• June 24, 2024

Not “A Solved Problem”

 Not “A Solved Problem”
Photo: nikodash

Acknowledging reality at the E-Cigarette Summit

By Cheryl K. Olson

After weary years of disdainful comments and dismissive studies about nicotine, and especially vaping, from my public health colleagues, the recent 2022 E-Cigarette Summit in Washington, D.C., gave me cause for hope. It was energizing to see researchers, advocates and regulators sincerely attempt to share and discuss their varied findings and experiences rather than “preach to the choir” more evidence supporting preexisting beliefs.

For example, Peter Hajek of Queen Mary University of London discussed nicotine’s effects on the developing brain. He threw cold water on assertions that nicotine can cut IQ by 10 or 15 points. These claims, he said, come primarily from chronic large doses, close to a lethal dose, in animal studies. It’s unclear whether this is relevant to voluntary dosing among humans. He went on to question the basis for accepted wisdom on age of smoking initiation and nicotine dependence. At last, nuance instead of diatribe!

The U.S. Food and Drug Administration and public health researchers have always been concerned about tobacco product effects on vulnerable populations: people at greater risk of starting to use tobacco, suffering from tobacco-related diseases or having problems stopping use of tobacco products. But the scales were tilted toward stopping youth from initiating use and thus away from all those adults getting sick who can’t or won’t quit.

At the E-Cigarette Summit, a rebalancing seemed to be underway. Along with the usual (and appropriate) concerns about youth and vaping, there were sessions with titles such as “Let’s not forget the smokers” and “‘Smoke-free’ means smoke-free not vape-free.” Could we be approaching a point where the famous appropriate for the protection of public health standard gives protection of smokers’ well-being the weight it deserves?

This reframing of tobacco harm involves acknowledging some unpalatable facts. First, smokers still exist in persistently large numbers, many in marginalized pockets of society. As Nancy Rigotti of Massachusetts General Hospital/Harvard Medical School noted, “Disparities in tobacco use really drive health inequities in the U.S. And that’s another reason why we need to be addressing the adult smokers.”

Second, medical best practice approaches to quitting are not working and have no hope of getting us to a smoke-free society. Third, although cessation of use is preferable, harm reduction is a valid goal, sometimes the only realistic one—and it requires actively promoting appealing alternatives to smoking.

Dated and Overrated

Various media campaigns have urged us to “make smoking history.” Sadly, that’s not the path we’re on. According to Vaughan Rees of the Harvard T.H. Chan School of Public Health, the commonly recommended “safe and effective” medications fail to help most smokers, especially those from marginalized populations. Calculating their overall impact at the population level, he said, “We see a less than 1 percent reduction in the prevalence of smoking using current first-line smoking cessation medications.”

He concluded, “The best evidence-based interventions are dated, overrated and cannot meet the challenge of reducing tobacco-related harm in this century.”

One problem is that people who could encourage smokers to quit have become complacent. As Rigotti described in her talk, “Let’s Not Forget the Smokers: A Clinician’s Perspective,” “These days, for some of our clinicians, it’s really tobacco use is a solved problem.”

Rigotti quoted a cardiologist colleague who told her, “Gee, most of my smokers have quit now.” This doctor’s patients are well-off, with good health insurance. “If instead she were working in a safety net hospital,” Rigotti noted, “she would know that there are lots of smokers but that their smoking behavior was very intractable.”

Even before Covid-19, tobacco treatment struggled to gain physician mindshare. “We’re not very exciting because we haven’t had a new tobacco product on the market for more than 10 years,” said Rigotti. That is, physicians lack new pharmaceuticals to treat nicotine addiction.

What might change clinicians’ attitudes and practices? The comfortable route, Rigotti said, would be e-cigarette products designated as medical devices, similar to the U.K. approach. But that is likely years away. In the meantime, promoting the fact that the FDA has authorized the marketing of some e-cigarettes “is an opportunity FDA could take advantage of to say the public health benefits outweigh the risks for some members of this class of products,” she noted.

Her final recommendation was increasing doctors’ comfort with the idea and practice of harm reduction: helping patients who can’t or won’t quit. “Everyone’s comfortable with long-term NRT [nicotine-replacement therapy] now; you’re doing it [harm reduction] already,” she said to her fellow physicians. “And maybe you should be doing more of it.”

