What will history say? Health Canada rushes approval of pro-vaping messages.

By law, one of the duties of the Minister of Health  is  "the protection of the people of Canada against risks to health and the spreading of diseases."  Mostly, we hope, he or she succeeds.  But every once in a while the Health Department fails its Minister and fails big time.

One such occasion was in the 1990s when early scientific evidence was ignored, and tainted blood was allowed into the blood transfusion supply.  Thousands became ill or died.  The Krever Commission of Inquiry slammed Health Canada for being too slow to act.  As a result, Health Canada was substantially re-organized. It was a career-ending debacle for several senior health bureaucrats.

On an earlier infamous occasion, federal officials acted too quickly in approving the sale of Thalidomide. Early evidence was ignored, and approval was given on the basis of manufacturers’ claims that regulators in the United States found insufficient. Health Canada officials responsible for that tragedy had long retired before the federal government moved to make amends in 2014.

A new crop of health officials seem prepared to make a similar high-stakes public health gamble on thin scientific ground. This fall, Health Canada is preparing draft regulations that would allow Big Nicotine companies to say that electronic cigarettes are safer than they really are.

New draft regulations are in development that would allow manufacturers of e-cigarettes to use one or more of the following proposed statements in their advertising and on packages of their products:

1. If you are a smoker, switching completely to vaping is a much less harmful option.

2. While vaping products emit toxic substances, the amount is significantly lower than in tobacco smoke.

3. By switching completely to vaping products, smokers are exposed to a small fraction of the 7,000 chemicals found in tobacco smoke.

4. Switching completely from combustible tobacco cigarettes to e-cigarettes significantly reduces users’ exposure to numerous toxic and cancer-causing substances.

5. Completely replacing your cigarette with a vaping product will significantly reduce your exposure to numerous toxic and cancer causing substances.

6. Switching completely from smoking to e-cigarettes will reduce harms to your health.

7. Completely replacing your cigarette with an e-cigarette will reduce harms to your health.

These statements have some truthiness, but they are not the whole truth.  They are likely not true in a public health sense, as using any of them is likely to do more harm than good.  In the all-too-brief period allowed for comments from the general public (September 6-17, 2018), Stan Glantz and Physicians for a Smoke-Free Canada collated the evidence showing that current science does not support the use of any of these statements. This evidence demonstrates:

·         Every study that has examined whether kids who start nicotine use with e-cigarettes are at increased risk of smoking has shown a strong positive effect.

·         The evidence that e-cigarettes pose substantial cardiovascular and pulmonary disease risk is piling up.

·         There is also evidence that e-cigarettes may increase cancer risk.

·         While some people do successfully quit smoking with e-cigarettes, for most people e-cigarettes reduce the odds of smoking cessation.

·         The dominant behavior is dual use, with people using both e-cigarettes and conventional cigarettes at the same time.  In this circumstance, risks are not reduced.  One risk adds to the other.

Other reputable public health voices agree. On August 30, 2018, the European Public Health Association issued a concise summary of current e-cigarette science entitled "Facts and fiction on e-cigs." The EUPHA report concluded:

"Given the available evidence, EUPHA strongly supports the precautionary approach taken in the EU Tobacco Products Directive and in statements by WHO. It is not possible, at this point, to make any claims about the relative safety of e-cigs compared to traditional cigarettes. The overall effect may well be to worsen the tobacco epidemic first by deflecting smokers from using proven smoking cessation strategies and shifting them to e-cigs, which, for most smokers, reduce successful smoking cessation, and second by deflecting discussion from measures opposed by the tobacco industry.

E-cigarettes are expanding the nicotine market by attracting youth who were at low risk of initiating nicotine use with conventional cigarettes, but many of whom are now moving on to those conventional cigarettes. Even if they do not progress, promoting nicotine use to youth is bad public health policy."

Health Canada’s 180 degree turn

In the version of Bill S-5 first presented to Parliament in November, e-cigarette manufacturers were banned from making any statements comparing the health effects of their products. (“No person shall promote a vaping product, including by means of the packaging, by comparing the health effects arising from the use of the product or from its emissions with those arising from the use of a tobacco product or from its emissions.”)

The first 90 degree turn was taken during the Senate review of the bill when Senator Chantal Petitclerc, on behalf of the government, proposed an amendment that gave the federal government the power to regulate comparative statements. The amendment was adopted and survived all the way through the Parliamentary process to Royal Assent.

The second 90 degree was taken earlier this year, when Health Canada made it a regulatory priority to design comparative statements for use by e-cigarette manufacturers. The haste with which this is being done is all the more staggering, considering the usual pace of regulatory development. S-5 authorizes much-needed regulation on tobacco and nicotine sales, but only ‘relative risk’ statements have been given the fast track.

On September 28, 2018 Canada officially notified the World Trade Organization of its intention to approve  the seven "draft" statements. Notification to the WTO is a routine step in the regulatory process - but it usually occurs late in the process and is usually an indication that domestic consultations are over. If Health Canada had wanted to send a signal that its consultation on these statements was a sham, the WTO notice would have been a very good choice.

The evidence is going in the opposite direction to Health Canada’s proposed regulations.

Although the scientific evidence was lacking when the amendment to allow these statements was first considered by the Senate, there was the hope that research would soon justify nicotine users receiving statements about the relative harms of e-cigarettes in comparison with their conventional predecessors.

In fact, the opposite has happened.  In the eighteen months since Senator Petitclerc's amendment, the scientific evidence that has accumulated support the conclusion of EUPHA:

"It is not possible, at this point, to make any claims about the relative safety of e-cigs compared to traditional cigarettes."

