Tuesday, July 24, 2012

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 8% 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 multiple pharmaceutical 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.

1 comment:

sakib raj said...

The new electronic cigarette is already a very popular item. Because of this, many different types have been created. This can be great because it offers many different options for all different types of people.
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