Thursday, 7 April 2022

A report commissioned by the Australian government reviews the evidence on the health outcomes of e-cigarettes.

 

This week the Australian National Centre for Epiemiology and Population Health released an updated systematic review of the health impacts from  the use of e-cigarettes. The report (Electronic cigarettes and health outcomes: systematic review of global evidence) was commissioned by the Australian Department of Health.

This post presents the key findings from this review.

A "top up" from previous reviews.

In preparing this report, the researchers prepared "an umbrella review of evidence from major national and international independent reviews with a “top-up” systematic review of evidence published since the NASEM review." Their methods followed established protocols and were guided by the  e-cigarette working group of the National Health and Medical Research Council.

As shown in their summary table, shown below, there is still not much evidence on many key issues (grey areas), and many of the studies are not helpful in establishing causation (red areas). This representation is a helpful reminder that  'no evidence about harm' cannot be read as 'evidence of no harm'.


The key findings of this Australian report and their conclusion, as presented in their executive summary, are pasted below. 

Dependence and abuse liability

  • Among non-smokers, there is substantial evidence that e-cigarette use results in dependence on e-cigarettes.
  • Among smokers, there is limited evidence that e-cigarette use results in dependence on e-cigarettes. There is limited evidence that e-cigarettes have lower abuse liability than combustible cigarettes and limited evidence that ecigarettes have a higher abuse liability than nicotine replacement therapy products among smokers.
  •  Among smokers, there is insufficient evidence whether abuse liability risk is influenced by flavour and nicotine concentration variations. 

Cardiovascular health outcomes

  • There is no available evidence on the effect of e-cigarette use on the risk of clinical cardiovascular disease outcomes, such as myocardial infarction, stroke or cardiovascular mortality.
  • There is no available evidence on e-cigarette use and the risk of subclinical atherosclerosis-related outcomes such as carotid intima-media thickness and coronary artery calcification.
  • Among non-smokers, there is insufficient evidence that e-cigarette use is related to other cardiovascular outcomes, including: increased blood pressure, heart rate, autonomic control and arterial stiffness; reduced endothelial function, hand microcirculation and cardiac function/geometry; and cardiac device interference.
  • Among smokers, there is moderate evidence that use of e-cigarettes increases heart rate, systolic blood pressure, diastolic blood pressure and arterial stiffness acutely after use; and limited evidence that use increases endothelial dysfunction, and that long term use after switching from combustible cigarette smoking decreases blood pressure.
Cancer

  • There is no available evidence on the relationship of e-cigarette use to invasive cancer risk.
  • There is no available evidence on the relationship of e-cigarette use to the risk of precancer/subclinical cancer outcomes. 

Respiratory health outcomes

  • There is conclusive evidence that the use of e-cigarettes can cause respiratory disease (EVALI) among smokers and non-smokers. Current evidence from the largest study to date is that this lung injury is chiefly related to e-cigarettes delivering THC, with half of cases related to THC in conjunction with vitamin E acetate, and 14% in patients reporting the use of nicotine-delivering products only, indicating that the latter products can cause EVALI.
  • There is insufficient evidence on the relationship of e-cigarette use to other clinical respiratory outcomes, including asthma, bronchitis and COPD in smokers and no available evidence in non-smokers.
  • There is insufficient evidence for a reduction in respiratory exacerbations and disease progression among adult healthy, asthmatic and COPD smokers who switch to exclusive or dual-use of e-cigarettes.
  • There is limited evidence in non-smokers and insufficient evidence in smokers that e-cigarettes have acute (up to two hours post-exposure) effects on spirometry parameters.
  • There is limited evidence that e-cigarette use increases respiratory resistance and impedance in healthy and asthmatic smokers up to 30 minutes post-exposure.
  • There is insufficient evidence on the effect of e-cigarettes on exhaled breath outcomes among smokers and non-smokers (healthy and asthmatic).
  • There is insufficient evidence on the relationship of e-cigarette use to other respiratory measures (sinonasal symptoms, airway hyperresponsiveness) in smokers and no available evidence in non-smokers.

Oral health

  • There is no available evidence on the relationship of e-cigarette use to clinical or intermediate/subclinical oral health outcomes in exclusive e-cigarette users, independent of the effect of smoking.
  • There is insufficient evidence of reduced plaque, gingival and papillary bleeding in smokers switching to e-cigarette use
  • In populations including exclusive e-cigarette users, dual users, and non-smokers (never and former smokers), there is insufficient evidence as to the relationship of e-cigarette use to increased gum disease, bone loss around the teeth and any periodontal disease. 

Developmental and reproductive effects

  • There is no available evidence as to how use of e-cigarettes affects the development of children or adolescents.
  • There is insufficient evidence as to how e-cigarette use relates to pregnancy and foetal outcomes, such as low birthweight, preterm birth, Apgar score and small-forgestational-age birth, among exclusive e-cigarette users and dual users.
  • There is no available evidence as to how use of e-cigarettes affects other reproductive outcomes.

Burns and injuries

  • There is conclusive evidence that e-cigarettes can cause burns and injuries, which can be severe and can result in death.

Poisoning

  • There is conclusive evidence that intentional or accidental exposure to nicotine eliquids can lead to poisoning, which can be severe and can result in death. A significant number of accidental poisonings occur in children under the age of six.
  • There is conclusive evidence that use of e-cigarettes can result in nicotine toxicity. 

Mental health effects

  • There is no available evidence as to how e-cigarette use affects clinical mental health outcomes. 
  • There is insufficient evidence as to the relationship of e-cigarette use to depressive symptoms and no available evidence regarding their effects on alternative subclinical mental health measures.

 Environmental hazards with health implications

  • There is conclusive evidence that e-cigarette use results in increased airborne particulate matter in indoor environments.
  • There is limited evidence that e-cigarette use results in increased concentrations of airborne nicotine and of nicotine and cotinine on indoor surfaces.
  • There is insufficient evidence that e-cigarette use results in increased air levels of carbon dioxide, carbon monoxide, propylene glycol, volatile organic compounds and carbonyls.
  • There is substantial evidence that e-cigarettes can cause fires and environmental waste and insufficient evidence as to the extent that these present a hazard to human health. 

