Showing posts with label dip. Show all posts
Showing posts with label dip. Show all posts

Monday, May 5, 2025

Fake Science Denying the Relative Safety of Smokeless Tobacco Cost Millions of Lives; Don’t Repeat that Error with New Smoke-Free Products

 

Dr. Jay Bhattacharya, recently confirmed as director of the National Institutes of Health, tweeted on November 23, 2024, “If the NIH were serious about the replication crisis, it would devote a significant chunk of its budget to funding replication studies by independent researchers and require NIH funded researchers to make research materials available to replicators.”

I welcomed that statement because, over the past decade, my colleague Nantaporn Plurphanswat and I have challenged distorted and blatantly false studies concerning safer tobacco products (examples here, here, here and the list below).  Those efforts followed my earlier work with other authors on similar flawed research articles, but together they addressed only a fraction of defective FDA/NIH-sponsored tobacco research.  Because replication is time-consuming, it detracts from the performance of original research; additionally, findings are rarely published, and they often draw derision from the original authors and the research establishment. 

One might ask, why bother to address bad studies?  I answer that question in a new Sensible Medicine article titled, “Defining the Risk of Oral Tobacco Products,” in which I focus on the false narrative of a 1981 New England Journal of Medicine study that fatally undercut the fact that smokeless tobacco is vastly safer than cigarettes.  As a result of the 1981 publication, millions of smokers were denied information that could have extended their lives. 

Repeating that deadly error with vapor products, heat-not-burn tobacco and nicotine pouches will cost millions more lives.

 


 

List

Plurphanswat N, Rodu B.  Is the smoking population in the United States really softening?  Addiction, 2016 Jul;111(7):1299-303. doi: 10.1111/add.13340. Epub 2016 May 13. http://www.ncbi.nlm.nih.gov/pubmed/27177450

Farsalinos K, Rodu B.  Metal emissions from e-cigarettes: a risk assessment analysis of a recently-published study.  Inhalation Toxicology 2018. https://pubmed.ncbi.nlm.nih.gov/30384783/ 

Rodu B, Plurphanswat N.  A re‐analysis of e‐cigarette use and heart attacks in PATH wave 1 data. Addiction, First published 13 August 2020.  https://pubmed.ncbi.nlm.nih.gov/32794213/

Rodu B, Plurphanswat N. Heterogeneity and other problems in a pooled analysis of snus use and mortality. F1000Research 2021, 10:388 (https://doi.org/10.12688/f1000research.52127.1 )

Rodu B, Plurphanswat N.  Cross-sectional e-cigarette studies are unreliable without timing of exposure and disease diagnosis. Internal and Emergency Medicine 18(1):319-323, 2023. Epub 2022 Nov 25. https://link.springer.com/article/10.1007/s11739-022-03141-3

Plurphanswat N, Selya A, Rodu B. Questionable effects of electronic cigarette use on cardiovascular diseases from the National Health Interview Survey (NHIS, 2014-2021). Cureus 2024. DOI:10.7759/cureus.57119. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11055619/

Rodu B, Cole P.  Excess Mortality in Smokeless Tobacco Users Not Meaningful (Letter).  American Journal of Public Health 85:118, 1995. https://pubmed.ncbi.nlm.nih.gov/7832248/

Rodu B, Cole P. A deficient study of smokeless tobacco use and cancer (letter).  International Journal of Cancer 118: 1585, 2006.  https://pubmed.ncbi.nlm.nih.gov/16206262/

Rodu B. Snus and the risk of cancer of the mouth, lung, and pancreas.  Lancet 370: 1207, 2007.  https://pubmed.ncbi.nlm.nih.gov/17920914/

Rodu B, Heavner KK.  Errors and omissions in the study of snuff use and hypertension (letter).  Journal of Internal Medicine 265: 507-8, 2009. https://pubmed.ncbi.nlm.nih.gov/19019185/

