Friday, May 31, 2013

Alere Wellbeing is Still Making Misleading Advertising Claims About the Effectiveness of Its Quit for Life Smoking Cessation Program

On its web site, Alere Wellbeing boasts that its Quit for Life smoking cessation program has a "47% quit rate."

For those unfamiliar with quit rates for smoking cessation programs, this is a phenomenal rate of success, dwarfing that of any other program.

The Rest of the Story

If only it were true.

If this blog were a PolitiFact fact checker, Alere Wellbeing's claim would get a rating of ...

... FALSE.

Or more properly, a rating of: "Liar, Liar, Pants on Fire."

It is not clear on what scientific basis Alere Wellbeing makes its claim, but presumably it comes from a study in which its own study team reported about a 41% quit rate for the program. However, this is based on the assumption that every smoker who was not successfully followed up was a quitter. Obviously, this is an unreasonable assumption. In an intent-to-treat analysis (which is the appropriate one to use), the quit rate was only 20.5%. It it were being honest, Alere Wellbeing would advertise a quit rate of 21%, instead of 47%.

If one cherry picks from the literature, the highest quit rate I can find - based on an intent to treat analysis - is 33% from this study.

In more realistic settings, such as this study of the Quit for Life program in actual routine use in Florida, the quit rate was only 16% (and that was only for three months).

Importantly, the web site does not indicate that the 47% figure is from a responder analysis, rather than an intent-to-treat analysis. This is highly misleading, and in my mind, fraudulent.

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. And presumably, the company knows this.

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.

If any fraudulent claims are being made about smoking cessation programs, they are not coming from electronic cigarette companies but from Alere Wellbeing, which is marketing an "FDA-approved" smoking cessation approach. Perhaps, to protect the public, the FDA should focus a little more attention on commercial smoking cessation service providers.

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