Theranos, The Trial of Elizabeth Holmes, ch. 7: Edison labs consistent–in deficiency and strange results

November 11, 2021 | by

And Elizabeth Holmes knew. The last two years of Theranos’ existence, were, to put it mildly, fraught, for anyone honest. Job 1 for the very last in a parade of lab directors, Kingshuk Das, MD, was to respond to CMS on substantial deficiencies found in a November 2015 on-site inspection. The CMS deficiency report, sent to the prior lab director in January 2016, two months before Dr. Das’ start, had a subject line that would grab anyone’s immediate attention: “CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY.”

The report went on to say that it was determined that your facility is not in compliance with all of the Conditions required for certification in the CLIA program.” and concluded that “the deficient practices of the laboratory pose immediate jeopardy to patient health and safety.”

Dr. Das found some interesting things in his early days on the job, such as the Edison labs producing results detecting abnormal levels of prostate-specific antigen (PSA)–in female patients. When he brought this to Holmes’ attention, she quoted a few journal articles stating that certain rare breast cancers in women might present that result. This didn’t seem quite plausible to Dr. Das. Holmes then told him that it wasn’t an instrument failure, but rather a quality control and quality assurance issue. Nevertheless, Dr. Das went back and voided every Edison lab test made in 2014 and 2015, stating to Holmes that the Edison labs were not performing from the start. Most Theranos results sent to patients were produced on third-party machines made by Siemens and others, often on inadequately sized blood samples. 

As Dr. Das testified to the defense, many skilled people at Theranos earnestly tried to fix the problems with the Edison lab machines, but, as The Verge put it in part, if Holmes didn’t believe Dr. Das, other employees, or multiple preceding lab directors that the machines were really, truly broken, did it matter?

The defense is maintaining that Holmes didn’t really understand the lab details and was heavily influenced (ahem!) by president Sunny Balwani. However, the Babe in the Medical Startup Woods defense falls apart when there’s no Sunny to blame–he departed shortly after Dr. Das’ arrival. 

The actual theme–a long-term pattern of deception aimed at those who wanted to believe, and ponied up Big Bucks--was reinforced by a witness before Dr. Das. Lynette Sawyer was a temporary co-lab director for six months during 2014 and 2015, but never came to the Theranos site. It seems that her main duties were signing off remotely on documents using Docusign and backing up then-lab director Dr. Sunil Dhawan, Balwani’s dermatologist who came to the lab a handful of times. Even more amazingly, she was unaware of Theranos’ signature ‘nanotainers’ and the backup use of third-party devices. After her six-month contract was up, she departed, uncomfortable with Theranos’ procedures.

Kicking off the day was Judge Davila’s regular admonition to those in the public section of the courtroom to type vewy, vewy quietly. Then the video display for exhibits broke down. This led to a two-hour delay while the court found an antique projector to show the images to the jury and the public on a blank wall.

One wonders if the tapping plus the tech breakdown topping off the Parade of Fraud is leaving the jurors numb–or wanting to jump into the well above, even if there is no bottom. CNBC, Wall Street Journal (15 Oct), 5KPIX

TTA’s earlier coverage: Chapter 6, Chapter 5, Chapter 4 (w/comment from Malcolm Fisk), Chapter 3, Chapter 2, Chapter 1

To be continued….

 

 

The Theranos Story, ch. 36: Their money–and time–are running out

February 22, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]A garage sale soon for Theranos? A report in the Wall Street Journal, citing sources on a January investor call, revealed that Theranos has $200 million on hand, but zero revenue in 2015 and 2016. $200 million on hand sounds like–and is–a lot. But Theranos is, once again, oh so special. It’s less than 25 percent of their over $900 million raise. They’ve made no money in the past two years and are likely to make none in 2017 with an unapproved miniLab. Their CEO cannot run a lab by Federal action. They’ve laid off all but 200+ employees, all of whom with any shred of intelligence are job hunting. Then think of all the lawsuits: Walgreens Boots seeking to claw back its $140 million, individual and class actions on behalf of other investors, and the looming Arizona state fraud action. It’s a mere pittance when Theranos has to hire armies of attorneys who charge Billable Hours Galore and will likely lose some if not all of the lawsuits. This Editor is making an educated guess that at least one legal team is working on a bankruptcy filing. Fortune, TechCrunch, Business Insider

Forbes, like TechCrunch once a hyper-overdrive cheerleader for Ms Elizabeth Holmes and Theranos, offers up a profile of John P.A. Ioannidis, MD, DSC who holds the C.F. Rehnborg Chair in Disease at Stanford University and is director of the Stanford Prevention Research Center at the School of Medicine. Dr Ioannidis, according to the article, was the first to raise questions about Theranos’ methodology based on the obvious–that Theranos had published nothing in scientific journals. Theranos’ general counsel then reached out to suggest co-authoring an article with Ms Holmes in a major journal. Per Dr Ioannidis, it would support “the company view that FDA clearance offered the highest possible level of evidence for any diagnostics blood test technology.” They also said, “recant your existing views and writings about these misgivings.” He did neither, to his credit. The article interestingly does not explore the heat he, in as prestigious a position as he was, must have received, based on the close ties this Editor and others have noted between Stanford and Ms Holmes. Hat tip to Bill Oravecz of Stone Health Innovations

“This is the way the world ends/Not with a bang but a whimper.” T.S. Eliot puts a fine point on a Hollow Company, indeed.

See here for the 35 previous TTA chapters in this Continuing, Consistently Amazing Saga.

Possible early detection test for chronic traumatic encephalopathy (CTE)

April 6, 2015 | by

A research study published today in the Proceedings of the National Academy of Sciences (US) presents the results of screening 14 retired professional American football players with suspected CTE. Using a tau-sensitive brain imaging agent, [F-18]FDDNP, the California and Illinois-based researchers were able to detect the abnormal accumulation of tau and other proteins, in the distinct CTE pattern, in the brains of living subjects who had received, during their playing careers, multiple concussions and head trauma. Of the 14, one had been diagnosed with dementia, 12 with mild cognitive impairment and one with no symptoms. Previous studies, such as Robert Stern, MD‘s pathfinding research at Boston University and for the NFL (see below), have been primarily post-mortem on brains donated for research, although Dr Stern’s last presentation at NYC MedTech and Inga Koerte, MD of the Ludwig-Maximilians-Universität München (LMU) have also used brain scan information on live subjects in their studies.

Where this differs is that the imaging agent injected binds to the tau  (more…)