Debate ignites over safety of e-cigarettes
By Paula S. Katz
When patients of Frank T. Leone, MD, tell him they’re now smoking e-cigarettes, he doesn’t tell them to stop. Instead, he recognizes that e-cigarettes may seem to be a logical option to these patients, who are concerned about their dependence on smoking and its impact on their health.
Dr. Leone is no fan of electronic cigarettes, citing the lack of data on their efficacy and lack of federal oversight guaranteeing their safety. But he uses the topic to start a conversation.
Illustration by David Cutler
“I say, ‘It makes sense to me you would want to use [e-cigarettes]. It may be promising, but right now I can’t tell you if it’s good,’” he said. Then he looks for his chance to discuss alternatives.
“I always find a crack in the door, like when a patient says, ‘It works most times, but when I’m home from work and relax in front of the TV it’s not enough and I need to smoke a regular cigarette.’ That’s my opening to say, ‘Because that’s still bothering you, we should consider starting a pill or patch.’ I won’t tell them they’re wrong, but I would evaluate them effectively and supplement with a known effective treatment,” said Dr. Leone, associate professor of medicine and director of the Comprehensive Smoking Treatment Program at the University of Pennsylvania in Philadelphia.
Consumer interest in e-cigarettes, now readily available in convenience stores, online, and from dedicated “vape” stores, is rising. But in the absence of hard data, debate is raging over whether these battery-operated nicotine inhalers and their secondhand “smoke” are safer than cigarettes, whether they wean smokers from the more dangerous combustible cigarettes, and whether they perilously serve as a gateway to smoking for nonsmokers, especially adolescents.
Fifty years after the U.S. Surgeon General’s report on the harms of smoking, e-cigarettes are also raising the specter of renormalizing smoking, or what e-cigarette users call “vaping.” Today, physicians are in a key position to help patients understand e-cigarettes and how they do or do not fit into a long-term smoking-cessation plan.
Many are extremely cautious. “This is a highly volatile situation with a lot of uncertainty,” said Tim McAfee, MD, MPH, director of the Centers for Disease Control and Prevention’s (CDC) Office on Smoking and Health. “There’s a lot of reason to be very worried.”
But some, like Mark H. Hyman, MD, FACP, said e-cigarettes may be a valuable part of physicians’ arsenals when working with patients.
“For patients who require assistance, my attitude is I will take anything that seems to break the cycle or change the habit,” he said.
E-cigarettes were invented in the 1960s but became more widely available about a decade ago. They use a cartridge called a cartomizer with an LED that lights at the end after a puff. The cartomizer is filled with a liquid, known as e-juice. E-cigarettes contain nicotine, flavorings and propylene glycol, according to the Smoke Free Alternatives Trade Association. A heating element boils the liquid, which produces the vapor that the user inhales.
Because there’s no combustion, e-cigarettes deliver lower levels of carcinogens, formaldehyde, acrolyn and benzene, according to Theodore L. Wagener, PhD, director of policy and program development at the Oklahoma Tobacco Research Center at the University of Oklahoma Health Sciences Center in Oklahoma City.
Some brands of e-cigarettes look like a regular cigarette or a pen. They are often “a gateway to vaping” for smokers who may then go on to tank systems, Dr. Wagener said. Tank systems have a battery and heating element, plus a reservoir that holds the liquid.
E-cigarettes come in kits that include rechargeable batteries and flavor options. Starter kits that include a car charger, 2 batteries and 10 cartridges can cost $50 or more. Disposable e-cigarettes, which depending on the brand and type can be equal to 2 or 3 packs of cigarettes, sell for between $7 and $10. They are clearly cheaper than regular cigarettes: 10 cartridges, equivalent to 10 packs of cigarettes, cost between $15 and $20, Dr. Wagener said. Depending on the state, a pack of cigarettes can cost between $5 and $15.
There are plenty of options from different colors of tanks to levels of nicotine. Without regulation, “innovation is going like crazy,” Dr. Wagener said. He noted that there are 300 vape stores in Oklahoma alone and that one store can carry between 50 and 250 vapor flavors such as cherry, piña colada and java.
Are they safe?
Because there are so many e-cigarette manufacturers, including some of the nation’s largest tobacco companies, and no oversight, e-cigarettes contain different particulates, contaminates and mechanisms to aerosolize different compounds in different amounts and degrees, said Dr. Hyman, associate clinical professor of medicine at the University of California, Los Angeles.
And Dr. Leone cautioned, “At this time there are over 400 different products that we refer to as e-cigs. They are all proprietary so there are no data on safety. We have no idea what’s in them.”
