Tuesday, January 03, 2017

You Can't Identify Potential Benefits of E-Cigarettes if You Only Look for the Risks: The Flaw in Current E-Cigarette Research

A new paper published online ahead of print in the journal Preventive Medicine finds that telling smokers that vaping is safer than smoking may lead them to try vaping. In the study, smokers randomized into groups that were either told that cigarettes contain many more toxic chemicals than e-cigarettes or that cigarettes and e-cigarettes contain an equal number of toxic chemicals. The smokers were then asked whether and how that might alter their interest in changing their smoking and/or vaping behavior.

The paper reports that 328 of the 1,164 smokers (28.2%) would likely be dual users of e-cigarettes and tobacco cigarettes after being told information about the relative hazards of smoking compared to vaping. Smokers who were told that e-cigarettes contain fewer harmful chemicals than vaping were much more likely to indicate an interest in dual use.

The paper concludes that: "Smokers associated higher chemical amounts in cigarettes versus e-cigarettes with greater health harms from cigarettes and thus expressed increased interest in dual use. The findings suggest that disclosing amounts of chemicals in cigarette smoke and e-cigarette aerosol could unintentionally encourage dual use."

In the discussion, the paper argues that these findings have implications for the messages that the FDA delivers to the public regarding vaping products:

"FDA is required to publicly display information about the quantities of chemicals in cigarettes and cigarette smoke in a way that is not misleading. This information, if paired with information from advertising or FDA disclosures indicating that e-cigarette aerosol contains lower amounts of those same chemicals, could have the unfortunate effect of encouraging smokers to become dual users or increase their existing dual use under the mistaken impression that they are significantly reducing their health risks."

The Rest of the Story

At first glance, this study makes it appear that telling smokers that vaping is safer than smoking will have adverse public health consequences because it will lead many smokers to become or remain dual users.

But there are four major problems with this conclusion:

1. If You Only Look at the Risks, You Can't Find the Benefits

While the paper only looks at one potential consequence of telling smokers that vaping is safer (i.e., dual use), there are actually three potential outcomes, each of which was measured in this study:
  • the smoker might express an interest in becoming or continuing as a dual user;
  • the smoker might express an interest in continuing to smoke without using e-cigarettes; or
  • the smoker might express an interest in quitting smoking using e-cigarettes.
The first outcome, the paper argues, is a bad one for public health. The second outcome might be considered neutral, since it does not change the status quo. However, the third outcome is a profoundly positive one for public health, because these smokers, who presumably have not been able to quit (they are still current smokers) intend to quit smoking by switching completely to vaping.

Importantly, this paper only reports the proportion of smokers with the first outcome (i.e., the "bad" one). The paper does not report the proportion of smokers with the second (neutral) or third (good) outcome. Nor does the paper compare the differences in the various messages in stimulating smokers to quit using e-cigarettes (a good outcome). It only examines differences in the messages in the supposedly "bad" outcome.

For example, in the group of smokers who were told that e-cigarettes contain 100 times fewer harmful chemicals than tobacco cigarettes, the paper reports that 88 of the 276 expressed an interest in dual use. But what the paper does not examine is the outcome for the other 188 smokers. Of those 188 smokers, some expressed no interest in quitting using e-cigarettes, but presumably there were some who did. It is critical to know the number of smokers who did express an interest in quitting using e-cigarettes because that would be a very positive outcome. And without knowing the potential benefits of the various health messages, you can't possibly assess the overall public health consequences.

This is particularly problematic because the intended purpose of this research is to inform the FDA and to provide guidance to the agency in deciding what health messages to encourage, use, or allow for vaping products. By only giving the FDA one side of the story, this research hides critical information necessary to weigh potential risks and benefits.

The costs are always going to outweigh the benefits if you only quantify the risks!

Frankly, the entire research and grant portfolio of the NIH and FDA's Center for Tobacco Products is designed in exactly this way. The research is focusing on quantifying the risks associated with electronic cigarettes, but little if any work is being done to quantify the benefits.

2. Dual Use is Not Necessarily a Bad Outcome

The paper makes the assumption that dual use is a bad thing, but it might actually be a very positive development. There is solid evidence that dual use can serve as a transition on the path to eventual smoking cessation. There is also solid evidence that if a smoker is able to cut down substantially on the amount smoked, it could lessen their addiction and make it easier for them to subsequently quit smoking. Moreover, there are health benefits associated with making substantial reductions in the amount smoked, especially in terms of respiratory function and decreasing the rate of progression of lung disease.

The only way in which dual use is a bad outcome is if the smoker, in the absence of e-cigarettes, would have quit smoking. However, we know that the overwhelming majority of smokers who are attracted to e-cigarettes use these products specifically because they have been unable to quit or are not interested in quitting. It is unlikely that any significant proportion of dual users are smokers who would have quit in the absence of e-cigarettes.

3. In Public Health, We Don't Lie to the Public

Even if it is true that telling smokers that vaping is safer than smoking will encourage dual use, and even if dual use had negative public health implications, we can't lie to the public. While there might be fewer vapers if we told the public that smoking is every bit as bad as vaping, lying to the public cannot be justified because honesty and transparency are core ethical principles of the public health code of conduct. The implication of this paper is that we need to avoid telling the public the truth about the relative safety of smoking compared to vaping and that we may even need to lie about the relative risks of vaping compared to smoking.

4. The Impression that Switching from Smoking to Vaping Will Lower Health Risks is Not a "Mistaken" Impression

The paper argues that telling smokers that e-cigarettes contain fewer toxic chemicals than real cigarettes may result in "the mistaken impression that they are significantly reducing their health risks." But this is not a mistaken impression at all! It is a correct impression. Telling smokers that vaping is just about the same as smoking in terms of health risks is what is creating a mistaken impression. If there is any problem with the public's understanding of the relative risks of vaping compared to smoking, it is not the perception that vaping is safer, but instead, it is the perception that vaping is not safer than smoking.

The rest of the story is that if you only quantify the risks of a health message, you can't possibly evaluate the risk-benefit ratio because you can't find benefits if you don't look for them. In this study, only risks are quantified and although the beneficial outcome was measured, it was not analyzed or reported. To properly inform the FDA so that it can formulate rational policies, the agency needs to know about both the negative and positive consequences of a potential action. This paper is only telling part of the story.

1 comment:

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