Tag: harm reduction

  • ‘Harm Reduction Is Human Right’

    ‘Harm Reduction Is Human Right’

    Photo: Horst Winkler from Pixabay

    The European Tobacco Harm Reduction Advocates (ETHRA) is calling on policymakers to recognize the benefits of tobacco harm reduction in advance of World No Tobacco Day on May 31.

    According to ETHRA, reduced-risk products such as e-cigarettes and snus are providing a gateway out of smoking for millions of Europeans, yet across the continent, consumer access to these products is being denied or is under threat.

    Today, the organization launched a manifesto to promote appropriate regulation of innovative solutions for people who wish to continue using nicotine in far safer forms than smoking tobacco, as well as on behalf of the many smokers who may be able to quit through switching to these products in the future.

    Among other things, the manifesto calls for access to harm reduction, including tobacco harm reduction, to be recognized as a human right; for consumers of safer nicotine products to be recognized as essential stakeholders in discussions of policy; and for the regulation for safer nicotine products to reflect the risks relative to the risks from smoking. 

    What’s more, regulators must recognize that having a wide choice of products and flavors is key to the success of safer nicotine products in enabling people to stop smoking, according to the manifesto. Regulation must consider the harm to adults when considering bans intended to protect youth, and tax policy must consider that high taxation of safer nicotine products increases rates of smoking.

    Comprising 21 consumer associations in 16 European countries, the ETHRA was created to increase understanding about the benefits of “new” risk-reduced nicotine products and to promote recognition of long-term recreational use of nicotine as an incentive for smoking cessation.

  • Licensed to Help

    Licensed to Help

    Credit: Voke
    The Voke has no batteries and no electronics and therefore generates no heat and no chemical reactions.

    By George Gay

    This story it is not about vaping nor about a vapor device. Vapor devices can be described as electronic nicotine-delivery systems (ENDS); however, Voke is a nicotine inhalation device and does not fit into such a classification, except in the limited sense that it delivers nicotine.

    Licensed by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) as a medicinal product that is a safer alternative to smoking, Voke can be usefully described as an alternative nicotine-delivery system that uses pharmaceutical-standard inhaler technology but offers it in a device that closely resembles a traditional cigarette in both the way it looks and in the way a consumer, in using the device, mimics most of the rituals of smoking. Voke has no batteries and no electronics and therefore generates no heat and no chemical reactions. It produces no smoke or vapor, just an invisible, odorless aerosol.

    In theory at least, Voke should be a game-changer. It will be interesting to follow its fortunes on the market—to see how committed smokers and vapers are to the pursuit of reduced risk. It will also be interesting to watch the reaction of those opposed to smoking and, especially, those opposed to smoking and vaping. In the case of smokers and vapers, for instance, will they prove to be willing, in the name of risk reduction, to move from inhaling warm smoke or vapor to inhaling a cool aerosol? And what will tobacco control make of a device that is licensed to save lives?

    Credit: Voke
    TESTING THE COMMITMENT

    For the time being, that commitment to risk reduction is being tested just among U.K. smokers. Alan Sutherland, the CEO of Kind Consumer, the independent, London-based healthcare research and development company that launched Voke in November, told Vapor Voice that the device was being made available only online at voke.com to people based in the U.K. who were over the age of 18. The online-only launch had been a deliberate choice, said Sutherland in an email reply. In that way, Kind could track and monitor initial consumer response and feedback, as well as ensure its manufacturing capability was able to keep abreast of demand as the company ran various consumer media tests.

    Already, Kind has been promoted through a number of communication channels. “We have used this launch phase to test and trial various media vehicles from out of home (buses/train stations/bus shelters) to regional and national radio and most recently TV,” said Sutherland. “We have also now been cleared to advertise on Facebook as well as the London Underground where we just ran a campaign.”

    While I have no experience in marketing, I would guess that Kind is hitting at least some of the right buttons. I learned about its launch from the man who owns the garage where I have my car serviced. He doesn’t smoke or vape but he is interested in the welfare of his mechanics, some of whom do smoke, vape or both.

    Certainly, while these are early days, Kind is pleased with the response. “We are very happy with the results so far and especially by the growing level of repeat purchases,” said Sutherland. “Despite Covid-19, we are still seeing good online sales performance for Voke. In particular, people like the fact that Voke is licensed as a medicine by the Department for Health and Social Care as a safer alternative to smoking. Customers are also commenting positively on how quickly Voke reduces their nicotine cravings.”

