Smokers who count on nicotine patches or gum to help them quit may want to reconsider: A new study finds that these and other nicotine replacement products aren’t effective at preventing former smokers from relapsing in real-world conditions.
Among 787 adults who had quit smoking within the previous two years, nearly a third reported having returned to using cigarettes, according to a study published online Monday by the journal Tobacco Control. Those who had used nicotine patches, gum, inhalers or nasal sprays were just as likely to relapse as those who had quit without them, researchers from Harvard University and the University of Massachusetts found.
The findings run counter to the results of several randomized clinical trials conducted before the Food and Drug Administration gave the thumbs-up to these nicotine replacement products in the 1990s. In those trials, volunteers using such products were up to three times more likely to kick the smoking habit.
But the latest results are in line with other studies that have found little — if any — benefit from the products when used by smokers in real life. In some cases, studies have found that people who use products like nicotine patches and gums are more likely to relapse than their counterparts who go cold turkey.
“This may indicate that some heavily dependent smokers perceive NRT [nicotine replacement therapy] as a sort of ‘magic’ pill, and, upon realizing it is not, they find themselves without support in their quitting efforts, doomed to failure,” the researchers wrote.
The new study examined former smokers three times over a five-year period. At the midpoint of the study, 30.6% of recent quitters had gone back to smoking. By the end, 31.3% had relapsed.
American smokers spend more than $1.5 billion on nicotine gum, patches and related products each year, according to the study. Much of that comes from public health programs, which are facing further rounds of budget cuts. Policymakers ought to rethink their willingness to pay for nicotine replacement therapy, the researchers wrote, and consider shifting that money to initiatives aimed at discouraging smoking in general, such as anti-smoking campaigns and efforts to raise tobacco taxes.
But GlaxoSmithKline Consumer Healthcare, which makes Nicorette, Nicoderm, Commit lozenges and other smoking cessation products, said that would be premature. The company noted that most of the adults in the study who used nicotine replacement products didn’t use them for the recommended eight weeks. Had those people followed directions, they might have had more success.
“Hundreds of clinical trials involving more than 35,000 participants and extensive consumer use for more than 20 years have proven both the efficacy and safety of NRT when used as directed,” the company said in a statement. “NRT products have helped millions of smokers quit by gradually weaning them off of their tobacco addiction and is recommended as a first-line therapy for quitting.”
It fell short by failing to tap any independent sources for commentary and perspective on the findings, by failing to compare the nicotine products to any alternatives for smoking cessation and by relying too heavily on a drugmaker’s press release.
Smoking continues to be a hugely destructive force in public health, even after decades of anti-smoking campaigns and mountains of studies documenting the damage. With dwindling resources for public health efforts, any study that can help policymakers better focus their resources could be a boon in the short and long term.
The story addresses the broad scope of costs: “American smokers spend more than $1.5 billion on nicotine gum, patches and related products each year, according to the study. Much of that comes from public health programs, which are facing further rounds of budget cuts.”
We would have liked to see actual costs for some of these products and a comparison to cigarettes. People might be more likely to continue buying nicotine products if they are cheaper than the cigarettes themselves.
This story and the New York Times story both failed to mention the actual number of people in the study who used nicotine products. Instead, it talked about the overall number of study participants and then provided percentages for the people who relapsed, perhaps leaving readers confused about whether and to what extent nicotine products made a difference in smoking cessation. It says, “The new study examined former smokers three times over a five-year period. At the midpoint of the study, 30.6% of recent quitters had gone back to smoking. By the end, 31.3% had relapsed.” It isn’t clear whether we are talking about the same 30% in each period or a total of roughly 60%.
No mention of the potential harms from taking nicotine, as opposed to quitting without drug therapy. There’s also the question of whether people are doing themselves more harm by continuing to smoke because they failed to quit with the help of a nicotine replacement product. If they had been able to more effectively quit earlier, would they live longer?
The story, like the others we reviewed, provides the basic outlines of the study design. It does not do a very good job pointing out any potential limitations with the research. It relies on one of the biggest makers of nicotine products — GlaxoSmithKline — as the sole voice criticizing the study. Unlike the New York Times story, this one did not place the study into context. The story notes: “The findings run counter to the results of several randomized clinical trials conducted before the Food and Drug Administration gave the thumbs-up to these nicotine replacement products in the 1990s. In those trials, volunteers using such products were up to three times more likely to kick the smoking habit.” The NYT did a better job by adding a proviso: “In medical studies the products have proved effective, making it easier for people to quit, at least in the short term.”
But it’s also important to note: the FDA approved nicotine replacement therapy for smoking cessation and only looked at short term outcomes (6 months to a year). Recidivism is a critical issue for any addiction including smoking. So it isn’t entirely accurate to report that “the findings run counter to the results of trials conducted before the FDA gave the thumbs up.”
This story quoted no independent experts. The only comments it used that were not from the lead researcher were from GlaxoSmithKline. “But GlaxoSmithKline Consumer Healthcare, which makes Nicorette, Nicoderm, Commit lozenges and other smoking cessation products, said that would be premature. The company noted that most of the adults in the study who used nicotine replacement products didn’t use them for the recommended eight weeks. Had those people followed directions, they might have had more success.” This idea appears to have been refuted in the study itself, which showed that the duration that people took the products did not seem to make a difference. A better criticism might have been that it is difficult to tell how these people truly complied with the product because they were not being actively monitored in a clinical trial but were only responding to survey questions.
There is no comparison to alternatives in this story.
The story basically used sales information to indicate availability. We did appreciate that this story mentioned a wide variety of nicotine products, including nasal sprays.
There were no claims of novelty in the story.
The story did not rely on this press release from Harvard, but it did rely on this press release from GlaxoSmithKline, one of the big makers of nicotine replacement products. The dependence on the company’s release for the sole outside perspective on the study casts a cloud over a story that already leaves too many questions unanswered. Fully 25% of the words in the story were turned over to the Glaxo response.
Systematic, Criteria-Driven
As always, encouraging news outlets covering medicine to practice journalism, not stenography. https://twitter.com/garyschwitzer/status/1267796903141539846
Thanks @garyschwitzer & @HealthNewsRevu
So helpful & rational as always:
"Often it is what journalists allow interviewees to say – unchallenged – that is most concerning" https://twitter.com/garyschwitzer/status/1267796903141539846
CBS @60Minutes promoted one hospital’s “promise of plasma” for #COVID19. Here are some things that you need to know about that story. https://www.healthnewsreview.org/2020/06/60-minutes-promotes-one-hospitals-promise-of-plasma/
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