Michael Siegel and colleagues at Boston University School of Public Health recently cancelled a planned crowd-funded study into the use of e-cigs, named the Behavioral Study of Cigarette and Tobacco Substitution (BSCiTS), just a week after its launch – despite having worked on the project for a year.
Among the reasons Siegel cited for abandoning the study were “great divisiveness within the e-cigarette community regarding the role of research”, “hostile” feedback directed toward his team, and – perhaps most serious of all – “the fact that we felt that pressure was being put on us to alter the methodology in order to produce more positive results”.
He singled out the advocacy group Consumer Advocates for Smoke-Free Alternatives Association (CASAA), which has robustly rebutted his charges.
Siegel told ECigIntelligence: “We received absolutely no criticism of the proposed study by any e-cigarette companies…The only opposition was from CASAA, [which] undermined the campaign by not merely failing to support it, but by actively opposing it, urging its members not to contribute.
“They don’t want to see a clinical trial conducted on electronic cigarettes. Attempting to exert influence on independent researchers to produce more favorable results is deeply unethical and extremely problematic. Moreover, this is hypocritical given the e-cigarette community’s rejection of biased research studies produced by tobacco companies and public health professionals.”
CASAA’s president Julie Woessner, however, dismissed Siegel’s accusation, saying that CASAA’s concerns lay with the study design itself.
“We maintain our recommendation that randomized controlled trials cannot adequately evaluate the diversity and potential of vapor products. Rather than seek ‘favorable’ outcomes from studies, we continue to advocate for accuracy,” she told ECigIntelligence.
Siegel’s team had proposed a randomised controlled trial (RCT) of switching from tobacco to e-cigarettes, studying the success or failure of individuals in giving up smoking with the aid of e-cigs.
But CASAA, and others, feel that people’s use of vaping is more complex than simply adopting one brand of e-cig as an alternative to tobacco. CASAA believes that a survey of vapers would be more informative on actual experiences.
“Testing [tobacco harm reduction] products as if they are just administered pharmaceuticals is a mistake,” the organisation wrote to Siegel. “THR is not a clinical process, and so a clinical study simply does not fit.
“Our experience, which is quite extensive, is that very few commit to a complete transition without a great deal of experimentation and use of various different devices, liquid flavors, and nicotine strengths. It is the diversity in product and the ability to infinitely customize the experience that is part of what makes e-cigarettes such a successful alternative to smoking. In addition, social networks are critical.
“The type of study you are proposing cannot even begin to address those complexities. There is a very good chance it will grossly understate the real-world effectiveness of e-cigarettes, and thus do the cause more harm than good.
“We believe that a survey could actually provide much better scientific information than an RCT at a reasonable cost, one that would not be so inappropriate to be asking from our community.”
CASAA also doubts whether the U.S. Food and Drug Administration (FDA), currently reviewing public comments on its proposed regulations for e-cigarettes, would be much helped by the kind of study Siegel proposed.
“It will have little or no apparent relevance to their most momentous decision, whether to effectively ban legal sales of open-system e-cigarettes,” the association maintains, although Siegel argues that “the FDA is going to require rigorous research to quantify the effects of electronic cigarettes on smoking behavior” and that “in the eyes of the FDA, this means – almost by definition – a clinical trial of some sort”.
According to Siegel, “while it is true that the methods of a randomized clinical trial need to be modified to study e-cigarettes, this doesn’t mean that the methodology is not appropriate. What is needed is a clinical trial that simulates the real-life situation, in that smokers are given a choice of brands and types of electronic cigarettes to try.”
CASAA was further concerned by financial aspects of Siegel’s proposed study, expected to cost around $4.5m (€3.5m). “If you were to raise even 5% of that sum from the community, it would be roughly equal to the sum of every penny the community has ever spent on non-corporate activism and research,” the organisation said in its letter to Siegel.
“Realistically, there is no way to fund this except through the federal government, and if you are seeking funding through the government, it makes no sense to try to fundraise an extraordinary sum of money from the community. If your project raises even a tiny fraction from the community, everything else that needs (comparatively modest) funding would be devastated.”
Siegel, a professor in the department of community health sciences at Boston University, had ruled out accepting funding from the tobacco industry and was not confident that independent e-cig companies could provide enough money.
His team now, however, says it is “still pursuing funding to conduct this much-needed research [and] hoping to secure funding from a number of electronic cigarette companies”. In the meantime, donations made to the abandoned study will be returned.
What This Means: The ins and outs of who said what to whom and when won’t matter in the long run. But this tale illustrates an important point: it is a microcosm of a much larger debate, sometimes spilling over into angry argument, over what needs to be studied and how.
While some may fondly believe that conclusive research on e-cigarettes, smoking cessation and health already exists (whether positive or negative in its findings), the reality is that even the basic parameters of research are subject to disagreement. This is a principal reason why the debate over the science (which may be slightly distinct from the strictly scientific debate) will run for quite some time yet.
Siegel may have a point about hostility, though. It was a little surprising to read one prominent figure in the e-cig world, associated with CASAA, coming very close in a blog post to comparing Siegel to “a scammer” for seeking to raise money from the vaping community. And Siegel is, sadly, not the only one on the receiving end of less-than-friendly comments from that community.
– Barnaby Page ECigIntelligence staff
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