Gold Rush: Measuring Nicotine Mortality by the Millimeter

 

The New Yorker magazine recently published an article, “Zyn and the New Nicotine Gold Rush,”  that included a remarkable passage from a discussion between the author and Thomas Ericsson, a former Swedish Match employee.  It perfectly describes the risks of using snus and nicotine. 

“I asked Ericsson whether he had any concerns about the possible harms of nicotine itself. ‘Of course you should have concerns,’ he told me. ‘Or you should do risk analysis.’ He walked out of the room and returned with a large ball of string. The string was exactly ninety-five metres long, each millimetre representing one of Sweden’s approximate ninety-five thousand annual deaths. Ericsson slowly unravelled the string until he reached a piece of tape representing the people who die early from smoking each year. He moved his fingers down to another marker, a few meters shorter, which represented the people who die from drinking. He continued shortening the string, indicating the number of deaths by suicide (fifteen hundred), drowning (a hundred and fifty), car accidents (two hundred), and workplace accidents (between fifty and seventy).

“‘You can ask yourself, What are Swedish people most afraid of? They’re afraid to fly. They’re afraid of wolves. They’re afraid of deer and other things,’ he said, holding a short length of string. ‘But what you should be afraid of is the wasp. It kills five to ten people every year.’ Finally, Ericsson reached the very tip of the string. While working on Nicorette, he and his colleagues did a risk-analysis calculation that estimated that fewer than two people per year would die of heart illnesses exacerbated by nicotine use. Compared with other hazards, he said, ‘this is not a big risk.’”

I have recognized the minuscule risks of snus since 1995, when I first described the Swedish experience in a peer-reviewed publication:

“Sweden has been the world's largest per capita consumer of smokeless tobacco (ST) throughout the 20th century, without a resultant oral cancer epidemic.  On the contrary, the age-adjusted mortality rate for oral cancer from 1960 to 1990 in Sweden was low and remarkably stable at 2.3 to 3.6 per 100,000 person-years.  A retrospective study of 200,000 male snuff dippers in Sweden found only one case of oral cancer per year.  This is in marked contrast to most other European countries where ST use is essentially nonexistent and where increases in oral cancer mortality have mirrored earlier increases in cigarette consumption.  The greatest increase in oral cancer mortality has occurred in France (13.4/100,000 person-years in 1955-59 to 32.3/100,000 person-years in 1985-89). 

“It is not surprising to find that Swedish lung cancer mortality rates have been the lowest in Europe over the past 40 years.  These large scale vital statistics from Sweden and France strongly support the suggestion that if tobacco is to be used, it should be in the form of ST and not cigarettes. The population that uses ST in lieu of smoking is, in effect, protected from lung cancer and other major smoking-related diseases and suffers little or no increased risk of oral cancer.” (emphasis added, references removed)

In 2004, following my research sabbatical at Sweden’s Umeå University, I published this:

Rodu B, Cole P.  The burden of mortality from smoking: comparing Sweden with other countries in the European Union.  European Journal of Epidemiology 19: 129-131, 2004. https://www.ncbi.nlm.nih.gov/pubmed/15074568  

In that article, epidemiologist Philip Cole and I described “the mortality currently attributable to smoking in the European Union (EU), and the change that would result if all EU countries had the smoking prevalence of Sweden.  Almost 500,000 smoking-attributable deaths occur annually among men in the EU; about 200,000 would be avoided at Swedish smoking rates.”

More than 20 years after our estimates were published, the Swedish Tobacco Experience has become a Gold Rush, meaning that more people are consuming nicotine and tobacco in a safer fashion.

Robert Kennedy’s Nicotine Pouch Can Make America Healthy Again

 

The level of misunderstanding among American doctors about vastly safer cigarette substitutes is stunning.  Last week I critiqued the president of the American Medical Association (here), and this week it’s Dr. Nicole Saphier, a breast cancer imaging specialist at the Memorial Sloan Kettering Cancer Center.  In her January 30 New York Post column she called Robert Kennedy a “hypocrite” because he appeared to use a nicotine pouch during his Senate confirmation hearing.

Here are excerpts from Dr. Saphier’s screed, followed by my comments.

“After decades of relentless public health campaigns and advocacy against cigarette smoking, we are witnessing the tangible benefits, with declining smoking rates and the illnesses associated with it.”

