Posted by Majo Vape Team on June 18, 2016
By David Amsden
Daniel Walsh was first drawn to electronic cigarettes for the same reason millions of smokers have taken up the devices. "I was a guy who could work 20 hour days and juggle a number of complex projects, but I couldn't quit," says Walsh. "It was my greatest deficit." The quixotic promise that have made e-cigs the subject of endless controversy — that smoking cessation and smoking as recreation can coexist — resonated with Walsh. After successfully making the switch, he was so enamored by the product that he left his job developing artificial intelligence in San Francisco, decamped to Michigan and launched Purebacco, a manufacturer of the flavored, nicotine-laced liquid that are battery-heated into an inhalable vapor inside e-cigs. With over 30 employees, satellite offices in San Francisco and London, and plans to expand into a 40,000-square-foot headquarters, Purebacco's growth is a microcosm of the industry as a whole, which is estimated to do $3.5 billion in sales this year. "There is so much anecdotal evidence out there supporting the idea that people like me have helped hundreds of thousands of smokers quit," says Walsh, who is known to colleagues as the High Priest of Vaping, a fitting nickname for an enigmatic scientist with a mane of blond dreadlocks who works long hours in his sleek laboratory. "Yet as an e-cig CEO, I'm not really supposed to say that, since current rules prohibit us from marketing our products as anything but another vice."
In August, when British health officials released what was billed as a "landmark review" of electronic cigarettes, Walsh savored a moment of vindication. Describing the devices in headline-grabbing language — "around 95 percent safer than smoking" — the study encouraged e-cigs to be labeled as an effective means of helping smokers curb and kick the deadly habit: a nicotine delivery system with the "potential to make a significant contribution to the endgame for tobacco," as the report boldly stated, that should be embraced as a public health breakthrough rather than shunned as a novel evil undermining the crusade against smoking. "It was what I've been preaching for years!" says Walsh. "Maybe we're seeing a shift where people like me don't sound so fringe and crazy."
In England, perhaps. In America, the dominant message regarding e-cigs is that they are a menace. They have been placed under similar restrictions as tobacco products in the U.S., despite the fact that they contain no tobacco, long understood to be the source of the carcinogens that make smoking the leading cause of preventable death worldwide. Campaigns by anti-smoking groups have successfully fostered the perception that the risks of e-cigs are interchangeable from ordinary cigarettes, and the mainstream media has largely followed in step, with much of the reporting on e-cigs focused on the sensational (exploding devices!) and the apocalyptic (worse than tobacco!). What makes this all particularly confounding is that most American public health officials agree with the core claim of the British report: namely, that puffing an e-cig is significantly less harmful than a tobacco cigarette. Maybe not a provocative 95 percent safer — the research remains spotty, open to interpretation, and e-cigs are too new to be the subject of any longitudinal studies — but at the very least free of the most pernicious toxins released when tobacco is burned. So why the reluctance to make this clear, when 480,000 Americans die from smoking each year?
While the e-cig industry was jumpstarted by entrepreneurs like Walsh, big tobacco companies have since waded into the fray — which might be part of the problem. They don't want to be shut out of a growing business that some predict may eventually overtake their own, but given that cigarette sales still generate a staggering $35 billion in annual profits for the world's six largest tobacco companies, they remain incentivized to keep smokers drawn to their bedrock product. With electronic offerings like MarkTen — made by Altria, manufacturers of Marlboro — now among the most visible brands, it's understandable that some view e-cigs as the latest ploy of an industry with a well-documented history of manipulation and subterfuge. Whereas 84 percent of smokers believed e-cigs to be safer than ordinary cigarettes in 2010, by 2013 that figure had dropped to 63 percent. A study last year found that a third of people who had abandoned e-cigs and resumed smoking tobacco did so out of concern for the health effects of vaping.
