What did we learn from the E-Cig Summit in Washington, D.C.?
By Derek Yach
The E-Cig Summit comes at a time of change in how tobacco harm reduction (THR) products are regarded by those who oppose or support their use as a means of ending smoking. In recent months, new reports, editorials and comments in leading medical journals have highlighted the benefits of vapes for smoking cessation.1,2,3,4 Further, calls for medically licensed vapes have increased from academics who rarely agree on THR policies.5
Robin Mermelstein, director of the Institute for Health Research and Policy at the University of Illinois, opened the meeting by noting that diverse perspectives are needed for innovations required to end combustible use. With no scientists from the private sector allowed to present research (except for former Center for Tobacco Products [CTP] Director Mitch Zeller, who is currently an advisor to Qnovia), this goal was tough to achieve. And it comes shortly after an editorial in Nicotine and Tobacco Research, the lead journal of the Society for Research on Nicotine and Tobacco, calling for complete exclusion of industry scientists.6 One wonders how widely supported this view is.
I summarize key inputs from the Summit that address six questions:
- What are the major trends in cigarettes and vape use in the United States?
Rafael Meza of the BC Cancer Research Institute showed that smoking and vaping prevalence in youth has declined. Frequent use (20 days or more over 30 days) is about 6 percent for smoking and vaping in both boys and girls. Among adults in middle age, cigarette consumption has declined in tandem with vaping increasing. Smoking rates, however, have not declined among people over 65 and remain highest among those with the lowest incomes and education. Meza’s projections of future trends are flawed by excluding probable impacts of heated-tobacco products and nicotine pounces joining vapes as providing alternatives to combustibles over the next few years.
Only 4 percent of all smokers live in the U.S. Resources and debate about global policies are shaped heavily by U.S. federal, academic, nonprofit, philanthropic and private sector perspectives. Global realities need to be brought into summits. To mention two. First, smoking rates exceed 40 percent in men across most Middle East and Eastern European countries and in China and Indonesia. Smoking rates exceed 20 percent in women across Eastern Europe and small island states. These were rates in the U.S. 40 years to 50 years ago. THR provides a route to leapfrog over the road taken by the USA.
Second, toxic smokeless tobacco products are commonly used, especially across South Asia, and cause about 350,000 oral cancer deaths. Nicotine pouches could well be the route to eliminating this dreadful cancer. A global perspective would place this as an achievable goal.
- Is there greater balance in addressing the needs of adults who smoke and those who have early disease compared to what has been a dominant focus in past summits on youth?
CTP Director Brian King stressed that youth issues remain his priority. In response to Mermelstein, he could not explain why this remains a priority, given extremely low vape use in youth and the absence of convincing evidence that vapes are a gateway to combustibles. In contrast, both the U.K. and New Zealand give priority to ending combustible use in adults.
King repeated his advice to adults who smoke: first use Food and Drug Administration-approved cessation medications and only then FDA-authorized reduced-risk products. Dual use is not supported. This advice is not in line with current evidence presented at the conference or multiple reports.1,2,3,4,5 Vapes are the most effective means to quit. Dual use lowers overall risks.
Scott Sherman of New York University stressed that the ultimate goals of tobacco control are to prevent the burden of tobacco-related disease. About 70 percent of people smoke when diagnosed with chronic obstructive pulmonary disease, peripheral vascular disease, schizophrenia, alcohol use disorders and several cancers, to name some major outcomes. The majority are still smoking years after their diagnosis. Sherman believes such patients would benefit from trying vapes. There are few studies in this area. He outlined a small pilot study of patients with chronic diseases comparing vape use to nicotine-replacement therapy (NRT) use that motivates for larger studies. Patients with early-stage chronic diseases who are between 40 years and 55 years of age who quit are likely to yield major health benefits.
- Is there evidence of the benefits of nicotine pouches, snus and heated-tobacco products as cessation interventions to complement studies of vapes? And are there studies comparing these products to NRTs and medicated solutions?
There are few such studies. Jamie Hartmann-Boyce of the University of Massachusetts and the Cochrane Collaboration presented a Cochrane review using indirect methods to compare a range of interventions. Vapes, NRTs and cytosine showed the strongest evidence of cessation effectiveness compared to other medications and interventions. She stressed the need for more high-quality studies. Public, philanthropic and industry funders should invest in such research among populations and countries where smoking and toxic smokeless tobacco rates are extremely high.
- Were the benefits of using biomarkers to demonstrate the effects of switching from tobacco products to THR options on proxy health outcomes discussed?
Zeller mentioned new real-world evidence using biomarkers that suggest benefits of dual use (of vapes and combustibles) in terms of proxy health outcomes. Mike Cummings briefly mentioned the need to use biomarkers of exposure and outcome to accelerate knowledge about THR impact on health outcomes. As an epidemiologist, I have long felt that we need to complement self-reporting and mortality-based studies with use of 21st century biomarkers that allow for more accurate assessment of exposure and earlier determination of outcomes. Tobacco industry scientists currently lead in developing and using biomarkers. Their extensive list of peer-reviewed publications should be cited and used by academics.
