Silicon Valley’s betting on ‘citizen doctors’, ‘citizen science’ and useful data

A fascinating and slightly cynical overview of Silicon Valley’s ideological view of health tech that will fix our ‘deeply flawed healthcare system’ and what is getting funded (or not) is in next month’s San Francisco magazine. It profiles the ‘citizen doctor’ founders of vital signs ‘tricorder’ Scanadu (Sam–who’s not often mentioned–and Walter De Brouwer), bacteria tracker uBiome, ‘personal data recorder’ and experience charter We Are Curious (founded by Linda Avey, a long-departed co-founder of 23andme) and touches on the Theranos debacle. While these stories are bracing and in the instance of the De Brouwers, courageous, the notion of ‘citizen science’ (defined as direct-to-consumer health data) and its companion, Dr Eric Topol’s patient-centered/controlled medicine, has its drawbacks, viewed through the slightly gimlety ‘digital doctor’ eye of UC San Francisco’s Dr Robert Wachter. “The overarching message—not just from Theranos but from other companies struggling to get a toehold—is that, ultimately, the laws of economic gravity hold. The companies will have to produce products that add real value, either to patients or to payers. If they don’t, the market—or the regulators—won’t treat them kindly.” Flatly, there aren’t enough Quantified Selfers right now to support these companies. And Mr Market is a hard master. 23andme is back in the good graces of the FDA after a two-year scuffle and back doing direct response TV here in the US. Scanadu’s two products, Vitals (formerly Scout) and Urine are still not through the long slog of FDA clearance. The jury’s out on Theranos. And all these companies, including ‘unicorn’ Theranos, are bleeding cash and nowhere near turning a profit. ModernLuxury. Hat tip to Dr Topol via Twitter, who had a patient-centered conversation with Dr Wachter that we covered back in September.  Another recent podcast with Dr Wachter is here (Community Health Center radio).

Update: ‘Citizen science’ is nothing new, as revealed by the Science Museum (London)–it’s over 300 years old. While it entered the OED in 2014, ‘in 1715, Edmund Halley used Philosophical Transactions to ask colleagues to help him observe a total solar eclipse, prompting observers from all over the country to respond.’ Other examples are from Benjamin Robins in the same publication in 1749 on fireworks, Charles Darwin and evolution, to the present day. The difference is the flow–similar to what we now call crowdsourcing versus the individual using the data to affect their care.


FDA tells 23andMe genomic test to stop marketing (US)

Quantified Selfers and the D3H (Digital Health Hypester Horde) are in a swivet. This past Friday, FDA slammed the door shut on the 23andMe Personal Genome Service (PGS) saliva test. This past summer, the company broadly marketed to US consumers, including a TV campaign [Charles Lowe, TTA 7 Aug]. The FDA cease-and-desist letter cites that 23andMe never provided requested data on their July and September 510(k) filings, which are now ‘considered withdrawn’, and cites that “after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.” The danger is that people will make medical decisions based on the testing information and that the results produced may be faulty. It appears from FierceHealthcare that the kit has actually been marketed for five years. According to MedCityNews, it is backed by Google Ventures (the CEO/co-founder is the estranged wife of Google head Sergey Brin), New Enterprise Associates, MPM Capital and the Moscow billionaire Yuri Milner. A private citizen is petitioning the White House to overrule the FDA (as if that extra-legal move would be possible, but who knows with the influence of the Googlesphere?) and states that the agency ‘grossly overstates the risks’ (also MedCityNews). As of 2 Dec there are 3,306 signatures of the 100,000 needed; one suspects this administration has bigger slices of uncooked turkey on its plate such as Obamacare and a kind-of-achieved 30 Nov deadline on, which is now clearly seen as just one problem.

The 23andMe website is still fully up and still selling kits.

Editor Donna sorts through the noise for possible reasons why:  (more…)