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A five-year, first-in-Canada study, led by McGill cardiologist Dr. Mark Eisenberg, is exploring whether vaping really is the magic ticket to finally breathing free and easy.
By James Martin
Although the holidays may seem like a distant memory, statistically speaking, most of us are still sticking with our New Year’s resolutions. (For now. Let’s not talk about how many of us last until July.) For many, that means quitting smoking — and they’re hoping that electronic cigarettes will help. According to the U.S. Centers for Disease Control and Prevention, nearly half of all American smokers have tried e-cigarettes to help them kick the habit. But Dr. Mark Eisenberg wants to know: Is vaping really the magic ticket to breathing free and easy?
Dr. Eisenberg is passionate about getting people to butt out. He gives a lot of smoking cessation talks — just last month, he spoke at the Jewish General Hospital, where he is staff cardiologist — and has noticed that, invariably, reformed smokers come up to him afterward to sing the praises of e-cigarettes, those increasingly popular handheld battery-operated vaporizers that mimic conventional cigarettes.
“They say, ‘I smoked for decades and I’ve tried everything — nicotine gum, patches, Zyban, Champix — and I couldn’t stop. Then I picked up an e-cigarette and I never smoked again,’” recalls Eisenberg, who is also a professor in McGill’s Faculty of Medicine and director of the Joint MD/PhD program. “Anecdotally, we have many, many cases like this.”
What doctors don’t have, however, is hard data to back it up. That’s why, this month Eisenberg will start a five-year clinical trial to look at how effective e-cigarettes are at aiding smoking cessation. It’s not just smokers and physicians who are interested in such clarity — so are lawmakers. Under Canada’s Food and Drug Act, e-cigarettes containing nicotine cannot be imported, advertised or sold without Health Canada’s approval; nicotine-free e-cigarettes are not restricted. Although Health Canada has yet to grant such approval, nicotine-loaded e-cigarettes are nevertheless widely and openly available in Canada.
The study, which is funded by the Canadian Institutes of Health Research (CIHR), will follow 486 outpatient smokers at 19 sites across Canada. The smokers will be randomized into three groups. One group will be given e-cigarettes that contain nicotine and counselling. The second group will receive e-cigarettes that do not contain nicotine, and counselling. The third group will only receive counselling. The researchers will supply the smokers with e-cigarettes for 12 weeks, and then follow up with them after six months and a year, observing whether they graduate to total non-smoking, continue with the e-cigarettes, or return to conventional cigarettes. Although some reformed smokers may fall off the wagon after a smoke-free year, Eisenberg clarifies that “statistically significant results at 12 months would still be important evidence” for the efficacy of e-cigarettes as a cessation aid. All 486 patients will not be enrolled simultaneously, with the study expected to roll out over the course of five years.
“The ultimate goal is to use the e-cigarette as a transitional tool in going from smoking conventional cigarettes to not smoking at all,” says Eisenberg. He notes that, at least in the early stages, e-cigarettes are about “transferring the addiction. You’re getting people onto something else that is giving them their nicotine, so they may never quit. E-cigarettes also provide other physical and social aspects because they feel like a cigarette; a pack-a-day smoker makes that hand-to-mouth motion more than 70,000 times a year, for example. That’s a difficult thing to break away from, and a nicotine patch doesn’t provide it.
“We have great hopes that e-cigarettes will be helpful for people trying to quit smoking,” he adds. “Even if they just switch to smoking e-cigarettes that would be better than continuing to smoke conventional cigarettes for decades. I’m not saying that e-cigarettes are safe, but they’re much safer than conventional cigarettes. They’re not going to give you lung cancer. They’re not going to give you heart disease. They’re not going to give you emphysema.
“But what we’re really hoping for is that e-cigarettes lead people to not smoking altogether.”