Rodu B, Heavner KK, Phillips CV.  Snuff use and stroke (letter).  Epidemiology 20: 468-9, 2009.  https://pubmed.ncbi.nlm.nih.gov/19363361/

Rodu B, Plurphanswat N, Phillips CV.  Discrepant results for smoking and cessation among electronic cigarette users (letter).  Cancer 2015 Mar 4. doi: 10.1002/cncr.29307. https://pubmed.ncbi.nlm.nih.gov/25740231/

Rodu B, Phillips CV.  Regarding “Discontinuation of Smokeless Tobacco and Mortality Risk after Myocardial Infarction” (letter).  Circulation 2015 Apr 28;131(17):e422. doi: 10.1161/CIRCULATIONAHA.114.012038.  https://pubmed.ncbi.nlm.nih.gov/25918044/

Rodu B.  Re: Smokeless tobacco use and the risk of head and neck cancer: pooled analysis of US studies in the INHANCE consortium.  American Journal of Epidemiology 2017.  https://pubmed.ncbi.nlm.nih.gov/28911014/

Rodu B, Plurphanswat N.  Response to Bhatta and Glantz.  Addiction First published: 13 August 2020. https://pubmed.ncbi.nlm.nih.gov/32794301/ 

Rodu B, Plurphanswat N.  Gaiha et al. disregarded conventional publishing standards (letter).  Journal of Adolescent Health 68;215, January 1, 2021. https://www.jahonline.org/article/S1054-139X(20)30566-8/fulltext 

Plurphanswat N, Rodu B.  “Association between electronic cigarette use and fragility fractures among US adults” contains significant errors.  American Journal of Medicine Open 8: December 2022, https://doi.org/10.1016/j.ajmo.2022.100017 

Rodu B.  Methods questions.  Tobacco Control June 12, 2023. https://tobaccocontrol.bmj.com/content/early/2023/03/20/tc-2022-057717.responses 

 

Rodu B.  The many dangers of e-cigarette misinformation. Oral Surgery Oral Medicine Oral Pathology 2024.  https://www.oooojournal.net/article/S2212-4403(24)00893-9/fulltext  

 

 


Monday, February 19, 2024

Scaremongering’s Forever Effects

 

With the emergence of nicotine pouches, claims from the 1980s about the health risks of smokeless tobacco (ST) use have reappeared. Nicotine pouches are an important addition to smokers’ options for reducing harm, but it is inappropriate to devalue them by overstating the risks of ST use, such as opining that it causes leukoplakia and periodontal disease.  This is not the case, and I wish to set the record straight.

Leukoplakia

In 1995, my research group published an article, “Tobacco Use and Cancer,” that discussed leukoplakia: “Oral leukoplakia was originally defined in 1978 by the World Health Organization as a ‘white patch or plaque that cannot be characterized clinically or pathologically as any other disease.’ This definition was recognized as overly broad, and in 1984 a revised definition excluded white lesions such as frictional keratoses and also specified tobacco-induced leukoplakias as a distinct category. Furthermore, [ST keratosis, STK] was separated from smoking-related leukoplakia on the basis of presentation with additional differences in prevalence, frequency of dysplasia, and rate of malignant transformation. STK is common; it occurs in up to 60% of ST users.” (references omitted)

While anti-tobacco zealots never adopted the accurate terminology, preferring the scarier term leukoplakia, findings from 92 biopsies in one of these scaremongering studies were consistent: “All lesions were benign, but one specimen had mild epithelial dysplasia.”  The term mild dysplasia is subjective, so it’s likely that none of the findings were significant.

When our article was published, we were unaware that the infamous study by Winn et al. in the New England Journal of Medicine involved only women who had used powdered dry snuff (here).  That misleading study led nearly everyone, including health professionals, to mistakenly believe that moist snuff (dip) and chewing tobacco use among men causes mouth cancer.  For confirmation of that fallacy, see the October 2016 report by Annah Wyss of the National Institute of Environment Health Science and 20 government-funded coauthors (discussed here) that found that American men had no excess mouth cancers associated with dipping or chewing tobacco (Odds Ratio, OR = 0.9), while women, who mainly use powdered dry snuff, had a 9-fold elevated risk (here). 