    In respect of sales, Sutherland said Kind was delivering ahead of its expectations, even though it had chosen to start cautiously. “We have had half a million visits on our site,” he said. “Conversion rates are good, and already, 23 percent of revenues are coming from repeat purchases, which is why we are confident to start scaling up now.”

    In the short term, Kind’s capacity is about 5 million packs annually, but it could increase that to 35 million packs next year. The Voke pack, which has an underlying plastic structure and a paperboard cover that looks and feels like a cigarette pack, includes a canister containing a gas under pressure in liquid form that comprises medicinal-standard nicotine and slight menthol flavor masking along with a cigarette-like device. This device, which is filled from the canister, provides for a period of consumption that aligns with that of a traditional cigarette while one canister provides for about 20 “cigarette” refills, so there is plenty of continuity for cigarette smokers.

    Also, in the short term, Kind says, it is focusing on expanding its U.K. business and, especially, trying to help smokers who are said by some to be more at risk than nonsmokers if they contract Covid-19. And there would seem to be a ready-made consumer base for Voke. “Research tells us more than 50 percent of smokers try to quit and fail, and more than one in five won’t try anymore because they believe it is too difficult,” Sutherland said. “We want to help them.”

    There can be little doubt that Voke has some advantages over cigarettes and electronic cigarettes when it comes to sales channels. While the product has a medicine license that allows it to be prescribed by a doctor in the U.K., it also has an over-the-counter or general sales list label, so it can be sold anywhere from pharmacies to major retailers, corner shops and garage forecourts.

    Additionally, despite the fact that Voke is not a vapor device, vape shops could prove to be an important sales channel since anyone who walks through the door of such an outlet is a person who has already decided to replace her smoking habit, or part of it, or who has at least decided to investigate doing so. And vape shops provide a space in which issues, such as Voke’s cool delivery, can be discussed.

    BEYOND CESSATION

    In the meantime, Kind is laying the groundwork for future international expansion, with a strong focus on the U.S., Europe and New Zealand, which aims to be smoke-free by 2025. Its U.K. medicine license can probably be leveraged in some other countries—with the notable exception of the U.S.—and, at the same time, there is no reason why Voke, under another name and possibly modified, could not be sold in other jurisdictions simply as a consumer product.

    However, Kind’s ambitions go way beyond smoking cessation. It says it is intent on pioneering new technologies to improve public health and address some of the most significant global healthcare challenges in the 21st century. “Vaporless valve technology (VVT) presents an exciting new way of administering medicines into the body with a potential to reach into a range of therapeutic areas beyond smoking cessation alone,” said Sutherland.

    It is not surprising that Kind wants to expand its areas of interest. The gestation period of Voke has been long and costly and has required a steep learning curve. Indeed, its appearance on the market can be seen as a remarkable act of faith.

    A HARD SLOG

    Kind was founded by Alex Hearn in 2006 with the aim of developing a safer alternative to cigarettes that would also address smokers’ psychological and physiological needs. Hearn is something of a polymath. He studied classics at Oxford University, is well read in science and has the sort of business acumen that led him to start an entrepreneurial body at Oxford whose model was adopted by other major universities in the U.K. and the U.S.

    In 2009, Kind set out in earnest on the development of Voke, and, though it did not yet have a product, it soon found itself in a commercial bind. At that time, when e-cigarettes were still something of a novelty, it was believed that, under the then forthcoming revised EU Tobacco Products Directive, all vapor products sold in the EU would need to have a medicine license, but such a requirement fell by the wayside. So Voke, a device being developed at great expense within the constraints necessary to make it conform with a medicine license, was going to have to compete with devices developed at less expense without such constraints, a situation that one close observer described as “commercially challenging.”

    It goes without saying that obtaining a medicine license, which Voke was granted only in 2014, was beyond challenging. And yet another major challenge arose in January 2017 when Kind and British American Tobacco, which had partnered with Kind in developing Voke, announced that they were going their separate ways. Kind, according to an announcement at the time, was going to take back ownership for the commercialization of Voke, allowing it to “embrace the full economics of the opportunity.”

    It was an opportunity but also a challenge because Kind needed to find another partner, one that could help it scale up the manufacturing process, an undertaking that was bound to be costly given that the medical license meant the company’s processes, manufacturing operations and products were subject to the strictest protocols, were under the tightest scrutiny and had to be fully traceable.

