Bad Blood

(Axel Boer) #1

I


Epilogue


n the days after my first Journal article, Holmes defiantly asserted
that she would publish clinical data from her blood-testing system
to disprove my reporting. “Data is a powerful thing because it
speaks for itself,” she said on October 26, 2015, at a conference hosted
by the Cleveland Clinic. Two years and three months later, she finally
delivered on that pledge: in January 2018, Theranos published a paper
about the miniLab in the peer-reviewed scientific journal
Bioengineering and Translational Medicine. The paper described the
device’s components and inner workings and included some data
purporting to show that it held its own when compared with FDA-
approved machines. But there was one major catch: the blood
Theranos had used in its study was drawn the old-fashioned way, with
a needle in the arm. Holmes’s original premise—fast and accurate test
results from just a drop or two pricked from a finger—was nowhere to
be found in the paper.


A close read revealed other significant shortcomings. For one thing,
the paper included data for only a few blood tests. And results for two
of those tests, HDL cholesterol and LDL cholesterol, diverged from the
FDA-approved machines by a margin that Theranos itself
acknowledged “exceeds recommended limits.” The company also
conceded that it had run the assays one at a time, belying Holmes’s
previous claim that her technology could do dozens of tests
simultaneously on one tiny blood sample. Last but not least, the tests
performed had required different configurations of the miniLab
because Theranos hadn’t yet figured out how to fit all the components
into one box. All of this was a far cry from the revolutionary
breakthrough Holmes had touted when Theranos launched its tests in

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