Wednesday, July 29, 2015

Cigarette-Nicotine Fadeout Fails; NIH-Funded Researchers Back “Easy Alternative Sources of Nicotine”

Drs. Neal Benowitz and Jack Henningfield were respected tobacco researchers in 1994 when they introduced a flawed smoking cessation prescription: force smokers to quit by reducing the nicotine content of cigarettes (here).  I criticized the idea in my 1995 book, For Smokers Only (now available as an e-book with a bonus chapter on e-cigarettes).

In the 20 years since, the nicotine fadeout strategy has failed to gain traction, while the alternate concept of tobacco harm reduction has attracted substantial support.  When Drs. Benowitz, Henningfield and their anti-tobacco allies attempted five years ago to resurrect nicotine fadeout as an FDA regulatory strategy, I labeled it “the most idiotic idea ever proposed by tobacco control advocates” (here) and described “the disaster that would result from radical reduction (prohibition) of nicotine in cigarettes” (here).

Today we have a fresh clinical trial (abstract here) from Dr. Benowitz that may mark the last gasp for this scheme.

Dr. Benowitz and coworkers enrolled 135 smokers who were “interested in a reduced nicotine cigarette study, and not interested in quitting smoking in the next 6 months.”  Eighty participants “smoked five levels of progressively lower nicotine content cigarettes, the first four levels being smoked for 4 weeks each.  The lowest nicotine content cigarette was smoked for 7 months.  [I call this the fade-out group.]  The control group smoked their usual brand of cigarettes for 12 months.”  Everyone got a year’s worth of free cigarettes, and information was collected for one additional year.

The results were dismal, starting with completion rates.  Smokers were paid to participate, which may have prompted 87% of the control group to complete the first year and 69% to make it through the second; the rates in the fade-out group were 46% and 38%.

The authors reported that “Quit rates were low in both [fade-out] and control groups, and not significantly different between groups at any time.”  That is an understatement.  The quit rate, validated by lab studies, was 2% among controls at one year and at two years.  Among the fade-out group, the rates were 3.8% at one year and 7.5% at two years.

There’s more bad news.  At one year, 43% of fade-out smokers admitted they had violated the study protocol by smoking regular cigarettes.

Dr. Benowitz likely intended the study to provide cover for the FDA to gradually reduce cigarette nicotine levels to near zero.  Instead, as he acknowledged, the fadeout theory was disproven: “Simply reducing the nicotine content of cigarettes alone may be insufficient to extinguish smoking behavior.”

Importantly, Dr. Benowitz concedes that “…easy access to alternative sources of nicotine (such as nicotine medications or electronic cigarettes) may be needed to achieve cessation of
cigarette smoking.”

Dr. Benowitz, welcome to Tobacco Harm Reduction.

A final note: I recently discussed how the National Institutes of Health have influenced the debate about tobacco harm reduction by doling out massive grants to university researchers nationwide (here).  The Benowitz study was supported by four grants from the National Cancer Institute and the National Institute on Drug Abuse; the total taxpayer tab was $29.2 million.

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