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 Researchers have counted 7,764 varieties of 'vape.' That adds up to
one of many challenges - from practical constraints to conflicts of
interest - in working out how safe e-cigs are, and whether they help
smokers quit.
Most scientists agree e-cigs have potential as a stop-smoking aid.
They can be used with or without nicotine and are free of the
thousands of toxins in conventional cigarettes. But e-cigs also
throw up some unusual obstacles.
Drug firms usually test one treatment against another. With
e-cigarettes, the huge variety of constantly evolving products means
it would be prohibitively expensive to test every flavor and
vaporizer.
“E-cigs are really the first product I’m aware of that have
challenged pharma in this way,” said Chris Bullen, an associate
professor at the University of Auckland and author of one of two
randomized trials of e-cigs in a recent major review of the science.
“I guess many alternative ‘natural’ products raise similar issues
when they start to make health claims.”
E-cigarettes can look like ordinary smokes but are metal and plastic
battery-powered gadgets that heat flavored liquids into a cloud
which users suck in, then exhale as dense white plumes. Invented in
their present form in China about a decade ago, e-cigarettes
generated $4 billion to $5 billion in sales in 2014, according to
Euromonitor, a market research firm.
The gadgets themselves come in hundreds of brands and are constantly
morphing, at the hands of both users and the small-scale
distributors who sell them online.
Because they are a strange hybrid between smoking – which kills
nearly 6 million people a year – and stop-smoking medications,
e-cigs rival both tobacco and pharma. Tobacco companies have
responded to that threat by buying up e-cig businesses, and are now
funding research. Pharma firms have kept their distance.
The products have also opened a rift between researchers who see
their goal as eliminating nicotine in all its forms, and others who
believe it makes more sense to reduce the harm of smoking.
“You’ve got people who’ve taken a position and they’re looking at
the evidence only in relation to the position they’ve got,” David
Sweanor, an e-cig enthusiast and law professor at the University of
Ottawa, told an e-cigarette symposium in London in November.
PHARMA BOWS OUT
There are more than 2,000 papers on e-cigarettes in the scholarly
journals covered by the Web of Science, a database. Of those in the
highest impact journals, most have been funded by public bodies.
Only a few contain original research; methodological problems or
potential bias are common, scientists have found.
Last month, in an attempt to clear matters up, Bullen and other
scientists in Britain and New Zealand published their assessment of
the most impartial studies. Known as a Cochrane Review - a study of
the best science on a subject - it aimed to see if e-cigs can help
people stop smoking.
The review concluded that e-cigs may help smokers quit, and that
there is little sign that they hurt users.
But it found the evidence thin and data poor. Of almost 600 studies
analyzed, only 13 published papers were up to the Cochrane standard.
Just two were randomized controlled trials, the most rigorous test.
Big Pharma is not helping. The pharmaceutical industry has backed
efforts to restrict e-cigarettes and is not sponsoring a single
current e-cigarette trial in the U.S. National Institutes of Health
database.
For drugs firms, smoking cessation is a small business, generating
$2.4 billion in sales in 2013, according to Euromonitor. That’s just
a fraction of the $206 billion the industry generated in global
consumer health products.
"We've decided we're not going to play (in e-cigs),” GlaxoSmithKline
Chief Executive Andrew Witty told Reuters. “We've consciously had a
think about it but we're not going to play."
VESTED INTEREST
This leaves e-cigarette companies to fund their own research, giving
rise to concerns over conflicts of interest.
In 2010 one European e-cig distributor, Italian firm Arbi Group Srl,
sponsored a significant body of work by a team at Catania University
in Sicily. Catania researchers are among the most prolific, records
in the Web of Science show; they conducted the second of the two
randomized trials included in the Cochrane Review and are working on
nine of the 48 trials on e-cigarettes logged with the U.S. National
Institutes of Health (NIH).
The Catania randomized trial took 300 smokers who did not intend to
quit and found that, with or without nicotine, e-cigarettes cut
cigarette consumption and helped some people stop completely,
without significant adverse effects. That supported claims
e-cigarettes had a role reducing the harm of smoking.
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"At the end of the day we were stuck accepting money from
e-cigarette owners because there was no other way to carry out
research," said Catania professor Riccardo Polosa, who designed the
trial. He said he had also received funding from pharma
That, says Charlotta Pisinger, a Danish doctor who runs stop-smoking
clinics, is a problem. Last October she published a review which
found one in three e-cigarette studies had a conflict of interest
because they were funded by e-cig manufacturers, pharma or tobacco,
or a combination. She saw evidence of bias: “We must exercise the
utmost caution in trusting their conclusions,” she wrote.
Experienced medical researchers say industry funding to test new
products is the norm.
“The majority of clinical research is sponsored by the
manufacturers,” said David Tovey, editor in chief of the Cochrane
Library, which vets Cochrane Reviews. Another Cochrane study has
found that scientific studies sponsored by private industry
generally reported greater benefits and fewer harmful side effects
than studies industry did not sponsor.
“MORAL STANCE”
E-cigarette opponents are also being scrutinized for bias.
A 2014 U.S. review of the literature, carried out for the World
Health Organization at the University of California, San Francisco (UCSF),
said that the two randomized trials had shown e-cigarettes were no
better than other nicotine replacement therapies at helping people
quit.
In August, the World Health Organisation recommended that smokers
should be encouraged to try already approved treatments, rather than
e-cigs.
Stanton Glantz, a veteran campaigner in the war against Big Tobacco
and professor at UCSF, was one author of the U.S. review. But some
researchers say activists like Glantz may have been prejudiced
against e-cigarettes by their past battles with the tobacco
industry.
Robert West, a professor at University College London, is an
e-cigarette enthusiast who has been funded by pharma, but not by
e-cig makers. He says some opponents present themselves as unbiased,
but “their professional and moral stance represents a substantial
vested interest.”
Glantz says he started his review “completely agnostic.”
IMAGE MAKEOVER
To add to the controversy, Big Tobacco is getting more deeply
involved. E-cigarettes are a threat to the $722 billion retail sales
of conventional cigarettes globally in 2013, but they are also an
opportunity. Fewer people are smoking in the rich world. Shane
MacGuill, senior tobacco analyst at Euromonitor, calls tobacco a
“terminally sick” industry. E-cigarettes may offset the decline.
Firms including Reynolds American Inc. and Imperial Tobacco Group
PLC have sponsored seven of the e-cig trials in the NIH trials
database.
Tobacco executives mingled with researchers and anti-smoking
activists at the London symposium last November. The conference was
held at the Royal Society, an association of scientists whose
fellows include around 80 Nobel Laureates. Beneath portraits of such
illustrious figures as Stephen Hawking, delegates puffed on
vaporizers.
Some delegates said they found being in the same room as tobacco
firms discomfiting. The industry’s history of suppressing the truth
about tobacco’s risks still prompts some universities and academic
journals to shun tobacco, and the World Health Organization is
forbidden from collaborating with it.
E-cigs are helping tobacco companies transform their image. Firms
that for years denied tobacco’s harms now emphasize that nicotine
itself is not harmful, we just need safer ways to administer it.
Some are stepping into smoking cessation: British American Tobacco
already has a medical license for a medicinal nicotine inhaler. A
Reynolds subsidiary sells nicotine gum.
Big Tobacco has some support among those in public health who think
it won’t be necessary to eliminate nicotine, so we should reduce the
harm of smoking. But as universities ban association with tobacco
firms, it will become even harder for independent researchers to
study vaping.
(Additional reporting by Kate Kelland; Edited by Simon Robinson and
Richard Woods)
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