The crux of the British report is that such misconceptions represent a public health failure, one that could be reversed by highlighting the comparative safety of e-cigs for current smokers, while making it clear that nonsmokers should steer clear of vaping. But the biggest hurdle for e-cigs in the U.S. is the very thing that makes them so appealing: by mimicking the hand-to-mouth ritual of smoking and delivering the same drug — nicotine — found in tobacco, they look and feel a whole lot like smoking. As a result, concerns about e-cigs center on whether encouraging people with a deadly habit to switch will rollback a decades-long trend of historically low smoking rates. Are e-cigs used by smokers to augment their habit rather than abstain? Could they prove to be a gateway toward "re-normalizing" tobacco smoking, especially among impressionable teens? Legitimate as such questions are, at this point they may be eclipsing the most pressing one of all: Is the United States, in applying the same tactics used to demonize smoking on a safer substitute, missing out on a chance to save the lives of millions of its citizens?
People smoke for nicotine but they die from tar." Michael Russell, a South African scientist widely considered to be the godfather of tobacco control, wrote those words in 1976. At the time it represented a drastic new way of understanding smoking: as a physiological addiction to a drug rather than a purely psychological habit. But nearly 40 years later, the revelation of Russell's research has been obscured, as the decades long war on smoking became, in effect, a war on nicotine. Rather than occupying a place on the same spectrum that allows caffeine and alcohol to be consumed without stigma, today the word "nicotine" conjures up images of amputated limbs and metastasizing tumors — even though, as Russell made clear, nicotine in itself has never been the deadly culprit in cigarettes.
It may come as a surprise to learn that nicotine, when removed from cigarettes, is relatively benign. Though not free of risks — it can harm a fetus and may affect developing adolescent brains — it also has some benefits. A beguiling substance, nicotine operates as both an upper and a downer depending on the state of the user, proven to simultaneously sharpen focus and calm nerves. "In some ways I think of nicotine as the perfect psychotropic drug," says Paul Newhouse, a scientist at Vanderbilt University. He has spent his career administering nicotine to improve cognitive functioning in those suffering a variety of conditions, from Alzheimer's to Parkinson's to the mental fog created by chemotherapy and HIV medications. "The nicotinic receptors in the brain act as modulators rather than classic transmitters, scanning the system and stimulating what needs to be stimulated and relaxing what needs to be relaxed," Newhouse says, explaining both nicotine's therapeutic potential and appeal for recreational use. "That's why you have a smoker who uses a cigarette to wake up and to go to sleep."
Since the Eighties, anti-smoking groups have taken to underscoring the dangers of smoking by declaring that nicotine is as addictive as heroin — a shudder-inducing claim repeated today in anti-vaping efforts like the "Still Blowing Smoke" campaign currently being rolled out in California. The truth, however, has always been far more complicated. Rats are not prone to self-administer the drug in laboratory settings, for instance, as they will a substance like cocaine. Newhouse, in his research, supplies nicotine to patients primarily through patches, and even those who have been on the drug for a year show no symptoms of withdrawal when their trial period concludes. "No one goes out and buys a pack of cigarettes when they're done," he says. "For someone like me, who is using nicotine to help people, it's a disservice to portray nicotine as being as addictive as heroin when it absolutely is nowhere close."
Mitch Zeller, the director of the FDA's Center for Tobacco Products, the arm of the agency currently working on regulations for e-cigs, concedes that the new products have presented a formidable challenge to the idea that nicotine is anything but a hazard. "Electronic cigarettes have become the poster child for the questions that, on a societal level, we need to be asking about nicotine," he says. "None of them have easy answers." Zeller points out that federal approval for over-the-counter doses of nicotine in the form of gums and patches (with no labels warning of addiction) is evidence that it is not the insidious substance many believe it to be. "How could the same compound associated with so much death and disease be so safe that you can buy it without a doctor's prescription?" he asks. "The answer is that it's about the delivery mechanism, not the drug."
