In applying the same tactics used to demonize
tobacco, are anti-smoking advocates and regulators missing out on a chance to
save millions of lives?
By David
Amsden December 21, 2015
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?
Daniel Walsh, founder of Purebacco, is known to colleagues as the
High Priest of Vaping. Jon Mold
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."
(Click Here) to view original article from Rolling Stones Magazine.
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