This seems to have deterred Health Canada not at all. They are stubbornly insistent on allowing nicotine companies to make statements that will lull many smokers and non-smokers into thinking that e-cigarettes are safer than they really are. (As with Thalidomide, the U.S. government is taking a more cautious approach.)

The seven proposed statements zero in on the narrow question of the reduced harm to smokers that can arise if one switches completely from combustible cigarettes to e-cigarettes, while ignoring the wider context of widespread dual use, ineffectiveness of e-cigarettes as a smoking cessation aid, widespread use by never smokers and their more likely subsequent uptake of conventional cigarettes.  When asked about this strategy, Health Canada officials indicated that the seven statements were deliberately designed to address only one narrow question.  All other problems would be addressed by other programming and regulatory actions to be implemented months and years later.  But e-cigarettes are causing unaddressed harms here and now.  Regrettably, Health Canada’s chosen strategy, by getting the priority order wrong, risks increasing, not decreasing harm.

Unusually, inaction on comparative statements would be the best course of action for federal tobacco regulators. Health Canada should and could simply do nothing for the time being to push these statements forward. Nothing in law compels them to approve comparative statements. No scientific consensus exists to give them the confidence to permit the wording they propose.

Instead, they could usefully turn their attention to developing programming and regulations where they are truly needed.  To be sure, work is already proceeding on a campaign to prevent vaping among youth.  Regulations are being developed for health warnings on vaping products, vaping promotion restrictions and vaping product reporting.  But it will be months and years before any of this work comes to fruition.  A better plan would be to speed up implementation of all these activities.  Once they were in place, then consideration could be given to whether or not prescribed comparative statements were needed, and if so, what they might say in the new context of a comprehensive set of vaping products programming and regulations.

Plain and standardized tobacco products and packaging move closer to reality in Canada

Twenty-four years ago, in the spring of 1994, the House of Commons Standing Committee on Health recommended that the government adopt plain packaging for cigarettes.  The government did not do so, at least not in 1994.  Since then, many countries have adopted plain packaging.  Australia led the way followed by France and the United Kingdom.  Twenty-one other countries will soon implement plain packaging or have announced their intentions to do so.

Now, 24 years after first studying the matter, the Canadian government is poised to leapfrog ahead with its proposal for what would be the toughest and most effective regulations for plain and standardized tobacco products and packaging in the world.  According to draft regulations published today in Part I of the Canada Gazette, (the tobacco regulatory proposal appears on pages 2574 to 2656)  cigarette packages would not only be a plain brownish-green, they would also be standardized to the slide-and-shell format of old.  Very large warnings would continue to appear on the packages.  Even the cigarettes would be standardized.   Only regular and king size would be allowed.  Gone would be gimmicky cigarettes like slims, superslims and luxury length.  Plain packaging requirements would extend to all tobacco products, not just cigarettes, with adaptations tailored to the nature of each product.

These are strong measures.  To stand up to tobacco industry opposition which will surely come, strong evidence is required.  And the government have provided strong evidence, in spades. The Regulatory Impact Assessment Statement (RIAS) accompanying the draft regulations provides convincing evidence to support these proposals.  The RIAS has no fewer than 130 references.  It draws on the experience of other countries, published scientific evidence from Canada and other countries, and, most deliciously of all, tobacco industry market research documents made public through court proceedings in Quebec and elsewhere. When market researchers many years ago recommended to companies how to make packages and products more attractive to consumers, their reports are now revived and become strong evidence to the government for how to make such products and packages less attractive by doing the opposite of what was once recommended to tobacco companies.

Here is just one example of how this works:

In 1991,  Canadian tobacco company RJR-Macdonald (now JTI-Macdonald) commissioned the market research firm Qualitative Science to report on how the package of their flagship brand
Export A might be re-designed to make it more appealing.  Among many other observations, this market research firm reported in 1991:

"Feelings of social rejection prompted some smokers to suggest that the ideal cigarette package design would make a contribution to alleviating their feelings of guilt." 

Now, in 2018, the words RJR-Macdonald bought and paid for in 1991 have come back to haunt them. They are being parroted back, this time in support of plain and standardized packaging.  On page 2585 of the June 23, Canada Gazette, Part I, the RIAS states:

"As well, tobacco industry documents indicate that the tobacco package can also be used to comfort smokers and ease or alleviate the feelings of guilt and social rejection in connection with their tobacco use."

This RIAS statement properly credits the 1991 Qualitative Science report as its source.  Throughout the RIAS, tobacco industry documents and third-party analyses of tobacco industry documents are cited as important parts of the evidence for the strong measures proposed to take away the sensory appeal of tobacco products and their packaging.

Instead of attractive colours, the background colour proposed for tobacco packages is Pantone colour 448C.  It looks like this:

The Government is inviting public comment on these draft regulations between now and September 6, 2018.  Comments can be sent to

Plain and Standardized Packaging Division,
Tobacco Products Regulatory Office,
Tobacco Control Directorate,
Healthy Environments and Consumer Safety Branch,
Health Canada, 150. Tunney’s Pasture Driveway,
Ottawa, Ontario K1A 0K9
(email: hc.pregs.sc@canada.ca)

See Vype Go!

The ink was barely dry on Bill S-5 before British American Tobacco had its e-cigarette Vype on the market to Canadians. The domain Govype.ca went live the week after Royal Assent was given to the new federal law which legalizes recreational nicotine products.

