August 17, 2017

Stanton A. Glantz, PhD

What the tobacco companies know about NRT: Without counselling, it keeps people smoking

Dorie Apollonio and I just published “Tobacco Industry Research on Nicotine Replacement Therapy: “If Anyone Is Going to Take Away Our Business It Should Be Us” in American Journal of Public Health.  This paper uses previously secret tobacco industry documents to show that the cigarette companies were originally afraid that nicotine replacement therapy, combined with counselling, would cost them customers.
But they were relieved when they figured out that most physicians did not use it properly and that, when used over the counter without counselling, they actually inhibited quitting.  The companies developed their own NRT products as complements to cigarettes, but originally did not take them to market for fear that doing so would trigger FDA regulation of cigarettes.
Now that the FDA has jurisdiction over cigarettes, Big Tobacco is getting into the NRT marker (sans counselling or even quitting).  As Phillip Morris concluded in 1992

Clinical results indicate the nicotine patch was more effective against placebos. . . . It is important to keep in mind, however, that in objectively validated tests (1 full year after quitting) nicotine patch scores were less impressive vs placebos. . . . Some sort of behavior modification was administered during the clinical tests. Without some degree of psychological therapy, many experts warn that the nicotine patch is powerless [as a method of smoking cessation].

We conclude our paper saying:

Although NRTis marketed as a cessation aid, the tobacco industry has been aware since the 1990s that it is unlikely to increase quitting. Although pharmaceutical industry studies of NRT use in clinical trials showed it increased quit attempts, these results appear to have been driven in part by the monitoring inherent to trials themselves; multiple studies show that adherence rates are higher in clinical trials than in real-world practice.  Medical research in the 21st century on population use of NRT has found results similar to those identified by the tobacco industry: NRT can expand nicotine use while maintaining smoking rates.
Tobacco industry research from the 1970s forward treated all products containing nicotine—including cigarettes, e-cigarettes and their precursors, and others (e.g., gums, patches, and candy)—as part of a single market: the nicotine delivery, or Craving Relief market. Industry marketing anticipates that noncigarette nicotine delivery products will be used by smokers for whom smoking is unacceptable, thus facilitating and normalizing lifelong nicotine addiction. These findings suggest that the least harmful way to sell nicotine delivery products is to restrict them to smokers whose quit attempts are medically supervised, consistent with the original studies of NRT for smoking cessation.  [citations eliminated]

What does this mean for clinical treatment and public health programs?  They should not just be distributing NRT without it being tied to counselling.  The FDA also needs to learn from the industry and avoid the possibility that their new “comprehensive nicotine policy” is falling into an industry trap.
Here is the abstract from the paper:

Nicotine replacement therapy (NRT) is recommended for tobacco cessation on the basis of pharmaceutical industry research showing its effectiveness when combined with counseling. The tobacco industry opposed NRT when it first appeared in the 1980s but by 2016 was marketing its own NRT products. We used internal tobacco industry documents dated 1960 through 2010 to identify the industry’s perceptions of NRT. As early as the 1950s, tobacco companies developed nonsmoked nicotine replacements for cigarettes, but they stopped out of concern that marketing such products would trigger Food and Drug Administration regulation of cigarettes. In the 1990s, after pharmaceutical companies began selling prescription NRT, tobacco companies found that many smokers used NRT to supplement smoking rather than to quit. In 2009, once the Food and Drug Administration began regulating tobacco, tobacco companies restarted their plans to capture the nicotine market. Although the tobacco industry initially viewed NRT as a threat, it found that smokers often combined NRT with smoking rather than using it as a replacement and began marketing their own NRT products. (Am J Public Health. Published online ahead of print August 17, 2017: e1–e7. doi:10.2105/AJPH.2017.303935)

The full citation is Apollonio D, Glantz S.  Tobacco Industry Research on Nicotine Replacement Therapy: “If Anyone Is Going to Take Away Our Business It Should Be Us.  Am J Public Health. Published online ahead of print August 17, 2017: e1–e7. doi:10.2105/AJPH.2017.303935

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