Thursday, December 09, 2010

Yet Another Article Calls for Removal of E-Cigs from Market in Absence of Any Evidence of Harm and Without Considering the Benefits of the Product

Another article has been published which calls for electronic cigarettes to be banned, but without providing any evidence that the products are dangerous to users or considering the benefits of the product that are currently being experienced by users.

This time, the article appears in the American Journal of Public Health, in the December issue.

The authors write about electronic cigarettes: "to allow their unregulated sale on presumption is not protecting public health. ENDS [electronic nicotine delivery systems] should be removed from the market and permitted back only if and when it has been demonstrated that they are safe, that their benefits outweigh their harms to overall public health, and that a comprehensive regulatory structure has been established under an appropriate FDA division."

The Rest of the Story

The article provides no documentation of any demonstrated harms from electronic cigarettes. It does mention that there are trace levels of carcinogens, but fails to mention that the same trace levels of carcinogens are also present in nicotine gum and nicotine patches. It also neglects to mention that the identified levels of carcinogens in electronic cigarette cartridges are up to 1400 times lower than in Marlboro cigarettes.

Given these existing data, which have been verified in multiple studies, it seems clear that electronic cigarettes are providing a tremendous public health benefit to those who are using them. One cannot ethically remove them from the market unless it can be demonstrated that the harms caused by the products exceed their benefits.

I agree that for a product not yet on the market, the drug must first be shown to be safe before it is approved. The reason for this is the basic ethical tenet of nonmaleficence - doing no harm. Since the product is not yet on the market, there is no public health benefit, only potential benefit. Thus, it is essential to prove that the product is safe before marketing it. To allow the product on the market prior to safety testing would violate the principle of nonmaleficence.

However, in the case of a product which is already on the market and which is reportedly providing immense benefits to thousands of people, the equation changes. Now, there are demonstrable benefits and the hypothesized harm is only a potential one. To remove the product from the market would cause harm. To cause definite harm merely to protect against a prospect that the product has adverse side effects violates the principle of nonmaleficence.

In other words, the cost-benefit analysis is different for products that are on the market compared to products that are not yet on the market. With electronic cigarettes, many thousands of users report that they have quit smoking thanks to these devices. To remove them from the market would cause severe public health harm. One doesn't want to take such an action unless it is first demonstrated that the product is unsafe. To remove the product on mere speculation would not be in the best interests of the public's health, as the potential benefits of a ban are outweighed by the known harms resulting from forcing thousands of ex-smokers to return to regular cigarettes.

Moreover, I need to emphasize that the critical question is not: "Are electronic cigarettes safe?" The relevant question is: "Are electronic cigarettes much safer than regular ones?" Since electronic cigarettes contain nicotine, they are not truly "safe" in any absolute sense. However, if they are much safer than regular cigarettes, getting smokers to switch to electronic cigarettes would have an incredible public health impact, even if there are some minor risks associated with the use of the product.

It is fascinating to me how none of the proponents of taking electronic cigarettes off the market have also called for the removal of Chantix from the market. With Chantix, there has been a documented demonstration of immense harm to a substantial number of people: namely, death. The product is obviously not "safe." Yet those who want e-cigarettes taken off the market are not calling for the removal of Chantix from the market. We know Chantix has killed hundreds of people. We don't know for a fact that electronic cigarettes have killed or even harmed anyone.

The logic makes no sense whatsoever. Moreover, it violates some very basic ethical principles of medicine and public health.

We must, first and foremost, not do harm to our patients. For those members of the public - thousands of them - who have quit smoking using electronic cigarettes - taking this product off the market would do significant and irreparable harm, as it would force them to return to cigarette smoking. It is therefore essential, from an ethical perspective, that electronic cigarettes not be removed from the market in the absence of evidence that they are actually harming people, and that the degree of harm exceeds the product's benefits.

In fact, this is the precise reason why Chantix is still on the market. Had the suicides from Chantix occurred prior to its approval by the FDA, it would never have seen the light of day. A drug that causes suicidal ideation and suicide is not safe and will not be approved by the FDA.

However, since Chantix was already on the market and already benefiting many people at the time its suicidal risk was identified, the criterion for pulling Chantix from the market changed. It was no longer an issue of whether Chantix is safe (clearly, it is not). Instead, the criterion was whether the benefits of Chantix for smoking cessation outweigh the demonstrated harms. The FDA decided that the benefits outweigh the harms, so Chantix remains on the market.

As it is already on the market, electronic cigarettes should be judged by the same criterion as Chantix. Do the recognized harms outweigh the benefits.

As of today, the benefits are significant for thousands of vapers who are now ex-smokers thanks to these products. The harms, however, are purely speculative. There are, in fact, no demonstrated harms from the product. More importantly, there are no incremental harms of the product compared to the product for which it is substituting: regular cigarettes.

The rest of the story is that not only would pulling electronic cigarettes from the market be a grave public health mistake, it would also be unethical, violating one of the most basic principles of medicine and public health.

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