While the FDA has expressed concern about what it considers to be inaccurate marketing claims by electronic cigarette manufacturers that use of these devices will help customers to quit smoking, it is apparently overlooking a clear example of marketing fraud being perpetuated not by e-cigarette companies but by a company that is promoting a phone- and web-based smoking cessation program.
The American Cancer Society and Free & Clear's Quit for Life program is boasting to potential customers that it "produces an average quit rate of 45% for employers, making it 9 times more effective than quitting 'cold turkey.'"
According to the web site for Free & Clear: "The Quit For Life® Program is brought to you via a collaboration between the American Cancer Society® and Free & Clear®. As the nation’s leading tobacco cessation program, it employs an evidence-based combination of physical, psychological and behavioral strategies to enable participants to take responsibility for and overcome their addiction to tobacco use. Using an integrated mix of medication support, phone-based cognitive behavioral coaching and web-based learning and support tools the Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.” We are so confident in our industry-leading performance that we are willing to put our fees at risk for agreed-upon service levels and outcomes that clients can easily track using our transparent reporting suite."
The Rest of the Story
What Free & Clear does not tell the consumer on its web site is that the quit rates reported on the site are known not to be accurate, as they are based only on survey responders and ignore respondents who are lost to follow-up, who we know are most likely those who have failed to quit smoking.
Free & Clear's own research has demonstrated that the actual quitting rates are likely to be much lower than the rates they are reporting. Thus, one could argue that Free & Clear is knowingly reporting a quit rate that is substantially higher than the actual quit rate. This, in my mind, is fraudulent marketing.
Let me try to explain the difference between a quit rate based only on survey responders and a quit rate based on all participants in the smoking cessation program (what is called an "intention to treat" quit rate).
Suppose I have a smoking cessation intervention. For the purposes of demonstration, let us say that my intervention consists of consuming a Vienna Finger every time a smoker trying to quit has a desire for a cigarette. I assemble a group of 100 people who want to quit and enter them into my Vienna Finger-assisted smoking cessation program.
After 6 months, I want to assess the percentage of participants who have successfully quit smoking. So I send out a survey to the 100 participants asking them if they are smoking at the present time.
Let's say I receive 20 surveys back, and 10 of those 20 respondents indicate that they have quit smoking.
I then have two basic choices for reporting the quit rate for my intervention:
First, I could base the quit rate only on those who have responded to the survey. There were 20 respondents and 10 indicated that they quit, so I could boast that the quit rate for my intervention is 50%. This is called a responder analysis or a responder quit rate.
Second, I could base the quit rate on all those who participated in the program. There were 100 participants, but I can only confirm that 10 of them quit smoking. Eighty respondents were lost to follow-up in the sense that they did not complete the evaluation survey. Chances are that a high proportion of the non-responders failed to quit smoking. One way to handle this is to assume that every non-responder failed to quit smoking. This is called an "intention-to-treat" analysis. The intention-to-treat quit rate would be 10 confirmed quitters out of 100 participants, or 10%.
You can see that with a low response rate, there is a vast difference between the responder quit rate and the intention-to-treat quit rate. What you need to recognize is that the true quit rate is somewhere in between the two quit rates. But most likely, it is much closer to the intention-to-treat quit rate. Why? Because research has demonstrated that non-responders are much, much more likely to be continuing or relapsing smokers.
The responder quit rate assumes that the rate of quitting among non-responders is the same as that among responders. This is an untenable assumption because non-response is almost certainly differential with respect to smoking status. In other words, those who are successful quitting are probably more excited about filling out the survey to tell you how successful the program was. Those for whom the program failed are much less likely to be excited and motivated to take the time to complete the survey.
Any company which only provides its responder quit rate is misrepresenting the true quit rate, unless the response rate to the survey was extremely high. In the case of Free & Clear, it appears that the survey response rate was not high enough to allow the company to use the responder quit rate as a valid indication of the effectiveness of the program.
An evaluation of the Free & Clear Quit for Life program, published in 2008 in the Journal of Medical Internet Research, found that 30-day quit rates at 6-month follow-up were 41% using responder analysis, but only 21% using intent-to-treat analysis.
Thus, the true quit rate is likely between 21% and 41%, but is probably much closer to 21%.
Free & Clear acknowledges that the 45% quit rate it boasts on its web site is based on the "responder quit rate." But it does not provide the intention-to-treat quit rate on that web page, nor does it inform the reader of the response rate to the evaluation survey.
In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.
I find it interesting that the FDA is going to great lengths to take electronic cigarette companies to task for suggesting that these devices can help smokers quit (when there is abundant evidence that numerous vapers have found the product to be effective for smoking cessation), yet the FDA is silent in the face of this fraudulent marketing for medication- and counseling-based smoking cessation.