Although only the tank system (left) is currently
available in Canada, BAT is illustrating two other models
on its new GOVYPE.CA web-site

On-line sales 

BAT's e-cigarette portal does more than offer on-line sales in the provinces where door-to-door delivery is allowed (online sales are banned by law in Quebec and Nova Scotia). The web-site also provides a list of the convenience stores (Circle K/Macs Milk) and gas stations (PetroCanada) where they can be bought directly, and gives some advice on using the product. (As a service to other researchers who may not be able to access the Canadian site, the text from some of these pages is pasted below).

To see health warnings on GoVype.ca,
the customer must scroll
down the page repeatedly

With small health warnings

The information on the web-site presents raises more profound concerns. The most notable aspect of the web-site is not what is visible on it, but what is nearly invisible. You have to scroll down several times to find the small print warning (circled above):

Vype products may be harmful to health and contain nicotine which is addictive. VYPE PRODUCTS ARE NOT SUITABLE FOR USE BY: persons who are not adults; persons who are under the legal age to purchase vaping products; persons who are allergic/sensitive to nicotine; pregnant or breast-feeding women; persons who have been advised to avoid using tobacco or nicotine products for medical reasons; persons with reduced physical, sensory, mental capabilities or lack of experience/knowledge unless they are under supervision or have been given instructions concerning the use of the product by a person responsible for their safety; and persons with an unstable heart condition, severe hypertension or diabetes. Keep Vype products out of reach of children.

Illustrations and specifications that appear on the web-site caution users about the "risk of fire, injury and damage" that could result from using a non-compatible charging device, but make no reference to any addiction or human health impact unrelated to device failure.

In-store displays (despite laws banning them)

Vype counter-displays, such as that shown below, are now prominent in the Circle K stores in our neighbourhood.

This may seem rather odd, given that the Smoke-Free Ontario Act clearly states: "No person shall, in any place where tobacco products, tobacco product accessories, vapour products or any prescribed products or substances are sold or offered for sale, display or permit the display of any of the following products, in any manner that would permit a consumer to view or handle the product before purchasing it."  

Vype counter displays at Circle K, ù
Wellington Street
Ottawa. June 11, 2018

Although neither the law nor the guidance document issued last year make any reference to a grace period for the display ban, the clerk at our local Circle K explained that the Ontario government had given a one-month exemption to the law before e-cigarettes would be stored behind shutters as cigarettes are by the end of June.

Voluntary package warnings (but proportional to harm?)

One advantages of the open displays at the retail store is the opportunity to look at the packaging of both nicotine-free and nicotine-containing e-liquids.
'
The warnings on nicotine-bearing and nicotine-free products are not the same. The nicotine free product carries a black-box warning "This product may be  harmful to your health" with the French version on the opposite side.

The nicotine-free version of the vype e-liquid had a larger text
warning on the package front than did either strength of the
nicotine-bearing version

The version with nicotine carries no black-framed warning.  On the front side there is the household chemical safety symbol for poison with the signal word "danger". On the back, in much smaller font, the following warning is printed: "This product may be harmful to health and contains nicotine which is addictive." 

The contrast between the visibility of the large-print nicotine-free warning (right) and the smaller text on the nicotinized version (left) is readily apparent. Curiously, the inside warning leaflet and bottle warning was identical in both the packages below, other than the poison symbol on the version with nicotine.

,

The back panel of the nicotine-free liquid has larger
text warning than the nicotine-bearing version.

Health Canada is letting the industry decide the warnings

S-5 gives the federal government the authority to regulate packaging and web-site advertising, and to require the manufacturers to provide "information ... about the product and its emissions and about the health hazards and health effects arising from the use of the product and from its emissions."  It also authorizes regulations to cover point-of-sale promotions.

No such regulations are yet in place, although Health Canada has had at least 18 months since the bill was introduced to prepare some. In the consultation paper issued last year, the department proposped the following warning: "Health Canada proposes to require that vaping products that contain nicotine display a warning such as:  'WARNING: This product contains nicotine. Nicotine is an addictive substance. Use of nicotine during pregnancy may harm the fetus.' "

The warning required by the European Union requires that consumers be warned that nicotine is a "highly addictive" substance.

More on Health Canada's communications on e-cigarettes in a later blog!

World No Tobacco Day 2018: The endgame is not in sight

Today was a very busy day on the communications front of the battle against tobacco use in Canada. Federal Health Minister, the Hon. Ginette Petitpas-Taylor appeared before delegates to the 2018 tobacco conference in Montreal to outline the next 5-year federal tobacco control strategy.

This was the latest in more than 50 years of similarly-designed ambitious-sounding federal plans to wrestle the problem of smoking to the ground. The first was set by Judy Lamarsh, whose 1964 strategy aimed at "the reduction or elimination of this health hazard". The way to do it in 1964 was by providing the public with information, encouraging smokers to quit and discouraging non-smokers from starting.

54 years later, much is the same. Today's goal is to "drive down the smoking rate in Canada to less than 5% by 2035." The way to do it is by "helping Canadians quit tobacco, protecting young people and non-tobacco users" with a nod also to "evidence-based decision-making" and "collaboration". (This year there are about 5.2 million smokers in Canada, about 17% of all people over 12.)

A well trodden path

The Minister and her advisors may believe that by repeating this established approach it will continue to make progress in much the same way as it has over past decades. There is no doubt that the the slow introduction of incremental measures has contributed to a steady decline. Tobacco packaging is a case in point: progress was announced with the first voluntary warnings in 1970s, as it was with small mandatory warnings in 1988, graphic warnings in 2000 and bigger graphic warnings in 2014, and as it will with plain packaging in a few years.

The problem with incrementalism is that it is just so, well, incremental.