A 2009 Food and Drug Administration (FDA) analysis found that e-cigarettes contained carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. Inhaling propylene glycol or other chemicals could impede lung function, which could lead to an asthma attack, chronic bronchitis or cancer, Dr. Leone said.
“Manufacturers state e-cigarettes are lower in cancer-causing [ingredients]. But what the impact is remains unclear,” he said.
However, some data have been more favorable. The one randomized clinical trial that compared e-cigarettes with the patch showed they are equally effective for smoking cessation. That study, published online Sept. 9, 2013, in The Lancet, found no statistical difference in smokers’ ability to quit with either product. It also found that dual users of both e-cigarettes and regular cigarettes had reduced cigarette consumption.
“If e-cigarettes turn out to be as good at helping smokers quit as FDA-approved nicotine replacement products are and they are not harmful, that would be a positive,” said Nancy A. Rigotti, MD, professor of medicine at Harvard Medical School and director of the Tobacco Research and Treatment Center at Massachusetts General Hospital in Boston, “but we don’t know that yet.”
In addition, a study published by Tobacco Control on March 6, 2013, analyzed the vapors from 12 types of e-cigarettes. It found some toxic substances but at levels that were 9 to 450 times lower than in cigarette smoke. The authors concluded that “substituting tobacco cigarettes with e-cigarettes may substantially reduce exposure to selected tobacco-specific toxicants.”
Here are other unanswered questions about e-cigarettes:
Do they actually lead to cessation? One study published in the September 2013 American Journal of Public Health showed that smokers using e-cigarettes reported higher motivation to quit and were treating e-cigarettes as cessation aids despite the lack of research supporting that use.
“It’s clear that thousands of people have quit smoking with e-cigs and are pure e-cig users,” Dr. Wagener said. “We don’t know if those thousands make up 1% of those who have tried or 95% of those who have tried.”
The next question, he noted, is whether smokers who switch to e-cigarettes will be better able to quit nicotine altogether or if they will remain addicted to nicotine.
Do they lead to dual users? Dr. McAfee said most e-cigarette users don’t switch from regular cigarettes entirely. “Will they ultimately switch or settle into a pattern of dual use for the rest of their lives or go back to smoking regular cigarettes?” he asked.
Are they a way to get around indoor air laws? This is a hot topic, with some states such as New York recently imposing restrictions on indoor e-cigarette use. E-cigarette users “will say they vape. They won’t ever say they smoke,” Dr. Wagener said.
Do they re-glamorize smoking? Experts are particularly worried that because they are marketed as being relatively harmless, e-cigarettes are separating themselves from the stigma now associated with smoking. Dr. Rigotti commented on actress Julia Louis-Dreyfus, who smoked an e-cigarette during a sketch during the January telecast of the Golden Globe Awards. Although the comedian used the prop as a joke, “I was disappointed about that,” Dr. Rigotti said. “We shouldn’t be renormalizing something that looks like smoking [without knowing] the long-term public health impact.”
Are they a gateway to regular cigarette smoking? This may be more the case for young new smokers. A CDC study showed that e-cigarette use more than doubled among U.S. middle school and high school students between 2011 and 2012, from 3.3% to 6.8%.
“A 2014 [regular] cigarette poses some barriers to an adolescent to get over 7,000 chemicals in smoke. It’s a shock to the system with heavy nicotine exposure. The e-cigarette is a lot more mellow as a starter product,” Dr. McAfee said.
For those who say e-cigarettes are an impediment to cessation and should be eliminated entirely, Amy L. Fairchild, PhD, MPH, a professor of sociomedical sciences at the Columbia University Mailman School of Public Health in New York, said it’s important to note the environment in which e-cigarettes are being introduced. Nineteen percent of Americans smoke and 443,000 deaths per year in the U.S. are tobacco-related.
As a result, she said, the risk of taking e-cigarettes out of the market is greater than the risk of allowing them in with careful monitoring, an opinion she wrote about in the Jan. 23 New England Journal of Medicine.
Talking to patients
The uptake in e-cigarette use has one sure silver lining, Dr. McAfee said. “The clinical benefit to physicians is that this is another way to have a conversation with a patient about the core question about smoking, why they don’t need to, and FDA-approved cessation products,” he said.
Like Dr. Leone, Dr. Wagener gives patients credit for trying something to address their cigarette habit. “I say, ‘Congratulations! You’re doing a great job. How are you feeling?’” he said. The answer, he said, is usually positive. Then he continues, saying, “I want to encourage you not to stop here. There are even safer alternatives for you.”
