smokers: namely, outside a carefully controlled clinical setting.
The researchers suggested that the findings might have broad public health implications, given pending plans under the federal health reform law that Medicare, Medicaid and private insurance plans cover the costs of nicotine replacement therapy.
"The FDA (U.S. Food and Drug Administration) has the responsibility for regulating medications to help smokers quit, as well as new responsibilities concerning tobacco products themselves," Alpert said. "So, on the one hand, it (the FDA) should only approve medications that are proven to be effective in helping smokers quit long-term. And it has the authority to intervene to actually reduce the addictiveness of cigarettes, which is what this study suggests is the real issue rendering NRT ineffective."
Stanton Glantz, a professor of medicine in the division of cardiology at the University of California, San Francisco's Center for Tobacco Control Research and Education, said the new study "is a real challenge to the routine use of over-the-counter NRT outside of a clinical setting."
"The findings don't surprise me," he added. "And they perhaps serve as an important cautionary tale about the way we might want to use our public dollars, and what is, and what is not, good public health policy."
"For example, we already know that increasing the pr
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