Smoking cessation: The time is now

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The need for a renewed focus on smoking cessation in the primary care setting has never been timelier.

Some may ask why this would be the case now that we have achieved historically low adult and youth cigarette smoking rates. Indeed, the most recently published national survey data shows this to be the case on a percentage basis.

But we need to unpack population-level percentages. Because the absolute number of cigarette smokers remains near 30 million. What has changed over time is the denominator. Our national population continues to grow, so the percentage of adult smokers is largely declining because of a larger denominator.

The troubling reality is that, even with the progress, tobacco use remains the leading preventable cause of disease and death in the United States. The landmark 50th Anniversary Surgeon General’s report on smoking and health in 2014 raised the annual death toll from tobacco use to over 480,000. The number went up, despite the decline in smoking rates, because the list of tobacco-related illnesses grew.

Mitch Zeller, JD

The simple arithmetic is astounding. That revised higher number means that between the release of the 2014 Report and the middle of the century, more than 17 million Americans will die prematurely from tobacco use.

As for kids, it is also true that we have achieved great success in reducing the overall number of youths who smoke cigarettes. But the media only reports the cigarette numbers. They fail to report that more young people experiment with cheap, flavored little cigars and cigarillos each day than with cigarettes. So, we still have much work to do to reduce the number of kids who smoke combustible tobacco products (to say nothing of youth use of e-cigarettes).

Physicians and other health care professionals in the primary care setting are uniquely qualified and positioned to speak with patients about tobacco use and find the time to counsel them on evidence-based approaches to quitting. You all know the basics. There are approved prescription and over-the-counter (OTC) medicines, some with nicotine and others without. You also know that combining counseling with pharmacotherapy can increase one’s chances of successfully quitting.

So why is it especially timely now to refocus your energies on helping patients quit smoking?

The main reason is that the U.S. Food and Drug Administration (FDA) is advancing game-changing policies to regulate cigarettes and other combustible tobacco products. When these policies are in effect, they will likely result in many smokers experiencing a newfound interest in quitting. And that is where you all come in.

The first of these policies may be the subject of final rules issued by FDA by year’s end. One will prohibit the use of menthol in cigarettes. The other will ban the use of any flavors in mass-produced cigars, little cigars, and cigarillos. The third policy will take longer but could have the biggest impact of them all on smokers’ desire to quit. This policy would establish a maximum allowable level of nicotine in cigarettes and certain other combustible tobacco products. The level that FDA selects will be supported by clinical research demonstrating that it would render the affected products minimally or nonaddictive.

Taken together, and based upon real-world experience with menthol bans in other countries, experts project that millions of current smokers will be looking for help to quit when these various policies go into effect.

A word about the tools at your disposal to help health-concerned smokers today and whenever the influx of new would-be quitters starts knocking on your doors down the road.

No doubt you are aware that FDA-approved OTC medicinal nicotine products are not all that effective in the real world. The main reason is because oral and dermal nicotine products like gums and patches deliver nicotine very slowly. Some of these products take over 30 minutes to reach the brain.

The cigarette, by contrast, is ingeniously designed to deliver the same drug to the brain in less than 10 seconds. Why? Because of inhalation.

So, what about a medicinal nicotine product that was also based upon the principle of inhalation but delivered nicotine without the 7,000 chemicals in tobacco smoke?

Wait, you say. Don’t we already have that with e-cigarettes? Well, not really. E-cigarettes are not therapeutic products. Many people who vape have stated publicly that these products helped them quit. No doubt that is the case. But the vast majority of e-cigarette users continue to smoke cigarettes. They are using their vaping products as an aid in harm reduction. None have received approval in the United States as a therapeutic agent for quitting.

I am working with a small startup company, Qnovia, to bring the first-ever inhalation product delivering pharmaceutical-grade nicotine to market as a cessation aid. For now, this means the company needs to engage with my former colleagues at FDA in the Center for Drug Evaluation and Research to gather the clinical and nonclinical evidence to support a marketing authorization.

The Qnovia product is a potential tool you can use down the road. I hope that day comes sooner rather than later.

For now, I urge physicians and all clinicians in the primary care setting to take the time to engage with your patients who smoke. Most are concerned about their health and have some degree of interest in quitting.

The tools you currently can use or recommend will help some smokers successfully quit. It all starts with you having that important conversation and being the trusted source of encouragement, support, and information for which they have come to rely on you.

Mitch Zeller, JD, retired in April 2022 from the U.S. Food and Drug Administration, where he served as director of the Center for Tobacco Products since March 2013. The mission of CTP – established by enactment of the 2009 Family Smoking Prevention and Tobacco Control Act – is "to make tobacco-related death and disease part of America's past, not America's future, and, by doing so, ensure a healthier life for every American family." A graduate of Dartmouth College and the American University Washington College of Law, he worked on FDA issues since 1982.