Sunday, May 27, 2018

Bad Blood: FDA Site-Visited the Army re Theranos; FDA Met Directly with Mattis Himself in 2012

There is a boom in new stories about Theranos, triggered by the May 2018 publication of journalist John Carreyou's book about the saga. See e.g. a story about the book and the saga this month on Sixty Minutes, here.

The FDA played a significant role.  There are 17 references in the book to Alberto Gutierrez, then director of the diagnostics regulatory division.   (There are 63 occurrences of "FDA.")

Around August 2011, Elizabeth Holmes took an occasional to directly introduce herself to Genl. Mattis (the current Secretary of Defense) "at the Marines Memorial Club in San Francisco."  (Carreyou doesn't tell us this any more about this particular backstory; it sounds like an audacious cold call.)   This brief encounter between Holmes and Mattis led to routing of potential procurement through an Army official, Lt Col. Schoemaker, who was an attorney who had FDA experience and he was concerned about potential developments between the DoD and Theranos.

Shoemaker informed Gutierrez at OIVD/FDA about Shoemaker's concerns about Theranos, and Gutierrez forwarded those concerns to CMS/CLIA (page 152).  This eventually led to a blow-up with Genl. Mattis at Department of Defense.

On page 156, it is August 23, 2012, and both Lt Col Shoemaker and the FDA's Dr. Gutierrez are together in Tampa, Florida (a 950 mile trip from FDA at Silver Spring, MD), and taking a meeting with General Mattis.   It will be three years in the future (October, 2015) when Theranos starts to melt down. 

Mattis had been asking "who the hell is Schoemaker?" and seems to have taken the Florida meeting with a senior FDA official with some annoyance.  It was far from his last contact with Theranos: Mattis joined Theranos as a board member "immediately after retiring from military service" in July 2013 (as noted here as part of a March 2018 article at Vox; see also here).
  • August 2011:  Unscheduled meeting with Holmes and Mattis (the prototypical cold call)
  • December 2011:   Military meetings at Theranos' DC attorneys' office about Theranos' "regulatory plan"
  • August 2012:  Shoemaker & Gutierrez @ Tampa to see Mattis in person
  • 2013:  Mattis joins Theranos board 

For screen shots of the meeting, here.

On July 28, 2015, a timepoint when Theranos was well aware of the investigative work against it by WSJ journalists, Elizabeth Holmes published an op ed in WSJ supportive of all LDTs undergoing FDA review.