    Given this, it was not surprising that, in August 2018, Kind announced that Voke had been delayed getting to market by issues surrounding the scaling up of its manufacturing process, though the good news was that the company had raised further funding from existing and new investors—funding that would be used to complete the setup of state-of-the-art manufacturing capacity for Voke, which was and still is centered on two pharmaceutical facilities at Runcorn in the U.K. and Waterford in Ireland.

    Having gone through so many challenges in getting Voke to market, it was something of a cruel irony that shortly afterward, the world was struck by a deadly coronavirus. But all is by no means lost. Kind has built up a three-month reserve of Voke in case manufacturing has to be interrupted. And though it seems callous to say so (and while Kind did not make any mention of this in its email), the coronavirus could have an upside in respect of demand for Voke simply because of the huge number of stories that are being published suggesting—with, I imagine, little evidence—that a smoker or vaper is more at risk than others of contracting Covid-19.

    BECAUSE IT WORKS

    In truth, Voke seems destined to be accepted because it works: It delivers a fast, effective and discreet craving relief that—and this surely is most important—can be enjoyed anywhere, anytime. This is a licensed medical device that produces no visible exhalation and produces no odor, so, a person could use it in the office, while on public transport, including airplanes, and while visiting a hospital. Of course, there is always a possibility that a business, perhaps an airline, might want to try to ban its use, though it is difficult to discern a rational reason why it might want to do so.

    Unfortunately, however, this powerful use-anywhere argument is also perhaps the device’s weakest point because it is the point where it will be attacked by some in tobacco control concerned that a smoker will be able to use it to maintain his or her addiction in places where otherwise she or he would not be able to do so.

    But this argument, often used against e-cigarettes, will surely be less effective in the case of Voke than in the case of other next-generation products. Firstly, because of the way that it delivers nicotine, Voke has to deliver only a low dose, 0.45 mg, from which, if the U.S. Food and Drug Administration is correct, it could be inferred that the new device creates a significantly lower risk of sustaining addiction than cigarettes or e-cigarettes.

    Secondly, any addiction maintenance effect will surely be more than offset by the product’s use by some smokers to substitute completely for cigarettes and by others to transition away from tobacco and nicotine products altogether.

    Finally, it is worth noting that Voke also offers a considerable advantage over lower risk tobacco/nicotine products and devices when it comes to the environment. As is mentioned above, Voke uses no battery, and it is a relatively simple device made of metal, card and plastic: materials that can be recycled. There’s no butts about it.

    Picture of George Gay

    George Gay

  • First, Do No Harm

    First, Do No Harm

    Doctors often recommend Chantix to their patients who smoke, but the drug has a long history of serious side effects.

    By Maria Verven

    Smokers have always been at a higher risk of heart and lung disease, but the Covid-19 pandemic has made quitting combustible cigarettes even more urgent. Cigarette smoking is a cause for concern because smoking inhibits the body’s ability to heal from infections such as the coronavirus, says Michael Siegel, a Boston University School of Public Health professor with more than 30 years’ experience in tobacco control, including two years at the U.S. Centers for Disease Control and Prevention (CDC) Office on Smoking and Health.

    While the U.S. Food and Drug Administration (FDA), the CDC and the media often denigrate and vilify e-cigarettes, the drug varenicline, sold as Chantix, continues to fly relatively smoothly under the radar screen. When searching Google for e-cigarettes, you’ll get a whopping 386,000 results, including the predictable articles about youth e-cigarette use. In contrast, a search for Chantix nets only about 7,000 results, including a new study (read on to learn more) the authors use to promote its supposed safety and support the FDA decision to remove its black box warning. 

    Search on the CDC site for Chantix and you’ll get only 66 results versus over 2,200 for e-cigarettes; the top results for e-cigarettes mention “pulmonary disease,” “lung injury” and “youth tobacco use” even though e-cigarettes contain no tobacco. In contrast to nearly 3,300 results for the search term e-cigarette, the FDA site also only lists 78 results in a search for Chantix, and the top result is an update on their September 2016 decision to remove the boxed warning based on the conclusion that the “risk of serious side effects on mood, behavior or thinking is lower than previously suspected.”

    Antwon Mcmullen I Dreamstime.com
    BLOCK BOX WARNS OF SUICIDE AND PSYCHIATRIC PROBLEMS

    Approved under the brand name Chantix in 2006 for smoking cessation, the drug varenicline originally carried a label warning consumers of the risk of suicide and other psychiatric problems, including depression and mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety and panic as well as suicide and suicidal ideation and attempt.

