In a call for innovation to reduce the public health harms of smoking, the National Institutes of Health and the Food and Drug Administration say they’re particularly interested in research on nicotine vapes. In a departure from their traditional emphasis on abstinence as the only study end point worth measuring, they also explicitly invited research focused on reduction in cigarette use.
In a joint call to action, senior officials from across both agencies “emphasize[d] smoking cessation as a high-priority area” and laid out the current regulatory pathways for developing new treatments. Their op-ed was published in Annals of Internal Medicine on October 15.
“Although abstinence is the primary end point accepted by FDA for smoking cessation studies, clinically meaningful reductions in smoking merit consideration as study end points,” the authors wrote, “because even patients who do not achieve full cessation might be gaining some benefit, especially if such reductions increase the probability of eventual cessation.”
Past research has associated cutting back on cigarettes with health benefits. But it’s notable for the agencies to acknowledge that abstinence isn’t the only outcome worth measuring. The authors also suggested that clinical studies be designed for “decentralized, point-of-care and community-based settings” and “facilitate enrollment and retention of persons from groups historically underrepresented in trials.”
This diverges from the views expressed in the FDA nicotine replacement therapy (NRT) guidance from May 2023, even though that document is heavily referenced in the new op-ed. The NRT guidance judges a treatment’s success in clinical trials by two outcomes: how many participants stopped smoking cigarettes for at least a month, and “the proportion of trial subjects not relapsing” after six or 12 months. Short-term abstinence and long-term abstinence, basically.
The NRT guidance endorses “reduce to quit,” AKA doing a gradual taper with abstinence as the end goal, but does not acknowledge cutting back as a harm reduction strategy in and of itself. The closest it gets is a brief suggestion that studies running longer than six or 12 months might “consider defining abstinence to incorporate a maximum allowable number of cigarettes.”
More emphasis from public health authorities on the fact that smoking fewer cigarettes is less harmful might cast a different light on dual use—a phenomenon often used to attack the idea of vapes as harm reduction tools. Many people who smoke and begin vaping use both, in a way that reduces the number of cigarettes they smoke. This is often a step on a journey to switching entirely, but not always.
Vapes were the only smoking cessation aid that the authors singled out explicitly.
Vapes were the only smoking cessation aid that the op-ed authors singled out explicitly. They expressed a particular interest in research that explored whether the devices could be marketed with a therapeutic claim, rather than just as a tobacco product.
The FDA has been found to have unfairly obstructed the authorization of devices that people use to reduce and quit smoking; a critical case concerning the status of flavored vapes, in particular, is due to be heard by the Supreme Court. The agency has also spread misinformation in service of its stated priority of reducing youth vaping. The new op-ed comes only after years of data showing cigarette smoking declining faster in countries where vapes are widely available.
“Many adults who smoke have used e-cigarettes to quit smoking,” the authors wrote. “Continued research on e-cigarettes is important, including long-term health outcomes and rigorous toxicology studies; given the history of suppressing tobacco-related research findings, it is essential that the results of research on e-cigarettes be made public.”
The FDA and NIH plan to host a joint meeting October 21 that will be free and open to the public, and accessible via Zoom. The public will also be able to submit comment on the agencies’ smoking cessation priorities until November 21.
Show Comments