(This particular study, Eisenberg notes, is not designed to investigate safety concerns, such as whether e-cigarette vapour contains trace elements of harmful substances. Other than their smoking habits, the trial’s participants are healthy, he explains, “so the chances that they’d have adverse effects over a short time like the course of one year are quite low.” The researchers will, however, track whether the smokers are hospitalized for any cardiopulmonary issues. They will also gather data about benign side effects, such as throat irritation.)
E-cigarettes are already big business, ringing up an estimated $500-plus million in sales in the U.S. alone — and that’s without being able to make any claims about helping smokers kick their habits. Eisenberg says that the e-cigarette industry itself isn’t clamouring to make such claims: “They don’t want to be regulated by the Food and Drug Administration [in the U.S.] and Health Canada, so they don’t want to support clinical trials,” he says. “And they don’t need to: Smokers are voting with their feet by buying e-cigarettes to help them quit smoking.” Governments, however, want more than anecdotal evidence.
“This study alone would not be enough for Health Canada to allow companies to market e-cigarettes as smoking cessation aids,” explains Eisenberg. “That said, if this trial shows that there is a substantial reduction in smoking traditional cigarettes, then Health Canada will have to rethink their policy.
“This is just a first step. Then we would need multiple big trials in multiple populations. We would need to use tapering [of nicotine levels] studies, and we would need to use interventions that are longer than 12 weeks. But the fact is that smoking is still the single most reversible cause of mortality in Canada — so it’s an important first step.”
Posted on Wednesday, February 3, 2016
People trying to give up smoking often use e-cigarettes to help wean themselves off tobacco. Most experts think they are safer than cigarettes but a surprising paper was published recently – it suggests that people who use e-cigarettes are less successful at giving up smoking than those who don’t.
“E-cigarettes WON’T help you quit,” reported the Daily Mail. “Smokers using vapers are ‘28% less likely to ditch traditional cigarettes,'” read the paper’s headline.
The story was reported on many other websites around the world, including CBS: “Study: E-cigarettes don’t help smokers quit,” it said.
The study causing the fuss was written by researchers at the Center for Tobacco Control Research and Education at the University of California, and published in one of the Lancet’s sister journals, Lancet Respiratory Medicine.
It is a meta-analysis, which means the authors reviewed the academic literature already available on the topic. They sifted out the weaker papers – ones that didn’t have control groups, for example – and were left with 20.
The conclusion? Smokers who use e-cigarettes have a 28% lower chance of quitting than smokers who don’t use them, according to Prof Stanton Glantz, one of the authors.
But while the conclusion is surprising, so is the number of academics who have criticised the paper.
One was Ann McNeill, professor of tobacco addiction at Kings College London, whose own research is included in Glantz’s analysis.
“This review is not scientific,” she wrote on theScience Media Centre website.
“The information… about two studies that I co-authored is either inaccurate or misleading… I believe the findings should therefore be dismissed.
“I am concerned at the huge damage this publication may have – many more smokers may continue smoking and die if they take from this piece of work that all evidence suggests e-cigarettes do not help you quit smoking; that is not the case.”
Prof Peter Hajek, director of the Tobacco Dependence Research Unit at the Wolfson Institute also called the findings “grossly misleading”.
The critics are making three main points. First, the definition of e-cigarettes is a bit loose. There are many different types – some look like cigarettes, others have tanks for the vaping liquid, some are disposable and other are multi-use. They all deliver different doses of nicotine. Many of the papers included in the analysis don’t specify which type people are using, according to Linda Bauld, professor of health policy at the University of Stirling.
Another point is that the studies vary in the way they measure how often people use e-cigarettes. “Some only assessed whether a person had ever tried an e-cigarette or if they had tried one recently, not whether they were using it regularly or frequently,” Bauld says.
Even the paper’s author admits it’s possible that in some of the studies e-cigarettes may only have been used once, which he says would not be a good predictor of whether they had affected people’s ability to stop smoking.
And there is another problem. You might expect, if you were going to draw conclusions about how useful e-cigarettes are in helping people quit, to focus on studies looking at people who are trying to give up.
Prof Robert West, who heads a team at University College London researching ways to help people stop smoking, says this analysis mashed together some very different studies – only some of which include people using e-cigarettes to help them quit.
