Friday, February 26, 2021

New Research Confirms Minimal Mortality Risks with Exclusive Cigar Use


Last year my colleague Nantaporn Plurphanswat and I published a study in the Harm Reduction Journal on causes of death among U.S. male smokeless tobacco (ST) users.  We showed that exclusive ST users do not have significantly elevated mortality from any smoking-related diseases, although younger ST users had elevated deaths from all other causes. 

While conducting that research, I testified (see here and here) at a field hearing convened by U.S. Senator Marco Rubio, then-chairman of the Senate Committee on Small Business & Entrepreneurship.  The hearing focused on proposed FDA regulations’ likely effect on premium cigar production and marketing. 

Subsequently, Dr. Plurphanswat and I conducted a cigar use mortality study.  Our report has just been published in the Harm Reduction Journal.  Our main finding:

“exclusive male cigar smokers age 40 + years had no statistically significant increased mortality from all causes, heart diseases, malignant neoplasms, cerebrovascular disease, smoking-related diseases or other causes. In contrast, the mortality experience of dual users of cigars and cigarettes and cigar smokers who formerly used cigarettes is similar to exclusive cigarette smokers.”

As with our ST study, our analysis of cigar users included only men age 40+ years, because it was designed to maximize the chance of producing significant results.  Many previous studies included women, who rarely smoke cigars, and young men, among whom death is rare; those groups do not produce relevant information.  Consider: Researchers aiming to measure breast cancer rates will likely not count men because while breast cancer does affect males, it occurs at such a minuscule rate that it would cut the rate among women in half, painting a grossly inaccurate picture.

Cigars are a complicated tobacco category, as we noted in our article:

“The cigar category consists mainly of two types of products: traditional, regular or premium cigars and cigarillos and little filtered cigars. The first type is larger and contains tightly rolled tobacco wrapped in a tobacco leaf. The second category has been described by the National Health Interview Survey questionnaires since 2015: ‘Cigarillos are medium cigars that sometimes are sold with plastic or wooden tips’ and ‘sold individually or in packs of 5 or fewer. Little filtered cigars look like cigarettes and are usually brown in color. Like cigarettes, little filtered cigars have a spongy filter and are sold in packs of 20.’ [reference here]  These differences are important. It has been known for decades that exclusive users of traditional cigars and pipes tend to puff, not inhale, the smoke, thus limiting systemic exposure to toxic constituents compared with cigarette smoking…In contrast, users of cigarillos and small cigars generally inhale the smoke. These cigar types are more commonly consumed by adults under age 40 who are less educated and lower income than regular cigar smokers. They are also more likely to be consumed daily, in larger numbers, and also concurrently with cigarettes.”

However, National Health Interview Surveys (NHIS) data that we used to conduct our study does not distinguish between smokers of premium cigars and those who smoke products in the second category.  The following figure from our HRJ article, which illustrates the hazard ratios (HRs, similar to relative risks) for cigar users, shows how we tried to overcome the NHIS deficiency.  We coupled current, former and never cigar users with the same groupings of cigarette smokers.  Cigar smokers in the red circles are likely to be in the cigarillos/little cigar group, whereas those in the green circle – who never smoked cigarettes – are likely to be premium users.

To be clear, neither puffing nor inhaling the smoke of burning tobacco is a healthy activity, but federal officials and others misrepresent the complex category when they make sweeping statements about how cigar smoking carries many of the same health risks as cigarette smoking.

All tobacco consumers deserve truthful information and guidance.  The sweeping FDA indictment ignores scientific evidence and misleads cigar smokers.  The following facts are indisputable: (1) In the U.S., the prevalence of cigar use, especially premium cigars, is very low; (2) premium products are used infrequently and in small numbers; and (3) they are puffed, not inhaled.  Low prevalence, infrequent use and reduced exposure translates into minimal harm at the population level.