He suggested physicians explicitly explain that e-cigarettes are completely unregulated by the FDA and are not an approved smoking-cessation device (see sidebar). Then he recommended saying, “I encourage you to quit smoking using FDA-approved products.” Physicians who want to stake out a more middle ground should say, “I encourage you to look for the opportunity to completely quit all nicotine.”
Dr. Rigotti said she first recommends combinations of nicotine replacement products to patients trying to quit smoking, but she’s open to other ideas. “The field of tobacco control recognizes cessation is the goal, but if the patient can’t quit then I think we should look at harm reduction,” she said.
For patients who smoke less than a pack a day, nicotine dependency may be less difficult to give up than the familiar behaviors such as holding the cigarette or inhaling, Dr. Hyman said. As a result, e-cigarettes may just perpetuate the habit. Instead, these patients may do better quitting “cold turkey” by using nicotine supplementation.
Still, when talking to his patients, he emphasizes that every step in the right direction is a good one. He says, “If we can’t set a quit date, can you agree to cut down?”
That leads to a discussion of the cessation aids. When asked which he recommends, he says, “The one with more medical literature documented for efficacy. That would not include e-cigarettes at this time.”
Given the health stakes, efficacious studies on e-cigarettes, especially their long-term harms and toxin exposure, need to be done immediately, experts said.
“We should call for fast, efficient, and effective study of [e-cigarettes],” Dr. Leone said. Those studies would be most useful by focusing on which brand to use at which dose and frequency, he noted.
Until there are more regulations and guidance, physicians may have to decide for themselves how to view e-cigarette use.
Despite today’s concerns, Dr. Rigotti said e-cigarettes could have a positive impact on quitting smoking. Ten years from now, she said, if smokers who can’t otherwise quit switch to e-cigarettes, that could mean the end of cigarettes entirely.
“It’s a very interesting product and we’ll have to see what happens,” she said. “They’re definitely game changers.”
FDA mulling position on e-cigarettes
So far, the FDA has been relatively silent on the issue of e-cigarettes.
In 2010, the agency’s Center for Tobacco Products was told by the U.S. Court of Appeals for the D.C. Circuit that it couldn’t regulate e-cigarettes as drug delivery devices unless manufacturers make therapeutic claims. As a result, the e-cigarette companies had to drop any therapeutic claims they had been making about their products.
The FDA is expected to release a proposed rule on how it intends to regulate additional types of tobacco products and make them subject to regulation under the Family Smoking Prevention and Tobacco Control Act, but it has yet to issue regulatory rules.
An FDA spokesperson said that a proposed rule has been sent to the Office of Management of Budget and that the FDA “intends to propose a regulation that would extend the agency’s ‘tobacco product’ authorities, which currently only apply to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, to other categories of tobacco products that meet the statutory definition of ‘tobacco product.’ Further research is needed to assess the potential public health benefits and risks of electronic cigarettes and other novel tobacco products.”
Proponents of FDA oversight, like Amy L. Fairchild, PhD, MPH, a professor of sociomedical sciences at the Columbia University Mailman School of Public Health in New York, hope the agency will step in to ensure that e-cigarettes use high-grade nicotine and reduce the level of contaminants, as well as ban sales to minors.
“The FDA has to get involved,” she said. “Nobody argues we need some kind of regulation. The question is how much.”
In the meantime, e-cigarette companies are pouring millions into something that hasn’t been available to cigarette companies since 1971, according to the Wall Street Journal—TV commercials and other ads. For example, Lorillard, which owns the blu e-cigarette brand, had planned to spend $30 million on marketing and celebrity endorsements in 2013, according to an August 2013 article in the New York Times.
Tim McAfee, MD, MPH, director of the Centers for Disease Control and Prevention’s (CDC) Office on Smoking and Health, finds that trend particularly worrisome, likening the new ads with celebrity endorsements to cigarette ads 50 years ago.
“It looks like somebody is smoking: They’re taking a white stick and putting it to their mouth and white stuff looking like smoke is coming out. They say they’re not glorifying smoking but vaping. But can a 13-year-old watching TV make that distinction?” he asked.
And they’re skirting near the issue of cessation, said Nancy A. Rigotti, MD, professor in the department of medicine at Harvard Medical School and director of the tobacco research and treatment unit at Massachusetts General Hospital in Boston. For example, the ad line for one e-cigarette brand is “Friends don’t let friends smoke cigarettes.”
“So why won’t friends do that?” Dr. Rigotti asked. “It’s very intriguing, suggesting they are harm reduction [aids]. They get as close to the line [as possible] without saying it.”
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