While the FDA's Center for Tobacco Products (CTP) has repeatedly claimed that it is intending to regulate e-cigarettes based on the results of scientific research, a close examination of the CTP's research portfolio reveals that the agency is heavily funding research on the potential risks of e-cigarettes but does not have a single long-term clinical trial to evaluate the potential benefits of e-cigarettes for smoking cessation.
It is great to claim to be evidence-based, but if the only evidence you produce is about the risks and none about the benefits, you can't help but conclude that the identified risks outweigh the benefits. And this appears to be exactly how the CTP has stacked the deck.
This bias is apparent even in the CTP's description of its e-cigarette research. In terms of research priorities regarding e-cigarettes, this is how CTP describes them:
"E-cigarette initiation, use (including transitions to other tobacco
products and multiple use), perceptions, dependence, and toxicity."
There's a lot here about potential risks, including youth initiation, dual use, gateway to tobacco product usage, dependence, and toxicity. However, there's nothing here about the potential benefits, such as effectiveness in getting people off cigarettes!
Then, if you examine the current research on e-cigarettes that CTP is funding, you will find plenty of studies on the potential risks of e-cigarettes, but not a single clinical trial that examines the effectiveness of e-cigarettes for smoking cessation or reduction over more than a three-week period.
Thus, the deck is stacked against e-cigarettes. The research will reveal many risks but it cannot possibly identify the most important potential benefit: long-term usefulness in smoking cessation, potentially at a level that exceeds that for current FDA-approved therapies. There's simply no way to find out without conducting such a clinical trial, yet none is being funded by CTP.
Given this heavily biased research agenda, there is no way that the CTP will be able to come up with any conclusion other than that e-cigarette risks outweigh their benefits.
Unfortunately, this is not an objective research plan. Although each individual study, taken separately, may be valid research, the plan as a whole is heavily biased. This story shows how one can bias research results not necessarily by altering the results of a single study, but by crafting a research agenda that stacks the deck toward the desired finding.
The Rest of the Story
Unfortunately, if we want to see research that evaluates the potential benefits of e-cigarettes, we're apparently not going to get it from the agency that is regulating these products. The only hope of obtaining such research is if the e-cigarette industry itself conducts the research. But this is a catch-22 because if the industry conducts the research, anti-smoking advocates will immediately discredit it on those grounds alone.
For good reason, I am therefore not optimistic about the prospects for an evidence-based approach to e-cigarette policy and/or for an evidence-based approach to e-cigarette regulation.
This is tragic, because the end result is to put a protective shield around tobacco cigarette sales and help to ensure that tens of millions of smokers remain addicted to the most toxic consumer product on the market, without the opportunity to transition to a much safer alternative that could save their lives.