Many other knowledgeable Canadians have spent considerable efforts to demonstrate that bolder measures are needed. Endgame reports, scientific reviews, expert consensus, and citizen's groups have called for bolder and more innovative measures.

As we veterans of several past federal strategies wrote in the Gazette earlier this week, what is needed now is "a strategy that acknowledges the fundamental role of the tobacco industry as the continuing vector of tobacco-related disease. This would include a true harm-reduction strategy with firm plans to eliminate the most dangerous of all tobacco products, the combustible cigarette. We also need measures to prevent price-based manipulations that undermine taxation, and well-funded mass media campaigns."

A year ago, there were signs that Health Canada was preparing for bigger steps. Speaking to a hundred or more people from across Canada who had paid their way to the Ottawa Convention Centre to participate in a Forum on the Future of Tobacco Control, the former Minister of Health, Jane Philpott encouraged the believe that the process was headed for "a bold and innovative plan".

Over the past year, the tobacco file at Health Canada has been handed to a new minister, a new assistant deputy minister, a new director general and a new director of policy. It soon became apparent that it was not only the planners who changed, but also the plan.

And some new directions.

It would be incorrect to suggest that  there is nothing new or different in the federal approach to tobacco. One key new element may well have a dramatic and long-lasting effect. Last week Royal Assent was given to bill S-5, which set the rules for vaping products. Harm reduction is here.
   

This is not the first time that harm reduction has appeared as an element of the federal plan -- the the version adopted in 2001 had used it as a fourth pillar in addition to prevention, protection and cessation. But the department's view of what harm reduction meant was only made public when it introduced Bill S-5 in the fall of 2016.

Harm reduction and the potential benefits and risks of vaping products remains controversial and much disputed in Canada, as it does elsewhere. Unlike most areas of tobacco control, there is no scientific consensus about the population impacts of the use of e-cigarettes.

By adopting a bullish view in favour of a market-driven transformation of the nicotine market, the Minister and her advisors have departed from their usual practice of insisting on a solid scientific footing before taking action. The department says that this approach will  "save lives". More on the evidence behind that claim in a later blog.

The candy coating

There are several welcome moves in the new strategy. Many of these were included in the Minister's speech, and do not yet appear on Health Canada's web-site. These notably are for measures that have been the target of recent advocacy efforts by some important health charities. The Minister announced that plain packaging will be implemented in the traditional Canadian slide-and-shell package and that warnings on individual cigarettes are under consideration. It was also announced that some funding may be available for some tobacco NGOs. (Full disclosure - we are among those who received funding before federal support ended in 2012).

There was more good news in the fine-print of the material made public. This includes the intention to make accessible to researchers more of the important information provided by the tobacco industry and a renewed (hopefully expanded) commitment to support the Framework Convention on Tobacco Control.

From a population approach to a sub-population approach

A key element of strategy is a focus on communities and groups of Canadians who smoke at higher rates than others. Special call-outs were given to Indigenous communities, LGBTQ+, young adults and construction workers -- all of whom smoke at rates much higher than the average. 

One month before cannabis is scheduled to become legal, the department made no mention of the risks of smoking associated with cannabis use. Yet our review of 2013-2014 Canadian smoking rates found that cannabis users (those who reported using it two or more times in the past year) were, at 49%,  the highest of any identified Canadian sub-population.

An important part of arithmetic missing from the federal strategy is the matching of higher smoking rates with the size of the population affected by the inequities. Gender is a case in point -- among those who self-identify as LGBTQ to Statistics Canada, smoking rates in 2013-2014 were are almost double (34% vs. 19%) the rate as those who self-identify as heterosexual. Those who self-identify as men were similarly more likely to smoke than those who self-identify as women (22% vs. 16%). By Health Canada presents this in a way that frames the inequity associated with sexual orientation as being more severe than that related to gender. From the perspective of the absolute number of people whose health is being harmed, however, the gender-related difference is higher. It appears likely that inequity results in about 900,000 additional male smokers and fewer than 100,000 additional LGBTQ smokers.

Ontario's "Next Chapter" for tobacco control

Last week a copy of the Ontario government's new 5-year plan for tobacco control was provided to us. (You can read it here!)

In many ways, this is an up-to-date strategy that modernizes the province's efforts to help smokers quit. In its acknowledgement of e-cigarettes and cannabis, the province clearly understands that circumstances in 2018 are very different than when the previous strategies were designed (The province first adopted a legislative approach in the mid 1990s when it became the first province to ban cigarette sales in pharmacies).

But in all significant other ways, the province has adopted a "forward to the past" approach. The objectives of the three strategic priorities - cessation, prevention and protection - are very little different than they were decades ago, although they are expressed in a modern management-speak.

There is little in the document to require tobacco companies to meet public health objectives, despite compelling reasons for doing so. Those who hoped that Ontario's slow-moving lawsuit against the companies would be a mechanism to assert industry change can only be disappointed by the complete silence on that file in this strategic document.

Smoke-Free Ontario - the Next Chapter for a Healthier Ontario

This government's "next chapter" for tobacco control is in most ways a shrunk-down and expurgated version of previous chapters. Future policy measures - like reducing availability of retail - are punted to never-never land of "exploring options". There are no new restrictions on tobacco industry practices. The much-discussed but not officially announced decision to de-fund major tobacco control activities (including research, training and youth mobilization) is kept in wraps. Previous commitments to mass media campaigns have been replaced with more modest suggestions of "public education" to "inspire people to quit."