Neurological outcomes 

  • There is conclusive evidence that the use of e-cigarettes can lead to seizures.
  • There is limited evidence that injuries due to e-cigarette explosions can lead to nerve damage.
  • There is no available evidence as to how the use of e-cigarettes affects the risk of other clinical neurological outcomes.

Sleep outcomes

  • There is no available evidence as to the effect of e-cigarettes on clinical sleep outcomes.
Less serious adverse events
  • There is moderate evidence that less serious adverse events – such as throat irritation, cough, dizziness, headache and nausea – occur with use of nicotine ecigarettes. 

Optical health

  • There is no available evidence on the relation of e-cigarette use to clinical optical outcomes.
  • There is insufficient evidence on the relation of e-cigarette use to corneal epithelial thickness or pre-corneal tear film stability and no evidence on other optical outcomes.

Wound healing

  • There is no available evidence as to the effect of e-cigarette use on clinical or subclinical wound healing outcomes.

Olfactory outcomes

  • There is no available evidence on the effect of e-cigarette use on clinical olfactory outcomes.
  • There is insufficient evidence on the relationship between use of e-cigarettes and subclinical olfactory measures.

Endocrine outcomes

  • There is no available evidence on the relationship of e-cigarette use to clinical endocrine outcomes and insufficient evidence regarding subclinical endocrine outcomes of prediabetes and insulin resistance.

Allergic diseases

  • There is limited evidence that e-cigarette use can lead to contact dermatitis and no available evidence on other clinical allergy outcomes. 

Haematological outcomes

  • There is no available evidence on the relationship of e-cigarette use to haematological outcomes.

 Smoking uptake

  • There is strong evidence that never smokers who use e-cigarettes are on average around three times as likely than those who do not use e-cigarettes to initiate cigarette smoking.
  • There is strong evidence that non-smokers who use e-cigarettes are also around three times as likely as those who do not use e-cigarettes to become current cigarette smokers.
  • There is limited evidence that former smokers who use e-cigarettes are more likely to relapse and resume current smoking than former smokers who have not used e-cigarettes.

Smoking and nicotine cessation

  • There is limited evidence that, in the clinical context, freebase nicotine e-cigarettes may be more efficacious for smoking cessation than existing NRT, and that nicotine e-cigarettes may be more efficacious than no intervention or usual care.
  • Trials demonstrating efficacy were limited to products with freebase nicotine concentrations ≤20mg/mL. There is no evidence that nicotine salt products are efficacious for smoking cessation.
  • There is insufficient evidence that freebase nicotine e-cigarettes are efficacious for smoking cessation, compared to non-nicotine e-cigarettes or that non-nicotine e-cigarettes are efficacious for smoking cessation compared to counselling or approved NRT.
  • There is insufficient evidence that freebase nicotine e-cigarettes are efficacious outside the clinical setting.
  • No evidence on nicotine salt products was located and their efficacy for smoking cessation is unknown.
  • There is limited evidence that use of nicotine e-cigarettes for smoking cessation results in greater ongoing exposure to nicotine than approved NRT, through ongoing exclusive e-cigarette use or dual use if smoking continues.
Conclusions

There is strong or conclusive evidence that nicotine e-cigarettes can be harmful to health and uncertainty regarding their impacts on a range of important health and disease outcomes. Based on the current worldwide evidence, use of nicotine e-cigarettes increases the risk of a range of adverse health outcomes, including: poisoning; toxicity from inhalation (such as seizures); addiction; trauma and burns; lung injury; and smoking uptake, particularly in youth. Their effects on most other clinical outcomes are unknown, including those related to cardiovascular disease, cancer, respiratory conditions other than lung injury, mental health, development in children and adolescents, reproduction, sleep, wound healing, neurological conditions other than seizures, and endocrine, olfactory, optical, allergic and haematological conditions. Nicotine e-cigarettes are highly addictive, underpinning increasing and widespread use among children and adolescents in many settings. Less direct evidence indicates adverse effects of e-cigarettes on cardiovascular health markers, including blood pressure and heart rate, lung function and adolescent brain development and function. Environmental impacts include indoor air pollution, waste and fires. The commonest pattern of e-cigarette use is dual e-cigarette use and tobacco smoking, which is generally considered an adverse outcome. There is limited evidence of efficacy of freebase nicotine e-cigarettes as an aid to smoking cessation in the clinical setting. E-cigarettes may be beneficial in some smokers who use them to quit smoking completely and promptly, with uncertainty about their overall balance of risks and benefits for cessation. Current evidence supports national and international efforts to avoid ecigarette use in the general population, particularly in non-smokers and youth. Better evidence is needed on health impacts, the overall balance of quality, safety and efficacy of e-cigarettes as potential aids for smoking cessation, and effective regulatory options.

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Sunday, 27 March 2022

Are e-cigarettes less harmful than cigarettes? By how much?

This post reviews research efforts to compare and quantify the risks of smoking conventional cigarettes in comparison with those of using e-cigarettes. 

Further insight into how such estimates can influence decision-making on e-cigarette regulation was provided last week in a webinar produced by the Ontario Tobacco Research Unit, which can be viewed here: https://www.youtube.com/watch?v=lbijYlq0iNI

OTRU Webinar: 
The Population Impact of E-Cigarettes in Canada: A Simulation Model 


2013: The meeting that decided that e-cigarettes are "95% safer"  

It was in July of 2013 that a dozen men met for a two-day workshop in London, England to exchange views on the various forms in which nicotine could be consumed and the harms that were associated with each of those products.

At the end of this exercise, they quantified their assessment of a continuum of risk for the different products they discussed. In their collective view, cigarettes were the most harmful, followed by small cigars which they felt were only two-thirds as harmful. Third and fourth on the list were cigars and water pipe (at less than 14% the risk of cigarettes). At the least harmful end of this spectrum was pharmaceutical nicotine (the nicotine patch, gums and oral sprays), which they ranked slightly ahead of e-cigarettes and snus for which the risk in comparison with cigarettes was thought to be 5% and 4%.