    By the end of 2007, the Institute for Safe Medicine Practices (ISMP), a nonprofit medication watchdog, reported that Chantix was responsible for more reports of serious drug adverse events than any other drug in the U.S. “Data show that varenicline, ‘Chantix,’ continues to account for more cases of suicidal, self-injurious or homicidal thoughts than any other therapeutic drug from 2007 through 2013 Q3—more than three times as many as the second-ranked drug,” the ISMP reported.

    Four leading nonprofit consumer, research and medical organizations—Consumer Reports, , the National Center for Health Research, the National Physicians Alliance and Public Citizen—joined the ISMP in filing a citizen petition with the FDA, documenting the extensive scientific evidence of Chantix’s substantial risks.

    The FDA finally added its strongest black box warning in July 2009 after receiving 153 reports from doctors who were deeply concerned when their patients suddenly started exhibiting suicidal behavior.

    By the fall of 2013, Chantix was associated with 2,748 adverse events (14.8 percent of all cases), including 293 suicides, 490 attempted suicides and many other cases involving self-injurious behavior or homicidal ideation—more than any other medication sold in the U.S. The ISMP ultimately recommended that “patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation.”

    CLASS-ACTION LAWSUIT FLIES UNDER THE RADAR

    Not surprisingly, these adverse events spurred thousands of lawsuits by families of loved ones who suddenly and inexplicably took their lives while on Chantix. In March 2013, Pfizer, the drug’s maker, settled 80 percent of these lawsuits out of court for an estimated $273 million.

    What’s odd is that any reports of adverse events associated with Chantix end then and there. Try searching for how and when the other 20 percent of lawsuits have been resolved or the latest statistics on how many attempted or successful suicides or homicides have taken place over the last six years, and the trail runs cold.

    However, it’s easy to uncover the fact that Chantix has been linked with a host of neurologic or cardiac risks, including blackouts, convulsions and impaired vision. Due to these and other well-known psychological side effects, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix; the Department of Defense and the Department of Transportation also disallow its use by missile crews, armed military personnel, police, fire and emergency professionals and anyone in a “sensitive” occupation. 

    Yet it recently became even easier to buy Chantix—as of 2019, at least 12 states now enable consumers to purchase the drug without a doctor’s prescription. Between 2013 and 2018, the cash price for Chantix increased by 106 percent. Pfizer reported that U.S. sales were $899 million in 2019, up 7 percent from 2018. But another development may make the drug even more accessible and affordable: Pfizer’s patent protection expires in May 2020, so a generic version could potentially be available as early as this June.

    Not surprisingly, Pfizer is seeking a court order to block copies of its drug until all its patents have expired—including those set to expire in November 2020, November 2022 and February 2023. 

    SUSPICIOUS STUDIES

    Back in September 2016 when the FDA’s advisory committee met to review the black box label on Chantix, the meeting got quite contentious. There appeared to be much disagreement over whether to remove the boxed warning. Indeed, of the 19-member panel, five actually recommended strengthening the label and four recommended a language change.

    But most suspicious was the evidence used to remove the black box warning: The voting members of the panel were presented with an April 2016 clinical trial paid for by Pfizer. Even the FDA noted a number of violations in Pfizer’s clinical trial protocols, including inconsistencies in source data, missing documents and safety assessments, and failure to record adverse events.

    Plus, the personnel who performed the diagnostic interviews and mental health evaluations failed to meet the most basic professional qualifications. In fact, six of the 10 authors worked for either Pfizer or GlaxoSmithKline, maker of Zyban, a brand of antidepressant bupropion that is used as a quit smoking aid, while three, including the lead and second-named authors, were regular consultants paid to promote Chantix. The study was so poorly done that the FDA’s Office of Scientific Investigation determined that “it was neither feasible nor possible to attempt to adjudicate the cases based on the provided information,” concluding that “[Pfizer’s] investigator assessment of relatedness has been altogether disregarded.”

    A more recent study reported in February 2020 in Addiction Magazine sought to assess Chantix’s relative cardiovascular and neuropsychiatric adverse effects in adults with no history of depression. Lo and behold, the retrospective study of over 600,000 adults found there was a 20 percent lower risk of of developing cardiovascular and neuropsychiatric adverse effects using Chantix when compared with the use of  nicotine-replacement therapies (NRTs) such as nicotine patches and gums, and a 35 percent lower one-year risk of neuropsychiatric hospitalization when compared to patients using NRTs.

