Tuesday, July 30, 2013

American Cancer Society and Alere Wellbeing are Now Apparently Knowingly Making a Fraudulent Claim about their Quit for Life Program

Back in May of this year, I revealed that the American Cancer Society (ACS) and Alere Wellbeing were making a fraudulent claim about their Quit for Life smoking cessation program. On their web site, these groups claimed that the Quit for Life program had an amazing 47% success rate.

At that time, I wrote: "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."

The Rest of the Story

Today, I report that the ACS and Alere Wellbeing have apparently responded to my commentary by updating their web page with a tiny footnote, which acknowledges, in the smallest font imaginable, that: "Quit rates are based on program enrollees who respond to the 6-month outcome survey." (Note: font size is theirs, not mine.)

Even with my $400 progressive lenses, it is a stretch to be able to read that fine print. It seems clear that the ACS and Alere Wellbeing have something to hide: there is something that they apparently don't really want the reader to know.

But even more problematically, the fact that they have apparently added this footnote suggests that they are knowingly defrauding the public, because they are apparently fully aware that they are using an invalid claim - the effectiveness rate based solely on responders - rather than a more accurate claim, which would be the intent-to-treat analysis. At very least, if they were going to be honest in their advertising, they would have to reveal and report the intent-to-treat results in addition to the responder analysis results.

I don't believe that the lay public is going to really understand the difference, so this tiny disclaimer hardly improves the honesty of the site. In fact, it may make it worse because it now knowingly appears to be attempting to deceive consumers.

I think that to be honest, it is the intent-to-treat analysis results that must be reported here. That is certainly the standard that has been adopted in all of the Cochrane reviews that summarize the results of the effectiveness of various smoking cessation treatments.

The rest of the story is that the American Cancer Society and Alere Wellbeing now acknowledge that the 47% quit rate they boast about on their web site is based on the responder quit rate. But they do not provide the intention-to-treat quit rate on that web page, nor do they 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.

Actually, to report the full extent of the rest of the story, the American Cancer Society and Alere Wellbeing are not fully acknowledging that their reported quit rate for Quit for Life is based on a shady responder analysis. On this web page, they continue to hide this fact from the public.

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.

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