Periodontal Disease

The CDC describes gum or periodontal disease as “mainly the result of infections and inflammation of the gums and bone that surround and support the teeth.”  The same scaremongering study cited above also reported that “gingival recession and attachment loss [4 mm or more] were greater in sites adjacent to lesions in [ST] users.”  These findings aren’t the same as infections and inflammation in and loss of the supporting bone, which is periodontal disease.  In fact, a comprehensive review by Kallischnigg et al. in BMC Oral Health concluded, “Two of four studies report a significant association of snuff with attachment loss and four out of eight with gingival recession. Snuff is not clearly related to gingivitis or periodontal diseases. Limited evidence suggests chewing tobacco is unrelated to periodontal or gingival diseases.” (emphasis added)

These two conditions, leukoplakia and periodontal disease, pale in comparison to lung cancer and heart attacks, so why am I focusing on them?  Because misinformation, particularly about safer smoke-free cigarette substitutes, has a dangerously long shelf-life.

I have dedicated the past 30 years to setting the record straight about ST use, but the American public remains grossly misinformed due to misinformation published decades ago.  For example, the National Cancer Institute Health Information National Trends Survey documents that 86% of Americans don’t believe – or don’t know – that ST use is less harmful than smoking (here).  Similar fake science now inundating the medical literature about newer smoke-free products, if not stopped, will have the same long-term effects. Public health and tobacco experts need to approach misinformation about tobacco risks as seriously as physicians counter quackery in medicine. 

 

Wednesday, April 26, 2017

Smokeless Tobacco 101



Huffington Post has published a discussion Joel Nitzkin and I had with psychotherapist Robi Ludwig (here).  HuffPo was not able to use the large number of resource links we provided, so I am republishing the article with the full complement, below.

Two Doctors on A Mission to Set the Record Straight about Smokeless Tobacco and Its Impact on Public Safety

By Robi Ludwig, PsyD, Contributor

The historical roots of tobacco go way back to almost the beginning of time. Some date it as early as 1 B.C. when the American Indians used it for religious and medicinal practices. Given what we know about tobacco today it’s almost impossible to believe tobacco was ever thought of as a cure-all for everything from dressing wounds to the standard go-to painkiller.

By the 1600’s tobacco was so popular that it was even used almost as frequently as money. Some even referred to it “as good as gold”.

But some of the dangerous effects of smoking tobacco was starting to become apparent during this time, too. Sir Francis Bacon, the 1st Viscount St Alban, an English philosopher, statesman, scientist, jurist, orator, and author, who served both as Attorney General and as Lord Chancellor of England, admitted to having a very hard time quitting his tobacco use and found it to be an impossible “bad” habit to break.

When we fast forward historically to the 1960’s, this is when the Surgeon General reported the various dangers of smoking to our health. And by 1971 Commercial Ads for cigarettes were taken off the air in the United States as an attempt to curb this dangerous and growing habit.

Even today, with everything we know about the dangers of smoking, there are still some misperceptions out there about tobacco use, which could negatively impact up to 8 million adult American Smokers, but not if two prominent doctors have their way.

Now Dr. Rodu and Dr. Nitzkin are trying to influence the public about Tobacco use by setting the record straight. Dr. Brad Rodu, who has studied the science behind tobacco harm-reduction strategies and has been appointed the first holder of the endowed chair in tobacco harm reduction research at the University’s James Graham Brown Cancer Center and Dr. Joel Nitzkin, public health physician, who is board certified in preventive medicine and has been involved in tobacco control activities since the late 1970’s, have made it their professional mission to reduce tobacco-related illnesses.