It didn't have to be this way. Not so long ago, the Ontario government sought advice of experts and encouraged the compilation of evidence that was to inform its renewed strategy. In 2016, the Smoke-Free Ontario Scientific Advisory Committee, which included government and non-government scientists, identified the evidence to support a fourth strategic direction - - the "industry", and the importance of "innovative" approaches like restructuring retailing or imposing requirements on tobacco manufacturers to meet certain public health objectives (i.e. with respect to the quantity of cigarettes they sold).

Evidence to Guide Action:Comprehensive tobacco control in
Ontario (2016) Smoke-Free Ontario Scientific Advisory Committee

This report was followed up the following year with recommendations of the Executive Steering Committee of the Smoke-Free Ontario modernization process.  At the head of their list of priority actions were ways to "Challenge and Contain the Tobacco Industry", suggestions for which included reducing the availability of tobacco in retail settings, reducing the supply of tobacco products in Ontario and making industry practices more transparent. Other suggestions were focused on beefing up the cessation system, providing protection from smoke in multi-unit dwellings, raising the minimum age from 19 to 21, and making university campuses smoke-free.

One might have thought that because these advisory processes were established by the ministry that some of the results would have been reflected in the final strategy. Few of the policy advances -- and none of the innovative measures -- appear to have survived the cut.

Not surprisingly, the government has done little to draw attention to its new plan. It is not, for example, listed on the Smoke-Free Ontario site and has been released without fanfare.

Where Ontario fails to lead, will Ottawa follow?

Health Canada's renewal of its tobacco control strategy was due to be renewed in April 2017, but was delayed to give the department an extra year to develop what we were told would be "bold" and "innovative" measures.

The extra year has come and gone without any signal from the department about what it has decided upon. In the meantime, the words "bold" and "innovative" have been dropped during discussions with outsiders.

Given what we know about tobacco industry behaviour, governments should be bringing the tobacco industry to heel, not giving them a free pass.  The tobacco industry is the source of the tobacco epidemic that is killing over 45,000 Canadian a year.

If neither the Ontario government nor the federal government is willing to make bold moves to address the problem at its source, who will protect Ontarians?

Do smoking cessation programs work?

After all we have learned about smoking since the 1950s, why have we still not conquered the tobacco epidemic? The tobacco epidemic is persistent. The Canadian Community Health Survey reports that from 2000 to 2014, the percentage of former smokers in the Canadian population changed barely all, hovering around 37% (Physicians for a Smoke_Free Canada, 2016).

New quitters only just replace the proportion of those who relapse or die. The tobacco industry has long known how few smokers quit, which is why it seldom opposes smoking cessation programming. According to tobacco industry monitoring data, from 1971 to 1991, people who managed to stay quit for one year as a percentage of ever-smokers was almost always in the very narrow range of 1–2% per year. The lowest value was 0.4% in 1983 and the highest was 2.2% in 1976 (Imperial Tobacco Ltd., 1991). More recent, but similar low rates of quitting in Ontario were reported by the Ontario Tobacco Research Unit (OTRU; 2016). During the period 2007–2014, annualized quit rates were reported to be in the range of 1.3–2.2%.

Still, people do successfully quit, eventually. It may take them many tries, but many are successful. By 2014, there were about twice as many former smokers as current smokers in Canada, as illustrated above.  (Physicians for a Smoke_Free Canada, 2016).

How do people quit? Most successful quitters do so on their own. In Ontario in 2014, only 1.7% of smokers succeeded in quitting for a full year, and most of these quit on their own.  About two-thirds of those successful quitters did not use any of the ten cessation services evaluated by OTRU (OTRU; 2016). Currently, about two-thirds to three-quarters of Americans who quit do so on their own (Chapman & Mackenzie, 2010). Looking back in time, the figures are even higher. In 1986, it was estimated that over 90% of Americans who had quit smoking up to that point in time had done so on their own (American Cancer Society, 1986). In earlier years, less assistance for smoking cessation was available.  Most people quit on their own.

But what of the others, those who do seek assistance for smoking cessation? How successful are they? Nicotine replacement therapy (NRT) is a popular form of providing smoking cessation assistance and a Cochrane review of over 130 studies found that NRT achieved a success rate that was 50–70% greater than that achieved with placebo (Stead et al.,2012). However, there are sound reasons to believe that this apparent success is not maintained when the therapy moves from the research environment to the real world. John Pierce and his colleagues reported that after three or more months of follow-up, Americans who quit smoking on their own had slightly higher success rates than those who used NRT or some other form of assistance. Among heavy smokers, the NRT three-month success rates was 9%, compared with 15% among those who quit unassisted (Pierce et al., 2012).

Cessation programs have neither broad reach nor outstanding success rates. The Ontario government provides support to 10 different smoking cessation programs. These programs all use well-established forms of assistance of proven worth. They range from minimal interventions like helplines to intensive system-wide interventions in health care settings. Their reach and effectiveness were carefully evaluated. Collectively they reached 139,000 people—about 7% of all Ontario smokers. Of these, it was estimated that about 12,000 actually quit smoking, which amounts to only about 0.6% of all smokers in Ontario (OTRU, 2016). Ten government-supported forms of smoking cessation assistance yielded a barely perceptible increase in the number of people in Ontario who successfully quit smoking.

Many have been hopeful that electronic cigarettes (e-cigarettes) would help people quit smoking.  However, the evidence is not encouraging.  Those who use e-cigarettes every day, particularly the newer tank systems, do show modest rates of success at quitting cigarette smoking.  However, in the United States daily e-cigarette users account for only 19% of the users of these products. (Berry et al., 2018). When the overall picture is considered, taking into account all users of e-cigarettes, the evidence shows that e-cigarettes depress smoking cessation behaviour. Moreover, they serve as a gateway drug.  Young users of e-cigarettes are more likely to take up regular smoking. (Glantz and Bareham,2018).

