Monday, December 06, 2010

Study Press Release Spreads Worldwide the Claim that E-Cigarettes are Hazardous to Health, But Study Provides No Such Evidence

A press release issued by the University of California Riverside last Thursday concludes that electronic cigarettes are hazardous to health and recommends that they be pulled from the market. This conclusion is based on a study to be published online ahead of print in the journal Tobacco Control.

The basis for the study's conclusion is that e-cigarettes are unregulated, the cartridges sometimes leak, and the instruction manuals are incomplete.

The headline of the press release reads: "Electronic Cigarettes Are Unsafe and Pose Health Risks, UC Riverside Study Finds."

This conclusion - that electronic cigarettes are unsafe and pose health risks - has been disseminated worldwide, as the press release has been picked up by numerous internet sites.

The Rest of the Story

The rest of the story is that there is no valid basis in the study itself to support a conclusion that electronic cigarettes are hazardous to users and that they produce dangerous health effects. For starters, the study didn't examine the hazards of the product to users. It looked instead at issues of quality control, integrity of packaging, adequacy of labeling, appropriateness of advertising, and other design issues. None of the flaws reported by the study, for example, that e-cigarettes are unregulated, that the cartridges sometimes leak, and that the instruction manuals are incomplete, demonstrate that electronic cigarettes are hazardous to users. They merely demonstrate that there is a potential risk associated with the use of the product.

The study did not measure the actual level of toxic chemicals or carcinogens in electronic cigarette vapor or study the health effects of the product among users. Thus, how can it possibly conclude that electronic cigarettes are unsafe and pose health risks?

In fact, the press release itself acknowledges that the headline is both misleading and unsupported by any scientific evidence.

The press release states: "“More research on e-cigarettes is crucially needed to protect the health of e-cigarette users and even those who do not use e-cigarettes,” said Kamlesh Asotra, a research administrator at UC TRDRP. “Contrary to the claims of the manufacturers and marketers of e-cigarettes being ‘safe,’ in fact, virtually nothing is known about the toxicity of the vapors generated by these e-cigarettes. Until we know any thing about the potential health risks of the toxins generated upon heating the nicotine-containing content of the e-cigarette cartridges, the ‘safety’ claims of the manufacturers are dubious at best.

“Justifiably, more information about the potential toxic and health effects of e-cigarette vapors is necessary before the public can have a definitive answer about the touted safety of e-cigarettes. Hopefully, in the near future, scientists can provide firm evidence for or against the claimed ‘safety’ of e-cigarettes as a nicotine-delivery tool.”"

Thus, the press release is stating that virtually nothing is known about the toxicity of the vapors produced by e-cigarettes and then we cannot draw conclusions about the safety of these products until we study the toxins generated. At the present time, the press release argues, we simply do not have evidence either way - we cannot conclude either that the products are safe or that they are hazardous.

Well, if that's the case - that we cannot conclude that the products are hazardous - then why does the headline of the press release state that electronic cigarettes are hazardous?

This is no small matter. The world has basically now been told that electronic cigarettes are unsafe to use. Despite the press release's own insistence that we need more research to answer this question, it no longer matters. Because a definitive answer has now been spread throughout the world via the internet. If we already are telling the public that electronic cigarettes are unsafe to use, then there is no need for further research.

Spreading to the public a possibly false conclusion could be extremely damaging to the public's health. If it turns out that electronic cigarettes are much safer than regular ones, and that they are very useful in smoking cessation, then this mistake by the press release could be devastating. It could literally cost thousands of lives.

Many ex-smokers who have quit smoking via the use of electronic cigarettes (and we know there are literally thousands of them) may well decide that the use of electronic cigarettes is unsafe - based on this press release - and may therefore decide to stop using them and return to regular cigarettes. Such a decision will almost certainly harm their health and could potentially kill them. Do we really want to encourage ex-smokers to make a potentially life-destroying decision like this if we really don't know whether electronic cigarettes are unsafe to use, or more relevantly, whether they are safer than regular cigarettes?

The press release acknowledges that we don't know enough to answer this question. Yet the press release goes ahead anyway and instructs people to stop using electronic cigarettes because they are unsafe. And it goes so far as to call for the removal of this product from the market, so that ex-smokers are in fact forced to stop using electronic cigarettes and most will then return to regular cigarette smoking.

The rest of the story, I believe, is that the researchers have essentially a pre-determined conclusion and that this conclusion does not depend on the results of the actual research. It appears that this research is really part of a crusade against electronic cigarettes and that the result of the work was going to be a conclusion that e-cigarettes are unsafe and should not be used regardless of how the results actually came out.

