Digital health news update: FDA relaxes (a bit) on DTC gene tests

April 8, 2017 Matthew Arnold

  • FDA reversed itself and gave 23andMe the green light to begin screening members for genetic risk factors for ten diseases, including Gaucher Disease, Parkinson’s and late-onset Alzheimer’s, after forcing the company to sharply curtail the scope of its consumer testing in 2013 (when their spit kits returned info on 254 genetic risk factors). It's a big win for consumer empowerment, and for enlightened, give-and-take regulation, but FDA’s concern -- that consumers, lacking the background in medicine and genetics required to interpret a finding of genetic susceptibility, would make poor medical decisions as a result -- remains valid.
     
  • Medicare is reimbursing a Dexcom Continuous Glucose Monitor (CGM). That’s a big step down the road to connected care for diabetes patients, their caregivers and the HCPs treating them.
     
  • UnderArmour is laying off employees in its Connected Fitness division, which maintains four mobile apps, and that’s giving Wall Street the willies, given how digital-centric UnderArmour’s value prop is (one exec just gave a talk about the company’s vision, in which “the physical product and the digital product are not distinguishable”), and raising anew the question of whether there’s a bubble in connected fitness or if players like UnderArmour are simply way ahead of the market.
     
  • There’s a debate raging in the pharma blogosphere over Kantar data in MM&M’s DTC report that have digital spend flat at around 8% of overall DTC. Does that indicate ineffectiveness of display advertising, or worries about “click fraud” driven waste? Or do the numbers (which track media spend and therefore exclude owned digital properties, etc.) provide a misleading window on overall pharma digital spending trends? Either way, it’s clear that pharma spending on TV ads still dwarfs digital.  
     
  • Check out this eBook MM&M did on how pharma is incorporating behavioral science – some great examples from Novo, BI, Sanofi Genzyme and Regeneron.
     
  • Reeling from an advertiser revolt over ads adjacent to objectionable content, Google signed on comScore to provide “brand safety” monitoring services.
     
  • Here’s a targeted advertising nightmare scenario for you – a small digital ad shop in Boston agreed to stop using geofencing to serve targeted anti-abortion ads to Massachusetts women entering reproductive health clinics and methadone treatment centers.
     
  • From Digger the Dermatophyte to Gut Guy, grossout anthromorphications of disease are a grand tradition in pharma advertising, and Synergy's "Poop Troop" suite of poop emojis (their constipation treatment Trulance launched in January) is firmly within it.
     
  • Forget the AHCA -- a LinkedIn survey (okay, it’s a glorified web poll, but…) found that physicians are so exasperated by wrestling with insurers that 48% are ready to give a single payer system a try.
     
  • Amgen is offering patients on its pricey PCSK9 inhibitor Repatha a money back guarantee should they suffer a heart attack while on the drug, and John LaMattina says this old retail pricing stratagem could soon be the norm for expensive treatments.
     
  • Food for thought which will soon be computer-enhanced: Elon Musk is launching an effort to develop “neural interfaces,” because he doesn’t have enough to do with Tesla and SpaceX and resistance is futile, and the founder of a neural prosthesis startup says humankind’s future will be determined through a combination of human and artificial intelligence. 
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