But first, a little back-story (or stories!) here: Merck’s incomparable Merck Manuals® have been digitized, and available as apps — for purchase — since December 2009. We love them! That is digitized pharma at its very best. On the other side of the ledger, however, back in January of 2011, Merck quietly withdrew several “home grown” medical apps that were available — for a time — in the Apple App Store.
There never was an official Whitehouse Station explanation of the reason(s) for the voluntary withrawal, but I speculated then that the apps were seen running afoul of the United Kingdom’s ban on “DTC” related to prescription medications.
A bit more background, if I might: DTC is “direct to consumer” advertising — and has been lawful in the United States for over a decade, now. The withdrawn apps included a Temodar® Dosing Calculator, a DAS28 Calculator for Healthcare Professionals, a Remicade® Dosage Calculator for Healthcare Professionals, a Remicade® RRP Matrix for Healthcare Professionals and a Bridion® Dose Calculator [Bridion® (sugammadex) is not FDA approved in the US (and may well never be), but it is, at present, in Europe].
Fascinatingly (to me, at least), the only post-industrial economies on Earth that allow DTC advertising for prescription medicines are. . . the United States, and New Zealand. And so, with a fully formed, borderless global digital economy — it is a rather ginger proposition to release such apps into the Apple App Store — at least ones that either directly or indirectly advertise behind-the-counter drugs, or help with diagnosis of conditions — and/or monitor subsequent dosing (and adherence) regimens — for prescription medications. This is so because Apps invariably downloaded in one geography make “appearances” all over the globe, as people travel, and devices are bought and sold, worldwide. [And one humorous additional background story, here — even if apocryphal!]
So, it is with some keen interest that I note this WellDoc investment, by Merck’s Innovation Fund. $20 million is less than a rounding error, to Whitehouse Station — so the money is irrelevant. What is significant, is that Merck may end up licensing in some of the tech that temporarily “bricks” the app outside of select geographies, at least as to viewers and would be users, other than patients (already under the care of a US or New Zealand licensed physician) who “fingerprint in,” for example, on their iPhone 5S.
I am given to understand that WellDoc’s first app has cleared FDA for use (with a doctor’s order), in the US. That, my friends, is likely the information pipeline Merck is after, with this investment — near real-time information on how patients are actually medicating themselves. The $20 large also gives Merck the inside track on access to the BlueStar related know-how, to get a specific med dosing and adherence app cleared, and keep it from raising the hackles of the EU authorities, where it is generally seen as interfering with the patient-physician interaction — unless it is downlodaed with, or after a prescription, from a doctor, just like the real-world med itself. I for one will keep a weather eye on the BlueStar app, to see when/if it crops up in the United Kingdom press. It seems the UK authorities are the most vigilant about policing these things.
So, will the app prefer (make recommendations toward) Merck branded diabetes medicines? I doubt it, actually. However, here is a bit of Friday’s story (as published in MobiHealth News, below) — do go read it all. And stay tuned!
. . . .“When you look at how active Merck GHI has been in investing in digital health, they have acquired a lot of knowledge about technology — consumer technology, digital health technology — you name it. For us, that blend of life sciences and consumer technology is really important for understanding WellDoc,” Sysko said. “We don’t really see that in a lot of other strategic investors.”
WellDoc’s flagship offering is BlueStar, an FDA-cleared mobile application and program for people with Type II diabetes that is prescribed by physicians and adjudicated through pharmacies just like pharmaceutical therapies. The program is supported by WellDoc’s Automated Expert Analytics System, which includes real-time motivational messages, behavioral coaching and educational content, delivered right to the patient’s mobile device. The program also provides patient’s physician with clinical decision support tools based on how they’re doing. . . .
“It’s about the information, Marty — the in-for-ma-tion!” — Cosmo (Ben Kingsley), to Marty Bishop (Robert Redford), in “Sneakers” (1992). Cheesy but fun techie flick. Enjoy your Saturday night NetFlicks date nights! (Me? I’m up early — and on the road north tomorrow. . .)