In fact, that is exactly what happened. The research reveals some design flaws that are of course of concern, but they do not demonstrate that the product is unsafe to use and should be pulled from the market. This apparently pre-determined conclusion nevertheless appears as the headline of the press release.

It is interesting to note that this is not the first time this has happened with the same group of researchers. In July, I reported that a study by the same researchers which demonstrated that vapers need to puff more intensely than cigarette smokers to produce aerosol was used to conclude that e-cigarettes may have adverse health effects. Yet the study failed to consider whether there was any evidence that the chemicals being inhaled in the vapor are dangerous. Nor did it consider the relative safety of the chemicals inhaled by vaping with those inhaled by smoking.

As I wrote: "Increased intensity of puffing on electronic cigarettes compared to conventional cigarettes would only make vaping more harmful if the constituents of electronic cigarette vapor were harmful to begin with. The abstract omits any mention of the fact that conventional cigarettes contain perhaps tens of thousands of chemicals and more than 40 carcinogens while electronic cigarettes contain none of the above, other than the nicotine. It also omits mention of the fact that there are no hazardous chemicals that have been identified in electronic cigarette vapor at anything other than trace levels that are known to have significant adverse health effects.

In other words, the paper is ignoring the factor which is the overwhelming determinant of the relative safety of electronic cigarettes: the chemicals present in the inhaled vapor.

Instead, the paper focuses exclusively on one small aspect of the product's use: the puffing intensity.

While this would be fine if the paper simply kept to a discussion of puffing intensity, it fails to do that, as the abstract's discussion section goes so far as to argue that the increased puffing intensity of electronic cigarettes may make these products more harmful to users. Why draw conclusions that are pure speculation and are not supported by any evidence within the paper itself? This editorializing makes it appear that the paper has a pre-determined conclusion about the safety of electronic cigarettes.

Similarly, the paper concludes that electronic cigarettes are not a useful nicotine delivery device based solely on one factor - the lack of consistency in nicotine delivery - but ignoring the much more important evidence: whether the product has been found to be or not to be effective as used by actual human beings. Once again, the paper is drawing a conclusion that goes beyond the scope of the actual findings. This editorializing also makes it appear that the paper has a pre-determined conclusion about the effectiveness of electronic cigarettes.

While the paper's findings regarding the level of puffing intensity for electronic cigarettes compared to conventional cigarettes are interesting, they clearly do not support the type of sweeping assertions that the paper makes in postulating the implications of the study."

It doesn't appear to me, then, that the real interest here is in determining whether electronic cigarettes are truly safer than regular cigarettes and therefore could play a role in saving lives from tobacco-related disease. Instead, the purpose appears to be to crusade against these products by using research to be able to disseminate pre-determined conclusions, regardless of the actual evidence that is relevant to the central research question at hand.

To maker matters worse, not only is the conclusion in the press release unsupported by the study, but this is another example of "science by press release." The press release was issued publicly, on the internet, about five days before the article will become available on the journal web site.

Science by press release is inappropriate because the findings are disseminated widely to the public without any opportunity for others to scrutinize the work. The findings must be accepted on faith. Therefore, it is impossible to judge whether the conclusions of the study are valid or not. And if the conclusions turn out to be unwarranted, then it will be too late to reverse them. The public has already been told the conclusion. Any correction given down the road would have little effect.

In most cases, I believe the results of a scientific study should not be released to the media prior to publication. However, if the results of a study are going to be released to the media, then I believe it is imperative that the study itself be made available for public scrutiny. You can't just release the conclusions, but not the study itself. While it is acceptable to send out press releases to reporters prior to the actual publication of a study, I do not believe it is acceptable to post these press releases online, as UC Riverside did in this instance.

Posting press releases online prior to publication of the study is essentially a form of "science by press release," because it amounts to disseminating the results of the study before there is any opportunity for public scrutiny of the research. Posting a press release online is essentially equivalent to the publication of an article about the study, and I believe that in spirit at least, it actually violates the embargo set by the journal.

With the widespread availability of the internet, and with multiple news services that reproduce press releases on numerous sites, publishing a press release online is tantamount to publishing a newspaper article about the study. So not only is the press release's headline misleading and unsupported by scientific evidence, the approach itself is inappropriate because it amounts to "science by press release."

(Thanks to Shadow Guest and Petrodus for pointing out information relevant to this commentary).

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