The results of this meeting were written up and submitted for publication to the journal European Addiction Research, where they were published in September 2014. (Nutt, DJ et al, Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach)(i). The report included a nod to the inherent subjectivity of the results: “A limitation of this study is the lack of hard evidence for the harms of most products on most of the criteria.”

This product of the ad-hoc committee took on a life of its own after it was embedded in reports and other communications issued by Public Health England, beginning in 2015.(ii) (The same year that Public Health England had engaged one of the participants in the process to lead its tobacco control efforts).
 


2015 - 2022: the persistence of "95% less harmful" in the face of direct and indirect rebuttal.

Very quickly PHE's claim and the study behind it came under fire. The medical journal the Lancet criticized the methods and also the conflict of interest by some of the authors (who were connected to e-cigarette manufacturers): "The reliance by PHE on work that the authors themselves accept is methodologically weak, and which is made all the more perilous by the declared conflicts of interest surrounding its funding, raises serious questions not only about the conclusions of the PHE report, but also about the quality of the agency's peer review process." (E-cigarettes: Public Health England's evidence-based confusion)(iii). 

Other criticisms followed. Some characterized the estimate as a "factoid" with an "unreliable provenance" (Eissenberg et al. Invalidity of an Oft-Cited Estimate of the Relative Harms of Electronic Cigarettes)(iv). Others warned that "non-factual based predictions of comparative safety, such as the ‘95% safer’ quantification, are not helpful for the risk estimation of e-cigarettes and should not be used when discussing or promoting e-cigarettes." (Burrowes et al, Human lungs are created to breathe clean air: the questionable quantification of vaping safety “95% less harmful”(v)

Subsequent scientific panels convened by other governments have directly and indirectly rejected the Public Health England position. Neither the Nutt et al paper nor the Public Health England conclusions are referenced in  the 775- page report prepared for the FDA by the National Academies of Science, Engineering and Medicine, (vi) although the 5% estimate of relative harm was identified as being supported by many scientists (p. 634). Nor  does the 122 page report of the European Commission's Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)(vii)  published last year reference the papers, in part because it was mandated to "focus only on health impacts compared to non-smoking." A report commissioned by the government of Spain and first released in 2020 concluded that the "the claim that the risk of e-cigarette use is reduced by  95% compared to traditional cigarettes is unsustainable with current evidence." (Informe Sobre los cigarillos electronicos: situacion actual, evidencia disponible  y regulacion, p. 11).(viii)

Nonetheless, the "95% less harmful" continues to influence discussions on vaping policies. When Health Canada met with Rights 4 Vapers last fall, (ix) one of the specific questions put to the officials  was: 'Do you agree with Public Health England’s view that vaping is 95% less harmful than smoking?'  (Government representatives neither endorsed nor refuted the estimate). The New Zealand cabinet made the decision to legalize vaping products with "light touch" regulations after receiving advice that they were 95% less harmful.(x)

Tobacco companies continue to use "95% less  harmful" in their disinformation campaigns, such as the current "Clear the Smoke" campaign, discussed here earlier. For example, Imperial Tobacco Canada said in a February 14, 2022 news release: "Public Health England has said that vapour products are 95 percent less harmful than cigarettes." (xi)

2014-2021: Accumulating research on risks 

As mentioned in previous posts, evidence on the risks of e-cigarettes is steadily growing, with increased research examining the impact of e-cigarette aerosols on cell tissues and other bio-markers of damage. 


Both individual studies and systematic reviews of this expanding evidence base have come to the conclusion that e-cigarettes cannot at this time be considered safer than cigarettes with respect to:

Respiratory health effects: Jeffrey Gotts and colleagues (xii), 2019: "We conclude that current knowledge of these effects is insufficient to determine whether the respiratory health effects of e-cigarette are less than those of combustible tobacco products."

Cardiovascular effects: In a 2020 review of the cardiovascular effects of e-cigarettes Nicholas Buchanan and colleagues (xiii) urged caution in drawing conclusions about the relative safety of e-cigarettes: "While the current but still limited literature suggests that e-cigarette use may lead to fewer negative cardiovascular effects than conventional cigarettes, our review supports that there is not sufficient data to conclusively make these resolutions."

Blood Flow: In a 2022 study, Poonam Rao and colleagues (xiv) showed that a wide range of e-cigarettes impaired blood flow (as measured by flow-mediated dilation) in much the same way and to the same degree as combustible cigarettes. E-cigarette aerosol, cigarette smoke and marijuana smoke all impaired blood flow to approximately the same degree. Repeated exposure of arteries to inhaled smoke or e-cigarettes aerosols over many years is a risk factor for developing cardiovascular disease many years later. This study suggests that the cardiovascular disease risks from e-cigarette aerosol would not be less than from cigarette smoke.

Quantifying the difference between apples and oranges

Some scientists maintain that it is not possible to arrive at a relative risk assessment at this time: "It doesn't make any sense for us to claim that we know that it's 95% safer than combustible cigarettes," says Thomas Eissenberg. "The fact is: we don't know whether e-cigarette use is as lethal as combustible cigarette use, less lethal than combustible cigarette use, or more lethal than combustible cigarette use."