    Interestingly, NRT was chosen for the comparison group “because it is the oldest, least expensive treatment, often available without prescription,” according to the authors. However, of the quit methods used, 35 percent of the subjects had substituted some regular cigarettes with e-cigarettes, and 24 percent had switched completely to e-cigarettes (a total of 60 percent) while only 25 percent used nicotine patches or gums.

    The most obvious problem with this study is that it excluded anyone with a history of depression. Indeed, even the authors had to include these caveats: “The exclusion of patients with a diagnosis or treatment for depression limits the external validity of our results.”

    “This study does not necessary demonstrate the safety of Chantix among people with baseline depression,” said Siegel. “It is possible that the suicidal ideation that seemed to be precipitated by Chantix in some cases occurs specifically among people with pre-existing depression.”

    And one must question why the authors chose to compare Chantix with less popular quit methods while neglecting to include comparisons with e-cigarettes. “It only compared Chantix with NRT therapies but excluded the millions of people who have switched to e-cigarettes. The comparison would have been enlightening,” Siegel said.

    WHICH METHOD HELPS SMOKERS QUIT?

    Has Chantix been effective in helping people quit smoking? A study reported in the National Institutes of Health, called “Diminishing benefit of smoking cessation medications,” found that only 18.7 percent of people treated with Chantix remained abstinent from smoking after one year.

    Even NRT, notoriously ineffective for long-term smoking cessation, was more effective. “There is no clinical trial directly comparing e-cigarettes with Chantix,” Siegel said. However, he cited a clinical trial published in the New England Journal of Medicine last year that reported a 20 percent quit rate with e-cigarettes—a similar rate to Chantix. “I would say that the best evidence at the current time suggests that e-cigarettes and Chantix are probably comparable in their efficacy in helping people quit smoking,” he said.

    While there are no studies comparing Chantix and e-cigarettes, a study published in February 2019 in the New England Journal of Medicine that was funded by the National Institute for Health Research and Cancer Research U.K. compared e-cigarettes with NRT. Of the 886 participants, 18 percent who used e-cigarettes achieved abstinence from smoking one year later compared with only 9.9 percent in the NRT group.

    Their conclusion? “E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy when both products were accompanied by behavioral support. Switching completely from cigarette smoking to e-cigarette use would be expected to reduce risks to health.”

    Unfortunately, it may take a long time before physicians and the public health community recommend e-cigarettes over Chantix to patients who want to quit smoking. The American Lung Association launched a “Quit, Don’t Switch” campaign earlier this year. Drawing a hard line that ignores the potential harm reduction offered by NRT and e-cigarettes, the site states, “Switching to e-cigarettes does not mean quitting. Quitting means ending your addiction to nicotine.”

    “I don’t think physicians will widely embrace e-cigarettes for smoking cessation until the FDA has officially approved these products and the major anti-smoking groups have also embraced these products,” Siegel said. “Although the FDA will eventually approve some e-cigarettes, I don’t see the major anti-smoking groups embracing e-cigarettes any time soon.”

    “I think Chantix should be recommended by public health officials as a Plan E smoking cessation remedy after cold turkey, e-cigarettes, smokeless tobacco and NRT, since Chantix poses far greater risks than these four other smoking cessation methods,” said Bill Godshall, founder and executive director of Smokefree Pennsylvania.

    “E-cigarettes should be recommended to smokers who are unable or unwilling to quit by themselves or with Chantix or any other method—and that’s the majority of smokers,” said  Konstantinos Farsalinos, a cardiologist, clinical researcher with the Onassis Cardiac Surgery Center in Athens and often-quoted expert on e-cigarettes.

    “In a real-world setting, I think it is important to approach smoking cessation on an individual level beyond the results of any randomized trials. But most doctors discourage e-cigarette use to those who are unable or unwilling to quit with Chantix,” he said. “Even worse, they discourage vapers who have already quit smoking from using e-cigarettes. The end result is that many of them relapse to smoking.”

    Picture of Maria Verven

    Maria Verven

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.

  • Spotlight on Nicotine

    Spotlight on Nicotine

    Liliya623 I Dreamstime.com

    The scientific evidence is clear that nicotine itself is not responsible for smoking-related diseases.

    By Ian Jones

    If you are as old as me, and happen to come from the U.K., you may recall Nick O’Teen, one of the central characters in an anti-smoking campaign run by the U.K. Health Education Council (HEC) in the early 1980s. With his cigarette-butt-shaped top hat and bright yellow teeth, O’Teen was the campaign’s arch villain and was regularly apprehended by the campaign’s hero, Superman.