She is only half correct, as smoking rates have declined, but mainly among children and young adults (here).  Too few older smokers at highest risk have quit, which is why nearly a half-million of them die prematurely every year.

“These small, flavored packets — filled with nicotine and other additives and tucked between the user’s gum and lip — are surging in popularity, mainly under the pretext that they are a safer alternative to traditional cigarettes.”

“The FDA has authorized Zyn and other pouches as a smoking reduction aid, giving them a reputation as a less harmful alternative.”

Nicotine pouches – in fact, any products delivering smoke-free nicotine – are vastly safer than smoking.  That is why the FDA authorized Zyn sales.  Also, the agency did not designate Zyn as a “smoking reduction aid.”  

“Yet this authorization does not equate to a declaration of safety.”

The FDA authorized Zyn as “appropriate for protection of public health.” 

“And these pouches come in varying strengths — with some providing far more nicotine than cigarettes or vapes.”

Saphier repeats a common, inaccurate claim comparing cigarettes, that deliver about 1 mg. of nicotine deep into the lungs, with a wide range of smoke-free products that deliver vastly different amounts of nicotine to the mouth and upper airway.  

“This is particularly dangerous to adolescents and young adults. Given their still-developing brains, nicotine can impair cognitive function, alter brain development…” 

The “brain development” claim has been fully debunked here.

“It’s alarming to see a new generation hooked on nicotine, reversing years of progress made in reducing smoking rates among young people.”

This is 180 degrees wrong, as the decline in smoking among young people has accelerated during the rise in use of alternative nicotine products (here).

“As he championed the Make America Healthy Again movement before the Senate committee, he was positioning himself as a warrior against chronic illness and discussing how he plans to combat diseases including food and drug addiction. Here is a figure publicly advocating for health, yet engaging in the use of a highly addictive product while doing so. In its most charitable interpretation, the incident shows how even those championing health can be ensnared by the allure of nicotine’s addictive nature.”

If Kennedy used a nicotine pouch during the hearing, it was entirely consistent with making America healthy again, and combatting the diseases and the consequences of smoking, America’s most dangerous drug addiction. 

 

 

 

Up in Smoke: The American Heart Association on Smokeless Tobacco

 

The American Heart Association published a policy statement in its journal Circulation, titled, “Impact of Smokeless Oral Nicotine Products on Cardiovascular Disease.” (here)  Below, I cite with permission excerpts from a review by Clive Bates, along with my comments.

The smokeless tobacco [ST] policy statement from the American Heart Association is too long to review in depth, but my main take outs are:

1. It’s a modest improvement on what came before and it has factually correct things in it, but it does not work as a basis for policymaking or risk communication.

Clive notes the biggest problem, the conclusion is preordained: “summarize implications of use for [the AHA’s] policy work toward ending tobacco and nicotine addiction in the United States.

So if your goal is a nicotine free society, no level of risk will ever be tolerable, and your search for harms (real, exaggerated or imaginary) will be driven by the need to support this conclusion.  We do not have this “elimination” philosophy with other common recreational drugs - caffeine, alcohol and cannabis, even though these are not risk-free.  We take the approach of managing risks to levels acceptable in society. AHA should also know by now that regulation and risk communication in this field is plagued by unintended consequences - adverse behaviour change (more smoking), illicit trade and risky workarounds - and these consequences can be more severely negative than the intended benefits.

Let me be clear - I am not recommending tobacco or nicotine use to anyone… this is better understood as a phenomenon in society driven primarily by its perceived or real benefits to users - it makes people feel better and feel as though they function better. No space was available in the paper to discuss this important aspect of nicotine use - why people use it. The demand for nicotine is not going to disappear and the availability of nicotine in much safer forms than smoking removes nearly all of the main deterrent for nicotine use - extreme harmfulness over the long term of inhalation of smoke. I suspect there would be a very different attitude to ST if the public had not been confused by years of deceptive risk communications [only 13.4% think ST can be safer than cigarettes - HINTS 2017]. There are no upfront statements that address this risk miscommunication.

2. No clarity on the place of ST on the nicotine risk continuum.

This is the only mention of ST in the AHA statement: “Although there are no safe tobacco products, a continuum of risk across tobacco and oral nicotine products exists, with the greatest risk associated with combustible products such as cigarettes and cigars.” 

Everyone agrees that there is no “safe” tobacco product, and that combustion and smoke produce the greatest risk, but it is unacceptable to ignore decades of evidence proving that ST is only about 2% as risky as smoking.

