Tuesday, 27 February 2024

Are e-cigarettes safer than regular cigarettes? 107 studies are compiled to provide a disturbing answer.

This post reports on a new study which calculates the risks of using e-cigarettes in comparison with those of using cigarettes alone, or using both e-cigarettes and cigarettes, or using neither. The study was published today in the digital journal NEJM Evidence: Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes.

The lead author of this systematic review and meta-analysis is Dr. Stan Glantz, who is well known for his pioneering tobacco control research. Co-authors are Dr. Nhung Nguyen, an epidemiologist specializing in substance use and Dr. Andre Luiz Oliveira da Silva, whose experience in tobacco regulatory science includes work with the Brazilian government health agency ANVISA. (Dr. Glantz provides more information on the study here.)

Their review looked for all population epidemiological studies published between January 2005 and October 1 2023 that reported on experience of disease in the general population by e-cigarette users. In that sense, this paper is the contribution of the authors of 107 studies aimed at building the epidemiological evidence base on e-cigarettes.

The results published today are in stark contrast to previously published estimates of relative risk (see below) and call into question the view of the government of Canada and others whose policy objective is to achieve population level health benefits by encouraging smokers to switch to e-cigarettes.

The meta-analysis was restricted to disease categories for which at least 5 previous papers had been published. There were six such conditions: cardiovascular disease, stroke, metabolic dysfunction asthma, COPD and oral disease. Other diseases (including cancer) did not meet this criteria.

The results of this study: 
* do not support the conclusion that smokers who switch completely to e-cigarettes are less likely to experience cardiovascular disease, stroke and metabolic dysfunction.
* support the conclusion that vapers who do not smoke are more likely to experience cardiovascular disease, metabolic dysfunction, asthma, COPD and oral disease than are those who neither smoke nor vape.
* support the conclusion that dual users (those who smoke and vape) have 20-40% higher odds of experiencing cardiovascular disease, stroke, metabolic dysfunction, asthma, COPD and oral disease than if they only smoked. 



The importance of this paper to tobacco control

This paper challenges previous conclusions that e-cigarettes produce meaningfully lower risks to the user than cigarettes, and counters beliefs that encouraging smokers to switch to e-cigarettes reduce population-level harm.

It suggests that the relative risks associated with vaping have been seriously understated:

* In 2015,  British researchers recommended that governments consider e-cigarettes to be "95% less harmful" than combustible cigarettes. This assessment was not based on data, but on the opinion of a small group of researchers, some of whom were associated with the vaping industry. 
* In 2023, American health economists assumed that the risk of dying from vaping is 15% that of smoking when building a simulation model for health outcomes. 
* In 2022, New Zealand researchers used studies on biomarkers to estimate that "vaping could be a third as harmful to health as smoking", although they rescinded (corrected) that conclusion a year later with the admission that "data limitations with the selected studies and the assumptions involved in our method, are too problematic to allow for a valid quantitative assessment."

The implications for health policy in Canada

In 2018 Health Canada adopted a harm reduction approach to tobacco centred on smokers' switching to e-cigarettes. Six years later, their stated intention remained to "increase the number of people who transition away from smoking (to vaping)".  

Official statements by the Government of Canada on the risks of vaping are mostly vague with respect to diseases other than addiction, with an overarching message that they are "not completely harmless". Not only do federal government communications fail to specify any diseases likely caused by e-cigarettes, they further blunt their warnings by simultaneously recommending that smokers switch to e-cigarettes.

Health Canada's advice on the risks of vaping

The department has acknowledged that this approach was developed with "limited scientific evidence and much uncertainty" and that that "this lack of evidence persists". (It has recently provided $1.2 million to CAMH to conduct an evidence review). 

Uncertainty should no longer be used as a cover for Canada's harm reduction strategy.  Canada's health policies should no longer assume that smokers who switch to e-cigarettes are likely to improve their health, given the greater likelihood that they will become dual users. The government should abandon its "balanced" approach which tolerates exposing young people and non-smokers to inducements to try vaping in the (unsupported) hopes that such marketing will result in substantial population health benefits.

Applying the disease odds published today to the situation in Canada suggests that vaping policies in this country have not reduced harm, but have instead increased it. Only a small proportion of e-cigarette users in Canada are former smokers (27%), with a much larger share being dual users (34%) or never smokers (40%). (CTNS 2023).

An appropriate response to the evidence published today would be for Canadian governments to move quickly to ban inducements to vape (flavours, package designs, promotions and pricing incentives), to increase risk communication (mass media, warning labels), to curb supply and to hold manufacturers responsible for the harms their products are causing.   

