New Article Calls for Removal of Electronic Cigarettes from Market With No Data to Substantiate Benefits of their Removal

This post can be found on the blog roll which is from http://tobaccoanalysis.blogspot.com/ by Michael Siegel.

New Article Calls for Removal of Electronic Cigarettes from Market With No Data to Substantiate Benefits of their Removal and Without Disclosure of Conflict of Interest of Study Author

A new article published online ahead of print in the American Journal of Public Health reviews the results of an American Legacy Foundation survey related to awareness and use of electronic cigarettes.

The study reports the survey results as follows: “In the online survey, 40.2% (95% confidence interval [CI] = 37.3, 43.1) had heard of e-cigarettes, with awareness highest among current smokers. Utilization was higher among current smokers (11.4%; 95% CI = 9.3, 14.0) than in the total population (3.4%; 95% CI = 2.6, 4.2), with 2.0% (95% CI = 1.0, 3.8) of former smokers and 0.5% (95% CI = 0.16, 1.4) of never-smokers ever using e-cigarettes. In both surveys, non-Hispanic Whites, current smokers, young adults, and those with at least a high-school diploma were most likely to perceive e-cigarettes as less harmful than regular cigarettes.”

Based on these findings, the article makes the following recommendation:

“Given the widespread availability, awareness, and use of ENDS by millions of consumers,
ENDS should not be marketed until adequately tested and regulated by the FDA.”

In a press release accompanying the article, David Abrams, PhD, Executive Director of the Schroeder Institute at Legacy and senior author of the paper, encouraged smokers to use all kinds of pharmaceutical products other than electronic cigarettes, stating: “Until adequate research and regulation is in place, smokers should be wary of using e-cigarettes, and smokers who want to quit should, instead, pursue research-proven effective cessation tools, such as nicotine replacement products, telephone quit lines and Web-based cessation services, as well as non-nicotine pharmacotherapies like bupropion and varenicline.”

The Rest of the Story

There are three major findings of this new paper:

1. Many smokers are now very aware of the existence of electronic cigarettes as an alternative to smoking tobacco cigarettes and a substantial proportion of smokers (11%) has used electronic cigarettes. Approximately 4.1% of current smokers are currently using electronic cigarettes, which translates into about 1.8 million smokers using the product.

2. Very few neversmokers appear to be using the product.

3. Smokers who use the product appear to have a greater interest in quitting smoking.

This study therefore confirms the findings of previous research which has found that electronic cigarettes are a growing phenomenon among smokers, that use is very low among nonsmokers, and that smokers are largely using the product as a safer alternative to smoking tobacco cigarettes and as a means to cut down on the amount they smoke or to attempt to quit altogether.

Based on the findings of the study, the paper concludes that ENDS should not be marketed until adequately tested and regulated by the FDA. Since these products have not been regulated by the FDA (and any regulations could not possibly be put in place before about 2 years), the paper is thus calling for the discontinuation of e-cigarette marketing, which is essentially a call for a ban on the sale of electronic cigarettes.

Strikingly, this conclusion has nothing to do with any data presented in the paper. In fact, if anything, the data actually presented in the paper point to the promise of electronic cigarettes as a harm reduction strategy in tobacco control. The popularity of the product speaks to its likely usefulness to smokers in keeping away from tobacco cigarettes. If the product were not useful, its popularity would not be growing as it is. The study also confirms previous findings that e-cigarettes are primarily being used by smokers as either a safer alternative to tobacco cigarettes or as a strategy for reducing or eliminating tobacco cigarettes.

All of these findings, taken together, suggest that electronic cigarettes have great promise as a harm reduction and smoking reduction/cessation strategy. Of course, FDA regulations are necessary and would help to ensure that these products are as safe as possible and that quality control standards and other safety measures are adhered to, as well as that youth cannot access these products.

However, there is nothing in the findings of the paper that speaks to the need to take the product off the market because of safety concerns or demonstrated hazards.

It may therefore strike some readers as curious that the paper draws this striking conclusion. The conclusion is striking, by the way, not only because it has nothing to do with the study findings, but because it runs afoul of the law. The District Court for D.C. has already ruled (and the FDA has accepted its decision) that the FDA cannot regulate electronic cigarettes as drug-delivery devices in the absence of therapeutic claims. Thus, this paper is calling on the FDA to do something (halt the marketing of electronic cigarettes) which it has no legal authority to do.

Equally striking is the recommendation of the paper’s senior author that smokers trying to quit not use electronic cigarettes but try every drug under the sun (nicotine replacement therapy, buproprion, Chantix, etc.). This is an odd recommendation because these drug products have dismal success rates: less than 92% long-term.

Even odder is the implied recommendation that smokers who have successfully quit  using electronic cigarettes stop using their e-cigarettes and make an attempt to stay quit using NRT or drugs, something which is very unlikely to be successful. Most electronic cigarette users acknowledge that taking these products off the market would most likely lead to their returning to cigarette smoking, not to their maintaining themselves smoke-free using NRT or other drugs.