The picture is bleak. Smoking cessation rates are low. Few people use assistance, and assistance is not very helpful.  E-cigarettes, a hoped-for solution to tobacco addiction are proving to be anything but.  The weight of evidence shows that, a population level, they depress quitting and serve as a gateway drug to regular cigarette smoking.

Yet no comprehensive tobacco control programs will be credible unless it includes smoking cessation programming. Even if smoking cessation is one of the least effective tobacco control measures, it is a necessary part of a comprehensive tobacco control policy.  Indeed Article 14 of the Framework Convention on Tobacco Control obliges Parties to provide smoking cessation programs.

The Canadian federal, territorial and provincial governments all fund smoking cessation programs. While funding for these programs should continue, we should not expect them to be more successful in the future than they have been in the past.  Progress towards the Canadian government's stated goal of achieving less than 5% tobacco use prevalence by 2035 will not be made by greatly increasing smoking cessation programming, but rather by strengthening other areas of comprehensive tobacco policies and programs.  In future entries on this blog, we will explore some of these other ways that real progress could be made in tobacco control. 

References

American Cancer Society. (1986). Cancer facts and figures. Atlanta, GA. https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/#id=yxyk0154

Berry, K.M., Reynolds, L.M., Collins, J.M., et al. (2018).  E-cigarette initiation and associated changes in smoking cessation and reduction: the Population Assessment of Tobacco and Health Study, 2013-2015. Tobacco Control. http://dx.doi.org/110.1136/tobaccocontrol-2017-054108.

Chapman, S. & Mackenzie, R. (2010). The global research neglect of unassisted smoking cessation: Causes and consequences. PLoS Medicine, 7(2): http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000216.

Glantz, S.A. and Bareham, D.W.  E-cigarettes: Use, effects on smoking, risks and policy implications. (2018).  Annual Review of Public Health. 39(28). 1-28.21. https://doi.org/10.1146/annurev-publhealth-040617-013757. 

Imperial Tobacco Canada Ltd. (1991). The Canadian Tobacco Market at a Glance–December 1991. Montreal, QC: Retrieved from Industry Documents Library website. www.industrydocumentslibrary.ucsf.edu/tobacco/docs/lphb0223

Ontario Tobacco Research Unit. (2016). Smoke-Free Ontario Strategy Monitoring Report. Toronto.https://otru.org/2016-smoke-free-ontario-strategy-monitoring-report/

Pierce, J.P., Cummins, S.E., White, M.M., Humphrey, A. & Messer, K. (2012). Quitlines and nicotine replacement for smoking cessation: Do we need to change policy? Annual Review of Public Health, 33, 341–356. https://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-031811-124624

Physicians for a Smoke-Free Canada (2016).  Tobacco Use 2000-2014:  Insights from the Canadian Community Health Survey. http://www.smoke-free.ca/CCHS/InsightsfromtheCCHS-2016.pdf 

Stead, L.F., Perera, R., Bullen, C., Mant, D., Hartmann-Boyce, J., Cahill, K. & Lancaster, T. (2012). Can nicotine replacement therapy (NRT) help people quit smoking? Cochrane Database of Systematic Reviews. Plain Language Summaries. http://www.cochrane.org/CD000146/TOBACCO_can-nicotine-replacement-therapy-nrt-help-people-quit-smoking

Even low-dose smoking is hazardous

A new study published on January 24 by Allan Hackshaw and his colleague in the British Medical Journal reports that smoking even one cigarette per day carries a high risk for heart disease and stroke.  One cigarette a day accounted for fully half of the excess heart disease risk associated with smoking 20 a day in men and one third of the risk in women.

To arrive at their results, Hackshaw and colleagues pooled data from 141 studies covering 5.6 million people for heart disease and 7.3 million people for stroke.  The studies came from 20 different countries and covered a span of fifty years.  Now we know the shape of the dose-response curve.  Risk increases rapidly for a low-dose and more slowly after that.  But it took 50 years and hundreds of thousands of deaths caused by smoking to arrive at this result.

A related editorial written by Canadian researcher Kenneth Johnson points out that second-hand smoking has also been shown to carry high risks for heart disease and stroke.  Use of e-cigarettes and heat-not-burn cigarettes are also forms of low-dose smoking that produce ultrafine particles and many of the same toxic substances that cause adverse effects on the cardiovascular system in light smokers and passive smokers.

We do not have fifty years of experience with e-cigarettes and heat-not-burn cigarettes, nor should we wait for fifty years for definitive epidemiological evidence to emerge.  We should recognize that these are forms of low-dose smoking that probably carry substantial increased risk for heart disease and stroke, similar to the risks of light cigarette smoking and passive smoking.  A cautious policy response is recommended that would restrict marketing of these products and, as much as possible, limit their use to current smokers only.

The government of Canada is committed to achieving less than 5% tobacco use by 2035. Our new knowledge that even light smoking is hazardous makes it imperative that firm plans be put in place to achieve this goal.  We should start by phasing out the most dangerous tobacco product of them all - combustible cigarettes.

With new nicotine products claimed to be less risky, why allow the sale of combustible cigarettes?

Getting the smoke out of cigarettes

2017 saw an acceleration in the move by Philip Morris International and British American Tobacco to rehabilitate their reputation and to re-invent their market.

For the first time in decades, the companies’ executives are not keeping a low profile in the media or staying out of tobacco control discussions. Instead, they have launched pro-active campaigns, including media events, speaking tours and pro-active lobbying for changes to tobacco laws.

