University of Louisville professors’ research on e-cigarettes has drawn them into a smoldering national debate that is pitting a burgeoning multi-billion dollar industry against regulators and health advocates.
Dr. Daniel J. Conklin, professor in UofL’s Division of Cardiovascular Medicine, told IL that his studies indicate exposure to e-cigarette vapors has revealed damage to blood vessels in mice.
“There’s evidence coming out that e-cigarette use has … genetic effects in humans that are like smoking to some degree, and that the effects in animals show … poor outcomes,” Conklin told IL.
The UofL professor presented part of his research this month at the annual meeting of the American Association for the Advancement of Science in Washington, D.C.
An e-cigarette industry spokesman told IL that e-cigarettes remain safe and help cigarette smokers quit, but government agencies and health organizations have voiced concerns, especially about e-cigarettes luring teens into nicotine addiction.
The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Under the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA can “deem” additional tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act.
The FDA in 2014 proposed a historic new rule that would extend the agency’s authority to regulate additional products that meet the legal definition of a tobacco product, such as electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” nicotine gels and waterpipe tobacco.
FDA spokesman Michael Felberbaum told IL via email that the proposed rule resulted in more than 135,000 comments for the agency to review and consider. The final rule was submitted in October to the Office of Management and Budget, which is required to review all significant regulatory actions.
The rule is still being reviewed, but FDA oversight could mean that manufacturers have to submit product and ingredient listings, that e-cigarette products display health warning labels, and that the products cannot be sold to underage youth.
Felberbaum said the FDA has to weigh e-cigarettes’ potential benefits against their harm.
“If e-cigarettes have reduced toxicity, help smokers quit or do not introduce adolescents to tobacco use, they may have the potential to reduce disease and death,” he said. “However, if e-cigarettes prompt young people to start using them separately or with other conventional tobacco products, or discourage or delay quitting tobacco use, then the public health impact could be negative.”
The FDA is spending millions of dollars on research to get answers to some of its questions. UofL was awarded more than $14 million in 2013 to study the health effects of tobacco products. Drs. Conklin and Sanjay Srivastava, also a professor with UofL’s Division of Cardiovascular Medicine, are investigating what components of tobacco products cause atherosclerosis, or the narrowing of blood vessels due to deposits of fatty materials.
Conklin said that while the public worries primarily about the connection between smoking and lung cancer, few smokers actually get lung cancer — but all smokers have a higher risk than nonsmokers for cardiovascular health problems, including heart attacks and strokes.
And in many ways, the cardiovascular effects of smoking are more insidious: Conklin said that while a smoker who smokes two packs a day is much more likely to get lung cancer than someone who smokes only a few cigarettes per day, both suffer about the same risk for developing cardiovascular problems.
Nonsmokers who live with a smoker have almost no increased risk for lung cancer, Conklin said, but such nonsmokers do have an increased risk for cardiovascular disease.
The UofL researcher recently sat down with IL in his Louisville office and explained how he used an octagonal chamber to expose mice to e-cigarette vapor puffs of various volumes and durations and then inspected the impact on the animal’s cardiovascular system.
Blood vessels of animals exposed to nicotine had about twice the plaque buildup as those who inhaled just air, Conklin’s research shows. Exposure to e-cigarette vapor and acrolein, an aldehyde produced by tobacco, also increased plaque buildup compared to the control groups.
E-cigarette vapor seems to reduce the number of angiogenic cells, which contribute to the repair of blood vessels. The greater the exposure to the vapor, the greater the reduction of those cells.
Conklin said questions also remain about the safety of e-cigarettes’ flavoring agents, which can range from strawberry to steak and cream of mushroom soup. While the substances have been deemed safe for ingestion, Conklin said their effects after inhalation, especially after being heated, are unknown.
The industry was projected to generate sales of $3.5 billion last year, double the amount from two years earlier, but the potential federal oversight has e-cigarette makers worried. The website of a major trade association indicates that it fears a collapse of the fledgling industry should the FDA succeed in its bid to oversee vaping products.
Under a flashing “Save The Industry” banner, the Tobacco Vapor Electronic Cigarette Association writes: “Our rights as vapers as well as the livelihoods of many working in the industry has been threatened. We at the TVECA are committed to the preservation of the industry as well as our right to a vastly less harmful alternative to smoking.”
TVECA Co-Founder Thomas Kiklas told IL that researchers like Conklin who are paid to conduct studies for the FDA have a vested interest in producing certain results to garner more money for such research.
In addition, Kiklas said, e-cigarettes are helping smokers quit — though government officials say the research is unclear.
Kiklas, who also is co-owner of NICMAXX Electronic Cigarette Brands, said that 9 million Americans use e-cigarettes, and “no single American has been harmed.”
He also said no studies indicate that nicotine by itself is harmful.
Dr. Conklin, the Centers for Disease Control and Prevention, and the American Heart Association disagree.
“There is no safe cigarette,” Conklin said. “Couching (e-cigs) as a safer product is just wrong.”
Brian King, deputy director for research translation in the CDC’s Office on Smoking and Health, said that while e-cigarettes do not contain the thousands of substances that make traditional cigarettes so dangerous — they are more than just harmless water vapor.
“Safer is not the same as safe,” he said.
E-cig use on rise, especially among kids
While vaping products are changing rapidly, nicotine remains addictive and can harm adolescent brain development, King said. That’s particularly troubling because e-cigarette use is skyrocketing among young people, and more than 90 percent of smokers begin before age 18.
The CDC said last month that e-cigarettes became the most commonly used tobacco product among youth in 2014, surpassing conventional cigarettes. From 2011 to 2014, e-cigarette use more than doubled among middle school students. Among high school students it soared from 1.5 percent to 13.4 percent.
Spending on e-cigarette advertising rose nearly 20-fold, from $6.4 million in 2011 to an estimated $115 million in 2014.
King said the lack of regulations, unfettered marketing and the perception that e-cigarettes are a safe alternative to conventional cigarettes has created a perfect firestorm that has engulfed some of the most vulnerable populations in nicotine addiction.
The American Heart Association agrees, telling IL that e-cigarettes are “a potential gateway to cigarettes and other tobacco products.”
King and the AHA also agree that the science on whether e-cigarettes help smokers quit is inconclusive. While some smokers use e-cigarettes to kick their smoking habit, many smokers use both products. The FDA has approved seven cessation methods that work, King said, and e-cigarettes are not among them.
Conklin said both the regulators and the industry have a lot at stake in the battle: If the FDA does not deliver an ironclad case, it will have to wait a decade before it can try again to initiate oversight of e-cigarettes. And manufacturers stand to lose billions of dollars in revenues.
The antagonistic atmosphere is palpable: Conklin said that he and the university have received several Freedom of Information Act requests, including one from the e-cigarette industry directly. The industry wants to know the opposition’s research so it can try to undermine it when it is presented to regulators.
In the meantime, Conklin has some advice to people who are thinking about trying e-cigarettes: “If you’re uncertain about the harm, I don’t think you should use (the) product.”