Thursday, July 21, 2011

NEJM Perspective Article Concludes that Electronic Cigarettes are Likely Ineffective for Smoking Cessation, But Without Any Supportive Evidence

Article Effectively Encourages Ex-Smokers Who Quit Using Electronic Cigarettes to Return to Regular Cigarette Smoking

In a Perspective article published today in the New England Journal of Medicine, Cobb and Abrams conclude that because of its ineffective nicotine delivery, electronic cigarettes are unlikely to be useful in attempts to quit smoking.

(see: Cobb NK, Abrams DB. E-Cigarette or Drug-Delivery Device? Regulating Novel Nicotine Products. New England Journal of Medicine 2011. Published online ahead of print on July 21, 2011).

According to the article: "testing of users in laboratory settings revealed minimal blood nicotine concentrations. Marketing claims aside, the devices tested did not efficiently deliver nicotine, much less deliver it into the arterial blood as tobacco smoke does. Smokers attempting to use e-cigarettes for smoking cessation will most likely find them ineffective; indeed, their use may instead perpetuate smokers' addiction."

The article argues that there are already many effective treatments for smoking cessation available: "In reality, both smokers and e-cigarette users have many alternatives: multiple nicotine products, approved, regulated, and deemed to be safe and effective by the FDA, are already widely available (in addition to other effective cessation tools, such as varenicline, bupropion, telephone quit-lines, and Web-based services)."

The article advises physicians to recommend against the use of electronic cigarettes: "clinicians should advise patients wishing to use nicotine to stick to the FDA-regulated forms, such as patches, gum, lozenges, nasal spray — or even, perhaps, the existing FDA-approved inhaler."

The Rest of the Story

The article is problematic for two major reasons.

First, it draws a conclusion -- that electronic cigarettes are unlikely to be effective in helping smokers quit -- based on no supporting evidence. In fact, the article ignores the overwhelming number of reports from actual individuals who have used electronic cigarettes successfully to quit smoking. Instead, it relies on a single study which under unrealistic conditions, found ineffective delivery of nicotine from an electronic cigarette among novice users.

The article's perspective is flawed because it only recognizes one aspect of addiction to cigarettes: the pharmacologic addiction to nicotine. It ignores the fact that there is a strong behavioral aspect to the addiction. The physical stimuli, the various acts associated with smoking, the social factors, are all part of the addiction. In fact, electronic cigarettes are effective for many smokers specifically because they mimic the behavioral act of smoking and thus address the behavioral and not merely the pharmacologic aspect of the addiction.

Instead of concluding that electronic cigarettes are unlikely to help smokers quit, the article should instead have noted how remarkable it is that a product which appears to deliver nicotine relatively ineffectively has been so effective in helping many smokers to quit. So much so that there are internet forums with thousands of vapers who testify to the effectiveness of these devices in keeping them off cigarettes completely, many of them for more than a year. With technological refinements that would improve nicotine delivery, the effectiveness of the product will only improve.

It is surprising that the article would draw a conclusion regarding the ineffectiveness of electronic cigarettes in helping smokers quit without actually reviewing the substantial evidence -- put forward by literally hundreds of ex-smokers -- that the electronic cigarette is what enabled them to quit smoking. In order for Cobb and Abrams' conclusion to be true, these hundreds of electronic cigarette users must apparently be lying.

It is interesting that while the authors completely discount hundreds of reports of the effectiveness of electronic cigarettes for complete smoking cessation, they are willing to put out dire warnings about the dangers of the product in the absence of a single reported case of nicotine toxicity - or any other serious adverse effect - caused by electronic cigarettes, despite their use by more than a million people over the past four years, and despite the failure of the FDA to report any serious adverse effects for two years following its urging of vapers to report such effects to the agency.

The second problem with the article is that it makes what I feel is an irresponsible medical recommendation: that ex-smokers who have quit successfully using the electronic cigarette discontinue the use of these devices and switch over to an FDA-approved therapy, like the nicotine patch.

The rest of the story is that the majority of these successful ex-smokers have tried FDA-approved therapies and failed. This is precisely why they have given electronic cigarettes a try. People do not generally pick up an electronic cigarette for $40 to $90 in a first attempt to quit smoking. Usually, they try the FDA-approved therapies first, get frustrated that they don't work well, and then decide to try an unconventional approach. It is almost undoubtedly true that if vapers stopped using electronic cigarettes and switched over to the nicotine patch or gum, most of them would end up smoking cigarettes within hours to days.

This is why I call it irresponsible advice: the result would be literally thousands of ex-smokers returning to regular cigarette smoking. It would be essentially a public health disaster. The complete reversal of tremendous health gains that these vapers have already realized. What a shame it would be to have thousands of these ex-smokers negate their success in quitting smoking and return to the analog cigarettes because of some unsupported and ill-thought-out advice that somehow they are worse off being ex-smokers on e-cigarettes than current smokers on Marlboros.

But the real shame of this story is that the ill advice is not coming from individuals who are objective and financially unconflicted. It is coming from authors who I believe have financial conflicts of interest that could be perceived as potentially biasing them to protect the profits of traditional smoking cessation approaches.

Dr. Cobb is a paid consultant to a company that makes its profits based on an internet smoking cessation site which heavily promotes smoking cessation drugs: "Dr Cobb is a consultant to Healthways Inc, the current owner of the QuitNet system." Thus, he is conflicted because to the extent that the use of electronic cigarettes presents a different pathway to cessation than the traditional one - the use of a smoking cessation internet site, medication, online support, etc. - e-cigarettes may represent a threat to the profits of Healthways. In this light, it is perhaps not surprising that "Web-based services" are called out in the article as an existing smoking strategy that should be relied upon instead of electronic cigarettes.

Dr. Abrams has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer. Dr. Abrams also reports having served as a senior scientific advisor for Johnson & Johnson. It is difficult to find a pharmaceutical company involved in smoking cessation drugs that Dr. Abrams has not had an association with over the years.

This is not to criticize him; the research has made important contributions. It is simply to make note of the financial conflicts of interest that are present with respect to his views on electronic cigarettes, a major threat to the profits of these very same pharmaceutical companies.

The bottom line is that the article draws a major conclusion which lacks supportive evidence and which ignores substantial evidence, that it advances a piece of medical advice which is ill-chosen and could be harmful to many people, and that both of these problems appear in the setting of substantial financial conflicts of interest.

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