Conflation of cigarette smoking with dip and chew, vaping, cigar and pipe smoking falsely informs consumers that all tobacco products are equally dangerous.  When Congress gave the FDA regulation of tobacco products 10 years ago, it did not direct the agency to treat all tobacco products as equally hazardous.  Unfortunately, the FDA’s regulatory actions have done just that. The FDA’s current posture wastes government resources, undermines public health, and does nothing to address the 500,000 annual deaths caused by cigarette smoking.


Tuesday, February 16, 2021

Vapers Can Draw Inspiration from this Type 1 Diabetes Story: We Are Not Waiting


Vapers, I hope you are inspired by the following story.  It’s about how do-it-yourselfers in the Type 1 diabetes community have achieved advances in treatment that are entirely independent of the medical and pharmaceutical industries, and of FDA regulation.  The manner in which these advancements were obtained mirrors how DIYs in the smoking community have promoted vaping devices that are substantially replacing deadly cigarettes.

People with Type 1 diabetes (PWDs for short) lack a functioning pancreas, making them reliant on a continuous external source of insulin.  There have been considerable advances in managing Type 1 over the past two decades, including better forms of insulin, small wearable pumps that provide the essential hormone 24/7, and continuous glucose monitors (CGMs) – tiny sensors that provide blood sugar levels day and night.  Remarkable as these advances are, PWDs must still be on guard 24/7 – even in the middle of the night – to maintain a normal blood sugar range.  With Type 1, blood sugar levels can soar or plunge in an instant.  Too much time at the high end can damage blood vessels, kidneys and other organs, while low blood sugars can trigger brain shutdown, coma and even death.

Of late, PWDs were convinced that insulin pumps and CGMs could be integrated into an “artificial pancreas”, but device manufacturers and the FDA were not moving fast enough.  In response, DIYs went into action (as described in a recent article in Healthline), and in 2013 the hashtag #WeAreNotWaiting became “the rally cry of folks in the diabetes community who are taking matters into their own hands by developing platforms, apps, and cloud-based solutions, and reverse-engineering existing products,” with a focus on developing an artificial pancreas.

Artificial pancreas systems (insulin pump, CGM and controller) have been available for several years.  One app, called Loop, is used by 10-15,000 people worldwide (here).  In my own 18-month experience with it I have found it truly life-changing.    

A DIY artificial pancreas program called Tidepool has just been submitted for FDA review.  If approved, it would be the first DIY product to have passed FDA scrutiny.  PWDs are hopeful, but those already using artificial pancreas solutions will never give them up.

 The reason this story is important for vapers is that you have been using unapproved devices as substitutes for cigarettes in order to lead longer and healthier lives.  Like PWDs, you are not waiting for FDA-approved options to step away from the fire. 

E-cigarettes and vapor products are scheduled for daunting reviews by the FDA, but vapers, you have demonstrated that, in order to quit smoking and stay smoke-free, you are not waiting.  Take heart with this diabetes story.




Monday, February 8, 2021

Author and Editors Defend the Indefensible Stanford Study on Vaping & Covid

In August, I discussed a Stanford University study published in the Journal of Adolescent Health (JAH) claiming that young people who ever use e-cigarettes are five to seven times more likely to be diagnosed with Covid-19.  A group of harm reduction researchers subsequently wrote that the claims are implausible and the results “so suspect that any conclusions drawn from it [sic] cannot be relied upon…the paper should be retracted.”

The JAH recently published four letters to the editor regarding that study (available here).  The letters were followed by a response from only one of three original contributors: senior author Bonnie Halpern-Felsher.  One is left to wonder about why her original co-authors didn’t sign on to the reply.  Halpern-Felsher’s response did have five co-signers from four other institutions defending the article that they had not written.  Additionally, the JAH editors penned their own response – indicating that they recognized that they had problems with Halpern-Felsher’s article.

The four letters focused on a variety of issues, including these key ones.

1. Halpern-Felsher writes “We adjusted our sample to be representative of the U.S. population.”

Halpern-Felsher incorrectly claimed that her results apply to the entire U.S.  The group calling for retraction noted that the number of participants Halpern-Felsher asserts were Covid-tested would have accounted for almost half of the nation’s 10.4 million tests (here).  In fact, youth and young adults were rarely tested early in the pandemic. 