These different product designs produce distinct types of harms. Last year, American researchers detailed their findings that the nature and the type of tissue injury inflicted by e-cigarettes are distinct from that caused by combustible cigarettes and concluded that "Comparing e-cigarettes with combustible cigarettes using the same readouts and endpoints may be misleading as the two exposures differ markedly in the nature of the injury they induce and the types of tissues they affect."(Keith, R et al. Cardiorespiratory and Immunologic Effects of Electronic Cigarettes):(xv) 

In reaching this conclusion they provided a useful overview of the ways in which e-cigarettes cause harm:
"First, avoiding combustion does not remove all noxious chemicals. Although e-cigarettes do not form high levels of strongly carcinogenic benzopyrenes and tobacco-specific nitrosamines, heating mixtures of nicotine and propylene glycol and vegetable glycerin (PG:VG) in e-cigarettes generates reactive carbonyls such as formaldehyde, acetaldehyde, and acrolein [11, 12, 13, ], which have been variably linked to carcinogenesis,[] cardiovascular injury [, ], and increased risk of cardiovascular disease []. The generation of carbonyls from e-cigarettes varies with use patterns, e-liquid ingredients, and operating conditions [], and even though the extent of carbonyl generation by e-cigarettes is generally lower than by combustible cigarettes, daily carbonyl exposure from e-cigarettes could still exceed exposure limits []. Second, e-cigarette aerosols sporadically contain metals (Fe, Ni, Cu, Cr, Zn, Pb), generated by the heating coil [], which could add to the toxicity of the aerosol. Third, like combustible cigarettes, e-cigarettes produce aerosols that contain fine and ultrafine particles [], which can trigger cardiovascular events and promote the progression of pulmonary and cardiovascular disease []. Finally, a direct comparison of the relative toxicity of e-cigarettes and combustible cigarettes may not be entirely meaningful. Toxicity due to a chemical, drug, or exposure depends upon its dose. Therefore, even though per puff, e-cigarettes may generate lower levels of toxins; their toxicity may approach that of combustible cigarettes if the use of e-cigarettes (exposure/dose) is higher than that of combustible cigarettes. For instance, if e-cigarettes are half as harmful as combustible cigarettes, but are used twice as much, there would be little harm reduction by using e-cigarettes over combustible cigarettes. Therefore, for both e-cigarettes and combustible cigarettes, harm could be reduced only by reducing exposure. Here too, the relationship is not straightforward. The dose response relationship between smoking and ischemic heart disease, for instance, is non-linear. It shows that smoking just 3 cigarettes a day imparts 80% of the harm attributable to smoking 20–40 cigarettes per day []. In other words, 85–92% reduction in exposure results in only 20% harm reduction. Therefore, reducing toxin exposure by using e-cigarettes may not result in proportional harm reduction. Indeed, as discussed below, recent evidence suggests that even though e-cigarettes generate lower levels of toxins than combustible cigarettes, their use may be associated with significant cardiorespiratory injury as well as immune dysregulation."

2021: More attempts to put a number on the concept of relative harm

Despite these cautions, and in the face of conflicting estimates, changing product designs and uncertain science, a group of New Zealand researchers nevertheless recently set out to establish a numerical comparison of the risks of smoking and vaping. Their motivation for doing so was ensure that policy makers who were using simulation models to evaluate regulatory options had a numerical estimate of harm to use in these calculations. Their results (Wilson, N et al. Improving on estimates of the potential relative harm to health from using modern ENDS (vaping) compared to tobacco smoking)(xvi) were published last November. 

These researchers used bio-marker studies to compare relative harm. They sought to establish equivalencies among e-cigarettes, combustible cigarettes, certain toxic emissions and their known relationship to certain diseases. 

In order to reflect the newer designs of products, they looked only at studies based on data collected after 2017. They only found 4 studies that provided the range of data their methods required, and within these studies was a wide range of results. The nature of the exercise meant significant lacunae remained, leading the research team to acknowledged "a high level of uncertainty of the relative harm of ENDS [electronic  nicotine delivery systems] use compared to smoking."

With these caveats, they nonetheless produced an overall estimate of relative harm, finding modern e-cigarettes had 33.2% the harm of cigarettes: "This analysis suggests that the use of modern ENDS devices (vaping) could be up to a third as harmful to health as smoking in a high-income country setting."

Wilson et al, 2021


Like Schrodinger's cat ?...

Is it logical to simultaneously state that "the long-term health effects of vaping are unknown" and also that "vaping is a (much) less harmful option than smoking".?  The underlying contradiction in this paradox -- that the harms are at the same time both not known and are known to be less than a certain value -- is analogous to Schrodinger's boxed cat, which was famously held to be both alive and dead until an actual observation could establish its true state. 

More and more scientists, including those cited above, are engaged in research which allows us to to reach a state of our knowledge and to know whether the cat is either alive or dead, but not both. From their work to date, we know that there are many adverse short-term health effects that presage future chronic disease, chiefly circulatory and respiratory diseases, for continuing vapers. This allows us to know that vaping has some harms. Until more observations are available, there can be no certainty in a conclusion that vaping is more or less hazardous than smoking, nor by how much.

References

(i) Nutt D, J, Phillips L, D, Balfour D, Curran H, V, Dockrell M, Foulds J, Fagerstrom K, Letlape K, Milton A, Polosa R, Ramsey J, Sweanor D: Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach. Eur Addict Res 2014;20:218-225. doi: 10.1159/000360220.

(ii) Public Health England. Vaping in England: evidence update. 2015.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/733022/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf

(iii). The Lancet. E-cigarettes: Public Health England's evidence-based confusion. Editorial. August 2015. 
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00042-2/fulltext

(iv) Thomas Eissenberg, Aruni Bhatnagar, Simon Chapman, Sven-Eric Jordt, Alan Shihadeh, and Eric K. Soule, 2020: Invalidity of an Oft-Cited Estimate of the Relative Harms of Electronic Cigarettes American Journal of Public Health 110, 161_162, https://doi.org/10.2105/AJPH.2019.305424.