In the last decade, recreational nicotine products have proliferated like wildflowers: pouches, gums, heat-not-burn and many more. I would add: Why not do more to educate physicians about those? Especially given the new recognition that alternatives to smoking should be (gasp) appealing.

Push and Pull

Treat nicotine addiction with a medicine: That’s the traditional approach to smoking. Another welcome development at the E-Cigarette Summit was hearing multiple speakers advocate for new options, even flavored ones.

Dorothy Hatsukami of the University of Minnesota focused on factors that might push people away from smoking and pull those who won’t quit toward alternatives. Given that (as her slides noted) “nicotine maintains addiction, but other constituents kill people,” her recommended “push” was policies to reduce the nicotine in cigarettes.

However, she noted, for those smokers who are unable or unwilling to quit, a “pull” is also needed toward alternative nicotine-delivery systems. Hatsukami described a colleague’s study supporting that “in the context of very low-nicotine cigarettes, you still need to have [alternative] products that are appealing. That have a range of flavors as well as higher nicotine doses.”

“New technologies clearly are needed to fulfill the promise of tobacco harm reduction,” Rees asserted in his talk. “We need reduced exposure products that meet the needs of smokers.” Such products, he said, along with regulatory standards that reduce or eliminate known toxicants, are the way to prevent a pandemic of 1 billion deaths from smoking in this century.

Rees showed a refreshing willingness to consider what works, whatever the source, including a 1991 paper from the Philip Morris archives. “One size does certainly not fit all. I learned that from seeing what were previously secret tobacco industry internal documents,” he said. “They designed cigarettes to meet the needs of specific subgroups of smokers. And were successful at creating demand for their products.”

Along with a focus on rapid delivery of nicotine to the brain, “they also worked very hard to ensure that tobacco products are attractive, that they are convenient, that they are easy to use. That the chemo-sensory qualities of smoking are appealing enough to promote continued use,” said Rees.

Several speakers made it clear, citing randomized trials and real-world evidence, that boosting continued use is key to reducing harm through e-cigarettes. This included Andrew Hyland of Roswell Park Comprehensive Cancer Center and the FDA-funded Population Assessment of Tobacco and Health (PATH) study. He talked about PATH data on the one in six U.S. daily smokers with no plans to ever quit and who don’t vape. About 2 percent of this group tried and stuck with e-cigarettes, becoming accidental quitters.

These never-quitting smokers deserve more attention, said Hyland; they are “at much higher risk for a bad cigarette-caused health outcome because they are much older, heavier smokers and at the low end of the socioeconomics distribution.” Electronic nicotine-delivery system products have the potential to expand the pool of smokers engaged in cessation, thus raising overall quit rates.

How can we get the level of switching success seen in randomized trials of e-cigarettes to happen for more smokers in the real world? David Ashley of Georgia State University, former director of the Office of Science at the FDA’s Center for Tobacco Products, focused much of his opening keynote, “Thinking Outside the Box on E-Cigarettes,” on that question. He stressed that smokers need the opportunity to try various products to find the right one for them as well as coaching on how to use the product.

“Purchasing a poor device from a gas station or grocery store shelf, trying it out by yourself with no instructions, does not maximize the likelihood of successful quitting,” Ashley said. He contrasted this with a vape shop that takes a “hands-on interactive approach … working with smokers to find the best product for them.”

Living with Uncertainty

Jamie Hartmann-Boyce of the Centre for Evidence-Based Medicine at the University of Oxford, summarizing the latest Cochrane Review of electronic cigarettes for smoking cessation, made a plea in her talk’s title for “Living with and Addressing Uncertainty.” There is now moderate-certainty evidence from randomized trials, for example, that quit rates are higher with nicotine e-cigarettes than with NRT. As more results pour in, the Cochrane Review is now updated monthly.

In closing, Hartmann-Boyce noted that this field “since its inception has been hampered by false dichotomies: Are [e-cigarettes] safe? Are they not safe? Do we protect children? Do we help adults? And now it’s ‘Is the evidence certain or is it uncertain?’”

She pointed out that just as risk exists on a continuum, so does uncertainty, and that science is working as it should to move us toward firmer ground on e-cigarette effects. “We are getting more certain,” she said. “But what always remains certain is how harmful cigarettes are. And we should not let unnuanced discussions about the uncertainties of e-cigarettes get in the way of communicating that evidence as well.”