Theranos, The Trial of Elizabeth Holmes, ch. 13: a crescendo of ‘I don’t knows’ and ‘I don’t remembers’…and the defense rests! (updated)

December 8, 2021 | by

Elizabeth Holmes returned to the stand in her own defense today, continuing with cross-examination by the prosecution’s Robert Leach. From the coverage published so far of six hours of questioning, Holmes has done everything to deny key statements she made multiple times to writers and investors, just short of ‘taking the Fifth’ (Amendment, which is a Constitutional guard against self-incrimination). 

Starting with the now-infamous 2014 Fortune cover story authored by Roger Parloff, Holmes admitted to Leach that the claim of 200 tests using the equally infamous nanotainers was incorrect, but used what marketers call ‘weasel words’: “I believe that now.” Did she not believe that then? She then proceeded not to remember that she forwarded the article via email to investors on 12 June 2014. “I think I could have handled those communications differently.” 

More not knowing or remembering. Were Theranos labs being used on military medevacs, as witnesses from Walgreens and Safeway, among others, have testified? Was Walgreens told of difficulties with the Theranos labs? Did or didn’t she dismiss concerns raised by Erika Cheung and Tyler Shultz to John Carreyrou of the WSJ as coming from disgruntled employees? Did she present a 2015 revenue projection of nearly $1 billion to investors, especially as the internal estimate was much lower and there were no contracts with pharma companies? Did she listen to her lab directors about problems with the tests?

But regrets, she had a few. The WSJ investigation, for instance. And slapping pharma company logos on Theranos reports.

It all comes down to who the jury believes. The prosecution either will close today or tomorrow (Wednesday). The defense will return to wrap up, either with Holmes or with expert witnesses such as Mindy Mechanic and, possibly, others. The defense will return to the 3 Ds–diffusion, deflection, and diminished capacity. The luridly resonant theme of Sunny Balwani as an abusive Svengali, which led her to be not in control of herself even after he departed, will be the coda. The Guardian, CNBC

Wednesday Update. Boy, was your Editor wrong. The defense rested today (Wednesday).

  • Dr. Mindy Mechanic, the defense’ expert on relationship violence, will not be testifying about the nature of the Balwani-Holmes relationship. By not calling Dr. Mechanic, the prosecution cannot call their psychiatrists who also spoke with the defendants. For his part, Balwani has consistently defended himself from these charges of relationship abuse. The prosecution is also seeking to strike Holmes’ testimony of being sexually assaulted while a freshman at Stanford as now being irrelevant to the case, but it is hard for a jury to unhear it.
  • Holmes was, of course, the star witness in her own defense, joined in minor roles by paralegal Trent Middleton from Williams & Connolly, Holmes’ law firm, who summarized evidence in the case, then former Theranos board member Fabrizio Bonanni, who testified that Holmes attempted to remedy Theranos’ problems–but only after it came under regulatory scrutiny, which was late in the game. He had been offered the COO position but declined as ‘too old for that’.
  • Holmes returned in her final testimony to Balwani. Sunny, she said, was her most important advisor though she was, admittedly, the decision-maker. He was volatile. She “tried not to ignite” Balwani in emails and frequent texts. “Sunny would often blow off steam or vent through text,” Holmes said. “I was trying to be supportive.”
  • Returning to tugging on the heartstrings of the four women on the jury, she stated that breaking up with him was a ‘process’. He’d just show up at places she would go, like church and The Dish near Stanford. 
  • Holmes explicitly denied ever trying to mislead investors, Her own summary was restating her original ‘healthcare vision’ and the impact the company would make on healthcare.

Summaries by the prosecution and defense will be next up. Mercury News (partial paywall), CNBC

To be continued…

TTA’s earlier coverage: Chapter 12, Chapter 11, Chapter 10, Chapter 9, Chapter 8, Chapter 7, Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

EHRs: The Bridge to Nowhere–other than despair. An investigative Must Read on ‘an unholy mess’.

April 4, 2019 | by

If you hate your EHR, think it’s swallowing your information, adding hours to your day, and if you don’t watch it, you’ll make an error, you’re not a Luddite. You’re right. An exhaustive investigation by Fortune and Kaiser Health News (KHN) concludes that it’s ‘an unholy mess’. In fact, even if you are not a physician or clinical staff, it will make you wonder what was going on the collective brains of the digerati, Newt Gingrich, Barack Obama–and the US government–in thinking that EHRs would actually “cut red tape, prevent medical mistakes, and help save billions of dollars each year,” committing $36 billion to pursuing the ‘shovel-ready’ HITECH stimulus in the depths of the 2008-9 recession. Perhaps the shovel should have been used on a body part. Now if only those billions went towards an interoperable, useful, and national system rather than a money giveaway–which even Farzad Mostashari, then ONC deputy director and later director, now admits was “utterly infeasible to get to in a short time frame.” (Mr. Mostashari is now head of Aledade, counseling those mostly independent practices which lined up–hungry or terrified–for meaningful use EHR subsidies on how they can continue to survive.) Even the vendors were a bit queasy, but nothing was stopping HITECH. (Your Editor was an observer of the struggle.)

