Monday, April 27, 2015

Journal Commentary on Electronic Cigarettes is a Scientifically Unsupportable Hatchet Job and Fails to Disclose Author's Conflict of Interest

A commentary that appears in the current issue of the journal Pediatric Allergy, Immunology, and Pulmonology demonizes electronic cigarettes, claiming that they are not necessarily safer than cigarettes, that they are a gateway to nicotine addiction and smoking, and that they are not helpful in smoking cessation.

(See: Schraufnagel DE. Electronic cigarettes: vulnerability of youth. Pediatric Allergy, Immunology, and Pulmonology 2015; 28(1):2-6.)

The commentary argues that e-cigarettes are not necessarily safer than tobacco cigarettes:

"Electronic cigarettes are widely promoted as a safe alternative to smoking and even many health advocates and medical journals declare how much safer they are than combustible cigarettes. Their premise is that electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer. Therefore, electronic cigarette use is a harm reduction strategy compared with combustible cigarettes. There are several problems with this reasoning: (1) the comparator, tobacco, is the most deadly substance to which humans are commonly exposed; (2) it assumes that electronic cigarettes are well-manufactured regulated products; (3) it ignores nicotine and its harmful effects; (4) it assumes that the harms of electronic cigarettes are known; and (5) it does not account for population effects, including the potential harm to nonsmokers."
The commentary also argues that e-cigarettes are a gateway to nicotine addiction and smoking:

"Youthful experimentation and susceptibility to the brain-modifying effects of nicotine may be the start of a lifelong addiction. ... Initiating nicotine use and increasing dependence in the population may be linked with increased tobacco and other addictive substance abuse... ."

The commentary also argues that e-cigarettes are not helpful for smoking cessation:

"Although many smokers used electronic cigarettes to stop smoking, the record of electronic cigarettes for smoking cessation is poor. It was generally not different from a placebo. The studies also did not find a difference from medicinal nicotine patches, but the patches were often not used by the study participants. ... Recently quit smokers felt that electronic cigarettes were not associated with success." 

The Rest of the Story

Unfortunately, this commentary is a heavily biased, unscientific hatchet job. All three of its major points are completely unsupported by scientific evidence. Moreover, the commentary misinterprets much of the scientific literature and misrepresents the major findings. It also ignores the literature where convenient so as not to ruin what appear to be pre-determined conclusions.

First, the article challenges the premises that: (1) "electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer"; and that (2) electronic cigarettes are "much safer ... than combustible cigarettes." But both of these premises have been solidly established with abundant scientific evidence.

There is no question that electronic cigarettes produce less tar than combustible cigarettes. In fact, they produce no tar. By definition, tar is the residue formed by the combustion of tobacco in cigarettes. Since e-cigarettes involve no combustion and do not contain tobacco, no tar is produced. Moreover, it is quite true that the tar in tobacco smoke causes emphysema, bronchitis, and cancer. Even the tobacco industry readily admits as such.

There is also no question that e-cigarettes are much safer than tobacco cigarettes. How could smoking possibly be no more hazardous than occasional use of a non-tobacco containing, non-combustible product that eliminates exposure to more than 10,000 of the chemicals and more than 60 of the carcinogens in tobacco smoke? In addition, electronic cigarettes have tobacco-specific nitrosamine levels that are two to three orders of magnitude lower than real cigarettes, have been shown not to cause acute changes in spirometry-measured lung function (unlike real cigarettes), are not known to have caused any deaths in the U.S (compared to more than 400,000 per year for real cigarettes), and have been shown to reduce respiratory symptoms and improve lung function in asthmatic smokers who switch to them. It is also well-documented that there is dramatic clinical improvement in smokers who switch to electronic cigarettes.

Second, there is absolutely no evidence that e-cigarettes are a gateway to smoking, and there is not even any evidence that e-cigarette experimentation is leading to nicotine addiction among youth. The studies which have examined this question have found that nonsmoking youth who experiment with e-cigarettes almost uniformly use these products only occasionally, not on a regular basis as would be the case if they were addicted. Moreover, there is strong evidence that as the use of e-cigarettes rose dramatically among youth, the rate of decline in youth smoking has accelerated. If anything, the current evidence supports the conclusion that e-cigarettes are a gateway away from smoking and over to vaping. These products do not normalize smoking. On the contrary, they denormalize smoking by drawing people away from it. What they normalize is vaping, not smoking.

