Friday, October 23, 2015

Female Unicorn Poop Gets Mixed Reviews From FDA

Elizabeth Holmes (photo above) and her startup Theranos are getting heavy heat from just about everybody, most crucially the FDA, which sprang a surprise inspection on the company. It is certainly worth checking out a great collection of articles on the Thernos controversy curated at ReDef.

Apparently there has been some misuse of “nanotainers” — possibly the douchiest thing ever invented by a woman — which are only supposed to be used for a Herpes test but seem to be used much more often. I was recently having lunch with two pathology industry executives and they were brutal in their assessment of the startup and its “joke” of a business model and while I couldn’t follow their gargon-laden conversation I was intrigued so I started doing some research.
The best commentary I have read so far on Theranos and the controversy surrounding its testing methods and materials is a piece Dan Munro of Forbes published on Medium emphatically titled Why I Believe My Theranos Blood Test Was Inaccurate and Useless. First of all, I found it weird that Munro would publish such a piece on Medium when it seems like it would get much greater attention under his Forbes by-line, but considering the inflammatory nature of the title perhaps it was prudent for Munro’s Forbes editor to hold off judgement and leave WSJ alone behind the 8-ball as Theranos fires back with full cannons blazing. But I digress…
In the piece Munro presents a brief and compelling vignette about his own personal user-experience at a Theranos clinic in Phoenix which he thoroughly reviewed in a post published on Forbes while simultaneously dissecting publicly available information from both Theranos and the FDA. Upon reflection Munro seems to be convinced he was hoodwinked, and while he appears to be basing his opinion on mostly speculation based on limited information, the questions he posed must be answered by the company or they will suffer irreparable harm to their reputation IMO.
Elizabeth Holmes has responded to her most vocal critics at the WSJ by attempting to shame the paper as “a tabloid”. It will be very difficult for the company to be so dismissive of Munro considering he is one of the best health care journalists and commentators who has actually written favorably of the company to date, concluding his piece in Forbes with the following assessment:
All in all ‒ the Theranos experience is well thought out as a retail experience and about as frictionless as possible…
I will hold off final judgement until I have a better understanding of the situation, but at first whiff it sure does smell to me like a huge load of female unicorn poop.
Meanwhile, 23andMe has been granted permission from the FDA to resume marketing limited version of its clinical risk reports suspended two years ago at the agencies request. The company was little phased by the temporary injunction, using it as an opportunity to shore up its scientific team and shift its business model to unlock the unknown value of its biobank and 1 million+ user-base.
The moniker chosen by CBS Morning News to place under 23andMe CEO Anne Wojocicki of “Most Daring CEO” (photo below) is apt as her pivot to focusing on drug development is logical, bold and not unthinkable to execute to some degree. However, they lack the phenotypic data to complement the very limited genotypic data they have accumulated, specifically the diagnoses and outcomes captured in electronic medical records. Without this information it is very difficult to determine what diseases one should be targeting based on purely genomic data.
It’s hard to imagine how one could possibly make investments in R&D while essentially flying blind and using data from subjects that is indecipherable without some deeper, complementary knowledge on what actually happened to each each individual longitudinally. I suspect the company’s strategy for filling the holes in the information will focus on attempting to replicate the EMR data using Q&A features on their website or via email surveys or something along these lines but does the use of unvalidated questionnaires designed by under-qualified 23andMe staff meet the standard of scientifically actionable phenotypic data?!? I think not…
In sorta related news, it was both saddening and slightly terrifying to learn from the new HBO documentary San Francisco 2.0 that the unicorn poop left in the wake of the Silicon Valley “tech bros” is systematically destroying the culture of San Francisco with its douchey stench. It is mind-boggling to think that the sudden appearance of unicorn poop on the sidewalk was all it took to cause property values and rent in the Bay area to get totally out of control. The film shows the tragic dichotomy of a city scrambling to cash in on the boom, renting 1400 sq/ft one bedroom houses for $10,000/month to 25 year-old Google and Facebook employees without the slightest consideration for the impact on longtime tenants who are basically left homeless, really city-less in a sense and with very little hope that the city they have loved still has a place for them.