(v) Burrowes et al, Human lungs are created to breathe clean air: the questionable quantification of vaping safety “95% less harmful”. New Zealand MJ. June 2020. 
https://journal.nzma.org.nz/journal-articles/human-lungs-are-created-to-breathe-clean-air-the-questionable-quantification-of-vaping-safety-95-less-harmful

(vi) National Academies of Sciences, Engineering and Medicine. Public Health Consequences of E-Cigarettes (2018) https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes

(vii) European Commission's Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). Opinion on electronic cigarettes. 2021. https://ec.europa.eu/health/system/files/2021-04/scheer_o_017_0.pdf

(viii) Government of Spain. Direccion general de salud publica. Informe Sobre los cigarillos electronicos: situacion actual, evidencia disponible  y regulacion, 2021 (revised 2022)
https://www.sanidad.gob.es/ciudadanos/proteccionSalud/tabaco/docs/InformeCigarrilloselectronicos.pdf

(ix) Health Canada and Rights4Vapers Webinar, “The Regulatory Process: How Vaping Regulations are Decided, Drafted and Developed” – December 2, 2021
https://www.canada.ca/en/health-canada/services/health-concerns/tobacco/meeting-summaries-tobacco-vaping-industry/rights4vapers-webinar-december-2-2021.html; webinar can be viewed at:
https://www.rights4vapers.com/it-was-historic-it-was-hotly-anticipated-it-was-the-must-see-event-of-the-fall/

(x) New Zealand Cabinet Social Policy Committee. Memo from Associate Minister of Health. Regulation of smokeless tobacco and nicotine-delivery products. https://www.health.govt.nz/system/files/documents/information-release/cabinet-paper-regulation-smokeless-tobacco-and-nicotine-delivery-products.pdf

(xi) Imperial Tobacco Canada. Let's clear the smoke. Press release. February 14, 2022. https://www.imperialtobaccocanada.com/group/sites/BAT_AXYKCM.nsf/vwPagesWebLive/DOCBMM84/$FILE/Vaping-Let%27s_clear_the_smoke.pdf?openelement.

(xii) Gotts J E, Jordt S, McConnell R, Tarran R. What are the respiratory effects of e-cigarettes? BMJ 2019; 366 :l5275 doi:10.1136/bmj.l5275.

(xiii) Nicholas D Buchanan, Jacob A Grimmer, Vineeta Tanwar, Neill Schwieterman, Peter J Mohler, Loren E Wold, Cardiovascular risk of electronic cigarettes: a review of preclinical and clinical studies, Cardiovascular Research, Volume 116, Issue 1, 1 January 2020, Pages 40–50. https://doi.org/10.1093/cvr/cvz256.

(xiv) Poonam Rao, MBBS, Daniel D Han, BA, Kelly Tan, Leila Mohammadi, MD, PhD, Ronak Derakhshandeh, MSc, Mina Navabzadeh, PharmD, Natasha Goyal, MD, Matthew L Springer, PhD, Comparable Impairment of Vascular Endothelial Function by a Wide Range of Electronic Nicotine Delivery Devices, Nicotine & Tobacco Research, 2022;, ntac019, https://doi.org/10.1093/ntr/ntac019.

(xv) Keith R, Bhatnagar A. Cardiorespiratory and Immunologic Effects of Electronic Cigarettes. Curr Addict Rep. 2021;8(2):336-346. doi:10.1007/s40429-021-00359-7

(xvi) Wilson, N., Summers, J.A., Ait Ouakrim, D. et al. Improving on estimates of the potential relative harm to health from using modern ENDS (vaping) compared to tobacco smoking. BMC Public Health 21, 2038 (2021). https://doi.org/10.1186/s12889-021-12103-x.
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Tuesday, 22 March 2022

Mediation to settle lawsuits with big tobacco is extended to 42 months

This post is an update of a near-identical bulletin sent a year ago. Little has changed.

Today Justice McEwan of Ontario's Superior Court was asked for the eighth time to extend the insolvency protection orders under which Canada's 3 main tobacco companies are maintaining "business as usual" while trying to negotiate an end to the lawsuits filed against them. None of the lawyers representing the provinces and smokers who are suing the companies raised any objections, and after a 15-minute hearing the extensions were granted. 

In most respects, there appear to be no new developments in this story. For the past 36 months lawyers representing Quebec smokers (who have won a $14 billion award against the companies) and lawyers representing the ten Canadian provinces (whose claims for $500 billion have yet to be heard in court) have been told to stand down their legal actions. (Background on these lawsuits can be found here)

The companies' protection from creditors has bene extended to September 30, 2022 -- bringing the mediation to the 42 month mark. 

Secrets and non-secrets

As long as the companies are protected by these orders made under the authority of the Companies Creditors' Arrangement Act (CCAA), the resolution of the governments' lawsuits against tobacco companies will be developed in closed-door negotiations. Very little information has been made public about the discussions being mediated by former Justice Warren Winkler.

In contrast to this secretiveness, the CCAA process is providing transparency where usually there is none. One requirement of this system is that accounting firms are recruited to provide regular updates to the court on the financial situation of the insolvent companies. With the documents filed this week by Imperial Tobacco Canada (ITC), Rothmans, Benson and Hedges (RBH) and JTI-Macdonald (JTIM) we now have around 36 months of financial reports for each of the companies. In the decades since these companies became wholly-owned subsidiaries of global firms, such information has generally not been available.

Another unusual aspect to the insolvency protection is that while the companies are able to continue "business as usual", they are restricted in how they can use any of their operating profits. In this case, for example, they cannot send dividends or other payments to their multinational owners. The money is notionally set aside for distribution to their creditors -- the people who are suing them.

The financial pictures provided in the monitors reports (links provided below) are presented somewhat differently than the financial statements typically seen in annual reports, and each company has chosen to provide different levels of details. JTI-Macdonald was the only one to identify its promotional expenditures, for example, only two of the companies revealed how much they paid for the main ingredient in their products (tobacco), and one company combined excise and income taxes in its report. The information tabled in these reports reflects cash flows, and is not adjusted for deferred revenues or accounts payable, as year-end statements usually are.

The table below summarizes the data for the three-year period spanning mid-March 2019 to mid-March 2022.



The bottom lines

The only money transfers are from smokers. The CCAA process has prevented smokers from receiving compensation from tobacco companies, but it has not stopped tobacco companies or the governments suing them from receiving money from smokers.

