Monday, November 19, 2012

Department of Health and Human Services Warns Smokers Wishing to Try Quitting Using Electronic Cigarettes to Stick With Regular Cigarettes Because They Don't Know How Much Nicotine They'll Get; Department Spreading False Information About the Scientific Evidence

On a new web site devoted to tobacco and smoking cessation, the Department of Health and Human Services (DHHS) warns smokers wishing to try quitting using electronic cigarettes not to do so because they will not know how much nicotine they are getting in each puff. In effect, this amounts to a recommendation that these smokers stick to their regular cigarettes, since many of them have tried unsuccessfully to quit using the other products recommended by DHHS: nicotine replacement products and smoking cessation drugs.

There is a large population of smokers who have tried to quit using traditional NRT or smoking cessation drugs and failed. Having heard from ex-smokers about their success with electronic cigarettes, many of these smokers wish to try quitting using these innovative products, which vaporize nicotine from a glycerin or propylene glycol base and involve no tobacco. The Department of Health and Human Services' official advice to these smokers: don't use electronic cigarettes because there is no evidence that they can help you quit and you don't know how much nicotine you're getting in each puff.

According to the DHHS information page on electronic cigarettes: "Because clinical studies about the safety of e-cigarettes have not been submitted to the U.S. Food and Drug Administration (FDA), you have no way of knowing:
  • If they are safe
  • Which chemicals they contain
  • How much nicotine you are inhaling
Nicotine is a highly addictive substance. Additionally, these products may be attractive to kids. Using e-cigarettes may lead kids to try other tobacco products—including conventional cigarettes—which are known to cause disease and lead to premature death.

Although e-cigarettes may be marketed as a tool to help smokers quit, they have not been submitted for FDA evaluation or approval and there is no evidence to support those claims. There are, however, a number of FDA-approved quit-aids available to smokers, including:
  • Nicotine gum
  • Nicotine skin patches
  • Nicotine lozenges
  • Nicotine oral inhaled products
  • Nicotine nasal spray
  • Zyban
  • Chantix"
On another of its information pages on electronic cigarettes, DHHS warns that: "When FDA conducted limited laboratory studies of certain samples, FDA found significant quality issues that indicate that quality control processes used to manufacture these products are substandard or non-existent. FDA found that cartridges labeled as containing no nicotine contained nicotine and that three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff. Experts have also raised concerns that the marketing of products such as e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products."

The Rest of the Story

The recommendation by DHHS that the many smokers who have failed to quit using NRT or smoking cessation drugs should not try electronic cigarettes in an attempt to quit smoking is tantamount to a recommendation that these smokers continue to smoke rather than risk possibly using a product that delivers markedly different amounts of nicotine in each puff.

What DHHS is actually saying is: "Rather than using electronic cigarettes, a much safer product but one which delivers unknown quantities of nicotine and widely varying amounts of nicotine in each puff, you are better off using regular cigarettes, which are finely tuned - due to years of experience and strict quality control procedures - to deliver precisely the same amount of nicotine in each puff."

I find this to be irresponsible advice and in a sense, a form of public health malpractice. Any physician who advised a patient unwilling to try NRT or a drug (because they failed in the past) to stay on cigarettes rather than switch to electronic cigarettes would perhaps be subject to a malpractice claim. Is not delivering such advice on a mass level an example of public health malpractice?

The Department's concern that electronic cigarettes do not deliver known or consistent quantities of nicotine is hardly something that makes the use of these products risky. In fact, it makes them less addictive than regular cigarettes because the consistent delivery of nicotine is one of the factors that makes cigarette smoking so addictive. Ineffective delivery of nicotine actually reduces the addictive potential of electronic cigarettes (which may explain why 2/3 of ex-smokers in my survey of electronic cigarette customers who had quit smoking six months after using these products reported having stopped using electronic cigarettes as well).

If anything, the inconsistent delivery of nicotine is a concern for the effectiveness, not the safety of these products. If electronic cigarette companies can find technology to better regulate the nicotine delivery, they be be more effective for smoking cessation.

Furthermore, consistency of nicotine delivery is not a particular concern of most electronic cigarette companies at the present time because their products are not being marketed with therapeutic claims. They are not being marketed as devices to treat nicotine dependence. Instead, they are being marketed as alternatives to cigarette smoking for smokers concerned about the health damage that is being caused by their smoking.

The Department's concern that these products may serve as a gateway for youth smoking is a purely hypothetical one, and there is no evidence to support this theory. There is, in fact, no evidence that electronic cigarettes have become popular among youth and there is no evidence that youth are initiating nicotine use with these devices and then progressing to cigarette smoking.

Finally, and perhaps most importantly, DHHS is lying to the public when it asserts that "there is no evidence to support" the claim that electronic cigarettes can help smokers quit. In fact, there is abundant evidence. We know for a fact that there are thousands of ex-smokers who have quit smoking using these devices. Moreover, we know from the first clinical trial of electronic cigarettes that 54% of smokers who were unmotivated to quit at baseline were nevertheless successful in either quitting or cutting down by more than half the amount that they smoke.

So the DHHS' assertion that there is no evidence that electronic cigarettes can help smokers quit is simply not true.

The rest of the story is that through its dissemination of false and misleading information about electronic cigarettes, the DHHS is not only violating basic principles of truth and honesty, but it is also giving inappropriate medical advice and helping to protect the cigarette companies from what might otherwise be a serious threat to their continued profits from the sale of cigarettes.

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