FDA approves digital therapeutics based on PAID patient studies with self-reported outcomes…

Ariel McNichol
2 min readJul 16, 2019

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Pear Therapeutics was the first fully digital therapeutic to win FDA approval for it’s addiction recovery app (only cocaine) based on a paid cohort study where it admits that efficacy without using incentives has not been studied.

Pear Therapeutics reSET trial: $400 incentives given per patient who sustained engagement. But, as they admit… “the benefit of reSET without the use of contingency management incentives has not been evaluated.”

Better+: $200 paid to participants if they lasted 3 months. Study reports they bought testers on Facebook & Craigslist and paid them if they sustained limited engagement and entered in self-reported biometrics.

But, once they stop paying patients, they don’t use these platforms because they are:

  • Too much text, demographically insensitive
  • Virtually all digital health companies rely around presenting the user with the ability to track progress as central UX because it’s easier than anything else. BUT, tracking UX induces shame which triggers worse outcomes in vulnerable populations. IE, trackers make fit people feel good — people like VCs, board-level executives. But, not for average people. In fact, studies have shown that people who struggle with their weight (70% of US population) actually gain more weight from using trackers…the theories range from that they either trigger moral licensing (oh i walked so much, i will treat myself with extra donuts!)or the What the Hell effect (I overdid my calories for today, fuck-it, i’ll eat ALL the donuts!) Not only are worse outcomes not nice…but they trigger churn.
  • Churn = Not used = no helpful data, no ongoing $

This part of why MotiSpark is a golden opportunity. :-)

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