    Now, obviously, Nick O’Teen’s name is a play on the word “nicotine,” so it is reasonable to assume that people who saw the campaign in the 1980s concluded that nicotine in cigarettes is the direct cause of smoking-related illnesses. In fact, according to recent surveys, this is still a commonly held belief, not only in the U.K. but in several other surveyed countries. But, given what we know today, does nicotine deserve this reputation or, as Mitch Zeller, director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products, the agency in the USA responsible for overseeing the implementation of tobacco product regulation, has previously asked, is it time for a “rethink within society on nicotine”?

    Let’s start with the basics: What exactly is nicotine, and what does it do?

    Nicotine is a chemical naturally found in tobacco and other related plants, in the same way that caffeine is naturally found in tea. Why does tobacco produce nicotine? Well, the commonly held belief is that nicotine helps protect the tobacco leaves from being eaten by insects and other predators. It does this in two ways.

    First, nicotine has a bitter taste, so it could make the leaves unpalatable to some potential diners. Second, and of more relevance to its namesake Nick O’Teen, nicotine mimics one of the natural chemicals that cells in the nervous system of animals use to communicate with each other. Thus, eating nicotine-containing leaves could impact the normal working of the nervous system (in fact, this could even be fatal to some insects).

    Auremar | Dreamstime.com

    Now, in you and me, the chemical that nicotine mimics, acetylcholine, is found throughout the nervous system and performs a myriad of functions. In the brain specifically, acetylcholine acts a bit like a volume control dial, turning up or turning down signals between brain cells. Which way the dial is turned depends on the brain region and the state of mind at the time.

    This is why nicotine, by mimicking acetylcholine, is said to not only help with attention (volume up) but also relaxation (volume down). It also explains the addictive property of nicotine. In the part of the brain responsible for identifying enjoyable experiences, nicotine can turn the volume up, making the experience of smoking stronger.

    Herein also lies a very important point; the addictive effects of nicotine are usually paired with a particular enjoyable experience. It explains why one of the common tests for tobacco addiction, the Fagerström Test for Nicotine Dependence, was renamed to the Fagerström Test for Cigarette Dependence; addiction to smoking is not solely due to the addictive nature of nicotine alone, but is a result of the interplay between nicotine, acting as volume up, and a series of sensory and other cues (smell, taste, ritual, etc.).

    But hold on a minute; doesn’t nicotine cause cancer and other diseases associated with smoking?

    This is one of the main misunderstandings about nicotine and the answer is simple—no. The scientific evidence is clear that nicotine itself is not responsible for smoking-related diseases. These are caused by other things in smoke, particularly chemicals formed when tobacco is burnt. Remember, tobacco-derived nicotine is an approved medicine and is even available without prescription in many countries.

    This would not be the case if there were serious health risks associated with its use. Furthermore, the use of tobacco products that are not burned during use, such as Scandinavian snus—a tobacco product that is placed under the consumer’s lip—is associated with much lower risks of developing cancer compared to smoking, even though the product also delivers nicotine to the user. The FDA in the U.S. recently acknowledged this by approving modified-risk claims for certain snus products.

    This is not to say, though, that nicotine is risk free. As mentioned above, it is addictive and can reinforce addiction to certain pleasurable behaviors. By mimicking acetylcholine, it can also affect certain biological processes such as the development of new blood vessels. There are also concerns about the potential effects of nicotine exposure in developing brains, an area that certainly deserves more research focus (as well as effective practical measures to prevent minors from accessing nicotine-containing products).

    OK, so the science to date noes not support the notion that nicotine causes cancer, but what about nicotine salts? I hear they are even worse than nicotine.

    I would contend that this is another misunderstanding, this time in part due to a lack of clear explanation by manufacturers as to what nicotine salts are when they first came onto the market. The key point to remember is that nicotine is nicotine, whether in salt form, nonsalt form (“nicotine base”), naturally derived or synthetic. Nicotine salts are simply nicotine attached to something else, in the same way that cooking salt is sodium attached to chloride (i.e. sodium chloride).

    Whether nicotine attaches to something else is simply down to how acidic the environment is. In acidic environments (e.g. an acidic e-liquid), nicotine is in salt form. At the other end of the scale, in alkaline environments, it is in base form (not attached to anything). In the middle (neutral pH), as in our bodies, nicotine is in a mixture of salt and base forms. An interesting aside is that nicotine salts are therefore not a new discovery; historically, e-liquids have been around neutral pH, so they have in fact always contained some nicotine salts.

