Another study shows nicotine patches do not work. Will the CDC and FDA pay attention?

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NICOTINE & HEALTHA well-designed study of smokers trying to quit, done by researchers at the University of Pennsylvania and the Feinberg Medical School at Northwestern, confirms previous studies showing that the nicotine patch does not really help smokers quit. But their sales keep Big Pharma raking it in and provide false hope to desperate smokers.

The authors, led by Dr. Robert Schnoll of U. of P., studied 525 smokers seeking to quit, between 2009 and 2014. Since the FDA had approved long-term use of nicotine-replacement patches (NRT) shortly before the study began, they sought to determine if longer-term NRT use had any better efficacy than the previously-mandated 8-week course. They divided their subjects into three groups: 1-standard, 8 weeks; 2-extended, 24 weeks; and 3-maintenance, 52 weeks of NRT. They assessed for abstinence, or reduced amount of cigarettes smoked among the non-abstinent. All received in addition 12 smoking cessation behavioral counseling sessions. Smoking cessation was determined by patient report and confirmed via breath levels of carbon monoxide.

To summarize, the 52-week NRT group had little to no better cessation success than the 8-week group: all three groups had abstinence rates in the low-twenty-percent range at 52 weeks out. As per the authors:

At 52 weeks, participants in the maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the standard and extended treatment arms (20.3% vs 23.8%). Similarly, we found no difference in week 52 abstinence rates between participants in the extended and standard treatment arms (26.0% vs 21.7%).

The authors did manage to come up with one sliver of good news from their study: they found no adverse effects of the patches, so there s that. The study I ve often referred to as the gold standard of NRT patch failure is the Alpert, et al study in BMJ, published in 2011, which showed ...that persons who have quit smoking relapsed at equivalent rates, whether or not they used NRT to help them in their quit attempts. The current study simply confirms that one and many others, although the success rate of NRT patches in this one is a bit higher than I ve seen in most others. And it must be kept in mind that even this terrible rate is artificially higher than would be found among a normal group of would-be quitters, since study subjects are carefully followed and evaluated with ongoing devoted medical attention.

The drumbeat of evidence showing NRT s non-benefits should be a wake-up call to those who stubbornly oppose the spread of e-cigs and vapor products, since the toll of smoking rises to close to half-million in our country each year: something must be done.