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My theory is that the company was originally developed for a military procurement play, for battlefield diagnostics or similar. Hence their board. The Washingt
by dbcooper 11y ago
My theory is that the company was originally developed for a military procurement play, for battlefield diagnostics or similar. Hence their board.
The Washington Post published a very interesting article earlier this month, in which they used email correspondence to reveal that Theranos pitched their system to the military, but there were concerns from a DoD official about it.[1]
>An official evaluating Theranos’s signature blood-testing technology for the Department of Defense sounded the alarm in 2012 and launched a formal inquiry with the Food and Drug Administration about the company’s intent to distribute its tests without FDA clearance
Holmes contacted General Mattis, who had been promoting Theranos within the military, and he tried to bypass the concerns. In the end, Theranos never demonstrated the system to the military. Mattis joined their board a year later.
>According to a Theranos spokeswoman, Mattis and Holmes met in 2011 at a Marine Memorial event. Mattis, busy overseeing the war in Afghanistan as commander of the U.S. Central Command, expressed interest in testing Theranos’s technology in combat areas, according to the e-mails.
>“I’ve met with my various folks and we’re kicking this into overdrive,” Mattis wrote to Holmes in June 2012. “I’m convinced that your invention will be a game-changer for us and I want it to be given the opportunity for a demonstration in-theater soonest.”
>He urged Holmes to call or e-mail him if she felt they needed to talk.
>A month later, frustrated by the military regulatory expert who had contacted the FDA, Holmes took him up on that offer.
>“I know how incredibly busy you are but thought it was the right thing to let you know the following,” Holmes wrote.
>She noted that a deputy director working for a division of the military that oversees regulatory issues and compliance had launched a formal inquiry to regulators without warning Theranos.
>“I would very much appreciate your help in getting this information corrected with the regulatory agencies,” Holmes wrote in the e-mail to Mattis. “Since this misinformation came from within DoD, it will be invaluable if this information is formally corrected by the right people in DoD.”
>Within hours, Mattis forwarded the exchange to military officials, asking “how do we overcome this new obstacle.”
>“I have tried to get this device tested in theater asap, legally and ethically,” Mattis wrote. “This appears to be relatively straight-forward yet we’re a year into this and not yet deployed.”
>The field demonstration Mattis was seeking never took place.
[1] https://www.washingtonpost.com/news/wonk/wp/2015/12/02/internal-emails-reveal-concerns-about-theranoss-fda-compliance-date-back-years/?postshare=3491449147304325&tid=ss_tw https://www.washingtonpost.com/news/wonk/wp/2015/12/02/inter...
- sk5t 11y agoStrongly agreed on the company's likely intent to integrate monitoring into US military training and deployment kits... imagine the military benefit in knowing every soldier's blood panel and derived data such as stress level on a near-continuous basis--that's a real force multiplier. Worth $10K/yr/man easily.
- anon4this1 11y agoMD here. The vast majority of soldiers are fit and healthy and will have completely normal labs 99% of the time. The times when they are not normal will be insignificant 99% of the time (had a few drinks last night? your GGT level will be slightly above normal briefly). This information is worth next to nothing to anyone.
- sk5t 11y agoDo soldiers remain so healthy-by-the-numbers in the field? I'm wondering if many data points would help to identify individuals on the edge of becoming unfit.
- anon4this1 11y agoOh .. and another thing. I do point of care needlestick blood testing on people every day. I check haemoglobin and blood sugar levels. When doing a needlestick test for Hb I always do it twice because these results are often spurious (especially when you "milk" blood out of the finger). The Hb/liter figure can vary by as much as 20-30% routinely. If this is the case I then do a proper venous draw to find the true result. These tests are marginally useful in screening for really low or really high values, but they are pretty much inadequate compared to a proper venous draw for clinical decision making.
- seehafer 11y agoIt's not a bad theory, but even the military medical establishment would demand that the tests are accurate.
- 11y ago