In the following table I use the 2020 National Youth Tobacco Survey and the 2019 National Health Interview Survey (the most recent available) to estimate populations of 13-17, 18-21 and 22-24 year-olds, according to whether they were ever, or never users of e-cigarettes.  I then multiply these numbers by the percentages who had a positive diagnosis for Covid-19, according to Table 1 in Halpern-Felsher’s response. 


Number of Covid Cases Among Youth and Young Adults in the U.S. On May 14, 2020, According to Dr. Bonnie Halpern-Felsher

Age Group (years)Population*Percent Covid+**Number Covid+


Never Vape13,461,2500.4763,268
Ever Vape6,022,5783.26196,336


Never Vape12,179,4150.7388,910
Ever Vape4,684,0182.68125,558

Never Vape7,682,8211.51116,011
Ever Vape4,169,2037.43309,772


*Population estimates from NYTS 2020 (13-17 years) and NHIS 2019.        **From Table 1, Halpern-Felsher et al. 

Her assertion that her numbers are nationally representative means that the total number of Covid-19 cases among youth and young adults in the U.S. when her survey ended on May 14, 2020, was 899,855.

In reality, according to the World Health Organization, the U.S. had a cumulative total of 1,361,522 Covid cases on May 14, 2020.  While it is widely acknowledged that the early epidemic in the U.S. impacted older Americans disproportionately, Halpern-Felsher’s national estimate means that 13-24 year-olds accounted for 66% of all U.S. cases.

2. Halpern-Felsher’s claims, based on tiny numbers.

In our letter, Nantaporn Plurphanswat and I used a standard epidemiologic table to estimate the numbers of cases underlying Halpern-Felsher’s five and seven times claims, as she had refused our request to publish the actual figures.   Her response confirmed that her claims were based on very small numbers.

3. Halpern-Felsher and the editors obtained questionable “independent” reviews.

In her response, Halpern-Felsher wrote, “we voluntarily decided to re-review our data set and analyses, and voluntarily asked another statistician not involved in the original study or any tobacco-related research to rerun the analyses.”  It is not clear to whom the “we” in that sentence refers, since, as noted above, the original co-authors of her article did not sign the response letter.  Further, her statement lacks substantive meaning.  Saying she “voluntarily asked another statistician” to “rerun the analyses” and later noting that “the results of the original main analyses were confirmed…by the independent analysis, and there are no changes to…the core study findings” simply means that there was no error in the analysis.  This response offers no clue as to the quality of the analytic approach, or whether the statistician thought that the whole project was worthless. 

Interestingly, the editors, in their response, also mentioned that “The independent re-analysis confirmed the original main findings” and they seemed to praise the effort by adding that “three independent scientific reviewers [were tasked] from the fields of sociology, epidemiology, and biostatistics.”

Unless the four heralded “independent” reviews are made available for scrutiny, they lend no credibility to the original work.

4. Halpern-Felsher failed to disclose conflicts of interest.

Our letter addressed the fact that Halpern-Felsher, “who is an editorial board member of the Journal of Adolescent Health, may have breached its policy on conflicts of interest” by failing to disclose that she had participated in a lawsuit against an e-cigarette manufacturer.

Halpern-Felsher responded by claiming to update her disclosure, but as of this date she had not done so.  And she reciprocated by accusing the letters’ authors of hiding conflicts themselves: “Several scientists who have raised concerns about this study receive funding from the tobacco industry, and as such, should disclose those conflicts of interest.”  She provided no evidence to support this claim.

The editors supported Halpern-Felsher’s demand, writing that “all potential conflicts of interest should be disclosed by authors… Accordingly, we have asked authors of all letters to update their disclosures.”  Importantly, the editors noted that disclosure “is a standard expectation within the scientific community.”  That is the only acknowledgment of Halpern-Felsher’s egregious disregard of the journal’s disclosure policy.

JAH editors should have better served their readers and public health by retracting the highly flawed Halpern-Felsher article.