Even in insolvency, tobacco companies are enormously profitable. During this period the annual combined net (after tax) cash retained by the companies is about $1.9 billion dollars. This is about one-half of the $3.95 billion they collectively averaged through sales and other activities during this three-year period (after excise, sales and income taxes are discounted). If these are final numbers, this will give them net profit margin of about 50%.

These high earnings are still not enough to satisfy claims. At the beginning of the CCAA process, the companies declared that they had $2.5 billion between them as cash available to pay their creditors. Two years later, that amount has grown to $7.5 billion. This is only 1.25% of the amount that is being claimed against them. (The savings to health care budgets from reducing tobacco sales would be worth more for governments than the amount they are likely to recover from their lawsuits).

Governments don't need lawsuits to get money from smokers. During this period, Canadian smokers contributed more than $6 billion per year in tax revenues to governments through the companies. (This will include taxes received by the federal government, which is not involved in the lawsuits). Smokers remain the only source of revenue for any compensation paid by the companies in settling these lawsuits.

The middle lines

The cheapest component of cigarettes appears to be tobacco. Two of the companies, RBH and JTIM, provided information on how much they spent on the main ingredient in their products, tobacco: 1% and 4% of their operating costs respectively.

Even in a dark market, promotions are a major cost. Only one of the companies, JTIM, provided expenditures on advertising and promotion. In the two-year period it spent $332 million on promotions, or 16% of its operating costs. JTI is the only company which does not have a direct contracting system with retailers, so the incentive payments it makes to retailers are not integrated with its billings, as they are for other companies.


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Monitor's reports with financial information:

Imperial Tobacco

Monitor's Eleventh Report, March 2022
Monitor's Tenth Report, September 2021
Monitor's Ninth Report March 19, 2021
Monitor's Eighth Report September 22, 2020
Monitor's Seventh Report February 13, 2020
Monitor's Fifth Report September 25, 2019
Monitor's Fourth Report June 24, 2019
Monitor's Second Report April 24, 2019
Monitor's First Report April 3, 2019


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Friday, 18 March 2022

Newly-released data shows quitting rates are stagnant -- and most vapers are not reducing harm

This post reports on the results of data provided by Statistics Canada as a custom tabulation (purchased data extraction). The data cited in this post are linked at the bottom of this page.

NB: Methodological concerns with the 2020 CCHS survey 

Last September, Statistics Canada released some of the results of the 2020 Canadian Community Health Survey (CCHS). Among the data made available on their web-site were estimates of the number of Canadians who smoked on a daily or occasional basis. The 2020 data was considered good news: smoking rates had fallen to 13% - a welcome reduction by half of the proportion of Canadians who were smoking at the beginning of the century. 

Celebration of this accomplishment was muted somewhat by the disclaimer that Statistics Canada had placed on the data. Because of COVID-19, surveyors had not been active during the summer, as they normally would have been. Face-to-face interviews had been terminated, and Canadians no longer had to look the interviewer in the eye as they reported on their health habits. The survey had captured more Canadians with higher education and homes than in previous cycles. As discussed here earlier, all of these methodological adjustments could be expected to somewhat depress measures of smoking. The agency has warned that: "users are advised to use the CCHS 2020 data with caution."

These cautions should be kept in mind when reviewing the data presented below. 

Data gaps resulted when tobacco surveys were terminated.

Even though reforms to vaping laws were introduced in 2016 and passed in 2018, the federal government did not amend its major health survey (the Canadian Community Health Survey) to include questions about vaping behaviour until the 2021 cycle. The Canadian Tobacco, Alcohol and Drug Survey had formerly included questions on vaping, but the tobacco-relatesd questions were dropped from this survey after the 2017 cycle. A consequence of these decisions was that there were no general survey in the field in the 18 months following the legalization of these products. 

As an interim measure, Statistics Canada implemented the smaller-scale Canadian Tobacco and Nicotine Survey in the fall of 2019. Health Canada also commissioned a handful of questions on vaping as part of a "Rapid Response" module for the 2020 CCHS. Rapid Response modules are generally asked of a portion of the survey and the results are made available to the commissioning agency and to qualified researchers in a reduced timeframe. Results are generally not included in the regular data releases

This module was in the field in January to March 2020, and September to December 2020. Results for 3 questions related to current, ever and daily use of vaping products (cross tabulated with smoking status) were provided to us last week by Statistics Canada as a custom tabulation. The sample size was not large enough to provide breakdown by age or province.  

Results from this module and other CCHS cycles suggest that:
  • The drop in smoking results from a growth in the never smoking population, not an increase in quitting.
  • Relatively few Canadian smokers (2%) are switching to vaping. 
  • Legalizing vaping has not increased recent quitting rates. 
  • Most (71%) Canadian vapers are not reducing harm 
  • Trying a vaping product results in daily use for 1 in 8 Canadians
  • Population turn-over has contributed to reductions in smoking rates.

The drop in smoking results from a growth in the never smoking population, not an increase in quitting.

The drop in smoking that was measured by this cycle of CCHS was accompanied by an equivalent uptick in rates of never smoking. The rate of former smokers was essentially unchanged. 

The customary 3-variable definition of smoking behaviour shows that the proportion of Canadians who are former smokers has barely changed over the past 15 years. 



A display of results of full set of smoking behaviour variables (shown below) provides a more detailed picture of the extent to which never-smoking is driving the change in smoking rates. Between 2017-18 and 2020, the percentage of Canadians who had never smoked a single cigarette increased by 4 percentage points. The proportion who had experimented (smoked under 100 cigarettes) remained steady at 13%, as did the proportion who had quit smoking more than a year before the survey was taken (23%). The proportion of daily and occasional smokers fell by a combined  3 percentage points (from 16% to 13%). 

Another figure smaller than in previous years was the proportion of the population that had quit smoking in the previous 12 months: 1.1% in 2020 compared with 1.3% in 2017-2018 and 2.6% in 2003. In absolute numbers, in 2020 there were 356,700 Canadians who said they had quit in the past 12 months compared with 414,900 average of  2017-18, and 679,900 in 2003.  


