Tuesday, September 01, 2015

New JAMA Article Offers Irresponsible Medical Advice to Physicians About Smoking Cessation

An article published yesterday online in the Journal of the American Medical Association Internal Medicine (JAMA Internal Medicine) advises physicians to discourage their patients from trying to quit smoking using electronic cigarettes.

(See: McMillen RC, Gottlieb MA, Winickoff JP. E-Cigarettes -- The roles of regulation and clinicians. JAMA Internal Medicine. Published online August 31, 2015. doi:10.1001/jamainternmed.2015.4436.)

Arguing that "e-cigarettes primarily emit a toxic aerosol," and that "the use of e-cigarettes as well as conventional cigarettes may actually frustrate cessation attempts," the article concludes that "counseling patients to use e-cigarettes is a practice that is currently not supported by evidence." The article also argues that counseling patients to quit smoking using e-cigarettes "should be considered off-label advice."

The article does acknowledge, however, that: "If research demonstrates health benefits to smokers who are able to completely switch from combustible tobacco products to e-cigarettes, these products could yet be approved for smoking cessation."

The Rest of the Story

Unfortunately, this article has it all wrong. It misrepresents the current scientific evidence, ignores much of the evidence, misconstrues the paradigm for e-cigarette use, and thus ends up offering inappropriate and irresponsible advice to clinicians regarding the potential role of electronic cigarettes in smoking cessation.

To see just how bad this advice is, consider the following scenario:

A 56-year old smoker with a 40 pack-year history (1 pack per day since age 16) presents to his physician with a desire to quit smoking. He has tried nicotine replacement therapy and varenicline unsuccessfully in the past. He therefore has no interest in using FDA-approved smoking cessation drugs again. However, several of his close friends and family members have quit successfully using e-cigarettes, and he is intrigued by the possibility that this approach might work for him, since he feels the need to maintain the physical acts of smoking behavior rather than just slop nicotine onto his chest. What should the physician recommend?

According to the article, there is no evidence for the physician to recommend that the patient go ahead and try to quit using e-cigarettes and instead, the physician should recommend that the patient once again use nicotine replacement therapy, even though it failed multiple times in the past. The physician is instructed to discourage the quit attempt with electronic cigarettes, which would constitute "off-label" use that is not supported by evidence and which might actually "frustrate" this smoker's cessation attempt.

Obviously, the most likely result of the physician's advice is that the smoker will return home and continue to puff like a chimney, since he has no desire to once again use the nicotine patch, nicotine gum, or Chantix, which nearly drove him crazy the first time he tried it.

Clearly, this recommended advice is inappropriate and irresponsible. Given the smoker's enthusiasm for trying e-cigarettes, he should be encouraged to give it a try, praised for his desire to quit, and wished the best of luck in his attempt. He should be advised to try to switch completely to e-cigarettes rather than become a dual user. However, if it comes to a choice between dual use or smoking only, he should be encouraged to use as many e-cigarettes as few real cigarettes as possible. Based on clinical data, the most likely outcome is that the smoker will either quit or greatly reduce the amount that he smokes, a much better outcome than what would have likely occurred had he been advised to try "FDA-approved" methods (which work about 10% of the time anyway).

The chances of the smoker quitting using e-cigarettes are at least as high as him quitting with NRT, but the chances of him at least greatly reducing his cigarette consumption are much higher. And, as the authors of the article acknowledge: "cutting back on smoking behavior is often more acceptable to smokers who resist quitting entirely and increases quit rates in the long term." In fact, this is precisely why encouraging smokers who have failed to quit using NRT or drugs in the past is such appropriate advice.

In this article, the problem is not merely that irresponsible advice is given but that this advice is based on a misrepresentation of the scientific evidence.

First, calling e-cigarette aerosol "primarily a toxic aerosol" is misleading. Consider the case of VUSE. With the exception of propylene glycol and nicotine, the aerosol has been shown not to contain detectable amounts of any "toxic" chemicals. The same is true with Mark Ten, NJOY, and many other e-cigarette brands in the market. While it is true that some e-cigarette brands produce formaldehyde, these brands are still much, much safer than real cigarettes. Moreover, if the physician is concerned, she can simply recommend one of the brands whose testing has demonstrated that carcinogens such as tobacco-specific nitrosamines and formaldehyde are not a problem. Even recommending a brand that does produce some formaldehyde is warranted, but the benefits of the patient quitting smoking far outweigh the slight risk of exposure to a relatively small dose of formaldehyde. Rather than characterizing e-cigarette vapor as "primarily a toxic aerosol," one could characterize it as "a relatively safe form of nicotine" (compared to cigarettes).

Second, it is simply not the case that the use of e-cigarettes "frustrates" quit attempts. There is absolutely no evidence to support this contention. Instead, the overwhelming body of evidence suggests that e-cigarettes are an effective smoking cessation aid, at least as effective as the current "FDA-approved" cessation methods.

Third, it is not true that counseling patients to quit using e-cigarettes is not supported by evidence. There is strong evidence that e-cigarettes have helped thousands of smokers quit and that these products have greatly improved the health of these vapers. There is solid evidence, for example, that asthmatic smokers who switch to e-cigarettes experience an immediate improvement in their respiratory symptoms as well as in their lung function.

Finally, advising patients to try e-cigarettes to quit smoking is not "off-label" advice. Why? Because there is no "on-label" advice. E-cigarettes are not drugs. They are properly viewed not as drugs, but as an alternative form of nicotine delivery that is much safer than smoking. This is a "recreational use" of the product, not an FDA-approved drug use. And it never will be an FDA-approved drug. These products will be regulated as nicotine-containing products, but not as drugs. (Note: They could be regulated as drugs if they make therapeutic claims, but no company is going to make such claims if it requires them to seek approval from the Center for Drug Evaluation and Research rather than from the Center for Tobacco Products.)

Interestingly, the paper acknowledges that "if" research shows health benefits to smokers who switch to e-cigarettes, then the products should then be recommended by physicians. But we already have that evidence! We know that switching to e-cigarettes conveys immediate health benefits to smokers. Ask any vaper! Or, simply look at the research.

I should note that I have no problem with most of the article's recommendations regarding the regulation of e-cigarettes. I agree that these products need to be regulated by the FDA, that there needs to be restrictions on the sale and marketing of these products to youth, that there needs to be basic safety and quality control guidelines, and that children need to be protected from accidental ingestion of liquid nicotine.

However, it is unfortunate that the article feels the need to go further than recommending these regulations, and that it extends to providing irresponsible advice to physicians regarding smoking cessation. 

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