Dr. Rodu and Dr. Nitzkin strongly believe that smokers who are unable or unwilling to quit cold turkey should be informed about much lower risk smokeless tobacco or e-cigarettes. I spoke with both doctors to find out how they believe adult smokers can potentially be spared from life-threatening smoking-related illnesses. Here’s more about what they both had to say on this topic.


Dr. Robi: What exactly is smokeless tobacco, why was it created?

Dr. Rodu and Dr. Nitzkin: Anthropologists and historians believe that tobacco has been used by humans for thousands of years.  The plant originated in the New World and was completely unknown outside the Americas until 1492, when Columbus first encountered native Americans using tobacco for ceremonial and medicinal purposes.  They smoked and chewed tobacco, the latter serving as the provenance of modern smokeless tobacco products.

Smokeless tobacco dominated the American market prior to the 20th Century, because a day’s supply could be carried and conveniently used in both industrial and agricultural work settings.  In contrast, smoking was uncommon because producing cigars, cigarettes and pipes was labor-intensive and expensive.  In addition, smoking was very inconvenient before a safe and portable source of fire was readily available, which didn’t happen until the widespread use of safety matches in the late 1800s.  


Dr. Robi: What are the different kinds of smokeless tobacco?

Dr. Rodu and Dr. Nitzkin: In the U.S. there are two main kinds of smokeless tobacco.  Loose leaf chewing tobacco (“chew”) consists of shredded tobacco leaves and stems packaged in foil pouches.  Chew is also heavily sweetened and flavored.  It is used in fairly large quantities, which produces the typical swollen cheek appearance and generates a lot of juice.

Moist snuff, also called dip tobacco, is the most popular smokeless product in the U.S.  It is manufactured from dark, fire-cured tobaccos grown in western Kentucky and Tennessee, fermented and ground to the consistency of finely chopped parsley.  Multiple flavors are available, but moist snuff does not contain sweeteners.  It is used in small amounts, generally as much as can be grasped between the thumb and forefinger in a “pinch.”  The tobacco is then placed inside the lower lip between the cheek and gum.

Moist snuff is hard to contain in one spot, so manufacturers have packaged pinch-sized portions in small tea-bag type paper pouches.  The pouches are no larger than a piece of chewing gum or a breath mint, making them virtually invisible to place and use.  They also don't disintegrate, which makes the tobacco easy to remove after use.

Since 2005 a Swedish version of moist snuff, called snus, has become more popular in the U.S.  Rather than fermented, the tobacco is treated by a pasteurization process that gives it a different flavor than American dip, and somewhat lower levels of unwanted contaminants.  Snus is also marketed in many flavors and small pouches.

Americans place moist snuff in the lower lip, where it generates juice and spitting.  In contrast, Swedes don’t have to spit when they use snus, mainly because they place it inside the upper lip.

Nicotine is absorbed from all smokeless tobacco products through the lining of the mouth, giving the user a “buzz” very similar to, but with a slower onset than that achieved by smoking a cigarette.  Nicotine is not the major cause of any disease; it is no more harmful than caffeine, which is also addictive but safely consumed in coffee, tea and cola drinks.   


Dr. Robi: Are different kinds of smokeless tobacco better for you than others?

Dr. Rodu and Dr. Nitzkin: No tobacco product is absolutely safe.  All contain traces of unwanted contaminants in addition to nicotine.  But it’s been known for two decades that, by avoiding smoke, chewers, dippers and snusers eliminate about 98% of the health risks associated with smoking.  The risks are so small that even large epidemiologic studies with hundreds of thousands of users cannot provide indisputable evidence that smokeless tobacco causes any disease. 

With risks that small, it is not possible to prove that one kind of dip, chew or snus is safer than the other.


Dr. Robi: Why is there so much confusion about smokeless tobacco and if this is a healthy alternative to regular cigarettes?