Relatively few Canadian smokers (2%) are switching to vaping.


These CCHS results will have disappointed those who were hoping that the change in legislation would encourage smokers to switch to vaping products. In the year before the survey, relatively few smokers (68,500 of 4.1 million smokers, or 2%) transitioned from cigarettes to vaping. There were an additional 288,200 recent quitters who were not vaping at the time of the survey.

One fifth of those who said they had stopped smoking in the past 4 years were vapers (206,100 of 1.1 million former smokers). This time period which coincides with the period when legislation to legalize vaping was introduced. 

The CCHS estimate of the number of past-year smokers who vape is consistent with the results of the 2020 CTNS, which found about 64,300 Canadian smokers used vaping to quit and were not smoking at the time of the survey. Because the CCHS had also asked about methods used to quit, the results suggested that those who used vaping products when trying to quit were no more likely to succeed than those who tried to quit using other methods.

 
Legalizing vaping does not appear to have increased recent quitting rates.

From the perspective of encouraging smokers to quit, the CCHS results are no better than in previous cycles. The survey found a third of a million Canadians (357,000) had stopped smoking in the previous year, down from 414,900 in the annualized estimate of 2017-2018.

In absolute terms of people, this is less than in any other survey cycle, although when measured as a percentage of remaining smokers, it is consistent with historic trends.


Most (71%) Canadian vapers are not reducing harm.

The 2020 CCHS Rapid Response module identified 1 million Canadians who vaped in the past month and 653,100 who did so on a daily basis.

Among past-month vapers, fewer than one-third (308,900) were using these products in a way Health Canada considers to reduce harm, in that they had once been smokers but no longer were. Virtually all of these were daily vapers (306,900), representing less than one-half of that total.

More than two-thirds of vapers had either never smoked at all (15%), had only experimented with cigarettes (13%), were also smoking either on an occasional or daily basis (20% and 24%). For these Canadians, the use of these products is not held by Health Canada to reduce harm. 

These results were very similar to those of the 2020 Canadian Tobacco and Nicotine Survey.


Trying a vaping product results in daily use for 1 in 8 Canadians

According to this survey, almost 5.6 million Canadians have ever tried a vaping product, which is 17% of the population surveyed. Of these, 1 million are past-month users (3.4% of all Canadians, and 19% of ever-users), and 653,100 vape on a daily basis (2% of all Canadians and 12% of ever-users).

The likelihood of becoming a daily vaper is very different for those who have never smoked than for those who have. While the estimates are qualified with coefficients of variation so large that caution is required, they suggest that 1 in 20 never smokers who tried a vaping product was a daily user in 2020, compared with 1 in 10 smokers and 1 in 4 former smokers.

This high retention rate makes vaping an attractive proposition for commercial businesses. Not surprising then that vaping companies give away free samples of their products.


 
Population turn-over contributes to reductions in smoking rates.

The Canadian population covered by this survey grew by almost 1 million people between the bi-annial cycle 2017-2018 and 2020 (from 31.2 million to 32.1 million Canadians aged 12 years or older). This growth included a gain of 1.7 million  more Canadians who report that they have never smoked 1 cigarette, 136,000 more who have smoked between 1 and 100 cigarettes (but don't smoke now) and 33,000 more Canadians who say they used to smoke, but no longer do. Those population increases were off-set by a decrease of almost 1 million smokers.

Recently-released results of the Canadian Census shed light on some of the underlying population changes. Four-fifths of the population growth in Canada in this period was the result of immigration, and not due to births and deaths. Immigrants are much less likely to have ever smoked than native-born Canadians. Both smokers and former smokers die sooner than do never smokers, so deaths also contribute to boosting the proportion of never-smokers in the country. 


Estimates vary

The reliability of a health survey can be affected by many factors -- especially when it depends on the public being willing to answer the phone and answer questions truthfully.

The different results  provided by the Canadian Tobacco and Nicotine Survey and the Canadian Community Health Survey illustrate that even when the same surveyors use the same questions of the same population, different estimates can be produced.

How many smokers were there in Canada in 2020? 
The CTNS reported 3.2 million of a population of 31.3 million aged 15+ (10.3%). 
The CCHS reported 4 million of a population of 32.1 million aged 12+ (12.6%)

How many vapers were there in Canada in 2020?
The CTNS reported 1.46 million of a population of 31.3 million aged 15+ (4.6%)
The CCHS reported 1.08 million of a population of 32.1 miillion aged 12+ (3.3%)

How many nicotine users were there in Canada (vapers and/or smokers) in 2020?
The CTNS reported 4.15 million Canadians either smoked or vaped (or both) of a population of 31.3 million aged 15+ (13.3%)
The CCHS reported 4.64 million Canadians either smoked or vaped (or both) of a population of 32.1 million aged 12+ (14.4%)


Definitions:

The categories of smoking behaviour used in the CCHS that are identified in this summary include:
  • Daily Smoker: someone who smokes on a daily basis
  • Occasional Smoker: someone who identifies as a smoker, but does not smoke daily. 
  • Current smoker: someone who smokes on a daily or occasional basis
  • Past year quitter: someone who has smoked more than 100 cigarettes in lifetime, but stopped doing so within the past year
  • Other Former Smoker: has smoked more than 100 cigarettes in lifetime, but stopped doing so more than a year ago
  • Former smoker: someone who has smoked more than 100 cigarettes in lifetime, but no longer smokes.  
  • Experimenter: has smoked between 1 and 100 cigarettes, but does not currently smoke. 
  • Abstainer: Has never smoked a cigarette
  • Never smoker: someone who has never smoked 1 cigarette or who has smoked fewer than 100 cigarettes. 
Data sheets:
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Saturday, 12 March 2022

Tobacco taxes and pricing: an update

Spring is budget time - a season of raised public health hopes for finance ministers to raise the price of tobacco and vaping  products by imposing taxes.

