As millions vape, e-cigarette researchers count puffs, scour Facebook
One team of researchers assessing the risks of electronic cigarettes is counting the puffs taken by volunteer “vapers.” Another will comb Facebook for posts on how people are tinkering with e-cigarettes to make the devices deliver extra nicotine. A third is building a virtual convenience store for 13-to-17-year-olds, measuring how e-cigarette displays and price promotions influence whether minors buy the increasingly popular devices.
The U.S. Food and Drug Administration is spending $270 million on these and 45 other research projects to determine the risks of e-cigarettes before millions more Americans become hooked on the devices.
“They want data and they want it yesterday,” said Dr Suchitra Krishnan-Sarin of Yale University, who is leading four projects.
“Yesterday,” however, is years away.
Final results may not be available before 2018, researchers leading the FDA-funded projects told Reuters. That timetable, which has not been reported before, underscores how the slow pace of science is contributing to a regulatory vacuum, allowing e-cigarette makers to sell their products virtually unchallenged.
To be sure, studies of e-cigarettes not funded by the FDA are also under way, and the agency can factor those results into any action it takes. But the FDA chose these 48 projects because they address questions central to future regulations.
The e-cigarette industry, which Wells Fargo Securities estimates will make $2 billion in global sales this year, says the FDA must wait for the results of the research before it issues any regulations, or manufacturers risk being driven out of business by unproven fears about their products.
“There shouldn’t be regulations akin to those for cigarettes without evidence of similar health impact, especially since the preliminary evidence is positive for the industry” when it comes to comparing the contents of e-cigarette vapor to tobacco smoke, said attorney Bryan Haynes. His Richmond, Virginia-based firm Troutman Sanders represents e-cigarette manufacturers.
In 1963, a young Korean war veteran and committed 40-a-day smoker called Herbert A Gilbert from Beaver Falls, Pennsylvania, filed a patent for a product he described as a “smokeless non-tobacco cigarette”. It functioned by gently heating a nicotine solution and producing inhalable steam, thereby “replacing burning tobacco and paper with heated, moist, flavoured air”.
As the health risks of tobacco-smoking slowly began to emerge, Gilbert hopefully touted his device around the big tobacco and medical supplies companies. Several professed interest, but - at a time when, in Britain alone, some 70% of adult males were regular smokers - none apparently saw enough potential in his oddball invention to put any money into it.
Half a century on, after a decisive intervention by a Chinese pharmacist called Hon Lik, whose company Ruyan (literally, “Resembling Smoking”) began exporting its version of the electronic cigarette in the mid-2000s, and - perhaps just as important - the widespread outlawing of tobacco smoking in enclosed public spaces in many western countries, the potential has become clearer.
In 2013, according to a survey by YouGov for the anti-tobacco charity Ash (Action on Smoking and Health), the number of e-cigarette users in the UK surged to 2.1 million, a three-fold increase over the previous year. The investment bank Goldman Sachs puts the products top of a list of “creative destroyers” - including big data, 3D printing and natural gas engines - that are likely to turn their markets upside down, and sees annual global sales of e-cigarettes hitting $10bn within a few years.
For V-Revolution in Covent Garden, which claims to be London’s first shop dedicated exclusively to e-cigarettes, that means business is brisk. Since opening last May, the store has seen a 90% increase in custom, says assistant manager Elizabeth Playle. It now sells well over 50 reusable e-cigarettes a day - at prices, depending on their size and voltage, ranging from £25 to £90 each - plus many more bottles of e-juice, the liquid mixture of nicotine, flavourings and dilutants that the devices vapourise. Internet sales are booming.
Backed by the world’s biggest tobacco companies, the industry is aggressively expanding its marketing across the country. More than 14 million U.S. adults and nearly 2 million teens and tweens have used e-cigarettes, and the rate of use among high-schoolers doubled from 2011 to 2012, the latest data available.
The FDA “will always make regulatory decisions based on the best available science,” said an agency spokeswoman. “With regard to e-cigarettes, the agency does not believe it will take many years to create the regulatory framework” once the FDA has the basic authority to regulate the products, which could happen next year.
The missing science includes basic questions such as what compounds are in the vapor produced by e-cigarettes. It also includes complicated ones like whether flavors such as butterscotch and bubble gum entice children to vape, how e-cigarette displays in online stores affect teenagers’ desire to buy vaping liquid, and, perhaps most crucial, whether e-cigarettes will reduce the number of smokers or produce millions of new nicotine addicts.
The Yale team, for instance, will study whether menthol and flavors such as chocolate and cherry increase the appeal of e-cigarettes, especially to 16-to-18-year-old smokers or “dual users” who both smoke and vape. If that turns out to be the case, the FDA would have scientific support for regulating.
“We’ll have the first results within two years” and complete ones in four to five, Krishnan-Sarin said.