Dr. Rodu and Dr. Nitzkin: Decades of scientific studies document that smokeless tobacco use is vastly safer than smoking with respect to cancer, heart attacks and strokes and many other diseases.  There is no confusion about smokeless tobacco among tobacco research and policy experts.  In 2002 a report by the British Royal College of Physicians, one of the world’s oldest and most prestigious medical societies, stated “As a way of using nicotine, the consumption of non-combustible [smokeless] tobacco is on the order of 10-1,000 times less hazardous than smoking, depending on the product.”  The Royal College issued another report in 2007 concluding “…that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.  In 2008 the American Association of Public Health Physicians became the first medical organization in the U.S. to formally adopt a policy of “…encouraging and enabling smokers to reduce their risk of tobacco-related illness and death by switching to less hazardous smokeless tobacco products.”   

Cigarettes are so popular that tobacco controllers incorrectly use the terms “smoking” and “tobacco use” as if they were synonyms, and they have become obsessed with the notion of a tobacco-free society.  They have transformed a legitimate war on smoking into a moral crusade against all tobacco products, a mistake that was tragically made with alcohol almost 100 years ago.

When a federal survey asked in 2015 if smokeless tobacco products are less hazardous than cigarettes, only 11% correctly answered “yes”; 67% responded “no” and 22% didn’t know.  In other words, 89% of Americans have no clue that dipping, chewing and snusing are 98% safer than smoking.  They are confused because they have been misinformed for decades by government agencies and medical organizations that all tobacco products are equally harmful. 

Misinformation from public health officials should no longer be tolerated.  Recently, two internationally renowned tobacco policy experts, Lynn Kozlowski, professor at the University of Buffalo School of Public Health and Health Professions, and David Sweanor, adjunct professor of law at the University of Ottawa, urged the FDA to end a $36 million campaign against smokeless tobacco “that fails to directly warn about the much greater harms from smoked tobacco (predominantly cigarettes).”  They concluded that “Public health agencies have an obligation to correct the current dramatic level of consumer misinformation on relative risks that they have fostered.” 


Dr. Robi: Why do you think the FDA has not informed the public about the whole truth about smokeless tobacco?

Dr. Rodu and Dr. Nitzkin: Obsessed with the notion of a tobacco-free society, the FDA so far has taken a hard line, falsely claiming that “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.”  In other words, no tobacco product is absolutely safe.  The agency is defying a key element of its stated mission – “to provide the American public with factual and accurate information about tobacco products.”  And Congress in 2009 prohibited tobacco companies from any communication with smokers regarding safer smokeless alternatives without the express approval of the FDA. 

The FDA has refused to acknowledge that its smokeless warnings are inaccurate.  Even worse, some of its regulations threaten to remove large numbers of smokeless and vapor products from the market.  In some cases the regulations require companies to conduct dozens of unnecessary studies on minute product details and human effects, which could take a decade or more.

This is regulatory fundamentalism, a bureaucratic maze that condemns smokeless tobacco products and e-cigarettes, and therefore tobacco harm reduction, to purgatory. With this delay, cigarettes will continue to dominate the American tobacco market, and 440,000 Americans will die from smoking-related disease every year.


Dr. Robi: How many adult smokers use smokeless tobacco as a way to quit smoking altogether?

Dr. Rodu and Dr. Nitzkin: Federal surveys are usually used to count current, former and never tobacco users.  The surveys generally don’t ask former smokers if they switched, but there was one exception.  In 2000, the National Health Interview Survey asked former smokers if they had quit by switching to smokeless; some 260,000 men said yes, providing the first population-level evidence that smokeless is a viable cigarette substitute. 

The 2015 NHIS documented that there were 5.1 million current smokeless tobacco users that year.  Unfortunately, the survey didn’t ask former smokers specifically about switching, but about 1.6 million smokeless users were former smokers, meaning they had switched to safer products like dip, chew or snus.  Almost 1.4 million smokeless users were current smokers; if they were made aware that smokeless was 98% safer, they might have fully switched.


Dr. Robi: How many smokers die every year from smoking cigarettes? How about from smokeless tobacco?