Their message? Heated tobacco is a disruptive technology that should be used to drive down smoking rates. Their goal? Looser rules on how they can sell their new devices.

The industry wants relaxed regulation of new “reduced risk” products
Over the past year, both BAT and ITL have introduced electronic devices which produce an aerosol by heating tobacco sticks that resemble short cigarettes. In support of the claim that these are “reduced risk” products, the companies point to a number of studies which show lower levels of toxins in the aerosol compared with the smoke from conventional cigarettes.

For the moment these products lie in a kind of legal limbo in Canada – they are subject to the federal laws that apply to all tobacco products (like restrictions on advertising), but are not captured by the regulations which are more product-specific (like health warnings and bans on flavourings). They also reveal a vulnerability in Canada’s health laws. Unlike the United States, Australia, New Zealand and many other developed countries, there is no requirement for them to be approved by any government before they can be marketed in Canada. 

There is not even an appropriate tax category for heated tobacco products — they are currently taxed at the rate set for oral tobacco. This is set on a per-gram basis, which makes the tax less than half the tax for cigarettes on a per-stick basis.

The manufacturers of these new types of cigarettes are using private visits with policy-makers, news events and other means to encourage regulators that the health of Canadian smokers would benefit if even fewer rules and lower taxes were in place for these products.

A better option: stronger measures on the old “high risk” cigarettes. 

We agree with the companies that federal law should respond to these new products. We agree that the new technologies should prompt a review of tobacco laws. But instead of justifying relaxing the rules on how nicotine is marketed, we think these products justify strengthening restrictions on conventional cigarettes.

Now that the companies have shown that they can produce a a product they claim is a less harmful form of inhaling tobacco, we think they should be required to remove their more harmful products from the market.

It’s time to stop exempting tobacco manufacturers from consumer protection laws that ensure products are no more dangerous than necessary.
Canadian law makes it relatively easy to put such a phase-out in place. Tobacco companies must regularly test the levels of toxins produced by their cigarettes and report the findings to government. They have recently used the same tests to show that their newer cigarettes are less toxic (and have published the results). The results of the toxic emission reports on the heated tobacco products could become a performance standard for all heated or ignited tobacco products.

This would give the marketing edge that the companies claim they need to encourage smokers to switch to a less bad option.

It is a much more prudent approach than granting their request to be able to use the tools of modern advertising and marketing to promote these brands– tools we know they would use to grow the number of people who use tobacco or other forms of nicotine.

Parliament has an opportunity in S-5 to ensure that nicotine, like gasoline and paint, is regulated so that most harmful products are phased out when better options become technically feasible. Either by amending the bill in committee -- or rejecting it and sending it back for a 're-do', the House of Commons can bring tobacco law up to date with technology. 

Bill S-5: The threat of widespread advertising for nicotine

E-cigarettes and other vaping products currently occupy a legal grey zone. Although the sale of these products is against the Food and Drugs Act, Health Canada has chosen not to enforce this law since about 2012.

The illegality of selling e-cigarettes has kept Big Tobacco (and mainstream retailers) out of the e-cigarette and nicotine vaping market, even though they have developed many such products and are marketing them in other countries.

All this will change when S-5 (the proposed Tobacco and Vaping Products Act) becomes law. Tobacco companies will likely enter the vaping market as aggressively in Canada as they have elsewhere. (S-5, which began in the Senate more than a year ago, in November, 2016, is now being studied by the House of Commons.)

This is a cause for concern. S-5 as it is now drafted gives e-cigarette and vaping manufacturers the right to advertise these products in all available media - TV, radio, internet, video-games, newspapers, billboards, corner store windows, bars, text messages, social media, etc. The types of "Vaping Rocks" promotions that BAT is using for its Vype Pebble in the U.K. may soon be invading the e-space of young Canadians.

The not-very safeguards

The government currently relies on three safeguards in the bill to protect young people and non-smokers from nicotine marketing:

• a ban on ads if there are “reasonable grounds” to believe that they would appeal to young persons, 
• restricting lifestyle ads to publications sent to adults or places where young persons are not permitted (information ads would be allowed in other publications)
• The power for government to impose regulations on e-cigarette advertising. (This was not included in the original bill, but was inserted by the Senate).

Decades of experience with enforcing tobacco laws suggest that tobacco companies will see these safeguards as a challenge, not a barrier.

The same experience suggests that the government will wait until a large number of people have been harmed by this advertising before they impose any stronger measures. Indeed, in the proposed regulations circulated late this summer, the government suggests regulations that are virtually identical to those in place under the tobacco industry voluntary code between the 1960s and the mid-1980s. 

A better approach is available 

Non-combustible nicotine and tobacco products are widely acknowledged to lower cancer risk when compared to regular cigarettes on a stick-to-stick basis. But they are only better for public health if smokers, and only smokers, use them. Dual use of combustible and non-combustible nicotine or tobacco, or use by former smokers or non-smokers, could all worsen the problems of nicotine addiction. These circumstances could result in more, not less, harm from these new vaping and heat-not-burn products.
The benefits of a legal, regulated market for nicotine products can be achieved without the risks contained in Bill S-5.

If the government wishes smokers to be informed about the availability of alternative forms of nicotine, targeted communications at smokers (including through tobacco package warnings and inserts) are a more prudent approach than risking the spill-over effect of television advertising and billboards.

Physicians for a Smoke-Free Canada continues to recommend to parliamentarians that Bill S-5 not be passed in its current form.

