Monday, July 27, 2009

Safe and Effective

Why in the world are people – educated people, medical doctors for goodness sake—so up in arms about a product that tens of thousands of people are saying has enabled them to refrain from smoking what amounts to millions—perhaps billions—of tobacco cigarettes?

Several health and anti-smoking groups, including the American Lung Association, American Cancer Society Cancer Action Network, American Heart Association, and Campaign for Tobacco-Free Kids have brought pressure on the FDA to remove electronic cigarettes from the market. "No studies have been done on e-cigarettes to date regarding their health effects or their effectiveness as cessation aids," reads one sentence from their March 2009 joint statement.

Many, many studies have been done regarding the harmful effects of inhaling tobacco smoke. If those effects are as bad as the studies claim, it is hard to imagine anything more harmful. And, unless the government and all these health organizations have been grossly exaggerating the harm done by smoking, it is hard to fathom why they would not be jumping up and down with joy at anything that enables people to stop smoking.

E-cigarettes haven't been proven safe? How do you prove something is safe? You can't. All you can do is observe whether any harm occurs when people use that something. The FDA approved Chantix (varenicline) as a safe and effective treatment for smoking after short term use (12 weeks) by carefully-selected subjects in clinical trials. Folks with cardiovascular disease, high blood pressure, and history of cancer were disqualified from participation. But aren't these exactly the people who might be most motivated to seek help to quit smoking? Unfortunately, the trials also did not include anyone with a history of psychological problems such as depression and panic disorder.

However, after the drug became available and used by the general public, reports of extremely serious adverse effects started coming in, including potentially lethal heart rhythm problems, depression, aggression, and suicide. You don't get more serious than "death" as an adverse side effect.

The FDA announced on 7/22/2009 that they had found "carcinogens and toxic chemicals such as diethylene glycol" in electronic cigarettes.

The FDA failed to mention that the same "carcinogens" (nitrosamines) are found in the FDA-approved nicotine replacement therapy (NRT) products such as the patch, gum, lozenges, and inhalers.

The electronic cigarette has been in use by the general public for several years in Europe and almost two years in the U.S. So far there have been no reports of suicide, depression, aggression, or death caused by them. And despite the FDA finding 1% diethylene glycol (DEG) in one of the 18 cartridges, there have been no reports of antifreeze poisoning by e-cigarette users.

So why are the health groups screaming for e-cigarettes to be pulled from the market, but keeping totally silent about Chantix and FDA-approved NRT products?

Largely in response to pressure by such groups, the FDA wants e-cigarette sellers to file a New Drug Application and conduct clinical trials such to prove they are safe and effective as a "smoking cessation" product. The problem is that the manufacturers and retailers do not view this as a medical product.

At first many people purchased them to be used as advertised. E-cigarettes allow the user to obtain sufficient nicotine to remain alert, relaxed, and able to concentrate at times and places where smoking tobacco is not permitted. It didn't take people long to figure out that if this product could satisfy their requirements at those times and places, why not all times and places? So some users consciously tried and succeeded to stop smoking tobacco. But surprisingly, some other users reported that they had no intention of quitting tobacco, but found themselves less and less interested in smoking the other (harmful) type of cigarette.

It is easy to understand why some retailers decided to capitalize on this effect and began mentioning that their product can help people stop smoking. So, ironically, because e-cigarettes (according to users) are effective at extinguishing the desire to smoke tobacco, they have captured the annoyed attention of the government.

Electronic cigarettes are unquestionably safer than tobacco cigarettes, and may be significantly safer than some products that have smoking cessation as their goal. If by "effective" we mean that a product meets one's needs, users say that electronic cigarettes are effective.

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