REAL-TIME EXPERIMENT
As an uncontrolled experiment in public health, the use of electronic cigarettes is rivaled only by conventional tobacco smoking, a habit adopted by half of American men and one-third of women during its peak in the 1960s. The first Surgeon General’s report on the health dangers of cigarettes was released in 1964, when more than 40 percent of American adults were already hooked. To date, more than 10 million Americans have died from illnesses tied to smoking tobacco.
Complaints of injury linked to e-cigarettes, from burns and nicotine toxicity to respiratory and cardiovascular problems, have jumped over the past year as the devices become more popular, the most recent U.S. data show.
Between March 2013 and March 2014, more than 50 complaints about e-cigarettes were filed with the U.S. Food and Drug Administration, according to data obtained through a public records request. That is on par with the combined number reported over the previous five years.
The health problems were not necessarily caused by e-cigarettes. And it is not clear that the rate of adverse events has increased. In 2011, about 21 percent of adult smokers had used e-cigarettes, according to federal data, more than double the rate in 2010.
Still, David Ashley, director of the office of science at the FDA’s tobacco division, said the uptick is significant, especially in light of a recent report from the U.S. Centers for Disease Control and Prevention showing an increase in the number of e-cigarette-related calls to poison control centers.
“Both together does suggest there are more instances going on,” he said.
The FDA is poised to regulate e-cigarettes and other “vaping” devices for the first time, potentially reshaping an industry that generates roughly $2 billion a year in the United States. Some industry analysts see e-vapor consumption outpacing that of traditional cigarettes, now an $85 billion industry, within a decade.
E-cigarettes are battery-powered cartridges filled with a nicotine liquid that, when heated, creates an inhalable mist. Little is known about the long-term health effects of the products, which were developed in China and moved into the U.S. market in 2007.
Research on e-cigarettes has moved more quickly, partly because scientists can draw on regular tobacco research to establish the biological effects of vaping.
The cartridge-like devices were first introduced in the United States by start-up manufacturers in 2007. Now, the U.S. market is dominated by blu, a brand owned by Lorillard Inc.
Other leading tobacco companies are making a big push for a share of the growing market: R.J. Reynolds Vapor Co., a subsidiary of Reynolds American, began selling its Vuse e-cigarette nationwide last month and Altria’s NuMark subsidiary plans to do so with its MarkTen later this year.
The FDA got authority to regulate tobacco products, both traditional and novel, with the 2009 Tobacco Control Act. In April, the FDA proposed banning e-cigarette sales to minors, angering public health advocates who want more far-reaching prohibitions on online sales, advertising and flavors.
The FDA began funding e-cigarette research in 2012. An FDA-funded project at the University of Louisville in Kentucky illustrates why the pace of science is slow.
Scientists there will look at three or four brands of e-cigarettes and analyze their volatile organic compounds, flavorings and particulate matter to see how they affect lung and other cells in lab mice, said lead researcher Dr Sanjay Srivastata.
This spring, he began exposing the animals to e-cigarette vapor for up to six months, with full results expected in 2015. While those findings could help FDA quantify risks from vaping, results extending the conclusions to humans are as much as five years away.
THE ‘PLEASURES OF NICOTINE’
Another crucial question researchers are trying to answer is whether e-cigarettes will be used mostly by nicotine newbies, including adolescents; by ex-smokers craving a nicotine hit without the carcinogens of tobacco; or by smokers trying to quit.
To get a handle on who is likely to use e-cigarettes, scientists at Georgia State University School of Public Health will conduct online surveys of 6,000 people to assess whether they perceive e-cigarettes as less harmful than the traditional kind, why those who have switched from the latter to e-cigarettes did so, and what influences people’s perceptions of the product’s risk.
“This is the kind of research that is going to be informing the FDA’s regulatory process,” said Michael Eriksen, dean of the School of Public Health and leader of three FDA-funded projects on tobacco.
The FDA’s proposed e-cigarette rules would give it the power to regulate the ingredients in the vaping liquid, but are silent on the plumes of vapor produced when the liquid is heated. According to research at Virginia Commonwealth University, that may be a dangerous oversight: a form of e-cigarettes called tank systems can get so hot the vapor can contain the carcinogen formaldehyde and other toxic compounds.
“We want to know what’s in the emissions, not just the ingredients,” said VCU toxicologist Robert Balster, who is helping to oversee four FDA-funded projects.
To find out, VCU engineers are constructing mechanical vaping devices to measure how temperature, voltage, and other parameters affect the content of the plumes from e-cigarettes. They will next comb through Facebook and blog postings to see whether vapers like super-hot temperatures, for instance. Combining the results of the mechanical vaper and real-life habits should show what emissions people are exposed to.
“If it turns out that people are tinkering with the electronics to increase the voltage of e-cigarettes, and FDA regulations limit the maximum voltage, that’s useful to know,” since it may justify a requirement that the devices be tinker-proof, said Balster.
Full results are years away, he said, “but we’re mindful of getting information to FDA in a timely manner. They’re under a lot of pressure to get moving.”
###
By Sharon Begley