With the ground rules for our conversation established, Alan let
down his guard and we talked for more than an hour. One of the first
things he said was that what Ian had told Rochelle was true: the
Theranos devices didn’t work. They were called Edisons, he said, and
were error prone. They constantly failed quality control. Furthermore,
Theranos used them for only a small number of tests. It performed
most of its tests on commercially available instruments and diluted the
blood samples.
It took me a while to understand the dilution part. Why would they
do that and why was it bad? I asked. Alan explained that it was to
make up for the fact that the Edison could only do a category of tests
known as immunoassays. Theranos didn’t want people to know its
technology was limited, so it had contrived a way of running small
finger-stick samples on conventional machines. This involved diluting
the finger-stick samples to make them bigger. The problem, he said,
was that when you diluted the samples, you lowered the concentration
of analytes in the blood to a level the conventional machines could no
longer measure accurately.
He said he had tried to delay the launch of Theranos’s blood tests in
Walgreens stores and had warned Holmes that the lab’s sodium and
potassium results were completely unreliable. According to Theranos’s
tests, perfectly healthy patients had levels of potassium in their blood
that were off the charts. He used the word “crazy” to describe the
results. I was barely getting my head around these revelations when
Alan mentioned something called proficiency testing. He was adamant
that Theranos was breaking federal proficiency-testing rules. He even
referred me to the relevant section of the Code of Federal Regulations:
42 CFR, part 493. I wrote it down in my notebook and told myself to
look it up later.
Alan also said that Holmes was evangelical about revolutionizing
blood testing but that her knowledge base in science and medicine was
poor, confirming my instincts. He said she wasn’t the one running
Theranos day-to-day. A man named Sunny Balwani was. Alan didn’t
mince his words about Balwani: he was a dishonest bully who
managed through intimidation. Then he dropped another bombshell: