What Trump’s FDA director gets wrong

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Newly installed Food and Drug Administration Commissioner Scott Gottlieb is proposing to shift his agency’s focus and strategy to reduce smoking and its consequences. Recognizing that not all forms of nicotine delivery are equally harmful, Gottlieb’s plan would undertake the vital job of communicating those differences in risk to the public.

Clearly, this long has been an area where more needs to be done. Two-thirds of smokers say they want to quit and roughly half of current smokers attempt to do so each year, but successful quit rates remain less than 10 percent.

Gottlieb’s suggestions for next steps include encouraging innovation in less harmful nicotine products, such as noncombustible products; increased effectiveness of existing nicotine replacement therapies, which are categorized as medicines; and the possible adoption of very low nicotine cigarettes that will contain the drug at concentrations that do not produce dependence. All of these proposals reflect the need for products that are less harmful than combustible cigarettes – including very low nicotine cigarettes, which, presumably, will be easier to quit in the absence of physiological dependence.

However, in both his FDA comments and recent article in the New England Journal of Medicine, Gottlieb failed to mention one of the most important things that could be done to help people transition away from cigarettes: make direct appeals to smokers that devote increased attention to the relative risk of various nicotine delivery devices. The FDA’s failure, to date, to acknowledge that e-cigarettes not only are safer than combustible cigarettes, but that they are much safer, results in confusion among would be consumers.

What the FDA should be telling consumers is that relative risk can be viewed two ways. The direct risk to users of e-cigarettes is not benign, although the absolute risk depends largely on the components of the e-liquid and delivery device. But in a head-to-head comparison, the relative risk—the risk of e-cigarettes compared to that of combustibles cigarettes—is only about 5 percent as much. Public Health England estimates this risk to be about the same as nicotine nasal spray, which is used as a nicotine replacement therapy.

The FDA and various other public health outlets would recommend lifetime use of nicotine replacement therapies if discontinuing them was shown to pose a risk that the user would revert back to cigarettes. That highlights the second form of relative risk to be considered – the relative risk of failure. When the success of these other products—the inhalers, oral products and patches—are factored in, the relative risk of use compared to e-cigarettes becomes much higher, because the failure to remain abstinent is higher with these products than with e-cigarettes. Again, Public Health England and, more recently, the Centers for Disease Control and Prevention both have reported that e-cigarettes are more popular than other quitting aids and that users enjoy higher rates of long-term success.

The fact is that people try to make decisions that are in their best long-term health interests and they do respond to the advice doled out by government health agencies. In the face of evidence that e-cigarettes are not a gateway to smoking among adolescents; that they do not produce 90 percent of the toxins found in combustible cigarettes; and that they have great potential to transition smokers away from combustibles more effectively than other quit aids, it is irresponsible for government agencies to continue to withhold acknowledging that e-cigarettes are a beneficial option for current smokers. Educating consumers about the continuum of relative risk, and where e-cigarettes fall on that spectrum, should be Gottlieb’s first step.

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