“To mix them in with studies where you’ve got people using an e-cigarette and are not particularly trying to stop smoking is mixing apples and oranges,” he says.
Some of the studies track smokers who use e-cigarettes for other reasons – perhaps because smoking a cigarette in a bar or an office is illegal and they want a nicotine hit.
“With the studies where people are using electronic cigarettes specifically in a quit attempt the evidence is consistent,” says West, referring to two randomised control trials.
Both are quite small and one was funded by the e-cigarette industry. They took two groups of smokers, and gave one real e-cigarettes, and the other a placebo. The studies reach a broadly similar conclusion to a large, real-world study called the Smoking Toolkit run by West.
West’s investigation follows people in their daily lives and assesses how successful various methods of giving up smoking are – this includes nicotine patches, medicines and going cold turkey.
These studies suggest that people using e-cigarettes to help them quit are 50% to 100% more successful than those who use no aids at all.
In his paper, Glantz acknowledges there are limitations to the research that he analysed. He agrees there are problems with the way the use of e-cigarettes is measured and accepts it’s not clear which devices people are using. But he is sticking by his analysis because he believes he has taken these factors into account.
The editor of Lancet Respiratory Medicine, Emma Grainger, defends the article too. She says she does not see a problem with the paper and that it has been through the normal peer-review process.
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If your New Year’s resolution was to stop smoking, and you were looking for support to help you quit, then recent headlines suggesting e-cigarettes ‘aren’t any safer than tobacco’ might have raised an eyebrow or two.
Since Christmas, we’ve seen three sets of critical headlines about e-cigarettes, each looking at a different aspect of a device now used by millions across the UK.
But how accurately do these stories reflect the scientific evidence? What do we really know about how safe e-cigarettes are? Can they really help you quit? And do candy flavours attract kids?
If you were to go on the media reports alone, you’d be forgiven for being alarmed.
But as is so often the case in the reporting of science and risk, taking a deeper look behind the headlines reveals a very different story.
Just because they’re not “safe” doesn’t mean they aren’t “safer”
The first study to make the headlines suggested that e-cigarettes were ‘as harmful as tobacco’. After studying cells in the lab, the researchers found some indications of increased levels of DNA damage and cell death in those treated with e-cigarette vapour.
This led one of the researchers to tell the media, “I believe [e-cigarettes] are no better than smoking regular cigarettes.” (More on this statement below).
The most important thing to remember here is that this was a study looking at the effect of chemicals on cells in a lab. Although this can be useful, it obviously can’t give a clear idea of what the impact would actually be in your body. So any claims of impact on health based only on lab studies will always be far-fetched.
The study also looked at an extremely high concentration of vapour. As the researchers admitted at the time, “it was similar to someone smoking continuously for hours on end, so it’s a higher amount than would normally be delivered.”
It boils down to this: the study showed that it might be worse for your cells to be exposed to e-cigarette vapour than the air in a lab. So e-cigarettes might not be 100 per cent harm free. Andprevious studies have shown there may be some dangerous chemicals present in vapour – so this isn’t a surprise. And there’s little in life that really is ‘safe’ – even drinking too much water can kill you.
But here’s the big caveat. The researchers also treated some cells with tobacco smoke. These died within 24 hours. Those treated with e-cigarette vapour were still alive to experiment on 8 weeks later.
So, contrary to the headlines, this study actually suggests that using e-cigarettes may be far less dangerous than smoking.
You’d never believe that from the headlines though.
Contrary to what was stated or implied in much of the news coverage resulting from this news release, the lab experiments did not find that e-cigarette vapor was as harmful to cells as cigarette smoke. In fact, one phase of the experiments, not addressed in the news release, found that cigarette smoke did in fact kill cells at a much faster rate. However, because similar cell-damage mechanisms were observed as the result of both e-vapor and regular cigarette smoke, Dr. Wang-Rodriguez asserts, based on the evidence from the study, that e-cigarettes are not necessarily a healthier alternative to smoking regular cigarettes. As stated in the journal paper and the news release, further research is needed to better understand the actual long-term health effects of e-cigarettes in humans.
