FDA should butt out of e-cigarette therapy

by... Michael L Marlow

WE don't smoke like we used to. Studies show cigarette consumption per capita has fallen by 62 percent since the 1964 U.S. Surgeon General's report on the health hazards of smoking.

Some of that decline is voluntary: Research indicates that 90 percent of today's smokers regret smoking and most want to quit. But government has hardly been a passive bystander, using the tax code in a public health push to get smokers to quit. (In 2010 alone, the federal and state governments collected more than $34 billion in tax revenues on tobacco products).

Leaving aside discussions of whether this particular form of government intervention is appropriate, I think we can all agree that quitting smoking is a generally positive endeavor - but also a very difficult one. For this reason, it's baffling to me that public health advocates - including those at the state's University of California school system - are turning their ire on electronic cigarettes, one of the most promising smoking cessation technologies.

Nicotine-replacement therapies (NRT), such as chewing gum or patches that provide a controlled amount of nicotine, have for years been the FDA-approved method of kicking the habit. New research published in Tobacco Control, however, casts doubt on the efficacy of these treatments: Persons who have quit smoking were shown to have relapsed at equivalent rates, whether or not they used NRT to help them in their quit attempts.

Electronic cigarettes (or e-cigarettes) provide an interesting alternative to NRT. These battery-powered devices resemble cigarettes but do not contain tobacco or produce the secondhand smoke that has so worried public health advocates. Rather, a small reservoir of liquid nicotine solution is converted into an aerosol mist that the e-cigarette user then inhales. E-cigarettes are believed to more effective because, unlike gum or the patch, they deliver nicotine with a device that mimics smoking. Thus far, the research backs up the intuition. One paper published in 2011 concluded that e-cigarettes were effective at helping smokers remain abstinent or reduce their cigarette consumption - behaviors that, over time, would ultimately save lives. Smokers themselves are even warming to the trend: Research shows that those most likely to try e-cigarettes are current tobacco users.

E-cigarettes would appear to be a market-based response to health concerns of smokers attempting to curb or quit smoking. Unfortunately, the FDA and a number of legislators have other ideas. The FDA has argued that e-cigarettes are unsafe because the cartridge may contain trace levels of toxic ingredients, and they may contain varying amounts of nicotine, leading users to be uninformed about their dosages. Their proposed solution was to ban the sale of them completely - a proposal that was overruled in court.

That hasn't stopped legislators in other jurisdictions from taking action themselves, including e-cigarettes in broader bans on smoking in certain public places. In addition to the University of California, such measures have been taken up in Arizona, Hawaii, Idaho, Kentucky, and Utah; also in the mix are the cities of Indianapolis and Augusta, Ga.

Set aside the preposterous notion that a product that produces no secondhand smoke would be included in a public smoking ban. Researchers at Harvard University and the University of California, Berkeley reviewed the evidence on the safety of e-cigarettes, and concluded that a "preponderance ... shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products. "In other words, though our knowledge of the health effects of e-cigarettes may be imperfect, we know for sure that they are considerably safer than lighting up a traditional cigarette. It seems public health advocates are more interested in controlling public behavior than seeing smokers choose a less harmful alternative.

History suggests that prohibition is not an effective public health strategy. Smokers aren't stupid - they understand that smoking is unhealthy and their flight to e-cigarettes may in fact reflect their desperate efforts to reduce their health risks. Instead of embracing their choice, the FDA has decided that a government-approved failure (like NRT or going "cold turkey") is better than an unapproved success. An interesting story indeed if smokers themselves who wish to quit are in fact being stymied by those who claim to promote public health.