Despite the striking lack of connection between the study conclusion and its actual findings, and despite the strange recommendation – coming from public health practitioners – that ex-smokers who are successfully staying off cigarettes by virtue of e-cigarettes should discontinue their e-cigarette use and risk returning to smoking, a presumably hidden fact which is not disclosed in the article may help explain the study conclusion and recommendations.

Specifically, the senior author of the paper has a significant financial conflict of interest by virtue of his previous grant funding from a number of pharmaceutical companies. Dr. Abrams has received grant funding from multiplepharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer. Dr. Abrams also reports having served as a senior scientific advisor for Johnson & Johnson. It is difficult to find a pharmaceutical company involved in smoking cessation drugs that Dr. Abrams has not had an association with over the years.

This is not to criticize him; the research has made important contributions. It is simply to make note of the financial conflicts of interest that are present with respect to his views on electronic cigarettes, a major threat to the profits of these very same pharmaceutical companies. I believe that these conflicts of interest should be readily disclosed in the paper.

The rest of the story is that:

1) the article draws a major conclusion which lacks supportive evidence and which has no relation to the findings actually reported in the paper;

2) the paper advances a piece of medical advice which is ill-chosen and could be harmful to many people; and

3) that both of these problems appear in the setting of substantial financial conflicts of interest which are not readily disclosed.

Thoughts? Comments?

11 comments ↓

#1 Candy Girl on 07.24.12 at 12:40 PM

Last gasp of the Big Pharma NRT proponents! As Siegel appropriately points out- the conclusion of the study advocates the FDA do something that it has agreed NOT to do per the order of the US federal court- halt the marketing of e-cigarettes. But, you can’t blame the authors (and their Big Pharma sponsors) for trying- Big Pharma has billions of unamortized research and development costs at stake here and they”re used to getting their way with the FDA.

#2 sf#sdf# on 07.24.12 at 1:53 PM

Well, not quite Candy Girl. The Sottera Court says that e-cigs must be regulated as a tobacco product. That does not mean that the FDA cannot make it very difficult — or impossible in the near term — for these products to be sold.

#3 Candy Girl on 07.24.12 at 6:20 PM

Agree. But, we are at least 18 to 36 months away from the FDA getting its act together on this issue. In the meantime, as the product gets greater distribution, higher visibility and more publicity NRT pharma products get less and less relevant. The FDA is going to take its time here because they do not want to get sued again- they still have a very bad taste in their collective mouths after losing the NJOY case.

#4 Ssdf@sdf.com on 07.25.12 at 9:49 AM

Not so sure about that. I don’t think the big chains will carry products that are not able to comply with the draft deeming regulations that we will see in the coming weeks. But the market will still grow in the interim, I agree, albeit at a slower rate if the chains are out.

#5 Vapor Vixen on 07.25.12 at 10:42 AM

Interesting comment by SSDF as I find it very interesting that many of the larger chains are the ones that just marketed the product pre judge leon’s decision. I don’t see them moving away from e-cigs any day in the near future. Not sure SSDF why you seem so anti-ecig.

#6 sdf@sdf.com on 07.25.12 at 8:50 PM

I am not — simply, the FDA tried to ban the product already. You expect that the Agency will be chastened by Sottera and issue relatively light regulation. I think the industry will be heavily regulated in a way that — initially at least — will substantially disrupt the existing marketplace.

I don’t work for the FDA and I have not seen any draft guidance. We will see soon though.

#7 Bill Godshall on 07.27.12 at 4:56 PM

The most important findings of Legacy survey (that was conducted from Jan-April of 2010, and e-cig consumption has likely tripled since then) include:

– 3.4% of American adults (about 8 million) reported ever using an e-cigarette,

– cigarette smokers were 22.8 times more likely to have used an e-cigarette than never smokers (11.4% vs .5%), while 2% of former smokers had ever used an e-cigarette (including some/many/most who may have quit smoking with e-cigarettes),

– 1.22% (about 2.9 million) of American adults used an e-cigarette in the past 30 days, including 4.1% of cigarette smokers, .5% of former smokers and .3% of never smokers,

– 40% of American adults had heard of e-cigarettes (including 57% of smokers and 32.5% of never smokers),

– 70% (of those who had heard of e-cigarettes) believed them to be less harmful than cigarettes, and

– e-cigarette users self-reported better health status.

But of course, Legacy failed to mention most of these key findings in their journal article’s abstract at
http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2011.300526
and on their press release
http://www.legacyforhealth.org/5118.aspx
because they didn’t support (and instead refuted) Legacy prohibitonist propaganda demonizing e-cigarettes.

#8 Custom Blends on 07.29.12 at 7:08 PM

I think its obvious, i mean really plainly obvious, like “what……are you a tool?” obvious that ecigs are the best thing to happen to nicotine addiction, and therefore Big Tobacco profits, since Winston sponsored the Flintstones.

Vaporizing tobacco is an obvious appeal to young people. And anyone in the industry knows it.

Mark

#9 cig city on 07.31.12 at 5:09 PM

This is a bunch of BS!

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