While nicotine can be ingested in a variety of generally harmless ways, it is only when inhaled that its full powers — and potential for addiction — are unlocked. From the lungs it reaches the brain within seconds, providing the satisfying jolt that smokers crave.(A nicotine patch, by contrast, takes many minutes longer.) The habit that is as addictive as heroin, in other words, is smoking tobacco cigarettes, not nicotine consumption. Which is to say that smoking never came to be demonized solely because it is addictive, but because its addictive qualities fueled a dependence that kills. This may seem like splitting hairs, save for the fact that America has anything but an unequivocal issue with drug addiction; if we did, we'd be funneling Starbucks patrons into rehab clinics, pitying those who "need" a glass of wine to unwind rather than joining them for happy hour, and viewing large swaths of the pharmaceutical industry in the same light we do corner drug-slingers.
Electronic cigarettes were invented in 2003 by a Chinese pharmacist whose father died from smoking, and who believed the technology could evolve, in a sense, into what smoking was always meant to be: a risky indulgence, without question, but not a deadly one. Like traditional cigarettes, e-cigs are designed to be a means of inhaling nicotine. But by replacing tobacco with a synthetic and non-toxic nicotine-laced "juice" (equal parts propylene glycol and vegetable glycerin), heated by battery rather than fire, the most harmful components of smoking are removed from the equation. As Walsh puts it, describing what led him to found Purebacco: "Our mission from the start has been to create an experience that is intrinsically more satisfying than smoking without the tars and heavy metals that make smoking so lethal." This really isn't fundamentally different from the thinking behind accepted cessation devices like gums and patches, with one notable difference — electronic cigarettes are designed to be enjoyed. For the government to embrace them means to rethink what has come to be unthinkable: that smoking, in some form, can be tolerated, even deemed socially acceptable.
Stanton Glantz, a professor of tobacco control at the University of California in San Francisco, does not mince words when offering a rebuttal to the utopian promise of e-cigs. "Total bullshit," he says.
It is not that Glantz disagrees entirely with the British review's assessment on e-cigs, though he believes they are more dangerous than the report concluded. "I'll eat my shoe if that 95 percent figure turns out to be correct five years from now," he says. "But, yes, there is no doubt that electronic cigarettes are better than cigarettes." While Glantz can entertain a fantasy where all current smokers switch to e-cigs — "That, of course, would be great" — what troubles him is how consumers actually use them. "Are there people who have totally made the switch or quit completely because of these?" he asks. "Yes, I believe there are. Terrific. But most are what we call dual users — those who smoke both, often to smoke in places where they can no longer smoke cigarettes. If you're talking about a smoker using these to inhale more dangerous chemicals, well, that has a net negative effect on public health."
In April of this year, the Centers for Disease Control and Prevention released a report finding that e-cig use had tripled in the past year among middle and high school students — results that Glantz and others cite as proof that e-cigs are initiating a new generation into nicotine addiction, especially by offering flavors he believes are designed to appeal to kids. Like so many reports on e-cigs, however, this one could be interpreted in a less distressing light. For instance, the study didn't differentiate between a teen who takes a single puff in the course of 30 days and a habitual user, which is to say that it didn't account for the reality that teenagers have a propensity toward experimentation. The report also found that, since the advent of e-cigs, teen smoking rates have not increased, but rather have reached historic lows.
Earlier this month, Harvard released a study suggesting at least one aspect of vaping might be as detrimental as traditional smoking. Researchers at the university found that 75 percent of flavored e-cigs contained a chemical called diacetyl, commonly used in artificial butter flavorings. While safe to eat, the dangers of inhaling diacetyl were revealed in the early 2000s, when workers at several popcorn factories came down with a condition that became known as "popcorn lung," an irreversible scarring of the lungs that causes shortness of breath and fits of coughing. The Harvard study led to the inevitable haunting headlines, some of which were testament to how little many in the media actually understand about the perils of tobacco smoking. "Flavored E-cigarettes May Be Worse For You Than Nicotine" declared Mother Jones, reinforcing the misguided notion that nicotine, present in all forms of vaping and tobacco smoking, is the leading scourge. While studies like Harvard's are critical to fully understanding e-cigs, they too often have the opposite effect. Tobacco cigarettes, for instance, have also long been known to contain diacetyl — at levels over 100 times those found in electronic cigarettes — yet earlier tobacco studies found that even these levels were not enough to cause popcorn lung in smokers.