But we’re concerned that, as far as public perception goes, the damage may already have been done.
How can you tell if something helps people quit?
So the scientific evidence on e-cigarette vapour to date suggests it’s far safer than tobacco smoke.
But can e-cigarettes actually help you quit?
Here we come across the second set of unfortunate stories, after a systematic evidence review and meta-analysis published last week claimed that those using e-cigarettes seemed to be less likely to quit smoking than those not using the devices.
But, again, there are a number of serious problems with the review.
Systematic reviews and meta-analyses are usually extremely useful, because they pull together all the evidence in one area, to paint a fuller picture than one study alone.
However the relationship between this picture and reality depends entirely on the quality and relevance of the original studies that are included. In this case, since there haven’t been many high-quality trials exploring whether e-cigarettes help people quit smoking, the researchers included a range of different types of studies.
The gold standard of evidence is the randomised control trial, which, in this case, would compare a group of smokers trying to quit using a nicotine-containing e-cigarette, to a similar group using nothing (or an e-cigarette without nicotine). But here’s the problem – there have only been two published studies like that.
A 2014 meta-analysis of these found people using nicotine via an e-cigarette were more likely to successfully quit than those using e-cigarettes without nicotine.
Last week’s review included both of these randomised trials alongside a range of other ‘real-world’ non-trial studies of e-cigarette use. This is a big problem. Whatever their strengths individually, these studies didn’t use consistent measurements – neither of e-cigarette use, nor of whether people had actually quit – so the studies aren’t necessarily comparable. And so including them together in a meta-analysis is questionable, at best.
Even so, when the analysis only included studies where people were actively trying to quit (as opposed to using e-cigarettes for other reasons) the results became inconclusive – people who said they’d ‘ever’ used an e-cigarette weren’t any more or less likely to succeed.
Furthermore, some of the studies included only looked at current smokers and asked about e-cigarette use. This would exclude anyone who had used an e-cigarette but successfully stopped smoking.
Quitting smoking can be incredibly hard. Someone trying an e-cigarette once probably wouldn’t have any better chance than if they hadn’t. Whatever support aid is used it would need to be as part of a concerted quit attempt and used enough to deliver sufficient nicotine to wean yourself off tobacco, and preferably alongside specialist support from a Stop Smoking Service to get the best possible chance of quitting.
E-cigarettes aren’t a magic bullet, but that doesn’t mean they couldn’t be a useful weapon in our arsenal against tobacco. The evidence for quitters using these products both within the Stop Smoking Services and without points towards this being the case in the UK.
The impact of advertising and flavours on kids
Whether or not they’re ‘safe’, or help people quit, another big concern about e-cigarettes is that they could encourage children to start smoking – either by exposing them to nicotine (the ‘gateway’ argument) or by making smoking seem more normal again (the ‘renormalisation’ argument).
The first of these arguments isn’t supported by the evidence to date: surveys across the UK last year found that young people who hadn’t smoked weren’t using e-cigarettes.
But a small study published this week found young people rated printed adverts with flavoured e-cigarettes more appealing than those without flavours, leading to headlines suggesting children are being lured in with sweet flavours.
But when you dig into the detail, again it’s a more complex picture – the young people in this study, including those who saw the flavoured e-cigarette adverts, had negative views about e-cigarettes, and said they didn’t intend to buy them. And, perhaps more importantly, it didn’t find any evidence that e-cigarette adverts increase the appeal of regular cigarettes.
There are now measures in place to protect young people (e-cigarettes cannot be sold to under 18s, and further legislation heavily restricting advertising will come into force in May) but it’s still important to continue looking at how e-cigarette adverts might appeal to children, and to track use of both e-cigarettes and tobacco cigarettes to make sure there isn’t a negative impact from these products.
