Thursday, August 8, 2013

Federal Officials Endorse Impossibly High Standard for E-Cigarettes

NPR host Diane Rehm on August 5 discussed “Smoking in America Today” with Dr. Tim McAfee, Director of Office of Smoking and Health at the Centers for Disease Control and Prevention; Mitch Zeller, Director of Center for Tobacco Products at the FDA; Dr. Thomas Glynn, Director of Cancer Science and Trends at the American Cancer Society; Michael Felberbaum, journalist covering tobacco for the Associated Press; and Craig Weiss, President and CEO of e-cigarette maker NJOY (program available here).

The federal officials and Dr. Glynn held essentially identical views on e-cigarettes, providing a strong signal that FDA regulation is likely to be burdensome or even punitive.

Early in the program, Rehm asked about relative risk: “Is there any evidence whatsoever from the public health community regarding electronic cigarettes and whether they are in fact safer than tobacco products?”

The CDC’s McAfee gave an extended answer, starting with: “Well, there’s several different ways that we’re thinking about this, we think it’s an incredibly important question.”  Important, but unanswered, as Dr. McAfee shifted to the familiar cigarette mantra: “… we need to focus on the harm that’s caused by cigarette smoking, and ways to get smokers to quit and to prevent nonsmokers from starting.”  As for e-cigarettes, “.. the challenge is that we don’t yet know how e-cigarettes are going to completely fit into that.  The availability of a cigarette alternative that does deliver nicotine without also delivering harmful by-products of combustion… could this play a beneficial role in reducing tobacco-related death and disease?  This would be especially true if a large number of smokers successfully switched completely to e-cigarettes, either permanently or as a transition phase to nicotine abstinence.”

Dr. McAfee expressed concern that alternative tobacco products might foster dual use, prevent smoking cessation and serve as a gateway to smoking for new users and former smokers. “… The other alternative is that the availability of e-cigarettes could result in harm by increasing the initiation of cigarette use among youth and young adults or by delaying quitting among smokers who, rather than switching, engage in dual use, which currently looks like that’s the majority situation.  People are using them in situations where it’s hard to smoke cigarettes.  And we see ex-smokers think ‘Hey, maybe I can go back to e-cigarettes,’ and that re-kindles their nicotine addiction.  And they actually start smoking cigarettes themselves.”    

Regulator Zeller returned to these themes later in the program.  He alluded to, but never quite acknowledged, the vast difference in risk between traditional and electronic cigarettes: “The thing that’s most interesting about e-cigarette is that we look at individual-level risk, what is the risk, say, to a current smoker who would be otherwise unable or unwilling to quit, if that person completely substituted all of their conventional cigarettes for an e-cigarette, that’s individual-level risk.”

However, he made clear that FDA regulation isn’t about individual smokers: “… Policy is going to be made here at the population level, and there’s population-level harm.  Who is actually using these products?  And how are they being used?  Tim [McAfee] talked about this earlier.  Are current smokers going to be less inclined to quit, and more likely to engage in what we call dual use of both the combustible version and the electronic version?  Are kids going to start using e-cigarettes?  These are the kinds of questions that we have that ultimately comes down to behavior, and right now we have far more questions than answers.”

I discussed in 2010 scientific evidence documenting that a population-level evidentiary standard was “unattainable” (here).  I also said that the standard was unprecedented.  The FDA has regulatory authority over other consumer items – food, cosmetics, drugs, medical devices and vaccines.  FDA regulations assure that drugs, medical devices and vaccines provide the intended medical benefit.  Far more importantly, they assure that all of these products are safe to consume.  The FDA does not traditionally compromise individual safety with a population standard.

Today, the FDA also regulates tobacco products.  One of these (the cigarette) is highly toxic, killing over 400,000 Americans every year.  When the FDA asserts regulatory authority over e-cigarettes, it would be criminal to use an arbitrary population standard to deny American smokers access to these products. 


Clive Bates said...

The attempt to draw in 'population' impacts is a a last desperate throw of the dice by the instinctively prohibitionist. They know quite well that population questions can only be answered after the fact - once the products are in use. Whilst they remain unanswered it is possible to construct tenuous scenarios in which much less harmful products appear to create more harm (eg. through gateway effects, dual use, deferred quitting etc). There's no substance to these concerns, but they can be framed as hypotheses and generate a lot of rhetoric in campaigners.

At the same time, regulatory action that denies access to low risk products because of unsettled population effects based on these hypotheses has the effect of denying individuals the right to make personal choices at their own initiative and their own expense to reduce their own risk. That's a pretty abusive thing for a regulator to do.

So I think there are two ways to approach it:

1. Recognise that it is ethically unacceptable for a regulator to deny one person a lifesaving choice because others might do something that regulators regard as wrong, namely smoking more (even though they are free to do that without the presence of the low risk alternative). Mitigation of unintended population effects, if any, should be through softer measures - eduction, campaigns etc.

2. Shift the burden of proof. It should be for regulators and officials to make an overwhelming case for regulatory intervention on population health grounds, if this involves suspending individual rights. They will be unable to do this.

FDA, CDC, ACS and the rest need a much clearer framework for deciding what should done using the coercive powers of the law, and what should be done through state-sponsored persuasion in its many forms. It is a common fallacy, especially amongst the medically trained, to believe that what should be done is no different to what must be done.

Individual rights and choices do matter in a liberal democracy, and not every health argument, however tenuous, should override these these freedoms.

Andy Gray said...

I definitely think that the FDA trying to regulate e-cigs will do more harm than good. But the FDA is going to do what it wants.