Thread by @AnneKopfSill

Day 32.Elizabeth cont’d testifying. My main thought is what a tragic, twisted world when the defense uses emails from the person that killed himself (Ian Gibbons) due to stress that the technology did not work as evidence in trial that Elizabeth concluded the technology did work.

Nov 22, 2021. This short day of testimony consisted of emails from Theranos employees to Elizabeth with positive reports about the technology and what it could do. Also many documents showing collaborations with pharma companies. Love fest, as expected.

The day started with a very long delay. The jury had arrived expecting trial to start at 9am. They were not seated until 10:30am. The attorneys and judge were conferring in private. Most legal issues have been resolved in public so this is unusual. Plea deal??? Who knows?

The defense started with asking about the 2009 Novartis demo (the demo that was a sham per the first 6 pages of Bad Blood). Then Elizabeth was given the chance to explain what the problems were with the v1.0 device and what they changed for later devices, namely 3.0.

She claimed they had problems with sealing the layers in the microfluidic cartridge in the 1.0. Arrgghhh – how could you work for 5 years on microfluidic products and not realize that sealing the layers was going to be a big problem? They worked hard at being ignorant…

Interestingly, they showed a picture of a Tecan liquid handling robot on the left. Then, claimed that the Theranos 3.0, shown on the right, was a miniaturized version and could do whatever the Tecan could do.

As it turns out, I worked at Tecan for 4 years on a new microfluidic technology. Tecan wanted such technology because any and every engineer at Tecan (and all such companies) knew that it was not reasonable to just shrink down the standard liquid handling robots!!! Photos:

The defense attorney put up an email that had an abstract about Preanalytical Variability. The Theranos employee had highlighted the statement that says “lack of procedures for sample collection, …, specimen acquisition, handling and storage, account for up to 93% of errors.”

Everything is wrong with Theranos using this exhibit. Earlier in the trial, we saw several times where Elizabeth claimed that the automation they did would reduce this 93% error.

But, the first sentence in the abstract points out correctly that the automated machines-these are ones made by others!-have reduced the error rate. So, at the time this abstract was written, 2006, automation had already improved diagnostic testing.

Some of the topics in the highlighted sentence – namely specimen acquisition and storage and handling – are ones that Theranos was particularly poor at…. especially with fingerstick samples.

We saw a powerpoint from Ian, 06/08/08. Some bullets for System Goals were: 20uL sample size, high sensitivity of 0.2 pg/mL, on-board chemistry controls, factory calibration. On last slide:
“Performance design goals have been demonstrated. Results have been excellent.”

In July of 2008, Ian sent a powerpoint to Elizabeth about a clinical study at Stanford on AML (acute myeloid leukemia) trying to identify possible sepsis early on. Among other conclusions is “Assay results have been precise.” [This Exh is 12065, previous one was 15022]

The attorney asked Elizabeth to confirm that it led to a peer-reviewed publication. . [Exh 15002]

Hahaha – this is the publication that was so minimal that when it was the only published paper that Elizabeth cited for journalist Ken Auletta’s New Yorker article, it made pathologist Adam Clapper so suspicious he contacted, @John Carreyrou. See Episode 6 of Bad Blood podcast.

We saw emails from Stefan Hristu and Susan DiGiaimo, summarizing pharma collaborations on 02/24/09 and 11/22/08. About 10 on each email. Curiously, Susan’s email was sent from her personal email; prosecution did not want that redacted so they can question it. [7742 & 15044]

We saw two cases in which the pharma company wanted to use Theranos-collaboration data in a scientific presentation. One request was from Centocor for a Biomarker Conference in 2011.

GSK report said: “machines worked well, precision acceptable (cv=11%), good correlations (R2=0.90 and 0.96 for two assays)” and “The Theranos system eliminates the need for a lab and provided quality data.” Elizabeth testified that GSK recommended going forward. [Exh 112]

We saw an email from Carolyn Balkenhol, an assistant to Elizabeth. She called Connie Cullen from Schering-Plough/Merck every day for 3 weeks in early March, 2010. You’ll recall that Connie testified on Day 22 and said “Elizabeth was cagey with answers.”

Connie also testified that she did not do anything with Theranos because she was very busy with merger and never spoke to Theranos after Dec '09. In email we saw today, Carolyn reported that she had a great call with Connie. “All in all, it was awesome, I think.” [Exh 15045]

There were collaborations with Celgene and Daiichi-Sankyo (Japanese pharma) through Mayo Clinic.

A few emails between Theranos and Pfizer that were after the time period Shane Weber testified to. He told us that he did not think Pfizer should work with Theranos. Some emails were from David Lester; they claimed he worked at Pfizer and then came to Theranos.

In Feb '15 email, Pfizer employees wanted to leverage the Walgreens in-store infrastructure as a clinical trial site. This is funny to me… Theranos used the purported Pfizer validation to get the Walgreens deal and is now using the Walgreens deal to get a Pfizer collaboration…

Pfizer also wanted to learn more about Theranos for their “know their numbers” with regards to lipids and cholesterol. (presumably, this could help sell statin drugs) [Exh 15039]

We saw a few emails in regards to collaborations with the military. One was from Gary Frenzel to Elizabeth, titled “ya done good today!” He states that the colonel wants additional technology like cytometry and GC/MS (=gas chromatography/mass spec) and PCR.

He closes saying: “You were awesome. If there is anything you need to help this along let me know.”

As is the case most recent days, defense brought up Prof. Channing Robertson. We saw an email from Oct '09 in which Channing tells Elizabeth that “We had our first group meeting today to start talking about assessing new technologies, thinking ahead and thinking out of the box.”

The defense attorney pointedly asked: “Did scientists and engineers think it [Device 4.0] could be configured to run any blood test?”
“yes.”

Another email from Ian G in Jan, 2010 where he has used the commercially-available Nanodrop and thinks that technology can expand their general chemistry assays and expand their immunoassays.

We ended with another powerpoint from Ian, summarizing the 4.0 system capabilities in Feb '10. Attorney highlighted the bullets:
“System 4.0 will be capable of performing any measurement required in a distributed test setting.”
“Open architecture for both reader and disposable.”

The attorney asked “What did you understand?”
“I understood that the 4 series could do any blood test.”
End of testimony for the day.

Hold on….I have more to say! This powerpoint from Ian sets out goals at the beginning of the presentation and then goes on to list many issues with many of the goals. It’s a long presentation, 112 pages.

Here’s a few issues. Rare cell analysis – hard to believe Theranos was considering that! Powerpoint says: “Detection goal is 10 cells / mL, a drop of blood is 20 uL. Therefore, only 0.2 cells/ drop of blood.” Ian writes: “Impossible to detect reliably.”

Theranos was clearly struggling with red blood cell removal. Ian lists some options on p. 10 and says on p. 66: “Need to invent and develop red cell separation technology.”
May I be blunt?: Removing the red cells is step #1 in making a diagnostic product from a drop of blood.

Ian has many slides reviewing competitors’ technologies that they could consider incorporating into the Theranos 4.0 He especially likes the Nanodrop technology. I always liked that product, too.

Many people, including people in the courthouse line this morning, ask me if Theranos had a good invention at its core.
Let me be clear: Theranos had no invention.
This powerpoint from Ian is a good demonstration of it. Everything listed is traditional or yet-to-be-figured out.

I recommend this exhibit if you like details about Theranos’ system. Ian is a very smart cookie – he reviews lots of background technology and concepts.
RIP Ian.
[Exh 7098] here is link to all exhibits. files.cand.uscourts.gov/files/18-CR-25…