Monday, March 8, 2021

IQOS Continued to Drive Down Japan Cigarette Sales in 2020; U.S. Cigarette Sales Steady

 

Japan is experiencing an unprecedented decline in cigarette consumption.  Japan Tobacco International reports (here) that cigarette sales dropped 8% in 2020, largely due to sales of reduced-risk products.  The dominant such product in Japan is Philip Morris International’s IQOS heat-not-burn HeatSticks.

U.K. veteran tobacco harm reduction advocate Clive Bates opined: “The only mystery is why the skies over Tokyo are not dark with chartered planes bringing officials from WHO, FDA, Truth Initiative, the Campaign for Tobacco-Free Kids, the European Commission and others on an emergency mission to learn about this most extraordinary shift.  What is the secret they would find? ‘Do nothing, stay out of the way....’  There was very little involvement from tobacco control – the demise of cigarettes in Japan has been driven by the market and consumer preference.” 

Meanwhile, the U.S. FDA finally authorized IQOS as a reduced exposure alternative to cigarettes on July 7, 2020, greenlighting these claims:

“AVAILABLE EVIDENCE TO DATE:

  • The IQOS system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.

The FDA advised that its approval is expected to benefit the health of the population as a whole.

The Covid-19 pandemic is hurting U.S. IQOS marketing and sales.  PMI’s retail program requires smokers to visit an IQOS store to get educated about the system and purchase the hardware.  After that, smokers can buy the heat sticks in convenience stores and other outlets.  PMI’s program aims to suppress teen adoption, but the added inconvenience has slowed adoption by adult smokers.  The Wall Street Journal reports that the decades-long decline of cigarette sales has ended. One hopes the trend line will improve again as the pandemic comes under control and smokers make the effort to learn about this new smoke-free alternative.

 

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.