• Like cannabis and tobacco, nicotine products should not be advertised on billboards, television or radio.
• Promotions for products accepted as reduced harm should be allowed if targeted only at smokers, perhaps at the time of tobacco sale. 

(More information on how Canada compares with other countries is available here.)

National Non-Smoking Week and the challenging year ahead

The third week of January has for many years been used as an occasion to reflect on public and personal measures that can be taken to reduce the toll from tobacco use. "Weedless Wednesday" falls in the middle of the week, and has long been promoted as a quit day for smokers. But Ministers of Health have in past years often used this week to reaffirm their commitment to address what, despite decades of progress, is still the largest preventable cause of death. (Last research funded by Health Canada concluded that the annual death toll from tobacco use in Canada exceeded 45,000 deaths, with Statistics Canada reporting more than 5 million Canadians smokers.)

Ottawa health advocates will be all ears this week for any signal from the new Minister of Health about her vision for tobacco control. Five months have passed since Ms. Petitpas Taylor was appointed to this position, but she has not yet publicly or privately said much to indicate whether tobacco is on her personal priority list. (Her mandate letter from the Prime Minister re-iterates a responsibility to implement plain packaging, but nothing more). She has  re-iterated the new goal of achieving 5% tobacco use by the year 2035, but has

This silence is not in itself worrisome (yet!). Over the past months opioid deaths and cannabis commercialization have dominated the political health agenda, and it may be a simple case of a political inbox piled too high.

But the clock is set, and soon she will have to decide how she will leave her mark on tobacco use.
Will she follow the footsteps of Ministers like Judy LaMarsh, John Munro, Jake Epp and Allan Rock and set a new course for protecting public health?  Or will she, like Marc Lalonde, Perrin Beatty, Anne McLellan and Rona Ambrose, oversee the diminishment of departmental ambition and resources for this file.

The federal vision for tobacco will be revealed this spring

In only 11 weeks, on March 31, 2018, the federal tobacco control strategy (FTCS) expires and will be replaced by a new 5-year plan for tobacco control. Although the department and Minister affirm the goal of reducing smoking prevalence to 5% by 2035, there are no signs on how they intend to get there.

The reboot on the FTCS will be the fourth 'refreshing' exercise on the federal approach since it was set up as a multi-departmental initiative in 2001. As I understand it, each of these renewals has required the buy in of senior health officials as well as the central agencies (Treasury Board, Privy Council Office, etc).

Sadly, each of these renewals has produced a smaller and less ambitious successor. What was once unveiled as a priority program has decayed into just-another-departmental-program. 

• Initially designed as a $110 million a year program, the budget for the FTCS is now only $43 million, of which Health Canada receives $37 million. Once inflation is taken into consideration, the budget has fallen by two-thirds from the original design.
• Whole swathes of federal activity have been abandoned: advertising and public education, community programming and international support. 
• Other aspects, like smoke-free environments, retail regulations, youth-programming and cessation support have largely been handed off to provincial governments. 
• Even in some areas of core federal responsibilities, such as those affecting the health of some indigenous communities, surveying tobacco use, funding research or controlling contraband, federal activities were pulled back.

Despite this attrition, the FTCS is generally viewed as a successful federal program and Health Canada is still regarded as a global leader in the area of tobacco product regulation. Health Canada's activities --  particularly in the early 2000s —are acknowledged as having made a real contribution to the changed social attitudes around tobacco use, to achieving smoke-free spaces across Canada, to adopting innovative regulations (like picture based warnings) and to reducing the smoking rate. 

It would be a mistake for planners to take a continued downward momentum for granted.

New challenges, new ideas

Circumstances are very different now than they were when the FTCS was initially designed, and there is general acknowledgement that it is time for a deep re-think of tobacco control strategies, and for the development of qualitatively different approaches.

Outside of government, a lot of deep-thinking has taken place about the pro-active steps that government can take to accelerate reductions in tobacco use. Last year, Health Canada received thoughtful input from experts and community leaders won how to modernize and strengthen tobacco control. Prominent among these are the results of an “Endgame” Summit in 2016 and the recommendations of the Executive Steering Committee for the Modernization of Smoke-Free Ontario, convened by the Ontario government.

The recommendations flowing from both of these expert-driven reviews were for governments to scope out their strategies (i.e. by including stronger controls over supply) and to scale up effective interventions. "Bold and innovative" was the catch-phrase often used to describe the elements of a modernized approach.

What worked yesterday may not work tomorrow 

"Bold and innovative" also describes the approach taken by the tobacco industry in recent years.

The regulatory and programming approach to tobacco that has developed over the past decades is now facing new challenges for which public health tools have not yet been adopted. These include the upcoming legalization and increased commercialization of two products closely linked with tobacco use — cannabis and nicotine vaping products. They also include the impact of emerging technologies developed by the tobacco industry (like heat-not-burn tobacco products).

The development by governments and health advocates of reactive strategies to respond to these challenges is lagging. How to respond to the tobacco industry's new approach to marketing a spectrum of nicotine products? To the potential that increased cannabis use will drive up tobacco use? (The Ontario Tobacco Research Unit reports that one third of Ontario cannabis users mix tobacco in their joint). 

The government's discrete and binary approach to nicotine
regulation fits poorly against the continuum of tobacco, nicotine,
hybrid and mixed products under development by BAT and other companies 

These challenges require new research, a willingness to innovate and stable and long-term funding. National Non-Smoking Week would be a good time for the Minister of Health to reassure Canadians that these are on the table. 

Having to wait until April for an articulated vision for tobacco control by the new government is a cause for concern. It may also be a symptom of the larger challenge we face in maintaining political and social interest in the long-standing crisis of tobacco use.