    In any case, the fact that our bodies like to maintain a “just so” neutral pH means that, from a biological point of view, the form of the nicotine in the liquid does not really matter much as it will conform to a salt/base mix as soon as it comes in contact with the body. What nicotine salts (and acidic e-liquids in general) do is provide a different sensory experience, especially at higher nicotine levels, which some consumers may prefer.

    So, back to Nick O’Teen. Does he deserve his reputation? In my opinion, he was an arch villain of his time. As we’ve gained more understanding over the intervening years about the effects of nicotine in the body, I think we can indeed rethink the role of nicotine in society, just as Mitch Zeller suggests. Nicotine is not risk free and is certainly not something that minors should ever consume given concerns about the impact on the developing brain. 

    Likewise, there are other susceptible groups of people, such as pregnant women, that either should not use nicotine-containing products or, at a minimum, seek medical advice before deciding whether to do so. For most adults, however, nicotine deserves acceptance of its new non-villainous persona as a cause of tobacco-related illness, and to be seen as an adult lifestyle choice, the same as many other adult consumer products.

    Ian Jones

    Ian Jones is the R&D principal scientist for Japan Tobacco International (JTI).

  • Common ground

    Common ground

    A pragmatic health advocate, David Sweanor, is recognized for philanthropy.

    By George Gay

    There seems to be an unwritten rule that says you should never talk to an adversary until circumstances dictate that you have to talk to him, no matter how much harm is caused in the meantime. To start with, you simply lob rocks at him in the certain knowledge that your rocks are bigger and sharper than are his, and that soon he will admit to this difference in firepower and capitulate. But, after a while, your arm becomes tired and your head sore, and you become conscious of the idea that there could be another way of settling your differences that would result in less harm being inflicted on both sides. With any luck, some of the rocks that fell short of their target will have mingled in no man’s land, forming a little common—if bumpy—ground. At this point, talks can start. They’re a bit formal to start with—stiff even—but they loosen up once you realize that the other guy isn’t all bad and, in fact, occasionally makes some fair points.

    Such a scenario has been mapped out during many government campaigns against freedom fighters/terrorists, and it reflects the course of the tobacco industry’s dealings with public health campaigners/anti-tobacco activists. The tobacco wars weren’t fought with rocks, of course, but they did involve statistics and arguments so weighted that they should have been banned under some international convention. If anybody is under the impression that truth first took flight during last year’s votes in the U.K.’s EU referendum and the U.S. presidential election, they should look back at the history of the tobacco wars.

    But at least we have reached the point where, barring some skirmishes, the wars are largely over. Both sides have made significant concessions. The major tobacco companies have stated publicly that cigarettes are addictive and can cause a wide range of diseases that are often fatal. And some thought leaders in the tobacco control community have conceded that, even given this danger, it is not an easy matter for people simply to stop consuming tobacco and nicotine in any form, a view that has led them to focus on tobacco’s most dangerous and most commonly used product, the cigarette.

    Stifling the conversation

    The common ground, of course, is the concept of harm reduction in the form of e-cigarettes, heat-not-burn devices, some smokeless tobacco products and no doubt other devices that researchers and entrepreneurs are developing. But it is also made up of the need for the industry—now the tobacco and nicotine industry—and tobacco control to work together to ensure that the process doesn’t take any wrong turns on its new journey toward massively less hazardous alternatives for consumers.

    Given the importance of the above, it seems odd that some would want to stop the nascent conversation between the industry and tobacco control. But that is clearly the case. The seventh meeting of the Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control, which was held in India in November, barred from attending—even as an observer—anybody associated with tobacco or nicotine, whether they were industry players or government employees, along with a lot of other groups, including the media, and individuals.

    And before Vapor Voice’s sister publication Tobacco Reporter staged the Global Tobacco & Nicotine Forum (GTNF) in Belgium in October, at least some tobacco control advocates and researchers who were scheduled to attend received a letter from the Campaign for Tobacco-Free Kids and the European Network for Smoking and Tobacco Prevention, informing them that these organizations hoped that the “misunderstanding” that had led to the prospective participants signing up to attend would soon be “rectified.”