- There have been important discussions recently in the New England Journal of Medicine (NEJM) and JAMA about the benefits of medical licensing THR products. What are the views of the regulators, industry and academics in going this route and, more broadly, in supporting vapes as an effective way to quit?
Zeller believes improved medically approved tobacco harm reduction products are part of increasing access for adults to reduced-risk products. Nancy Rigotti of Mass General Hospital stated that a medical pathway is needed despite no medically approved products being available. Her views are based on knowledge that physician practices have widespread impact on their patients and on policies. She is concerned that the U.S. Preventive Services Task Force, the American Cancer Society, the Centers for Disease Control and Prevention, and the American Heart Association are still unclear about the benefits of vapes as being the most cost-effective means of achieving cessation. Their statements are either ambiguous or explicitly oppose vape use for cessation. She restated her NEJM call for clinicians to strongly advise patients who smoke to try vapes.2
King did not address this, and he deflected issues related to cessation to the FDA’s Center for Drug Evaluation and Research (CDER). The lead FDA tobacco chief should have an integrated approach to ending smoking that involved the CTP and the CDER. That is the spirit of the messages in recent influential journals by leading academics and former FDA heads.3,5 Further, the FDA 2015 CDER guidance on alcohol shows how it accepts abstinence and harm reduction endpoints used for drug approvals. It seems time that the CTP and the CDER could learn how well this is working to end the harm of tobacco use.
Both Neal Benowitz and Clive Bates of Counterfactual Consulting said we need to address the benefits of nicotine as a range of new products become available. This has implications for future medical licensing and recreational use. We need innovative ways to tease nicotine effects from combustible smoke effects to make progress on the regulatory front and to inform messaging to health professionals and smokers. A recent paper by Jasmine Khouja and her colleagues that used biobank data and multivariable Mendelian Randomization elegantly showed that most harms of smoking are unrelated to nicotine.8 Hopefully, work looking at the benefits of nicotine for Parkinson’s disease will follow. I recommend readers watch this space.
- Can THR practices outside of the U.S. inform U.S. policy?
Like the U.S., adult smoking rates in the U.K. and New Zealand have declined as vaping has increased. Deborah Arnott of Action on Smoking and Health (ASH) U.K. indicated that dual use has followed the path seen years ago when NRTs were introduced and regarded this as a transitional route to eventual cessation. This is an important insight for U.S. policymakers to acknowledge.
The U.K.-proposed legislation includes a ban on disposables, a new tax on e-liquid (which may reduce illicit trade from China and will maintain a differential tax relative to cigarettes) and measures to reduce the appeal of vaping to children in ways that allow adults to have continued access. Arnott supports vape promotion approaches that have more clinical and fact-based features and other policies that regulate proportionate to risk.
Ben Youdan of ASH New Zealand showed that for years, New Zealand and Australia had similar rates of decline in adult smoking. Over five years, however, adult rates have diverged, with New Zealand rates falling faster. He believes this is based on differences in vape policies and messaging. New Zealand media and policies support vaping to quit, especially among the Indigenous population. Martin Dockrell of the U.K. Department of Health and Social Care described U.K. government-funded programs to provide vapes to homeless people, people with mental illness and other groups with high smoking rates. The hope is that these initiatives will lower social class inequalities in chronic diseases that are strongly driven by differences in smoking rates.
Ben Youdan stated that Australia “treats people who vape as criminals or as sick people incapable of self-determination.” The result of this is that 90 percent of vapes on the Australian market are illicit while cigarette access is universal. The opposite is true in New Zealand.
King mentioned that the FDA is committed to health equity. The FDA should learn from the U.K.’s and New Zealand’s vape policies.Concluding Comments
The extent of misinformation was a topic that pervaded sessions. Alex Clark of the Consumer Advocates for Smoke Free Alternatives Association gave examples of how the FDA’s youth education campaigns have contributed to negatives views about vapes and nicotine. This could accelerate with the deployment of Chatbots that are explicitly programmed to spread misinformation about vapes and nicotine, the latest WHO one being a notable worrying example.9 Researchers need to rapidly engage computer scientists in building AI-driven ways to address misinformation continuously and at scale before the digital space is dominated by those who oppose harm reduction. This could draw upon the promising results of correcting misbeliefs about nicotine causing cancer and about vapes reported by Andrea Villanti of Rutgers.
For several years, E-Cig Summits and related standalone vape meetings have led thought leadership about the value of tobacco harm reduction. With the growth of a spectrum of reduced-risk products now available, is it time to consider transitioning such meetings into opportunities to address emerging ways to end smoking and the use of toxic smokeless tobacco products through a wider range of products? That would encourage comparative studies and for a deeper examination of how consumers use products throughout the day. It would also allow for policy discussions that focus more on harnessing a wider community of users and innovative companies to compete to accelerate an end to smoking.
David Levy of Georgetown University and Bates both made these point very strongly by placing the needs and interests of consumers first and seeing competition between companies and products as beneficial to meeting consumer needs to improve their health.
For that to succeed, future conferences will need to adopt Mermelstein’s opening words in practice and end boycotts and bans of industry scientists so that all actively developing innovative ways to make progress can debate the best ways forward together.