Friday, 23 February 2024

Cannabis, caffeine and chocolate -- BAT's expanding footprint in Canada

BAT presentation 2021 showing
three areas of focus
Four years have now passed since British American Tobacco revamped its branding and proclaimed a "better tomorrow" business plan focused on new nicotine delivery systems, and three years since it announced that it was going "beyond nicotine" to sell other psychoactive substances ("On the go wellbeing and stimulation").

The release earlier this month of BAT's most recent annual report provides an update these activities. This post reports on those which  have particular relevance to Canada.

BAT adds cannabis to its business plan

BAT has added a fourth product category of activity. To the three areas identified in 2021 (Tobacco, New Nicotine and Beyond nicotine wellbeing and stimulation) it has now added a fourth drug - cannabis - to its strategy for "Quality Growth". 

The company notes that revenues from the global legal market for cannabis have doubled from £5.2 billion in 2019 to £11.1 billion in 2022. In this year's annual report the company boasts that cannabis is "an exciting potential category for the future".

BAT Combined Annual and Sustainability Report for 2023

Coming soon: "disruptive inhalation formats" for cannabis 

Canada is a proving ground for BAT's entry into cannabis. The tobacco giant now owns 45% of Organigram. Based in New Brunswick, Organigram is one of the larger cannabis manufacturers in Canada and sell a range of combustible, edible and vaporized products.

Organigram reports that its partnership with BAT is aimed at "innovative technologies in the edible, vape and beverage categories in addition to new disruptive inhalation formats"  BAT reports that its collaboration with Organigram "is in late-stage development of a suite of emulsions, novel vapour formulations, flavour innovations and packaging solutions which are soon to be commercialised by Organigram in the Canadian market."

Organigram Investor Presentation 2024

Water soluble cannabis for beverages and cosmetics

Organigram is not the only cannabis-related investment of BAT in Canada. Through its venture capital arm, BtomorrowVentures, BAT is funding the development of water-soluble cannabis by the Vancouver-based company Trait.  This technology is promoted as a way to infuse cosmetics and to increase the dosage of cannabinoids in beverages. In October 2023 Traitbio posted:

“The collaboration between Btomorrow Ventures and Gotham Green Partners, in particular, has been a powerful catalyst in advancing Trait’s development and commercialization activities,” says Hanny Kanafani, PhD, President and COO at Trait, “thereby enabling the launch of unique first-generation cannabinoids which, when added to waters/beverages, maintain beverage clarity and do not impart turbidity, even when added at competitive dosages.

“When added into cosmetic applications, Trait’s water-soluble materials do not require additives typically used in skincare products to maintain quality; and opens the door for unique and differentiated infused cosmetic applications.”

British American Tobacco and the candy counter

Awake chocolate manufactures caffeinated chocolate under the eponymous brand name ("each bite .... contains as much caffeine as a half a cup of joe!". It also makes chocolate designed to help people relax ("mello milk and dark chocolate bites are the perfect way to wind down. Infused with a natural botanical blend of lemon balm and L-Theanine, our delicious chocolate promotes relaxation without drowsiness.")

The company is privately owned and is based in Mississauga. British American Tobacco first invested in Awake in 2021 and increased its financing again in 2023

Although Mello 'relaxing chocolate' is not currently available, the caffeinated product Awake can be found in convenience and other stores across Canada.





Tuesday, 20 February 2024

Health groups call on Federal government to deliver on its commitment to protect kids against nicotine addiction

This post includes a copy of an advertisement placed in this Monday's edition of the Hill Times by several Canadian health organizations, as well as the accompanying press release issued by the Quebec Coalition on Tobacco Control yesterday.


Montreal, February 19, 2024 – Leading health organizations concerned about the health and wellbeing of youth in Canada have united to publish a full-page ad today in The Hill Times to draw Ottawa lawmakers’ attention to the urgent need to intervene to protect minors against nicotine addiction.

The ad is signed by Action on Smoking & Health, the Canadian Cancer Society, the Canadian Lung Association, the Quebec Coalition for Tobacco Control, Heart & Stroke and Physicians for a Smoke-Free Canada.

It highlights how flavours play a key role in attracting kids to nicotine products and calls on the federal government to ban flavours in vaping products, including mint and menthol (tobacco flavour would be allowed). Banning flavours has been on the government’s agenda since the publication of draft regulations in June 2021, although no concrete action has materialized since then.

While the government’s existing proposal would exempt mint/menthol, health groups have argued that a complete ban on non-tobacco flavours is required to protect young people from nicotine addiction, as mint/menthol is the second-most popular flavour amongst youth and young adults. A comprehensive ban would be consistent with developments in a growing number of jurisdictions, including Finland, Hungary, Lithuania, Netherlands, Norway, five U.S. states (California, Massachusetts, New Jersey, New York, and Rhode Island, as well as D.C.) and six Canadian provinces and territories.