However, Linda Bauld, Professor of Health Policy at the University of Stirling (and our Cancer Prevention Champion), said the study “should provide some reassurance to those who say that e-cigarette advertising will result in a new generation of tobacco smokers.”
Where does this leave us?
When you look at the bigger picture, rather than the headlines, the evidence so far actually points towards a positive role for e-cigarettes in helping combat the biggest preventable cause of cancer. However none of the questions posed here – on safety, effectiveness and impact on children – have full answers.
As we’ve said before we need years of good quality science before we can definitively answer these questions, and at Cancer Research UK we are working towards that. But for now the evidence we have suggests e-cigarettes are far safer than smoking tobacco, they might help you quit and non-smoking children aren’t being lured into using them regularly.
While the evidence on e-cigarettes continues to accumulate, and the media controversy rages on, if you’re looking for evidence-based inspiration to quit smoking in 2016, speak to your GP or localStop Smoking Service, or check out our website… but maybe keep reading the headlines with an appropriate dose of scepticism.
Nikki Smith is a senior health information officer at Cancer Research UK
By Phil Kerpen
After a lengthy and heavily contested regulatory process, a final rule deeming vapor products to be subject to pervasive FDA regulation is currently in the White House Office of Management and Budget for a final review before it is published and takes effect this year. Leaks of the purported final rule suggest it remains deeply flawed and will impose a draconian, one-size-fits-all model that risks disrupting the fast-growing vapor industry and denying access to products that pose vastly less health danger than conventional tobacco cigarettes. Unfortunately, in the final negotiations over last year’s omnibus bill a provision addressing this issue was dropped, but that should not be the last word on the issue from Congress.
Mitch Zeller, the FDA’s top tobacco regulator, told Congress “If we could get all of those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health.”
Indeed, vapor products are displacing regular cigarettes. The most recent data from the CDC show the percentage of the adult population that smokes has dropped six consecutive years, from 20.6 percent in 2009 to 14.9 percent in the first half of 2015. An estimated two million ex-smokers are using vapor products.
So we’re on the right track, and Zeller warned: “Let’s not lose our focus on what the primary cause is for those 480,000 avoidable deaths each year—it’s primarily burning, combusting cigarettes.”
Unfortunately, his agency is poised to do precisely that with its deeming rule.
“This is not really regulation. It’s prohibition,” says Boston University community health sciences professor Dr. Michael Siegel.
He’s referring to a feature of the rule that sets a grandfather date of February 15, 2007 – effectively denying grandfather status to nearly every vapor product on the market and forcing each to go through a lengthy approval process or be pulled from the market within 24 months.
That date and timeline were established by the Family Smoking Prevention and Tobacco Control Act, passed by Congress in 2009 – and it grandfathered all but the very newest cigarette products. By now deeming vapor products subject to regulation seven years later, the FDA is subjecting these safer products to more draconian regulation.
Jan Verleur, co-founder and CEO of VMR Products, a major manufacturer of vapor devices, said: “It’s essentially a death sentence for industry. It could be held up in litigation for many years.”
That’s only slight hyperbole.
Once the rule is final, manufacturers would be required to submit to the FDA, for each product, a Premarket Tobacco Application (PMTA) or a Substantial Equivalence (SE) report. The PMTA process is complex and expensive and would be challenging for all but the largest manufacturers – the major tobacco companies – to navigate. The SE choice depends upon showing that a predicate product is already approved, but vapor technology is new and rapidly evolving, ruling this option out. The investment driving that innovation would be chilled by time and expense of submitting every product for regulatory approval – and the agency already has a substantial backlog.
The solutions are simple but will require Congress to act quickly, because the rule currently sits at OMB and could be published any day. On the next appropriate must pass vehicle Congress should include language that either delays the rule completely or fixes its most egregious flaws – the imposition of an inappropriate grandfather date and an insufficient approval period. Failure to do so will result in regulating vapor more strictly than cigarettes, destroying thousands of small businesses, and, tragically, likely increasing tobacco-related sickness and death.