ENDS in the Public Health Dialogue
By Robyn Gougelet , VP of US Regulatory Affairs
STAT News recently published an in-depth article (paywalled) about the 15 million adult Americans who attempt to quit smoking each year, and how five out of six fail due to the lack of effective treatment options. This article is of great importance given the premature death and unnecessary suffering caused by cigarette use. It provides a comprehensive look at the challenges drug makers face in getting regulatory approval for smoking cessation pharmaceuticals.
Ending smoking requires an all-of-the-above approach, including increasing access to proven pharmacotherapies and new medicinal options regulated by FDA’s Center for Drug Evaluation and Research (CDER), behavioral support, and access to products that deliver nicotine without smoke regulated by FDA’s Center for Tobacco Products (CTP). This includes Electronic Nicotine Delivery Systems (ENDS), more commonly known as e-cigarettes or vapes, which were not mentioned in the original piece.
A large and growing body of scientific literature demonstrates that ENDS are quite effective at enabling adults who smoke to switch away from combustible cigarettes.
One randomized control trial published this year in NEJM Group found that adults who smoke were nearly 80-percent more likely to completely abstain from cigarette use after six months when given smoking cessation counseling and ENDS instead of smoking cessation counseling with the option to access traditional nicotine replacement therapies (NRTs) such as the nicotine patch or gum.
At Juul Labs, our own longitudinal studies have found that more than half of adults who smoke who use JUUL products switched completely away from cigarettes. We estimate 2 million American adults switched completely using JUUL products.
The success that we have seen with JUUL products in the real world is likely due to the superior delivery of nicotine compared to NRTs coupled with similar rituals to smoking. It may also be due to a different mindset than smoking cessation. With NRTs and other pharmacotherapies, people who smoke must be committed to quit – completely, abruptly, immediately, and forever. It requires them admitting they need medical help, and many people who smoke do not see themselves as sick. Any slip – a cigarette while drinking with friends or during a stressful time – is seen as a failure, and over 90% of these lapses lead to a relapse into smoking.
With ENDS, there does not need to be a defined goal. We see incremental success over time as people who smoke try out ENDS. If they like it, they begin to substitute vaping for smoking. This process takes place over time and leads to incremental success with each cigarette not smoked.
This trend of increased and sustained switching over time away from cigarettes to ENDS products stands in contrast to smoking cessation via NRT use (Figure 1). In our longitudinal study analyses, we have seen high switching rates, including amongst adults who smoke who, at the start of the study, had no intention to ever stop using combusted cigarettes. These individuals instead purchased a JUUL product and “accidentally switched” completely away from their cigarette use at sustained and increasing rates over time.
Figure 1: Different Trajectory of Cigarette Abstinence Over Time
An all-of-the-above approach to address smoking requires both NRTs regulated by CDER as well as consumer nicotine products regulated by CTP.
The best option for adults who smoke to reduce the risks to their health from combustible cigarettes is to quit tobacco and nicotine products altogether. For adults using combustible products who have not successfully quit, potentially less harmful nicotine products like ENDS can play an important role in leaving smoking behind.
While these products can help adults, it remains crucially important to continue restricting underage access and appeal to preserve the harm reduction opportunity. We are encouraged by recent government data showing that underage vaping rates are at their lowest levels in more than a decade, and that use of JUUL products has been cut by more than 98% since its peak in 2019.
We at Juul Labs appreciate STAT drawing attention to this important topic, and hope that future coverage also incorporates evidence on harm reduction alternatives regulated by CTP. STAT was right to call for an augmentation of the work CDER can do to combat the continued prevalence of smoking in our country, which the article rightly calls “an indictment of the [currently available] treatment options.”
But to end the era of combustible cigarettes, we must think beyond treatment options and provide an array of satisfying smoke-free alternatives for those who have not had success with or do not want to use pharmacotherapies.
Freelance writer covering psychedelics, philanthropy, tobacco control. etc
2wI can't help wondering whether the article overlooked the role of ENDS in helping people to quit smoking because STAT's coverage is funded by Bloomberg Philanthropies.
Global health advocate (Self-employed)
1moThanks Robyn Gougelet Important points and a powerful graphic. However, before jumping to conclusions about the benefits of vapes over NRTs in terms of long term adherence, researchers need to provide data showing that the graphics represent similar populations in terms of their age, amount smoked per day, and past quit efforts. It is possible that NRT users, being on average 15 years older than vape users (according to several published studies) and more likely to be heavy smokers, are more dependent on nicotine, less motivated to quit or switch, and less encouraged to do so by their physicians. If so, the graphics may represent very different populations. Please clarify with the needed data. It could well be that we need a more tailored approach to support smokers quit that is based on the above and other behavioral factors. Saul Shiffman Mohamadi Sarkar Jasjit Ahluwalia, MD Patrudu Makena Dr. Jessica Zdinak Dr. Cother Hajat MBBS MPH PhD FFPH FRCP #Quit #Switch