The ad also calls for swift action to protect minors against the sale and promotion of nicotine pouches, namely by making them a prescription-only product. Under the current federal rules, nicotine pouches authorized under the Natural Health Products Regulation can be legally sold to minors in convenience stores and promoted on television, billboards and social media, including by means of lifestyle advertising.

In fact, it was Imperial Tobacco’s lifestyle promotion in favour of their new “Zonnic” pouches that pushed health groups to sound the alarm last fall. Making nicotine pouches available on a prescription-only basis would give time to both federal and provincial governments to establish a proper regulatory framework.

So far, only British Columbia and Quebec have taken steps to address this issue, by requiring consumers to go through a pharmacist to purchase these products.

Quotes:

“Several additional options are available to the Health Minister, like temporarily suspending the sale of nicotine products, which would also allow federal, provincial and territorial authorities to strengthen relevant laws and regulations. For example, nicotine pouches could be subject to many of same provisions regarding promotion that apply to tobacco and vaping products,” explains Cynthia Callard, Executive Director of Physicians for a Smoke-Free Canada.

“Nicotine is a highly addictive drug, and there needs to be adequate controls before a nicotine product is allowed on the market,” says Sarah Butson, Senior Director, Public Affairs at the Canadian Lung Association. “Nicotine pouches are popular with youth in other countries – a trend not observed with other forms of smoking cessation products. We are concerned about a rise in popularity by Canadian youth and the resulting early exposure to nicotine.”

“Nicotine gum was initially only sold by prescription in Canada, and only later on was a non-prescription approach allowed,” says Manuel Arango, Director of Policy & Advocacy at Heart & Stroke. “Using that same precautionary approach for a new type of nicotine product is totally reasonable and could be done easily and quickly.”

“This is the first time in more than 100 years that it is legal for a nicotine product from a tobacco company to be sold to minors in Canada,” says Rob Cunningham, Senior Policy Analyst, Canadian Cancer Society. “Tobacco companies cannot be trusted. It is essential that the federal Health Minister take action on an urgent basis.”

“Imperial Tobacco can claim all it wants that its pouches are intended for adult smokers who want to quit, but unlike other manufacturers of nicotine replacement therapies (NRT), this company deliberately chose to distribute its product through convenience stores and promote them with lifestyle messaging and images of young adults,” explains Flory Doucas, Co-Director and Spokesperson of the Quebec Coalition for Tobacco Control.

“The Minister said last Monday that we can expect an announcement regarding nicotine pouches ‘in the coming days’. We look forward to seeing what the Minister plans to do. We hope that the government will be consistent in protecting kids from nicotine addiction and will rapidly move to ban all flavours in vaping products. Time is of the essence when it comes to kids getting hocked on nicotine,” said Les Hagen, Executive Director of ASH Canada.

Thursday, 8 February 2024

Newly released JUUL documents show the company felt welcomed by Canadian and UK health regulators

At the end of January the first release of 4 million internal documents from JUUL were made public on the UCSF Industry Documents Library. The disclosure of these documents was a condition of the 2021 settlement between the State of North Carolina. The documents date from 2015 to 2019. 

Among the 280,000 documents contained in this release are some which show that  JUUL felt its products were not only acceptable to regulators, but were initially welcomed by them. 

CANADA

Vaping products were legalized in Canada in May 2018. A few weeks later (August 13, 2018) JUUL officials met with representatives of Health Canada. Their notes of this meeting suggest some mutual enthusiasm for the sale of JUUL products in Canada: "We had a very positive meeting with Health Canada this morning.... The main takeaway was that they are excited to have new entrants into the market for nicotine-containing e-cigarettes that are compliant with the regulatory framework that they have put in place."

The JUUL meeting report says that government officials suggested that the company work reports that it was suggested to them that they "work with credible academics in Canada to generate research on safety and health impact of our products." 

Health Canada's report of the meeting is somewhat different. (The department makes public notes from its meeting with tobacco and vaping companies). On the question of the the government's receptiveness to the launch of JUUL, their notes record "JUUL asked if HC had any concerns with its upcoming market entry. HC responded that JUUL would need to ensure compliance with the Tobacco and Vaping Products Act and the Canada Consumer Product Safety Act."

UNITED KINGDOM

During the previous summer (June 2017) JUUL went out for "an excellent dinner" with the tobacco control program lead at Public Health England (Martin Dockrell) and the chief executive of ASH UK (Deborah Arnott).  