Now that we have been living with them for over a decade, EHRs have been found culpable of:

  • Soaring error rates, especially in medication and lab results
  • Increasing patient safety risks in lack of pass-through of critical information
  • Corporate secrecy, enforced by system non-disclosures, around failures
  • Lack of real interoperability–even with regional HIEs, which only exchange parts of records
  • Incomplete information
  • A very real cognitive burden on doctors–an Annals of Family Medicine study calculated that an average of 5.9 hours of a primary care doctor’s 11.4 hour working day was spent on the EHR
  • Alert fatigue
  • Note bloat
  • Plain old difficulty or unsuitability (ask any psychiatrist or neurologist)
  • A main cause of doctor burnout, depression, and fatigue–right up to high suicide rates, estimated at one US physician per day
  • Lack of patient contact (why the scribes are making a good living)
  • All those dropdowns and windows? Great until you click on the wrong one and find yourself making a mistake or in the wrong record.

Not even the head of the Centers for Medicare and Medicaid Services is immune. Seema Verma’s husband, a physician, collapsed in the Indianapolis airport. She couldn’t collect his records without great difficulty and piecing together. When he was discharged, he received a few papers and a CD-ROM containing some medical images, but without key medical records.

A long read for lunch or the weekend. Death by a Thousand Clicks: Where Electronic Health Records Went Wrong. Also the accompanying essay by Clifton Leaf. 

Blood is drawn: Theranos responds vigorously to TTA re WSJ

October 22, 2015 | by

From his very first interactions with Theranos, the reporter made abundantly clear that he considered Theranos to be a target to be taken down, and not simply the subject of an objective news story. The articles that appeared last week are the inevitable product of that approach.–Theranos Facts, 22 Oct

Breaking news. Blood is drawn. A spokesperson for Theranos (from FTI Consulting), Ms Shea Maney, has responded directly to this Editor regarding the content of the Wall Street Journal article, previously covered here (The $9 billion question mark) along with followup in primarily Fortune but also commentary in the Health Care Blog. Her note to me (which undoubtedly has gone to other press) is reprinted below in its entirety, save the standard closing line:

We read your coverage of Theranos with interest, and noticed you were particularly interested in accuracy and our finger-stick tests, among other themes. There have been a lot of inaccuracies in the coverage of these topics, which is why we have posted detailed information on our technology, accuracy, and conversations with The Wall Street Journal on our website: https://www.theranos.com/news/posts/custom/theranos-facts

On accuracy: Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve. We are confident in the reliability of our tests, because we have validated their accuracy. (more…)

The Theranos Kerfuffle: a setback, but is it for the best? (updated)

October 20, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/question_mark.jpg” thumb_width=”120″ /]Some clarity emerges from the controversy around Theranos and last week’s Wall Street Journal exposé [TTA 16 Oct]. Last week’s rebuttal/denial released by the company said remarkably little, which disturbed Roger Parloff, the Fortune writer who profiled the company in June 2014’s high-profile cover story. He failed to reach CEO Elizabeth Holmes, who on her break from an all-day with the Harvard Medical School Board of Fellows, taped a segment with CNBC stock tout Jim Cramer (a questionable priority indeed–Ed.) Fortunately he received more specific answers via email from General Counsel Heather King. It clarifies among other things that venipuncture, not finger stick, is used in the majority of their tests in practice, and that dilution of samples is within industry practice for use in third-party analyzing machines. There also seem to be two sides to the proficiency-testing story. (Oddly, no mention of the sensational claims around British biochemist Ian Gibbons who was key to Theranos’ patent development and the alleged legal threats to his widow.)

For those who have difficulty getting through the WSJ paywall, Mr Parloff’s summary of the WSJ article’s main points is helpful. His conclusion: Theranos is wisely ‘dialing back’ its USP on drawing blood through finger stick to “Smaller samples. Smaller needles. Better experience.” (A neat pivot from what Theranos ‘made their bones’ on and still features–tiny finger-sticks.) His open-ended question (for, presumably, the next article): can it profitably run its low-cost testing business when it’s using the same analyzing machines as the big testing labs; and while cheaper, can doctors and patients trust the Theranos tests (which are a matter of health, and perhaps life and death) if they’ve flunked their first test at transparency?

Another view from Health 2.0 supremo Matthew Holt over at his Health Care Blog is that for Theranos, this blow is eminently recoverable if they play their cards right. Witness the recovery made by 23andMe, now in the good graces of FDA after having blown it badly to near-shutdown. (more…)