Picking up the pace on Rx pricing reform
FDA missing in action on e-cigarettes
Electronic cigarettes (e-cigarettes) are being promoted as wonder products that can satisfy a smoker by providing a nicotine fix without the smoke and ash of regular cigarettes. This implies, but purposefully does not directly state, that these products eliminate the staggering health risks of smoking cigarettes. They also are advertised as devices that can be used to circumvent current no-smoking policies. So the message to the consumer is that e-cigarettes are clean and safe and you can use them when and where you choose.
While it seems a matter of common sense to conclude that e-cigarettes are safer than regular cigarettes for current smokers who haven't been able to quit, the question the FDA should be asking is whether they are safe for general use and, if not, what restrictions should be placed on them. There is no evidence to assure that inhalation of the vapors of e-cigarettes--either directly or in second hand fashion--is actually safe and there is some evidence to suggest they may carry negative health effects that should not be ignored. Therefore, unless and until independent evidence is compiled proving their safety, regulation would seem the prudent course.
But there is another problem we are inclined to overlook--e-cigarettes are delivery devices for nicotine, a highly addictive drug. Dismissing this fact as inconsequential is a big mistake. Of particular concern should be the effect of nicotine on a child or a teen's developing brain. Because the parts of the brain responsible for judgment, decision-making, emotion and impulse control are not fully developed until early adulthood, adolescents are more likely than adults to take risks, including experimenting with nicotine, alcohol and other drugs. At the same time, because these regions of the brain are still developing, they are more susceptible to the negative impact of addictive substances, further impairing judgment, interfering with brain development and increasing the vulnerability to addiction.
Nicotine use results in addiction for many people but addiction is a disease that is not limited to one drug. Addiction is about what happens in the brain in response to the rewarding effects of nicotine, alcohol and other drugs. Among those with this disease, 56% are risky users of multiple addictive substances, 17 percent have addiction involving multiple substances, and ending use of one addictive substance often results in increasing use of others. We can't think of nicotine in isolation.
While many factors contribute to the risk of addiction, biological research suggests early nicotine use can affect the brain in ways that increase the rewarding effects of other drugs. High school students who have ever smoked cigarettes are nine times likelier to have addiction involving alcohol or other drugs than those who have never smoked. Further, people who began smoking before age 15 are twice as likely to have addiction involving alcohol compared to those who first smoked at age 21 or older, three times as likely to have addiction involving a prescription drug and seven times as likely to have addiction involving marijuana.
The tobacco industry knows only too well that the best way to get a lifetime user is to start them young. While some states have moved to restrict sale of e-cigarettes to kids, in many states there are no prohibitions against an eight year old purchasing and using these products nor are there restrictions on including kid friendly candy and fruit flavorings.
This is deplorable, especially since we know that adolescence is the critical period of vulnerability for the onset of substance use and the development of addiction and that the road to addiction can be very short for young users of nicotine. A study of 12- to 13-year-old cigarette smokers found that 40 percent developed symptoms of addiction involving nicotine after just trying smoking. Of those who reported symptoms, fully half developed them by the time they were smoking only two cigarettes one day a week, and two-thirds had symptoms by the time they were smoking one cigarette a day. Other studies have confirmed this link between early nicotine use and quick onset of symptoms of addiction.
These facts explain current e-cigarette marketing tactics that revive the glamorous promotional cues which for decades have attracted young people to the deadly habit of cigarette smoking. The success of these marketing ploys in an environment without regulation is reflected in the recent Center for Disease Control (CDC) report documenting a significant increase in e-cigarette use among middle and high school students. Placing the financial interests of an industry above protecting the health of our children is unconscionable.
The bottom line is that nicotine, no matter how it is delivered, is not a safe drug. The use of nicotine puts people at risk for addiction, a disease that currently affects 40 million Americans. Addiction and the risky substance use that drives it is our nation's most costly and preventable health problem.
We, of course, should be doing the research needed to understand the health effects of these products and whether, if properly formulated and regulated, they could be an important contribution to FDA approved smoking cessation products. But the FDA is charged first and foremost with protecting the public health and there is ample evidence questioning e-cigarettes' safety for general use and showing that these products can be particularly dangerous when used by young people. How many more lives is the FDA willing to risk before it acts?
Foster is vice-president and director of the Division of Policy Research and Analysis at CASAColumbia.