Dr. Rodu and Dr. Nitzkin: According to the CDC, the annual death toll among smokers is 440,000.  Despite the fact that smoking rates have been plummeting for three decades, the CDC death toll hasn’t changed for nearly 20 years.  In 2013, an FDA scientist concluded that the CDC estimate is too high.

One might assume that the CDC tracks smoking deaths throughout the year, but that’s not the case.  Instead, they estimate the number of smokers in the U.S., then they apply secret mathematical formulas based on comparisons between current, former and never smokers.  A reporter years ago tried unsuccessfully to crack the black-box formulas.  Here is her summary: “The computer is fed raw data and... employs various complex  mathematical  formulas  to  determine  how  many people in various age groups, locations, and heaven knows what other categories are likely to get sick or die from what diseases and how many of these can be assumed to be smoking related.”

The CDC provides death counts among smokers with single-digit precision (the current number is 439,033), but when it comes to deaths from smokeless use, the agency claims it can’t be done.  In fact, the CDC has the necessary data; its disinclination is likely due to the very low number that would result.  British researchers are not so inhibited; they reported in 2015 that there were no cancer deaths due to smokeless tobacco in the U.S. and Canada.  Last year, U.S. government-sponsored research revealed that the number of mouth cancer deaths among men who use dip or chew is zero.        


Dr. Robi: What is the “Swedish Experience” and how does it connect to tobacco harm reduction?

Dr. Rodu and Dr. Nitzkin: In virtually all developed countries, cigarette smoking has been the dominant form of tobacco consumption for over 100 years.  Sweden is a remarkable exception.  Smoking rates among men in Sweden have always been lower than in any other developed country, resulting in the lowest rates of lung cancer – indeed, of all smoking-related deaths.  The reason is that, instead of smoking, Swedes enjoy nicotine and tobacco by using snus, a 200-year old smokeless product.

A study published in the Scandinavian Journal of Public Health examined lung cancer – the sentinel disease of smoking – among men and women in all European Union countries.  It concluded “that snus use is inversely correlated with cigarette consumption among men in Sweden, resulting in the lowest [lung cancer mortality rates] in Europe for most of the past 50 years.” 

Numerous published studies have documented that male smokers in Sweden have used snus as a gateway to a smoke-free life, but that is only part of the story.  Snus use has also played a valuable role in steering tobacco initiators away from cigarettes.  Any tobacco use among children should be discouraged, but Swedish boys who experiment with tobacco choose snus, the product their fathers use.  This fact is well-received by tobacco research and policy experts who focus on eliminating deaths from smoking, not on eliminating tobacco.

With respect to tobacco, Sweden is unique in the 28-country EU, which bans snus everywhere else.  The effect of this prohibition is profound.  If men in all EU countries had the smoking rate of Swedish men, nearly 300,000 deaths from smoking could be avoided each year.    

The Swedish experience also has implications for its neighbors Norway and Finland.  In 1995, when Sweden and Finland joined the EU, Sweden applied for and received a waiver on the EU’s existing snus prohibition, thereby allowing Swedes to continue producing and selling within the country.  Finland adopted the ban, and since Norway never joined the EU, snus remained available there.

Norwegian tobacco research experts have documented that snus suppressed smoking rates there.  In Finland, the decline in smoking levelled off after the 1995 snus ban, while the decline in Sweden continued.

The Swedish experience wasn’t launched as a government program or anti-tobacco campaign.  It arose organically as tobacco users in Sweden made rational choices to use snus instead of cigarettes. 


Dr. Robi: If you had to state a clear message to the public about smokeless tobacco, what would it be?

Dr. Rodu and Dr. Nitzkin: The Swedish experience exemplifies harm reduction: consumers making rational choices to use smokeless instead of cigarettes, based on accurate perceptions and preferences.  The 40-50 million Americans who consume tobacco deserve truthful information from government and health organizations about vastly safer smokeless tobacco, e-cigarettes and vapor.  Millions of them could make the switch from combustible to smoke-free and lead longer and healthier lives.  How Swede it could be.