Wednesday, May 29, 2013

Authors of Electronic Cigarette/Quitline Article Fail to Disclose Significant Conflict of Interest

Two weeks ago, I discussed a new study that appeared online ahead of print in the journal Nicotine & Tobacco Research. The study reported on the efficacy of electronic cigarettes in smoking cessation. However, instead of estimating cessation rates among a cohort of smokers who made quit attempts using these products, the study analyzed cessation rates of a large number of smokers who had previously tried to quit using e-cigarettes but failed, and then called a quitline because they had failed and wanted to try again. Then, it compared the quit rate among these smokers to that among smokers without such a history of a failed quit attempt using electronic cigarettes. In other words, this study did not estimate quit rates among smokers trying to quit using e-cigarettes. Instead, it estimated quit rates among many smokers who were not using e-cigarettes in their quit attempt at all! I showed, further, that the results of this study are being misused by anti-smoking advocates to argue that electronic cigarettes are not effective for smoking cessation.

Today, I reveal that the authors of the study hid a significant conflict of interest that I believe should have been reported.

At the end of the article, under the section entitled "Declaration of Interests," the article states: "None declared." Thus, the authors are denying that there are any relevant conflicts of interests related to this work.

The Rest of the Story

The truth is that there are two major financial conflicts of interest that the authors are apparently hiding and which should have been disclosed.

Note, first, that the authors are employed by (and the study funded by) Alere Wellbeing, a company which provides commercial smoking cessation services, including the administration of state tobacco quitlines which tend to use the Quit for Life program. This program relies heavily upon the use of nicotine replacement therapy (NRT and other drugs), but shuns the use of electronic cigarettes.

First, the article reports cessation rates among callers to six state tobacco quitlines. What the article does not make clear is that these programs are run by Alere Wellbeing, which has contracts (i.e., it receives lots of money) to administer these programs. Moreover, Alere Wellbeing has a vested interest in reporting high levels of success with its programs. Obviously, if its evaluations were to report low smoking cessation rates, states would be less likely to contract with Alere Wellbeing for smoking cessation services. Thus, the company (and these authors) has a strong financial conflict of interest: the company makes money and its profits are dependent upon reporting high levels of success with its services.
That this conflict of interest was not reported in the paper is mind-boggling to me. It is difficult for me to think of a conflict that would be more severe or more significant than this one. If this is not a conflict of interest, then I don't know what is!

Not only is there the threat that states could turn to other commercial programs if Alere reports low cessation rates, but states as a whole might put less money into these types of programs if they don't work very well. In fact, Alere Wellbeing readily acknowledges that state funding cuts represent a significant threat to profits, writing:

"Future reductions in state spending on existing preventative care programs could reduce our net revenues, net income and cash flows. Due to budgetary shortfalls, many states are considering, or have enacted, cuts to existing preventative care programs. These cuts have included, or may include, elimination or reduction of coverage for some or all of our preventative care programs. For example, in 2011, several states reduced their funding of smoking cessations programs provided by our Alere Wellbeing business. During 2011, approximately 58% of the net revenue of our Alere Wellbeing business was derived from sales to state governments. Continued state budgetary pressures could lead to further reductions in funding for our services which, in turn, could have a material adverse effect on our financial position and operating results."

Elsewhere in its annual report, Alere reiterates that its revenue depends upon continued levels of state funding for quitline services: "Wellness net product sales and services revenue from our Alere Wellbeing business, formerly known as Free & Clear, has been negatively impacted as a result of the continuation of decreased funding under certain states’ quitline programs."

Clearly, this is a conflict of interest that should have been reported in the article.

We are not just talking about small potatoes here. In its annual report, the intangible asset value acquired from the acquisition of Free & Clear (now Alere Wellbeing) from customer relationships is listed at $36 million. Don't you think it would be of importance to journal readers to understand that this article is evaluating a service that is provided by the company for which these authors work? How would readers react if they found out that the article is hiding the fact that the services being evaluated in the paper are worth perhaps $36 million to the company that is sponsoring the study?

As if this first conflict were not enough, there is a second major conflict of interest. Alere Wellbeing's business depends upon producing data showing that its services are effective. But the business also depends on the absence of significant competition. Electronic cigarettes represent what is probably the greatest potential competition to existing smoking cessation services. Thus, this also represents a significant conflict of interest that should have been disclosed.

The journal Nicotine & Tobacco Research is very clear that all competing interests must be disclosed. The journal puts no qualifications on this reporting: all competing interests are to be reported. The journal's guidelines state: "...all authors must disclose any competing interests in a Competing Interests section."

To make it eminently clear, this article does specifically report on the effectiveness of the services provided by Alere Wellbeing. In Table 2, the article provides the 7-month quit rates (30-day abstinence) for quitline callers. It turns out that this figure was 27%. It should be easy for readers to see that this figure has significant financial implications for Alere Wellbeing.

Say, for example, that the article had reported a 7-month quit rate of only 6%. This would suggest that the services provided are quite ineffective and would obviously have negative potential financial implications for the company. How can this possibly not be considered a significant competing interest?

Now to be clear, I am not arguing that the authors have intentionally or unintentionally altered their data or analyses to come up with this 27% figure. In fact, I am not actually arguing that there was any conscious bias present. My point is simply that there is undeniably a competing interest present and that it should have been reported.

In the absence of this disclosure, the rest of the story is that this article hides a significant conflict of interest that journal readers should have been made aware of. Hopefully, this error will be corrected in an erratum statement in a subsequent journal issue.


According to the article, the data presented come from six state quitlines: Connecticut, Louisiana, Nebraska, North Carolina, South Carolina, and Texas.

The article does not disclose that the sponsoring company makes money off of these quitlines and therefore has a financial interest in reporting a high 7-month quit rate in this study.

Below is documentation that the quitlines in each of these states are administered, or have been administered, by Alere Wellbeing (formerly Free & Clear):

"Connecticut Quitline is funded by the Connecticut Department of Public Health and administered by Alere Wellbeing, a commercial tobacco treatment provider."

"The Louisiana Tobacco Quitline, 1-800-QUIT-NOW, is a free, confidential, 24-hour helpline that links individuals who want to quit using tobacco with trained Quit Coaches®. The Quitline is funded by the LTCP and The Louisiana Campaign for Tobacco-Free Living; it is administered by Free & Clear, Inc."

"©2013 Alere, Inc. All rights reserved."

North Carolina
"©2013 Alere, Inc. All rights reserved."

South Carolina
"The Quitline is a contractual partnership between the S.C. Department of Health and Environmental Control and Alere Wellbeing, Inc., a Seattle-based tobacco treatment and behavioral health provider with vast experience running quitlines across the nation."

"Funder of quitline services: Texas Department of State Health Services
Operator of counseling services: Alere Wellbeing"

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