    Even leaving aside the fact that the letter seemed to insult the intelligence of those to whom it was addressed by suggesting that they didn’t have the wit to realize that a tobacco and nicotine forum staged by a tobacco and nicotine industry magazine would attract tobacco players, this was an extraordinary missive. It seemed to be aimed at raining down “friendly fire” on tobacco control’s advanced units as they used the GTNF to gauge whether the industry was serious about tobacco harm reduction and whether significant numbers of people could be encouraged to quit smoking by switching to the new generation of products being offered by the industry, the use of which might not be 100 percent safe—what is?—but that are by most people’s reckoning hugely safer than is smoking.

    But if that weren’t insult enough, in reporting on the GTNF, The Times newspaper, while generally supporting the case for tobacco harm reduction using new-generation nicotine products, turned its fire on the industry, which was to have been expected, but also on five of the nonindustry tobacco control advocates and nicotine researchers and experts who attended. In fact, its aim when it came to the nonindustry people was so far off target that it retracted the stories and had to issue an apology, saying that, despite what it had previously written, the five were “internationally respected for their long-standing global work to reduce smoking, and their work on the issue of nicotine harm reduction,” and that their work “has not been tainted by the influence of tobacco industry funding.”

    Vapor Voice asked one of those who had been named in the Times report, David Sweanor, a long-standing public health expert and adjunct professor of law with the Centre for Health Law, Policy & Ethics at the University of Ottawa, what his reaction had been to the newspaper’s piece, and he simply replied, “Here we go again.”

    “I have studied the history of public health and know that virtually any rational advance engenders vicious attacks from those committed to the status quo,” he said in an email exchange. “Their challenges are not based on facts but on very personal attacks. It is disturbing but it is very common, and I feel I am walking in the footsteps of many of the historical public health innovators I have long admired.”

    Sweanor made the point that it was not just “working with” the industry that was condemned as on a par with “working for” the industry, but any contact at all, even if you were simply trying to understand the dynamics within and between the various players within the tobacco/nicotine universe by, sensibly, talking to the various players. “This really hits home when senior anti-tobacco people claim that there is no difference between, say, [Philip Morris International] and an independent vape shop—that they are all, equally, ‘industry’ and thus the enemy!” he said.

    Quiet philanthropist

    Sweanor wasn’t chosen randomly to answer the question about how he had reacted to the suggestion that he had been working on tobacco harm reduction for the money. On Nov. 17, not long after attending the GTNF and the publication of the Times piece, he was named by the Ottawa chapter of the Association of Fundraising Professionals as the city’s Outstanding Individual Philanthropist for 2016, an award for which he had been nominated by HealthBridge. It turns out that, far from accepting tobacco money, he has been working on tobacco harm reduction for free, while donating millions of dollars to charity.

    Sixteen years ago, Sweanor created a family fund with the Community Foundation of Ottawa, but he has only recently chosen to go public about his philanthropy. And it is interesting to note that his reasons for giving anonymously at first, for lately going public and for his support for tobacco harm reduction are all grounded in his rationality and pragmatism.

    As Don Butler wrote in a piece for the Ottawa Citizen, Sweanor gave anonymously when he set up his family fund with the foundation in 2001 because he wanted to protect his young children from the glare of publicity; because he saw anonymity as representing the highest level of gift giving, one where you expected absolutely nothing in return; and because it shielded him from being bombarded by requests from charities he wasn’t supporting. But when the circumstances surrounding his giving started to change, Sweanor decided to discard his cloak of anonymity. With his children grown into young adults, it was time to go public in the hope of encouraging other people to look at setting up funds within the foundation.

    Rationality and practicality were there from the start. In a video interview posted on the Ottawa Citizen website (goo.gl/zdBx5f), Sweanor describes how he spent his legal career doing public policy work to reduce smoking. He said he had found there were many things that could be done that were incredibly cost-effective. There were things that could be done that saved a tremendous number of lives for very little in terms of time, effort and money. And there were so many issues like that in the world, so many things where people could cost-effectively make a difference, and that was why he had worked with HealthBridge, which he described as a really cost-effective international development body working on a wide range of projects in a number of countries.

    And rationality and practicality are still there. Having spent much of his working life in the front lines of the fight against smoking, he now thinks that e-cigarettes could be one of the biggest breakthroughs ever in public health. And watching him speaking on the Ottawa Citizen video, it is hard to avoid the conclusion that he is not going to be shaken from this view by a few sticks and stones. If you want to change his opinion, you’re going to have to venture onto the common ground—armed with some impressive arguments.