Third, there is clinical trial evidence that e-cigarettes are helpful for smoking cessation. In fact, they are at least as helpful as the nicotine patch, which is a well-accepted smoking cessation approach. The commentary acknowledges as much. However, it misinterprets this evidence and/or misrepresents it by arguing that it shows that e-cigarettes are not effective for cessation. But how could that be the case if these products are as effective as the nicotine patch?

The commentary tries to write off this finding by arguing that "the patches were often not used by the study participants." But that is exactly the point! You have to be quite biased to not count as a failure subjects who try to quit smoking using the patch but discontinue using it. And you would also have to dismiss all of the e-cigarette users who stop using those products, which would greatly increase the observed cessation rate among e-cigarette users.

Furthermore, while the commentary cites one study to support the contention that "smokers felt that electronic cigarettes were not associated with success," it ignores a number of studies in which smokers overwhelmingly indicated the helpfulness of e-cigarettes in smoking cessation. This is what we call "cherrypicking."

Finally, the commentary argues that e-cigarettes are ineffective because in the New Zealand clinical trial, nicotine-containing e-cigarettes performed no better than what the commentary calls "placebo." But what the commentary fails to mention is that in the trial, "placebo" was actually the use of e-cigarettes, only without nicotine in the e-liquid. What the finding demonstrates is that the delivery of nicotine is only part of the reason why e-cigarettes can help smokers quit. The e-cigarette, in and of itself, aids in cessation because it simulates the smoking behavior. E-cigarettes are potentially more effective than nicotine replacement therapy because they address not only the pharmacologic aspect of smoking addiction, but also the behavioral, physical, psychological, and social aspects of the addiction to smoking.

Despite these serious flaws in the article, what I find most problematic is that the commentary fails to disclose a significant conflict of interest of its author. The author of the article is a past president and vice-president of the American Thoracic Society, and during his tenure as president and vice-president, the Society received financial support from two pharmaceutical companies that manufacture smoking cessation drugs: GlaxoSmithKline and Pfizer.

In fact, the American Thoracic Society readily acknowledges that it partners with the pharmaceutical industry and that its corporate partners include GlaxoSmithKline and Pfizer, along with at least nine other drug companies. Both GlaxoSmithKliine and Glaxo market smoking cessation drugs. Electronic cigarettes are a direct competitor of these drugs for the smoking cessation market. Thus, being president of an organization that takes money from these companies is a significant financial interest that should have been disclosed in the article. But the article states that there are no conflicts of interest.

Imagine if I were president of the American Heart Health Association (AHHA), and during my tenure as president, the AHHA received financial support from several electronic cigarette companies. Suppose I went on to publish a commentary arguing that e-cigarettes are a great strategy for smoking cessation and harm reduction. It would certainly be expected that I disclose my being president of the AHHA and receiving e-cigarette industry funding as a conflict of interest. I can guarantee that anti-smoking advocates, including Stan Glantz, would try to vilify and discredit me for not revealing this financial conflict.

The American Thoracic Society continues to receive financial support from Pfizer, which is supporting its 2015 international conference in May. The commentary's author is still affiliated with the American Thoracic Society, as he is listed as being a member of the Board of Trustees of the American Thoracic Society Foundation, on which also sits the Vice President of MedCenter Sales for GlaxoSmithKline.

The rest of the story is that the commentary fails to disclose a significant financial conflict of interest of its author, which has the appearance of creating a bias in the reporting of the scientific evidence and in the formation of the opinions expressed in the article.

It is particularly unfortunate that this conflict of interest was hidden from the public and the media, because news articles are reporting that e-cigarettes are a "gateway to addiction" and that they are "not a safer option." These unsupported and false conclusions are misleading the public and causing public health damage by undermining years of progress in convincing the public of the severe hazards of cigarette smoking. And unfortunately, the media and the public are not being made aware of the financial conflict of interest of the commentary's author, which would at least allow the conclusions to be taken with a grain of salt.

1 comment:

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