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. 

 

 

 

Ohio State University Gets $20 Million FDA Grant to Trash Nicotine Pouches

 

Ten Ohio State University faculty members, led by Brittney Keller-Hamilton, published a study in the journal Addiction concluding that two strengths of Zyn nicotine pouches (3 and 6 milligrams) did not relieve “craving symptoms at 5 minutes as strongly as a cigarette.”  They also reported that “using 6-mg pouches was associated with greater plasma nicotine delivery at 30 minutes than 3-mg [pouches] or cigarettes…”

The OSU authors emphasized only one time point for assessing craving relief: five minutes after using the products.  They likely knew that cigarettes would win this contest, as no one expects a nicotine pouch to produce a blood-nicotine spike as quickly as inhaled smoke.  However, they also acknowledged that “no other differences in craving relief were observed through the 90 minutes of follow-up.”

Those familiar with nicotine absorption know that at 30 minutes, users of pouches or other smokeless tobacco products can be equally or more satisfied than those inhaling cigarettes.  The study’s nicotine levels show that in the figure below. 

 

 

Further, satisfaction with smokeless products may last longer than with cigarettes, so smokers who normally light up every hour might be able to use fewer nicotine pouches or dips of moist snuff.  That is an observation we made 30 years ago in our pilot study switching smokers from cigarettes to Skoal Bandits.

The OSU results regarding appeal were reasonable.  “Overall, participants reported moderate appeal (e.g. pleasantness, wanting to use, extent of liking and enjoyment) of the study [pouches]…Participants consistently reported both [pouches] as less appealing than their usual brand cigarette.”

OSU handcuffed Zyn with respect to enjoyment.  While the researchers instructed participants to smoke their “usual brand cigarette,” they assigned them only one flavor of Zyn (Wintergreen), even though nine other flavors are marketed (Spearmint, Cool Mint, Menthol, Peppermint, Chill, Smooth, Citrus, Coffee and Cinnamon).  The authors explain this as a typical clinical trial control, but in that case, they should not have judged the product based on subjective participant impressions.

For these reasons, their “less appealing” finding was predestined.  No substitute can perfectly replicate a cigarette’s nicotine/tobacco satisfaction.  However, the results demonstrate that Zyn pouches, while not perfect, were moderately appealing and moderately satisfying.  It’s too bad that the OSU group didn’t include other FDA-approved substitutes, such as nicotine patches, gum and lozenges. 

OSU’s press release grossly misstated the results, with the headline, “pouch products do little to curb addictive nicotine cravings,” causing media outlets to amplify the fabrication (here and here). 

The OSU press release also touts the center’s “newly funded $20 million Tobacco Center for Regulatory Science grant from the Food and Drug Administration and National Institutes of Health. The grant will enable scientists to conduct further research to inform oral nicotine pouch regulations and promote public health.”

Readers of this blog know the sort of research that $20 million will generate (here here, here and here). There is little here for inveterate smokers or tobacco harm reduction proponents to celebrate.