So far this year 5 of Canada's 13 subnational governments have presented their annual budgets, and one (British Columbia) has included a tax increase of 7% of the total purchase price. Neither the Yukon nor Northwest Territories changed tobacco taxes. Prince Edward Island has indicated that it will be introducing a vaping tax and increasing tobacco taxes this year, but did not provide specifics. Alberta, by contrast, introduced one of the first tax reductions in many years by cutting taxes on smokeless products by one-third (from $0.4125/g to $0.275/g). 

This post updates and recaps ways in which health officials can raise the price of tobacco products, and reasons for them to do so.

Higher tobacco taxes are good for public health...

When prices go up, sales go down. This basic rule of economics applies to tobacco as it does to other market goods. Raising tobacco taxes is an efficient and effective way to reduce the diseases caused by smoking.

Elasticity of demand is the measure used by economists to define the change in quantity of a good purchased in response to the change in its price. It is generally calculated as the percentage change in quantity purchased divided by the percentage change in price. This concept is frequently applied to tobacco products (usually cigarettes) by considering the elasticity of consumption (the change in the amount of tobacco smoked), the elasticity of participation (the change in the number of people who smoke or who smoke daily) and the elasticity of initiation (the change in the number of young people who start smoking)

A variety of estimates have been made for the Canadian response to tax and price changes, confirming that this is an effective and efficient way to reduce tobacco use in Canada, as elsewhere.

... but without price controls, their impact is blunted.

Taxes are a very blunt instrument to influence tobacco pricing, especially in comparison with the flexible pricing powers of manufacturers. Suppliers manipulate their wholesale pricing and use their contracts with retailers to manage retail prices in ways that undermine the impact of tobacco taxes.

Two useful articles discussing these problems were recently published in the journal Tobacco Control. One (Ribisl et al) describes how industry pricing can harm vulnerable populations, and suggests that governments buttress excise taxes with minimum price policies and restrictions on price promotions. The other (Scollo et al) proposes innovative ways to address the issue. Their proposals include a price cap at the wholesale level to reduce the ability of the companies to adjust prices and to curb their profits. They also propose a form of price management as conditions of license on retail suppliers. These measures are consistent with proposals for standardized pricing, which some Canadian health groups have called for for some time.  

 Ribisl et al, 2022

France has a system of price controls in place. Manufacturers cannot change their prices without the approval (homologation) of the government, which is done by regulation. The price list that is set by government is applied to all stores, and includes a set percentage mark-up for retailers.

Price controls on tobacco are needed in Canada to protect health ... 

Although coupons and most other price promotions directed at consumers have been legislated out of existence in most provinces, they have been replaced with pricing schemes that operate through agreements with retailers. Cooperative retailers who meet sales targets, for example, are eligible to buy cigarettes for lower wholesale prices or to receive rebates on past purchases. The companies use carrots (contracts) and sticks (incentives) with retailers to increase sales and profits by:

Reducing the impact of tax and price increases.
A 40 cent a package increase is much more noticeable to smokers than two 20 cent increases -- which is why the companies favour multiple small increases rather than a few large ones. In Canada there are no restrictions on when or how often tobacco companies can change wholesale prices. 

Keeping cheaper brands on the market.
Not so long ago, all cigarette brands in Canada were sold at the same price. Now the companies use price-segmentation to divide their brands into higher priced premium brands, mid-range value brands and lower cost budget or super-value brands. This gives smokers a new option when faced with a tax increase - switching to a lower-priced brand. In Canada there are no minimum price laws or other legal restrictions on tobacco companies selling brands as lost-leaders or below the cost of production.

Keeping cheaper prices at some retailers
Until 2009 it was illegal for manufacturers to charge different prices to different retailers for the same product. But after the federal Competition Act was amended, tobacco companies were able to charge different prices to different retailers, a practice that was made easier because they replaced traditional wholesale distribution with their own 'direct distribution' contracts with retailers. 

The result is that the same brands of cigarettes are sold at lower prices in some neighbourhoods than in others.  An example from our price survey in Montreal in early November 2021 shows how large these differences can be: among 19 stores displaying prices for Pall Mall cigarettes, the price the same package of 20 was advertised from $8.49 to $11.19


Nunavut is the only jurisdiction to have passed legislation to prohibit this practice, but its 2021 legislative change is not yet in effect.

Pressuring governments to keep taxes low 
Tobacco companies want governments to keep taxes low because a) lower prices will not encourage smokers to quit (and may encourage more young people to start smoking) and b) when taxes are low the companies have more "pricing room" in which they can escalate their profit margins. One of the tactics they use to raise fears about contraband sales (as they did through their retail allies this January in Newfoundland.) This has worked particularly well for them in Ontario and Quebec, where taxes have remained low for decades. The Quebec government has not increased tobacco taxes since 2014; the Ontario government last raised tobacco taxes in March 2018.

.... and without price controls, tobacco company profits have grown while tax revenues have fallen

Tobacco manufacturers are getting an increased share of tobacco revenues. Industry prices are growing while tax revenues are falling. Industry prices have climbed significantly across Canada, including in the largest provinces of Quebec and Ontario where taxes have been kept low. Reports filed with Health Canada show that the average manufacturers' revenue per cigarette doubled over the 6 year period 2014 to 2020 (from $0.095 to $0.190 per cigarette). 

Our annual survey of prices in downtown Montreal shows that even among the lowest-priced brands the companies raised prices by more than 10% per year. In the four year period 2017 to 2021 the median price charaged by suppliers (excluding tax) increased by more than 10% per year, the equivalent of a tax increase of more than $6 per carton. By discouraging taxes while raising prices, the companies were able to extract more profits from Quebec, while continuing to externalize the costs of treating tobacco-caused disease to government and consumers.



These multi-priced market has benefitted their revenues, and also their bottom-line profits. From the income statements filed in the Ontario court, we know that the profit margin of the three large companies averages around 50% of gross revenues. Data compiled by Health Canada shows that although the volume of cigarettes has fallen in recent years, and federal tax revenues have fallen with it, industry wholesale sales revenues have grown steadily. Last year there was a decline in provincial tax revenues also.



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