This was a year before JUUL was launched in the UK , and the company was trying to figure out its regulatory approach. The meeting notes show that two avenues were considered -- one where the device would be licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) - a process that JUUL was cautioned could take a year or two. 

Their meeting notes report that the Public Health England representative suggested an alternative and faster route. If they marketed JUUL as a "novel tobacco product", there was no need to seek pre-approval. "We hadn't considered this pathway till Martin suggested it," the notes record. The memo concludes in bold that "This previously unconsidered approach has the potential to be very attractive."


A record of this meeting prepared by Public Health England has not been located. 

Saturday, 3 February 2024

Varia: Newly-posted information on Government of Canada web-sites.

This post identifies information recently posted on some federal government websites that is relevant to tobacco control.

Compared with cannabis and alcohol, Canadians continue to think smoking and vaping are less acceptable and more risky.

On January 12, Health Canada released the results of the most recent Cannabis survey. This is the sixth release of the annual survey, which is one of the few Canadian surveillance tools which looks at the social acceptability of using legal recreational drugs by mode of delivery. 

Of the six behaviours (oral cannabis use, smoked cannabis use, vaped cannabis, alcohol drinking, vaping nicotine and smoking tobacco ), smoked tobacco continues to be the least socially acceptable behaviour, followed by vaping. 


This survey also asks about perceived risks of product use. Again, tobacco use and vaping are perceived to be the most risky. There have been statistically significant shifts in perceptions of risk for both vaping (higher then lower) and tobacco (lower) when compared to 6 years ago.


The survey also found that using dried leaf (smoking) cannabis remains the most popular form of delivery (60% of past-year users), but that this has fallen in recent years, with increasing use of edibles and vaping. Among daily cannabis users, dried leaf is the most common form of use (31% of dried leaf users are daily users). The combined use of tobacco and cannabis has fallen slightly since 2018 (from 30% to 24%). 

Twice as many post-secondary students are vaping as smoking.

The results of the 2020-2021 Canadian Postsecondary Education Alcohol and Drug Use Survey (CPADS) were posted on the federal government website in January. This survey engaged 31,643 Canadian students aged 17 to 25 enrolled in any program at a university, college or CEGEP. 

Alcohol remains the most frequent substance consumed (two-thirds of students in the past month), with Cannabis coming second (29% past month use, 8% daily use), vaping third (17% past month use, 8% daily use) followed by smoking (8% past month use, 2% daily use). Gender differences in vaping and smoking were not observed.


New trademark registrations may signal new products

In January, Corporations Canada reported new trademark filings by Philip Morris for:
* vaping products (VEEV CLEAR TASTE, VEEV NOW ULTRA V);
* PR campaigns  (STAY CURIOUS)

From these it seems reasonable to assume that:
* Philip Morris is following the path laid by British American Tobacco in seeking authorization to market their Zyn/Velo nicotine pouches in Canada, but to use a different brand name (Advance/Zonnic) in doing so.
* PMI is introducing a fourth version of its vaping product to Canada (in addition to the capsule Veev One, and the disposables Veev NOW 2ml and Veev NOW 5 ml)


Changing surveillance tools 

Although it has not made an announcement to this effect, Health Canada has terminated its support for the Canadian Tobacco and Nicotine Survey, making the winter of 2022-23 the last period in which this survey was conducted. 

The 2024 questionnaire of the Canadian Community Health Survey contains 8 questions on vaping, and the Rapid Response Module (a smaller sample component of the survey) has one question on quit intention, one question on "other" tobacco products and two questions on nicotine pouches. These were released in late December 2023. 

In January, Health Canada issued an Advanced Contract Award Notice for a $700,000 contract with the University of Waterloo for a "Evaluating and understanding cigarette smoking, nicotine vaping, and policies on both products among adults in Canada in the international context" The contract appears to be for an additional wave of the ITC study of smokers and former smokers, with increased sampling in each province.

I Quit for Me

Health Canada has updated and re-branded its Quit4Life resources. The new resources became available on the web-site in January. The website also asks young people to answer a long survey on smoking and vaping and their feelings of addiction (including 8 options for gender!). Those who participate are invited to contact Health Canada for a follow-up survey.

Administrative modifications to the federal Vaping Products Tax

Canada has imposed a tax on vaping liquids at retail since January 2023 and a number of provinces have indicated that they will be partnering in this tax (with a rumoured start date of July 2024).

Amendments to the Excise Act on how this tax will be administered are the subject of a bill currently before Parliament

In January the Finance Department provided an explanation on the impact of these changes. (They shift the point at which manufacturers must remit taxes.)