"The Harvard study is a perfect example of something that happens over and over," says Michael Siegel, a physician and professor at Boston University. "It creates a scare by omitting a key piece of information, undermining the public's appreciation of the severe hazards of tobacco smoking and leading to perverse public health outcomes." Siegel, who studied under Glantz in San Francisco, has spent much of his career fighting tobacco companies: testifying against them in court, pushing for smoking bans in bars and restaurants, advocating for policies making it illegal to market cigarettes to youth. When e-cigs first started gaining popularity, he was skeptical, believing them to be little more than a product designed to mask the dangers of smoking. Today, however, he has become one of the most outspoken supporters of the idea that e-cigs can succeed where the crusade against smoking has come up short. Given that the current e-cig market is dominated by habitual smokers, Siegel calls the U.S. government's reluctance to allow them to be pitched as a safer alternative "irresponsible." "Even the worst case scenario — that a current pack a day smoker replaces a single cigarette with an e-cig — is better than where we are right now," he says. "All conclusive evidence shows that these are safer, so why aren't we encouraging smokers to make the shift? If we did, we'd be saving millions of lives and talking about the greatest public health moment of our generation."
Last April, the FDA's Center for Tobacco Products released a set of "deeming" regulations for e-cigs — essentially a preview of the formal ones still being tweaked, which the agency will only say will be made official "as soon as possible." Plenty of the guidelines—like banning sales to minors and requiring manufacturer's to disclose all ingredients — are sensible. But by modeling them primarily on those in place for tobacco cigarettes, the suggestion seems to be that e-cigs carry similar risks. The chief concern for someone in Walsh's position is that the rules would deem each flavor an "SKU" — basically, a product needing approval. "The cost of admission would be 5,000 hours per SKU," he says of the lawyer's fees involved. "At a minimum of one hundred bucks an hour, that's five million per SKU. Well, my company currently manages 240 SKUs, which means I'm looking at a billion dollars plus if I want to stay in business."
The irony looming over the entire controversy is that cigarettes remain perfectly legal — in the United States, in England, across the globe. As long as this is the case, a certain subset of the population will smoke, for reasons physiological and psychological, and regardless of whether they have to shiver outside a bar or listen to lectures by friends and family about their senseless behavior. While America may have some of the strictest rules on cigarettes, their continued legality is testament that other deeply-engrained national ideals — the freedom of choice, the minting of money — often trump the aims of protecting the health of our citizens. As a result, Walsh insists on what he calls an "FDA clause" in all of his leases, allowing him to break contracts and close up shop without penalty if the regulations make business untenable. "I refer to it as living life under the regulatory guillotine," he says with a grim chuckle. "It's an odd dichotomy, isn't it? After years of trying to disempower Big Tobacco, we are now looking at legislation that will remove all the independents like me from the game and put the industry right into the hands of Big Tobacco."
Walsh is still optimistic that e-cigs can be, if not quite the end of smoking, then a reinvention of sorts; it's just likely that, in the end, it will be the big tobacco companies who reap the rewards. Many of his colleagues, he notes, have begun transitioning to another growth industry: marijuana, a drug that has been on the path from demonization toward acceptance during the same period that nicotine has been on the opposite trajectory. "That industry is booming right now, with a fraction of the hurdles we have to jump through," he says. "The way the regulatory climate is going, huge portions of the e-cig business may transition to marijuana. You have all these people who want to help people quit smoking, but they have no way to conduct commerce." He pauses. "Sometimes you just have to laugh at the randomness that says one substance is okay and the other is not."