Doctors, myself included (here, here and here), value clinical trials, for good reason: They are powerful tools using sophisticated scientific methods to precisely determine the effectiveness of treatments for specific diseases. But clinical trials are ill-suited to the measurement of consumers' preferences for products in the marketplace. The appropriate tool for that is post-market surveillance.
The latter mechanism can be used, for example, to analyze whether coffee drinkers can be induced to switch to Coca Cola. Looking at the American South, for example, observational research will show that some consumers prefer the cold caffeinated, carbonated beverage over coffee, giving rise to the jest, “Coke, it’s not just for breakfast anymore.” In this case, one survey is more informative and accurate than a dozen clinical trials.
In reality, and contrary to the notions of many clinicians, there are distinct parallels in the consumption of smoke-free tobacco and coffee. Both products are addictive but largely harmless. Most importantly, use of either product is not itself a disease. The vast majority of smokers aren’t “sick” and don’t want to be “treated,” yet most smoking cessation efforts are designed around the clinical trial model where smoking is the “illness,” pharmaceutical nicotine, e-cigarettes or snus is the “treatment,” and nicotine/tobacco abstinence is the “cure.” Given this, it is not surprising that most smokers don’t want to enroll in quit-smoking trials – leading researchers to select only smokers who are highly motivated to quit, then paid and pampered to remain in the trial. Even so, most trials end with abysmally low compliance, completion and success rates.
The futility of the clinical trial model is illustrated by a new UK study appearing in Annals of Internal Medicine (abstract here). Twenty-three nurses enrolled nearly 700 highly motivated smokers; the treatment was quitting abruptly or gradually two weeks later, accompanied by intense behavioral support and medicinal nicotine; the desired outcome (i.e., the “cure”) was abstinence.
In public comments, the lead author touted abrupt quitting as the best strategy, effectively celebrating a 73% failure rate at six months compared to an 82% failure rate among gradual quitters. One-year rates, which are the gold standard for cessation trials, were not reported; they were likely higher.
Why does the medical research establishment demand clinical trial proof for quit-smoking aids, including e-cigarettes and smokeless tobacco products? Perhaps because the clinical trial model enables the tobacco prohibitionist establishment to maintain the “illness-treatment-cure” perception of smoking and heathcare. In fact, as I note in my book, For Smokers Only, tobacco harm reduction puts smokers in control of their health choices and consequences.
Clinical trials are the wrong way to evaluate cigarette substitutes as smoking cessation aids, and they should not be the standard by which these products are judged. Instead, the FDA, along with other health authorities, should endorse e-cigarettes and smokeless tobacco products as safer cigarette substitutes. The success or failure of smoke-free products in deterring smoking should be analyzed through post-market surveillance – that is, simply observing consumer activity.
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