3. Nothing to correct huge false risk perceptions and more to add to them.

While many studies have found that ST use confers minimal to no increased risk for cardiovascular diseases, the AHA cherry-picked research that portrays ST badly and they ignored, or were ignorant of, those studies’ major flaws.  For example, the AHA cited a seriously defective 2014 Swedish study in Circulation showing increased deaths among snus users with heart attacks (here).  Using that study’s results, my colleague and I found that continuing snus users actually had a lower death rate than those who used neither snus nor cigarettes (here).  Our analysis was so persuasive that the journal published it for the record (here).

Every ST prohibition screed includes a section on oral cancer, and this report, ostensibly about cardiovascular disease, adheres to the formula by quoting an infamous 2016 study by Wyss and colleagues that claimed a positive association of ST use and oral cancer.  Still, in a rare nod to truth and clarity, the AHA authors opine:

“It is noteworthy that many meta-analyses included individuals who reported use of high-nitrosamine ST products from many years in the past. These differences need to be considered carefully when extrapolating to oral cancer effects among individuals reporting use of currently available products with lower nitrosamine levels.”

Kudos, because that is what I have been documenting since 1994.  Wyss revealed that American men had zero excess mouth cancers associated with [low-nitrosamine] dipping or chewing tobacco (Odds Ratio, OR = 0.9), while women, who mainly use[d] [high-nitrosamine] powdered dry snuff, had a 9-fold elevated risk (here).

4. Detailing the mechanisms behind minor risks in a way that conveys greater risk than exists.

Almost every study showing some sort of material risk has been open to confounding or other methodological weaknesses - the high level mortality data show no excess risk for exclusive smokeless use in the US.

The AHA studiously ignores published research that failed to show excess risk from ST use; the FDA took a similar tack in an internal report last year (here). 

5. Not presenting a simplistic approach to nicotine use, and why people use it.

The AHA dwells on nicotine chemistry, toxicity, pharmacology and physiology, but in the end, they focus on the harm of nicotine addiction.  In doing so, they ignore the fact that hundreds of millions of people worldwide consume combustible tobacco and nicotine products, despite the long-term increased risk of dying prematurely from a plethora of diseases that could easily be avoided.

6. Disregards interactions between different forms of tobacco use with radically differing risks.

The AHA repeatedly mentions dual use as a negative side effect of ST, yet the association perpetuates dual use by ignoring or downplaying the well-documented differential risks between smoke and smoke-free tobacco.  This has been going on for decades; in 1991, the CDC reported that at least 23% of ST users also smoked (here).  Imagine how many dual users’ lives would have been extended if health professionals had been honest about the risk differential.    

7. A naive policy platform based on weak evidence of impact and blind to unintended consequences.

This review does have some useful though equivocating text buried within it as the truth is essentially undeniable.

Nicotine is the proximate cause of all tobacco-induced disease because it drives dependence and compulsive use. However, most of the harm from tobacco use results from inhalation of tobacco combustion products, which delivers high levels of oxidizing chemicals, numerous toxic volatile organic compounds, and carbon monoxide. Because oral nicotine products do not expose users to combustion toxins, an important question is the intrinsic toxicity of nicotine.

No, the real question is about the magnitude of risk - how this compares with smoking and how it looks in absolute terms compared to other risks that are routinely tolerated in society. It should also draw attention to the likelihood that ST use is likely safer than vaping, as there is no lung exposure and no thermal processes -just because something contains tobacco doesn’t make it more harmful than something that doesn’t.

Sadly, if predictably, there are no clear statements in this policy statement that aim to reset the public, medical or political misunderstanding of relative risk.  Even on cardiovascular risk there are statements that suggest minimal risk in the American context, but buried deep within

The policy proposals are poorly supported with policy impact evidence and are more like an uncritical shopping list… Given it is a policy paper, it is completely dominated by largely irrelevant biomedical findings, with policy proposals made as if they are somehow obvious, rather than a perturbation of a complex adaptive and interconnected market-based system for nicotine use

The question is what happens to demand for nicotine when you try to adjust behaviour against smokless tobacco use? We have already seen that excessive FDA regulation has caused the vast majority of the vape market to be traded through unauthorised and/or illicit channels. 

If the demand for nicotine is robust, the policy problem is to move to ways of using it that are much less harmful than the dominant method, smoking tobacco. ST, responsibly manufactured and marketed, is one such option.

Amen.