Wednesday, February 20, 2013

The First Ever "Dear Doctor" Letter Regarding a Mobile Medical App Recall

When I wrote the Pharma Marketing News article "Some Unregulated Physician Smartphone Apps May Be Buggy" back in January 2012, I reported that Pfizer "recalled" its Rheumatology Calculator app because of "a bug in the app ... gives wrong results."

Considering that the "recalled" Pfizer app was the most downloaded app tracked by POCKET.MD at the time, there must be many many users (physicians) out there who still have the app on their phones. At the time, I asked "Did Pfizer send these physicians a 'Dear Doctor' letter informing them of the problem and advising them to remove the app from their phones?" My best guesstimate answer at was: "Probably not."

It turns out, however, that Pfizer UK DID send out a "Dear Doctor" letter in October 2011, warning doctors that:
“the Apple iPhone application gives on average a 15-20% higher score for DAS28-ESR compared to a score calculated using the published DAS28-ESR formula (with higher or lower incorrect scores in certain cases). It gives on average a 10-15% lower score for DAS28-CRP compared to a score calculated using the published DAS28-CRP formula2. Incorrect values are also obtained for the ASDAS-CRP score (scores are on average 15-25% lower) and for the PASI score (scores are up to 50% lower). There may also be minor errors in the Framingham scores.”
You can access a copy of that letter here and see a screen capture of the first  page below. I believe this is the first ever "Dear Doctor" letter regarding a mobile medical app recall.  Many physicians and consumers may believe that mobile health apps developed by pharmaceutical companies are accurate and reliable, but as this case demonstrates, that may not be so.

Shouldn't the pharma industry develop best practices for mobile apps to assure that they are rigorously tested before they are made available to doctors and consumers? This is a topic discussed in this Pharma Marketing News article, published today: "Reigning in the 'Wild West' of Mobile Health Apps" (subscription required). The articles reviews the results of the Regulation of Pharma Health Apps Survey.


The first ever "Dear Doctor" letter regarding the recall of a mobile medical app (click to enlarge).

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